Promethazine DM Dosage & Rx Info

Promethazine Dm Generic Name & Formulations

Legal Class

General Description

Promethazine HCl 6.25mg, dextromethorphan HBr 15mg; per 5mL; liq; contains alcohol 7%.

Pharmacological Class

Antihistamine + antitussive.

How Supplied

Contact supplier.

Manufacturer

Various generic manufacturers

Mechanism of Action

Dextromethorphan is an antitussive agent and, unlike the isomeric levorphanol, it has no analgesic or addictive properties. It acts centrally and elevates the threshold for coughing. It is about equal to codeine in depressing the cough reflex. In therapeutic dosage dextromethorphan does not inhibit ciliary activity. Promethazine is an H₁ receptor blocking agent. In addition to its antihistaminic action, it provides clinically useful sedative and antiemetic effects.

Promethazine Dm Indications

Indications

Cough and upper respiratory symptoms associated with allergy and common cold.

Promethazine Dm Dosage and Administration

Adult

5mL every 4–6hrs; max 30mL/24hrs.

Children

<2yrs: not recommended. 2–6yrs: 1.25–2.5mL every 4–6hrs; max 10mL/24hrs. 6–<12yrs: 2.5–5mL every 4–6hrs; max 20mL/24hrs.

Promethazine Dm Contraindications

Contraindications

Concomitant MAOIs. Comatose states. Lower respiratory tract symptoms. Asthma. Pediatric patients <2yrs.

Promethazine Dm Boxed Warnings

Boxed Warning

Do not use in pediatric patients <2yrs due to the potential for fatal respiratory depression.

Promethazine Dm Warnings/Precautions

Warnings/Precautions

Pediatric patients ≥2yrs: caution; use lowest effective dose. Atopic children. Compromised respiratory function (eg, COPD, apnea), signs/symptoms of Reye's syndrome or hepatic disease in children: avoid. Discontinue immediately and treat appropriately if neuroleptic malignant syndrome occurs. Seizure disorder. Bone-marrow depression. Narrow-angle glaucoma. Prostatic hypertrophy. Stenosing peptic ulcer. Pyloroduodenal obstruction. Bladder-neck obstruction. Cardiovascular disease. Hepatic impairment. Debilitated. Elderly. Sedated patients or those confined to supine position. Avoid prolonged sun exposure. Labor & delivery. Pregnancy (Cat.C). Nursing mothers.

Promethazine Dm Pharmacokinetics

Metabolism

Hepatic. 93% serum protein bound (promethazine).

Elimination

Renal. Half-life: 3–30 hours (dextromethorphan); 12-15 hours (promethazine).

Promethazine Dm Interactions

Interactions

See Contraindications. Increased extrapyramidal effects with MAOIs. Avoid use with concomitant respiratory and CNS depressants (eg, alcohol, sedatives/hypnotics, narcotics, general anesthesia, tricyclics, tranquilizers); if unavoidable, may need to reduce dose. Concomitant epinephrine: not recommended. Caution with other anticholinergics. May get false pregnancy test results.

Promethazine Dm Adverse Reactions

Adverse Reactions

Drowsiness, dizziness, confusion, sedation, insomnia, convulsive seizures, hallucinations, hyperexcitability, GI upset, respiratory depression, cardiovascular effects; possible neuroleptic malignant syndrome, cholestatic jaundice, blood dyscrasias.

Promethazine Dm Clinical Trials

See Literature

Promethazine Dm Note

Not Applicable

Promethazine Dm Patient Counseling