Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3659
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Chlorothiazide (Tablet)
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Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.<br/>Adults:<br/>For Edema: The usual adult dosage is 0.5 g to 1 g once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.<br/>For Control of Hypertension: The usual adult starting dosage is 0.5 g or 1 g a day as a single or divided dose. Dosage is increased or decreased according to blood pressure response. Rarely some patients may require up to 2 g a day in divided doses.<br/>Infants and Children:<br/>For Diuresis and For Control of Hypertension: The usual pediatric dosage is 5 to 10 mg per pound (10 to 20 mg/kg) per day in single or two divided doses, not to exceed 375 mg per day in infants up to 2 years of age or 1 g per day in children 2 to 12 years of age. In infants less than 6 months of age, doses up to 15 mg per pound (30 mg/kg) per day in two divided doses may be required.
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Chlorothiazide is a diuretic and antihypertensive. It is 6- chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1, 1-dioxide. Its molecular formula is CHCINOSand its structural formula is: Chlorothiazide, USP is a white, or practically white crystalline compound with a molecular weight of 295.73 which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7. Each tablet for oral administration contains either 250 mg or 500 mg of chlorothiazide and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium-Type A, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate.
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The mechanism of the antihypertensive effect of thiazides is unknown. Chlorothiazide does not usually affect normal blood pressure. Chlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosages, all thiazides are approximately equal in their diuretic efficacy. Chlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate. After oral use diuresis begins within 2 hours, peaks in about 4 hours, and lasts about 6 to 12 hours.<br/>Pharmacokinetics and Metabolism: Chlorothiazide is not metabolized but is eliminated rapidly by the kidney. The plasma half-life of chlorothiazide is 45 to 120 minutes. After oral doses, 10 to 15 percent of the dose is excreted unchanged in the urine. Chlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.
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Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.
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Chlorothiazide tablets, USP are available containing 250 mg or 500 mg of Chlorothiazide, USP. The 250 mg tablets are white, round, scored tablets debossed with M to the left of the score and 50 to the right of the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0150-01bottles of 100 tablets The 500 mg tablets are white, round, scored tablets debossed with MYLAN above the score and 162 below the score on one side of the tablet and blank on the other side. They are available as
follows: NDC 0378-0162-01bottles of 100 tablets Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. The degree to which chlorothiazide sodium is removed by hemodialysis has not been established. The oral LDof chlorothiazide is 8.5 g/kg, greater than 10 g/kg, and greater than 1 g/kg, in the mouse, rat and dog respectively.
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Chlorothiazide
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Chlorothiazide (Tablet)
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The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity. Body as a whole: Weakness. Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs). Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia. Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia. Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura. Metabolic: Electrolyte imbalance , hyperglycemia, glycosuria, hyperuricemia. Musculoskeletal: Muscle
spasm. Nervous System / Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness. Renal: Renal failure, renal dysfunction, interstitial nephritis . Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia. Special Senses: Transient blurred vision, xanthopsia. Urogenital: Impotence. Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.
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Chlorothiazide is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Chlorothiazide is indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.<br/>Use in Pregnancy: Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy . Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascularvolume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
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Chlorothiazide
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