Promethazine Hcl

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Promethazine Hcl Recall

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Side Effects & Adverse Reactions

WARNING: PROMETHAZINE HCl INJECTION SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.

POSTMARKETING CASES OF RESPIRATORY DEPRESSION, INCLUDING FATALITIES, HAVE BEEN REPORTED WITH USE OF PROMETHAZINE HCl INJECTION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HCl INJECTION HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HCl INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE HCl INJECTION BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.

Sulfite Sensitivity

Promethazine HCl Injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthma episodes, in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

CNS Depression

Promethazine HCl Injection may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The impairment may be amplified by concomitant use of other central-nervous-system depressants such as alcohol, sedative/hypnotics (including barbiturates), general anesthetics, narcotics, narcotic analgesics,tricyclic antidepressants, and tranquilizers; therefore such agents should either be eliminated or given in reduced dosage in the presence of promethazine HCl (see PRECAUTIONS-Information for Patients and Drug Interactions).

Respiratory Depression

Promethazine HCl Injection may lead to potentially fatal respiratory depression.

Use of Promethazine HCl Injection in patients with compromised respiratory function (e.g. COPD, sleep apnea) should be avoided.

Lower Seizure Threshold

Promethazine HCl Injection may lower seizure threshold and should be used with caution in persons with seizure disorders or in persons who are using concomitant medications, such as narcotics or local anesthetics, which may also affect seizure threshold.

Bone-Marrow Depression

Promethazine HCl Injection should be used with caution in patients with bone-marrow depression. Leukopenia and agranulocytosis have been reported, usually when promethazine HCl has been used in association with other known marrow-toxic agents.

Neuroleptic Malignant Syndrome

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with promethazine HCl alone or in combination with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias).

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of promethazine HCl, antipsychotic drugs, if any, and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

Since recurrences of NMS have been reported with phenothiazines, the reintroduction of promethazine HCl should be carefully considered.

Use in Pediatric Patients

PROMETHAZINE HCl INJECTION IS CONTRAINDICATED FOR USE IN PEDIATRIC PATIENTS LESS THAN TWO YEARS OF AGE.

CAUTION SHOULD BE EXERCISE WHEN ADMINISTERING PROMETHAZINE HCl INJECTION TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION. RESPIRATORY DEPRESSION AND APNEA, SOMETIMES ASSOCIATED WITH DEATH, ARE STRONLGY ASSOCIATED WITH PROMETHAZINE PRODUCTS AND NOT FIRMLY WIEGHT-RELATED, WHICH MIGHT OTHERWISE PERMIT SAFE ADMINISTRATION OF INDIVIDUALIZED DOSING. CONCOMITANT ADMINISTRATION OF PROMETHAZINE PRODUCTS WITH OTHER RESPIRATORY DEPRESSANTS HAS AN ASSOCIATION WITH RESPIRATORY DEPRESSION, AND SOMETIMES DEATH, IN PEDIATRIC PATIENTS.

ANTIEMETICS ARE NOT RECOMMENDED FOR TREATMENT OF UNCOMPLICATED VOMITING IN PEDIATRIC PATIENTS, AND THEIR USE SHOULD BE LIMITED TO PROLONGED VOMITING OF KNOWN ETIOLOGY. THE EXTRAPYRAMIDAL SYMPTOMS WHICH CAN OCCUR SECONDARY TO PROMETHAZINE HCl INJECTION ADMINISTRATION MAY BE CONFUSED WITH THE CNS SIGNS OF UNDIAGNOSED PRIMARY DISEASE, E.G., ENCEPHALOPATHY OR REYE’S SYNDROME. THE USE OF PROMETHAZINE HCl INJECTION SHOULD BE AVOIDED IN PEDIATRIC PATIENTS WHOSE SIGNS AND SYMPTOMS MAY SUGGEST REYE’S SYNDROME OR OTHER HEPATIC DISEASES.

Excessively large dosages of antihistamines, including Promethazine HCl Injection, in pediatric patients may cause sudden death (see OVERDOSAGE). Hallucinations and convulsions have occurred with therapeutic doses and overdoses of Promethazine HCl in pediatric patients. In pediatric patients who are acutely ill associated with dehydration, there is an increased susceptibility to dystonias with the use of Promethazine HCl Injection.

Injection Site Reactions

Promethazine HCl Injection can cause severe chemical irritation and damage to tissues, regardless of the route of administration. Irritation and damage can also result from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration.

Signs, symptoms, and manifestations of severe tissue irritation include burning, pain, erythema, swelling, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, and gangrene. Administration of Promethazine HCl Injection has resulted in nerve damage ranging from temporary sensory loss to palsies and paralysis. Injection into or near a nerve may result in permanent tissue damage. In some cases, surgical intervention (including fasciotomy, skin graft, and/or amputation) may be required (see ADVERSE REACTIONS).

