Promethazine Dm

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Promethazine Dm Recall

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Side Effects & Adverse Reactions

WARNING:

PROMETHAZINE HYDROCHLORIDE 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 HYDROCHLORIDE IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE. A WIDE RANGE OF WEIGHT-BASED DOSES OF PROMETHAZINE HYDROCHLORIDE HAVE RESULTED IN RESPIRATORY DEPRESSION IN THESE PATIENTS.

CAUTION SHOULD BE EXERCISED WHEN ADMINISTERING PROMETHAZINE HYDROCHLORIDE TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND 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.

Dextromethorphan:

Administration of dextromethorphan may be accompanied by histamine release and should be used with caution in atopic children.

Promethazine:

CNS Depression

Promethazine 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, sedatives/hypnotics (including barbiturates), narcotics, narcotic analgesics, general anesthetics, 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 may lead to potentially fatal respiratory depression.

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

Lower Seizure Threshold

Promethazine may lower seizure threshold. It 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 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.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.

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History

There is currently no drug history available for this drug.

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Other Information

Each 5 mL (one teaspoonful), for oral administration contains: Dextromethorphan hydrobromide 15 mg; promethazine hydrochloride 6.25 mg. Alcohol 7%.

Inactive Ingredients: Ascorbic acid, citric acid, D&C yellow #10, FD&C yellow #6, menthol, methylparaben, orange pineapple flavor, propylene glycol, propylparaben, purified water, saccharin sodium, sodium benzoate, sodium citrate and sucrose.

Dextromethorphan hydrobromide is a salt of the methyl ether of the dextrorotatory isomer of levorphanol, a narcotic analgesic. It is chemically designated as 3-methoxy-17-methyl-9α, 13α, 14α-morphinan hydrobromide monohydrate. Dextromethorphan hydrobromide occurs as white crystals sparingly soluble in water and freely soluble in alcohol. It has a molecular weight of 370.32, a molecular formula of C18H25NO•HBr•H2O, and the following structural formula:

This is an image of the structural formula of Dextromethorphan

Promethazine is a racemic compound. Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as 10H-Phenothiazine-10-ethanamine, N,N, α-trimethyl-monohydrochloride.

Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air. It is soluble in water and freely soluble in alcohol. It has a molecular weight of 320.88, a molecular formula of C17H20N2S•HCI, and the following structural formula:

This is an image of the structural formula of Promethazine

Sources

Promethazine Dm Manufacturers

Proficient Rx Lp

Promethazine Dm | Proficient Rx Lp

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.

Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.

Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall
Qualitest Pharmaceuticals

Promethazine Dm | Qualitest Pharmaceuticals

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall
Preferred Pharmaceuticals, Inc

Promethazine Dm | Preferred Pharmaceuticals, Inc.

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.

Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.

Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall
Physicians Total Care, Inc.

Promethazine Dm | Physicians Total Care, Inc.

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall
A-s Medication Solutions Llc

Promethazine Dm | A-s Medication Solutions Llc

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall
Remedyrepack Inc.

Promethazine Dm | Remedyrepack Inc.

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall
Remedyrepack Inc.

Promethazine Dm | Remedyrepack Inc.

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall
Aidarex Pharmaceuticals Llc

Promethazine Dm | Aidarex Pharmaceuticals Llc

Promethazine hydrochloride and dextromethorphan hydrobromide syrup is contraindicated for children under 2 years of age (see WARNINGS –Black Box Warning and Use In Pediatric Patients).

The average effective dose is given in the following table:

Adults

1 teaspoonful (5 mL) every 4 to 6 hours,
not to exceed 30 mL in 24 hours.
Children 6 Years To Under 12 Years

½ to 1 teaspoonful (2.5 to 5 mL) every 4 to 6 hours,
not to exceed 20 mL in 24 hours.
Children 2 Years To Under 6 Years

¼ to ½ teaspoonful (1.25 to 2.5 mL) every 4 to 6 hours,
not to exceed 10 mL in 24 hours.

No Recall