Otosil 10 mg (Tablet)

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
• Adjunct in pre-operative sedation in surgery and obstetrics
• Pediatric sedative

Pharmacology

• Acts on postsynaptic mesolimbic dopaminergic receptors
• Exhibits strong alpha-adrenergic blocking effect
• Competes with histamine for the H1-receptor
• Reduces stimuli to the brainstem reticular system
• Metabolized by the liver to a variety of compounds

Dosage & Administration

• Adult initial dose: one 25 mg tablet at night
• Elderly: No specific dosage recommendations
• Children: Treatment by the elixir containing 5 mg/5 ml, varying dosage based on age
• Antihistamine dosage for different age groups
• Sedative dosage for different age groups

Interaction

• May enhance the action of anticholinergic agents, tricyclic antidepressants, sedatives or hypnotics
• May interfere with immunologic urine pregnancy tests
• Should be discontinued before skin tests using allergen extracts

Contraindications

• Contraindicated for use in children less than two years of age
• Hypersensitivity to promethazine or excipients
• Not to be used in patients who are in a coma or suffering from CNS depression
• Avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days

Side Effects

• Nervous system disorders, immune system disorders, skin and subcutaneous tissue disorders, metabolism and nutrition disorders, gastrointestinal disorders, eye disorders, blood and lymphatic system disorders, renal and urinary disorders, psychiatric disorders, cardiac disorders, vascular disorders, hepatobiliary disorders, general disorders and administration site conditions

Pregnancy & Lactation

• Epidemiological evidence for the safety of promethazine in pregnancy
• Not recommended in the two weeks prior to delivery
• Use in pregnancy only if potential benefits outweigh possible risk to the fetus
• Excreted in breastmilk with risks of neonatal irritability and excitement

Precautions & Warnings

• Avoided in children and adolescents with signs suggestive of Reye’s syndrome
• May thicken or dry lung secretions 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 in children and adults
• Convulsions in both adults and children
• Coma or excitement may precede convulsions
• Treatment is supportive and may involve induction of vomiting or gastric lavage

Therapeutic Class

• Anti-emetic drugs
• Miscellaneous sedatives & hypnotics
• Sedating antihistamine

Storage Conditions

• Protect from light
• Do not use later than the date of expiry
• Keep out of the reach of children
• To be dispensed only on the prescription of a registered physician

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