HYDROCHLOROTHIAZIDE capsule

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Mylan Institutional Inc.

Designació comuna internacional (DCI):

HYDROCHLOROTHIAZIDE

Composición:

HYDROCHLOROTHIAZIDE 12.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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. 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 tre

Resumen del producto:

Hydrochlorothiazide Capsules, USP are available containing 12.5 mg of hydrochlorothiazide, USP. The 12.5 mg capsule is a white opaque cap/white opaque body, hard-shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with MYLAN over 810 in black ink on both the cap and body. They are available as follows: NDC 51079-776-20 – Unit dose blister packages of 100 (10 cards of 10 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light, moisture and freezing. Manufactured by: Mylan Pharmaceuticals, Inc. Morgantown, WV 26505 U.S.A. Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-12582 4/19

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
MYLAN INSTITUTIONAL INC.
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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 297.75; 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 capsules, USP for oral administration, are
available containing 12.5 mg of
hydrochlorothiazide, USP. In addition, each capsule also contains the
following inactive ingredients:
colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, pregelatinized starch and
sodium lauryl sulfate. In addition, each of the empty gelatin capsules
contains gelatin and titanium
dioxide.
The imprinting ink contains the following: black iron oxide, D&C
Yellow No.10 Aluminum Lake,
FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red
No. 40 Aluminum
Lake, propylene glycol and shellac glaze.
_Meets USP Dissolution Test 2._
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 (