Inadvertent Intra-Arterial Injection

Due to the close proximity of arteries and veins in the areas most commonly used for intravenous injection, extreme care should be exercised to avoid perivascular extravasation or unintentional intra-arterial injection. Reports compatible with unintentional intra-arterial injection of Promethazine HCl Injection, usually in conjunction with other drugs intended for intravenous use, suggest that pain, severe chemical irritation, severe spasm of distal vessels, and resultant gangrene requiring amputation are likely under such circumstances. Intravenous injection was intended in all the cases reported but perivascular extravasation or arterial placement of the needle is now suspect. There is no proven successful management of unintentional intra-arterial injection or perivascular extravasation after it occurs. Sympathetic block and heparinization have been employed during the acute management of unintentional intra-arterial injection, because of the results of animal experiments with other known arteriolar irritants. Aspiration of dark blood does not preclude intra-arterial needle placement, because blood is discolored upon contact with Promethazine HCl Injection. Use of syringes with rigid plungers or of small-bore needles might obscure typical arterial backflow if this is relied upon alone.

When used intravenously, Promethazine HCl Injection should be given in a concentration no greater than 25 mg per mL and at a rate not to exceed 25 mg per minute. When administering any irritant drug intravenously, it is usually preferable to inject it through the tubing of an intravenous infusion set that is known to be functioning satisfactorily. In the event that a patient complains of pain during intended intravenous injection of Promethazine HCl Injection, the injection should be stopped immediately to provide for evaluation of possible arterial placement or perivascular extravasation.

Visual Inspection

This product is light sensitive and should be inspected before use and discarded if either color or particulate is observed.

Other Considerations

Sedative drugs or CNS depressants should be avoided in patients with a history of sleep apnea.

Administration of promethazine has been associated with reported cholestatic jaundice.

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Legal Issues

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Promethazine HCl Injection is indicated for the following conditions:

Amelioration of allergic reactions to blood or plasma.
In anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled.
For other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated.
For sedation and relief of apprehension and to produce light sleep from which the patient can be easily aroused.
Active treatment of motion sickness.
Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.
As an adjunct to analgesics for the control of postoperative pain.
Preoperative, postoperative, and obstetric (during labor) sedation.
Intravenously in special surgical situations, such as repeated bronchoscopy, ophthalmic surgery, and poor-risk patients, with reduced amounts of meperidine or other narcotic analgesic as an adjunct to anesthesia and analgesia.

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History

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Other Information

Promethazine HCl Injection USP, is a sterile, pyrogen-free solution for deep intramuscular or intravenous administration. Promethazine HCl (10H-Phenothiazine-10 ethanamine,N,N,α-trimethyl-, monohydrochloride, (±)-) is a racemic compound and has the following structural formula:

C17H21ClN2S MW 320.88

Each mL contains Promethazine HCl, either 25 mg or 50 mg with 0.1 mg edetate disodium, 0.04 mg calcium chloride, 0.5 mg sodium metabisulfite in water for injection. The pH range is 4.0 to 5.5; buffered with acetic acid-sodium acetate, and it is sealed under nitrogen.

Promethazine HCl Injection is a clear, colorless solution. The product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed.

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Promethazine Hcl Manufacturers

Wockhardt Usa Inc.

Promethazine Hcl | Wockhardt Usa Inc.

Promethazine HCl Injection is contraindicated for use in pediatric patients less than 2 years of age.

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

Do not use Promethazine HCl Injection if solution has developed color or contains precipitate.

To avoid the possibility of physical and/or chemical incompatibility, consult specialized literature before diluting with any injectable solution or combining with any other medication. Do not use if there is a precipitate or any sign of incompatibility.
Important Notes on Administration
The preferred parenteral route of administration for Promethazine HCl Injection is by deep intramuscular injection. The proper intravenous administration of this product is well tolerated, but use of this route is not without some hazard. Not for subcutaneous administration.

UNINTENTIONAL INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY (see CONTRAINDICATIONS, WARNINGS-Injection Site Reactions). SUBCUTANEOUS INJECTION IS CONTRAINDICATED, AS IT MAY RESULT IN TISSUE NECROSIS (see CONTRAINDICATIONS, WARNINGS-Injection Site Reactions, and ADVERSE REACTIONS).

Injection into or near a nerve may result in permanent tissue damage (see ADVERSE REACTIONS).

When used intravenously, Promethazine HCl Injection should be given in a concentration no greater than 25 mg/mL at a rate not to exceed 25 mg per minute; it is preferable to inject through the tubing of an intravenous infusion set that is known to be functioning satisfactorily.
Allergic Conditions
The average adult dose is 25 mg. This dose may be repeated within two hours if necessary, but continued therapy, if indicated, should be via the oral route as soon as existing circumstances permit. After initiation of treatment, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The average adult dose for amelioration of allergic reactions to blood or plasma is 25 mg.
Sedation
In hospitalized adult patients, nighttime sedation may be achieved by a dose of 25 to 50 mg of Promethazine HCl Injection.
Nausea and Vomiting
For control of nausea and vomiting, the usual adult dose is 12.5 to 25 mg, not to be repeated more frequently than every four hours. When used for control of postoperative nausea and vomiting, the medication may be administered either intramuscularly or intravenously and dosage of analgesics and barbiturates reduced accordingly.

Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS–Use in Pediatric Patients).
Preoperative and Postoperative Use
As an adjunct to preoperative or postoperative medication, 25 to 50 mg of Promethazine HCl Injection in adults may be combined with appropriately reduced doses of analgesics and atropine-like drugs as desired. Dosage of concomitant analgesic or hypnotic medication should be reduced accordingly.

Promethazine HCl is contraindicated for use in pediatric patients less than two years of age.
Obstetrics
Promethazine HCl Injection in doses of 50 mg will provide sedation and relieve apprehension in the early stages of labor. When labor is definitely established, 25 to 75 mg (average dose, 50 mg) Promethazine HCl Injection may be given intramuscularly or intravenously with an appropriately reduced dose of any desired narcotic. If necessary, Promethazine HCl Injection with a reduced dose of analgesic may be repeated once or twice at four-hour intervals in the course of a normal labor. A maximum total dose of 100 mg of Promethazine HCl Injection may be administered during a 24-hour period to patients in labor.
Pediatric Patients
Promethazine HCl Injection is contraindicated for use in pediatric patients less than 2 years of age (see WARNINGS-Black Box Warning and Use in Pediatric Patients). Caution should be exercised when administering promethazine HCl to pediatric patients 2 years of age or older. It is recommended that the lowest effective dose of promethazine hydrochloride be used in pediatric patients 2 years of age and older and concomitant administration of other drugs with respiratory depressant effects be avoided (see WARNINGS-Black Box Warning and Use in Pediatric Patients).

In pediatric patients 2 years of age and older, the dosage should not exceed half that of the suggested adult dose. As an adjunct to premedication, the suggested dose is 0.5 mg per lb of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine-like drug. Antiemetics should not be used in vomiting of unknown etiology in pediatric patients.

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Cardinal Health

Promethazine Hcl | Cardinal Health

Promethazine hydrochloride tablets are contraindicated for children under 2 years of age (see WARNINGS: Black Box Warning and Use in Pediatric Patients).
Allergy
The average oral dose is 25 mg taken before retiring; however, 12.5 mg may be taken before meals and on retiring, if necessary. Single 25 mg doses at bedtime or 6.25 mg to 12.5 mg taken 3 times daily will usually suffice. After initiation of treatment, in children or adults, dosage should be adjusted to the smallest amount adequate to relieve symptoms. The administration of promethazine HCl in 25 mg doses will control minor transfusion reactions of an allergic nature.
Motion Sickness
The average adult dose is 25 mg taken twice daily. The initial dose should be taken one-half to one hour before anticipated travel and be repeated 8 to 12 hours later if necessary. On succeeding days of travel, it is recommended that 25 mg be given on arising and again before the evening meal. For children, promethazine hydrochloride tablets, syrup, or rectal suppositories, 12.5 mg to 25 mg, twice daily, may be administered.
Nausea and Vomiting
Antiemetics should not be used in vomiting of unknown etiology in children and adolescents (see WARNINGS: Use in Pediatric Patients ).

The average effective dose of promethazine hydrochloride tablets for the active therapy of nausea and vomiting in children or adults is 25 mg. When oral medication cannot be tolerated, the dose should be given parenterally or by rectal suppository. 12.5 mg to 25 mg doses may be repeated, as necessary, at 4 to 6 hour intervals.

For nausea and vomiting in children, the usual dose is 0.5 mg per pound of body weight, and the dose should be adjusted to the age and weight of the patient and the severity of the condition being treated.

For prophylaxis of nausea and vomiting, as during surgery and the postoperative period, the average dose is 25 mg repeated at 4 to 6 hour intervals, as necessary.
Sedation
This product relieves apprehension and induces a quiet sleep from which the patient can be easily aroused. Administration of 12.5 mg to 25 mg promethazine HCl by the oral route or by rectal suppository at bedtime will provide sedation in children. Adults usually require 25 mg to 50 mg for nighttime, presurgical, or obstetrical sedation.
Pre- and Postoperative Use
Promethazine HCl in 12.5 mg to 25 mg doses for children and 50 mg doses for adults the night before surgery relieves apprehension and produces a quiet sleep.

For preoperative medication, children require doses of 0.5 mg per pound of body weight in combination with an appropriately reduced dose of narcotic or barbiturate and the appropriate dose of an atropine like drug.

Usual adult dosage is a 50 mg promethazine HCl with an appropriately reduced dose of narcotic or barbiturate and the required amount of a belladonna alkaloid.

Postoperative sedation and adjunctive use with analgesics may be obtained by the administration of 12.5 mg to 25 mg in children and 25 mg to 50 mg doses in adults. Promethazine hydrochloride tablets are contraindicated for children under 2 years of age.

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Cantrell Drug Company

Promethazine Hcl | Cantrell Drug Company

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Cantrell Drug Company

Promethazine Hcl | Cantrell Drug Company

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Cantrell Drug Company

Promethazine Hcl | Cantrell Drug Company

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall