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Bd Rx Inc. Drugs

Amoxicillin

Amoxicillin

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.

Note: Oral formulation should not be given as an initial dose.

Use minimum effective dose for the individual patient.

Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.
Diphenhydramine Hydroch...

Diphenhydramine Hydrochloride

THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY.

Diphenhydramine hydrochloride in the injectable form is indicated when the oral form is impractical.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT.

Pediatric Patients, other than premature infants and neonates: 5 mg/kg/24 hr or 150 mg/m2/24 hr. Maximum daily dosage is 300 mg. Divide into four doses, administered intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly.

Adults: 10 mg to 50 mg intravenously at a rate generally not exceeding 25 mg/min, or deep intramuscularly, 100 mg if required; maximum daily dosage is 400 mg.
Metoclopramide

Metoclopramide

For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide Injection (intramuscular or intravenous). Doses of 10 mg may be administered slowly by the intravenous route over a 1 to 2 minute period.

Administration of Metoclopramide Injection, USP up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further Metoclopramide treatment.

For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy

Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.

The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.

For doses in excess of 10 mg, Metoclopramide Injection, USP should be diluted in 50 mL of a parenteral solution.

The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with Metoclopramide Injection, USP can be stored frozen for up to 4 weeks. Metoclopramide Injection, USP is degraded when admixed and frozen with Dextrose-5% in Water. Metoclopramide Injection, USP diluted in Sodium Chloride Injection, Dextrose-5% in Water, Dextrose-5% in 0.45% Sodium Chloride, Ringer's Injection or Lactated Ringer's Injection may be stored up to 48 hours (without freezing) after preparation if protected from light. All dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation.

If acute dystonic reactions should occur, inject 50 mg Benadryl® (diphenhydramine hydrochloride) intramuscularly, and the symptoms usually will subside.

For the Prevention of Postoperative Nausea and Vomiting

Metoclopramide Injection, USP should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.

To Facilitate Small Bowel Intubation

If the tube has not passed the pylorus with conventional maneuvers in 10 minutes, a single dose (undiluted) may be administered slowly by the intravenous route over a 1 to 2 minute period.

The recommended single dose is: Pediatric patients above 14 years of age and adults –

10 mg metoclopramide base. Pediatric patients (6 to 14 years of age) – 2.5 to 5 mg metoclopramide base; (under 6 years of age) – 0.1 mg/kg metoclopramide base.

To Aid in Radiological Examinations

In patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, a single dose may be administered slowly by intravenous route over a 1 to 2 minute period.

For dosage, see intubation above.

Use in Patients with Renal or Hepatic Impairment

Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

See OVERDOSAGE section for information regarding dialysis.

Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Morphine Sulfate

Morphine Sulfate

Morphine Sulfate Injection is intended for intravenous and intramuscular administration.

2.1 General Dosing Considerations

Avoid Medication Errors

Morphine Sulfate Injection is available in five concentrations for direct injection. Take care when prescribing and administering Morphine Sulfate Injection to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and total dose in volume.

Administration of Morphine Sulfate Injection should be limited to use by those familiar with the management of respiratory depression. Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity.

Selection of patients for treatment with morphine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

2.2 Individualization of Dosage

Adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of Morphine Sulfate Injection USP, give attention to the following:
the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent Morphine Sulfate Injection USP dose needed; the patient's degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; the type and severity of the patient's pain; risk factors for abuse, addiction or diversion, including a prior history of abuse, addiction.
The following dosing recommendation, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in management of the pain of each individual patient.

Continual re-evaluation of the patient receiving Morphine Sulfate Injection USP is important, with special attention to the management of pain and the occurrence of side effects associated with therapy.

