TRIAMTERENE AND HYDROCHLOROTHIAZIDE capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

AvKARE

INN (שם בינלאומי):

TRIAMTERENE

הרכב:

TRIAMTERENE 37.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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, USP are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. Triamterene and hydrochlorothiazide capsules, USP 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, USP may be used alone or as an adjunct to other antihypertensive drugs, such as beta-blockers. Since triamterene and hydrochlorothiazide capsules, USP may enhance the action of these agents, dosage adjustments may be necessary. 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

leaflet_short:

Triamterene and Hydrochlorothiazide Capsules, USP contain 37.5 mg triamterene and 25 mg hydrochlorothiazide, and are available in size # 4 white opaque/white opaque capsules imprinted with Logo “LANNETT” on the cap and “1632” on the body. They are supplied as follows: Bottles of 1000, NDC 42291-841-10 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 04/11 AV 06/12

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

TRIAMTERENE AND HYDROCHLOROTHIAZIDE- TRIAMTERENE AND
HYDROCHLOROTHIAZIDE CAPSULE
AVKARE
----------
TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULES, USP
RX ONLY
DESCRIPTION
Each triamterene and hydrochlorothiazide capsule for oral use contains
triamterene 37.5
mg and hydrochlorothiazide 25 mg. Hydrochlorothiazide is a
diuretic/antihypertensive
agent and triamterene is an antikaliuretic agent.
Hydrochlorothiazide is slightly soluble in water. It is soluble in
dilute ammonia, dilute
aqueous sodium hydroxide, and dimethylformamide. It is sparingly
soluble in methanol.
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H-1, 2,
4-benzothiadiazine-7- sulfonamide
1,1-dioxide, and its structural formula is:
Molecular Formula: C
H
CIN
O
S
M.W. 297.74
At 50°C, triamterene is practically insoluble in water (less than
0.1%). It is soluble in
formic acid, sparingly soluble in methoxyethanol, and very slightly
soluble in alcohol.
Triamterene is 2, 4, 7-triamino-6-phenylpteridine and its structural
formula is:
7
8
3
4
2
Molecular Formula: C
H
N
M.W. 253.26
Inactive ingredients consist of lactose monohydrate, pregelatinized
starch, sodium
starch glycolate, polysorbate 80, citric acid anhydrous, povidone, and
magnesium
stearate. The capsule shell consists of titanium dioxide and gelatin.
The capsule
imprinting ink consists of shellac glaze in ethanol, iron oxide black,
n-butyl alcohol,
propylene glycol, ethanol, methanol, FD&C Blue # 2 Aluminum Lake, FD&C
Red # 40
Aluminum Lake, FD&C Blue # 1 Aluminum Lake, and D&C Yellow # 10
Aluminum Lake.
Triamterene and hydrochlorothiazide capsules, USP meet USP Dissolution
Test 3 as
published in the current USP monograph for triamterene and
hydrochlorothiazide
capsules.
CLINICAL PHARMACOLOGY
The triamterene and hydrochlorothiazide capsule is a
diuretic/antihypertensive drug
product that combines natriuretic and antikaliuretic effects. Each
component
complements the action of the other. The hydrochlorothiazide component
blocks the
reabsorption of sodium and chloride ions, and thereby increases the
qu