Otosil 5 mg/5 ml (Oral Solution)

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

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