Mitargan 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, insomnia
• Adjunct in pre-operative sedation in surgery and obstetrics
• Paediatric sedative

Pharmacology

• Promethazine is a phenothiazine derivative which blocks postsynaptic mesolimbic dopaminergic receptors in the brain
• Exhibits strong α-adrenergic blocking effect
• Reduces stimuli to the brainstem reticular system
• Well absorbed from the gastrointestinal tract
• Clinical effects are apparent within 20 minutes after oral administration
• Metabolized by the liver to a variety of compounds

Dosage & Administration

• Initial dose one 25 mg tablet at night for adults
• Elderly: No specific dosage recommendations
• Children may be treated more conveniently by the elixir containing 5 mg/5 ml
• Specific dosage ranges for children based on age groups
• Different dosage for antihistamine in allergy and sedative purposes

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 using allergen extracts

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 coma or CNS depression
• Avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days

Side Effects

• Neuroleptic Malignant Syndrome
• Anticholinergic effects and confusion in the elderly
• Allergic reactions, including urticaria, rash, pruritus, and anaphylaxis
• Photosensitivity reaction
• Anorexia, epigastric discomfort, dry mouth
• Blurred vision, blood dyscrasias, urinary retention
• Paradoxical hyperexcitability, restlessness, nightmares, disorientation
• Palpitations, arrhythmias, hypotension, jaundice, tiredness
• Case reports of promethazine abuse

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
• 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 of Reye's syndrome
• May thicken or dry lung secretions and impair expectoration
• Use with caution in patients with asthma, bronchitis, bronchiectasis, severe coronary artery disease, narrow angle glaucoma, epilepsy, hepatic insufficiency, renal insufficiency, bladder neck obstruction, pyloro-duodenal obstruction

Overdose Effects

• Symptoms of severe over dosage are variable
• Characterized in children by various combinations of excitation, ataxia, incoordination, athetosis, hallucinations
• In adults: drowsiness, coma, convulsions, tachycardia
• Treatment involves inducing vomiting, gastric lavage, and supportive care for cardiorespiratory status
• 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

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