HYDROCHLOROTHIAZIDE capsule, gelatin coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Aidarex Pharmaceuticals LLC

INN (Mezinárodní Name):

HYDROCHLOROTHIAZIDE

Složení:

HYDROCHLOROTHIAZIDE 12.5 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

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. 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 uterus is properly treated

Přehled produktů:

Hydrochlorothiazide Capsules USP are opaque teal two piece hard gelatin capsules imprinted with "V" and "3566". They are supplied in: Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
AIDAREX PHARMACEUTICALS LLC
----------
HYDROCHLOROTHIAZIDE CAPSULES USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide Capsules USP 12.5 mg 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
empirical 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. 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
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
fol