Starlix

Starlix is a prescription medication used to lower blood sugar levels in people with type 2 diabetes. Starlix belongs to a group of drugs called meglitinides. It causes the pancreas to produce more insulin and lower blood sugar levels after meals.

This medication comes in tablet form, and can be taken any time from 30 minutes before a meal to just before the meal.

Common side effects of Starlix include low blood sugar, flu-like symptoms, and dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Starlix is a prescription medication used alone or in combination with other medications to treat type 2 diabetes in people whose diabetes cannot be controlled by diet and exercise alone.

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

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Starlix. See "Drug Precautions".

Common side effects of Starlix include:

• upper respiratory infection
• headache
• nasal congestion
• runny nose
• joint aches
• back pain
• constipation
• cough
• flu-like symptoms

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

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:

• aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) such as:
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin)
  • indomethacin (Indocin)
  • ketoprofen (Orudis)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• a beta blocker such as:
  • acebutolol (Sectral)
  • atenolol (Tenormin)
  • betaxolol (Kerlone)
  • bisoprolol (Zebeta)
  • carvedilol (Coreg)
  • esmolol (Brevibloc)
  • labetalol (Trandate)
  • metoprolol (Lopressor, Toprol XL)
  • nadolol (Corgard)
  • nebivolol (Bystolic)
  • penbutolol (Levatol)
  • propranolol (Inderal)
  • sotalol (Betapace)
  • timolol (Blocadren)
• allergy or cold medicines
• amiodarone (Cordarone, Pacerone)
• corticosteroids such as:
  • betamethasone (Celestone)
  • cortisone
  • dexamethasone (Decadron)
  • fludrocortisone (Florinef)
  • hydrocortisone (Cortef)
  • methylprednisolone (Medrol)
  • prednisolone (Orapred, Pediapred)
  • prednisone (Deltasone, Orasone)
  • triamcinolone (Kenacort, Aristocort)
• diuretics, such as:
  • acetazolamide (Diamox)
  • amiloride (Midamor)
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
  • metolazone (Zaroxolyn)
  • torsemide (Demadex)
  • triamterene (Dyrenium, Dyazide, Maxzide)
• fluconazole (Diflucan)
• miconazole (Monistat, Micatin)
• monoamine oxidase inhibitors such as:
  • tranylcypromine (Parnate)
  • phenelzine (Nardil)
  • selegiline (Eldepryl, Zelapar)
  • isocarboxazid (Marplan)
  • rasagiline (Azilect)
• oxandrolone (Oxandrin)
• phenytoin (Dilantin, Phenytek)
• St. John's wort
• thyroid medicines such as:
  • levothyroxine (Levothroid, Levoxyl, Synthroid, Tirosint, Unithroid)
  • liothyronine (Cytomel)
  • thyroid (Armour Thyroid)
  • thyrolar

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

Serious side effects have been reported with Starlix including:

• low blood sugar. Starlix can cause low blood sugar (hypoglycemia). This medication should be taken only before meals. If you skip a meal, you should also skip your dose of Starlix.

Do not take Starlix if you:

• are allergic to Starlix
• have type 1 diabetes
• have diabetic ketoacidosis

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 Starlix, there are no specific foods that you must exclude from your diet when receiving this medication. Ask your doctor about the safe use of alcoholic beverages while you are taking Starlix.

Before receiving Starlix, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Starlix or any ingredient in it
• have type 1 diabetes
• have liver or kidney problems
• have pituitary disease
• have adrenal insufficiency
• are pregnant or breastfeeding

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.

Starlix falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Starlix 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 Starlix.

• Take Starlix exactly as prescribed.
• This medication comes in tablet form and is taken before every meal.
• Take Starlix up to half an hour (30 minutes) before meals.
• Do not take Starlix if you skip a meal.
• If you miss a dose, wait to until your next meal to take Starlix again. Do not take two doses of Starlix at the same time.

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

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

• other medical conditions you have
• other medications you are taking
• your hemoglobin A1c (HbA1c)

The recommended starting and maintenance Starlix dose is 120 mg, taken three times a day before meals. For people who are close to their hemoglobin A1c goal, the Starlix dosage may be reduced to 60 mg, taken three times a day before meals.

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

• Store Starlix room temperature between 15ºC and 30ºC (59ºF - 86ºF).
• Keep this and all medications out of the reach of children.