"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 "...
The following serious adverse reaction is also described elsewhere in the labeling:
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
|Upper Respiratory Infection||8.1||10.5|
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].
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.
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.
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
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
Last reviewed on RxList: 4/11/2017
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