HYDROCHLOROTHIAZIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

State of Florida DOH Central Pharmacy

INN (International Name):

HYDROCHLOROTHIAZIDE

Composition:

HYDROCHLOROTHIAZIDE 12.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hydrochlorothiazide capsules 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 capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy : The routine use of diuretics in an otherwise healthy woman 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 developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics 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 expanded u

Product summary:

Hydrochlorothiazide capsules, USP 12.5 mg are available as hard gelatin capsules with opaque white cap and opaque white body imprinted with "U" on cap and "130" on the body in grey ink along the horizontal axis. They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 200 to 250 C (680 to 770 F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -200 C (-40 F). Rx only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HYDROCHLOROTHIAZIDE CAPSULES USP 12.5 MG
DESCRIPTION
Hydrochlorothiazide is the 3,4-dihydro derivative of chlorothiazide.
Its chemical name is 6-Chloro-
3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its
molecular formula is
C H ClN O S ; 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.
_Inactive ingredients: _microcrystalline cellulose, pregelatinized
starch, colloidal silicon dioxide,
magnesium stearate, gelatin, titanium dioxide, sodium lauryl sulfate
and black iron oxide.
CLINICAL PHARMACOLOGY
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.
PHARMACOKINETICS AND METABOLISM
Hydrochlorothiazide is well absorbed (65% to 75%) following oral
administration. Absorption of
hydrochlorothiazide is reduced in patients with congestive heart
failure.
Peak plasma concentrations are observed within 1 to 5 hours of dosing,
and range from 70 to 490 ng/mL
following oral doses of 12.5 to 100 mg. Plasma concentrations are
linearly related to the administered
dose. Concentr