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Side Effects & Adverse Reactions
Diazepam is not recommended in the treatment of psychotic patients and should not be employed instead of appropriate treatment.
Since diazepam has a central nervous system depressant effect, patients should be advised against the simultaneous ingestion of alcohol and other CNS-depressant drugs during diazepam therapy.
As with other agents that have anticonvulsant activity, when diazepam is used as an adjunct in treating convulsive disorders, the possibility of an increase in the frequency and/or severity of grand mal seizures may require an increase in the dosage of standard anticonvulsant medication. Abrupt withdrawal of diazepam in such cases may also be associated with a temporary increase in the frequency and/or severity of seizures.
An increased risk of congenital malformations and other developmental abnormalities associated with the use of benzodiazepine drugs during pregnancy has been suggested. There may also be non-teratogenic risks associated with the use of benzodiazepines during pregnancy. There have been reports of neonatal flaccidity, respiratory and feeding difficulties, and hypothermia in children born to mothers who have been receiving benzodiazepines late in pregnancy. In addition, children born to mothers receiving benzodiazepines on a regular basis late in pregnancy may be at some risk of experiencing withdrawal symptoms during the postnatal period.
Diazepam has been shown to be teratogenic in mice and hamsters when given orally at daily doses of 100 mg/kg or greater (approximately eight times the maximum recommended human dose [MRHD = 1 mg/kg/day] or greater on a mg/m2 basis). Cleft palate and encephalopathy are the most common and consistently reported malformations produced in these species by administration of high, maternally toxic doses of diazepam during organogenesis. Rodent studies have indicated that prenatal exposure to diazepam doses similar to those used clinically can produce long-term changes in cellular immune responses, brain neurochemistry, and behavior.
In general, the use of diazepam in women of childbearing potential, and more specifically during known pregnancy, should be considered only when the clinical situation warrants the risk to the fetus. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients should also be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.
Special care must be taken when diazepam is used during labor and delivery, as high single doses may produce irregularities in the fetal heart rate and hypotonia, poor sucking, hypothermia, and moderate respiratory depression in the neonates. With newborn infants it must be remembered that the enzyme system involved in the breakdown of the drug is not yet fully developed (especially in premature infants).
Diazepam passes into breast milk. Breastfeeding is therefore not recommended in patients receiving diazepam.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Diazepam Tablets USP are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
In acute alcohol withdrawal, Diazepam Tablets USP may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Diazepam Tablets USP are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome.
Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.
The effectiveness of Diazepam Tablets USP in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
History
There is currently no drug history available for this drug.
Other Information
Diazepam Tablets USP are a benzodiazepine derivative. Chemically, diazepam, USP is 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one. It is a colorless to light yellow crystalline compound, and is insoluble in water. Its structural formula is:
C16H13ClN2O M.W. 284.75
Diazepam Tablets USP are available as 2 mg, 5 mg, and 10 mg tablets for oral administration and contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide; colorants: 5 mg only (D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6); 10 mg only (FD&C Blue No. 1 aluminum lake); magnesium stearate, microcrystalline cellulose, pregelatinized corn starch, and sodium starch glycolate.
Sources
Diazepam Manufacturers
- Remedyrepack Inc.
Diazepam | Remedyrepack Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS:
USUAL DAILY DOSE
Management of Anxiety Disorders and Relief of Symptoms of Anxiety
Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.
1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
- Lake Erie Medical Dba Quality Care Products Llc
Diazepam | Lake Erie Medical Dba Quality Care Products Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS:
USUAL DAILY DOSE
Management of Anxiety Disorders and Relief of Symptoms of Anxiety
Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.
1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
- A-s Medication Solutions Llc
Diazepam | A-s Medication Solutions Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - A-s Medication Solutions Llc
Diazepam | A-s Medication Solutions Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - A-s Medication Solutions Llc
Diazepam | A-s Medication Solutions Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Direct Rx
- U.s. Army Medical Research And Development Command (Mcmr-rcq-hr)
Diazepam | U.s. Army Medical Research And Development Command (mcmr-rcq-hr)
Administration of the Diazepam Autoinjector Pull off gray safety cap Place Black end on mid outer thigh Push hard until injector functions Withdraw after 10 seconds Dosage:Caution: Because the autoinjector automatically delivers a fixed dose of 10 mg of diazepam, it cannot be used in situations requiring lower total doses or those in which small incremental increases of diazepam are required.
The usual recommended dose in older children and adults ranges from 10 mg to 20 mg I.M. depending on the indication and its severity. The cumulative total dose and individual maximum dose for intramuscular administration will vary with the specific indication (See dosage for specific indications).
Intramuscular: When instructions are followed properly the Diazepam Autoinjector injects deeply into the muscle.
Intravenous Use: The Diazepam Autoinjector is not designed or intended for intravenous use.
Severe Anxiety Disorders and Symptoms of Anxiety:Usual Adult Dosage: 10 mg, I. M. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal: As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
Usual Adult Dosage: 10 mg, I. M. initially, then 10 mg in 3 to 4 hours, if necessary.
Endoscopic procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Usual Adult Dosage: 10 mg I. M., approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
Usual Adult Dosage: 10 mg, I. M., initially, then 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the I.V. route is preferred. However, if conditions preclude intravenous administration, the I.M. route may be used.
Usual Adult Dosage: 10 mg, initially. This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg. If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and re-administration should be made with this consideration.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Preoperative Medication: To relieve anxiety and tension. (if atropine, scopolamine or other premedications are desired, they must be administered in separate syringes).
Usual Adult Dosage: 10 mg, I.M. (preferred route), before surgery.
General:Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Management of Overdosage:Manifestations of diazepam overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of norepinephrine or metaraminol. Dialysis is of limited value.
Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazapine and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airways, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for resedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long term benzodiazepine users and in cyclic antidepressant overdosage. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
- Apotheca, Inc.
Diazepam | Apotheca, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed. Adjunctively for Relief of Skeletal Muscle Spasm 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated. PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated. - Stat Rx Usa Llc
Diazepam | Stat Rx Usa Llc
DOSAGE AND ADMINISTRATIONDosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Redpharm Drug Inc.
Diazepam | Redpharm Drug Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
Adults: Usual Daily Dose Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute AlcoholWithdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2 ½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated Children:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2 ½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Rebel Distributors Corp
Diazepam | Rebel Distributors Corp
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg I.M. or I.V., depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle.
Intravenous use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS). NOTE: Solution may appear colorless to light yellow.
USUAL ADULT
DOSAGE
DOSAGE RANGE
IN CHILDREN
(I.V. administration should be made slowly)Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal: As an
aid in symptomatic relief of acute
agitation, tremor, impending or
acute delirium tremens and
hallucinosis.
10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Titrate I.V. dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg I.V. may be given, particularly when concomitant narcotics are omitted. If I.V. cannot be used, 5 mg to 10 mg I.M. approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
5 mg to 10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg I.M. or I.V., slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the I.V. route is by far preferred. This injection should be administered slowly. However, if I.V. administration is impossible, the I.M. route may be used.
