Generic Medicines
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GENERIC NAME: metformin
DRUG CLASS AND MECHANISM
Metformin is an oral medication that lowers blood glucose (sugar) and
is used for treating type 2 diabetes. Insulin is a hormone produced by the
pancreas that controls glucose levels in blood by reducing the amount of
glucose made by the liver and by increasing the removal of glucose from
the blood by muscle and fat tissues. As a result, blood glucose levels
fall. Diabetes caused by a decrease in production of insulin that causes
increased production of glucose by the liver, and reduced uptake (and
effects) of insulin on fat and muscle tissues. Metformin acts by
increasing the sensitivity of liver, muscle, fat, and other tissues to the
uptake and effects of insulin. These actions lower the level of sugar in
the blood.
Unlike glucose-lowering drugs of the sulfonylurea class, for example
glyburide (Micronase; DiaBeta) or glipizide (Glucotrol), metformin does
not increase the concentration of insulin in the blood and, therefore,
does not cause excessively low blood glucose levels (hypoglycemia) when
used alone. In scientific studies, metformin reduced the complications of
diabetes such as heart disease, blindness and kidney disease. Metformin
was approved by the FDA in December 1994.
PRESCRIPTION: Yes
GENERIC AVAILABLE: Yes
PREPARATIONS: Tablets: 500, 850, and 1000 mg. Tablets (extended
release): 500, 750, and 1000 mg. Solution: 500 mg/5 ml
PRESCRIBED FOR
Metformin is used for treating type 2 diabetes in adults and children.
It may be used alone or in combination with other diabetic medications.
Metformin also has been used to prevent the development of diabetes in
people at risk for diabetes, treatment of polycystic ovaries, and weight
gain due to medications used for treating psychoses.
DOSING
For treating type 2 diabetes in adults, metformin (immediate release)
usually is begun at a dose of 500 mg twice a day or 850 mg once daily. The
dose is gradually increased by 500 mg weekly or 850 mg every two weeks as
tolerated and based on the response of the levels of glucose in the blood.
The maximum daily dose is 2550 mg given in three divided doses. If
extended tablets are used, the starting dose is 500 mg or 1000 mg daily
with the evening meal. The dose can be increased by 500 mg weekly up to a
maximum dose of 2000 mg (2500 mg of Fortamet) once daily or in two divided
doses. Glumetza tablets are given once daily. Metformin should be taken
with meals.
For pediatric patients 10-16 years of age, the starting dose is 500 mg
twice a day. The dose can be increased by 500 mg weekly up to a maximum
dose of 2000 mg. Glucophage XR has not been studied in children.
DRUG INTERACTIONS
Before using this medication, tell your doctor or pharmacist of all
prescription and nonprescription/herbal products you may use, especially
of: birth control pills, high blood pressure drugs (beta-blockers such as
propranolol, calcium channel blockers such as nifedipine, ACE inhibitors
such as captopril), cimetidine, clomiphene, corticosteroids (e.g.,
prednisone), decongestants, other diabetes drugs (e.g., glyburide,
insulin), estrogens, fenugreek, ginseng, isoniazid, niacin, phenothiazines
(e.g., chlorpromazine), phenytoin, thyroid drugs, "water pills" (diuretics
such as hydrochlorothiazide, furosemide). If you are scheduled to undergo
any x-ray or scanning procedure using injectable iodinated contrast
material, be sure to inform your doctor that you are taking this
medication. You will need to temporarily stop this medication around the
time of your procedure. Consult your doctor for further instructions.
USES
This medication is a biguanide-type medicine that is used along with a
diet and exercise program to control high blood sugar in diabetic
patients. This medication works by helping to restore your body's proper
response to the insulin you naturally produce, and by decreasing the
amount of sugar that your liver makes and that your stomach/intestines
absorb. Controlling high blood sugar helps prevent heart disease, strokes,
kidney disease, blindness and circulation problems, as well as decreased
sexual ability (impotence).
HOW TO USE
This medication is best taken by mouth with meals. Drink plenty of
fluids while taking this medication. Use this medication regularly in
order to get the most benefit from it. Remember to use it at the same
time(s) each day. Your dosage is based on your medical condition and
response to therapy. This medication may come with a Patient Information
Leaflet. Read it carefully and ask your doctor or pharmacist any questions
you may have about your medication.
