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

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