I am diabetic

Possible side effects
Stop taking nateglinide and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives). Other, less serious side effects from nateglinide result mostly from blood sugar levels that are either too high or too low. You should be familiar with the symptoms of both high and low blood sugar levels and know how to treat both conditions. Also, be sure your family and close friends know how to help you in an emergency situation.
Low blood sugar may occur when too much nateglinide is taken; when meals are missed or delayed; if you exercise more than usual; during illness, especially with vomiting or diarrhea; if you take other medications; after drinking alcohol; and in other situations.

Hypoglycemia or Low blood sugar has the following symptoms:

• shaking;
• headache;
• cold sweats;
• pale, cool skin;
• anxiety; and
• difficulty concentrating.

Keep hard, sugary candy; chocolate; fruit juice; or glucose tablets on hand to treat episodes of low blood sugar.
Increased blood sugar may occur when not enough glimepiride is taken; if you eat significantly more food than usual; if you exercise less than usual; if you take other medications; during fever or other illness; and in other situations.

Hyperglycemia or High blood sugar has the following symptoms:

• increased thirst,
• increased hunger,
• and increased urination.

There may be an increased risk of death due to cardiovascular (heart and blood vessels) complications with the use of glimepiride when compared to the treatment of diabetes with diet or diet plus insulin. The long-term use of glimepiride should be discussed with your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Starlix?
Before taking nateglinide, tell your doctor if you are taking any of the following medicines:

• a nonsteroidal anti-inflammatory drug (NSAID) such as diclofenac (Voltaren, Cataflam), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin, Nuprin, others), indomethacin (Indocin), ketoprofen (Orudis KT, Orudis, Oruvail), nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprosyn, others), piroxicam (Feldene), sulindac (Clinoril), tolmetin (Tolectin), and others;
• aspirin (Bayer Aspirin, Ecotrin, Easprin, others) or another salicylate such as salsalate (Disalcid, Salflex, Salsitab, others), choline magnesium trisalicylate (Tricosal, Trilisate), and others;
• a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate);
• a beta-blocker such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL), or propranolol (Inderal);
• a steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), dexamethasone (Decadron), prednisolone (Prelone, others), and others;
• a diuretic (water pill) such as hydrochlorothiazide (HCTZ, HydroDiuril, Esidrix, Microzide, Oretic, others), chlorothiazide (Diuril), chlorthalidone (Thalitone, Hygroton), metolazone (Mykrox, Zaroxolyn), indapamide (Lozol), and others;
• a thyroid supplement such as Levoxyl, Synthroid, Levothroid, Levotabs, Thyrolar, Cytomel, and others; or
• a respiratory medication such as albuterol (Ventolin, Proventil, others), bitolterol (Tornalate), metaproterenol (Alupent, Metaprel), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and others.

The medicines listed above may interact with nateglinide or affect blood sugar control. You may require dosage adjustments or special monitoring during treatment.
Drugs other than those listed here may also interact with nateglinide or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

What should I avoid while taking Starlix?
Follow your diet, medication, and exercise routines very closely. Changing any of these routines can affect blood sugar levels.
Avoid alcohol. It lowers blood sugar and may interfere with diabetes treatment.
Tell your doctor and dentist that you are taking this medication before you undergo any surgery.
Do not take any over-the-counter cough, cold, allergy, pain, or weight-loss medications without first talking to your doctor or pharmacist.

Contraindications
Starlix� (nateglinide) is contraindicated in patients with:

• Known hypersensitivity to the drug or its inactive ingredients.
• Type 1 diabetes.
• Diabetic ketoacidosis. This condition should be treated with insulin.

