An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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30-mg: Non-insulin dependent diabetes (type 2) in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose.
80-mg:Qualizide is a sulphonylurea hypoglycemic agent which is given by mouth in the treatment of non-insulin dependent diabetes mellitus. It is used to supplement treatment by diet modification when such modification has not proved effective on its own. Its duration of action is 12 hours or more. Qualizide may be used in place of chlorpropamide in elderly patients.
Uses of Qualizide in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Qualizide is used to lower the blood sugar levels in type 2 diabetes mellitus when diet, physical exercise and weight reduction alone are not adequate.
Qualizide description
Qualizide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release. Medications in this class differ in their dose, rate of absorption, duration of action, route of elimination and binding site on their target pancreatic β cell receptor. Sulfonylureas also increase peripheral glucose utilization, decrease hepatic gluconeogenesis and may increase the number and sensitivity of insulin receptors. Sulfonylureas are associated with weight gain, though less so than insulin. Due to their mechanism of action, sulfonylureas may cause hypoglycemia and require consistent food intake to decrease this risk. The risk of hypoglycemia is increased in elderly, debilitated and malnourished individuals. Qualizide has been shown to decrease fasting plasma glucose, postprandial blood glucose and glycosolated hemoglobin (HbA1c) levels (reflective of the last 8-10 weeks of glucose control). Qualizide is extensively metabolized by the liver; its metabolites are excreted in both urine (60-70%) and feces (10-20%).
Qualizide dosage
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Usual Dose: ½-2 tablets as a single dose taken at breakfast. Maximum: 120 mg. This depends on the response to treatment.
The dose is determined by the physician depending upon blood (and possibly urine) sugar levels.
Change in external factors (eg, weight reduction, change in lifestyle, stress) or improvements in the blood sugar control may require changed Qualizide doses.
If a combination therapy of Qualizide with metformin, an α-glucosidase inhibitor, thiazolidinedione, a dipeptidyl peptidase-4 inhibitor, a GLP-1 receptor agonist or insulin is initiated, the physician will determine the proper dose of each medicine individually.
Talk to a physician or pharmacist if the effect of Qualizide is too strong or not strong enough.
Missed Dose: It is important to take Qualizide everyday as regular treatment works better.
However, in case of a missed dose, the next dose of Qualizide should be taken at the usual time. Do not take a double dose to make up for a forgotten dose.
Discontinuation of Treatment: Consult a physician first before stopping Qualizide, as the treatment for diabetes is usually life long.
Stopping could cause high blood sugar (hyperglycemia).
Administration: Swallow ½ or whole tablet(s) in 1 piece. Do not chew or crush. The tablet can be divided into equal doses.
Take the tablet(s) with a glass of water at breakfast and preferably at the same time each day.
Always eat a meal after taking the tablet(s).
Qualizide interactions
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Tell the physician or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription, as these may interact with Qualizide.
The blood sugar lowering effect of Qualizide may be strengthened and signs of low blood sugar levels may occur when one of the following medicines is taken: Other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin); antibiotics (eg, sulfonamides, clarithromycin); medicines used to treat high blood pressure or heart failure (β-blockers, ACE inhibitors eg, captopril and enalapril); medicines used to treat fungal infections (miconazole, fluconazole); medicines used to treat ulcers in the stomach or duodenum (H2-receptor antagonists); medicines used to treat depression (monoamine oxidase inhibitors); painkiller or antirheumatics (phenylbutazone, ibuprofen); medicines containing alcohol.
The blood glucose lowering effect of Qualizide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken: Medicines used to treat disorders of the central nervous system (chlorpromazine); medicines reducing inflammation (corticosteroids); medicines used to treat asthma or used during labor (IV salbutamol, ritodrine and terbutaline); medicines used to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol).
Qualizide may increase the effects of medicines which reduce blood clotting (eg, warfarin). Consult the physician before taking another medicinal product. When hospitalized, patient should inform the medical staff of taking Qualizide.
Qualizide side effects
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Good clinical acceptability of Qualizide, has been established in many studies as well as in medical practice.
The safety of a modified-release formulation of Qualizide (30-120 mg) has been evaluated in controlled clinical trials in 955 patients, of which 728 patients were treated in long-term comparative trials, against a Qualizide immediate-release formulation (80-320 mg), for up to 10 months. In these comparative trials, the overall incidence and type of adverse events were similar in both groups. Adverse events were generally mild and transient, not requiring discontinuation of therapy.
However, where patients did discontinue due to adverse events, the percentage was lower in the modified-release group (2.9%) than in the immediate-release group (4.5%).
