Product Elements:
Hydrochlorothiazide hydrochlorothiazide calcium phosphate, dibasic, dihydrate fd&c yellow no. 6 lactose monohydrate magnesium stearate starch, corn sodium starch glycolate type a potato hydrochlorothiazide hydrochlorothiazide light orange to peach colored h;3
Drug Interactions:
Drug interactions: when given concurrently the following drugs may interact with thiazide diuretics. alcohol, barbiturates, or narcotics: potentiation of orthostatic hypotension may occur. antidiabetic drugs - (oral agents and insulin): dosage adjustment of the antidiabetic drug may be required. other antihypertensive drugs: additive effect or potentiation. cholestyramine and colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. corticosteroids, acth: intensified electrolyte depletion, particularly hypokalemia. pressor amines (e.g., norepinephrine): possible decreased response to pressor amines but not sufficient to preclude their use. skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): possible increased responsiveness to the muscle relaxa
Read more...nt. lithium: generally should not be given with diuretics. diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide. non-steroidal anti-inflammatory drugs: in some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. therefore, when hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
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
Read more... pregnancy. 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 d
Read more...ecreased 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 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 hyper
Read more...tension: 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. postmarketing experience non-melanoma skin cancer hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. in a study conducted in the sentinel system, increased risk was predominantly for squamous cell carcinoma (scc) and in white patients taking large cumulative doses. the increased risk for scc in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of â¥50,000 mg the risk increase was approximately 1 additional scc case for every 6,700 patients per year.
Drug Interactions:
Drug interactions: when given concurrently the following drugs may interact with thiazide diuretics. alcohol, barbiturates, or narcotics: potentiation of orthostatic hypotension may occur. antidiabetic drugs - (oral agents and insulin): dosage adjustment of the antidiabetic drug may be required. other antihypertensive drugs: additive effect or potentiation. cholestyramine and colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85% and 43%, respectively. corticosteroids, acth: intensified electrolyte depletion, particularly hypokalemia. pressor amines (e.g., norepinephrine): possible decreased response to pressor amines but not sufficient to preclude their use. skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine): possible increased responsiveness to the muscle relaxa
Read more...nt. lithium: generally should not be given with diuretics. diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. refer to the package insert for lithium preparations before use of such preparations with hydrochlorothiazide. non-steroidal anti-inflammatory drugs: in some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. therefore, when hydrochlorothiazide and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Use in Specific Population:
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 (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 as
Read more...sociated 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.
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 ). information for patients non-melanoma skin cancer: instruct patients taking hydrochlorothiazide to protect skin from the sun and undergo regular skin cancer screening.
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-2 h -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 12.5 mg, 25 mg or 50 mg hydrochlorothiazide, usp. in addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate dihydrate, fd & c yellow, lactose monohydrate, magnesium stearate, pregelatinized starch (starch 1500) and sodium starch glycolate. 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% of the oral dose is eliminated unchanged within 24 hours. hydrochlorothiazide crosses the placental but not the blo
Read more...od-brain barrier and is excreted in breast milk.
Pharmacokinetics:
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% of the oral dose is eliminated unchanged within 24 hours. hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.
How Supplied:
How supplied: hydrochlorothiazide tablets, usp are available containing 12.5 mg, 25 mg and 50 mg hydrochlorothiazide, usp. the 12.5 mg tablets are light orange to peach colored, round, biconvex tablets debossed with h on one side and 1 on another side. they are available as follows: the 25 mg tablets are light orange to peach colored, round, flat tablets with beveled edges and debossed with h & 2 on either side of break line and another side is plain. they are available as follows: the 50 mg tablets are light orange to peach colored, round, flat tablets with beveled edges and debossed with h & 3 on either side of break line and another side is plain. they are available as follows: bottle of 30 tablets ndc 70934-883-30 store at 20° - 25°c (68° - 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. manufactured for: accord healthcare, inc., 1009 slater road, suite 210-b, durham
Read more..., nc 27703, usa manufactured by: intas pharmaceuticals limited, ahmedabad -380 009, india 10 4475 0 6001846 issued april 2020
Package Label Principal Display Panel:
50 mg container label ndc: 70934-883-30 label