Glumeform 850

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Diabetic Treatment group biguanid
Barcode: 8935206003970
Description

COMPOSITION:
Metformin hydrochloride ..................850 mg
Excipients q.s ...................................1 tablet
(HPMC K100, HPMC 606, HPMC 615, aerosil, PVP K90, methacrylic acid copolymer, magnesium stearate, PEG 6000, talc, titanium dioxide).
PHARMACEUTICAL FORM: Film coated tablet.
PHARMACODYNAMIC PROPERTIES:
ATC code: A10BA02
Glumeform is a biguanide antidiabetic agent including active ingredient metformin. Metformin lowers both fasting and postprandial plasma glucose concentrations in patients with type 2 diabetes. Metformin may act via mechanisms: reduction of hepatic glucose production, delay of intestinal glucose absorption, increase in cellular glucose utilization, improvement of insulin binding to receptors, stimulation of glucose disintegration via anaerobic pathway. Glumeform reduces hyperglycemia in diabetic patients but does not produce hypoglycemia (except for cases of fasting or combination with other synergic drugs). The drug also does not produce hypoglycemia in nondiabetic individuals.
Independently of its action on glycaemia, metformin has favourable effects on lipid metabolism in patients with type 2 diabetes. Metformin reduces total cholesterol, LDL cholesterol and triglyceride levels. The activities of increased fibrinogenolysis and decreased platelet aggregation are recorded in diabetic patients after treatment with metformin.
PHARMACOKINETIC PROPERTIES:
Metformin is slowly and incompletely absorbed from the GI tract. Bioavailability is reported to be approximately 50-60%. Food decreases the extent and slightly delays the absorption of metformin. Plasma protein binding is negligible. Metformin is excreted in the kidneys as non-metabolite. Half-life is approximately 1.5 - 4.5 hours.
PRESENTATIONS: Box of 10 blisters x 5 tablets.
THERAPEUTIC INDICATIONS: For the treatment of type 2 (non-insulin dependent) diabetes mellitus, especially for obese patients whose diabetes cannot be managed on diet.
DOSAGE & ADMINISTRATION:
Recommended dosage
The starting dose of metformin in patients who are not currently taking metformin is 500 mg orally, once daily. Increase the dose in 500 mg increments every 1-2 weeks if a higher dose of metformin is needed and there are no gastrointestinal adverse reactions. The dosage of metformin must be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2000 mg.
Adults:
Monotherapy and combination with other oral antidiabetic agents
The usual starting dose is 1 tablet of 500 mg or 1 tablet of 850 mg metformin hydrochloride 2 or 3 times daily given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 3 g daily, taken as 3 divided doses.
If transfer from another oral antidiabetic agent is intended: discontinue the other agent and initiate metformin at the dose indicated above.
Combination with insulin: Metformin and insulin may be used in combination therapy to achieve better blood glucose control. Metformin is given at the usual starting dose of 1 tablet of 500 mg or 1 tablet of 850 mg 2 or 3 times daily, while insulin dosage is adjusted on the basis of blood glucose measurements.
Elderly: Due to the potential for decreased renal function in elderly subjects, the metformin dosage should be adjusted based on renal function. Regular assessment of renal function is necessary.
Paediatric population:
Monotherapy and combination with insulin
Glumeform can be used in children from 10 years of age and adolescents.
The usual starting dose is 500 mg or 850 mg metformin hydrochloride once daily, given during or after meals.
After 10 to 15 days the dose should be adjusted on the basis of blood glucose measurements. A slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 2 g daily, taken as 2 or 3 divided doses.
Recommendations for use in renal impairment
Assess renal function prior to initiation of metformin and periodically thereafter.
Metformin is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.
Initiation of metformin in patients with an eGFR between 30-45 mL/min/1.73 m2 is not recommended.
In patients taking metformin whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy.
Discontinue metformin if the patient's eGFR later falls below 30 mL/min/1.73 m2 [see Contraindications, Warnings and Precautions].
