Otosil 5 mg/5 ml (Oral Solution)
60 ml bottle: ৳ 21.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Promethazine hydrochloride |
| Company | Opsonin pharma ltd |
| Also available as |
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, allergic rhinitis, urticaria, and insomnia
- Adjunct in pre-operative sedation in surgery and obstetrics
- Paediatric sedative
Pharmacology
- Phenothiazine derivative
- Blocks postsynaptic mesolimbic dopaminergic receptors
- Exhibits strong α-adrenergic blocking effect
- Depresses the release of hypothalamic and hypophyseal hormones
- Competes with histamine for the H1-receptor
- Metabolized by the liver
Dosage & Administration
- Initial dose of one 25 mg tablet at night for adults
- Elderly: No specific dosage recommendations
- Children's dosage: Conveniently by the elixir containing 5 mg/5 ml
- Antihistamine dosage for children of 2-5 years: 5-15 mg
- Sedative dosage for children of 2-5 years: 15-20 mg
Interaction
- May enhance the action of anticholinergic agents, tricyclic antidepressants, sedatives, or hypnotics
- May interfere with immunologic urine pregnancy tests
- Should be discontinued at least 72 hours before skin tests using allergen extracts
Contraindications
- Contraindicated for use in children under two years
- Hypersensitivity to promethazine or any 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 taken monoamine oxidase inhibitors within the previous 14 days
Side Effects
- Nervous system disorders including somnolence, dizziness, and neuroleptic malignant syndrome
- Allergic reactions, including urticaria, rash, and pruritus
- Metabolism and nutrition disorders like anorexia
- Gastrointestinal disorders including epigastric discomfort and dry mouth
- Eye disorders such as blurred vision
- Blood and lymphatic system disorders including hemolytic anemia and agranulocytosis
- Renal and urinary disorders such as urinary retention
- Psychiatric disorders including paradoxical hyperexcitability and restlessness
- Cardiac disorders like palpitations and arrhythmias
- Vascular disorders including hypotension
- Hepatobiliary disorders such as jaundice
- General disorders and administration site conditions including tiredness
Pregnancy & Lactation
- Epidemiological evidence for safety in pregnancy and no hazard in animal studies
- Not recommended in the two weeks prior to delivery
- Use only if potential benefits outweigh possible risks to the fetus
- Excreted in breastmilk with 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
- Use with care in patients with narrow-angle glaucoma
- Use with care in patients with epilepsy
- Use with care in patients with hepatic insufficiency
- Use with care in patients with renal insufficiency
Overdose Effects
- Varied symptoms in children and adults
- Characterized by excitation, ataxia, incoordination, athetosis, and hallucinations
- May lead to drowsiness and coma in adults
- Convulsions may occur in both adults and children
- Tachycardia may develop
- Supportive treatment with attention to respiratory and circulatory status
Therapeutic Class
- Anti-emetic drugs
- Miscellaneous sedatives & hypnotics
- Sedating antihistamine
Storage Conditions
Protect from light and keep out of reach of children