Promethazine DM (promethazine/dextromethorphan) dosing, indications, interactions, adverse effects, and more.

Sections

Sections promethazine/dextromethorphan
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

promethazine/dextromethorphan

oral syrup

(6.25mg/15mg)/5mL

Cough

Temporary relief of cough and upper respiratory tract symptoms associated with allergy or the common cold

5 mL (6.25 mg/15 mg) PO q4-6hr PRN

Maximum: 30 mL/24 hr

Other Information

Administer with special measuring device for accurate dose

Dosage Forms & Strengths

promethazine/dextromethorphan

oral syrup

(6.25mg/15mg)/5mL

Cough

<2 years: Contraindicated

2-6 years: 1.25-2.5 mL PO q4-6hr, up to 12.5 mg/30 mg (10 mL) in 24 hr

6-12 years: 2.5-5 mL PO 4-6hr, up to 25 mg/60 mg (20 mL) in 24 hr

>12 years: 6.25 mg/15 mg (5 mL) PO q4-6hr PRN, not to exceed 30 mL/24 hr

Frequency Not Defined

Promethazine

Anticholinergic effects: dry mouth, blurred vision
Tachy/bradycardia
Confusion, disorientation, EPS, sedation
Photosensitivity
Agranulocytosis, leukopenia
Obstructive jaundice

Dextromethorphan

Dizziness
Drowsiness
Sedation
Constipation
Nausea
Vomiting
Blurred vision
Nystagmus

Black Box Warnings

Do not use in patients <2 years of age because of potential for fatal respiratory depression; administer with caution to children >2 years of age

Contraindications

Promethazine

Hypersensitivity
Newborn/premature infants, <2 years (risk of potentially fatal respiratory depression)
Subcutaneous or intra-arterial administration
BPH
Narrow angle glaucoma
Pyloroduodenal obstruction, stenosing peptic ulcer, bladder neck obstruction
Severe CNS depression
Coma, Severe respiratory depression

Dextromethorphan

Concurrent nonselective MAO inhibitors: serotonin syndrome

Cautions

Promethazine

CVD, asthma, hepatic impairment, peptic ulcer, respiratory impairment
Anaphylaxis in susceptible individuals
May impair ability to drive or perform hazardous tasks
Monitor closely in patients with
-Cardiovascular disease
- Hepatic impairment
- Reye syndrome
- History of sleep apnea
Depresses hypothalamic thermoregulatory mechanism; exposure to extreme temperatures may cause hypo- or hyperthermia
Antiemetic effect may obscure toxicity of chemotherapeutic drugs

Dextromethorphan

Phenylketonuria: Contains aspartame

Pregnancy & Lactation

Pregnancy category: C

Lactation: Not recommended

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Promethazine: Antidopaminergic effect due to blocking mesolimbic dopamine receptors and alpha-adrenergic receptors in the brain; antihistaminic effect due to blocking H1-receptors

Dextromethorphan: Acts on cough center in medulla; derivative of levorphanol

Promethazine

Onset: 20 min

Duration: 4-6 hr

Bioavailability: 25% (PO)

Protein Bound: 93%

Vd: 12.9-17.7 L/hr

Metabolism: Hepatic P450 enzyme CYP2D6

Metabolites: Promethazine sulfoxide and glucuronides (inactive)

Excretion: Urine, feces

Dialyzable: No

Dextromethorphan

Onset: 15-30 min

Duration: 3-6 hr

Metabolism: Hepatic P450 enzyme CYP2D6

Excretion: Urine

Half-life: 2-4 hr (extensive metabolizers); 24 hr (poor metabolizers)

Peak plasma time: 2-3 hr

Images

No images available for this drug.

Patient Handout

A Patient Handout is not currently available for this monograph.

Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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