Metformin may be used in patients with moderate renal impairment, stage 3a (creatinine clearance [CrCl] 45-59 mL/min or estimated glomerular filtration rate [eGFR] 45-59 mL/min/1.73m2) only in the absence of other conditions that may increase the risk of lactic acidosis and with the following dose adjustments:
The starting dose is 500 mg or 850 mg metformin hydrochloride, once daily. The maximum dose is 1000 mg daily, given as 2 divided doses. The renal function should be closely monitored (every 3-6 months).
Discontinuation for iodinated contrast imaging procedures
Discontinue metformin at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart metformin if renal function is stable [see Warnings and Precautions].
CONTRAINDICATIONS: Hypersensitivity to metformin or to any of the excipients.
Acute catabolism state, severe infections (diabetes which must be treated with insulin).
Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: heart failure, respiratory failure, recent myocardial infarction, shock.
Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (metformin should be reinitiated only when patient's renal function has been shown to be normal).
Hepatic insufficiency, acute alcohol intoxication, alcoholism.
Anesthesia: Metformin should be discontinued in the morning before surgery and restarted only if normal renal function has been established.
Type 1 diabetes, diabetic ketoacidosis, diabetic pre-coma.
Severe renal failure (eGFR below 30 mL/min/1.73m2) [see Warnings and Precautions].
Known hypersensitivity to metformin.
Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
WARNINGS AND PRECAUTIONS: 
Lactic acidosis:
Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmia. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (> 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 µg/mL.
Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information [see Dosage and Administration, Contraindications, Warnings and Precautions, Interactions and Use in specific populations].
If metformin-associated lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of metformin. In metformin treated patients with a diagnosis or strong suspicion of lactic acidosis, prompt hemodialysis is recommended to correct the acidosis and remove accumulated metformin (metformin hydrochloride is dialyzable, with a clearance of up to 170 mL/minute under good hemodynamic conditions). Hemodialysis has often resulted in reversal of symptoms and recovery.
Educate patients and their families about the symptoms of lactic acidosis and if these symptoms occur instruct them to discontinue metformin and report these symptoms to their healthcare provider.
For each of the known and possible risk factors for metformin-associated lactic acidosis, recommendations to reduce the risk of and manage metformin-associated lactic acidosis are provided below:
Renal impairment: The postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment. The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patient's renal function include [see Dosage and Administration, Clinical Pharmacology]:
- Before initiating metformin, obtain an estimated glomerular filtration rate (eGFR).
- Metformin is contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 [see Contraindiations].
- Initiation of metformin is not recommended in patients with eGFR between 30 - 45 mL/min/1.73 m2.
- Obtain an eGFR at least annually in all patients taking metformin. In patients at increased risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently.
- In patients taking metformin whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit and risk of continuing therapy.
Drug interactions: The concomitant use of metformin with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance or increase metformin accumulation [see Drug Interactions]. Therefore, consider more frequent monitoring of patients.
Age 65 or greater: The risk of metformin-associated lactic acidosis increases with the patient's age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal function more frequently in elderly patients.
Radiological studies with contrast: Administration of intravascular iodinated contrast agents in metformin-treated patients has led to an acute decrease in renal function and the occurrence of lactic acidosis. Stop metformin at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of hepatic impairment, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and restart metformin if renal function is stable.
Surgery and other procedures:
Withholding of food and fluids during surgical or other procedures may increase the risk for volume depletion, hypotension and renal impairment. Metformin should be temporarily discontinued while patients have restricted food and fluid intake.
Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia. Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Hypoxic states: Several of the postmarketing cases of metformin-associated lactic acidosis occurred in the setting of acute congestive heart failure (particularly when accompanied by hypoperfusion and hypoxemia). Cardiovascular collapse (shock), acute myocardial infarction, sepsis, and other conditions associated with hypoxemia have been associated with lactic acidosis and may also cause prerenal azotemia. When such events occur, discontinue metformin.
Excessive alcohol intake: Alcohol potentiates the effect of metformin on lactate metabolism and this may increase the risk of metformin-associated lactic acidosis. Warn patients against excessive alcohol intake while receiving metformin.
Hepatic impairment: Patients with hepatic impairment have developed with cases of metformin-associated lactic acidosis. This may be due to impaired lactate clearance resulting in higher lactate blood levels. Therefore, avoid use of metformin in patients with clinical or laboratory evidence of hepatic disease.