2.3 Direct Intravenous Injection

The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain.
Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration. Administer the injection slowly. Monitor the patient closely for signs of respiratory and central nervous system depression.
2.4 Intramuscular Injection

The initial IM dose is 10 mg, every 4 hours as needed to manage pain (based on a 70 kg adult).
Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration. Monitor the patient closely for signs of respiratory and central nervous system depression.
2.5 Dosing with Hepatic and Renal Impairment

Morphine Sulfate pharmacokinetics have been reported to be significantly altered in patients with cirrhosis and renal failure. Start these patients with lower doses of Morphine Sulfate Injection USP and titrate slowly while carefully monitoring for respiratory and central nervous system depression. [See Use in Specific Populations (8.7 and 8.8).]
Divalproex Sodium

Divalproex Sodium

Intravenous or intramuscular administration.
The initial dosage of Dexamethasone sodium phosphate Injection may vary from 0.50 mg/day to 9.0 mg/day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. Usually the parenteral dosage ranges are one-third to one-half the oral dose given every 12 hours. However, in certain overwhelming, acute, life-threatening situations, administration of dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

For the treatment of unresponsive shock high pharmacologic doses of this product are currently recommended. Reported regimens range from 1 to 6 mg/kg of body weight as a single intravenous injection to 40 mg initially followed by repeat intravenous injection every 2 to 6 hours while shock persists.

For the treatment of cerebral edema in adults an initial intravenous dose of 10 mg is recommended followed by 4 mg intramuscularly every six hours until maximum response has been noted. This regimen may be continued for several days postoperatively in patients requiring brain surgery. Oral dexamethasone, 1 to 3 mg t.i.d., should be given as soon as possible and dosage tapered off over a period of five to seven days. Nonoperative cases may require continuous therapy to remain free of symptoms of increased intracranial pressure. The smallest effective dose should be used in children, preferably orally. This may approximate 0.2 mg/kg/24 hours in divided doses.

In treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4–8 mg dexamethasone every other day for 1 month have been shown to be effective.

The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, dexamethasone sodium phosphate injection, USP should be discontinued and the patient transferred to other appropriate therapy. It should be emphasized that dosage requirements are variable and must be individualized on the basis of the disease under treatment and the response of the patient.

After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this later situation it may be necessary to increase the dosage of dexamethasone sodium phosphate injection, USP for a period of time consistent with the patient's condition. If after a long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.
Intra-articular, soft tissue or intralesional administration.
The dose for instrasynovial administration is usually 2 to 4 mg for large joints and 0.8 to 1 mg for small joints. For soft tissue and bursal injections a dose of 2 to 4 mg is recommended. Ganglia require a dose of 1 to 2 mg. A dose of 0.4 to 1 mg is used for injection into tendon sheaths. Injection into intervertebral joints should not be attempted at any time and hip joint injection cannot be recommended as an office procedure.

Intrasynovial and soft tissue injections should be employed only when affected areas are limited to 1 or 2 sites. It should be remembered that corticoids provide palliation only and that other conventional or curative methods of therapy should be employed when indicated.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Frequency of injection usually ranges from once every 3 to 5 days to once every 2 to 3 weeks. Frequent intra-articular injection may cause damage to joint tissue.
Midazolam

Midazolam

Midazolam injection is a potent sedative agent that requires slow administration and individualization of dosage. Clinical experience has shown midazolam to be 3 to 4 times as potent per mg as diazepam. BECAUSE SERIOUS AND LIFETHREATENING CARDIORESPIRATORY ADVERSE EVENTS HAVE BEEN REPORTED, PROVISION FOR MONITORING, DETECTION AND CORRECTION OF THESE REACTIONS MUST BE MADE FOR EVERY PATIENT TO WHOM MIDAZOLAM INJECTION IS ADMINISTERED, REGARDLESS OF AGE OR HEALTH STATUS. Excessive single doses or rapid intravenous administration may result in respiratory depression, airway obstruction and/or arrest. The potential for these latter effects is increased in debilitated patients, those receiving concomitant medications capable of depressing the CNS, and patients without an endotracheal tube but undergoing a procedure involving the upper airway such as endoscopy or dental (see Boxed WARNING and WARNINGS).

Reactions such as agitation, involuntary movements, hyperactivity and combativeness have been reported in adult and pediatric patients. Should such reactions occur, caution should be exercised before continuing administration of midazolam (see WARNINGS).

