Prozen

Adults: Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary. In allergic conditions more frequently administration, twice or three times daily, may be necessary, starting with one or two 10 mg tablets and increasing as required.

Elderly: No specific dosage recommendations.

Children: They may be treated more conveniently by the elixir containing 5 mg/5 ml.

As an antihistamine in allergy:

• Children of 2-5 years: 5-15 mg
• Children of 5-10 years: 10-25 mg
• In the case where two doses in 24 hours are required, the lower dose stated should be given.

As a sedative:

• Children of 2-5 years: 15-20 mg
• Children of 5-10 years: 20-25 mg
• Given as a single night-time dose

• Nervous system disorders: Frequency Unknown: Neuroleptic Malignant Syndrome the elderly are particularly susceptible to the anticholinergic efects and confusion due to Promethazine, somnolence, dizziness, headaches, extrapyramidal efects including muscle spasm, tic-like movements of the head and face. A very serious and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Stop treatment and call your doctor right away if you have high fever, muscle cramps or stifness, dizziness, very bad headache, fast heartbeat, confusion, agitation, hallucinations, or are sweating a lot.
• Immune System Disorders- Frequency unknown: Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis, have been reported.
• Skin and Subcutaneous Tissue Disorders- Frequency unknown: Photosensitivity reaction
• Metabolism and Nutrition Disorders- Frequency unknown: Anorexia
• Gastrointestinal Disorders- Frequency unknown: Epigastric discomfort, dry mouth
• Eye Disorders- Frequency unknown: Blurred vision
• Blood and Lymphatic System Disorders- Frequency unknown: Blood dyscrasias including hemolytic anemia, agranulocytosis
• Renal and Urinary Disorders- Frequency unknown: Urinary retention
• Psychiatric Disorders- Frequency unknown: Infants, newborns and premature are susceptible to the anticholinergic efects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
• Cardiac Disorders- Frequency unknown: Palpitations, arrhythmias
• Vascular disorders- Frequency unknown: Hypotension
• Hepatobiliary disorders- Frequency unknown: Jaundice
• General Disorders and Administration Site Conditions- Frequency unknown: Tiredness

Use this drug only as recommended. Do not exceed the recommended dose. There have been case reports of promethazine abuse. Do not take for longer than 10 days.

Symptoms of severe over dosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic efect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or other suitable anticonvulsant.

Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain. It exhibits strong α-adrenergic blocking effect and depresses the release of hypothalamic and hypophyseal hormones. It competes with histamine for the H1-receptor; muscarinic blocking effect may be responsible for antiemetic activity. It also reduces stimuli to the brainstem reticular system.

Promethazine is well absorbed from the gastrointestinal tract. Clinical effects are apparent within 20 minutes after oral administration and generally last four to six hours, although they may persist as long as 12 hours. Promethazine is metabolized by the liver to a variety of compounds; the sulfoxides of promethazine and N-demethylpromethazine are the predominant metabolites appearing in the urine.

Anti-emetic drugs, Miscellaneous sedatives & hypnotics, Sedating Anti-histamine