Warnings
You should periodically test your blood or urine for abnormal sugar (glucose) levels. Even people with well-controlled diabetes may find that injury, infection, surgery, or fever results in a temporary loss of blood sugar control. At such times, the doctor may recommend that you take insulin instead of Starlix.
The effectiveness of any antidiabetic drug, including Starlix, may decrease with time. This may occur because of either a diminished responsiveness to the medication or a worsening of the diabetes.
If you have liver disease, use Starlix with caution. Also, be aware that dialysis treatments may reduce the effectiveness of the drug.
The safety and effectiveness of Starlix in children have not been established.
If you have type 1 (insulin-dependent) diabetes, you cannot use Starlix. The drug also cannot be used for diabetic ketoacidosis (a life-threatening medical emergency caused by insufficient insulin and marked by excessive thirst, nausea, fatigue, pain below the breastbone, and fruity-smelling breath).
If you are already taking a drug that promotes insulin secretion, such as Micronase, you should not switch to Starlix or add it to your current drug. In addition, Starlix is not for you if you have been taking other antidiabetic drugs for a long time, or if Starlix gives you an allergic reaction.

Precautions

Hypoglycemia
All oral blood glucose lowering drugs that are absorbed systemically are capable of producing hypoglycemia. The frequency of hypoglycemia is related to the severity of the diabetes, the level of glycemic control, and other patient characteristics. Geriatric patients, malnourished patients, and those with adrenal or pituitary insufficiency or severe renal impairment are more susceptible to the glucose lowering effect of these treatments. The risk of hypoglycemia may be increased by strenuous physical exercise, ingestion of alcohol, insufficient caloric intake on an acute or chronic basis, or combinations with other oral antidiabetic agents. Hypoglycemia may be difficult to recognize in patients with autonomic neuropathy and/or those who use beta-blockers. Starlix� (nateglinide) should be administered prior to meals to reduce the risk of hypoglycemia. Patients who skip meals should also skip their scheduled dose of Starlix to reduce the risk of hypoglycemia.

Hepatic Impairment
Starlix should be used with caution in patients with moderate-to-severe liver disease because such patients have not been studied.

Hypoglycemia
Transient loss of glycemic control may occur with fever, infection, trauma, or surgery. Insulin therapy may be needed instead of Starlix therapy at such times. Secondary failure, or reduced effectiveness of Starlix over a period of time, may occur.

Information For Patients

Carcinogenesis/ Mutagenesis/ Impairment of Fertility
Carcinogenicity: A two-year carcinogenicity study in Sprague-Dawley rats was performed with oral doses of nateglinide up to 900 mg/kg/day, which produced AUC exposures in male and female rats approximately 30 and 40 times the human therapeutic exposure respectively with a recommended Starlix dose of 120 mg, three times daily before meals. A two-year carcinogenicity study in B6C3F1 mice was performed with oral doses of nateglinide up to 400 mg/kg/day, which produced AUC exposures in male and female mice approximately 10 and 30 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals. No evidence of a tumorigenic response was found in either rats or mice.
Mutagenesis: Nateglinide was not genotoxic in the in vitro Ames test, mouse lymphoma assay, chromosome aberration assay in Chinese hamster lung cells, or in the in vivo mouse micronucleus test. Impairment of Fertility: Fertility was unaffected by administration of nateglinide to rats at doses up to 600 mg/kg (approximately 16 times the human therapeutic exposure with a recommended Starlix dose of 120 mg three times daily before meals).

Pregnancy
Pregnancy Category C
Nateglinide was not teratogenic in rats at doses up to 1000 mg/kg (approximately 60 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals). In the rabbit, embryonic development was adversely affected and the incidence of gallbladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 40 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals). There are no adequate and well-controlled studies in pregnant women. Starlix should not be used during pregnancy.

Nursing Mothers
Studies in lactating rats showed that nateglinide is excreted in the milk; the AUC0-48h ratio in milk to plasma was approximately 1:4. During the peri- and postnatal period body weights were lower in offspring of rats administered nateglinide at 1000 mg/kg (approximately 60 times the human therapeutic exposure with a recommended Starlix dose of 120 mg, three times daily before meals). It is not known whether Starlix is excreted in human milk. Because many drugs are excreted in human milk, Starlix should not be administered to a nursing woman.

Pediatric Use
The safety and effectiveness of Starlix in pediatric patients have not been established.

Geriatric Use
No differences were observed in safety or efficacy of Starlix between patients age 65 and over, and those under age 65. However, greater sensitivity of some older individuals to Starlix therapy cannot be ruled out.

