Paride M Plus

Paride M Plus

Manufacturer:

Pharos
Concise Prescribing Info
Contents
Per 1/250 mg FC caplet Glimepiride 1 mg, metformin HCl 250 mg. Per 2/500 mg FC caplet Glimepiride 2 mg, metformin HCl 500 mg
Indications/Uses
Adjunct to diet & exercise in NIDDM when glimepiride or metformin monotherapy results in inadequate glycemic control. Replacement of combination therapy of glimepiride & metformin.
Dosage/Direction for Use
Individualized dosage. Once or twice daily. Generally initiated from lowest effective dose and titrate according to the patients' blood glucose level.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to additives, sulfonylureas, sulfonamides or biguanides. IDDM (type 1 DM), diabetic ketonemia & coma/precoma; acute or chronic metabolic acidosis. Patients susceptible to lactic acidosis. Use of intravascular iodinated contrast materials. Severe infections, pre- & post-op, serious trauma; malnourished, starving or debilitated patients, pituitary/adrenal insufficiency. Severe lung dysfunction, hypoxemia, excessive alcohol intake, dehydration, GI disturbances eg, diarrhea & vomiting. CHF. Severe renal or hepatic impairment or hemodialysis. Women of child-bearing potential, pregnancy & lactation.
Special Precautions
Lactic acidosis. Increased risk of CV mortality. Temporary changeover to insulin in exceptional stress situations (eg, trauma, surgery, febrile infections). Discontinue if administered w/ iodinated contrast IV. Temporarily suspend for any surgical procedure (except minor procedures not associated w/ restricted food & fluid intake). Increased risk of hypoglycaemia in case of unwillingness or incapacity to cooperate; undernourishment, irregular meal times or skipped meals; imbalance between physical exertion & carbohydrate intake; alterations of diet; alcohol consumption; overdosage w/ glimepiride; certain uncompensated endocrine disorders affecting carbohydrate metabolism or counter-regulation of hypoglycaemia; concurrent administration of certain other medicines. Regularly monitor glucose & glycosylated Hb. Milder or absent symptoms of hypoglycaemia eg, in the elderly, patients w/ autonomic neuropathy or taking β-blockers, clonidine, reserpine, guanethidine or other sympatholytic drugs. Patients w/ G6PD deficiency. Regularly monitor TSH in patients w/ hypothyroidism. Concomitant medications that may affect renal function. Hypoxic states; surgical procedures; excessive alcohol intake. Decreased vit B12 serum levels. Discontinue immediately if unexplained hyperventilation, myalgia, malaise, unusual somnolence or other nonspecific symptoms occur. Monitor renal function. Renal or hepatic impairment. May impair ability to drive or operate machinery. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Hypoglycemia; temporary visual impairment; GI disturbances, elevation of liver enzyme; liver impairment; allergic or pseudo-allergic reactions eg, itching, urticaria or rashes; severe thrombocytopenia & thrombocytopenic purpura. Metformin: Lactic acidosis; metallic taste.
Drug Interactions
Influenced glimepiride metabolism by CYP2C9 inducers (eg, rifampicin) or inhibitors (eg, fluconazole). Potentiation of the blood glucose-lowering effect by insulin & other oral antidiabetics, ACE inhibitors, allopurinol, anabolic steroids, male sex hormones, chloramphenicol, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluoxetine, guanethidine, ifosfamide, MAOIs, miconazole, fluconazole, aminosalicylic acid, pentoxifylline (high dose parenteral), phenylbutazone, azapropazone, oxyphenbutazone, probenecid, quinolones, salicylates, sulfinpyrazone, clarithromycin, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide. Weakening of the blood glucose-lowering effect by acetazolamide, barbiturates, corticosteroids, diazoxide, diuretics, epinephrine & other sympathomimetics, glucagon, laxatives (long-term use), nicotinic acid (high dose), oestrogens & progestogens, phenothiazines, phenytoin, rifampicin, thyroid hormones. May either potentiate or weaken effects w/ H2 receptor antagonist, clonidine, guanethidine & reserpine, acute & chronic alcohol intake. Effect of coumarin derivatives may be potentiated or weakened. β-blockers decrease glucose tolerance. Reduced absorption w/ colesevelam. Metformin: Concomitant use w/ iodinated contrast materials, gentamicin. Weakened effect w/ epinephrine, pyrazinamide, INH. Increased plasma conc w/ furosemide, nifedipine & cationic drugs. May decrease anticoagulant effect of phenprocoumon. Reduced hypoglycemic effect w/ levothyroxine.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD02 - metformin and sulfonylureas ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Paride M Plus 1/250 mg FC caplet
Packing/Price
3 × 10's
Form
Paride M Plus 2/500 mg FC caplet
Packing/Price
3 × 10's
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