I am diabetic

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