Getryl tablets

Getryl

  • Active Ingredient: Glimepiride
  • 4 mg, 2 mg, 1 mg
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What is Getryl?

The active ingredient of Getryl brand is glimepiride. Glimepiride is an oral diabetes medicine that helps control blood sugar levels. Glimepiride tablets contain the active ingredient Glimepiride and the following inactive ingredients:lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and sodium starch glycolate (potato). In addition, the 2 mgand 4 mg tablets contain D&C Yellow No. 10 Aluminum Lake and the 4 mg also contains D&C Red No. 27 Aluminum Lake.

Used for

Getryl is used to treat diseases such as: Diabetes, Type 2.

Side Effect

Possible side effects of Getryl include: rapid weight gain; skin rash; painful or difficult urination; nausea and vomiting; Abdominal or stomach pain; light-colored stools; pale skin; pinpoint red spots on the skin.

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Getryl

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Getryl is a prescription drug. It comes as an oral tablet.

Getryl is available as the brand-name drug Amaryl and as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

This drug may be used as part of a combination therapy. That means you need to take it with other drugs.

What are the uses for Getryl?

  • Getryl is used for controlling blood sugar in adults with type 2 diabetes in addition to diet and exercise.
  • Management of blood sugar with Getryl can help decrease the risk of eye, kidney, and nerve damage.
  • It is not used for treating type 1 diabetes.

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Studies in rats at doses of up to 5000 parts per million (ppm) in complete feed (approximately 340 times the maximum recommended human dose, based on surface area) for 30 months showed no evidence of carcinogenesis. In mice, administration of Getryl for 24 months resulted in an increase in benign pancreatic adenoma formation that was dose-related and was thought to be the result of chronic pancreatic stimulation. No adenoma formation in mice was observed at a dose of 320 ppm in complete feed, or 46-54 mg/kg body weight/day. This is about 35 times the maximum human recommended dose of 8 mg once daily based on surface area.

Getryl was non-mutagenic in a battery of in vitro and in vivo mutagenicity studies (Ames test, somatic cell mutation, chromosomal aberration, unscheduled DNA synthesis, and mouse micronucleus test).

There was no effect of Getryl on male mouse fertility in animals exposed up to 2500 mg/kg body weight ( > 1,700 times the maximum recommended human dose based on surface area). Getryl had no effect on the fertility of male and female rats administered up to 4000 mg/kg body weight (approximately 4,000 times the maximum recommended human dose based on surface area).

What Other Drugs Interact with Getryl?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Getryl has no known severe interactions with other drugs.

Serious Interactions of Getryl include:

  • aminolevulinic acid
  • ethanol
  • lumacaftor/ivacaftor
  • methyl aminolevulinate

Getryl has moderate interactions with at least 146 different drugs.

Getryl has mild interactions with at least 89 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Dosage for type 2 diabetes

Adult dosage (ages 18 to 64 years)

  • The recommended starting dose is 1 mg or 2 mg taken once per day with breakfast or the first main meal of the day.
  • After reaching a dose of 2 mg per day, your doctor may increase your dose by 1 mg or 2 mg based on your blood sugar levels. They may increase your dose every 1 to 2 weeks until your blood sugar levels are controlled.
  • The maximum recommended dose is 8 mg taken once per day.

Child dosage (ages 0 to 17 years)

Getryl isn’t recommended for people under 18 years old because it may affect body weight and cause low blood sugar.

Senior dosage (ages 65 years and older)

  • The starting dose is 1 mg taken once per day with breakfast or the first main meal of the day.
  • Your doctor may adjust your dose based on your blood sugar levels. Since seniors may be more sensitive to Getryl and are more likely to have decreased kidney function, your doctor may increase your dose more slowly.
  • The maximum recommended dose is 8 mg taken once per day.

Drug that treats cholesterol and type 2 diabetes

Colesevelam can decrease the amount of Getryl that’s absorbed by your body. This means that the drug may not work as well. This interaction may cause high blood sugar.

