Histin 5 mg/5 ml (Oral Solution)
Medicine Details
Category | Details |
---|---|
Generic | Promethazine hydrochloride |
Company | Apollo pharmaceutical ltd |
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
- Paediatric sedative
Pharmacology
- Blocks postsynaptic mesolimbic dopaminergic receptors in the brain
- Exhibits strong alpha-adrenergic blocking effect
- Depresses the release of hypothalamic and hypophyseal hormones
- Competes with histamine for the H1-receptor
- Metabolized by the liver
Dosage & Administration
- Adults: Initial dose one 25 mg tablet at night; may be increased if necessary
- Elderly: No specific dosage recommendations
- Children: May be treated more conveniently by the elixir containing 5 mg/5 ml
- Antihistamine in allergy:
- Children of 2-5 years: 5-15 mg
- Children of 5-10 years: 10-25 mg
- Sedative:
- Children of 2-5 years: 15-20 mg
- Children of 5-10 years: 20-25 mg
Interaction
- May enhance the action of anticholinergic agents
- 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 of the 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
- Safety in pregnancy based on epidemiological evidence
- Not recommended in the two weeks prior to delivery
- Potential benefits to the patient weighed against the possible risk to the fetus
- 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 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
- Caution should be exercised in patients with bladder neck obstruction
- Caution should be exercised in patients with pyloro-duodenal obstruction
Overdose Effects
Symptoms of severe overdose are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used. Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory 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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