5 mg to 10 mg initially (I.V. preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg.
If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (I.V. preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow I.V. administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication: To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, I.M. (preferred route), before surgery.
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, I.V., within 5 to 10 minutes prior to the procedure.
- General Injectables And Vaccines, Inc.
Diazepam | General Injectables And Vaccines, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg IM or IV, depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam injection should be injected deeply into the muscle.
Intravenous Use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly IV, it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
RECOMMENDED DOSAGE FOR INJECTABLE DIAZEPAM (IV administration should be made slowly)
USUAL ADULT DOSAGE
DOSAGE RANGE IN CHILDREN
Moderate Anxiety Disorders and Symptoms of Anxiety
2mg to 5mg, IM or IV. Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5mg to 10mg, IM or IV. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal:
As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, and hallucinosis.
10mg, Im or IV initially, then 5mg to 10mg in 3 to 4 hours, if necessary.
Endoscopic Procedures:
Adjunctively, if apprehension, anxiety or acute stress reaction are present prior ot endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See PRECAUTIONS for peroral procedures.
Titrate IV dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10mg or less is adequate, but up to 20mg IV may be given, particularly when concomitant narcotics are omitted. If IV cannot be used, 5mg to 10mg IM approximately 30 minutes prior to the procedure.
Muscle Spasm:
Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome, or tetanus.
5mg to 10mg, IM or IV initially, then 5mg to 10mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1mg to 2mg IM or IV, slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5mg to 10mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the IV route is by far preferred. This injection should be administered slowly. However, if IV administration is impossible, the IM route may be used.
5mg to 10mg initially (IV preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30mg. If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration. Ext4reme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2mg to 0.5mg slowly every 2 to 5 minutes up to a maximum of 5mg (IV preferred). Children 5 years or older, 1mg every 2 to 5 minutes up to a maximum of 10mg (slow IV administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication:
To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
20mg, IM (preferred route), before surgery.
Cardioversion:
To relieve anxiety and tension and to reduce recall of procedure.
5mg to 15mg, IV, within 5 to 10 minutes prior to the procedure.
- Blenheim Pharmacal, Inc.
Diazepam | Blenheim Pharmacal, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Contract Pharmacy Services-pa
Diazepam | Contract Pharmacy Services-pa
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
Adults: Usual Daily Dose Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute AlcoholWithdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2 ½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated Children: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2 ½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Pd-rx Pharmaceuticals, Inc.
Diazepam | Sandoz Inc
For all indications, toxicities may warrant dosage adjustments [see Dosage and Administration (2.7)].
Administer in a facility equipped to manage possible complications (e.g. anaphylaxis).
2.1 Breast Cancer • For locally advanced or metastatic breast cancer after failure of prior chemotherapy, the recommended dose of Docetaxel Injection is 60 mg/m 2 to 100 mg/m 2 administered intravenously over 1 hour every 3 weeks. • For the adjuvant treatment of operable node-positive breast cancer, the recommended Docetaxel Injection dose is 75 mg/m 2 administered 1 hour after doxorubicin 50 mg/m 2 and cyclophosphamide 500 mg/m 2 every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematological toxicities [see Dosage and Administration (2.7)]. 2.2 Non-Small Cell Lung Cancer • For treatment after failure of prior platinum-based chemotherapy, docetaxel was evaluated as monotherapy, and the recommended dose is 75 mg/m 2 administered intravenously over 1 hour every 3 weeks. A dose of 100 mg/m 2 in patients previously treated with chemotherapy was associated with increased hematologic toxicity, infection, and treatment-related mortality in randomized, controlled trials [see Boxed Warning, Dosage and Administration (2.7), Warnings and Precautions (5), Clinical Studies (14)]. • For chemotherapy-naïve patients, docetaxel was evaluated in combination with cisplatin. The recommended dose of Docetaxel Injection is 75 mg/m 2 administered intravenously over 1 hour immediately followed by cisplatin 75 mg/m 2 over 30-60 minutes every 3 weeks [see Dosage and Administration (2.7)]. 2.3 Prostate Cancer • For hormone-refractory metastatic prostate cancer, the recommended dose of Docetaxel Injection is 75 mg/m 2 every 3 weeks as a 1 hour intravenous infusion. Prednisone 5 mg orally twice daily is administered continuously [ see Dosage and Administration (2.7)]. 2.4 Gastric Adenocarcinoma • For gastric adenocarcinoma, the recommended dose of Docetaxel Injection is 75 mg/m 2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m 2, as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m 2 per day given as a 24-hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration [see Dosage and Administration (2.7)]. 2.5 Head and Neck CancerPatients must receive premedication with antiemetics, and appropriate hydration (prior to and after cisplatin administration). Prophylaxis for neutropenic infections should be administered. All patients treated on the docetaxel containing arms of the TAX323 and TAX324 studies received prophylactic antibiotics.
• Induction chemotherapy followed by radiotherapy (TAX323)For the induction treatment of locally advanced inoperable SCCHN, the recommended dose of Docetaxel Injection is 75 mg/m2 as a 1 hour intravenous infusion followed by cisplatin 75 mg/m2 intravenously over 1 hour, on day one, followed by fluorouracil as a continuous intravenous infusion at 750 mg/m2 per day for five days. This regimen is administered every 3 weeks for 4 cycles. Following chemotherapy, patients should receive radiotherapy. [see Dosage and Administration (2.7)].
• Induction chemotherapy followed by chemoradiotherapy (TAX324)For the induction treatment of patients with locally advanced (unresectable, low surgical cure, or organ preservation) SCCHN, the recommended dose of Docetaxel Injection is 75 mg/m2 as a 1 hour intravenous infusion on day 1, followed by cisplatin 100 mg/m2 administered as a 30-minute to 3 hour infusion, followed by fluorouracil 1000 mg/m2/day as a continuous infusion from day 1 to day 4. This regimen is administered every 3 weeks for 3 cycles. Following chemotherapy, patients should receive chemoradiotherapy [see Dosage and Administration (2.7)].
2.6 Premedication RegimenAll patients should be premedicated with oral corticosteroids (see below for prostate cancer) such as dexamethasone 16 mg per day (e.g., 8 mg twice daily) for 3 days starting 1 day prior to Docetaxel Injection administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions [see Boxed Warning, Warnings and Precautions (5.4)].
For hormone-refractory metastatic prostate cancer, given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours and 1 hour before the Docetaxel Injection infusion [see Warnings and Precautions (5.4)].
2.7 Dosage Adjustments During TreatmentBreast Cancer
Patients who are dosed initially at 100 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, or severe or cumulative cutaneous reactions during Docetaxel Injection therapy should have the dosage adjusted from 100 mg/m2 to 75 mg/m2. If the patient continues to experience these reactions, the dosage should either be decreased from 75 mg/m2 to 55 mg/m2 or the treatment should be discontinued. Conversely, patients who are dosed initially at 60 mg/m2 and who do not experience febrile neutropenia, neutrophils <500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during Docetaxel Injection therapy may tolerate higher doses. Patients who develop ≥grade 3 peripheral neuropathy should have Docetaxel Injection treatment discontinued entirely.
