Biopride-M Uses

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Biopride-M indications

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Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who have inadequate glycemic control with metformin or Glimepiride (Biopride-M) monotherapy or already treated with a combination of metformin and a sulfonylurea as separate tablets.

To maintain the efficacy of drug therapy, management of type 2 diabetes mellitus should also include nutritional counseling, appropriate exercise and weight reduction if obese or overweight. Secondary causes of poor glycemic control (eg, infection) should be investigated and treated prior to initiation or escalation of oral antidiabetic therapy.

Biopride-M description

Each tablet contains Glimepiride (Biopride-M) 2 mg and metformin HCl (in sustained-release form) 500 mg.

It also contains the following excipients: Hypromellose, sodium carboxymethyl cellulose, methacrylic acid copolymer dispersion, macrogol, povidone, magnesium stearate, purified water, sodium starch glycolate, lactose, titanium dioxide, microcrystalline cellulose, magnesium stearate and pregelatinized starch. Colors: Yellow ferric oxide and titanium dioxide.

Biopride-M dosage

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In principle, the dosage of Biopride-M is governed by the desired blood glucose level. The starting dose of Biopride-M is 1 tab once a day before or with breakfast or first main meal. The dosage of Biopride-M must be the lowest which is sufficient to achieve the desired metabolic control.

During treatment with Biopride-M, glucose levels in blood and urine must be measured regularly. In addition, it is recommended that regular determinations of the proportion of glycated haemoglobin be carried out.

Mistakes eg, forgetting to take a dose, must never be corrected by subsequently taking a larger dose.

Measures for dealing with such mistakes (in particular, forgetting a dose or skipping a meal) or situations where a dose cannot be taken at the prescribed time must be discussed and agreed between physician and patient beforehand.

As an improvement in control of diabetes is, in itself, associated with higher insulin sensitivity, Glimepiride (Biopride-M) requirements may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Biopride-M therapy must therefore be considered.

The highest recommended dose per day should be Glimepiride (Biopride-M) 8 mg and metformin 2000 mg.

Daily doses of Glimepiride (Biopride-M) of >6 mg are more effective only in a minority of patients.

In order to avoid hypoglycaemia, the starting dose of Biopride-M should not exceed the daily doses of Glimepiride (Biopride-M) or metformin already being taken.

When switching from combination therapy of Glimepiride (Biopride-M) plus metformin as separate tablets, Biopride-M should be administered on the basis of dosage currently being taken.

Titration: The daily dose should be titrated in increments of 1 tab only, corresponding to the lowest strength (in case various strengths are available).

Duration of Treatment: Treatment with Biopride-M is normally a long-term therapy.

Administration: Biopride-M should be administered once per day during breakfast or at the first main meal. Due to the sustained-release formulation, Biopride-M must be swallowed whole and not crushed or chewed.

Biopride-M interactions

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The hypoglycaemic action of sulphonylurea drugs may be potentiated by certain drugs, including nonsteroidal anti-inflammatory drugs (NSAIDs) and other drugs that are highly protein bound. These include drugs eg, insulin and other oral antidiabetics, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarins, cyclophosphamide, disopyramide, fenfluramine, fibrates, fluoxetine, guanethidine, iphosphamide, β-blockers, MAO inhibitors, miconazole, para-amino salicylic acid, pentoxifylline, (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, sulphonamides, tetracyclines, tritoqualine, trofosfamide.

Weakening of the blood sugar lowering effect and, thus, raised blood sugar levels may occur when one of the following medicines are taken concomitantly, eg, acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, adrenaline and other sympathomimetic agents, glucagon, laxatives (after protracted use), nicotinic acid (in high doses), oestrogen and progestogen, phenothiazines, phenytoin, rifampicin, thyroid hormones.

H2 receptor antagonists, clonidine and reserpine may lead to either potentiation or weakening of the blood sugar lowering effect.

Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim and vancomycin) which are eliminated by renal tubular secretion could have the potential for interaction with metformin by competing for common renal tubular transport systems.

Concomitant cimetidine leads to 60% increase in peak metformin plasma and whole blood concentrations.

Furosemide increased the metformin plasma and blood Cmax without altering metformin renal clearance in a single dose study. Nifedipine was reported to cause increases in plasma metformin Cmax and AUC.

Incompatibilities: None reported.

Biopride-M side effects

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Metformin may provoke or augment lactic acidosis particularly if it is present in high concentrations in the blood. Some of the symptoms of lactic acidosis may mimic certain adverse effects of metformin.

