HYDROCHLOROTHIAZIDE capsule, gelatin coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

Hydrochlorothiazide (UNII: 0J48LPH2TH) (Hydrochlorothiazide - UNII:0J48LPH2TH)

Dostupné z:

JUBILANT CADISTA PHARMACEUTICALS INC.

INN (Medzinárodný Name):

Hydrochlorothiazide

Zloženie:

Hydrochlorothiazide 12.5 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 expan

Prehľad produktov:

Hydrochlorothiazide capsules USP, 12.5 mg are Size 4 capsules, light blue opaque cap and white opaque body with "TL 382" axially printed in black ink on cap and body. Bottles of 30 with child-resistant closure, NDC 59746-382-05 Bottles of 100 with child-resistant closure, NDC 59746-382-06 Bottles of 1000, NDC 59746-382-10 Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. Protect from light, moisture, freezing, -20°C (-4°F) and Store at 20°-25°C (68°-77°F) [See USP Controlled Room temperature]. Keep container tightly closed. Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA Rev. # 10/2021

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
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HYDROCHLOROTHIAZIDE CAPSULES USP, 12.5 MG
RX ONLY
DESCRIPTION
Hydrochlorothiazide capsules, USP 12.5 mg is the 3,4-dihydro
derivative of chloro­
thiazide. Its chemical name is
6-chloro-3,4-dihydro-2H-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: colloidal silicon dioxide, D&C
Yellow No. 10, FD&C Blue
No. 1, FD&C Blue No. 2, FD&C Red No. 40, gelatin, iron oxide black,
lactose
monohydrate, magnesium stearate, pregelatinized starch, propylene
glycol, shellac, 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:
7
8
3
4 2
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