Midazolam injection should only be administered IM or IV (see WARNINGS).

Care should be taken to avoid intra-arterial injection or extravasation (see WARNINGS).

Midazolam Injection may be mixed in the same syringe with the following frequently used premedications: morphine sulfate, meperidine, atropine sulfate or scopolamine. Midazolam, at a concentration of 0.5 mg/mL, is compatible with 5% dextrose in water and 0.9% sodium chloride for up to 24 hours and with Lactated Ringer's solution for up to 4 hours. Both the 1 mg/mL and 5 mg/mL formulations of midazolam may be diluted with 0.9% sodium chloride or 5% dextrose in water.

Monitoring: Patient response to sedative agents, and resultant respiratory status, is variable. Regardless of the intended level of sedation or route of administration, sedation is a continuum; a patient may move easily from light to deep sedation, with potential loss of protective reflexes. This is especially true in pediatric patients. Sedative doses should be individually titrated, taking into account patient age, clinical status and concomitant use of other CNS depressants. Continuous monitoring of respiratory and cardiac function is required (i.e., pulse oximetry).

Adults and Pediatrics: Sedation guidelines recommend a careful presedation history to determine how a patient's underlying medical conditions or concomitant medications might affect their response to sedation/analgesia as well as a physical examination including a focused examination of the airway for abnormalities. Further recommendations include appropriate presedation fasting.

Titration to effect with multiple small doses is essential for safe administration. It should be noted that adequate time to achieve peak central nervous system effect (3 to 5 minutes) for midazolam should be allowed between doses to minimize the potential for oversedation. Sufficient time must elapse between doses of concomitant sedative medications to allow the effect of each dose to be assessed before subsequent drug administration. This is an important consideration for all patients who receive intravenous midazolam.

Immediate availability of resuscitative drugs and age- and size-appropriate equipment and personnel trained in their use and skilled in airway management should be assured (see WARNINGS).

Pediatrics: For deeply sedated pediatric patients a dedicated individual, other than the practitioner performing the procedure, should monitor the patient throughout the procedure.

