Promalex-M 5 mg/5 ml (Oral Solution)
60 ml bottle: ৳ 18.70
Medicine Details
| Category | Details |
|---|---|
| Generic | Promethazine hydrochloride |
| Company | Modern pharmaceuticals 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
- Sedation, allergic rhinitis, urticaria, and insomnia
- Adjunct in pre-operative sedation in surgery and obstetrics
- Paediatric sedative
Pharmacology
- Phenothiazine derivative
- Blocks postsynaptic mesolimbic dopaminergic receptors
- 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
- Metabolized by the liver to a variety of compounds
Dosage & Administration
- Initial dose for adults: one 25 mg tablet at night
- May be increased to two or three 25 mg tablets at night if necessary
- Elderly: No specific dosage recommendations
- Children may be treated more conveniently by the elixir containing 5 mg/5 ml
- Antihistamine dosage for children of 2-5 years: 5-15 mg
- Antihistamine dosage for children of 5-10 years: 10-25 mg
- Sedative dosage for children of 2-5 years: 15-20 mg
- Sedative dosage for children of 5-10 years: 20-25 mg
Interaction
- May enhance the action of anticholinergic agents, tricyclic antidepressants, sedatives, or hypnotics
- 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 any excipients
- Not to be used in patients who are in a coma or suffering from CNS depression of any cause
- Should be avoided in patients who have been taking monoamine oxidase inhibitors within the previous 14 days
Side Effects
- Neuroleptic Malignant Syndrome
- Anticholinergic effects
- Confusion
- Somnolence
- Dizziness
- Headaches
- Muscle spasm
- Allergic reactions including urticaria, rash, pruritus, and anaphylaxis
- Photosensitivity reaction
- Anorexia
- Epigastric discomfort
- Dry mouth
- Blurred vision
- Blood dyscrasias including hemolytic anemia
- Urinary retention
- Paradoxical hyperexcitability in children
- Palpitations
- Arrhythmias
- Hypotension
- Jaundice
- Tiredness
- Potential for abuse
- Do not take for longer than 10 days
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
- Used in pregnancy only if the potential benefits are 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
- Used with caution in patients with asthma, bronchitis, or bronchiectasis
- 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
- Characterized in children by combinations of excitation, ataxia, incoordination, athetosis, and hallucinations
- Adults may become drowsy and lapse into a coma
- Convulsions may occur in both adults and children
- Coma or excitement may precede convulsions
- Tachycardia may develop
- Cardiorespiratory depression is uncommon
- Induce vomiting with ipecacuanha despite the antiemetic effect of promethazine
- Supportive treatment with attention to 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