SULFORID

Patients Information Leaflet (PIL)

 

SULFORID

Glimepiride BP

 

Composition

Product name:

  • Sulforid 1 Tablet

Strength: Each film coated tablet contains Glimepiride BP 1 mg.

  • Sulforid 2 Tablet

Strength: Each film coated tablet contains Glimepiride BP 2 mg.

  • Sulforid 3 Tablet

Strength: Each film coated tablet contains Glimepiride BP 3 mg.

  • Sulforid 4 Tablet

Strength: Each film coated tablet contains Glimepiride BP 4 mg.

 

Pharmacology

The product contains Glimepiride which is an oral blood-glucose-lowering drug of the sulphonylurea class. Chemically Glimepiride is identified as 1-[[p- [2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido) ethyl]phenyl] sulphonyl]-3-(trans-4-methylcyclohexyl) urea. The primary mechanism of action of Glimepiride is lowering of blood glucose by stimulating the release of insulin from functioning pancreatic beta cells. In addition, extra pancreatic effects may also play vital role in the activity of Glimepiride. Administration of the product can lead to increase sensitivity of peripheral tissues to insulin.

Indication

Non-insulin dependent (type-II) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction.

It is also indicated for use in combination with Insulin to lower blood glucose in patients whose hyperglycemia can not be controlled by diet and exercise or in conjunction with an oral hypoglycemic agent.

 

Dose & administration

In principle, the dosage of the product is governed by the desired blood sugar level. The dosage must be the lowest which is sufficient to achieve the desired metabolic control.

The initial and the maintenance doses are set based on the results of regular checking of glucose in blood and urine. Monitoring of glucose levels in blood and urine also serves to detect either primary or secondary failure of therapy.

Initial dose and dose titration: Usual initial dose is 1 mg once daily. If necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of one to two weeks and carried out stepwise at follows : 1 mg-2 mg-3 mg-4 mg-6 mg.

Dose range in patients with well controlled diabetes: Usual dose range in patients with well controlled diabetes is 1 to 4 mg daily.

 

Distribution of doses: Timing and distribution of doses are decided by the physician, in consideration of the patient’s current life style. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or – if none is taken – immediately before the first main meals. It is very important not to skip meals after taking the drug.

Secondary dosage adjustment: As the control of diabetes improves, sensitivity to insulin increases; therefore, its requirement may fall as treatment proceeds. To avoid hypoglycemia, timely dose reduction or cessation of Glimepiride therapy must be considered.

A dose adjustment must also be considered whenever the patient’s weight or life style changes or other factors arise which cause an increased susceptibility to hypo- or hyperglycemia.

Changeover from other oral antidiabetics to Glimepiride: There is no exact dosage relationship between Glimepiride and other oral blood sugar lowering agents. When substituting Glimepiride for other such agents, the initial daily dose is 1 mg; this applies even in changeover from the maximum dose of other oral blood sugar lowering agents. Any dose increase should be in accordance with guideline given above in initial dose and dose titration.

Consideration must be given to the potency and duration of action of the previous blood sugar lowering agent. It may be necessary to interrupt treatment to avoid additive effects which would increase the risk of hypoglycemia.

Administration: Glimepiride tablet must be swallowed without chewing and with sufficient amount of liquid (approximately ½ glasses).

 

Contraindication

Glimepiride is not suitable for the treatment of insulin dependent (type-I) diabetes mellitus, or of diabetic pre-coma or coma. Glimepiride must not be used in patients hypersensitive to Glimepiride or other sulfonylureas.

 

Warnings and precautions

In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates careful monitoring. If such risk is present it may be necessary to adjust the dosage of Glimepiride. Hypoglycemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g., sugar sweetened fruit juice or sugar sweetened tea).

 

Side effects

Hypoglycemia, temporary visual impairment, nausea, vomiting, diarrhea, abdominal pain, urticaria, fall in blood pressure.

 

Use in pregnancy and lactation

Pregnancy: Glimepiride must not be taken during pregnancy; a changeover to Insulin is necessary. Patients planning a pregnancy must inform their physician, and should be shifted to insulin.

Lactation: Ingestion of Glimepiride with breast milk may harm the child. Therefore, Glimepiride must not be taken by lactating women. Either a changeover or a complete discontinuation of breast-feeding is necessary.

Use in children, adolescents& elderly patients

Glimepiride isn’t recommended for people under 18 years old because it may affect body weight and cause low blood sugar.

Senior dosage (ages 65 years and older)

  • The starting dose is 1 mg taken once per day with breakfast or the first main meal of the day.
  • Your doctor may adjust your dose based on your blood sugar levels. Since seniors may be more sensitive to glimepiride and are more likely to have decreased kidney function, your doctor may increase your dose more slowly.
  • The maximum recommended dose is 8 mg taken once per day.

 

Drug interactions

Potentiation of the blood-sugar-lowering effect may occur with Insulin and other oral anti-diabetics, ACE inhibitors, Allopurinol, anabolic steroids and male sex hormones, Chloramphenicol, coumarin derivatives, Fluoxetine, MAO inhibitors, Miconazole, Para-aminosalicyclic acid, Pentoxifylline (high dose parenteral), Phenylbutazone, Oxyphenbutazone, quinolones, salicylates, sulphonamides, tetracyclines, b blockers.

Weakening of the blood-sugar-lowering effect may occur with Acetazolamide, barbiturates, corticosteroids, Diazoxide, diuretics, Epinephrine and other sympathomimetic agents, laxative, estrogens and progestogens, phenothiazines, Phenytoin, Rifampicin, and thyroid hormones.

H2 -receptor antagonists, Clonidine and Reserpine may lead to either potentiation or weakening of the blood-sugar-lowering effect.

Both acute and chronic alcohol intake may potentiate or weaken the blood-sugar-lowering action of Glimepiride unpredictably.

Overdose

Overdosage of sulfonylureas, including Glimepiride, can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dl. Patients should be closely monitored for a minimum of 24 to 48 hours, because hypoglycemia may recur after apparent clinical recovery.

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About Us

Desh Pharmaceuticals (Pvt). Ltd. is a GMP CERTIFIED leading pharmaceutical company in Bangladesh established in the year 1988. The company has a very big manufacturing facility located at Mirpur-7, Dhaka, 2 kilometer away from the Mirpur-10 of the capital city Dhaka The company produces various types of dosage forms which include tablets, capsules, oral liquids, dry […]

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Head office
2-D/11-C, Extention Pallabi
Mirpur, Dhaka-1216 .
Mob: +880 1611 228 877
+880 1719 596 112
E-mail: info@deshpharmabd.com
mlutfor1957@gmail.com

Factory
Plot# Shi-07, Milk Vita Road
Section-7, Mirpur
Dhaka, Bangladesh
Mob: +880 1711 706 476

Export/ International Marketing 
mizan.deshpharma@gmail.com
Mob: +880 1797191985


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