Product Elements:
Hydrochlorothiazide hydrochlorothiazide hydrochlorothiazide hydrochlorothiazide starch, corn fd&c yellow no. 6 dibasic calcium phosphate dihydrate silicon dioxide lactose monohydrate magnesium stearate light orange circular, flat t;154 hydrochlorothiazide hydrochlorothiazide hydrochlorothiazide hydrochlorothiazide starch, corn fd&c yellow no. 6 dibasic calcium phosphate dihydrate silicon dioxide lactose monohydrate magnesium stearate light orange circular, flat t;155
Indications and Usage:
Indications and usage hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. hydrochlorothiazide tablets are 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. 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 p
Read more...regnancy. thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see precautions: 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 intravascular volume 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.
Warnings:
Warnings use with caution in severe renal disease. in patients with renal disease, thiazides may precipitate azotemia. cumulative effects of the drug may develop in patients with impaired renal function. thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. thiazides may add to or potentiate the action of other antihypertensive drugs. sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma. the possibility of exacerbation or activation of systemic lupus erythematosus has been reported. lithium generally should not be given with diuretics (see precautions, drug interactions ). acute myopia and secondary angle-closure glaucoma hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. symptoms include acute onset of dec
Read more...reased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. untreated acute angle-closure glaucoma can lead to permanent vision loss. the primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Dosage and Administration:
Dosage and administration therapy should be individualized according to patient response. use the smallest dosage necessary to achieve the required response adults for edema the usual adult dosage is 25 mg to 100 mg daily as a single or divided dose. many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on 3 to 5 days each week. with an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur. for control of hypertension the usual initial dose in adults is 25 mg daily given as a single dose. the dose may be increased to 50 mg daily, given as a single or two divided doses. doses above 50 mg are often associated with marked reductions in serum potassium (see also precautions ). patients usually do not require doses in excess of 50 mg of hydrochlorothiazide daily when used concomitantly with other antihypertensive agents. infants and children for diuresis and for control of hyperten
Read more...sion the usual pediatric dosage is 0.5 mg to 1 mg per pound (1 to 2 mg/kg) per day in single or two divided doses, not to exceed 37.5 mg per day in infants up to 2 years of age or 100 mg per day in children 2 to 12 years of age. in infants less than 6 months of age, doses up to 1.5 mg per pound (3 mg/kg) per day in two divided doses may be required. (see precautions: pediatric use .)
Contraindications:
Contraindications anuria. hypersensitivity to this product or to other sulfonamide-derived drugs.
Adverse Reactions:
Adverse reactions 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 (see precautions ), hyperglycemia, glycosuria, hyperuricemia. musculoskeletal: muscle spasm. nervous system/psychiatric: vertigo, paresthesias, dizziness, headache, restlessnes
Read more...s. renal: renal failure, renal dysfunction, interstitial nephritis (see warnings ). 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.
Use in Pregnancy:
Pregnancy teratogenic effects-pregnancy category b studies in which hydrochlorothiazide was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg hydrochlorothiazide/kg, respectively, provided no evidence of harm to the fetus. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. nonteratogenic effects thiazides cross the placental barrier and appear in cord blood. there is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Pediatric Use:
Pediatric use there are no well controlled clinical trials in pediatric patients. information on dosing in this age group is supported by evidence from empiric use in pediatric patients and published literature regarding the treatment of hypertension in such patients. (see dosage and administration: infants and children. )
Overdosage:
Overdosage 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 hydrochlorothiazide is removed by hemodialysis has not been established. the oral ld 50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.
Description:
Description hydrochlorothiazide is a diuretic and antihypertensive. it is the 3,4-dihydro derivative of chlorothiazide. it is chemically designated as 6-chloro-3,4-dihydro- 2h -1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide and has the following structural formula: hydrochlorothiazide, usp is a white, or practically white, crystalline powder which is slightly soluble in water, freely soluble in sodium hydroxide solution, in n -butylamine, and in dimethylformamide; sparingly soluble in methanol; insoluble in ether, in chloroform, and in dilute mineral acids. each tablet for oral administration contains 25 mg or 50 mg hydrochlorothiazide usp. in addition, each tablet contains the following inactive ingredients: corn starch, fd&c yellow #6, dibasic calcium phosphate, pregelatinized starch, colloidal silicon dioxide, lactose monohydrate and magnesium stearate. hydrochlorothiazide-structure
Clinical Pharmacology:
Clinical pharmacology the mechanism of the antihypertensive effect of thiazides is unknown. hydrochlorothiazide does not usually affect normal blood pressure. hydrochlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. at maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy. hydrochlorothiazide 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. pharmacokinetics and metabolism hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. when plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5.6 and 14.8 hours. at least 61 percent of the oral dose is eliminated unchanged within 24 hours. hydrochlorothiazide crosses the placental but not th
Read more...e blood-brain barrier and is excreted in breast milk.
How Supplied:
How supplied hydrochlorothiazide tablets usp are available as light orange, circular, flat, beveled, uncoated tablets, with score line having "t" and "154" debossed across the score line on one side and plain on other side containing 25 mg of hydrochlorothiazide usp. bottles of 90 : ndc 76282-154-90 bottles of 100 : ndc 76282-154-01 bottles of 500 : ndc 76282-154-05 bottles of 1000 : ndc 76282-154-10 hydrochlorothiazide tablets usp are available as light orange, circular, flat, beveled, uncoated tablets, with score line having "t" and "155" debossed across the score line on one side and plain on other side containing 50 mg of hydrochlorothiazide usp. bottles of 90 : ndc 76282-155-90 bottles of 100 : ndc 76282-155-01 bottles of 500 : ndc 76282-155-05 bottles of 1000 : ndc 76282-155-10 pharmacist: dispense in a well-closed container as defined in the usp. use child-resistant closure (as required) store at 20° - 25° c (68°-77° f) [see usp controlled room temperature]. please a
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Package Label Principal Display Panel:
Package label-principal display panel ndc 76282-154-90 hydrochlorothiazide tablets usp 25 mg pharmacist: dispense in a well-closed containeras defined in the usp. use child-resistant closure (as required). exelan pharmaceuticals, inc. rx only 90 tablets this is a picture of the label hydrochlorothiazide tablets, usp, 25 mg, 30 count.
Package label-principal display panel ndc 76282-155-90 hydrochlorothiazide tablets usp 50 mg pharmacist: dispense in a well-closed containeras defined in the usp. use child-resistant closure (as required). exelan pharmaceuticals, inc. rx only 90 tablets this is a picture of the label hydrochlorothiazide tablets, usp, 25 mg, 30 count.