If you experience any of the following symptoms, call your doctor immediately:

allergic reaction (hives, difficulty breathing, swelling of your face, lips, tongue, or throat)

Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):

extreme thirst frequent urination extreme hunger weakness blurred vision Eat or drink a food or beverage with sugar in it, such as hard candy or fruit juice, and call your doctor immediately if you have any of the symptoms of hypoglycemia (low blood sugar):

shakiness dizziness or lightheadedness sweating confusion nervousness or irritability sudden changes in behavior or mood headache numbness or tingling around the mouth weakness pale skin sudden hunger clumsy or jerky movements seizures

Getryl may cause other side effects. Call your doctor if you have any unusual problems that are not mentioned above while taking this medication.

What storage conditions are needed for this medicine?

Always keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is recommended that you throw away any medication that is outdated or no longer needed. Should you have any questions regarding this, please talk to your pharmacist about the proper disposal of your medication.

In case of an emergency/overdose

In the case of a suspected overdose, call your local poison control center on 1-800-222-1222. However, if the victim has collapsed or is not breathing, then please call the local emergency services on 911.

Is Getryl safe to take if I'm pregnant or breastfeeding?

  • In animal studies, Getryl 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 Getryl is excreted in breast milk like other sulfonylureas. Because of the risk of low blood sugar in the infant, it is recommended that Getryl be discontinued in nursing mothers. If therapy other than diet and exercise is needed, insulin is preferred.

Quinolone antibiotics

These drugs can increase the effect of Getryl and cause low blood sugar. Examples of these drugs include:

  • ciprofloxacin (Cipro)
  • levofloxacin (Levaquin)

What are the possible side effects of Getryl (Amaryl)?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • pale or yellowed skin, dark colored urine;
  • confusion, weakness; or
  • fever.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pediatric Use

The pharmacokinetics, efficacy and safety of Getryl have been evaluated in pediatric patients with type 2 diabetes as described below. Getryl 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 Getryl and metformin was 0.2%, favoring metformin (95% confidence interval -0.3% to +0.6%).

Based on these results, the trial d >1c with Getryl compared to metformin.

COMMON BRAND(S): Amaryl

GENERIC NAME(S): Getryl

OTHER NAME(S): Getryl Tablet

Getryl is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Getryl belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.

Mechanism of Action

Getryl primarily lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

What happens if I overdose (Amaryl)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Getryl overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I discuss with my healthcare prov >

You should not use Getryl if you are allergic to it, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Getryl is safe for you, tell your doctor if you have:

It is not known whether Getryl will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether Getryl passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

2.1 Recommended Dosing

Getryl tablets should be administered with breakfast or the first main meal of the day.

The recommended starting dose of Glimepir >Warnings and Precautions ( 5.1) and Use in Specific Populations ( 8.5, 8.6) ].

After reaching a daily dose of 2 mg, further dose increases can be made in increments of 1 mg or 2 mg based upon the patient’s glycemic response. Uptitration should not occur more frequently than every 1 to 2 weeks. A conservative titration scheme is recommended for patients at increased risk for hypoglycemia .

The maximum recommended dose is 8 mg once daily.

Patients being transferred to Getryl tablets from longer half-life sulfonylureas (e.g., chlorpropamide) may have overlapping drug effect for 1 to 2 weeks and should be appropriately monitored for hypoglycemia.

When colesevelam is coadministered with Getryl, maximum plasma concentration and total exposure to Getryl is reduced. Therefore, Getryl tablets should be administered at least 4 hours prior to colesevelam.

Dosing considerations

  • Use in monotherapy or, if glycemic response to Getryl is inadequate at maximum dose, with insulin or metformin

Lactation

Breastfed infants of lactating women using Glimepir >Clinical Considerations) . It is not known whether Glimepir > . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Getryl and any potential adverse effects on the breastfed child from Getryl or from the underlying maternal condition.

Monitoring for adverse reactions

Monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures).

During prenatal and postnatal studies in rats, significant concentrations of Getryl were present in breast milk and the serum of the pups. Offspring of rats exposed to high levels of Getryl during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. These skeletal deformations were determined to be the result of nursing from mothers exposed to Getryl.


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