Product Description

Most important information about Starlix

Pharmacokinetics

More information about STARLIX (Nateglinide) :

Starlix Combination Therapy

Starlix approved for use in combination with thiazolidinedione class of antidiabetic drugs

Study: Starlix enhances glucose control in people with impaired tolerance

To buy STARLIX (Nateglinide) click HERE: My Family Drugstore

Absorption
Following oral administration immediately prior to a meal, nateglinide is rapidly absorbed with mean peak plasma drug concentrations (Cmax) generally occurring within 1 hour (Tmax) after dosing. When administered to patients with Type 2 diabetes over the dosage range 60 mg to 240 mg three times a day for one week, nateglinide demonstrated linear pharmacokinetics for both AUC (area under the time/plasma concentration curve) and Cmax. Tmax was also found to be independent of dose in this patient population. Absolute bioavailability is estimated to be approximately 73%. When given with or after meals, the extent of nateglinide absorption (AUC) remains unaffected. However, there is a delay in the rate of absorption characterized by a decrease in Cmax and a delay in time to peak plasma concentration (Tmax). Plasma profiles are characterized by multiple plasma concentration peaks when nateglinide is administered under fasting conditions. This effect is diminished when nateglinide is taken prior to a meal.

Distribution
Based on data following intravenous (IV) administration of nateglinide, the steady-state volume of distribution of nateglinide is estimated to be approximately 10 liters in healthy subjects. Nateglinide is extensively bound (98%) to serum proteins, primarily serum albumin, and to a lesser extent ?1 acid glycoprotein. The extent of serum protein binding is independent of drug concentration over the test range of 0.1-10 �g/mL.

Metabolism
Nateglinide is metabolized by the mixed-function oxidase system prior to elimination. The major routes of metabolism are hydroxylation followed by glucuronide conjugation. The major metabolites are less potent antidiabetic agents than nateglinide. The isoprene minor metabolite possesses potency similar to that of the parent compound nateglinide.

Excretion
Nateglinide and its metabolites are rapidly and completely eliminated following oral administration. Within 6 hours after dosing, approximately 75% of the administered 14C-nateglinide was recovered in the urine. Eighty-three percent of the 14C-nateglinide was excreted in the urine with an additional 10% eliminated in the feces. Approximately 16% of the 14C-nateglinide was excreted in the urine as parent compound. In all studies of healthy volunteers and patients with Type 2 diabetes, nateglinide plasma concentrations declined rapidly with an average elimination half-life of approximately 1.5 hours. Consistent with this short elimination half-life, there was no apparent accumulation of nateglinide upon multiple dosing of up to 240 mg three times daily for 7 days.

Special Populations

Geriatric
Age did not influence the pharmacokinetic properties of nateglinide. Therefore, no dose adjustments are necessary for elderly patients.

Gender
No clinically significant differences in nateglinide pharmacokinetics were observed between men and women. Therefore, no dose adjustment based on gender is necessary.

Race
Results of a population pharmacokinetic analysis including subjects of Caucasian, Black, and other ethnic origins suggest that race has little influence on the pharmacokinetics of nateglinide.

Renal Insufficiency
Compared to healthy matched subjects, patients with Type 2 diabetes and moderate-to-severe renal insufficiency (CrCl 15-50 mL/min) not on dialysis displayed similar apparent clearance, AUC, and Cmax. Patients with Type 2 diabetes and renal failure on dialysis exhibited reduced overall drug exposure. However, hemodialysis patients also experienced reductions in plasma protein binding compared to the matched healthy volunteers.

Hepatic Impairment
The peak and total exposure of nateglinide in non-diabetic subjects with mild hepatic insufficiency were increased by 30% compared to matched healthy subjects. Starlix� (nateglinide) should be used with caution in patients with chronic liver disease.