Intravenous access is not thought to be necessary for all pediatric patients sedated for a diagnostic or therapeutic procedure because in some cases the difficulty of gaining IV access would defeat the purpose of sedating the child; rather, emphasis should be placed upon having the intravenous equipment available and a practitioner skilled in establishing vascular access in pediatric patients immediately available.
USUAL ADULT DOSAGE INTRAMUSCULARLY For preoperative sedation/anxiolysis/amnesia(induction of sleepinessor drowsiness and reliefof apprehension and toimpair memory ofperioperative events).For intramuscular use,midazolam should beinjected deep in a largemuscle mass. The recommended premedication dose of midazolam forgood risk (ASA Physical Status I & II) adult patients belowthe age of 60 years is 0.07 to 0.08 mg/kg IM (approximately5 mg IM) administered up to 1 hour before surgery.The dose must be individualized and reduced whenIM midazolam is administered to patients with chronicobstructive pulmonary disease, other higher risk surgicalpatients, patients 60 or more years of age, and patients whohave received concomitant narcotics or other CNSdepressants (see ADVERSE REACTIONS). In a study ofpatients 60 years or older, who did not receive concomitantadministration of narcotics, 2 to 3 mg (0.02 to 0.05 mg/kg)of midazolam produced adequate dosing during the preoperativeperiod. The dose of 1 mg IM midazolam maysuffice for some older patients if the anticipated intensityand duration of sedation is less critical. As with any potentialrespiratory depressant, these patients require observation forsigns of cardiorespiratory depression after receiving IMmidazolam. Onset is within 15 minutes, peaking at 30 to 60 minutes. Itcan be administered concomitantly with atropine sulfate orscopolamine hydrochloride and reduced doses of narcotics. INTRAVENOUSLY Sedation/anxiolysis/amnesia for procedures(see INDICATIONS):Narcotic premedicationresults in less variabilityin patient response anda reduction in dosage ofmidazolam.For peroral procedures,the use of an appropriatetopical anesthetic isrecommended. Forbronchoscopic procedures,the use of narcotic premedicationsisrecommended. When used for sedation/anxiolysis/amnesia for a procedure,dosage must be individualized and titrated. Midazolamshould always be titrated slowly; administer over at least2 minutes and allow an additional 2 or more minutes to fullyevaluate the sedative effect. Individual response will varywith age, physical status and concomitant medications, butmay also vary independent of these factors. (see WARNINGS concerning cardiac/respiratory arrest/airway obstruction/hypoventilation). Midazolam 1 mg/mLformulation isrecommended forsedation/anxiolysis/amnesia for procedures tofacilitate slower injection.Both the 1 mg/mL andthe 5 mg/mL formulationsmay be diluted with 0.9%sodium chloride or 5%dextrose in water. Healthy Adults Below the Age of 60: Titrate slowly tothe desired effect (e.g., the initiation of slurred speech).Some patients may respond to as little as 1 mg. No morethan 2.5 mg should be given over a period of at least2 minutes. Wait an additional 2 or more minutes tofully evaluate the sedative effect. If further titration isnecessary, continue to titrate, using small increments, tothe appropriate level of sedation. Wait an additional 2 ormore minutes after each increment to fully evaluate thesedative effect. A total dose greater than 5 mg is notusually necessary to reach the desired endpoint.If narcotic premedication or other CNS depressants areused, patients will require approximately 30% lessmidazolam than unpremedicated patients. Patients Age 60 or Older, and Debilitated or Chronically IllPatients: Because the danger of hypoventilation, airwayobstruction, or apnea is greater in elderly patients andthose with chronic disease states or decreased pulmonaryreserve, and because the peak effect may take longer inthese patients increments should be smaller and the rateof injection slower. Titrate slowly to the desired effect(e.g., the initiation of slurred speech). Some patients mayrespond to as little as 1 mg. No more than 1.5 mg shouldbe given over a period of no less than 2 minutes. Wait anadditional 2 or more minutes to fully evaluate the sedativeeffect. If additional titration is necessary, it should be givenat a rate of no more than 1 mg over a period of 2 minutes,waiting an additional 2 or more minutes each time tofully evaluate the sedative effect. Total doses greater than3.5 mg are not usually necessary.If concomitant CNS depressant premedications are usedin these patients, they will require at least 50% lessmidazolam than healthy young unpremedicated patients. Maintenance Dose: Additional doses to maintain thedesired level of sedation may be