Indications
Limpet is indicated in following
conditions-
Limpet is indicated as an adjunct
to diet and exercise to lower the blood glucose in patients with noninsulin
dependent (Type II) diabetes mellitus (NIDDM) whose hyperglycaemia cannot be
controlled by diet and exercise alone.
Limpet may be used concomitantly
with metformin when diet, exercise, and Limpet or metformin alone does not
result in adequate glycaemic control.
Limpet is also indicated for use
in combination with insulin to lower blood glucose in patients whose
hyperglycaemia cannot be controlled by diet and exercise in conjunction with an
oral hypoglycaemic agent.
Combined use of Limpet and
insulin may increase the potential for hypoglycaemia.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Pharmacology
Glimepiride is a sulfonylurea
antidiabetic agent which decreases blood glucose concentration. The primary
mechanism of action of Glimepiride appears to be dependent on stimulating the
release of insulin from functioning pancreatic beta cells. Glimepiride acts in
concert with glucose by improving the sensitivity of beta cells to
physiological glucose stimulus, resulting in insulin secretion. In addition,
extrapancreatic effects like reduction of basal hepatic glucose production,
increased peripheral tissue sensitivity to insulin and glucose uptake may also
play role in the activity of Glimepiride. In non-fasting diabetic patients, the
hypoglycaemic action of a single dose of Glimepiride persists for 24 hours.
Dosage
In principle, the dosage of Glimepiride is governed by the desired blood sugar level. The dosage of Glimepiride 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 check 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: the 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 1 to 2 weeks, and carried out stepwise, as follows: 1 mg -> 2 mg -> 3 mg -> 4 mg -> 6 mg.
Dose in patients with well controlled diabetes: the 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 meal. It is very important not to skip meals after taking the drug.
Secondary dosage adjustment: As control of diabetes improves, sensitivity to insuiin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycaemia, 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-styie changes, or other factors arise which cause an increased susceptibility to hypo or hyperglycaemia.
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 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 hypoglycaemia.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Administration
Glimepiride tablet must be
swallowed with sufficient amount of liquid.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
Based on experience with Limpet and known interactions for other sulfonylureas, the following interactions must be considered.
In addition to insulin and other oral antidiabetic agents, drugs which may potentiate the hypoglycaemic action of Limpet include: ACE inhibitors, aminosalicylic acid, anabolic steroids and male sex hormones, azapropazone, chloramphenicol, ciofibrate, coumarin derivatives, cyclophosphamide, disopyramide, fenfluramine, fenyramidol, fibrates, fluconazole, fluoxetine, guanethidine, ifosfamide, MAO-inhibitors, miconazole, oxpentifylline (high dose parenteral), oxyphenbutazone, para-aminosalicylic acid, phenylbutazone, probenecid, quinolones, salicylates, sulphinpyrazone, sulfonamide antibiotics, tetracyclines, tritoqualine, trofosfamide.
Drugs which may attenuate the hypoglycaemic
action of Limpet include:
Acetazoiamide, barbiturates,
calcium channel blockers, corticosteroids, diazoxide, diuretics, glucagon,
isoniazid, laxatives, nicotinic acid (high doses), oestrogens, phenothiazines,
phenytoin, progestagens, rifampicin, sympathomimetic agents, thyroid hormones.
H2 receptor antagonists,
beta-blockers, clonidine and reserpine may lead to either potentiation or
weakening of the blood-glucose-lowering effect.
Concomitant treatment with a
beta-receptor blocker, clonidine, guanethidine or reserpine may mask the
warning symptoms of a hypoglycaemic attack.
Acute and chronic aicohol intake
may either potentiate or attenuate the activity of Limpet in an unpredictable
fashion.
Contraindications
Glimepiride is not suitable for
the treatment of insulin dependent (type I) diabetes mellitus, or for the
treatment of diabetic ketoacidosis, nor for the treatment of diabetic coma.
Glimepiride must not be used in patients hypersensitive to Glimepiride, other
sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe
impairment of renal function and dialysis patients.
Side Effects
Hypoglycaemia, temporary visual
impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in
blood pressure.
Pregnancy & Lactation
Glimepiride must not be taken
during pregnancy; a changeover to insulin is necessary. Patients planning a
pregnancy must inform their physician, and should change over to insulin.
Ingestion of Glimepiride with breast milk feeding may harm the child.
Therefore, Glimepiride must not be taken by breastfeeding women. Either a
changeover or complete discontinuation of breastfeeding is necessary.
Precautions & Warnings
in the initial weeks of
treatment, the risk of hypoglycaemia may be increased and necessitates careful monitoring.
If such risk present it may be necessary to adjust the dosage of Limpet,
Hypoglycaemia can almost be promptly controlled by immediate intake of
carbohydrates (glucose or sugar).
Overdose Effects
Overdosage of sulfonylureas,
including Limpet, can produce hypoglycaemia. Mild hypoglycaemic 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 hypoglycaemic reactions with coma, seizure, or
other neurological impairment occur infrequently, but constitute medicai
emergencies requiring immediate hospitalization. If hypoglycaemic 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 hypoglycaemia may recur after apparent clinical recovery.
Therapeutic Class
Sulfonylureas
Storage Conditions
Do not store above 30°C. Keep
away from light and out of the reach of children.
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