HYDROCHLOROTHIAZIDE TABLETS 25mg, USP, Rx only

/HYDROCHLOROTHIAZIDE TABLETS 25mg, USP, Rx only
HYDROCHLOROTHIAZIDE TABLETS 25mg, USP, Rx only2018-09-06T09:12:40+00:00

Prescription Drug Name:

HYDROCHLOROTHIAZIDE TABLETS 25mg, USP, Rx only

ID:

d4424cb8-19eb-48b6-bfbd-08beb0e7c67b

Code:

34391-3

DESCRIPTION


id: ea4e16a3-a56a-447f-878b-0a5848e666c2
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

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: C7H8ClN3O4S2                           M.W. 297.74 Hydrochlorothiazide is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Each tablet for oral administration contains 12.5 mg, 25 mg and 50 mg hydrochlorothiazide, USP.  In addition, each tablet contains the following inactive ingredients:  corn starch, dibasic calcium phosphate, FD&C yellow #6, lactose monohydrate, magnesium stearate, pregelatinized starch, and sodium starch glycolate.

CLINICAL PHARMACOLOGY


id: 7f6d64d8-8dd6-41dc-9002-27a3a59303a3
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

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.

INDICATIONS AND USAGE


id: 67cc47a2-297a-4b61-a07c-97ec90bb2987
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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.

CONTRAINDICATIONS


id: e5ba5df1-0ae4-419f-a84f-3a0420f47ef2
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Anuria. Hypersensitivity to this product or to other sulfonamide-derived drugs.

WARNINGS


id: 3b2c3511-fe2c-4e51-b0ad-d0992e07296f
displayName: WARNINGS SECTION
FDA Article Code: 34071-1

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).

ADVERSE REACTIONS


id: 6057f97c-b6ec-4251-9f20-d4b8f5bf0615
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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, restlessness. 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.

OVERDOSAGE


id: 754147ea-2de0-4f8c-b219-dd32aa5585f8
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5

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 LD50 of hydrochlorothiazide is greater than 10 g/kg in the mouse and rat.

DOSAGE AND ADMINISTRATION


id: 371dcadd-5a89-4570-9836-1c24f32e1507
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.

HOW SUPPLIED


id: 8050ea11-a8f0-49b1-9c64-a10089b814d8
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrochlorothiazide tablets, USP 12.5 mg and 25 mg, are available as light orange colored, round, flat face, beveled edge, uncoated tablets. Hydrochlorothiazide tablets, USP 50 mg are available as white to off-white colored, round, flat face, beveled edge, uncoated tablets. 25 mg: Each tablet contains 25 mg hydrochlorothiazide, USP and is debossed with “HP” above the bisect and “47” below the bisect on one side and plain on the other side.

Bottle of 30: NDC 10544-047-30
Bottle of 90: NDC 10544-047-90

50 mg: Each tablet contains 50 mg hydrochlorothiazide, USP and is debossed with “HP” above the bisect and “46” below the bisect on one side and plain on the other side.

Bottle of 30: NDC 10544-136-30
Bottle of 90: NDC 10544-136-90

PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Storage: Store at 20 – 25°C (68 – 77°F).  [See USP Controlled Room Temperature]. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for:
Heritage Pharmaceuticals Inc.
Edison, NJ 08837
1.866.901. DRUG (3784)

Manufactured by:
Ipca Laboratories Limited
48, Kandivli Ind. Estate, Mumbai 400 067, India Packaged by: Bleheim Pharmacal, Inc. North Blenheim, New York 12131 Iss.01/11

PRINCIPAL DISPLAY PANEL – 25mg 90s


id: b43f9325-c4c8-402e-b8c4-f60d49db90c2
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 10544-047-90 HYDROCHLOROTHIAZIDE TABLETS, USP
25 mg
90 Tablets

PRINCIPAL DISPLAY PANEL – 50mg 90s


id: 6e11acdf-c69e-4823-977b-a595d124554d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 10544-136-90 HYDROCHLOROTHIAZIDE TABLETS, USP
50 mg
90 Tablets