Hypoglycaemia : As is the case with all sulfonylurea drugs, hypoglycaemic reactions have been reported following Qualizide administration. However, a number of studies have shown that hypoglycaemia is less common with Qualizide than with glibenclamide.
Possible symptoms of hypoglycaemia are: Headache, intense hunger, nausea, vomiting, lassitude, sleep disorders, agitation, aggression, poor concentration, reduced awareness and slowed reactions, depression, confusion, visual and speech disorders, aphasia, tremor, paresis, sensory disorders, dizziness, feeling of powerlessness, loss of seIf-control, delirium, convulsions, shallow respiration, bradycardia, drowsiness and loss of consciousness, possibly resulting in coma and/or death.
In addition, signs of adrenergic counter-regulation may be observed: Sweating, clammy skin, anxiety, tachycardia, hypertension, palpitations, angina pectoris and cardiac arrhythmia. Usually, symptoms disappear after intake of carbohydrate eg, sugar (artificial sweeteners have no effect). Experience with other sulfonylureas shows that hypoglycaemia can recur even when these measures are initially effective. If a hypoglycaemic episode is severe or prolonged and even if it is temporarily controlled by intake of sugar, immediate medical treatment or even hospitalisation is required.
In long-term comparative studies, the percentage of patients experiencing hypoglycaemic episodes was similar between patients treated with the modified-release formulation of Qualizide (11.6%) and those treated with the immediate-release formulation of Qualizide (11.1 %). However, the number of hypoglycaemic episodes/100 patient-months was lower in the modified-release group (3.5) than in the immediate-release group (4.8).
Analysis of elderly patients (>65 years old) showed less hypoglycaemia than in the general population, with a prevalence of hypoglycaemic episodes lower in the modified-release group (2.6 hypoglycaemic episodes for 100 patient-months) than in the immediate-release group (4.1).
The percentage of patients experiencing hypoglycaemic episodes in the sub-population with renal failure, was similar to that observed in the general population.
Other Adverse Events: Adverse events reported during controlled clinical trials with the modified-release formulation of Qualizide were those expected in an ageing population with diabetes.
Adverse events that were reported in at least 2% of patients, in long-term controlled clinical studies, are presented in Table 2. The most frequent adverse events were not specifically related to the disease (eg, respiratory infections or back pain).
Analysis of adverse events in sub-populations showed a similar pattern to that seen in the general population. Gender, age and renal insufficiency had no significant influence on the safety profile of the modified-release formulation of Qualizide.
Gastrointestinal disturbances (reported with Qualizide), including nausea, dyspepsia, diarrhoea, abdominal pain, vomiting and constipation may be avoided or minimised if Qualizide is taken with breakfast.
The following adverse events have been rarely reported: Skin and mucosae reactions: Pruritus, urticaria, maculopapular rashes, rash, erythema and bullous reactions.
Haematological Disorders (As with Other Sulfonylurea Drugs): A few rare cases of anaemia, leucopenia, thrombocytopenia and agranulocytosis.
Occasional elevations of serum creatinine, blood urea nitrogen, serum bilirubin and hepatic enzymes (AST, ALT, alkaline phosphatase) levels and exceptionally, hepatitis. Treatment should be discontinued if cholestatic jaundice appears.
These symptoms usually disappear after discontinuation of treatment.
As with any glucose-lowering medication, transient visual disturbances may occur on initiation of treatment due to changes in blood glucose levels.
Qualizide contraindications
Hypersensitivity to Qualizide, other sulfonylureas, sulfonamides or to any of the excipients of Qualizide.
Type I diabetes, diabetic ketoacidosis, diabetic pre-coma and coma; severe renal or hepatic insufficiency.
Treatment with miconazole.
Lactose Intolerance: Due to the presence of lactose in Qualizide, patients with rare hereditary problems of galactose intolerance, glucose galactose malabsorption or Lapp lactase deficiency should not take this medicinal product.
Use in pregnancy: Category C: It is important to achieve strict normoglycaemia during pregnancy.
Oral hypoglycaemic agents should be replaced by insulin. The sulfonylureas may enter the fetal circulation and cause neonatal hypoglycaemia. In animal studies, embryotoxicity and/or birth defects have been demonstrated with some sulfonylureas.
Qualizide should not be used in pregnant women although animal studies of Qualizide have not shown any teratogenic effect. From a clinical point of view, there are no adequate data to allow evaluation of the possible malformative or foetotoxic effects of Qualizide, when administered during pregnancy.
Use in lactation: In the absence of data on the transfer of Qualizide into breast milk and given the risk of neonatal hypoglycaemia, breastfeeding is contraindicated during treatment with Qualizide.
DTP/NCI. "gliclazide: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
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