Otosil 25 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.
• Sedation, allergic rhinitis, urticaria, and insomnia.
• Adjunct in pre-operative sedation in surgery and obstetrics.
• Paediatric sedative

Pharmacology

• 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
• Reduces stimuli to the brainstem reticular system
• Well absorbed from the gastrointestinal tract
• Clinical effects apparent within 20 minutes after oral administration

Dosage & Administration

• Initial dose one 25 mg tablet at night
• May be increased to two or three 25 mg tablets at night if necessary
• More frequent administration in allergic conditions
• Elderly: No specific dosage recommendations
• Children may be treated more conveniently by the elixir containing 5 mg/5 ml

Interaction

• May enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic
• Alcohol should be avoided during drug treatment
• May interfere with immunologic urine pregnancy tests
• Should be discontinued at least 72 hours before the start of skin tests

Contraindications

• Contraindicated for use in children less than two years of age
• Hypersensitivity to promethazine or to 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

• Neuroleptic Malignant Syndrome
• Anticholinergic effects and confusion
• Allergic reactions including urticaria, rash, pruritus, and anaphylaxis
• Photosensitivity reaction
• Anorexia
• Epigastric discomfort
• Dry mouth
• Blurred vision
• Blood dyscrasias including hemolytic anemia, agranulocytosis
• Urinary retention
• Paradoxical hyperexcitability, restlessness, nightmares, disorientation
• Palpitations, arrhythmias
• Hypotension
• Jaundice
• Tiredness

Pregnancy & Lactation

• Safety in pregnancy based on epidemiological evidence
• Animal studies have shown no hazard
• Not recommended in the two weeks prior to delivery
• 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
• Use with care in patients with narrow angle glaucoma
• Use with care in patients with epilepsy
• Use with care in patients with hepatic insufciency
• Use with care in patients with renal insufciency
• Exercise caution in patients with bladder neck obstruction
• Exercise caution in patients with pyloro-duodenal obstruction

Overdose Effects

• Various combinations of excitation, ataxia, incoordination, athetosis and hallucinations in children
• Adults may become drowsy and lapse into coma
• Convulsions may occur in both adults and children
• Tachycardia may develop
• Cardiorespiratory depression is uncommon
• Symptoms may be variable

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

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