HYDROCHLOROTHIAZIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

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. 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

Product summary:

Hydrochlorothiazide Capsules, USP are available containing 12.5 mg of hydrochlorothiazide, USP. The 12.5 mg capsules are hard-shell gelatin capsules with a white opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 810 in black ink on both the cap and body. They are available as follows: NDC 0378-0810-93 bottles of 30 capsules NDC 0378-0810-01 bottles of 100 capsules NDC 0378-0810-05 bottles of 500 capsules 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 and freezing. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Rx only For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 9/2020 HCTZ:RX1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
DESCRIPTION
Hydrochlorothiazide capsules, USP 12.5 mg are 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:
Hydrochlorothiazide, USP is a white, or practically white, crystalline
powder which is
slightly soluble in water, but freely soluble in sodium hydroxide
solution.
Hydrochlorothiazide capsules are supplied as 12.5 mg capsules for oral
use.
Inactive ingredients: colloidal silicon dioxide, gelatin, magnesium
stearate,
microcrystalline cellulose, pregelatinized starch (corn), sodium
lauryl sulfate and titanium
dioxide.
.
In addition, the black imprinting ink contains 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.
7
8
3
4 2
PHARMACOKINETICS AND METABOLISM
Hydrochlorothiazide is well absorbed (65% to 75%) following oral
administration.
Absorption of hydrochlorothiazide is reduced in