Combination Therapy with Docetaxel Injection in the Adjuvant Treatment of Breast Cancer
Docetaxel Injection in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is ≥1,500 cells/mm3. Patients who experience febrile neutropenia should receive G-CSF in all subsequent cycles. Patients who continue to experience this reaction should remain on G-CSF and have their Docetaxel Injection dose reduced to 60 mg/ m2. Patients who experience grade 3 or 4 stomatitis should have their Docetaxel Injection dose decreased to 60 mg/ m2. Patients who experience severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during Docetaxel Injection therapy should have their dosage of Docetaxel Injection reduced from 75 mg/m2 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/ m2, treatment should be discontinued.
Non-Small Cell Lung Cancer
Monotherapy with Docetaxel Injection for NSCLC treatment after failure of prior platinum-based chemotherapy
Patients who are dosed initially at 75 mg/m2 and who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or other grade 3/4 non-hematological toxicities during Docetaxel Injection treatment should have treatment withheld until resolution of the toxicity and then resumed at 55 mg/m2. Patients who develop ≥grade 3 peripheral neuropathy should have Docetaxel Injection treatment discontinued entirely.
Combination therapy with Docetaxel Injection for chemotherapy-naïve NSCLC
For patients who are dosed initially at Docetaxel Injection 75 mg/m2 in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is <25,000 cells/mm3, in patients who experience febrile neutropenia, and in patients with serious non-hematologic toxicities, the Docetaxel Injection dosage in subsequent cycles should be reduced to 65 mg/m2. In patients who require a further dose reduction, a dose of 50 mg/m2 is recommended. For cisplatin dosage adjustments, see manufacturers' prescribing information.
Prostate Cancer
Combination therapy with Docetaxel Injection for hormone-refractory metastatic prostate cancer
Docetaxel Injection should be administered when the neutrophil count is ≥1,500 cells/mm3. Patients who experience either febrile neutropenia, neutrophils <500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during Docetaxel Injection therapy should have the dosage of Docetaxel Injection reduced from 75 mg/m2 to 60 mg/ m2. If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.
Gastric or Head and Neck Cancer
Docetaxel Injection in combination with cisplatin and fluorouracil in gastric cancer or head and neck cancer
Patients treated with Docetaxel Injection in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In both studies, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days. If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the Docetaxel Injection dose should be reduced from 75 mg/m2 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur the Docetaxel Injection dose should be reduced from 60 mg/m2 to 45 mg/m2. In case of grade 4 thrombocytopenia the Docetaxel Injection dose should be reduced from 75 mg/m2 to 60 mg/m2. Patients should not be retreated with subsequent cycles of Docetaxel Injection until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3. Discontinue treatment if these toxicities persist [see Warnings and Precautions (5.3)].
Recommended dose modifications for toxicities in patients treated with Docetaxel Injection in combination with cisplatin and fluorouracil are shown in Table 1.
Table 1 Recommended Dose Modifications for Toxicities in Patients Treated with Docetaxel Injection in Combination with Cisplatin and Fluorouracil
Toxicity
Dosage adjustment
Diarrhea grade 3
First episode: reduce fluorouracil dose by 20%.
Second episode: then reduce Docetaxel Injection dose by 20%.
Diarrhea grade 4
First episode: reduce Docetaxel Injection and fluorouracil doses by 20%.
Second episode: discontinue treatment.
Stomatitis/mucositis grade 3
First episode: reduce fluorouracil dose by 20%.
Second episode: stop fluorouracil only, at all subsequent cycles.
Third episode: reduce Docetaxel Injection dose by 20%.
Stomatitis/mucositis grade 4
First episode: stop fluorouracil only, at all subsequent cycles.
Second episode: reduce Docetaxel Injection dose by 20%.
Liver dysfunction:
In case of AST/ALT >2.5 to ≤5 × ULN and AP ≤2.5 × ULN, or AST/ALT >1.5 to ≤5 × ULN and AP >2.5 to ≤5 × ULN, Docetaxel Injection should be reduced by 20%.
In case of AST/ALT >5 × ULN and/or AP >5 × ULN Docetaxel Injection should be stopped.
The dose modifications for cisplatin and fluorouracil in the gastric cancer study are provided below:
Cisplatin dose modifications and delays
Peripheral neuropathy: A neurological examination should be performed before entry into the study, and then at least every 2 cycles and at the end of treatment. In the case of neurological signs or symptoms, more frequent examinations should be performed and the following dose modifications can be made according to NCIC-CTC grade:
• Grade 2: Reduce cisplatin dose by 20%. • Grade 3: Discontinue treatment.Ototoxicity: In the case of grade 3 toxicity, discontinue treatment.
Nephrotoxicity: In the event of a rise in serum creatinine ≥grade 2 (>1.5 × normal value) despite adequate rehydration, CrCl should be determined before each subsequent cycle and the following dose reductions should be considered (see Table 2).
For other cisplatin dosage adjustments, also refer to the manufacturers’ prescribing information.
Table 2 Dose Reductions for Evaluation of Creatinine Clearance
Creatinine clearance result before next cycle
Cisplatin dose next cycle
CrCl ≥60 mL/min
Full dose of cisplatin was given. CrCl was to be repeated before each treatment cycle.
CrCl between 40 and 59 mL/min
Dose of cisplatin was reduced by 50% at subsequent cycle. If CrCl was >60 mL/min at end of cycle, full cisplatin dose was reinstituted at the next cycle.
If no recovery was observed, then cisplatin was omitted from the next treatment cycle.
CrCl <40 mL/min
Dose of cisplatin was omitted in that treatment cycle only.
If CrCl was still <40 mL/min at the end of cycle, cisplatin was discontinued.
If CrCl was >40 and <60 mL/min at end of cycle, a 50% cisplatin dose was given at the next cycle.
If CrCl was >60 mL/min at end of cycle, full cisplatin dose was given at next cycle
CrCl = Creatinine clearance
Fluorouracil dose modifications and treatment delays
For diarrhea and stomatitis, see Table 1.
In the event of grade 2 or greater plantar-palmar toxicity, fluorouracil should be stopped until recovery. The fluorouracil dosage should be reduced by 20%.
For other greater than grade 3 toxicities, except alopecia and anemia, chemotherapy should be delayed (for a maximum of 2 weeks from the planned date of infusion) until resolution to grade ≤1 and then recommenced, if medically appropriate.
For other fluorouracil dosage adjustments, also refer to the manufacturers’ prescribing information.
