Manufactured by: Allergan, Inc
In what dosage form and strengths is Lumigan available?
It is available in the form of an ophthalmic solution in the strengths of 0.1 mg/mL bimatoprost and 0.3 mg/mL bimatoprost.
What should the patients know about this drug?
- The patients should be advised to read the medication guide thoroughly before taking the medicine and each time when getting a refill as there may be new information incorporated.
- It is not recommended for patients under the age of 16 years.
- Patients should be informed of eyelash changes associated with Lumigan, as it can cause increase in length, thickness, and number of lashes. These changes are reversed upon stoppage of this drug.
- Lumigan contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses. Advise patients to remove contact lenses prior to instillation of Lumigan and may reinsert them 15 minutes following its administration.
- Lumigan has not been assessed for the treatment of angle-closure, inflammatory or neovascular glaucoma.
- Caution needs to be exercised in active intraocular inflammation (e.g., uveitis).
- It can also lead to bacterial keratitis i.e., inflammation of the cornea, specifically in patients using multiple-dose containers of topical ophthalmic products that may have gotten contaminated.
- Caution should be taken with aphakic and pseudophakic i.e., patients lacking the lens of the eye, with a torn posterior lens capsule as it could result in macular edema.
- Counsel patients about the continuing increase in pigmentation of the iris, eyelid and eyelashes on the administration of Lumigan.
- Do not allow the tip of the Lumigan eye dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated, it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.
- After using Lumigan, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.
In which conditions can this drug be used?
Lumigan is used to treat open angle glaucoma and to lower the increased intra-ocular pressure associated with glaucoma.
- Only your doctor is fully authorised to prescibe the exact dose form for you. However, the FDA has approved instillation of one drop per day in the affected eye.
- Do not use Lumigan more than the recommended dose because it can lead to reduced pressure in eyes (intraocular pressure) causing discomfort.
- Also, if you are using other opthalmic products along with Lumigan, consult your doctor. You should not instill both drops (or other formulation such as ointment, solution etc) at the same time.
- Keep the eye drops away from children.
How Should You Use Lumigan? To apply the Lumigan eye drops:
- Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.
- Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
- Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.
- Wait at least 10-15 minutes before using any other eye drops your doctor has prescribed.
- Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.
- Do not use Lumigan eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.
- Store Lumigan ophthalmic solution in a refrigerator or at room temperature, away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.
- Tell your doctor at once if you have an eye injury, if you develop an eye infection, or if you plan to have an eye surgery.
Contra-Indications And Precautions Related To Lumigan Use:
- The drug is contra-indicated in those patients who are allergic to Lumigan or any of its constituents.
- Caution should be taken in patients who lack ocular lens or are with known risk factors for macular edema.
- It should not be used with contact lenses as it contains benzalkonium chloride, which may be absorbed by and cause discoloration of soft contact lenses, so take soft contact lenses out when applying and then reinsert at least 15 min later.
- Bacterial keratitis may result from inadvertent contamination of multi-dose ophthalmic solutions, so precautions should be taken to reduce the contamination.
- It can permanently change brown pigmentation of the iris, eyelid skin, and eyelashes and patients developing such signs should have their eyes periodically tested.
- It is not advised to use Lumigan for the treatment of angle-closure, inflammatory or neovascular glaucoma.
Adverse Effects Or How This Drug Can Adversely Affect You?
The most common adverse reactions seen with Lumigan include conjunctival hyperemia (excess of blood). Other unpleasant side effects caused by this drug are:
- Growth of eyelashes
- Ocular pruritus
- Ocular dryness
- Visual disturbance
- Ocular burning
- Foreign body sensation
- Ocular pain
- Pigmentation of the periocular skin
- Eyelid erythema
- Ocular irritation
- Eyelash darkening
- Ocular discharge
- Allergic conjunctivitis
- Increases in iris pigmentation
- Conjunctival edema
- Eye swelling
- Eyelids: burning sensation, edema, irritation, pruritus
- Iris hyperpigmentation
- Periorbital and lid changes associated with a deepening of the eyelid sulcus
- Rash (including macular, erythematous, and pruritic limited to the eyelids and periorbital region)
- Skin discoloration (periorbital)
- Blurred vision
Post-Marketing Surveillance: The following reactions have been identified during post-marketing use of Lumigan: dizziness, eyelid edema, hypertension, nausea, and periorbital and lid changes associated with a deepening of the eyelid sulcus.
How Can Lumigan Interact With Other Drugs?
Extensive drug interactions with Lumigan have not been clarified.
Can This Drug Be Used In The Specific Populations?
- In Pregnant Women: It is a pregnancy category C There are no adequate and well-controlled studies of Lumigan in pregnant mothers. Because animal reproductive studies are not always predictive of human response, Lumigan should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- In Nursing Mothers: Excretion in milk is unknown so it should be used with caution in breast-feeding women; only if benefits outweigh the risks to both mother and the baby.
- In Pediatrics: As the long-term chronic use of Lumigan can lead to augmented pigmentation, use in pediatric patients below the age of 16 years is not recommended.
- In Geriatrics: No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
- In Hepatic Impairment: In patients with a history of liver disease or abnormal ALT, AST and/or bilirubin at baseline, bimatoprost had no hostile effect on liver function over 48 months.
How This Drug Acts Pharmacologically?
Lumigan (bimatoprost ophthalmic solution) is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide.
Bimatoprost, a prostaglandin analog, is a synthetic structural analog of prostaglandin with ocular hypotensive activity. It selectively mimics the effects of naturally occurring substances, prostamides. Bimatoprost is believed to lower intraocular pressure (IOP) in humans by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes.
What Is The Pharmacokinetics Of This Drug?
Absorption: No significant systemic accumulation occurs with this drug.
Distribution: Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.
Metabolism and Elimination: It gets metabolized via Oxydation; N-deethylation and glucoronidation. About 67% of drug gets excreted renally and about 25% gets removed through feces.
Toxicology Of Lumigan:
- This medicine was not found to be carcinogenic during pre-clinical trials.
- It was found to be non-mutagenic or clastogenic.
- It did not affect the reproductive functioning of the tested mice and rats.
What Should You Tell Your Doctor Before Taking This Medication?
To make sure this medicine is safe for you, tell your doctor if you:
- Have an eye condition called uveitis; or
- Have a swelling or infection of your eye
- Are or planning on becoming pregnant. It is not known whether Lumigan will harm an unborn baby.
- Are nursing a baby. It is not known whether bimatoprost passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
- Are 16 or less. Lumigan is not approved for use by anyone younger than 16 years old.