Tuesday, 20 September 2016

Lumigan

DRUG DESCRIPTION


LUMIGAN® 0.01% and 0.03% (bimatoprost ophthalmic solution) 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]cyclopentylj-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C25H37NO4. Its chemical structure is:




Lumigan (bimatoprost) structural formula illustration

Bimatoprost is a powder, which is very soluble in ethyl alcohol and methyl alcohol and slightly soluble in water. LUMIGAN® (bimatoprost ophthalmic solution 0.03% for glaucoma) 0.01% and 0.03% 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; Preservative: benzalkonium chloride 0.2 mg/mL; Inactives: 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.


LUMIGAN® 0.03% contains Active: bimatoprost 0.3 mg/mL; Preservative: benzalkonium chloride 0.05 mg/mL; Inactives: 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.






What are the possible side effects of bimatoprost ophthalmic (Lumigan)?



Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.


Stop using bimatoprost ophthalmic and call your doctor at once if you have any of these serious side effects:


  • redness, swelling, itching, or pain in or around your eye;

  • oozing or discharge from your eye;

  • increased sensitivity to light;

  • vision changes.

Less serious side effects may include:



    ...

Read All Potential Side Effects and See Pictures of Lumigan »



What are the precautions when taking bimatoprost ophthalmic solution 0.03% for glaucoma (Lumigan)?


Before using bimatoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., latanoprost, travoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop an eye infection or injury, or have eye surgery, check with your doctor about the continued use of your current bottle of bimatoprost. You may be advised to start using a new bottle.

This drug may cause temporary...


Read All Potential Precautions of Lumigan »








Lumigan Consumer (continued)


SIDE EFFECTS: Burning/stinging/irritation/redness of the eye, feeling as if something is in your eye, dry eyes, watering eyes, and increased sensitivity to light may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may slowly (over months to years) cause brown discoloration of the colored portion of the eye (iris). If you are using bimatoprost in only one eye, only that iris may change color. An increase in eyelash number/length/thickness and darkening of the eyelashes/eyelids may also occur in the treated eye. These changes may be permanent, but the long-term effects are uncertain. Notify your doctor if this occurs, and schedule regular eye exams to monitor it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, eye pain/swelling, swelling/redness of the eyelids.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.


PRECAUTIONS: Before using bimatoprost, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (e.g., latanoprost, travoprost); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., macular edema, iritis, uveitis, lens extraction/aphakia).

If you develop an eye infection or injury, or have eye surgery, check with your doctor about the continued use of your current bottle of bimatoprost. You may be advised to start using a new bottle.

This drug may cause temporary unstable vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.



Lumigan Patient Information Including Side Effects


Brand Names: Lumigan


Generic Name: bimatoprost ophthalmic (Pronunciation: bih MAT o prost)




  • What is bimatoprost ophthalmic (Lumigan)?

  • What are the possible side effects of bimatoprost ophthalmic (Lumigan)?

  • What is the most important information I should know about bimatoprost ophthalmic (Lumigan)?

  • What should I discuss with my health care provider before using bimatoprost ophthalmic (Lumigan)?

  • How should I use bimatoprost ophthalmic (Lumigan)?

  • What happens if I miss a dose (Lumigan)?

  • What happens if I overdose (Lumigan)?

  • What should I avoid while using bimatoprost ophthalmic (Lumigan)?

  • What other drugs will affect bimatoprost ophthalmic (Lumigan)?

  • Where can I get more information?

What is bimatoprost ophthalmic (Lumigan)?



Bimatoprost ophthalmic reduces pressure in the eye by increasing the amount of fluid that drains from the eye.


Bimatoprost ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye. Bimatoprost is also used to improve fullness, length, and color of the eyelashes in people with a condition called hypotrichosis (HYE-poe-trye-KOE-sis), a lack of eyelash growth.


Bimatoprost ophthalmic may also be used for other purposes not listed in this medication guide.


What are the possible side effects of bimatoprost ophthalmic (Lumigan)?



Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.


Stop using bimatoprost ophthalmic and call your doctor at once if you have any of these serious side effects:


  • redness, swelling, itching, or pain in or around your eye;

  • oozing or discharge from your eye;

  • increased sensitivity to light;

  • vision changes.

Less serious side effects may include:


  • mild eye discomfort;

  • dizziness;

  • feeling like something is in your eye;

  • dry or watery eyes; or

  • stinging or burning of the eyes after using the drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What is the most important information I should know about bimatoprost ophthalmic (Lumigan)?



Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using bimatoprost before putting your contact lenses in.


Bimatoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.


Do not allow the dropper to touch any surface, including the 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 this medication, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.


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