Glipizide and Metformin Hydrochloride (Page 10 of 10)
Specific Patient Populations:
Glipizide and metformin hydrochloride tablets are not recommended for use during pregnancy or for use in pediatric patients. The initial and maintenance dosing of glipizide and metformin hydrochloride tablets should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of glipizide and metformin hydrochloride tablets to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see WARNINGS and PRECAUTIONS).
HOW SUPPLIED
Glipizide and Metformin Hydrochloride Tablets, 5 mg/500 mg are pink-colored, biconvex, modified capsule-shaped, film-coated tablet, debossed with “ZE66” on one side and plain on other side and are supplied as follows:
NDC: 70518-0908-00
NDC: 70518-0908-01
PACKAGING: 180 in 1 BOTTLE PLASTIC
PACKAGING: 90 in 1 BOTTLE PLASTIC
Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
Dispense in a tight container.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
STORAGE AND HANDLING
Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
Dispense in a tight container.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Glipizide and Metformin Hydrochloride
(GLIP-ih-zyd and met-FOR-min HYE-droe-KLOR-ide)
Tablets, USP
WARNING:
A small number of people who have taken metformin hydrochloride have developed a serious condition called lactic acidosis. Tell your doctor if you have severe kidney problems. (see Question Nos. 9 to 12).
Q1. Why do I need to take Glipizide and Metformin Hydrochloride Tablets?
Your doctor has prescribed glipizide and metformin hydrochloride tablets to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus.
People with diabetes are not able to make enough insulin and/or respond normally to the insulin their body does make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.
Q3. Why is it important to control type 2 diabetes?
The main goal of treating diabetes is to lower your blood sugar to a normal level. Studies have shown that good control of blood sugar may prevent or delay complications such as heart disease, kidney disease, or blindness.
Q4. How is type 2 diabetes usually controlled?
High blood sugar can be lowered by diet and exercise, by a number of oral medications, and by insulin injections. Before taking glipizide and metformin hydrochloride tablets you should first try to control your diabetes by exercise and weight loss. Even if you are taking glipizide and metformin hydrochloride tablets, you should still exercise and follow the diet recommended for your diabetes.
Q5. Does Glipizide and Metformin Hydrochloride Tablet work differently from other glucose-control medications?
Yes it does. Glipizide and metformin hydrochloride tablet combines two glucose lowering drugs, glipizide and metformin. These two drugs work together to improve the different metabolic defects found in type 2 diabetes. Glipizide lowers blood sugar primarily by causing more of the body’s own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you achieve better glucose control.
Q6. What happens if my blood sugar is still too high?
When blood sugar cannot be lowered enough by glipizide and metformin hydrochloride tablets, your doctor may prescribe injectable insulin or take other measures to control your diabetes.
Q7. Can Glipizide and Metformin Hydrochloride Tablets cause side effects?
Glipizide and metformin hydrochloride tablets, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor. However, there are also serious, but rare, side effects related to glipizide and metformin hydrochloride tablets (see Question Nos. 9-13).
Q8. What are the most common side effects of Glipizide and Metformin Hydrochloride Tablets?
The most common side effects of glipizide and metformin hydrochloride tablets are normally minor ones such as diarrhea, nausea, and upset stomach. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your glipizide and metformin hydrochloride tablets with meals can help reduce these side effects.
Symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness, or hunger may occur. The risk of hypoglycemic symptoms increases when meals are skipped, too much alcohol is consumed, or heavy exercise occurs without enough food. Following the advice of your doctor can help you to avoid these symptoms.
Q9. Are there any serious side effects that Glipizide and Metformin Hydrochloride Tablets can cause?
People who have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency and who take glipizide and metformin hydrochloride may develop hemolytic anemia (fast breakdown of red blood cells). G6PD deficiency usually runs in families. Tell your doctor if you or any members of your family have been diagnosed with G6PD deficiency before you start taking Glipizide and metformin hydrochloride tablets.
Glipizide and metformin hydrochloride tablets rarely cause serious side effects. Metformin, one of the medicines in glipizide and metformin hydrochloride can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
Call your doctor right away if you have any of the following symptoms, which could be
signs of lactic acidosis:
- you feel cold in your hands or feet
- you feel dizzy or lightheaded
- you have a slow or irregular heartbeat
- you feel very weak or tired
- you have unusual (not normal) muscle pain
- you have trouble breathing
- you feel sleepy or drowsy
- you have stomach pains, nausea or vomiting
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with glipizide and metformin hydrochloride if you:
- have severe kidney problems
- your kidneys are affected by certain x-ray tests that use injectable dye. Tell your doctor if you are going to get an injection or dye or contrast agents for an x-ray procedure.
- have liver problems
- drink alcohol very often, or drink a lot of alcohol in short-term “binge” drinking
- get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids
- have surgery
- have a heart attack, severe infection, or stroke
The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your glipizide and metformin hydrochloride for a while if you have any of these things.
Glipizide and metformin hydrochloride can have other serious side effects. See “What are the possible side effects of glipizide and metformin hydrochloride?”
Q10. Can I take Glipizide and Metformin Hydrochloride Tablets with other medications?
Remind your doctor that you are taking glipizide and metformin hydrochloride tablets when any new drug is prescribed or a change is made in how you take a drug already prescribed.
Glipizide and metformin hydrochloride tablets may interfere with the way some drugs work and some drugs may interfere with the action of glipizide and metformin hydrochloride tablets.
Q11. What if I become pregnant while taking Glipizide and Metformin Hydrochloride Tablets?
Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take glipizide and metformin hydrochloride tablets during pregnancy.
Usually your doctor will prescribe insulin while you are pregnant. As with all medications, you and your doctor should discuss the use of glipizide and metformin hydrochloride tablets if you are nursing a child.
Q12. How do I take Glipizide and Metformin Hydrochloride Tablets?
Your doctor will tell you how many glipizide and metformin hydrochloride tablets to take and how often.
This should also be printed on the label of your prescription. You will probably be started on a low dose of glipizide and metformin hydrochloride tablets and your dosage will be increased gradually until your blood sugar is controlled.
Q13. Where can I get more information about Glipizide and Metformin Hydrochloride Tablets?
This leaflet is a summary of the most important information about glipizide and metformin hydrochloride tablets.
If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as glipizide and metformin hydrochloride tablets and its side effects. There is also a leaflet (package insert) written for health professionals that your pharmacist can let you read.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
DRUG: Glipizide and Metformin Hydrochloride
GENERIC: Glipizide and Metformin Hydrochloride
DOSAGE: TABLET, FILM COATED
ADMINSTRATION: ORAL
NDC: 70518-0908-0
NDC: 70518-0908-1
COLOR: pink
SHAPE: CAPSULE
SCORE: No score
SIZE: 15 mm
IMPRINT: ZE66
PACKAGING: 180 in 1 BOTTLE, PLASTIC
PACKAGING: 90 in 1 BOTTLE, PLASTIC
ACTIVE INGREDIENT(S):
- METFORMIN HYDROCHLORIDE 500mg in 1
- GLIPIZIDE 5mg in 1
INACTIVE INGREDIENT(S):
- CELLULOSE, MICROCRYSTALLINE
- CROSCARMELLOSE SODIUM
- FERRIC OXIDE RED
- HYPROMELLOSES
- MAGNESIUM STEARATE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- TITANIUM DIOXIDE
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| Labeler — REMEDYREPACK INC. (829572556) |
Revised: 02/2023 REMEDYREPACK INC.
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