Promestin 5 mg/5 ml (Oral Solution)

60 ml bottle: ৳ 9.94

Medicine Details

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 for 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.
  • Competes with histamine for the H1-receptor.
  • Reduces stimuli to the brainstem reticular system.
  • Well absorbed from the gastrointestinal tract.
  • Clinical effects apparent within 20 minutes after oral administration and generally last four to six hours.
  • Metabolized by the liver to a variety of compounds.

Dosage & Administration

  • Initial dose one 25 mg tablet at night for adults; may be increased to two or three 25 mg tablets at night if necessary.
  • Twice or three times daily administration may be necessary in allergic conditions.
  • Elderly: No specific dosage recommendations.
  • Children may be treated more conveniently by the elixir containing 5 mg/5 ml.
  • Specific dosage recommendations for antihistamine in allergy and sedative for children.

Interaction

  • May enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative, or hypnotic.
  • 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 any of the excipients.
  • Not to be used in patients who are in a coma or suffering from CNS depression of any cause.
  • Avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days.

Side Effects

  • Nervous system disorders: Neuroleptic Malignant Syndrome, anticholinergic effects, confusion, somnolence, dizziness, headaches, extrapyramidal effects, muscle spasm, tic-like movements, neuroleptic malignant syndrome (NMS), high fever, fast heartbeat, agitation, hallucinations.
  • Immune System Disorders: Allergic reactions including urticaria, rash, pruritus, anaphylaxis, photosensitivity reaction.
  • Skin and Subcutaneous Tissue Disorders: Photosensitivity reaction.
  • Metabolism and Nutrition Disorders: Anorexia.
  • Gastrointestinal Disorders: Epigastric discomfort, dry mouth.
  • Eye Disorders: Blurred vision.
  • Blood and Lymphatic System Disorders: Blood dyscrasias incl. hemolytic anemia, agranulocytosis.
  • Renal and Urinary Disorders: Urinary retention.
  • Psychiatric Disorders: Anticholinergic effects, paradoxical hyperexcitability, restlessness, nightmares, disorientation.
  • Cardiac Disorders: Palpitations, arrhythmias.
  • Vascular disorders: Hypotension.
  • Hepatobiliary disorders: Jaundice.
  • General Disorders and Administration Site Conditions: Tiredness.
  • Advised use and duration of treatment.

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 due to the risk of irritability and excitement in the neonate.
  • May cause prolonged neurological disturbances in the infant when given in high doses during late pregnancy.
  • 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 caution in patients with asthma, bronchitis, or bronchiectasis.
  • Use with care in patients with severe coronary artery disease, narrow angle glaucoma, epilepsy, hepatic or renal insufficiency, bladder neck obstruction, or pyloro-duodenal obstruction.

Overdose Effects

  • Symptoms of severe overdose are variable.
  • Characterised by excitation, ataxia, incoordination, athetosis, hallucinations, drowsiness, and coma.
  • Convulsions may occur in both adults and children.
  • Tachycardia may develop.
  • Supportive treatment with attention to respiratory and circulatory status required.
  • 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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