Indications of Amaryl 1 mg
Amaryl 1 mg is indicated in following conditions- Amaryl 1 mg 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. Amaryl 1 mg may be used concomitantly with metformin when diet, exercise, and Amaryl 1 mg or metformin alone does not result in adequate glycaemic control. ... Read moreAmaryl 1 mg is indicated in following conditions- Amaryl 1 mg 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. Amaryl 1 mg may be used concomitantly with metformin when diet, exercise, and Amaryl 1 mg or metformin alone does not result in adequate glycaemic control. Amaryl 1 mg 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 Amaryl 1 mg and insulin may increase the potential for hypoglycaemia.
Theropeutic Class
Sulfonylureas
Pharmacology
Amaryl 1 mg stimulates the insulin release from pancreatic β-cells and reduces glucose output from the liver. It also increases insulin sensitivity at peripheral target sites.
Dosage of Amaryl 1 mg
In principle, the dosage of Amaryl 1 mg is governed by the desired blood sugar level. The dosage of Amaryl 1 mg 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, Amaryl 1 mg requirement may fall as treatment proceeds. To avoid hypoglycaemia, timely dose reduction or cessation of Amaryl 1 mg 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 Amaryl 1 mg: There is no exact dosage relationship between Amaryl 1 mg and other oral blood sugar lowering agents. When substituting Amaryl 1 mg 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.
Administration of Amaryl 1 mg
Amaryl 1 mg tablet must be swallowed with sufficient amount of liquid.
Interaction of Amaryl 1 mg
Based on experience with Amaryl 1 mg 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 Amaryl 1 mg 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 Amaryl 1 mg 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 Amaryl 1 mg in an unpredictable fashion.
Contraindications
Amaryl 1 mg 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. Amaryl 1 mg must not be used in patients hypersensitive to Amaryl 1 mg, other sulfonylureas, other sulfonamides, severe hepatic dysfunction, severe impairment of renal function and dialysis patients.
Side Effects of Amaryl 1 mg
Hypoglycaemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.
Pregnancy & Lactation
Pregnancy: Amaryl 1 mg 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 Amaryl 1 mg with breast milk may harm the child. Therefore, Amaryl 1 mg must not be taken by lactating women. Either a changeover or a complete discontinuation of breast-feeding 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 Amaryl 1 mg, Hypoglycaemia can almost be promptly controlled by immediate intake of carbohydrates (glucose or sugar).
Overdose Effects of Amaryl 1 mg
Overdosage of sulfonylureas, including Amaryl 1 mg, 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.
Storage Conditions
Do not store above 30°C. Keep away from light and out of the reach of children.
Use In Special Populations
Pediatric use: Safety and effectiveness in pediatric patients have not been established.Geriatric use: No overall differences in safety or effectiveness were observed between elderly and adult subjects, but greater sensitivity of some older individuals cannot be ruled out. The drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.Use in renal insufficiency: A starting dose of 1 mg Amaryl 1 mg may be given to NIDDM patients with kidney disease, and the dose may be titrated based on fasting blood glucose levels. Use in hepatic insufficiency: No studies were performed in patients with hepatic insufficiency. Adverse reactions: Hypoglycemia. Adverse events, other than hypoglycemia, are dizzines, asthenia, headache, and nausea.
Drug Classes
Sulfonylureas
Mode Of Action
Amaryl 1 mg is a sulfonylurea antidiabetic agent which decreases blood glucose concentration. The primary mechanism of action of Amaryl 1 mg appears to be dependent on stimulating the release of insulin from functioning pancreatic beta cells. Amaryl 1 mg 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 Amaryl 1 mg. In non-fasting diabetic patients, the hypoglycaemic action of a single dose of Amaryl 1 mg persists for 24 hours.
Pregnancy
Amaryl 1 mg 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 Amaryl 1 mg with breast milk feeding may harm the child. Therefore, Amaryl 1 mg must not be taken by breastfeeding women. Either a changeover or complete discontinuation of breastfeeding is necessary.
