METFORMIN HYDROCHLORIDE (Page 7 of 7)

Who should not take metformin?

Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take metformin. Most of the conditions listed below can increase your chance of getting lactic acidosis.

Do not take metformin if you:

  • have kidney problems
  • have liver problems
  • have heart failure that is treated with medicines, such as Lanoxin® (digoxin) or Lasix® (furosemide)
  • drink a lot of alcohol. This means you binge drink for short periods or drink all the time
  • are seriously dehydrated (have lost a lot of water from your body)
  • are going to have an x-ray procedure with injection of dyes (contrast agents)
  • are going to have surgery
  • develop a serious condition, such as heart attack, severe infection, or a stroke
  • are 80 years or older and you have NOT had your kidney function tested

Tell your doctor if you are pregnant or plan to become pregnant. Metformin may not be right for you. Talk with your doctor about your choices. You should also discuss your choices with your doctor if you are nursing a child.

Can metformin hydrochloride tablets, USP be used in children?

Metformin hydrochloride tablets, USP has been shown to effectively lower glucose levels in children (ages 10 to 16 years) with type 2 diabetes. Metformin hydrochloride tablets, USP have not been studied in children younger than 10 years old.

Metformin hydrochloride tablets, USP have not been studied in combination with other oral glucose-control medicines in children. If you have any questions about the use of metformin hydrochloride tablets, USP in children, talk with your doctor or healthcare provider.

How should I take metformin hydrochloride tablets, USP?

Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take metformin with meals.

Your doctor may have you take other medicines along with metformin to control your blood sugar. These medicines may include insulin shots. Taking metformin hydrochloride tablets, USP with insulin may help you better control your blood sugar while reducing the insulin dose.

Continue your excercise and diet program and test your blood sugar regularly while taking metformin.

Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally. There is no evidence that metformin causes harm to the liver or kidneys.

Tell your doctor if you

  • have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking metformin for a short time.
  • plan to have surgery or an x-ray procedure with injection of dye (contrast agent). You may need to stop taking metformin hydrochloride tablets for a short time.
  • start to take other medicines or change how you take a medicine. Metformin can affect how well other drugs work, and some drugs can affect how well metformin works. Some medicines may cause high blood sugar.

What should I avoid while taking metformin hydrochloride tablets, USP?

Do not drink a lot of alcoholic drinks while taking metformin. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.

What are the side effects of metformin?

Lactic Acidosis.

In rare cases, metformin can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This build-up can cause serious damage. Lactic acidosis caused by metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the people who develop it.

It is also important for your liver to be working normally when you take metformin. Your liver helps remove lactic acid from your blood.

Make sure you tell your doctor before you use metformin if you have kidney or liver problems. You should also stop using metformin and call your doctor right away if you have signs of lactic acidosis. Lactic acidosis is a medical emergency that must be treated in a hospital.

Signs of lactic acidosis are:

  • feeling very weak, tired, or uncomfortable
  • unusual muscle pain
  • trouble breathing
  • unusual or unexpected stomach discomfort
  • feeling cold
  • feeling dizzy or lightheaded
  • suddenly developing a slow or irregular heartbeat

If your medical condition suddenly changes, stop taking metformin and call your doctor right away. This may be a sign of lactic acidosis or another serious side effect.

Other Side Effects.

Common side effects of metformin include diarrhea, nausea, and upset stomach. These side effects generally go away after you take the medicine for a while. Taking your medicine with meals can help reduce these side effects. Tell your doctor if the side effects bother you a lot, last for more than a few weeks, come back after they’ve gone away, or start later in therapy. You may need a lower dose or need to stop taking the medicine for a short period or for good.

About 3 out of every 100 people who take metformin have an unpleasant metallic taste when they start taking the medicine. It lasts for a short time.

Metformin rarely cause hypoglycemia (low blood sugar) by themselves. However, hypoglycemia can happen if you do not eat enough, if you drink alcohol, or if you take other medicines to lower blood sugar.

General advice about prescription medicines

If you have questions or problems, talk with your doctor or other healthcare provider. You can ask your doctor or pharmacist for the information about metformin that is written for health care professionals. Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use metformin for a condition for which it was not prescribed. Do not share your medicine with other people.

CARACO PHARMACEUTICAL LABORATORIES, LTD.

Manufactured by:
Sun Pharmaceutical Ind. Ltd.
Halol-Baroda Highway,
Halol-389 350, Gujarat, India.
Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive, C.S. No: 5249T34
Detroit, MI 48202

Repackaged By:
Aidarex Pharmaceuticals, LLC. Corona, CA 92880 Iss.3/10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 500 mg 90 Tablets

Image Label
(click image for full-size original)

METFORMIN HYDROCHLORIDE metformin hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-145(NDC:57664-474)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METFORMIN HYDROCHLORIDE (METFORMIN) METFORMIN HYDROCHLORIDE 1000 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONES
POLYETHYLENE GLYCOLS
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
HYPROMELLOSES
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE (White to Off-White) Score 2 pieces
Shape OVAL Size 19mm
Flavor Imprint Code C;474
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-145-00 100 TABLET (100 TABLET) in 1 BOTTLE None
2 NDC:33261-145-02 120 TABLET (120 TABLET) in 1 BOTTLE None
3 NDC:33261-145-10 10 TABLET (10 TABLET) in 1 BOTTLE None
4 NDC:33261-145-20 20 TABLET (20 TABLET) in 1 BOTTLE None
5 NDC:33261-145-30 30 TABLET (30 TABLET) in 1 BOTTLE None
6 NDC:33261-145-60 60 TABLET (60 TABLET) in 1 BOTTLE None
7 NDC:33261-145-90 90 TABLET (90 TABLET) in 1 BOTTLE None
8 NDC:33261-145-99 180 TABLET (180 TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075967 01/29/2002
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 10/2012 Aidarex Pharmaceuticals LLC

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