Nateglinide- Antidiabetic gents- (FDC- List )- (Mar 1986)
Drug Name:
Nateglinide- Antidiabetic gents- (FDC- List )- (Mar 1986)
List Of Brands:
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Efficacy of nateglinide may be affected by drugs independently increasing or decreasing blood glucose concentrations
Indication:
Non-insulin dependent diabetes
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Nateglinide Ant-hypertensive 01-05-2002
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1. Nateglinide 60/120mg + 1-08-2004
Metformin 500mg/500mg SR tablet
2. Natelglinide 60mg/120mg + 08-01-2004
Metformin Hcl 500mg/500mg SR tablet
In patients with type II diabetes inadequately
controlled by diet, excrcise and maximally
tolerated dose of Metformin alone
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Nateglinide Diabetes Novartis 28-03-2006
Adverse Reaction:
Dizziness, diarrhea, nausea, hypoglycemia, back pain, arthropathy, upper respiratory tract infection, bronchitis, coughing, flu like syndrome, accidental injuries.
Contra-Indications:
Hypersensitivity Diabetic ketoacidosis with Type daibetes
Special precautions:
Hypoglycemia: Geriatric patients, malnourished patients, and those with adrenal or pitutiary insufficiency are more susesptible to the glucose lowering effect of these treatments.
The risk of hypoglycemia may be increased by strenuous physical excercise, ingestion of alcohol, insufficient calorie intake of an acute or chronic basis, or combinations with oral antidiabetic agents.
Hepatic impairment: Should be used with caution in patients with moderate-to-severe hepatic impairment because such patients have not been studied Loss of glycemic control
To maintain glycemic control during periods of stress(eg, fever, trauma, infection, surgery) temporarary discontinuation of nateglinide and administration of insulin may be required. The efficacy of nateglinide may be decreased over time.
Pregnancy and lactation:
Use of nateglinide during pregnancy and lactation is not recommended.
Dosages/ Overdosage Etc:
Indication-
Non-insulin dependent diabetes
Dosage-
Adult- given by mouth upto 30 minutes before meals in doses of 60 to 120mg three times daily This may be increased to 180mg three times daily if necessary Nateglinide is also given in combination with metformin inn type 2 diabetes not controlled by metformin alone
Pharmacology/ Pharmacokinetics:
Pharamacology:
Nateglinide which is a derivative of D-phenylanine is a non-sulfonylurea , insulin serectagogue. Like repaglinide, nateglinide belongs to the megalitinde class of oral hypoglycemic agents. It causes insulin secretion via the inhibition of the hypoglycemic agents.It causes insulin secretion via inhibition of the ATP-sensitive potassium channels in the pancreatic beta cells. Unlike other oral hypoglycemics agents, nateglinide stimulation results in a rapid onset and short duration of action. The latter effect decrease the incidence of sustained hypoglycemia.
Pharmacokinetics:
Following ingestion, gastrointestinal absorption is rapid, with a maximum plasma concentration occuring within one-half to two hours (tmax 1.5 +/- 1.1 hours). Neteglinide has a bioavailability of 73%. Peak drug effect is reached in two hours. The drug is highly protein bound(98%) . Absorption of nateglinde is delayed if ingested following a meal as compared to on an empty stomach. Nateglinde is extensively metabolised in the liver. Excretion of hepatic metabolites occurs primarily in the kidney.
Interaction with Food:
Absorption of nateglinde is delayed if ingested following a meal as compared to on an empty stomach.
Pregnancy and lactation:
Use of nateglinide during pregnancy and lactation is not recommended.