given in increments of25% of the dose used to first reach the sedative endpoint,but again only by slow titration, especially in the elderlyand chronically ill or debilitated patient. These additionaldoses should be given only after a thorough clinicalevaluation clearly indicates the need for additionalsedation. Induction of Anesthesia: For induction of generalanesthesia, beforeadministration of otheranesthetic agents. Individual response to the drug is variable, particularly whena narcotic premedication is not used. The dosage should betitrated to the desired effect according to the patient's ageand clinical status.When midazolam is used before other intravenous agents forinduction of anesthesia, the initial dose of each agent may besignificantly reduced, at times to as low as 25% of the usualinitial dose of the individual agents.Unpremedicated Patients: In the absence of premedication,an average adult under the age of 55 years will usuallyrequire an initial dose of 0.3 to 0.35 mg/kg for induction,administered over 20 to 30 seconds and allowing 2 minutesfor effect. If needed to complete induction, increments ofapproximately 25% of the patient's initial dose may be used;induction may instead be completed with inhalationalanesthetics. In resistant cases, up to 0.6 mg/kg total dosemay be used for induction, but such larger doses mayprolong recovery.Unpremedicated patients over the age of 55 years usuallyrequire less midazolam for induction; an initial dose of0.3 mg/kg is recommended. Unpremedicated patients withsevere systemic disease or other debilitation usually requireless midazolam for induction. An initial dose of 0.2 to0.25 mg/kg will usually suffice; in some cases, as little as0.15 mg/kg may suffice.Premedicated Patients: When the patient has receivedsedative or narcotic premedication, particularly narcoticpremedication, the range of recommended doses is 0.15 to0.35 mg/kg. In average adults below the age of 55 years,a dose of 0.25 mg/kg, administered over 20 to 30 secondsand allowing 2 minutes for effect, will usually suffice.The initial dose of 0.2 mg/kg is recommended for good risk(ASA I & II) surgical patients over the age of 55 years.In some patients with severe systemic disease or debilitation,as little as 0.15 mg/kg may suffice.Narcotic premedication frequently used during clinical trialsincluded fentanyl (1.5 to 2 mcg/kg IV, administered 5 minutesbefore induction), morphine (dosage individualized, up to0.15 mg/kg IM), and meperidine (dosage individualized, upto 1 mg/kg IM). Sedative premedications were hydroxyzinepamoate (100 mg orally) and sodium secobarbital (200 mgorally). Except for intravenous fentanyl, administered5 minutes before induction, all other premedications shouldbe administered approximately 1 hour prior to the timeanticipated for midazolam induction. Injectable midazolamcan also be used duringmaintenance of anesthesia,for surgical procedures, asa component of balancedanesthesia. Effectivenarcotic premedication isespecially recommendedin such cases. Incremental injections of approximately 25% of the inductiondose should be given in response to signs of lightening ofanesthesia and repeated as necessary. CONTINUOUS INFUSION For continuous infusion,midazolam 5 mg/mLformulation isrecommended diluted toa concentration of0.5 mg/mL with 0.9%sodium chloride or 5%dextrose in water. Usual Adult Dose: If a loading dose is necessary to rapidlyinitiate sedation, 0.01 to 0.05 mg/kg (approximately 0.5 to4 mg for a typical adult) may be given slowly or infusedover several minutes. This dose may be repeated at 10 to15 minute intervals until adequate sedation is achieved.For maintenance of sedation, the usual initial infusion rateis 0.02 to 0.10 mg/kg/hr (1 to 7 mg/hr). Higher loading ormaintenance infusion rates may occasionally be required insome patients. The lowest recommended doses should beused in patients with residual effects from anesthetic drugs,or in those concurrently receiving other sedatives andopioids.Individual response to midazolam is variable. The infusionrate should be titrated to the desired level of sedation, takinginto account the patient's age, clinical status and currentmedications. In general, midazolam should be infused atthe lowest rate that produces the desired level of sedation.Assessment of sedation should be performed at regularintervals and the midazolam infusion rate adjusted up ordown by 25% to 50% of the initial infusion rate so as toassure adequate titration of sedation level. Largeradjustments or even a small incremental dose may benecessary if rapid changes in the level of sedation areindicated. In addition, the infusion rate should be decreasedby 10% to 25% every few hours to find the minimumeffective infusion rate. Finding the minimum effectiveinfusion rate