Physicians should instruct their patients to recognize the onset of symptoms of lactic acidosis to avoid this adverse reaction.

There is a great potential risk for hypoglycemia to occur due to the sulfonylurea component of Biopride-M.

Possible symptoms include headache, ravenous hunger, nausea, vomiting, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, impaired alertness and reactions, depression, confusion, speech disorders, aphasia, visual disorders, tremor, pareses, sensory disturbances, dizziness, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence, and loss of consciousness up to and including coma, shallow respiration and bradycardia.

Reported Adverse Events to Metformin are as Follows: Gastrointestinal: Adverse effects appear to be dose-related and include diarrhea, nausea, vomiting, abdominal discomfort (eg, abdominal cramps or pain), abnormal stools, constipation, abdominal distention, dyspepsia, epigastric discomfort, flatulence, viral gastroenteritis, taste disturbance specifically metallic taste in the mouth, toothache, tooth abscess. Most of these reactions are transient and can be controlled by taking metformin with meals or by a temporary reduction in dosage.

Body as a Whole: Chills, flu syndrome, fatigue, lethargy, asthenia, accidental injury, headache, infection

Cardiovascular: Chest discomfort/pain, hypertension, palpitations

Hematologic: Vitamin B12 and folate malabsorption, thrombocytopenia, neutropenia and rare reports of megaloblastic anemia

Hepatic: Severe acute hepatitis associated with liver function tests abnormalities and cholestasis have been associated with long-term metformin therapy resolving upon discontinuation of metformin.

Endocrine Effects: Hypoglycemia may occur when metformin is given concomitantly with sulfonylureas and/or alcohol; hyperglycemia (NOS) and sexual dysfunction.

Musculoskeletal: Asthenia, muscle cramp, muscle strain, myalgia, pain in limb.

Nervous System: Agitation, dizziness, migraine, paresthesia, syncope, sinus headache, hypoesthesia, lightheadedness, tremor.

Respiratory: Dyspnea, flu syndrome, nasal congestion, sinus congestion, rhinorrhea, rhinitis, tonsillitis, upper respiratory infection.

Skin and Appendages: Rash, erythema, pruritus, urticaria, increased sweating, contusion.

Others: Pneumonitis with vasculitis, aggravated edema, peripheral edema, ear pain, blurred vision, fungal infection, flushing, nail disorder and seasonal allergy.

The profile of adverse reactions in pediatric patients is similar to those observed in adults.

Laboratory Findings: Decreased blood glucose, abnormal liver function tests and increased white blood cell count.

Reported Adverse Events to Glimepiride (Biopride-M) are as Follows: Metabolic-Nutritional: Hypoglycemia, hyperglycemia, hyponatremia, increased appetite, dyspepsia, anorexia.

Gastrointestinal (GI): Diarrhea, nausea, vomiting, abdominal discomfort, abdominal distention, sensation of fullness.

Cardiovascular: Hypertension, tachycardia, bradycardia, palpitations, angina pectoris, cardiac arrhythmias, vasodilation.

Hematologic: Hemolytic and aplastic anemia, leukopenia, agranulocytosis, thrombocytopenia, thrombocytopenic purpura, pancytopenia due to myelosuppression, eosinophilia, erythrocytopenia, granulocytopenia.

Central Nervous System: Disulfiram-like reactions, headache, dizziness, lassitude, sleepiness, disordered sleep, restlessness, aggressiveness, impaired concentration, alertness and reaction time, depression, confusion, aphasia, tremor, paresis, sensory disturbance, helplessness, loss of self-control, delirium, cerebral convulsions, somnolence and loss of consciousness up to and including coma.

Hepatobiliary: Cholestasis, jaundice, abnormal liver function, hepatitis which may lead to liver failure or hepatic dysfunction, hepatic porphyria reactions, increased liver enzyme levels, granulomatous hepatitis, bilirubinemia.

Skin and Subcutaneous Tissue Disorders: Allergic or pseudo-allergic skin reactions (eg, pruritus, erythema, urticaria, vasculitis, and morbilliform or maculopapular eruptions). Such mild reactions may develop into serious reactions with dyspnea and hypotension, sometimes progressing to shock. These may be transient and may disappear despite continued use of Glimepiride (Biopride-M). If skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda, photosensitivity reactions and clammy skin were also observed.

Miscellaneous: Asthenia, allergic vasculitis, sweating, impaired speech disorder, visual disturbance/abnormal vision, dyspnea, increased urinary frequency.

