Allergan 5 mg/5 ml (Oral Solution)
100 ml bottle: ৳ 24.00
Medicine Details
Category | Details |
---|---|
Generic | Promethazine hydrochloride |
Company | Cipla limited |
Indications
- Potent long-acting antihistamine with additional anti-emetic and sedative/calming effects
- Indicated in symptomatic treatment of allergic conditions of the respiratory tract and skin
- Sensitization reactions to drug or foreign proteins, anaphylactic reactions
- For sedation, allergic rhinitis, urticaria and insomnia
- As an adjunct in pre-operative sedation in surgery and obstetrics
- As a 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
- Muscarinic blocking effect responsible for antiemetic activity
- Reduces stimuli to the brainstem reticular system
- Well absorbed from the gastrointestinal tract
- Clinical effects appear within 20 minutes after oral administration
- Metabolized by the liver to a variety of compounds
- Sulfoxides of promethazine and N-demethylpromethazine are predominant metabolites appearing in the urine
Dosage & Administration
- Initial dose one 25 mg tablet at night; may be increased to two or three 25 mg tablets at night if necessary
- In allergic conditions more frequent administration may be necessary
- Elderly: No specific dosage recommendations
- Children may be treated more conveniently by the elixir containing 5 mg/5 ml
- Specific dosage recommendations for antihistamine and sedative use in children
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 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 patients who are in a coma or suffering from CNS depression
- To be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days
Side Effects
- Nervous system disorders including somnolence, confusion, dizziness, headaches, and extrapyramidal effects
- Allergic reactions, including urticaria, rash, and pruritus
- Photosensitivity reaction, anorexia, epigastric discomfort, dry mouth, and blurred vision
- Blood dyscrasias, urinary retention, and cardiac and vascular disorders
- Jaundice, tiredness, neuroleptic malignant syndrome, and potential promethazine abuse
Pregnancy & Lactation
- Epidemiological evidence for the safety of promethazine in pregnancy
- Caution advised in the two weeks prior to delivery and high doses during late pregnancy
- Excreted in breastmilk with risks of neonatal irritability and excitement
Precautions & Warnings
- To be 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, bronchiectasis, severe coronary artery disease, narrow angle glaucoma, epilepsy, hepatic insufficiency, renal insufficiency
- Caution needed in patients with bladder neck or pyloro-duodenal obstruction
Overdose Effects
- Symptoms of severe overdose include excitation, ataxia, incoordination, athetosis, hallucinations, drowsiness, and coma
- Convulsions may occur and treated with diazepam or other suitable anticonvulsant
- Supportive treatment with attention to respiratory and circulatory status
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