Combination Therapy with Strong CYP3A4 inhibitors:
Avoid using concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole). There are no clinical data with a dose adjustment in patients receiving strong CYP3A4 inhibitors. Based on extrapolation from a pharmacokinetic study with ketoconazole in 7 patients, consider a 50% Docetaxel Injection dose reduction if patients require co-administration of a strong CYP3A4 inhibitor [see Drug Interactions (7), Clinical Pharmacology (12.3)].
2.8 Administration PrecautionsDocetaxel Injection is a cytotoxic anticancer drug and, as with other potentially toxic compounds, caution should be exercised when handling and preparing Docetaxel Injection solutions. The use of gloves is recommended. Please refer to [see How Supplied/Storage and Handling (16.3)].
If Docetaxel Injection or diluted solution for intravenous infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. If Docetaxel Injection or diluted solution for intravenous infusion should come into contact with mucosa, immediately and thoroughly wash with water.
Contact of the Docetaxel Injection with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP (di-2-ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, the final Docetaxel Injection dilution for infusion should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
Docetaxel Injection requires dilution prior to administration. Please follow the preparation instructions provided below.
2.9 Preparation and AdministrationDocetaxel Injection (10 mg/mL) requires NO prior dilution with a diluent and is ready to add to the infusion solution.
Dilution for Infusion
1. Aseptically withdraw the required amount of Docetaxel Injection solution (10 mg docetaxel /mL) with a calibrated syringe and inject (as a single injection) into a 250 mL infusion bag or bottle of either 0.9% Sodium Chloride solution or 5% Dextrose solution to produce a final concentration of 0.3 to 0.74 mg/ mL. If a dose greater than 200 mg of Docetaxel Injection is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL Docetaxel Injection is not exceeded. 2. Thoroughly mix the infusion bag or bottle manually by gentle inversion and rotation in a controlled manner and avoid foaming. Shaking or vigorous agitation should be avoided during preparation and transportation to the patient for administration. 3. As with all parenteral products, Docetaxel Injection should be inspected visually for particulate matter or discoloration prior to administration whenever the solution and container permit. If the Docetaxel Injection vial or diluted solution is not clear or appears to have precipitation, these should be discarded.The Docetaxel Injection diluted solution for infusion should be administered intravenously as a 1-hour infusion under ambient room temperature below 25°C (77°F) and lighting conditions.
2.10 StabilityDocetaxel Injection infusion solution, if stored between 2°C and 25°C (36°F and 77°F) is stable for 4 hours in either 0.9% Sodium Chloride solution or 5% Dextrose solution. Use within 4 hours including storage and administration. Do not freeze infusion solution.
- Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
- General Injectables And Vaccines, Inc.
Diazepam | General Injectables And Vaccines, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg I.M. or I.V., depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle.
Intravenous use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS). NOTE: Solution may appear colorless to light yellow.
(I.V. administration should be made slowly.
USUAL ADULT DOSAGE
DOSAGE RANGE IN CHILDREN
Moderate Anxiety Disorders and Symptoms of Anxiety
2mg to 5mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary
Severe Anxiety Disorders and Symptoms of Anxiety
5mg to 10mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary
Acute Alcohol Withdrawal: As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
10mg, I.M. or I.V. initially, then 5mg to 10mg in 3 to 4 hours, if necessary
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Titrate I.V. dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10mg or less is adequate, but up to 20mg I.V. may be given, particularly when concomitant narcotics are omitted. If. I.V. cannot be used 5mg to 10mg I.M. approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
5mg to 10mg, I.M. or I.V. initially, then 5mg to 10mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1mg to 2mg I.M. or I.V., slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5mg to 10mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent convulsive Seizures: In the convulsing patient, the I.V. route is by far preferred. This injection should be administered slowly. However, if I.V. administration is impossible, the I.M. route may be used.
5mg to 10mg initially (I.V. preferred. This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg. If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration. Extreme cautions must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2mg to 0.5mg slowly every 2 to 5 minutes up to a maximum of 5mg (I.V. preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 20mg (slow I.V. administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication: To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10mg, I.M. (preferred route), before surgery
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure
5mg to 15mg, I.V., within 5 to 10 minutes prior to the procedure.
- Stat Rx Usa Llc
Diazepam | Stat Rx Usa Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief
of Symptoms of Anxiety Depending upon severity of symptoms - 2mg
to 10 mg, 2 or 4 times daily Symptomatic Relief in Acute Alcohol
Withdrawal 10 mg, 3 or 4 times during the first 24 hours,
reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle
Spasm 2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of
debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially;
increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting
drugs, initiate therapy with lowest dose and
increase as required. Not for use in pediatric
patients under 6 months 1 mg to 2.5 mg, 3 or 4 times daily initially;
increase gradually as needed and tolerated - Cardinal Health
Diazepam | Cardinal Health
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially increase gradually as needed and tolerated - Physicians Total Care, Inc.
Diazepam | Physicians Total Care, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg I.M. or I.V., depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle.
Intravenous use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS). NOTE: Solution may appear colorless to light yellow.
USUAL ADULT
DOSAGE
DOSAGE RANGE
IN CHILDREN
(I.V. administration should be made slowly)Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal: As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Titrate I.V. dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg I.V. may be given, particularly when concomitant narcotics are omitted. If I.V. cannot be used, 5 mg to 10 mg I.M. approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
5 mg to 10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg I.M. or I.V., slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the I.V. route is by far preferred. This injection should be administered slowly. However, if I.V. administration is impossible, the I.M. route may be used.
5 mg to 10 mg initially (I.V. preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg.
If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (I.V. preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow I.V. administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication: To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, I.M. (preferred route), before surgery.
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, I.V., within 5 to 10 minutes prior to the procedure.
- Unit Dose Services
Diazepam | Unit Dose Services
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Pd-rx Pharmaceuticals, Inc.
Diazepam | Pd-rx Pharmaceuticals, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating
disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Mckesson Contract Packaging
- Pd-rx Pharmaceuticals, Inc.
Diazepam | Pd-rx Pharmaceuticals, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating
disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Physicians Total Care, Inc.
Diazepam | Physicians Total Care, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Bryant Ranch Prepack
Diazepam | Bryant Ranch Prepack
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Bryant Ranch Prepack
- Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Diazepam | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating
disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Lake Erie Medical Dba Quality Care Products Llc
- Bryant Ranch Prepack
- Aphena Pharma Solutions – Tennessee, Llc
Diazepam | Aphena Pharma Solutions - Tennessee, Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - A-s Medication Solutions Llc
Diazepam | A-s Medication Solutions Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - A-s Medication Solutions Llc
Diazepam | A-s Medication Solutions Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Unit Dose Services
- A-s Medication Solutions Llc
Diazepam | A-s Medication Solutions Llc
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg I.M. or I.V., depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle.
Intravenous use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS). NOTE: Solution may appear colorless to light yellow.
USUAL ADULT
DOSAGE
DOSAGE RANGE
IN CHILDREN
(I.V. administration should be made slowly)
Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal: As an
aid in symptomatic relief of acute
agitation, tremor, impending or
acute delirium tremens and
hallucinosis.
