April 23, 2017
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Starlix

"Jan. 29, 2013 -- The American Academy of Pediatrics has issued the first-ever guidelines for the management of type 2 diabetes in children and teens.

Type 2 diabetes is rising rapidly among children and teens because of soaring obesity "...

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Starlix Tablet




Side Effects
Interactions

SIDE EFFECTS

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

Hypoglycemia [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with STARLIX. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with STARLIX.

Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in STARLIX-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials

  Placebo
N=458
STARLIX
N=1441
Preferred Term
Upper Respiratory Infection 8.1 10.5
Back Pain 3.7 4.0
Flu Symptoms 2.6 3.6
Dizziness 2.2 3.6
Arthropathy 2.2 3.3
Diarrhea 3.1 3.2
Accidental Trauma 1.7 2.9
Bronchitis 2.6 2.7
Coughing 2.2 2.4

Hypoglycemia

Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with STARLIX. Non-severe hypoglycemia occurred in 2.4 % of STARLIX treated patients and 0.4 % of placebo treated patients [see WARNINGS AND PRECAUTIONS].

Weight Gain

Patients treated with STARLIX had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with STARLIX 60 mg (3 times daily) and STARLIX 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively.

Laboratory Test

Increases in Uric Acid: There were increases in mean uric acid levels for patients treated with STARLIX alone, STARLIX in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of STARLIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Hypersensitivity reactions: Rash, itching, and urticaria
  • Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes

Read the Starlix Tablet (nateglinide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with STARLIX and instructions for managing or preventing them.

Table 2: Clinically Significant Drug Interactions with STARLIX

Drugs That May Increase the Blood-Glucose-Lowering Effect of STARLIX and Susceptibility to Hypoglycemia
Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, anabolic hormones (e.g. methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g. amiodarone, fluconazole, voriconazole, sulfinpyrazone), alcohol.
Intervention: Dose reductions and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs.
Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of STARLIX and Increase Susceptibility to Hyperglycemia
Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g. lanreotide, octreotide), and CYP inducers (e.g. rifampin, phenytoin and St John’s Wort).
Intervention: Dose increases and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs.
Drugs That May Blunt Signs and Symptoms of Hypoglycemia
Drugs: beta-blockers, clonidine, guanethidine, and reserpine
Intervention: Increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs.

Read the Starlix Tablet Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/11/2017

Side Effects
Interactions

Starlix - User Reviews

Starlix User Reviews

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