Fml-s

Fml-s is a prescription medication used to treat eye inflammation and bacterial infections of the eye.

It is a combination product containing two medications: sulfacetamide and fluorometholone. Sulfacetamide belongs to a class of medications called sulfonamide antibacterials. These drugs work by preventing bacteria from making certain chemicals they need in order to survive. Fluorometholone belongs to a class of medications called corticosteroids, which reduce inflammation by preventing the body from making chemicals that are involved in inflammation.

This medication comes in eyedrop suspension form and is typically administered four times daily.

Common side effects of Fml-s include allergic reactions, increased eye blood pressure, and delayed wound healing.

Fml-s is a prescription medication used to treat inflammation of the eye and bacterial infections of the eye caused by susceptible bacteria.

Fml-s is not effective in treating bacterial eye infections caused by Neisseria species and Serratia marcescens species.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Allergan, Inc.

• Cheshire Pharm. Systems

• Compumed Pharmaceuticals, Inc.

Serious side effects have been reported with Fml-s. See the “Fml-s Precautions” section.

Common side effects of Fml-s include the following:

• allergic skin reactions
• increased blood pressure in the eye
• skin irritation
• delayed wound healing

This is not a complete list of Fml-s side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications, supplements, or alternative medication products containing silver
• chloroprocaine
• tetracaine
• procaine

This is not a complete list of Fml-s drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Fml-s  including the following:

• High blood pressure of the eye and/or glaucoma. If Fml-s  is used for 10 days or longer, eye blood pressure should be routinely monitored.
• Bacterial and fungal corneal ulcers. Consult your physician right away and stop taking Fml-s  if you experience severe eye pain and/or pus or blood discharge from the eye.
• Non-specific conjunctivitis, conjunctival hyperemia, and secondary infections. Consult your physician right away and stop taking Fml-s  if you experience eye hypersensitivity, eye aggravation, eye swelling, or severe eye pain.
• Acute anterior uveitis. Consult your physician right away and stop taking Fml-s  if you experience abnormal eye pain.
• Defects in visual acuity and fields of vision. Consult your physician right away and stop taking Fml-s  if you experience impaired vision.
• Stevens-Johnson syndrome and toxic epidermal necrolysis. Consult your physician right away and stop taking Fml-s  if you experience skin rashes or other serious reactions after taking Fml-s .
• Posterior subcapsular cataract formation. Consult your physician right away and stop taking Fml-s  if you experience grey spots in your field of vision.

Do not take Fml-s if:

• you are allergic to Fml-s or any of its ingredients
• you have a viral or fungal eye infection

To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this tube by more than one person may spread infection. Keep tube tightly closed when not in use.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fml-s, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Fml-s, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed
• are allergic to 'sulfa' drugs or corticosteroids
• are allergic to Fml-s or to any of its ingredients
• have or recently have had any fungal, viral, or bacterial infections
• have recently taken antibiotics for any reason
• have mustard gas keratitis or Sjögren's keratoconjunctivitis

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fml-s falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Fml-s should be given to a pregnant woman only if clearly needed.

It is not known if Fml-s crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Fml-s.

Take Fml-s exactly as prescribed.

Fml-s comes in eyedrop suspension form and is typically administered four times daily.

Fml-s is not effective for treating bacterial infections caused by Neisseria species or Serratia species. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs like Fml-s.

To avoid contamination, do not touch the tip of the Fml-s bottle to the eye, eyelid or any surface.

If symptoms fail to improve after 48 hours, consult your physician.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Fml-s at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Fml-s for the treatment of inflammatory conditions of the eye and bacterial infections of the eye caused by susceptible bacteria is one drop instilled into the lower eyelid four times daily. If symptoms fail to improve after two days, consult your physician.

If you take too much Fml-s, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 15°C - 30°C (59° -86°F).
• Protect from freezing and light.
• Shake well before using.
• Do not use if Fml-s is dark brown.
• Keep out of the reach of children.