Biopride-M contraindications

Hypersensitivity to metformin HCl, Glimepiride (Biopride-M), sulfonylureas, other sulfonamides or any of the excipients of Biopride-M (risk of hypersensitivity reactions).

Biopride-M is not suitable for the treatment of diabetes mellitus type 1 (eg, for the treatment of diabetics with a history of ketoacidosis) or of diabetic precoma or coma.

Impaired renal function; acute complications (severe infections, major operations and trauma); before x-ray examinations with iodinated contrast materials; liver damage; alcoholism; deficiencies of vitamin B12, folic acid and iron; ketosis-prone diabetes; severe cardiovascular or respiratory disease; general ill health (malnutrition, dehydration); diabetes with significant late complications (nephropathy, retinopathy).

Use in pregnancy: Pregnancy is generally regarded as a contraindication and insulin should be used in all pregnant diabetic women.

Active ingredient matches for Biopride-M:

Glimepiride/metformin hydrochloride in India.


Unit description / dosage (Manufacturer)Price, USD
BIOPRIDE-M tab 10's (Lividus)$ 0.54

List of Biopride-M substitutes (brand and generic names):

Azulix-MF Forte Glimepiride 2mg, Metformin HCI1000mg TAB / 10 (Torrent (Azuca))$ 0.62
CARBOPHAGE-G FORTE tab 10's (Merck)$ 0.81
10's (Jagsonpal)$ 0.33
Diaswich-M1 Glimepiride 1 mg, Metforminhydrochloride 500 mg. TAB / 10 (Jagsonpal)$ 0.33
DIASWICH-M1 tab 10's (Jagsonpal)$ 0.33
Diaswich-M1 Glimepiride 1 mg, Metforminhydrochloride 500 mg. TAB / 10 (Jagsonpal)$ 0.33
ECOPRIDE-FM tab 10's (CE-Biotec)$ 0.90
ECOPRIDE-M tab 10's (CE-Biotec)$ 0.54
EXERMET-GM FORTE tab 10's (Cipla)$ 0.84
GIMIBAY tab 10's (Bayer)$ 0.77
GLIMFIRST-M bilayer coated tab 10's (Sinsan)$ 0.90
GLIMFIRST-M2 FORTE bilayer coated tab 10's (Sinsan)$ 0.88
GLIMICER-M FORTE tab 10's (Retra)$ 0.49
10's (Triton (Calyx))
Glimidot-M Glimepiride 1mg, Metformin HCI500mg TAB / 10 (Triton (Calyx))
GLIMIDOT-M tab 10's (Triton (Calyx))$ 0.42
Glimidot-M Glimepiride 1mg, Metformin HCI500mg TAB / 10 (Triton (Calyx))
GLIMITISE-SR tab 10's (Avyukt)$ 0.67
GLIMITONE-M tab 10's (Medicron)
GLIMLAZE-M tab 10's (Ablaze)
GLIMNOM-M tab 10's (Acinom Healthcare)$ 0.51
GLIMP-M tab 10's (Biochem)$ 1.08
GLUREST-M bilayer coated tab 10's (Alde Medi)
GLUREST-M tab 10's (Alde Medi)
GLUREST-M FORTE tab 10's (Alde Medi)
GLYCIPHAGE-G FORTE tab 10's (Franco-Indian)$ 0.62
10's$ 0.64
Glycomet-GP 2 Forte Metformin HCI 1000mg, Glimepiride 2mg TAB / 10$ 0.64
Glycomet-GP 2 Forte Metformin HCI 1000mg, Glimepiride 2mg TAB / 10$ 0.64
Glycomet-GP 2 Forte Tablet SR (USV Ltd)$ 0.10
GLYCOMET-GP1 FORTE tab 10's (USV)$ 0.72
GLYCOMET-GP2 tab 15's (USV)$ 1.30
GLYCOMET-GP2 FORTE tab 10's (USV)$ 0.92
GLYCOMET-GP3 tab 10's (USV)$ 0.90
GLYCOMET-GP4 FORTE tab 10's (USV)$ 0.95
GLYMIX-M tab 10's (Malody)
IXOGLIME-GM bilayer coated tab 10's (Unique Life Sciences)
METZIDE tab 10's (Saint)
SUGLOW-G bilayer coated tab 10's (BRD)$ 0.80
WALAPHAGE-GP film-coated tab 10's (Wallace (Lyfestyle DC))$ 0.55
WALGLIM-M tab 10's (Walton)$ 0.63

References

  1. DailyMed. "GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "metformin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "glimepiride". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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