Product Description

Most important information about Starlix

Possible Side Effects

More information about STARLIX (Nateglinide) :

Starlix Combination Therapy

Starlix approved for use in combination with thiazolidinedione class of antidiabetic drugs

Study: Starlix enhances glucose control in people with impaired tolerance

To buy STARLIX (Nateglinide) click HERE: My Family Drugstore

What is the most important information I should know about Starlix?
Do not use Starlix if you are allergic to nateglinide, if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).
Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them. Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. Severe hypoglycemia may cause loss of consciousness, seizures, or death. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection. If your blood sugar gets too high (hyperglycemia), you may feel very thirsty or hungry. You may also urinate more than usual. Call your doctor right away if you have any symptoms of hyperglycemia.
Starlix is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.
It is important to take Starlix regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Avoid alcohol. It lowers blood sugar and may interfere with diabetes treatment.

What should I discuss with my doctor before taking Starlix?
Some medical conditions may interact with Starlix. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have adrenocortical, pituitary, liver, or kidney problems
• if you have a high fever or are malnourished

Some MEDICINES MAY INTERACT with Starlix . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Rifampin because it may decrease Nateglinide ’s effectiveness
• Beta-adrenergic blockers (eg, metoprolol), gemfibrozil, imidazoles (eg, ketoconazole), monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), or salicylates (eg, aspirin) because side effects, such as decreased blood sugar, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nateglinide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
You may not be able to take nateglinide, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Nateglinide is in the FDA pregnancy category C. This means that it is not known whether nateglinide will be harmful to an unborn baby. Insulin is often the drug chosen for controlling diabetes during pregnancy. Do not take nateglinide without first talking to your doctor if you are pregnant or could become pregnant during treatment.
It is not known whether nateglinide passes into breast milk. Do not take nateglinide without first talking to your doctor if you are breast-feeding a baby.

Product Description

Pharmacokinetics

Possible Side Effects

More information about STARLIX (Nateglinide) :

Starlix Combination Therapy

Starlix approved for use in combination with thiazolidinedione class of antidiabetic drugs

Study: Starlix enhances glucose control in people with impaired tolerance

To buy STARLIX (Nateglinide) click HERE: My Family Drugstore

Drug Name
Starlix (Nateglinide)

Generic Name
Nateglinide (na-te-GLYE-nide)

Manufacturer / Distributor
Novartis Pharmaceuticals Corporation

Looks like
Nateglinide is available with a prescription under the brand name Starlix. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Starlix 60 mg – round, pink tablets
• Starlix 120 mg – oval, yellow tablets

Dosage Form
Tablets

Route Of Administration
ORAL

Imprint Code
Starlix;60 / Starlix;120

Size
10mm / 18mm

Alternatives
Diabecon, Karela, Actoplus Met

Drug Uses

Starlix is used to control blood glucose levels in type 2 diabetes. It may be used with diet and exercise when diet and exercise alone are not successful in controlling blood glucose. It also may be used with metformin, another drug that is used for controlling blood glucose in type 2 diabetes. Starlix is not recommended if blood glucose levels have not been controlled by a sulfonylurea since starlix and sulfonylureas have a similar mechanism of action. Therefore, if sulfonylureas are ineffective, it is likely that starlix also will be ineffective. Drug class
Starlix is an oral drug used to lower blood sugar (glucose) levels in type 2 diabetes. It is in a class of drugs called meglitinides which also includes repaglinide (Prandin). Approximately 90% of patients with diabetes have type 2 diabetes. Type 2 diabetes usually occurs in adults and is associated with obesity and a strong family history of diabetes. Insulin is an important hormone that controls the blood level of glucose. Type 2 diabetics have an inability to control blood glucose levels. This is caused by reduced secretion of insulin from the pancreas after meals and resistance of the body’s cells to the effect of insulin which is to stimulate the cells to remove glucose from the blood. This leads to high levels of blood glucose. Starlix stimulates cells in the pancreas to produce insulin in a manner similar to the class of drugs called sulfonylureas, e.g., glyburide (Diabeta, Glynase and Micronase) which also are used in type 2 diabetes. However, starlix appears to have a faster onset and a shorter duration of action than sulfonylureas. The benefit of this faster, shorter effect may be to prevent the rapid, transient rise in blood glucose that occurs in diabetics immediately following a meal.

