Appformin

Appformin

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Questions & Answers

Side Effects & Adverse Reactions

WARNING
A small number of people who have taken metformin have developed a serious condition called lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take metformin. (See “What are the side effects of metformin?”)

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    Iss 3/10
Detroit, MI 48202


Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

INDICATIONS AND USAGE
Metformin hydrochloride tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

INDICATIONS FOR USE
AppTrim is intended for the clinical nutritional management of the metabolic processes in patients with obesity, morbid obesity, and metabolic syndrome.
- To control appetite and carbohydrate cravings in obese patients who are undergoing a medically supervised weight loss program.
- To control appetite and carbohydrate cravings in patients who are being treated for metabolic syndrome.
- To control appetite and carbohydrate cravings in patients preparing for bariatric surgery.
- To control appetite and carbohydrate cravings in patients following bariatric surgery.

History

There is currently no drug history available for this drug.

Other Information

DESCRIPTION
Metformin hydrochloride, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:

Metformin Hydrochloride Formula

Metformin hydrochloride, USP is a white to off-white crystalline compound with a molecular formula of C4H11N5 - HCl and a molecular weight of 165.63. Metformin hydrochloride, USP is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride, USP is 6.68.  Metformin hydrochloride tablets, USP contain 500 mg, 850 mg, and 1000 mg of metformin hydrochloride, USP. Each tablet contains the inactive ingredients povidone, polyethylene glycol and magnesium stearate. In addition, the coating for 500 mg, 850 mg and 1000 mg contains:lactose monohydrate,hypromellose,titanium dioxide,triacetin.

PRODUCT DESCRIPTION
Primary Ingredients
AppTrim consists of a proprietary formulation of amino acids, cocoa, and flavonoids in specific proportions. These ingredients fall into the classification of Generally Recognized as Safe (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.

Amino Acids
Amino Acids are the building blocks of protein and are GRAS listed as they have been safely ingested by humans for thousands of years. The formulations of the amino acids in AppTrim are equivalent to those found in the usual human diet. Obese patients may require an increased amount of certain amino acids that cannot be obtained from normal diet alone. Tryptophan, for example, is an obligatory amino acid. The body cannot make tryptophan and must obtain tryptophan from the diet. Tryptophan is needed to produce serotonin. Serotonin is required to reduce appetite and carbohydrate cravings. Obese and morbidly obese patients frequently have altered serotonin metabolism. Some obese and morbidly obese patients have a resistance to the use of tryptophan that is similar to the mechanism found in insulin resistance. Some obese and morbidly obese patients cannot acquire sufficient tryptophan from the diet without ingesting a prohibitively large amount of calories, particularly calories from protein.

Flavonoids
Flavonoids are a group of phytochemical compounds found in all vascular plants including fruits and vegetables. They are a part of a larger class of compounds known as polyphenols. Many of the therapeutic or health benefits of colored fruits and vegetables, cocoa, red wine, and green tea are directly related to their flavonoid content. The specially formulated flavonoids found in AppTrim cannot be obtained from conventional foods in the necessary proportions to elicit a therapeutic response.

Other Ingredients
AppTrim contains the following inactive or other ingredients, as fillers, excipients, and colorings: gelatin, silicon dioxide, vegetable magnesium stearate, FDandC blue #1, FDandC Red #3, FDandC red #40, titanium dioxide.

Physical Description
AppTrim is a yellow to light brown powder. L-Glutamic Acid, Choline Bitartrate, L-Tyrosine, L-Serine, Whey Protein Hydrolysate, Griffonia Seed Extract (5-HTP), Cocoa Extract (6%Theobromine), Caffeine, and Grape Seed Extract (95% Proanthocyanidins).

Appformin Manufacturers


  • Physician Therapeutics Llc
    Appformin (Metformin Hydrochloride, Tyrosine) Kit [Physician Therapeutics Llc]

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