decreases the potential accumulation ofmidazolam and provides for the most rapid recovery oncethe infusion is terminated. Patients who exhibit agitation,hypertension, or tachycardia in response to noxiousstimulation, but who are otherwise adequately sedated,may benefit from concurrent administration of an opioidanalgesic. Addition of an opioid will generally reduce theminimum effective midazolam infusion rate. PEDIATRIC PATIENTS UNLIKE ADULT PATIENTS, PEDIATRIC PATIENTSGENERALLY RECEIVE INCREMENTS OF MIDAZOLAM ONA MG/KG BASIS. As a group, pediatric patients generally require higherdosages of midazolam (mg/kg) than do adults. Younger (lessthan six years) pediatric patients may require higher dosages(mg/kg) than older pediatric patients, and may require closemonitoring (see tables below). In obese PEDIATRIC PATIENTS,the dose should be calculated based on ideal body weight.When midazolam is given in conjunction with opioids orother sedatives, the potential for respiratory depression,airway obstruction, or hypoventilation is increased. Forappropriate patient monitoring, see Boxed WARNING,WARNINGS and DOSAGE AND ADMINISTRATION, Monitoring . The health care practitioner who uses thismedication in pediatric patients should be aware of andfollow accepted professional guidelines for pediatric sedationappropriate to their situation. OBSERVER'S ASSESSMENT OF ALERTNESS/SEDATION (OAA/S) Assessment Categories Responsiveness Speech Facial Expression Eyes Composite Score Responds readily to name spoken in normal tone normal normal clear,no ptosis 5 (alert) Lethargic response to name spoken in normal tone mild slowing or thickening mild relaxation glazed ormild ptosis(less than half the eye) 4 Responds only after name is called loudly and/or repeatedly slurring or prominentslowing markedrelaxation (slack jaw) glazed andmarked ptosis(half the eye or more) 3 Responds only after mild prodding or shaking fewrecognizable words – – 2 Does not respond to mild prodding or shaking – – – 1 (deep sleep) FREQUENCY OF OBSERVER'S ASSESSMENT OF ALERTNESS/SEDATION COMPOSITE SCORES IN ONE STUDY OF PEDIATRIC PATIENTS UNDERGOING PROCEDURES WITH INTRAVENOUS MIDAZOLAM FOR SEDATION Age Range (years) n OAA/S Score 1-2 16 1 (deep sleep) 2 3 4 5(alert) 6 (38%) 4 (25%) 3 (19%) 3 (19%) 0 > 2-5 22 9 (41%) 5 (23%) 8 (36%) 0 0 > 5-12 34 1 (3%) 6 (18%) 22 (65%) 5 (15%) 0 > 12-17 18 0 4 (22%) 14 (78%) 0 0 Total (1 – 17) 90 16 (18%) 19 (21%) 47 (52%) 8 (9%) 0 INTRAMUSCULARLY USUAL PEDIATRIC DOSE (NONNEONATAL) For sedation/anxiolysis/amnesiaprior to anesthesia or forprocedures, intramuscularmidazolam can be used tosedate pediatric patients tofacilitate less traumaticinsertion of an intravenouscatheter for titration ofadditional medication. Sedation after intramuscular midazolam is age and dosedependent: higher doses may result in deeper and moreprolonged sedation. Doses of 0.1 to 0.15 mg/kg areusually effective and do not prolong emergence fromgeneral anesthesia. For more anxious patients, dosesup to 0.5 mg/kg have been used. Although notsystematically studied, the total dose usually does notexceed 10 mg. If midazolam is given with an opioid, theinitial dose of each must be reduced. INTRAVENOUSLY BYINTERMITTENT INJECTION USUAL PEDIATRIC DOSE (NONNEONATAL) For sedation/anxiolysis/amnesia prior to and duringprocedures or prior toanesthesia. It should be recognized that the depth of sedation/anxiolysis needed for pediatric patients depends on thetype of procedure to be performed. For example, simplelight sedation/anxiolysis in the preoperative period isquite different from the deep sedation and analgesiarequired for an endoscopic procedure in a child. For thisreason, there is a broad range of dosage. For all pediatricpatients, regardless of the indications for sedation/anxiolysis, it is vital to titrate midazolam and otherconcomitant medications slowly to the desired clinicaleffect. The initial dose of midazolam should beadministered over 2 to 3 minutes. Since midazolam iswater soluble, it takes approximately three times longerthan diazepam to achieve peak EEG effects, thereforeone must wait an additional 2 to 3 minutes to fullyevaluate the sedative effect before initiating a procedureor repeating a dose. If further sedation is necessary,continue to titrate with small increments until theappropriate level of sedation is achieved. If othermedications capable of depressing the CNS arecoadministered, the peak effect of those concomitantmedications must be considered and the dose ofmidazolam adjusted. The importance of drug titrationto effect is vital to the safe sedation/anxiolysis of thepediatric patient. The total dose of midazolam willdepend on patient response, the type and duration of theprocedure, as well as the type and dose of concomitantmedications.Pediatric