Description:

Amitriptyline Hydrochloride 25mg film-coated tablets is a tricyclic antidepressant (TCA). It is used to treat major depressive disorder, nocturnal enuresis (bedwetting) in children, neuropathic pain, migraine prophylaxis, and sometimes chronic tension-type headache or insomnia. It works by increasing the levels of serotonin and norepinephrine in the brain and also has significant anticholinergic and sedative effects, which can be beneficial for sleep disturbances or pain management.

Prescription: Prescription-only (Rx). Requires a doctor’s prescription (typically from a psychiatrist, neurologist, or general practitioner) with careful monitoring for side effects, especially in the elderly or those with cardiac conditions.

Therapeutic Category: Tricyclic antidepressant (TCA) / Neuropathic pain agent / Migraine prophylactic (N06AA09 ATC code).

Active Ingredients/Composition:

Each film-coated tablet contains: Amitriptyline hydrochloride 25 mg. Excipients: Standard tablet components (e.g., microcrystalline cellulose, lactose monohydrate, starch, magnesium stearate, hypromellose, titanium dioxide, and other coating agent).

Vitamins: None.

Minerals: None.

Variant: 25 mg strength film-coated tablets (common starting or maintenance dose; often in blister packs of 10 or 30 tablets; yellow or white film-coated tablets).

Consume Type:

Oral (tablet; swallow whole with water; can be taken with or without food, but bedtime dosing is common due to sedative effect).

Directions/Usage: Adults (for depression): Starting dose is usually 25–75 mg daily at bedtime, gradually increased to 150–300 mg daily if needed (divided doses or single bedtime dose). For neuropathic pain or migraine prophylaxis: Lower doses, typically 10–75 mg at bedtime. For nocturnal enuresis in children: 10–50 mg at bedtime (age-dependent). Take at bedtime to minimise daytime sedation. Full antidepressant effect may take 2–4 weeks. Taper gradually when discontinuing to avoid withdrawal symptoms. Follow the doctor’s exact instructions.

Common Side Effects:

• Sedation/drowsiness
• Dry mouth, blurred vision, constipation, urinary retention (anticholinergic effects)
• Weight gain
• Orthostatic hypotension, dizziness
• Tachycardia
• Sexual dysfunction Serious rare: Cardiac arrhythmias (especially in overdose or elderly), seizures, serotonin syndrome (if combined with other serotonergic drugs), suicidal thoughts (especially in young adults at start of treatment).

Package Type:

Blister packs (commonly 10 or 30 tablets per pack; foil-aluminum blisters in carton box).

Storage Advice: Store at room temperature (below 25–30°C), in a cool, dry place away from direct sunlight, heat, and moisture. Keep in original packaging. Keep out of reach of children.

Safety Advice:

• High risk of suicidality in young adults and children — close monitoring required at the start of treatment and with dose changes.
• Caution in elderly (increased risk of falls, confusion, cardiac effects), glaucoma, prostate enlargement, heart disease, or seizure disorders.
• Contraindicated in recent myocardial infarction, arrhythmias, severe liver disease, or during acute recovery phase of MI.
• Avoid with MAOIs (or within 14 days of stopping MAOIs) — risk of serotonin syndrome.
• Pregnancy: Use only if benefits outweigh risks (Category C). Breastfeeding: Caution (excreted in milk).
• Report mood changes, suicidal thoughts, or severe side effects immediately.
• Do not stop abruptly (risk of withdrawal symptoms like nausea, headache, irritability).

Product Substitutes: Other amitriptyline 25mg tablets in Ghana: Generic amitriptyline (various importers), Tryptizol (original MSD, if available), or brands from Kinapharma or Dannex. Alternatives: Other TCAs (e.g., imipramine), SSRIs (e.g., sertraline, fluoxetine), or SNRIs (e.g., duloxetine) for depression or neuropathic pain. Consult a psychiatrist or doctor for suitable options.

Manufacturer/Marketer:

Flamingo Pharmaceuticals Ltd.

Country of Origin:

India.