Starlix


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nateglinide

Starlix

Pharmacologic class: Amino acid derivative

Therapeutic class: Hypoglycemic

Pregnancy risk category C

Action

Decreases blood glucose level by stimulating insulin secretion from pancreatic beta cells; interacts with calcium and potassium channels in pancreas

Availability

Tablets: 60 mg, 120 mg

Indications and dosages

To decrease glucose levels in type 2 (non-insulin-dependent) diabetes mellitus not adequately controlled by diet and exercise

Adults: 120 mg P.O. t.i.d. up to 30 minutes before meals, or 60 mg P.O. t.i.d. if patient is near glycosylated hemoglobin (HbA1c) goal

Contraindications

• Hypersensitivity to drug or its components

• Diabetic ketoacidosis

• Type 1 (insulin-dependent) diabetes mellitus

Precautions

Use cautiously in:

• renal or hepatic impairment, adrenal or pituitary insufficiency

• elderly or malnourished patients

• pregnant or breastfeeding patients.

Administration

• Give 30 minutes before meals. If meal is missed, don't give dose.

• Know that drug may be given alone or with metformin.

Adverse reactions

CNS: dizziness

GI: diarrhea

Metabolic: hypoglycemia

Musculoskeletal: back pain, joint pain

Respiratory: upper respiratory tract infection, bronchitis, coughing

Other: flulike symptoms, trauma

Interactions

Drug-drug. Beta-adrenergic blockers, MAO inhibitors, nonsteroidal antiinflammatory drugs, salicylates: increased hypoglycemic effect

Corticosteroids, sympathomimetics, thiazides, thyroid products: reduced hypoglycemic effect

Drug-diagnostic tests. Glucose: decreased level

Patient monitoring

• Monitor blood glucose and HbA1c levels.

• Assess pulmonary status for bronchitis, upper respiratory infection, and flulike signs and symptoms.

• Monitor musculoskeletal status. Check for back pain and arthropathy.

• Note GI complaints, and identify nutritional deficiencies.

Patient teaching

• Instruct patient to take dose up to 30 minutes before each main meal.

• Advise patient not to skip a meal. If he does, tell him to also skip accompanying nateglinide dose, to prevent hypoglycemia.

• Teach patient how to monitor blood and urine for glucose and ketones, as prescribed.

• Instruct patient to report adverse CNS effects and signs and symptoms of respiratory infection.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects sensation and balance.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

nateglinide

(na-teg-li-nide) ,

Starlix

(trade name)

Classification

Therapeutic: antidiabetics
Pharmacologic: meglitinides
Pregnancy Category: C

Indications

To improve glycemic control in patients with type 2 diabetes (with diet and exercise); may also be used with metformin or a thiazolidinedione (pioglitazone, rosiglitazone).

Action

Stimulates the release of insulin from pancreatic beta cells by closing potassium channels, which results in the opening of calcium channels in beta cells. This is followed by release of insulin. Requires functioning pancreatic beta cells.

Therapeutic effects

Lowering of blood glucose.

Pharmacokinetics

Absorption: Well absorbed (73%) following oral administration; absorption is rapid.
Distribution: Unknown.
Protein Binding: 98%.
Metabolism and Excretion: Mostly metabolized by the liver (CYP2C9 [70%] and CYP3A4 [30%]); 16% excreted unchanged in urine.
Half-life: 1.5 hr.

Time/action profile (effect on blood glucose)

ROUTEONSETPEAKDURATION
POwithin 20 min1 hr4 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Diabetic ketoacidosis;Type 1 diabetes; Obstetric: Insulin recommended to control diabetes during pregnancy; Lactation: Effects on nursing infant unknown.
Use Cautiously in: Malnourished patients, patients with pituitary or adrenal insufficiency (↑ susceptibility to hypoglycemia);Strenuous physical exercise, insufficient caloric intake (increased risk of hypoglycemia);Autonomic neuropathy (hypoglycemia may be masked);Moderate to severe liver impairment;Fever, infection, trauma, or surgery (may lead to transient loss of glycemic control; insulin may be required); Pediatric: Safety not established; Geriatric: May have ↑ sensitivity to drug effects (↑ risk of hypoglycemia).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness

Respiratory

  • bronchitis
  • coughing
  • upper respiratory infection

Gastrointestinal

  • diarrhea

Endocrinologic

  • hypoglycemia (life-threatening)

Musculoskeletal

  • arthropathy
  • back pain

Miscellaneous

  • flu symptoms

Interactions

Drug-Drug interaction

Concurrent use with beta blockers may mask hypoglycemia.Alcohol, combination with other antidiabetics, NSAIDs, MAO inhibitors, nonselective beta blockers, amiodarone, fluconazole, miconazole, or oxandrolone may ↑ the risk of hypoglycemia.Hypoglycemic effects may be ↓ by thiazide diuretics, corticosteroids, thyroid supplements, sympathomimetic (adrenergic) agents, somatropin, rifampin, or phenytoin.Blood levels and effects are significantly ↓ when administered prior to a liquid meal.

