HYDROCHLOROTHIAZIDE CAPSULES USP

/HYDROCHLOROTHIAZIDE CAPSULES USP
HYDROCHLOROTHIAZIDE CAPSULES USP2018-09-06T09:12:40+00:00

Prescription Drug Name:

HYDROCHLOROTHIAZIDE CAPSULES USP

ID:

93b2b693-3119-426e-bcca-4ae59380c69a

Code:

34391-3

DESCRIPTION


id: 10f9cee3-2a7a-44c9-b857-79f909a9fe8a
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Hydrochlorothiazide Capsules USP 12.5 mg is the 3,4-dihydro derivative of chlorothiazide. Its chemical name is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2; its molecular weight is 297.74; and its structural formula is: It is a white, or practically white, crystalline powder which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Each capsule contains the following inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium benzoate. Gelatin capsules contain D&C Red #28, D&C Yellow #10, FD&C Blue #1, gelatin and titanium dioxide.

CLINICAL PHARMACOLOGY


id: 5b5dc5de-8e60-4072-8e11-1400e54a68af
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Hydrochlorothiazide blocks the reabsorption of sodium and chloride ions, and it thereby increases the quantity of sodium traversing the distal tubule and the volume of water excreted. A portion of the additional sodium presented to the distal tubule is exchanged there for potassium and hydrogen ions. With continued use of hydrochlorothiazide and depletion of sodium, compensatory mechanisms tend to increase this exchange and may produce excessive loss of potassium, hydrogen and chloride ions. Hydrochlorothiazide also decreases the excretion of calcium and uric acid, may increase the excretion of iodide and may reduce glomerular filtration rate. Metabolic toxicities associated with excessive electrolyte changes caused by hydrochlorothiazide have been shown to be dose-related.

INDICATIONS AND USAGE


id: 7418426f-8ba7-4895-93e1-092822f00bfd
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Hydrochlorothiazide Capsules USP are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors.

CONTRAINDICATIONS


id: c166a005-5d62-4470-85c2-75a5feed47d8
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Hydrochlorothiazide is contraindicated in patients with anuria. Hypersensitivity to this product or other sulfonamide derived drugs is also contraindicated.

ADVERSE REACTIONS


id: 53e264bd-81df-4fb4-9844-4a9b5cc32af0
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The adverse reactions associated with hydrochlorothiazide have been shown to be dose related. In controlled clinical trials, the adverse events reported with doses of 12.5 mg hydrochlorothiazide once daily were comparable to placebo. The following adverse reactions have been reported for doses of hydrochlorothiazide 25 mg and greater and, within each category, are listed in the 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, paresthesia, 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: e1242619-5c89-4978-80ba-aaed19c02974
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.

HOW SUPPLIED


id: bd354654-7e0c-41c1-84fb-379c888ab248
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Hydrochlorothiazide Capsules USP are opaque teal two piece hard gelatin capsules imprinted with “V” and “3566”. They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0841-1 12.5 mg 30 Capsules in a Blister Pack teal opaque 0603-3855

PRINCIPAL DISPLAY PANEL


id: b71c1e3f-2d87-4dc4-a869-4b4fd53a2f6d
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4