Promestin 5 mg/5 ml (Oral Solution)
60 ml bottle: ৳ 9.94
Medicine Details
Category | Details |
---|---|
Generic | Promethazine hydrochloride |
Company | Pharmadesh laboratories ltd |
Indications
- Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects.
- Symptomatic treatment of allergic conditions of the respiratory tract and skin.
- Sensitization reactions to drug or foreign proteins, anaphylactic reactions.
- Sedation for allergic rhinitis, urticaria, and insomnia.
- Adjunct in pre-operative sedation in surgery and obstetrics.
- Paediatric sedative.
Pharmacology
- Blocks postsynaptic mesolimbic dopaminergic receptors in the brain.
- Exhibits strong α-adrenergic blocking effect.
- Competes with histamine for the H1-receptor.
- Reduces stimuli to the brainstem reticular system.
- Well absorbed from the gastrointestinal tract.
- Clinical effects apparent within 20 minutes after oral administration and generally last four to six hours.
- Metabolized by the liver to a variety of compounds.
Dosage & Administration
- Initial dose one 25 mg tablet at night for adults; may be increased to two or three 25 mg tablets at night if necessary.
- Twice or three times daily administration may be necessary in allergic conditions.
- Elderly: No specific dosage recommendations.
- Children may be treated more conveniently by the elixir containing 5 mg/5 ml.
- Specific dosage recommendations for antihistamine in allergy and sedative for children.
Interaction
- May enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative, or hypnotic.
- May interfere with immunologic urine pregnancy tests.
- Should be discontinued at least 72 hours before the start of skin tests using allergen extracts.
Contraindications
- Contraindicated for use in children less than two years of age.
- Hypersensitivity to promethazine or any of the excipients.
- Not to be used in patients who are in a coma or suffering from CNS depression of any cause.
- Avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days.
Side Effects
- Nervous system disorders: Neuroleptic Malignant Syndrome, anticholinergic effects, confusion, somnolence, dizziness, headaches, extrapyramidal effects, muscle spasm, tic-like movements, neuroleptic malignant syndrome (NMS), high fever, fast heartbeat, agitation, hallucinations.
- Immune System Disorders: Allergic reactions including urticaria, rash, pruritus, anaphylaxis, photosensitivity reaction.
- Skin and Subcutaneous Tissue Disorders: Photosensitivity reaction.
- Metabolism and Nutrition Disorders: Anorexia.
- Gastrointestinal Disorders: Epigastric discomfort, dry mouth.
- Eye Disorders: Blurred vision.
- Blood and Lymphatic System Disorders: Blood dyscrasias incl. hemolytic anemia, agranulocytosis.
- Renal and Urinary Disorders: Urinary retention.
- Psychiatric Disorders: Anticholinergic effects, paradoxical hyperexcitability, restlessness, nightmares, disorientation.
- Cardiac Disorders: Palpitations, arrhythmias.
- Vascular disorders: Hypotension.
- Hepatobiliary disorders: Jaundice.
- General Disorders and Administration Site Conditions: Tiredness.
- Advised use and duration of treatment.
Pregnancy & Lactation
- Epidemiological evidence for the safety of promethazine in pregnancy.
- Animal studies have shown no hazard.
- Not recommended in the two weeks prior to delivery due to the risk of irritability and excitement in the neonate.
- May cause prolonged neurological disturbances in the infant when given in high doses during late pregnancy.
- Excreted in breastmilk, risks of neonatal irritability and excitement.
Precautions & Warnings
- Avoided in children and adolescents with signs and symptoms suggestive of Reye’s syndrome.
- May thicken or dry lung secretions and impair expectoration.
- Use with caution in patients with asthma, bronchitis, or bronchiectasis.
- Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy, hepatic or renal insufficiency, bladder neck obstruction, or pyloro-duodenal obstruction.
Overdose Effects
- Symptoms of severe overdose are variable.
- Characterised by excitation, ataxia, incoordination, athetosis, hallucinations, drowsiness, and coma.
- Convulsions may occur in both adults and children.
- Tachycardia may develop.
- Supportive treatment with attention to respiratory and circulatory status required.
- Convulsions should be treated with diazepam or other suitable anticonvulsant.
Therapeutic Class
- Anti-emetic drugs
- Miscellaneous sedatives & hypnotics
- Sedating Anti-histamine
Storage Conditions
- Protect from light.
- Do not use later than the date of expiry.
- Keep all medicines out of the reach of children.
- To be dispensed only on the prescription of a registered physician.