renese-r- polythiazide and reserpine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

polythiazide (UNII: 36780APV5N) (polythiazide - UNII:36780APV5N), reserpine (UNII: 8B1QWR724A) (reserpine - UNII:8B1QWR724A)

Available from:

Pfizer Labs

INN (International Name):

polythiazide and reserpine

Pharmaceutical form:

TABLET

Composition:

2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Hypertension (see box warning). 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. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (however, see Precautions/Pregnancy section). 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 dis

Product summary:

RENESE-R tablets (2 mg polythiazide–0.25 mg reserpine) are available as blue scored tablets, (NDC-0069-4460-82). RENESE-R should be stored at room temperature. Dispense in tight, light-resistant container.

Summary of Product characteristics

RENESE-R- POLYTHIAZIDE AND RESERPINE TABLET
PFIZER LABS
----------
RENESE®-R
(POLYTHIAZIDE/RES ERPINE)
TABLETS
WARNING
This fixed combination drug is not indicated for initial therapy of
hypertension. Hypertension
requires therapy titrated to the individual patient. If 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
RENESE®-R tablets combine polythiazide and reserpine, two
antihypertensive agents with
complementary properties. Each blue, scored tablet of RENESE-R
provides:
Renese (polythiazide). . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . 2.0 mg
Reserpine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..
. . . . . . . .0.25 mg
RENESE (polythiazide) is a member of the benzothiazide (thiazide)
family of diuretic/antihypertensive
agents. It is designated chemically as
2H-1,2,4-Benzothiadiazine-7-sulfonamide,6-chloro-3,4-dihydro-
2-methyl-3-[[2,2,2-trifluoroethyl)thio]methyl]-,1,1-dioxide with a
molecular formula of
C
H ClF N O S and a molecular weight of 439.87.
Polythiazide is a white crystalline substance insoluble in water, but
readily soluble in alkaline solution,
and has the following structural formula:
Reserpine, one of the alkaloids of _Rauwolfia serpentina_, has the
following structural formula:
11
13
3
3
4
3
Reserpine – which is administered orally, is insoluble in water,
very slightly soluble in ether, l g in
about 1800 mL alcohol and about 6 mL chloroform, slightly soluble in
benzene, freely soluble in acetic
acid.
It has a molecular weight of 608.69 and its molecular formula is C
H N O . Reserpine is chemically
designated as Yohimban-16-carboxylic acid,
11,17-dimethoxy-18-[(3,4,5-trimethoxybenzoyl)oxy]-,
methyl ester, (3β,16β,17α,18β,20α)-. It is a white or pale buff
to slightly yellowish crystalline powder
that is insoluble in water.
Inert Ingredients: FD&C Blue No. 1; dibasic calciu