Contains
Starlix� (nateglinide) is an oral antidiabetic agent used in the management of Type 2 diabetes mellitus [also known as non-insulin dependent diabetes mellitus (NIDDM) or adult-onset diabetes].
Starlix biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration (active ingredient).
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, iron oxides (red or yellow), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.

Chemical formula
Starlix, (-)-N-[(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues.
The structural formula is as shown

Nateglinide is a white powder with a molecular weight of 317.43. It is freely soluble in methanol, ethanol, and chloroform, soluble in ether, sparingly soluble in acetonitrile and octanol, and practically insoluble in water.

Mechanism of Action
Nateglinide is an amino-acid derivative that lowers blood glucose levels by stimulating insulin secretion from the pancreas. This action is dependent upon functioning beta-cells in the pancreatic islets. Nateglinide interacts with the ATP-sensitive potassium (K+ATP) channel on pancreatic beta-cells. The subsequent depolarization of the beta cell opens the calcium channel, producing calcium influx and insulin secretion. The extent of insulin release is glucose dependent and diminishes at low glucose levels. Nateglinide is highly tissue selective with low affinity for heart and skeletal muscle.
How Taken
Take nateglinide exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Take nateglinide one to thirty minutes before meals.
If you plan to skip a meal, skip the nateglinide dose for that meal, unless otherwise directed by your doctor. If you add a meal or significantly more food to your diet than is usual, ask your doctor if you may need an additional dose of nateglinide.
It is important to take nateglinide regularly to get the most benefit.
Your healthcare provider may recommend regular monitoring of blood sugar levels with blood or urine tests and/or additional types of monitoring during treatment with nateglinide.
Dosage and Administration
The dose of nateglinide will be different for different patients. Follow your doctor’s orders or the directions on the label . The following information includes only the average doses of nateglinide. If your dose is different, do not change it unless your doctor tells you to do so.

• Adults-60 to 120 mg three times a day taken between one and thirty minutes before meals.
• Children-Use and dose must be determined by your doctor.

Monotherapy and Combination with Metformin or a Thiazolidinedione
The recommended starting and maintenance dose of Starlix, alone or in combination with metformin or a thiazolidinedione, is 120 mg three times daily before meals.
The 60-mg dose of Starlix, either alone or in combination with metformin or a thiazolidinedione, may be used in patients who are near goal HbA1C when treatment is initiated.

Dosage in Geriatric Patients
No special dose adjustments are usually necessary. However, greater sensitivity of some individuals to Starlix therapy cannot be ruled out.

Dosage in Renal and Hepatic Impairment
No dosage adjustment is necessary in patients with mild-to-severe renal insufficiency or in patients with mild hepatic insufficiency. Dosing of patients with moderate-to-severe hepatic dysfunction has not been studied. Therefore, Starlix should be used with caution in patients with moderate-to-severe liver disease.

Missed Dose
Take the missed dose as soon as you remember, but only if you are getting ready to eat a meal. If it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.

Overdose
Seek emergency medical attention if you think you have used too much of this medicine. Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm ), or emergency room immediately. Symptoms of a Starlix overdose include:

• hunger,
• nausea,
• anxiety,
• cold sweats,
• weakness,
• drowsiness,
• loss of consciousness,
• and coma.

Storage
Store Starlix at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted.
Store in a tightly closed container.
Store away from heat, light, and moisture.
Do not store in the bathroom.
Keep Starlix out of the reach of children and away from pets.

How Supplied
60 mg
Pink, round, beveled edge tablet with “Starlix” debossed on one side and “60″ on the other.
Bottles of 100 – NDC 0078-0351-05
Bottles of 500 – NDC 0078-0351-08

120 mg
Yellow, ovaloid tablet with “Starlix” debossed on one side and “120″ on the other.
Bottles of 100 – NDC 0078-0352-05
Bottles of 500 – NDC 0078-0352-08

Most important information about Starlix

Pharmacokinetics

Possible Side Effects

More information about STARLIX (Nateglinide) :

Starlix Combination Therapy

Starlix approved for use in combination with thiazolidinedione class of antidiabetic drugs

Study: Starlix enhances glucose control in people with impaired tolerance

To buy STARLIX (Nateglinide) click HERE: My Family Drugstore