10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Titrate I.V. dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg I.V. may be given, particularly when concomitant narcotics are omitted. If I.V. cannot be used, 5 mg to 10 mg I.M. approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
5 mg to 10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg I.M. or I.V., slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the I.V. route is by far preferred. This injection should be administered slowly. However, if I.V. administration is impossible, the I.M. route may be used.
5 mg to 10 mg initially (I.V. preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg.
If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (I.V. preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow I.V. administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication: To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, I.M. (preferred route), before surgery.
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, I.V., within 5 to 10 minutes prior to the procedure.
MANAGEMENT OF OVERDOSAGE
Manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of norepinephrine or metaraminol. Dialysis is of limited value.
Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
- Remedyrepack Inc.
Diazepam | Remedyrepack Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief
of Symptoms of Anxiety Depending upon severity of symptoms - 2mg
to 10 mg, 2 or 4 times daily Symptomatic Relief in Acute Alcohol
Withdrawal 10 mg, 3 or 4 times during the first 24 hours,
reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle
Spasm 2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of
debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially;
increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting
drugs, initiate therapy with lowest dose and
increase as required. Not for use in pediatric
patients under 6 months 1 mg to 2.5 mg, 3 or 4 times daily initially;
increase gradually as needed and tolerated - Preferred Pharmaceuticals, Inc
- Dispensing Solutions, Inc.
Diazepam | Dispensing Solutions, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating
disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Dispensing Solutions, Inc.
Diazepam | Dispensing Solutions, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Dispensing Solutions, Inc.
Diazepam | Dispensing Solutions, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Cardinal Health
Diazepam | Cardinal Health
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms - 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal.10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease.2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Aidarex Pharmaceuticals Llc
Diazepam | Aidarex Pharmaceuticals Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Mylan Institutional Inc.
Diazepam | Mylan Institutional Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief
of Symptoms of Anxiety Depending upon severity of symptoms - 2mg
to 10 mg, 2 or 4 times daily Symptomatic Relief in Acute Alcohol
Withdrawal 10 mg, 3 or 4 times during the first 24 hours,
reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle
Spasm 2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of
debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially;
increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting
drugs, initiate therapy with lowest dose and
increase as required. Not for use in pediatric
patients under 6 months 1 mg to 2.5 mg, 3 or 4 times daily initially;
increase gradually as needed and tolerated - Mckesson Packaging Services Business Unit Of Mckesson Corporation
Diazepam | Mckesson Packaging Services Business Unit Of Mckesson Corporation
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS:
USUAL DAILY DOSE:
Management of Anxiety Disorders and relief of Symptoms of Anxiety.
Depending on severity of symptoms - 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal.
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm.
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders.
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease.
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months.
1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
- Ivax Pharmaceuticals, Inc.
Diazepam | Sandoz Inc
The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.
Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient, therefore it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with oxacillin should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer term of therapy.
Concurrent administration of oxacillin and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (See PRECAUTIONS: General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.
Recommended Dosages for Oxacillin Sodium for Injection, USPIn ADD-Vantage® System: For Intravenous Use Only
Adults: 1 to 6 grams per 24-hour period.
NOTE: For doses smaller than 1 gram use the conventional vial. Insert for conventional vial lists dosages for infants and children.
Directions for useOxacillin for Injection Vials in the ADD-Vantage® Drug Delivery System are for intravenous use only and are to be used with ADDVantage® diluent containers of 0.9% Sodium Chloride Injection, USP, 50 mL and 100 mL, or 5% Dextrose Injection, USP, 50 mL and 100 mL.
Reconstitute ADD-Vantage® vials as directed in the INSTRUCTIONS FOR USE section.
Only 0.9% Sodium Chloride Injection, USP, and 5% Dextrose Injection, USP, are available for use in the ADD-Vantage® Delivery System for intravenous infusion of Oxacillin Sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use.
If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.
INSTRUCTIONS FOR USETo Open Diluent Container:
Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
1. Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1), then pull straight up to remove the cap. (SEE FIGURE 2.)
NOTE: Do not access vial with syringe.
b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.) 2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once vial is seated, do not attempt to remove. (SEE FIGURE 4.) 3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly. 4. Label appropriately.To Prepare Admixture:
1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial. 2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.) 3. Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix. 4. Mix container contents thoroughly and use within the specified time.Preparation for Administration:
(Use Aseptic Technique)
1. Confirm the activation and admixture of vial contents. 2. Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired. 3. Close flow control clamp of administration set. 4. Remove cover from outlet port at bottom of container. 5. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
NOTE: See full directions on administration set carton. 6. Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger. 7. Squeeze and release drip chamber to establish proper fluid level in chamber. 8. Open flow control clamp and clear air from set. Close clamp. 9. Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture. 10. Regulate rate of administration with flow control clamp.WARNING: Do not use flexible container in series connections.
At concentrations ranging from 10 to 40 mg/mL in 0.9% Sodium Chloride Injection, USP, Oxacillin will have utility times of 4 days at room temperature (25°C).
In 5% Dextrose Injection, USP, at concentrations from 10 to 40 mg/mL Oxacillin will have utility times of 6 hours at room temperature (25°C).
- Qualitest Pharmaceuticals
Diazepam | Qualitest Pharmaceuticals
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Kaiser Foundation Hospitals
Diazepam | Kaiser Foundation Hospitals
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Hospira, Inc.
Diazepam | Hospira, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg I.M. or I.V., depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle.
Intravenous use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS). NOTE: Solution may appear colorless to light yellow.
USUAL ADULT DOSAGE
DOSAGE RANGE IN CHILDREN
(I.V. administration should be made slowly)
Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal: As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Titrate I.V. dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg I.V. may be given, particularly when concomitant narcotics are omitted. If I.V. cannot be used, 5 mg to 10 mg I.M. approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
5 mg to 10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg I.M. or I.V., slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the I.V. route is by far preferred. This injection should be administered slowly. However, if I.V. administration is impossible, the I.M. route may be used.
5 mg to 10 mg initially (I.V. preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg.
If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (I.V. preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow I.V. administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication: To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, I.M. (preferred route), before surgery.
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, I.V., within 5 to 10 minutes prior to the procedure.
MANAGEMENT OF OVERDOSAGE
Manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of norepinephrine or metaraminol. Dialysis is of limited value.
Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
- Hospira, Inc.
Diazepam | Hospira, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg I.M. or I.V., depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle.
Intravenous use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS). NOTE: Solution may appear colorless to light yellow.
USUAL ADULT DOSAGE
DOSAGE RANGE IN CHILDREN
(I.V. administration should be made slowly)
Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal: As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Titrate I.V. dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg I.V. may be given, particularly when concomitant narcotics are omitted. If I.V. cannot be used, 5 mg to 10 mg I.M. approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
5 mg to 10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg I.M. or I.V., slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the I.V. route is by far preferred. This injection should be administered slowly. However, if I.V. administration is impossible, the I.M. route may be used.
