Bimatoprost Ophthalmic Solution 0.03% (3ml)

Misc (Generics)

Prescription anti-glaucoma ophthalmic medicine

Prostamide / prostaglandin analogue eye drops (bimatoprost 0.3 mg/ml)

UK Licensed medicinal products containing bimatoprost 0.3 mg/ml eye drops solution are authorised by the MHRA as Prescription Only Medicines.
Manufactured in accordance with Good Manufacturing Practice (GMP) for sterile ophthalmic medicinal products.
Complies with relevant pharmacopoeial standards for ophthalmic solutions and active substance bimatoprost.
Subject to ongoing pharmacovigilance, quality control and batch release testing under national and EU/UK medicines legislation.

UK Licensed medicinal products containing bimatoprost 0.3 mg/ml eye drops solution are authorised by the MHRA as Prescription Only Medicines.
Manufactured in accordance with Good Manufacturing Practice (GMP) for sterile ophthalmic medicinal products.
Complies with relevant pharmacopoeial standards for ophthalmic solutions and active substance bimatoprost.
Subject to ongoing pharmacovigilance, quality control and batch release testing under national and EU/UK medicines legislation.

Prostamide / prostaglandin analogue eye drops (bimatoprost 0.3 mg/ml)

Description

Bimatoprost Ophthalmic Solution 0.03% (3ml) is a prescription-only antiglaucoma preparation containing bimatoprost, a synthetic prostamide/prostaglandin analogue. Each 1 ml of solution contains 0.3 mg bimatoprost (0.03% w/v), formulated as sterile eye drops for topical ocular use. The medicine is used to reduce raised intraocular pressure in patients with open-angle glaucoma or ocular hypertension by increasing aqueous humour outflow, thereby lowering intraocular pressure and helping to prevent optic nerve damage and progressive loss of vision. It may be used as monotherapy or as adjunctive therapy to topical beta-blockers and other intraocular pressure-lowering agents. The 3 ml multi-dose bottle is intended for repeated once-daily administration to the affected eye(s) as directed by a prescriber.

Bnefits

Potent reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension when used once daily in the evening.
Prostamide/prostaglandin analogue mechanism that increases aqueous humour outflow, providing effective IOP control with a single daily dose.
Can be used as monotherapy in patients not adequately controlled or intolerant to first-line agents, or as adjunctive therapy with topical beta-blockers.
Well-established safety and efficacy profile supported by many years of clinical use in branded and generic bimatoprost eye drops.
Convenient 3 ml multi-dose bottle suitable for several weeks of therapy at one drop per eye per day.
Helps reduce the risk of glaucomatous optic nerve damage and associated progressive visual field loss when used regularly as prescribed.

Indications

Reduction of elevated intraocular pressure in patients with open-angle glaucoma.
Reduction of elevated intraocular pressure in patients with ocular hypertension.
Use as monotherapy or as adjunct to beta-blocker ophthalmic solutions when additional IOP lowering is required, in accordance with local product information.
Use in adult patients (18 years and older); use in paediatric patients depends on the specific product licence and local guidelines.

Composition

Active ingredient: Bimatoprost 0.3 mg/ml (0.03% w/v) – 0.3 mg bimatoprost per 1 ml solution.
Excipients (typical for 0.03% bimatoprost multi-dose solutions): benzalkonium chloride (as preservative), sodium phosphate dibasic/sodium phosphate dibasic heptahydrate, citric acid monohydrate or anhydrous citric acid, sodium chloride, sodium hydroxide and/or hydrochloric acid for pH adjustment, and purified water / water for injection.
Clear, colourless to slightly yellow isotonic ophthalmic solution.

Formulation

Pharmaceutical form: Eye drops, solution.
Strength: 0.3 mg/ml bimatoprost (equivalent to 0.03% w/v).
Appearance: Sterile, clear, colourless to slightly yellow aqueous solution in a multi-dose dropper bottle.
Ophthalmic formulation adjusted to physiological pH and tonicity suitable for ocular use, preserved with benzalkonium chloride (or another approved preservative) depending on the exact generic product.

Packaging

One 3 ml low-density polyethylene (LDPE) or similar plastic eye drop bottle with a dropper tip and tamper-evident screw cap, filled with 3 ml of 0.03% bimatoprost ophthalmic solution.
Bottle and cap supplied in a cardboard outer carton bearing product name, strength, batch number, expiry date, storage conditions and legal classification (e.g. Prescription Only Medicine).
Each pack contains 1 × 3 ml bottle as described in the Teleta listing.
Package leaflet / patient information leaflet (PIL) providing detailed instructions for use, warnings, contraindications and side effects (accessed via the linked patient leaflet).

