Histaphen 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

• Blocks postsynaptic mesolimbic dopaminergic receptors in the brain
• 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
• Clinical effects apparent within 20 minutes after oral administration
• Lasts four to six hours, with potential for effects up to 12 hours

Dosage & Administration

• Adults initial dose: one 25 mg tablet at night
• Children treated more conveniently by the elixir containing 5 mg/5 ml
• Antihistamine dosage for children of 2-10 years
• Sedative dosage for children of 2-10 years

Interaction

• Enhances 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 less than two years of age
• Hypersensitivity to promethazine or any excipients
• Not to be used in patients who are in a coma or suffering from CNS depression
• Avoided in patients who have taken 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
• Metabolism and nutrition disorders - anorexia
• Gastrointestinal disorders - epigastric discomfort, dry mouth
• Eye disorders - blurred vision
• Blood dyscrasias including hemolytic anemia, agranulocytosis
• Urinary retention
• Infants, newborns and premature susceptible to anticholinergic effects of promethazine
• Palpitations, arrhythmias
• Hypotension
• Jaundice
• Tiredness

Pregnancy & Lactation

• Epidemiological evidence for safety in pregnancy
• Not recommended in the two weeks prior to delivery
• Caution in high doses during late pregnancy
• 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 care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy, hepatic or renal insufficiency
• Caution in patients with bladder neck obstruction and pyloro-duodenal obstruction

Overdose Effects

• Symptoms of severe overdose in children and adults
• Possible induction of vomiting with ipecacuanha
• Supportive treatment with attention to respiratory and circulatory status
• Treatment of convulsions 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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