5 mg to 10 mg initially (I.V. preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg.
If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (I.V. preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow I.V. administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication: To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, I.M. (preferred route), before surgery.
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, I.V., within 5 to 10 minutes prior to the procedure.
MANAGEMENT OF OVERDOSAGE
Manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of norepinephrine or metaraminol. Dialysis is of limited value.
Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
- Hospira, Inc.
Diazepam | Hospira, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg IM or IV, depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam injection should be injected deeply into the muscle.
Intravenous Use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly IV, it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
RECOMMENDED DOSAGE FOR INJECTABLE DIAZEPAMUSUAL ADULT DOSAGE
DOSAGE RANGE IN CHILDREN
(IV administration should be made slowly)Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, IM or IV Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, IM or IV. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal:
As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, and hallucinosis.
10 mg, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures:
Adjunctively, if apprehension, anxiety or acute stress reaction are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See PRECAUTIONS for peroral procedures.
Titrate IV dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg IV may be given, particularly when concomitant narcotics are omitted. If IV cannot be used, 5 mg to10 mg IM approximately 30 minutes prior to the procedure.
Muscle Spasm
Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome, or tetanus.
5 mg to 10 mg, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg IM or IV, slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures:
In the convulsing patient, the IV route is by far preferred. This injection should be administered slowly. However, if IV administration is impossible, the IM route may be used.
5 mg to 10 mg initially (IV preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg. If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration. Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (IV preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow IV administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication
To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, IM (preferred route), before surgery.
Cardioversion
To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, IV, within 5 to 10 minutes prior to the procedure.
- Hospira, Inc.
Diazepam | Hospira, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg IM or IV, depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam injection should be injected deeply into the muscle.
Intravenous Use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly IV, it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
RECOMMENDED DOSAGE FOR INJECTABLE DIAZEPAMUSUAL ADULT DOSAGE
DOSAGE RANGE IN CHILDREN
(IV administration should be made slowly)
Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, IM or IV Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, IM or IV. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal:
As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, and hallucinosis.
10 mg, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures:
Adjunctively, if apprehension, anxiety or acute stress reaction are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See PRECAUTIONS for peroral procedures.
Titrate IV dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg IV may be given, particularly when concomitant narcotics are omitted. If IV cannot be used, 5 mg to10 mg IM approximately 30 minutes prior to the procedure.
Muscle Spasm
Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome, or tetanus.
5 mg to 10 mg, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg IM or IV, slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures:
In the convulsing patient, the IV route is by far preferred. This injection should be administered slowly. However, if IV administration is impossible, the IM route may be used.
5 mg to 10 mg initially (IV preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg. If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration. Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (IV preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow IV administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication
To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, IM (preferred route), before surgery.
Cardioversion
To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, IV, within 5 to 10 minutes prior to the procedure.
- Direct Rx
- Watson Laboratories, Inc.
Diazepam | Lupin Pharmaceuticals, Inc.
Adult Hypertensive PatientsLosartan potassium tablets may be administered with other antihypertensive agents, and with or without food.
Dosing must be individualized. The usual starting dose of losartan potassium tablets is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) (see WARNINGS, Hypotension — Volume-Depleted Patients ) and patients with a history of hepatic impairment (see PRECAUTIONS, General). Losartan potassium tablets can be administered once or twice daily with total daily doses ranging from 25 mg to 100 mg.
If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response. The effect of losartan is substantially present within one week but in some studies the maximal effect occurred in 3-6 weeks (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).
If blood pressure is not controlled by losartan potassium tablets alone, a low dose of a diuretic may be added. Hydrochlorothiazide has been shown to have an additive effect (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Hypertension).
No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients on dialysis.
Pediatric Hypertensive Patients greater than or equal to 6 years of age
The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension (see Preparation of Suspension). Dosage should be adjusted according to blood pressure response. Doses above 1.4 mg/kg (or in excess of 100 mg) daily have not been studied in pediatric patients. (See CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations and Pharmacodynamics and Clinical Effects, and WARNINGS, Hypotension — Volume-Depleted Patients.)
Losartan potassium tablets are not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m2 (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Special Populations, Pharmacodynamics and Clinical Effects, and PRECAUTIONS).
Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension)
Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-PlusTM** and Ora-Sweet SF TM** .Add 190 mL of the 50/50 OraPlus TM/Ora-Sweet SF TM** mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2-8°C (36-46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
Hypertensive Patients with Left Ventricular HypertrophyThe usual starting dose is 50 mg of losartan potassium tablets once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium tablets should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Reduction in the Risk of Stroke).
Nephropathy in Type 2 Diabetic PatientsThe usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Nephropathy in Type 2 Diabetic Patients). Losartan potassium tablets may be administered with insulin and other commonly used hypoglycemic agents (e.g., sulfonylureas, glitazones and glucosidase inhibitors).
- Aphena Pharma Solutions – Tennessee, Llc
Diazepam | Aphena Pharma Solutions - Tennessee, Llc
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and Relief of Symptoms of Anxiety. Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease. 2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Cardinal Health
Diazepam | Cardinal Health
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS:
USUAL DAILY DOSE:
Management of Anxiety Disorders and Relief
of Symptoms of AnxietyDepending upon severity of symptoms - 2mg
to 10 mg, 2 or 4 times dailySymptomatic Relief in Acute Alcohol
Withdrawal10 mg, 3 or 4 times during the first 24 hours,
reducing to 5 mg, 3 or 4 times daily as neededAdjunctively for Relief of Skeletal Muscle
Spasm2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of
debilitating disease2 mg to 2.5 mg, 1 or 2 times daily initially;
increase gradually as needed and toleratedPEDIATRIC PATIENTS:
Because of varied responses to CNS-acting
drugs, initiate therapy with lowest dose and
increase as required. Not for use in pediatric
patients under 6 months1 mg to 2.5 mg, 3 or 4 times daily initially;
increase gradually as needed and tolerated - Cardinal Health
Diazepam | Cardinal Health
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg IM or IV, depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam injection should be injected deeply into the muscle.
Intravenous Use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly IV, it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
RECOMMENDED DOSAGE FOR INJECTABLE DIAZEPAMUSUAL ADULT DOSAGE
DOSAGE RANGE IN CHILDREN
(IV administration should be made slowly)
Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, IM or IV Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, IM or IV. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal:
As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens, and hallucinosis.
10 mg, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures:
Adjunctively, if apprehension, anxiety or acute stress reaction are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See PRECAUTIONS for peroral procedures.
Titrate IV dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg IV may be given, particularly when concomitant narcotics are omitted. If IV cannot be used, 5 mg to10 mg IM approximately 30 minutes prior to the procedure.
Muscle Spasm
Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome, or tetanus.
