SER-AP-ES- reserpine, hydralazine hydrochloride and hydrochlorothiazide tablet, coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

hydralazine hydrochloride (UNII: FD171B778Y) (hydralazine - UNII:26NAK24LS8), hydrochlorothiazide (UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH), reserpine (UNII: 8B1QWR724A) (reserpine - UNII:8B1QWR724A)

Διαθέσιμο από:

Novartis Pharmaceuticals Corporation

INN (Διεθνής Όνομα):

reserpine, hydralazine hydrochloride and hydrochlorothiazide

Φαρμακοτεχνική μορφή:

TABLET, COATED

Σύνθεση:

25 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Hypertension (see boxed WARNING). Hypersensitivity to reserpine; mental depression or history of mental depression (especially with suicidal tendencies); active peptic ulcer, ulcerative colitis; patients receiving electroconvulsive therapy. Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease. Anuria; hypersensitivity to this or other sulfonamide-derived drugs.

Περίληψη προϊόντος:

Tablets – round, salmon pink, dry-coated (imprinted CIBA 71) 0.1 mg of reserpine, 25 mg of hydralazine hydrochloride, 15 mg of hydrochlorothiazide Bottles of 100.......................................... NDC 0083-0071-30 Bottles of 1000.........................................NDC 0083-0071-40 Do not store above 30ºC (86ºF). Dispense in tight, light-resistant container (USP). C97-38 (Rev. 1/98) Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936

Αρχείο Π.Χ.Π.

SER-AP-ES- RESERPINE, HYDRALAZINE HYDROCHLORIDE AND
HYDROCHLOROTHIAZIDE TABLET, COATED
NOVARTIS PHARMACEUTICALS CORPORATION
----------
SER-AP-ES
C97-38 (Rev. 1/98) 666496
SER-AP-ES
RESERPINE USP 0.1 MG
HYDRALAZINE HYDROCHLORIDE USP 25 MG
HYDROCHLOROTHIAZIDE USP 15 MG
COMBINATION TABLETS
CAUTION: FEDERAL LAW PROHIBITS DISPENSING WITHOUT PRESCRIPTION.
PRESCRIBING INFORMATION
WARNING
This fixed-combination drug is not indicated for initial therapy of
hypertension. Hypertension requires
therapy titrated to the individual patient. It the fixed combination
represents the dosage so determined, its
use may be more convenient in patient management. The treatment of
hypertension is not static but must
be reevaluated as conditions in each patient warrant.
DESCRIPTION
Ser-Ap-Es is an antihypertensive-diuretic combination, available as
tablets for oral administration. Each
tablet contains Serpasil (reserpine USP), 0.1 mg; Apresoline
(hydralazine hydrochloride USP), 25 mg;
and Esidrix (hydrochlorothiazide USP), 15 mg.
Reserpine is methyl
18β-hydroxy-11,17α-dimethoxy-3β,20α-yohimban-16β-carboxylate
3,4,5-
trimethoxybenzoate (ester), and its structural formula is
Reserpine USP, a pure crystalline alkaloid of rauwolfia, is a white or
pale buff to slightly yellowish,
odorless crystalline powder. It darkens slowly on exposure to light,
but more rapidly when in solution.
It is insoluble in water, freely soluble in acetic acid and in
chloroform, slightly soluble in benzene, and
®
®
very slightly soluble in alcohol and in ether. Its molecular weight is
608.69.
Hydralazine hydrochloride is 1-hydrazinophthalazine monohydrochloride,
and its structural formula
is
Hydralazine hydrochloride USP is a white to off-white, odorless
crystalline powder. It is soluble in
water, slightly soluble in alcohol, and very slightly soluble in
ether. It melts at about 275ºC, with
decomposition, and has a molecular weight of 196.64.
Hydrochlorothiazide is
6-chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide, and its structural