There are no adequate and well-controlled studies of AMARYL in pregnant women. In animal studies there was no increase in congenital anomalies, but an increase in fetal deaths occurred in rats and rabbits at Paride doses 50 times (rats) and 0.1 times (rabbits) the maximum recommended human dose (based on body surface area). This fetotoxicity, observed only at doses inducing maternal hypoglycemia, is believed to be directly related to the pharmacologic (hypoglycemic) action of Paride and has been similarly noted with other sulfonylureas. AMARYL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because data suggest that abnormal blood glucose during pregnancy is associated with a higher incidence of congenital abnormalities, diabetes treatment during pregnancy should maintain blood glucose as close to normal as possible.
What is the most important information I should know about Paride (Amaryl)?
You should not use Paride if you have diabetic ketoacidosis, or if you are allergic to sulfa drugs.
There have been postmarketing reports of hypersensitivity reactions in patients treated with Glimepir >Adverse Reactions ( 6.2 ) ]. If a hypersensitivity reaction is suspected, promptly discontinue Paride, assess for other potential causes for the reaction, and institute alternative treatment for diabetes.
What is Paride?
Paride is an oral diabetes medicine that helps control blood sugar levels.
Paride is used together with diet and exercise to treat type 2 diabetes. Insulin or other diabetes medicines are sometimes used in combination with Paride if needed.
Paride may also be used for purposes not listed in this medication guide.
Glimepir >Glimepir >24 H 34 N 4 O 5 S) with a molecular weight of 490.62. Paride USP is a white to almost white powder, soluble in dimethyl formamide, sparingly soluble in methylene chloride, practically insoluble in water.
The structural formula is:
The pharmacokinetics, efficacy and safety of Paride have been evaluated in pediatric patients with type 2 diabetes as described below. Paride tablets are not recommended in pediatric patients because of its adverse effects on body weight and hypoglycemia.
The pharmacokinetics of a 1 mg single dose of Glimepir >(0-last) (339±203 ng•hr/mL), C max (102±48 ng/mL) and t 1/2 (3.1±1.7 hours) for Glimepir >(0-last) 315±96 ng•hr/mL, C max 103±34 ng/mL and t 1/2 5.3±4.1 hours).
The safety and efficacy of Glimepir >
After 24 weeks, the overall mean treatment difference in HbA 1c between Paride and metformin was 0.2%, favoring metformin (95% confidence interval -0.3% to +0.6%).
Based on these results, the trial d >1c with Paride compared to metformin.
These drugs can decrease the effect of Paride and cause high blood sugar. Examples of these drugs include:
All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:
- your age
- the condition being treated
- how severe your condition is
- other medical conditions you have
- how you react to the first dose
What should I avoid while taking Paride (Amaryl)?
Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.
Avoid exposure to sunlight or tanning beds. Paride can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Paride is completely metabolized by oxidative biotransformation after either an intravenous or oral dose. The major metabolites are the cyclohexyl hydroxy methyl derivative (M1) and the carboxyl derivative (M2). Cytochrome P450 2C9 is involved in the biotransformation of Paride to M1. M1 is further metabolized to M2 by one or several cytosolic enzymes. M2 is inactive. In animals, M1 possesses about one-third of the pharmacological activity of Paride, but it is unclear whether M1 results in clinically meaningful effects on blood glucose in humans.
Drugs that contain salicylate
These drugs can increase the effect of Paride and cause low blood sugar. Examples of these drugs include:
- magnesium salicylate (Doan’s)
- salsalate (Disalcid)