Lumigan

What is Lumigan?

Lumigan is a prescription medicine that is used to treat glaucoma. It is used to lower high eye pressure.

Description

LUMIGAN® (bimatoprost ophthalmic solution) 0.01% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:

Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. LUMIGAN® 0.01% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg.

LUMIGAN® 0.01% contains Active: bimatoprost 0.1 mg/mL; Inactives: benzalkonium chloride 0.2 mg/mL; sodium chloride; sodium phosphate, dibasic; citric acid; and purified water. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8-7.8.

 Mechanism of Action

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. Elevated IOP presents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

Before taking Lumigan, tell your doctor:

• If you are allergic to Lumigan; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Lumigan with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Lumigan?

• Tell all of your health care providers that you take Lumigan. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Have your eye pressure and eyesight checked as you have been told by the doctor.
• Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
• Do not give to a child younger than 16 years of age.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Lumigan best taken?

Use Lumigan as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• For the eye only.
• Use in the evening.
• Wash your hands before and after use.
• Take out contact lenses before using Lumigan. Lenses may be put back in 15 minutes after Lumigan is given. Do not put contacts back in if your eyes are irritated or infected.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of Lumigan that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• If bright lights bother your eyes.
• Eye discharge.
• Eye color may change to a brown color. This change may be long-lasting. Eye color changes may happen a few months to years after starting Lumigan. If eye color changes, call the doctor.

What are some other side effects of Lumigan?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.
• This medicine may cause dark eyelids. Most of the time, this change goes back to normal after Lumigan is stopped.
• Dry eyes.
• Feeling that something is in the eye.
• Burning.
• This medicine may cause eyelash changes like dark eyelashes, thickness, or more eyelashes. Most of the time, these changes go back to normal after Lumigan is stopped.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Lumigan?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep lid tightly closed.
• Store upright with the cap on.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

• ALLERGAN
• NDC 0023-3205-05
• LUMIGAN® 
  (bimatoprost
  ophthalmic solution)
• 0.01%
• Rx only
• 5 mL sterile
• 

SRC: NLM .