TRIAMTERENE AND HYDROCHLOROTHIAZIDE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Prieinama:

Bryant Ranch Prepack

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules are also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene and hydrochlorothiazide capsules may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules may enhance the action of these agents, dosage adjustments may be necessary. 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 through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is illogical and unnecessary. There is hypervolemia during normal pregnancy which is harmful to neither the fetus nor the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances this edema may cause extreme discomfort which is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate. Triamterene and hydrochlorothiazide capsules should not be given to patients receiving other potassium-sparing agents such as spironolactone, amiloride, or other formulations containing triamterene. Concomitant potassium-containing salt substitutes should also not be used. Potassium supplementation should not be used with triamterene and hydrochlorothiazide capsules except in severe cases of hypokalemia. Such concomitant therapy can be associated with rapid increases in serum potassium levels. If potassium supplementation is used, careful monitoring of the serum potassium level is necessary. Triamterene and hydrochlorothiazide capsules are contraindicated in patients with anuria, acute and chronic renal insufficiency, or significant renal impairment. Hypersensitivity to either drug in the preparation or to other sulfonamide-derived drugs is a contraindication. Triamterene and hydrochlorothiazide capsules should not be used in patients with pre-existing elevated serum potassium. WARNINGS

Produkto santrauka:

Triamterene and Hydrochlorothiazide Capsules USP, 37.5 mg/25 mg are light yellow to yellow colored powder filled in size '4' empty hard gelatin capsule having yellow opaque colored cap imprinted with "855" in black ink and white opaque colored body NDC: 71335-2034-1: 100 Capsules in a BOTTLE NDC: 71335-2034-2: 30 Capsules in a BOTTLE NDC: 71335-2034-3: 60 Capsules in a BOTTLE NDC: 71335-2034-4: 90 Capsules in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
BRYANT RANCH PREPACK
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Each capsule of triamterene and hydrochlorothiazide for oral use, with
opaque yellow
cap and opaque white body, contains triamterene 37.5 mg and
hydrochlorothiazide 25
mg, and is imprinted with 855. Hydrochlorothiazide is a
diuretic/antihypertensive agent
and triamterene is an antikaliuretic agent.
Hydrochlorothiazide, USP is very slightly soluble in water. It is
freely soluble in sodium
hydroxide solution, n-butylamine and dimethyl formamide. It is
sparingly soluble in
methanol. It is insoluble in ether, chloroform and dilute mineral
acids.
Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1, 2,
4-benzothiadiazine-7-
sulfonamide 1,1-dioxide, and its structural formula is:
Triamterene, USP is soluble in formic acid. It is sparingly soluble in
methoxyethanol. It is
very slightly soluble in acetic acid, alcohol and dilute mineral
acids. It is practically
insoluble in water, benzene, ether, chloroform and dilute alkali
hydroxides.
Triamterene, USP is 2, 4, 7-triamino-6-phenylpteridine and its
structural formula is:
Each triamterene and hydrochlorothiazide capsule, USP intended for
oral administration
contains 37.5 mg triamterene USP with 25 mg hydrochlorothiazide USP.
In addition,
each capsule contains the following inactive ingredients: citric acid
monohydrate,
colloidal silicon dioxide, croscarmellose sodium, gelatin, glycine,
hypromellose, iron oxide
yellow, magnesium stearate, microcrystalline cellulose, sodium lauryl
sulfate and titanium
dioxide. Each capsule is printed with black pharmaceutical ink which
contains ferric oxide
black, potassium hydroxide and shellac.
Capsules of triamterene and hydrochlorothiazide meet Drug Release Test
3 as published
in the current USP monograph for Triamterene and Hydrochlorothiazide
Capsules.
CLINICAL PHARMACOLOGY
Triamterene and hydrochlorothiazide capsule is a
diuretic/antihypertensive drug p