5 mg to 10 mg, IM or IV initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg IM or IV, slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures:
In the convulsing patient, the IV route is by far preferred. This injection should be administered slowly. However, if IV administration is impossible, the IM route may be used.
5 mg to 10 mg initially (IV preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg. If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration. Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (IV preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow IV administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication
To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, IM (preferred route), before surgery.
Cardioversion
To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, IV, within 5 to 10 minutes prior to the procedure.
- Hospira, Inc.
Diazepam | Hospira, Inc.
Dosage should be individualized for maximum beneficial effect. The usual recommended dose in older children and adults ranges from 2 mg to 20 mg I.M. or I.V., depending on the indication and its severity. In some conditions, e.g., tetanus, larger doses may be required. (See dosage for specific indications.) In acute conditions the injection may be repeated within one hour although an interval of 3 to 4 hours is usually satisfactory. Lower doses (usually 2 mg to 5 mg) and slow increase in dosage should be used for elderly or debilitated patients and when other sedative drugs are administered. (See WARNINGS and ADVERSE REACTIONS.)
For dosage in infants above the age of 30 days and children, see the specific indications below. When intravenous use is indicated, facilities for respiratory assistance should be readily available.
Intramuscular: Diazepam Injection, USP should be injected deeply into the muscle.
Intravenous use: (See WARNINGS, particularly for use in children.) The solution should be injected slowly, taking at least one minute for each 5 mg (1 mL) given. Do not use small veins, such as those on the dorsum of the hand or wrist. Extreme care should be taken to avoid intra-arterial administration or extravasation.
Do not mix or dilute diazepam with other solutions or drugs in syringe or infusion flask. If it is not feasible to administer diazepam directly I.V., it may be injected slowly through the infusion tubing as close as possible to the vein insertion.
Once the acute symptomatology has been properly controlled with diazepam injection, the patient may be placed on oral therapy with diazepam if further treatment is required.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit (see PRECAUTIONS). NOTE: Solution may appear colorless to light yellow.
USUAL ADULT
DOSAGE
DOSAGE RANGE
IN CHILDREN
(I.V. administration should be made slowly)
Moderate Anxiety Disorders and Symptoms of Anxiety
2 mg to 5 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Severe Anxiety Disorders and Symptoms of Anxiety
5 mg to 10 mg, I.M. or I.V. Repeat in 3 to 4 hours, if necessary.
Acute Alcohol Withdrawal: As an aid in symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary.
Endoscopic Procedures: Adjunctively, if apprehension, anxiety or acute stress reactions are present prior to endoscopic procedures. Dosage of narcotics should be reduced by at least a third and in some cases may be omitted. See Precautions for peroral procedures.
Titrate I.V. dosage to desired sedative response, such as slurring of speech, with slow administration immediately prior to the procedure. Generally 10 mg or less is adequate, but up to 20 mg I.V. may be given, particularly when concomitant narcotics are omitted. If I.V. cannot be used, 5 mg to 10 mg I.M. approximately 30 minutes prior to the procedure.
Muscle Spasm: Associated with local pathology, cerebral palsy, athetosis, stiff-man syndrome or tetanus.
5 mg to 10 mg, I.M. or I.V. initially, then 5 mg to 10 mg in 3 to 4 hours, if necessary. For tetanus, larger doses may be required.
For tetanus in infants over 30 days of age, 1 mg to 2 mg I.M. or I.V., slowly, repeated every 3 to 4 hours as necessary. In children 5 years or older, 5 mg to 10 mg repeated every 3 to 4 hours may be required to control tetanus spasms. Respiratory assistance should be available.
Status Epilepticus and Severe Recurrent Convulsive Seizures: In the convulsing patient, the I.V. route is by far preferred. This injection should be administered slowly. However, if I.V. administration is impossible, the I.M. route may be used.
5 mg to 10 mg initially (I.V. preferred). This injection may be repeated if necessary at 10 to 15 minute intervals up to a maximum dose of 30 mg.
If necessary, therapy with diazepam may be repeated in 2 to 4 hours; however, residual active metabolites may persist, and readministration should be made with this consideration.
Extreme caution must be exercised with individuals with chronic lung disease or unstable cardiovascular status.
Infants over 30 days of age and children under 5 years, 0.2 mg to 0.5 mg slowly every 2 to 5 minutes up to a maximum of 5 mg (I.V. preferred). Children 5 years or older, 1 mg every 2 to 5 minutes up to a maximum of 10 mg (slow I.V. administration preferred). Repeat in 2 to 4 hours if necessary. EEG monitoring of the seizure may be helpful.
Preoperative Medication: To relieve anxiety and tension. (If atropine, scopolamine or other premedications are desired, they must be administered in separate syringes.)
10 mg, I.M. (preferred route), before surgery.
Cardioversion: To relieve anxiety and tension and to reduce recall of procedure.
5 mg to 15 mg, I.V., within 5 to 10 minutes prior to the procedure.
MANAGEMENT OF OVERDOSAGE
Manifestations of diazepam overdosage include somnolence, confusion, coma, and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal. General supportive measures should be employed, along with intravenous fluids, and an adequate airway maintained. Hypotension may be combated by the use of norepinephrine or metaraminol. Dialysis is of limited value.
Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.
- Mylan Pharmaceuticals Inc.
Diazepam | Mylan Pharmaceuticals Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS:
USUAL DAILY DOSE:
Management of Anxiety Disorders and Relief of Symptoms of Anxiety
Depending upon severity of symptoms—2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months
1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
- Cardinal Health
- Cardinal Health
Diazepam | Direct Rx
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
Anxiety Disorders and Transient Symptoms of Anxiety
Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
Panic Disorder
The successful treatment of many panic disorder patients has required the use of alprazolam at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.
Dose Titration
Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.
Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.
Dose Maintenance
For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE.)
The necessary duration of treatment for panic disorder patients responding to alprazolam is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.
Dose Reduction
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).
In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.
In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.
Dosing in Special Populations
In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.
- Bryant Ranch Prepack
- Tya Pharmaceuticals
Diazepam | Tya Pharmaceuticals
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE Management of Anxiety Disorders and Relief of Symptoms of Anxiety Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating disease 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Tya Pharmaceuticals
Diazepam | Tya Pharmaceuticals
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute AlcoholWithdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily or in the presence of debilitating disease. Geriatric Patients,
2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - Preferred Pharmaceuticals, Inc.
Diazepam | Astrazeneca Pharmaceuticals Lp
2.1 Recommended DosingBYDUREON (2 mg per dose) should be administered once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.
Missed DoseIf a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).
If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.
Changing Weekly Dosing ScheduleThe day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.
2.2 AdministrationBYDUREON must be injected immediately after the dose is prepared. BYDUREON is administered as a subcutaneous (SC) injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region. BYDUREON must not be administered intravenously or intramuscularly. BYDUREON is intended for patient self-administration.
