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COMPOSITION :
Metformin 500
Each uncoated Extended release tablet contains:
Metformin Hydrochloride equivalent IP……………………500mg
Metformin 850
Each uncoated Extended-release tablet contains:
Metformin Hydrochloride equivalent IP……………………850mg
Metformin 1000
Each uncoated Extended-release tablet contains:
Metformin Hydrochloride equivalent IP………………….1000mg
INDICATIONS :
Metformin tablets, used as a once per day, are indicated as
an adjunct to diet and exercise, to lower blood glucose. Metformin
can be used concomitantly with a sulphonylurea or insulin to
improve glycaemic control in adults.
Metformin is indicated in patients 17 years of age and older
as either monotherapy or in combination therapy.
DOSAGE AND ADMINISTRATION :
There is no fixed dosage regimen for the management of
hyperglycaemia in patients with type 2 diabetes with metformin or
any other pharmacologic agent. Dosage of Metformin must be
individualized on the basis of both effectiveness and tolerance,
while not exceeding the maximum recommended daily dose.The maximum
recommended daily dose of metformin extended release tablets in
adults is 2000 mg/day.
Metformin should generally be given once daily with the
evening meal. Metformin should be started at a low dose, with
gradual dose escalation, both to reduce gastrointestinal side
effects and to permit identification of the minimum dose required
for adequate glycaemic control of the patient. During treatment
initiation and dose titration (see Recommended Dosing Schedule ) ,
fasting plasma glucose should be used to determine the therapeutic
response to Metformin and identify the minimum effective
dose for the patient.
Thereafter, glycosylated haemoglobin should be measured at
intervals of approximately three months. The therapeutic goal
should be to decrease both fasting plasma glucose and glycosylated
haemoglobin levels to normal or near normal by using the lowest
effective dose of Metformin , either when used as
monotherapy or in combination with sulphonylurea or insulin.
CONTRAINDICATIONS :
Metformin is contraindicated in patients with:
1. Renal disease or renal dysfunction (e.g., as suggested by serum
creatinine levels >/=1.5 mg/dL [males], >/=1.4 mg/dL [females] or
abnormal creatinine clearance), which may also result from
conditions such as cardiovascular collapse (shock), acute
myocardial infarction, and septicemia.
2. Congestive heart failure requiring pharmacologic treatment.
3. Known hypersensitivity to metformin.
4. Acute or chronic metabolic acidosis, including diabetic
ketoacidosis, with or without coma. Diabetic ketoacidosis should
be treated with insulin.
Metformin should be temporarily discontinued in patients
undergoing radiologic studies involving intravascular
administration of iodinated contrast materials, because use of
such products may result in acute alteration of renal function
PACKAGING INFORMATION :
Metformin 500 ...............Strip of 10 tablets
Metformin 850 ...............Strip of 10 tablets
Metformin 1000 ..............Strip of 10 tablets
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.
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).
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, therefore
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.
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