patients less than 6 months of age: limitedinformation is available in nonintubatedpediatricpatients less than 6 months of age. It is uncertainwhen the patient transfers from neonatal physiologyto pediatric physiology, therefore the dosingrecommendations are unclear. Pediatric patients lessthan 6 months of age are particularly vulnerable toairway obstruction and hypoventilation, thereforetitration with small increments to clinical effect andcareful monitoring are essential. Pediatric patients 6 months to 5 years of age: initialdose 0.05 to 0.1 mg/kg. A total dose up to 0.6 mg/kgmay be necessary to reach the desired endpoint butusually does not exceed 6 mg. Prolonged sedation andrisk of hypoventilation may be associated with thehigher doses. Pediatric patients 6 to 12 years of age: Initial dose0.025 to 0.05 mg/kg; total dose up to 0.4 mg/kg maybe needed to reach the desired endpoint but usuallydoes not exceed 10 mg. Prolonged sedation and riskof hypoventilation may be associated with thehigher doses. Pediatric patients 12 to 16 years of age: should bedosed as adults. Prolonged sedation may beassociated with higher doses; some patients in thisage range will require higher than recommendedadult doses but the total dose usually does notexceed 10 mg.The dose of midazolam must be reduced in patientspremedicated with opioid or other sedative agentsincluding midazolam. Higher risk or debilitated patientsmay require lower dosages whether or not concomitantsedating medications have been administered(see WARNINGS). CONTINUOUS INTRAVENOUSINFUSION USUAL PEDIATRIC DOSE (NONNEONATAL) For sedation/anxiolysis/amnesiain critical care settings. To initiate sedation, an intravenous loading dose of0.05 to 0.2 mg/kg administered over at least 2 to3 minutes can be used to establish the desired clinicaleffect IN PATIENTS WHOSE TRACHEA IS INTUBATED.(Midazolam should not be administered as a rapidintravenous dose.) This loading dose may be followedby a continuous intravenous infusion to maintain theeffect. An infusion of midazolam has been used inpatients whose trachea was intubated but who wereallowed to breathe spontaneously. Assisted ventilationis recommended for pediatric patients who are receivingother central nervous system depressant medicationssuch as opioids. Based on pharmacokinetic parametersand reported clinical experience, continuous intravenousinfusions of midazolam should be initiated at a rate of0.06 to 0.12 mg/kg/hr (1 to 2 mcg/kg/min). The rate ofinfusion can be increased or decreased (generally by 25%of the initial or subsequent infusion rate) as required, orsupplemental intravenous doses of midazolam can beadministered to increase or maintain the desired effect.Frequent assessment at regular intervals using standardpain/sedation scales is recommended. Drug eliminationmay be delayed in patients receiving erythromycin and/orother P4503A4enzyme inhibitors (see PRECAUTIONS, Drug Interactions ) and in patients with liverdysfunction, low cardiac output (especially thoserequiring inotropic support), and in neonates.Hypotension may be observed in patients who arecritically ill, particularly those receiving opioids and/orwhen midazolam is rapidly administered.When initiating an infusion with midazolam inhemodynamically compromised patients, the usualloading dose of midazolam should be titrated in smallincrements and the patient monitored for hemodynamicinstability, e.g., hypotension. These patients are alsovulnerable to the respiratory depressant effects ofmidazolam and require careful monitoring of respiratoryrate and oxygen saturation. CONTINUOUS INTRAVENOUSINFUSION USUAL NEONATAL DOSE For sedation in critical caresettings. Based on pharmacokinetic parameters and reportedclinical experience in preterm and term neonates WHOSETRACHEA WAS INTUBATED, continuous intravenousinfusions of midazolam should be initiated at a rate of0.03 mg/kg/hr (0.5 mcg/kg/min) in neonates < 32 weeksand 0.06 mg/kg/hr (1 mcg/kg/min) in neonates> 32 weeks. Intravenous loading doses should not beused in neonates, rather the infusion may be run morerapidly for the first several hours to establish therapeuticplasma levels. The rate of infusion should be carefullyand frequently reassessed, particularly after the first24 hours so as to administer the lowest possible effectivedose and reduce the potential for drug accumulation.Hypotension may be observed in patients who arecritically ill and in preterm and term infants, particularlythose receiving fentanyl and/or when midazolam isadministered rapidly. Due to an increased risk of apnea,extreme caution is advised when sedating preterm andformer preterm patients whose trachea is not intubated.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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