TRIAMTERENE AND HYDROCHLOROTHIAZIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Fachinformation Fachinformation (SPC)
24-12-2017

Wirkstoff:

TRIAMTERENE (UNII: WS821Z52LQ) (TRIAMTERENE - UNII:WS821Z52LQ)

Verfügbar ab:

St Marys Medical Park Pharmacy

INN (Internationale Bezeichnung):

TRIAMTERENE

Zusammensetzung:

TRIAMTERENE 37.5 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

                                TRIAMTERENE AND HYDROCHLOROTHIAZIDE - TRIAMTERENE,
HYDROCHLOROTHIAZIDE CAPSULE
ST MARYS MEDICAL PARK PHARMACY
----------
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-2H-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:
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
7
8
3
4
2
12
11
7
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,
                                
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