Usage

For ocular use only. Do not inject or swallow.
The usual recommended dose in adults is one drop of Bimatoprost Ophthalmic Solution 0.03% in the affected eye(s) once daily, typically in the evening, as directed by the prescribing clinician.
Do not use more than once a day; using bimatoprost more often than once daily may reduce its IOP-lowering effect.
Before first use, check that the tamper-evident seal on the bottle neck is unbroken. Wash hands thoroughly before handling the bottle.
To apply: tilt the head back, gently pull down the lower eyelid to form a small pocket, hold the bottle above the eye, and instil one drop into the conjunctival sac, taking care not to touch the eye, eyelids or any surface with the dropper tip to avoid contamination.
If using with other ophthalmic medicines (e.g. beta-blocker eye drops), instil bimatoprost at least 5 minutes apart from other eye drops to prevent washout.
If a dose is missed, administer the next dose at the usual time the following day; do not double the dose to make up for a missed dose.
Contact lenses should generally be removed before instilling drops (particularly if benzalkonium chloride is present), and may be reinserted after about 15 minutes, in line with the specific product leaflet.
Continue treatment for as long as prescribed. Do not stop using the drops without consulting your doctor, as IOP may rise again.
Discard the bottle a specified number of weeks after first opening (often 4 weeks) according to the product leaflet, even if solution remains.

Contraindications

Hypersensitivity to bimatoprost or any of the excipients (including benzalkonium chloride in preserved formulations).
Current or previous severe hypersensitivity reactions to prostaglandin analogues / prostamides or other components of the formulation.
Use in pregnancy is generally avoided unless the potential benefit justifies the potential risk to the fetus, according to the SmPC for the specific product.
Caution or avoidance in breastfeeding women where local product information advises, as it is unknown whether bimatoprost is excreted in human breast milk.
Not recommended for use in children and adolescents unless specifically licensed and under specialist supervision, as clinical experience in paediatric populations is limited for many generic preparations.
Use with caution in patients with active ocular inflammation (e.g. uveitis/iritis), macular oedema (including cystoid macular oedema), aphakia or pseudophakia with torn posterior lens capsule, and in those with a history of intraocular viral infections such as herpes simplex keratitis, as stated in relevant SmPCs for bimatoprost 0.3 mg/ml eye drops.
Use with caution in patients with severe respiratory, cardiovascular or systemic conditions where changes in IOP or ocular blood flow could be clinically significant.
Contact lens wearers should use with caution due to the presence of benzalkonium chloride, which can be absorbed by soft contact lenses and may cause irritation.

Adverse Effects

Very common ocular adverse effects (≥1/10) include conjunctival hyperaemia (eye redness), mild ocular irritation or discomfort, pruritus (itching) and foreign body sensation.
Common adverse effects include eye dryness, burning or stinging on instillation, eyelid erythema, eyelid pruritus and increased tearing or discharge.
Gradual increase in brown pigmentation of the iris (particularly in patients with mixed-colour irides), which may be permanent; darkening of periocular skin and eyelid hyperpigmentation may also occur.
Increased eyelash growth, including length, thickness and number of lashes, and occasional misdirected eyelashes; these changes may be reversible after discontinuation but can be long-lasting.
Blurred vision shortly after instillation, usually transient.
Less common but clinically significant reactions include macular oedema (including cystoid macular oedema), uveitis, iritis and corneal changes, especially in predisposed patients.
Allergic conjunctivitis, eyelid oedema, eyelid dermatitis or other hypersensitivity reactions.
Systemic side effects are uncommon due to low systemic exposure, but may include headache, dizziness, and rarely worsening of asthma or respiratory symptoms in susceptible individuals.
As with other ocular medications, contamination of the bottle tip or improper use can lead to ocular infection.
Any sudden visual change, severe ocular pain, marked redness or swelling should prompt immediate medical evaluation.

Storage Conditions

Store below 25°C (or within the temperature range specified in the individual product leaflet); do not freeze.
Keep the bottle in the outer carton when not in use to protect from light.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the bottle label and carton.
After first opening, the bottle should normally be discarded after 4 weeks (or the period specified in the product leaflet), even if solution remains, to reduce the risk of contamination.
Ensure the cap is tightly closed after each use and avoid touching the dropper tip to any surface.

Duration

Long-term, chronic therapy: treatment is usually continued indefinitely or for as long as necessary to maintain satisfactory intraocular pressure control, subject to periodic ophthalmic review. Individual bottles are typically discarded 4 weeks after opening; patients then continue with a new bottle as prescribed.

Onset

Intraocular pressure-lowering effect generally begins within hours of the first dose, with maximal IOP reduction typically achieved within approximately 2 weeks of once-daily dosing. Full clinical benefit is assessed at follow-up appointments after several weeks of therapy.