Promethazine Hydrochloride / Codeine Phosphate

Trade Names:
Promethazine with Codeine
- Syrup 10 mg codeine phosphate/6.25 mg promethazine hydrochloride per 5 mL

Pharmacology

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Competitively antagonizes histamine at H ₁ -receptor sites and produces sedative as well as antiemetic effects.

Stimulates opiate receptors in the CNS in addition to causing respiratory depression, peripheral vasodilation, inhibition of intestinal peristalsis, stimulation of the chemoreceptors that cause vomiting, increased bladder tone, and suppression of cough.

Indications and Usage

Temporary relief of coughs and upper respiratory tract symptoms associated with allergies or the common cold.

Contraindications

Treatment of lower respiratory tract symptoms, including asthma; known hypersensitivity or idiosyncratic reaction to promethazine or other phenothiazines; hypersensitivity to any component of the product; children younger than 16 yr of age.

Dosage and Administration

PO 1 tsp (5 mL) every 4 to 6 h (max, 30 mL per 24 h).

General Advice

• Give with food or milk if GI upset occurs.
• Use dosing spoon or syringe for pediatric doses.

Storage/Stability

Store syrup at controlled room temperature (68° to 77°F). Keep tightly capped and protect from light.

Drug Interactions

Additive CNS depression.

Excessive narcotic effects or MAOI interaction may occur.

May decrease the analgesic effect of codeine by interference with metabolism of codeine to morphine.

Sedative action of promethazine is additive with these agents.

May decrease action of promethazine.

Coadministration with promethazine may increase risk of neuromuscular excitation and hypotension.

Because promethazine may reverse vasopressor effect of epinephrine, do not use epinephrine to treat promethazine-associated overdose.

Coadministration with promethazine may prolong and intensify anticholinergic effects; may cause hypotension and extrapyramidal effects.

Laboratory Test Interactions

Increased plasma levels of amylase or lipase, making determination of these enzyme levels unreliable for 24 h after taking codeine.

False-negative or false-positive interpretations of diagnostic pregnancy tests based on immunological reactions between human chorionic gonadotropin (HCG) and anti-HCG; increased blood glucose tests.

Adverse Reactions

Cardiovascular

Bradycardia; circulatory depression; faintness; orthostatic hypotension; palpitation; syncope; tachycardia; weakness.

Increased or decreased BP.

CNS

CNS depression; convulsions; disorientation; dizziness; dysphoria; euphoria; headache; lightheadedness; sedation; transient hallucinations.

Confusion; disorientation; dizziness; extrapyramidal effects (including oculogyric crisis, tongue protrusion, and torticollis); sedation; sleepiness.

Dermatologic

Facial flushing; sweating.

Photosensitivity; rash.

EENT

Visual disturbances.

Blurred vision.

GI

Biliary tract spasm; constipation; nausea; toxic dilation in patients with acute ulcerative colitis; vomiting.

Dry mouth; nausea; vomiting.

Genitourinary

Antidiuretic effect; oliguria; urinary retention.

Hematologic-Lymphatic

Agranulocytosis; leukopenia; thrombocytopenia.

Hypersensitivity

Angioneurotic edema; giant urticaria; laryngeal edema; pruitus.

Respiratory

Respiratory depression.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Undetermined.

Children

Contraindicated in children younger than 16 years of age.

Elderly

Use with caution, usually starting at low end of dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.

Special Risk Patients

Use with caution in the very young, elderly, or debilitated patient. Use with caution in patients with acute abdominal conditions, convulsive disorders, significant hepatic or renal function impairment, bone marrow depression, fever, hypothyroidism, Addison disease, ulcerative colitis, prostatic hypertrophy, CV disease, recent GI or urinary tract surgery, head injury or increased intracranial pressure, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, narrowing of the bladder neck. Use with caution in atopic children because of possible histamine release.

Cholestatic jaundice

May occur.

Dependency

Codeine has abuse potential. Psychological and physical dependence as well as tolerance may occur.

Extrapyramidal symptoms

Extrapyramidal symptoms that can occur secondary to promethazine and codeine may be confused with the CNS signs of undiagnosed primary disease (eg, encephalopathy, Reye syndrome). Avoid use in children whose signs and symptoms may suggest Reye syndrome or other hepatic diseases.

Respiratory conditions

Codeine should not be used in acute febrile illness associated with productive cough or in chronic respiratory disease where interference with ability to clear the tracheobronchial tree of secretion would be deleterious to respiratory function.

Seizure threshold

Seizure threshold may be lowered; use with caution in patients with known seizure disorders or when giving in combination with narcotics or local anesthetics that may also affect seizure threshold.

Avoid use in patients with history of sleep apnea.

Overdosage

Symptoms

Apnea, bradycardia, cardiac arrest, circulatory collapse, cold clammy skin, death, extreme somnolence progressing to stupor or coma, hypotension, respiratory depression, skeletal muscle flaccidity; promethazine is additive to depressant effects of codeine.

Signs range from mild depression of the CNS and CV system to profound hypotension, respiratory depression, and unconsciousness; stimulation (especially in children and elderly patients); paradoxical hyperexcitability and nightmares in children; convulsions; dry mouth; fixed, dilated pupils; flushing; GI symptoms.

Patient Information

• Advise patient to take prescribed dose every 4 to 6 h as needed.
• Advise caregiver to use dosing spoon or syringe when giving suspension to children.
• Advise patient to take with food or milk if GI upset occurs.
• Advise patient that if a dose is missed to take as soon as remembered unless it is nearing time for the next dose. Caution patient to not double the dose to catch up.
• Advise patient that if cough, allergy, or cold symptoms are not controlled, not to increase the dose of medication but to inform health care provider.
• Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise patient to avoid alcohol and other CNS depressants because of risk of excessive sedation.
• Caution patient not to take any OTC antihistamines or decongestants while taking this medication unless advised by health care provider.
• If patient is to have allergy skin testing, advise to not take the medication for at least 6 days before the skin testing.
• Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: abnormal muscle movements, dizziness, excessive drowsiness, unusual sensitivity to sunlight.

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