Promethazine W. Codeine Generic Name & Formulations
Legal Class
CV
General Description
Codeine phosphate 10mg, promethazine HCl 6.25mg; per 5mL; syrup; contains alcohol 7%.
Pharmacological Class
Antitussive + antihistamine.
How Supplied
Contact supplier.
Manufacturer
Promethazine W. Codeine Indications
Indications
Cough and upper respiratory symptoms associated with allergy or common cold.
Promethazine W. Codeine Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Use accurate measuring device. ≥12yrs: 5mL every 4–6hrs; max 30mL/24hrs.
Children
<12yrs: see Contraindications.
Promethazine W. Codeine Contraindications
Contraindications
Children <12yrs. Post-op management in children <18yrs following tonsillectomy and/or adenoidectomy. Coma. Lower respiratory disorders. Asthma.
Promethazine W. Codeine Boxed Warnings
Not Applicable
Promethazine W. Codeine Warnings/Precautions
Warnings/Precautions
Risk of life-threatening respiratory depression and death related to ultra-rapid metabolizers of codeine (esp. in children for post-tonsillectomy and/or adenoidectomy pain). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant drugs that cause respiratory depression). Head injury, intracranial lesions or pre-existing increase in intracranial pressure. Avoid in chronic respiratory disease, acute febrile illness with productive cough, compromised respiratory function (eg, COPD, sleep apnea). Discontinue if neuroleptic malignant syndrome (NMS) occurs. Seizure disorders. Bone marrow depression. Acute abdomen. Fever. Hypothyroidism. Addison's disease. Ulcerative colitis. Prostatic hypertrophy. Recent GI or urinary tract surgery. Narrow-angle glaucoma. Stenosing peptic ulcer. Pyloroduodenal or bladder-neck obstruction. Dehydration. Avoid prolonged sun exposure. Severe hepatic or renal impairment. Ultra-rapid metabolizers (due to CYP2D6 polymorphism): avoid. Atopic children. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Promethazine W. Codeine Pharmacokinetics
See Literature
Promethazine W. Codeine Interactions
Interactions
Increased risk of respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, opioids, antihistamines, antipsychotics, anxiolytics, alcohol); avoid. Concomitant epinephrine: not recommended. Increased risk of NMS with concomitant antipsychotics. Caution with anticholinergics. Increased extrapyramidal effects with MAOIs. Concomitant narcotics, local anesthetics: may lower seizure threshold. May alter hCG pregnancy test and glucose tolerance test results.
Promethazine W. Codeine Adverse Reactions
Adverse Reactions
Drowsiness, CNS or respiratory depression, constipation, anticholinergic effects, orthostatic hypotension, photosensitivity, paradoxical excitement, changes in blood pressure, convulsions, jaundice, blood dyscrasias.
Promethazine W. Codeine Clinical Trials
See Literature
Promethazine W. Codeine Note
Notes
Formerly known under the brand name Phenergan with Codeine.
Promethazine W. Codeine Patient Counseling
See Literature