Prior to initiation of BYDUREON, patients should be trained by their healthcare professional. For the BYDUREON Pen, study data demonstrated that training reduced the risk of administration errors such as inadequate mixing or incomplete dosing. Patients using the BYDUREON Pen should be trained on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at www.bydureon.com.
2.3 Changing from BYETTA to BYDUREONPrior treatment with BYETTA is not required when initiating BYDUREON therapy. If the decision is made to start BYDUREON in an appropriate patient already taking BYETTA, BYETTA should be discontinued. Patients changing from BYETTA to BYDUREON may experience transient (approximately 2 weeks) elevations in blood glucose concentrations.
2.1 Recommended DosingBYDUREON (2 mg per dose) should be administered once every 7 days (weekly). The dose can be administered at any time of day, with or without meals.
Missed DoseIf a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).
If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.
Changing Weekly Dosing ScheduleThe day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.
Missed DoseIf a dose is missed, it should be administered as soon as noticed, provided the next regularly scheduled dose is due at least 3 days later. Thereafter, patients can resume their usual dosing schedule of once every 7 days (weekly).
If a dose is missed and the next regularly scheduled dose is due 1 or 2 days later, the patient should not administer the missed dose and instead resume BYDUREON with the next regularly scheduled dose.
Changing Weekly Dosing ScheduleThe day of weekly administration can be changed if necessary as long as the last dose was administered 3 or more days before.
2.2 AdministrationBYDUREON must be injected immediately after the dose is prepared. BYDUREON is administered as a subcutaneous (SC) injection in the abdomen, thigh, or upper arm region. Advise patients to use a different injection site each week when injecting in the same region. BYDUREON must not be administered intravenously or intramuscularly. BYDUREON is intended for patient self-administration.
Prior to initiation of BYDUREON, patients should be trained by their healthcare professional. For the BYDUREON Pen, study data demonstrated that training reduced the risk of administration errors such as inadequate mixing or incomplete dosing. Patients using the BYDUREON Pen should be trained on proper mixing and injection technique to ensure the product is adequately mixed and a full dose is delivered. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. The instructions can also be found at www.bydureon.com.
2.3 Changing from BYETTA to BYDUREONPrior treatment with BYETTA is not required when initiating BYDUREON therapy. If the decision is made to start BYDUREON in an appropriate patient already taking BYETTA, BYETTA should be discontinued. Patients changing from BYETTA to BYDUREON may experience transient (approximately 2 weeks) elevations in blood glucose concentrations.
- Preferred Pharmaceuticals, Inc.
Diazepam | Preferred Pharmaceuticals, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases, dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE:Management of Anxiety Disorders and Relief of Symptoms of Anxiety.
Depending upon severity of symptoms – 2 mg to 10 mg, 2 to 4 times daily
Symptomatic Relief in Acute Alcohol Withdrawal.
10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed
Adjunctively for Relief of Skeletal Muscle Spasm.
2 mg to 10 mg, 3 or 4 times daily
Adjunctively in Convulsive Disorders.
2 mg to 10 mg, 2 to 4 times daily
Geriatric Patients, or in the presence of debilitating disease.
2 mg to 2½ mg, 1 or 2 times daily initially; increase gradually as needed and tolerated
PEDIATRIC PATIENTS:
Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months.
1 mg to 2½ mg, 3 or 4 times daily initially; increase gradually as needed and tolerated
- Proficient Rx Lp
- Major Pharmaceuticals
Diazepam | Actavis Pharma, Inc.
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending upon severity of symptoms — 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating
disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated - A-s Medication Solutions Llc
- Direct Rx
Diazepam | American Health Packaging
Gout:Therapy with probenecid should not be started until an acute gouty attack has subsided. However, if an acute attack is precipitated during therapy, probenecid may be continued without changing the dosage, and full therapeutic dosage of colchicine, or other appropriate therapy, should be given to control the acute attack.
The recommended adult dosage is 250 mg (1/2 probenecid tablet), twice a day for one week, followed by 500 mg (1 tablet) twice a day thereafter.
Some degree of renal impairment may be present in patients with gout. A daily dosage of 1000 mg may be adequate. However, if necessary, the daily dosage may be increased by 500 mg increments every 4 weeks within tolerance (and usually not above 2000 mg per day) if symptoms of gouty arthritis are not controlled or the 24 hour uric acid excretion is not above 700 mg. As noted, probenecid may not be effective in chronic renal insufficiency particularly when the glomerular filtration rate is 30 mL/minute or less.
Gastric intolerance may be indicative of overdosage, and may be corrected by decreasing the dosage.
As uric acid tends to crystallize out of an acid urine, a liberal fluid intake is recommended, as well as sufficient sodium bicarbonate (3 to 7.5 g daily), or potassium citrate (7.5 g daily) to maintain an alkaline urine (see PRECAUTIONS).
Alkalization of the urine is recommended until the serum urate level returns to normal limits and tophaceous deposits disappear, i.e., during the period when urinary excretion of uric acid is at a high level. Thereafter, alkalization of the urine and the usual restriction of purine-producing foods may be somewhat relaxed.
Probenecid should be continued at the dosage that will maintain normal serum urate levels. When acute attacks have been absent for 6 months or more and serum urate levels remain within normal limits, the daily dosage may be decreased by 500 mg every 6 months. The maintenance dosage should not be reduced to the point where serum urate levels tend to rise.
Probenecid and Penicillin Therapy (General):Adults: The recommended dosage is 2000 mg (4 tablets of probenecid) daily in divided doses. This dosage should be reduced in older patients in whom renal impairment may be present.
Children: 2-14 years of age:
Initial dose: 25 mg/kg body weight (or 0.7 g/square meter body surface).
Maintenance Dose: 40 mg/kg body weight (or 1.2 g/square meter body surface) per day, divided into 4 doses.
For children weighing more than 50 kg (110 lb) the adult dosage is recommended.
Probenecid is contraindicated in children under 2 years of age.
The PSP excretion test may be used to determine the effectiveness of probenecid in retarding penicillin excretion and maintaining therapeutic levels. The renal clearance of PSP is reduced to about one-fifth the normal rate when dosage of probenecid is adequate.
Penicillin Therapy (Gonorrhea)1In uncomplicated gonococcal infections in men and women (urethral, cervical, rectal), 1 g of probenecid should be given orally with 4.8 million units of aqueous procaine penicillin G2 (given IM), or 3 g of amoxicillin2 (given orally), or 3.5 g of ampicillin2 (given orally).
For further guidance, see CDC recommendations for definition of regimens of choice, alternative regimens, treatment of hypersensitive patients, and other aspects of therapy.
1 Recommended by the Center for Disease Control, U.S. Department of Health and Human Services, Public Health Service (Morbidity and Mortality Weekly Report Supplement, Volume 34, Number 4S, October 18, 1985). 2 See package circulars of manufacturers for detailed information about CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS. - Proficient Rx Lp
Diazepam | Laboratoires Clarins
• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• children under 6 months: Ask a doctor
• Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
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