SIDE EFFECTS
Also see Warning section. Nausea, stomach upset, diarrhea or metallic
taste may occur initially as your body adjusts to the medication. If
stomach symptoms recur later (after you are on the same dose for several
days or weeks), tell your doctor immediately. A late recurrence of stomach
symptoms may be due to lactic acidosis. Remember that your doctor has
prescribed this medication because the benefit to you is greater than the
risk of side effects. Many people using this medication do not have
serious side effects. This medication usually does not cause low blood
sugar (hypoglycemia), but this effect may occur if you do not consume
enough calories (from food, juices, fruit, etc.). The symptoms include
chills, cold sweat, dizziness, drowsiness, shaking, rapid heartbeat,
weakness, headache, fainting, tingling of the hands or feet, or hunger. It
is a good habit to carry glucose tablets or gel to treat low blood sugar.
If you are in a situation where you don't have these reliable forms of
glucose, eat a quick source of sugar such as table sugar, honey, or candy,
or drink a glass of orange juice or non-diet soda to quickly raise your
blood sugar level. Tell your doctor immediately about the reaction. To
help prevent hypoglycemia, eat meals on a regular schedule and do not skip
meals. Symptoms of high blood sugar (hyperglycemia) include thirst,
increased urination, confusion, drowsiness, flushing, rapid breathing, or
fruity breath odor. If these symptoms occur, tell your doctor immediately.
Your medication dosage may need to be increased. A very serious allergic
reaction to this drug is unlikely, but seek immediate medical attention if
it occurs. Symptoms of a serious allergic reaction may include: rash,
itching, swelling, severe dizziness, trouble breathing. If you notice
other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS
Before taking metformin, tell your doctor or pharmacist if you are
allergic to it; or if you have any other allergies. This medication should
not be used if you have certain medical conditions. Before using this
medicine, consult your doctor or pharmacist if you have: kidney disease,
liver disease, conditions that may cause a low oxygen blood level or poor
circulation (e.g., severe congestive heart failure, recent heart attack,
recent stroke), metabolic acidosis (e.g., diabetic ketoacidosis), serious
infection, lack of body fluids (dehydration). Before using this
medication, tell your doctor or pharmacist your medical history,
especially of: severe breathing problems (e.g., obstructive lung disease,
severe asthma), blood problems (e.g., anemia, vitamin B-12 deficiency),
scheduled upcoming surgery, scheduled upcoming x-ray or scanning
procedures, fertility problems (e.g., ovulation problems), alcohol use.
Limit alcohol while using this medication. During times of stress, such as
fever, infection, injury or surgery, it may be more difficult to control
your blood sugar. Consult your doctor, as a change in your medication may
be required. This medication can cause changes in the menstrual cycle
(promote ovulation) in women with certain fertility problems, increasing
the risk of becoming pregnant. Consult your doctor or pharmacist about the
use of reliable birth control while using this medication. Caution is
advised when using this drug in the elderly because they may be more
sensitive to the effects of the drug. This medication should be used only
when clearly needed during pregnancy. Discuss the risks and benefits with
your doctor. It is not known whether this drug passes into breast milk.
Breast-feeding is not recommended while using this drug.
OVERDOSE
If overdose is suspected, contact your local poison control center or
emergency room immediately. US residents can call the US national poison
hotline at 1-800-222-1222. Canadian residents should call their local
poison control center directly. Symptoms of overdose may include: rapid or
trouble breathing, severe drowsiness, slow or irregular heartbeat.
MISSED DOSE
If you miss a dose, use it as soon as you remember. If it is near the
time of the next dose, skip the missed dose and resume your usual dosing
schedule. Do not double the dose to catch up.
STORAGE
Store the U.S. product between 68-77 degrees F (20-25 degrees C) away
from light and moisture. Brief storage from 59-86 degrees F (15-30 degrees
C) is permitted. Do not store in the bathroom. . Store the Canadian
product between 59-86 degrees F (15-30 degrees C) away from light and
moisture. Do not store in the bathroom. Keep all medicines away from
children and pets.
WARNING:-Metformin can rarely cause a
condition called lactic acidosis, which can be fatal. Seek immediate
medical attention if you develop any of the following symptoms of lactic
acidosis: unusual tiredness (fatigue) or severe drowsiness, cold skin,
muscle pain, breathing trouble or rapid breathing, unusually slow or
irregular heartbeat. Lactic acidosis is more likely to occur in patients
who have: kidney or liver disease, conditions that may cause a low oxygen
blood level or poor circulation (e.g., severe congestive heart failure,
recent heart attack, recent stroke), excessive alcohol use, a lack of body
fluids (dehydration), X-ray or scanning procedures that require an
injectable iodinated contrast drug, surgery, or a serious infection. Also
at higher risk are those who are elderly, especially if you are over 80
years of age and have not had kidney and liver tests.
Note : This product information is intended only for residents of the India. Taj Pharmaceuticals Limited, medicines help to treat and prevent a range of conditions—from the most common to the most challenging—for people around the world.