Progan 5 mg/5 ml (Oral Solution)

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.
• For sedation, allergic rhinitis, urticaria, and insomnia.
• As an adjunct in pre-operative sedation in surgery and obstetrics.

Pharmacology

• Phenothiazine derivative
• Blocks postsynaptic mesolimbic dopaminergic receptors in the brain
• Exhibits strong α-adrenergic blocking effect
• Competes with histamine for H1-receptor
• Reduces stimuli to the brainstem reticular system
• Well absorbed from the gastrointestinal tract
• Clinical effects within 20 minutes after oral administration

Dosage & Administration

• Initial dose for adults: one 25 mg tablet at night
• Increased dose for adults: two or three 25 mg tablets at night if necessary
• Dosing for children: 5-25 mg based on age and condition

Interaction

• Enhances the action of anticholinergic agents and tricyclic antidepressants
• Interferes with immunologic urine pregnancy tests
• Should be discontinued 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 in a coma or suffering from CNS depression
• Avoid in patients who have been taking monoamine oxidase inhibitors within the previous 14 days

Side Effects

• Neuroleptic Malignant Syndrome
• Allergic reactions including urticaria, rash, and pruritus
• Photosensitivity reaction
• Anorexia
• Epigastric discomfort
• Dry mouth
• Blurred vision
• Blood dyscrasias including hemolytic anemia and agranulocytosis
• Urinary retention
• Restlessness, nightmares, and disorientation in children
• Palpitations and arrhythmias
• Hypotension
• Jaundice
• Tiredness. Promethazine abuse cases reported

Pregnancy & Lactation

• Epidemiological evidence for safety in pregnancy
• Animal studies have shown no hazard
• Not recommended in the two weeks prior to delivery
• Excreted in breastmilk with risks of neonatal irritability and excitement

Precautions & Warnings

• Avoid in children and adolescents with signs 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 insufficiency, renal insufficiency, bladder neck obstruction, and pyloro-duodenal obstruction

Overdose Effects

• Variable symptoms including excitation, ataxia, incoordination, athetosis, hallucinations, drowsiness, coma, convulsions, and tachycardia
• Cardiorespiratory depression is uncommon
• Treatment involves inducing vomiting, gastric lavage, and supportive care

Therapeutic Class

• Anti-emetic drugs
• Miscellaneous sedatives & hypnotics
• Sedating anti-histamine

Storage Conditions

• Protect from light
• Do not use after the expiry date
• Keep out of the reach of children
• To be dispensed only on the prescription of a registered physician

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