The pharmacokinetics, efficacy and safety of AMARYL have been evaluated in pediatric patients with type 2 diabetes as described below. AMARYL is not recommended in pediatric patients because of its adverse effects on body weight and hypoglycemia.
The pharmacokinetics of a 1 mg single dose of AMARYL was evaluated in 30 patients with type 2 diabetes (male = 7; female = 23) between ages 10 and 17 years. The mean (± SD) AUC (339±203 ngÂ·hr/mL), Cmax (102±48 ng/mL) and t½ (3.1±1.7 hours) for Gluconor were comparable to historical data from adults (AUC(0-last) 315±96 ngÂ·hr/mL, Cmax 103±34 ng/mL and t½ 5.3±4.1 hours).
The safety and efficacy of AMARYL in pediatric patients was evaluated in a single-blind, 24-week trial that randomized 272 patients (8-17 years of age) with type 2 diabetes to AMARYL (n=135) or metformin (n=137). Both treatment-naive patients (those treated with only diet and exercise for at least 2 weeks prior to randomization) and previously treated patients (those previously treated or currently treated with other oral antidiabetic medications for at least 3 months) were eligible to participate. Patients who were receiving oral antidiabetic agents at the time of study entry discontinued these medications before randomization without a washout period. AMARYL was initiated at 1 mg, and then titrated up to 2, 4 or 8 mg (mean last dose 4 mg) through Week 12, targeting a self-monitored fasting fingerstick blood glucose
The profile of adverse reactions in pediatric patients treated with AMARYL was similar to that observed in adults .
Hypoglycemic events documented by blood glucose values 65 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
There were no significant differences in glimepir > 65 years (n=42) .
Gluconor is substantially excreted by the kidney. Elderly patients are more likely to have renal impairment. In addition, hypoglycemia may be difficult to recognize in the elderly . Use caution when initiating AMARYL and increasing the dose of AMARYL in this patient population.
There were no differences between males and females in the pharmacokinetics of Gluconor when adjustment was made for differences in body weight.
No studies have been conducted to assess the effects of race on glimepir >
What should I avoid while taking Gluconor (Amaryl)?
Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
Avoid exposure to sunlight or tanning beds. Gluconor can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
What is the dosage for Gluconor?
Like other medicines used to treat diabetes, the dose of Gluconor is individualized using periodic measurements of blood sugar to determine the best dose. The usual starting dose is 1 or 2 mg given orally once daily with breakfast or the first major meal of the day. The dose may be increased by 1-2 mg in 1-2 weeks interval up to 8mg maximum based on blood sugar response and given once daily.
In a randomized, double-blind, placebo-controlled monotherapy trial of 14 weeks duration, patients already on sulfonylurea therapy underwent a 3-week washout period then were randomized to Glimepir >Clinical Studies ( 14.1)]. The overall incidence of possible hypoglycemia (defined by the presence of at least one symptom that the investigator believed might be related to hypoglycemia; a concurrent glucose measurement was not required) was 4% for Gluconor tablets 1 mg, 17% for Gluconor tablets 4 mg, 16% for Gluconor tablets 8 mg and 0% for placebo. All of these events were self-treated.
In a randomized, double-blind, placebo-controlled monotherapy trial of 22 weeks duration, patients received a starting dose of either 1 mg Glimepir >Clinical Studies ( 14.1) ]. The overall incidence of possible hypoglycemia (as defined above for the 14-week trial) for Gluconor vs. placebo was 19.7% vs. 3.2%. All of these events were self-treated.
Glimepir >Clinical Studies ( 14.1) ].
In clinical trials, allergic reactions, such as pruritus, erythema, urticaria, and morbilliform or maculopapular eruptions, occurred in less than 1% of Glimepir >Warnings and Precautions ( 5.2) ].
Elevated Serum Alanine Aminotransferase (ALT)
In 11 pooled placebo-controlled trials of Gluconor, 1.9% of Gluconor-treated patients and 0.8% of placebo-treated patients developed serum ALT greater than 2 times the upper limit of the reference range.
Gluconor is used to treat diabetes along with diet changes and exercise. Talk to your doctor about how to change your eating habits.
Is Gluconor safe to take if I'm pregnant or breastfeeding?
- In animal studies, Gluconor and other sulfonylureas were associated with a higher risk of fetal death. However, there have been no good studies in women. Abnormal blood sugar concentrations (high or low) during pregnancy increase the risk of abnormalities in the fetus. Therefore, physicians must carefully weigh the benefits and risks of sulfonylurea treatment during pregnancy. Insulin is the drug of choice for treating diabetes in pregnant women.
- It is not known if Gluconor is excreted in breast milk like other sulfonylureas. Because of the risk of low blood sugar in the infant, it is recommended that Gluconor be discontinued in nursing mothers. If therapy other than diet and exercise is needed, insulin is preferred.
Conversion from other oral hypoglycemic agents
- Observe patients carefully for 1-2 weeks when being converted from long half-life sulfonylureas to Gluconor, because of potential for overlapping of hypoglycemic effects
The sections below will provide you with more specific information and guidelines related to Gluconor and its correct use. Please read them carefully.
Gluconor was approved by the FDA in December 1995.
In July 2005, Ranbaxy Pharmaceuticals Inc. received tentative approval from the U.S. Food and Drug Administration to manufacture and market Gluconor tablets in 3 milligram and 6 milligram strengths.
The brand version of Gluconor, Amaryl®, has annual sales of $336.6 million. Amaryl® is a registered trademark of Aventis Pharmaceuticals Inc., based in Bridgewater, N.J.
Please visit the official site of the FDA for further information.
Why is this medication prescribed?
Gluconor is an oral blood sugar-lowering drug in a class of medicines called sulfonylureas, used for controlling diabetes.
This medication is related to other sulfonylureas including glyburide (Micronase® and Diabeta®), glipizide (Glucotrol®), tolbutamide (Orinase®) and tolazamide (Tolinase®).
Gluconor is used in type II diabetes, the most common type of diabetes that is found in 90% of patients with diabetes. In type II diabetes, insulin usually is not necessary to control the blood sugar. Instead, diet and oral medications often are sufficient. Intolerance to sugar that results in elevated blood sugar is caused by reduced insulin secretion by the pancreas and resistance to insulin’s effects by the body’s cells. Gluconor works by lowering the sugar level in the blood by stimulating insulin to be secreted from the pancreas into the blood. Insulin causes sugar to leave the blood and enter cells throughout the body.
Other uses for this medicine
Gluconor is sometimes prescribed for other uses. Therefore, it is advised that you consult your doctor or pharmacist for further information before taking this medication.
Dosage and using this medicine
Gluconor comes as a tablet to be taken orally.
It is usually taken once a day. The tablet should be taken with breakfast or the first big meal of the day.
Take Gluconor exactly as directed by your doctor. Do not take more or less of it or take it more often than prescribed by your doctor.
Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.
It is important that you know the signs of low blood sugar (hypoglycemia) and how to recognize them. Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. Severe hypoglycemia may cause loss of consciousness, seizures, or death. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.
Additionally, Gluconor is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
Continue to take Gluconor even if you feel well. and do not stop taking Gluconor without first talking to your doctor.
What special precautions should I follow?
glimepir > n glimepirida
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