Replacement of metformin with insulin should be given in severe infections, postoperative trauma, and pregnancy.
Patients with heart failure are more at risk of hypoxia and renal insufficiency. In patients with stable chronic heart failure, metformin may be used with a regular monitoring of cardiac and renal function.
For patients with acute and unstable heart failure, metformin is contraindicated.
Pregnancy and lactation: Metformin is contraindicated in pregnant women. A decision on whether to discontinue breast-feeding should be made, taking into account the benefit of breast-feeding.
Effects on works: Metformin monotherapy does not cause hypoglycaemia. However, patients should be alerted to the risk of hypoglycaemia when metformin is used in combination with other antidiabetic agents.
INTERACTIONS: Certain drugs may lead to loss of glycemic control of metformin. These drugs include other diuretics, corticosteroids, phenothiazines, oral contraceptives, estrogens, phenytoin, nicotinic acid, calcium channel blocking drugs, isoniazid, and sympathomimetics.
Cationic drugs (e.g., amiloride, digoxin, morphine, ranitidine, trimethoprim, vancomycin, etc.) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems. Cimetidine shows a 60% increase in peak metformin plasma; therefore, metformin should not be combined with cimetidine.
UNDESIRABLE EFFECTS:
Adverse GI effects appear to be dose related, generally occur at initiation of therapy, and usually temporary.
Common, ADR > 1/100
GI disorders:  diarrhea, nausea, vomiting, flatulence, dyspepsia, abdominal distension, abnormal feces, constipation, heartburn, taste disorder.
Nervous system disorders: headache, chills, dizziness.
Musculoskeletal disorders: muscle weakness.
Respiratory disorders: dyspnea, upper respiratory tract infections.
Skin disorders: rash.
Uncommon, 1/1000 ≤ ADR < 1/100
Lactic acidosis (very rare), megaloblastic anaemia, pneumonia.
Treatment of ADRs: Adverse GI effects can be diminished if metformin is taken with foods and the dose is increased gradually.
Hypoglycemia is uncommon in patients receiving metformin as monotherapy; however, it may occur when metformin is used concomitantly with a sulfonylurea agent, alcohol.
Decrease of vitamin B12 absorption (insignificantly and rarely), megaloblastic anaemia has been reported during long-term use of metformin. These cases are effectively treated with vitamin B12.
Lactic acidosis is a very rare, but fatal.
Metformin therapy should be discontinued if plasma lactate concentrations exceed 5 mmol/L.
The drug must be discontinued if evidence of renal or hepatic impairment is present.
Metformin therapy should be withheld promptly in patients any condition associated with myocardial infarction or blood infection.
Patients should be advised not to consume excessive amounts of alcohol because of a risk of lactic acidosis.
If a patient during prolonged fasting conditions or treated with a very low caloric intake, metformin should be discontinued.
OVERDOSE: Hypoglycemia has not been seen even with ingestion of up to 85 grams of metformin, although lactic acidosis has occurred in such circumstances.
Metformin is dialyzable with a clearance of up to 170 mL/min. Therefore, hemodialysis may be useful for removal of accumulated drug from patients in whom metformin overdosage is suspected.
Read the directions carefully before use.
This drug is for prescription only.
STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.
SHELF-LIFE: 36 months from the manufacturing date.
DATE OF REVISION OF THE TEXT: November 8, 2017















Read all of this leaflet carefully before you start taking this medicine.
Keep out of reach of children.
Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.
The drug is for prescription only.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Metformin hydrochloride .......................... 850 mg
Excipients q.s ...........................................1 tablet
(HPMC K100, HPMC 606, HPMC 615, aerosil, PVP K90, methacrylic acid copolymer, magnesium stearate, PEG 6000, talc, titanium dioxide).
PRODUCT DESCRIPTION: Round, white to off-white tablet, smooth on one side, a cross-line on other side, intact edges.
PRESENTATION: Box of 10 blisters x 5 tablets.        
WHAT THE DRUG IS USED FOR: For the treatment of type 2 (non-insulin dependent) diabetes mellitus, especially for obese patients whose diabetes cannot be managed on diet. 
HOW TO TAKE THIS MEDICINE: 
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