Route/Dosage

Oral (Adults) 120 mg 3 times daily before meals; patients who are approaching glycemic control may be started at 60 mg 3 times daily.

Availability (generic available)

Tablets: 60 mg, 120 mg

Nursing implications

Nursing assessment

  • Observe for signs and symptoms of hypoglycemic reactions (sweating, hunger, weakness, dizziness, tremor, tachycardia, anxiety).
  • Lab Test Considerations: Monitor serum glucose and HbA1c periodically during therapy to evaluate effectiveness.
    • May cause ↑ uric acid levels.
  • Overdose is manifested by symptoms of hypoglycemia. Mild hypoglycemia may be treated with administration of oral glucose. Severe hypoglycemia should be treated with IV D50W followed by continuous IV infusion of more dilute dextrose solution at a rate sufficient to keep serum glucose at approximately 100 mg/dL.

Potential Nursing Diagnoses

Imbalanced nutrition: more than body requirements (Indications)
Noncompliance (Patient/Family Teaching)

Implementation

  • Patients stabilized on a diabetic regimen who are exposed to stress, fever, trauma, infection, or surgery may require administration of insulin.
  • Oral: Administer 1–30 min prior to meals.
    • May be administered concurrently with metformin, pioglitazone, or rosiglitazole.

Patient/Family Teaching

  • Instruct patient to take medication at same time each day. Take missed doses as soon as remembered unless almost time for next dose. Do not take if unable to eat.
  • Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long term.
  • Review signs of hypoglycemia and hyperglycemia with patient. If hypoglycemia occurs, advise patient to take a glass of orange juice or 2–3 tsp of sugar, honey, or corn syrup dissolved in water and notify health care professional.
  • Encourage patient to follow prescribed diet, medication, and exercise regimen to prevent hypoglycemic or hyperglycemic episodes.
  • Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness and health care professional notified if significant changes occur.
  • May occasionally cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially, especially aspirin and alcohol.
  • Advise patient to inform health care professional of medication regimen prior to treatment or surgery.
  • Insulin is the recommended method of controlling blood glucose during pregnancy. Counsel female patients to use a form of contraception other than oral contraceptives and to notify health care professional promptly if pregnancy is planned or suspected.
  • Advise patient to carry a form of sugar (sugar packets, candy) and identification describing disease process and medication regimen at all times.
  • Emphasize the importance of routine follow-up exams.

Evaluation/Desired Outcomes

  • Control of blood glucose levels without the appearance of hypoglycemic or hyperglycemic episodes.

Starlix

(stär′lĭks′)
A trademark for the drug nateglinide.
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Starlix "should be thought of as an oral agent analogous to Lispro insulin, which is taken immediately before meals, acts very rapidly, and then gets out of the way," said Dr.
The effect of Starlix and Diovan on the progression to diabetes will be evaluated in the initial phase.
Novartis Starlix shrink sleeves are manufactured at Alcoa's Downingtown Printing Plant in Downingtown, Pennsylvania using 50 micron PVC film.
Starlix is awaiting FDA clearance, but the product, in tablet form, was approved last month by Swiss authorities.
By contrast, panelists reported pull-through programs as the topic of only 8% of Starlix meetings.
Starlix works by stimulating rapid, short-acting insulin secretion.
Studies show that Starlix has a "fast on, fast off" mode of action on the beta-cell (the cell in the pancreas that produces insulin) that stimulates rapid, short-acting insulin secretion, addressing a basic defect in type 2 diabetes.
One 24-week, randomized, double-blind, placebo-controlled study of 701 patients with type 2 diabetes evaluated the effects of Starlix, metformin, and the combination of Starlix with metformin on glycemic control, including postprandial glucose control, and assessed the tolerability and safety of these treatment regimens.
In all studies, Starlix was well-tolerated with an overall safety profile comparable to placebo.
Starlix is marketed by Novartis Pharmaceuticals Corporation and is the company's first drug for the treatment of type 2 diabetes.
On December 17, 1999 Novartis Pharma AG filed a regulatory submission for Starlix with the European Medicines Evaluation Agency (EMEA).
For Starlix prescribing information, patients and healthcare providers may call 1-877-STARLIX.