Description:

Atrolant D (Atropine 1.0% p/v collyre 10ml) is a sterile ophthalmic solution containing atropine sulfate. It is a potent mydriatic and cycloplegic agent used to dilate the pupil (mydriasis) and paralyze the ciliary muscle (cycloplegia) in the eye. It is mainly indicated for:

• Refraction procedures (especially in children, to determine true refractive error by relaxing accommodation).
• Uveitis / iritis (to prevent or relieve painful ciliary spasm and posterior synechiae formation).
• Amblyopia treatment (penalization therapy in children by blurring the good eye).
• Certain diagnostic and therapeutic procedures requiring pupillary dilation. In Ghana (Accra), it is a prescription eye drop commonly used in ophthalmology clinics and hospitals for paediatric refraction and inflammatory eye conditions.

Prescription: Prescription-only (requires a doctor’s prescription in Ghana; dispensed by pharmacies with Rx; administered or prescribed by ophthalmologists or trained eye care professionals; not OTC due to strong and long-lasting effects, risk of systemic absorption, and need for proper ocular examination).

Therapeutic Category:

Mydriatic / Cycloplegic Agent (Anticholinergic ophthalmic preparation).

Active Ingredients/Composition:

• Active ingredient: Atropine sulfate – 1.0% p/v (10 mg per ml).
• Each 10 ml bottle contains 100 mg atropine sulfate. Other ingredients: Sodium chloride (for isotonicity), boric acid or sodium borate (buffering agents), purified water, and preservatives (e.g., benzalkonium chloride or chlorobutanol). The solution is clear, colourless, sterile, and slightly viscous.

Vitamins: None.

Minerals: None (trace sodium from sodium chloride, but not therapeutic).

Variant:

• Atrolant D 1.0% p/v collyre 10ml (standard 1% atropine eye drop). Related variants: Atropine 0.5% or 1% eye drops (lower strength for less intense mydriasis), atropine ointment (longer contact time), or homatropine/cyclopentolate (shorter-acting cycloplegics). The 1% 10ml bottle is the most common strength and volume for diagnostic and therapeutic use.

Consume Type:

Ophthalmic – Eye drops (instilled into the conjunctival sac; not for oral or systemic use).

Directions/Usage: Instilled only as directed by an ophthalmologist.

• Refraction (cycloplegia): 1 drop in each eye 2–3 times daily for 3 days before examination (children often require longer).
• Uveitis/iritis: 1 drop in affected eye(s) 1–3 times daily (or as prescribed).
• Amblyopia penalization: 1 drop in the good eye daily or as advised.
• Tilt head back, pull lower eyelid down, instil 1 drop without touching the dropper tip to the eye.
• Close eye gently for 1–2 minutes and press inner corner (tear duct) to reduce systemic absorption.
• Duration: Short-term (days) for refraction; longer (weeks) for uveitis under supervision.
• Wash hands before and after use.

Common Side Effects: Common:

• Prolonged pupil dilation (mydriasis) and blurred near vision (lasting 7–14 days).
• Photophobia (light sensitivity – wear sunglasses).
• Local irritation, burning, stinging, or redness on instillation.
• Dry mouth, flushing, tachycardia (systemic absorption – more in children). Rare/serious (seek help): Severe allergic reactions (swelling, rash), increased intraocular pressure (in narrow-angle glaucoma), or systemic anticholinergic effects (confusion, fever, dry skin, urinary retention – especially in children or overdose).

Package Type:

Plastic dropper bottle of 10 ml (with controlled-drop dispenser tip; often in individual carton with patient information leaflet and instructions).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Keep tightly closed. Discard 4 weeks after first opening (check label for exact discard date).

Safety Advice:

• For ophthalmic use only; avoid touching dropper tip to eye or any surface (risk of contamination).
• Contraindicated in narrow-angle glaucoma (risk of acute angle closure), known hypersensitivity to atropine, or certain cardiac arrhythmias.
• Caution in children (higher risk of systemic absorption and toxicity – monitor for flushing, fever, tachycardia).
• Use with caution in elderly or patients with prostatic hypertrophy, urinary retention, or gastrointestinal obstruction (anticholinergic effects).
• Remove contact lenses before instillation (wait 15 minutes before reinserting).
• If severe eye pain, vision loss, headache, nausea, or systemic symptoms (dry mouth, confusion) occur, seek immediate ophthalmic care.
• Keep out of reach of children (accidental ingestion risk – toxic in high doses).

Product Substitutes: Similar atropine 1% eye drops in Ghana include:

• Generic atropine sulfate 1% ophthalmic solution (various importers).
• Atropine Sulphate Eye Drops BP 1% (other brands).
• Alternatives: Cyclopentolate 1% eye drops (shorter-acting cycloplegic), homatropine 2%, tropicamide 1% (for refraction – shorter duration). Consult ophthalmologist/pharmacist in Accra (e.g., Korle Bu Eye Clinic pharmacy) for alternatives.

Manufacturer/Marketer:

Swiss Pharma (often Swiss Pharma or licensed Indian manufacturers produce atropine eye drops under brands like Atrolant or similar for export markets). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked as imported generic).

Country of Origin:

India (primary source for generic atropine 1% eye drops imported to Ghana; BP/USP-compliant generics common in African markets).