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Starlix

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Overview

What is Starlix?

STARLIX (nateglinide) is an oral blood glucose-lowering drug of the glinide class. 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. STARLIX biconvex tablets contain 60 mg, or 120 mg, of nateglinide for oral administration.

Inactive Ingredients:



What does Starlix look like?



What are the available doses of Starlix?

Tablets: 60 mg and 120 mg ()

What should I talk to my health care provider before I take Starlix?

How should I use Starlix?

STARLIX is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

STARLIX should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

The recommended dose of STARLIX is 120 mg orally three times daily before meals.

The recommended dose of STARLIX is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated.

Instruct patients to take STARLIX 1 to 30 minutes before meals.

In patients who skip meals, instruct patients to skip the scheduled dose of STARLIX to reduce the risk of hypoglycemia .


What interacts with Starlix?

Sorry No Records found


What are the warnings of Starlix?

Sorry No Records found


What are the precautions of Starlix?

Sorry No Records found


What are the side effects of Starlix?

Sorry No records found


What should I look out for while using Starlix?

STARLIX is contraindicated in patients with a history of hypersensitivity to STARLIX or its active ingredients.


What might happen if I take too much Starlix?

There have been no instances of overdose with STARLIX in clinical trials. However, an overdose may result in an exaggerated glucose-lowering effect with the development of hypoglycemic symptoms. Hypoglycemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns. Severe hypoglycemic reactions with coma, seizure, or other neurological symptoms should be treated with intravenous glucose. As STARLIX is highly protein bound, dialysis is not an efficient means of removing it from the blood.


How should I store and handle Starlix?

Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP. How Supplied60 mgPink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other.Bottles of 100……………………………………………….NDC 0078-0351-05120 mgYellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other.Bottles of 100……………………………………………….NDC 0078-0352-05Storage and HandlingStore at 25ºC (77ºF); excursions permitted to 15ºC-30ºC (59ºF-86ºF). Dispense in a tight container, USP.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Nateglinide 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+) 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.

Non-Clinical Toxicology
STARLIX is contraindicated in patients with a history of hypersensitivity to STARLIX or its active ingredients.

See Table 1 for clinically significant drug interactions with naproxen.

Table 1: Clinically Significant Drug Interactions with naproxen

Drug/Laboratory Test Interactions

All glinides, including STARLIX, can cause hypoglycemia ]. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).

Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy (nerve disease), in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) , or in patients who experience recurrent hypoglycemia.

Factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content), changes in level of physical activity, changes to coadministered medication [see Drug Interactions (7)], and concomitant use with other antidiabetic agents. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia .

Patients should take STARLIX before meals and be instructed to skip the dose of STARLIX if a meal is skipped . Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.

The following serious adverse reaction is also described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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