A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Capozide Indications, Dosage, Storage, Stability - Captopril and Hydrochlorothiazide
Capozide Indications, Dosage, Storage, Stability - Captopril and Hydrochlorothiazide
INDICATIONS
CAPOZIDE (captopril and hydrochlorothiazide
tablets, USP) is indicated for the treatment
of hypertension. The blood pressure
lowering effects of captopril
and thiazides are approximately additive.
This fixed combination drug
may be used as initial therapy
or substituted for previously titrated doses of the individual components.
When captopril and hydrochlorothiazide
are given together it may not be necessary to administer captopril in
divided doses to attain blood
pressure control
at trough (before the next
dose). Also, with such a combination, a daily dose
of 15 mg of hydrochlorothiazide
may be adequate.
Treatment may, therefore, be initiated with CAPOZIDE 25 mg/15 mg
once daily. Subsequent titration
should be with additional doses of the components (captopril, hydrochlorothiazide)
as single agents or as CAPOZIDE 50 mg/15 mg, 25 mg/25 mg, or 50 mg/25
mg (see DOSAGE
AND ADMINISTRATION).
In using CAPOZIDE, consideration should be given to the risk
of neutropenia/agranulocytosis (see WARNINGS).
CAPOZIDE may be used for patients with normal
renal function, in whom the
risk is relatively low. In
patients with impaired renal
function, particularly those with collagen
vascular disease,
CAPOZIDE should be reserved for hypertensives who have either developed
unacceptable side effects on
other drugs, or have failed to respond satisfactorily to other drug
combinations. ACE inhibitors (for
which adequate data are available) cause
a higher rate of angioedema in
black than in non-black patients
(see WARNINGS: Angioedema).
DOSAGE AND ADMINISTRATION
DOSAGE MUST BE INDIVIDUALIZED ACCORDING TO
PATIENT’S RESPONSE. CAPOZIDE may be substituted for the previously titrated
individual components.
Alternatively, therapy may
be instituted with a single tablet
of CAPOZIDE 25 mg/15 mg taken once
daily. For patients insufficiently responsive to the initial
dose, additional captopril
or hydrochlorothiazide
may be added as individual components or by using CAPOZIDE 50 mg/15 mg,
25 mg/25 mg or 50 mg/25 mg, or divided doses may be used. Because the
full effect of a given dose
may not be attained for 6-8 weeks, dosage
adjustments should generally be made at 6 week intervals, unless the clinical
situation demands more rapid
adjustment. In general, daily doses
of captopril should not
exceed 150 mg and of hydrochlorothiazide
should not exceed 50 mg. CAPOZIDE should be taken one hour before meals.
Dosage Adjustment in Renal Impairment— Because captopril
and hydrochlorothiazide
are excreted primarily by the kidneys, excretion rates are reduced in
patients with impaired renal
function. These patients will take
longer to reach steady-state captopril
levels and will reach higher
steady-state levels for a given daily dose
than patients with normal renal function. Therefore, these patients may
respond to smaller or less frequent doses of CAPOZIDE. After the desired
therapeutic effect
has been achieved, the dose intervals
should be increased or the total daily dose reduced until the minimal
effective dose is achieved. When
concomitant diuretic therapy
is required in patients with severe renal
impairment, a loop diuretic
(e.g., furosemide), rather than a thiazide diuretic
is preferred for use with captopril; therefore, for patients with severe
renal dysfunction the captopril-hydrochlorothiazide combination tablet
is not usually recommended. (See WARNINGS:
CAPTOPRIL: Anaphylactoid reactions during membrane
exposure and PRECAUTIONS: Hemodialysis.)
HOW SUPPLIED
CAPOZIDE (captopril and hydrochlorothiazide
tablets, USP)
25 mg captopril
combined with 15 mg hydrochlorothiazide
in bottles of 100 (NDC 0003-0338-50). Tablets are white
with distinct orange mottling; they are biconvex
rounded squares with quadrisect
bars.
25 mg captopril
combined with 25 mg hydrochlorothiazide
in bottles of 100 (NDC 0003-0349-50). Tablets are peach-colored and may
show slight mottling; they are
biconvex rounded squares
with quadrisect bars.
50 mg captopril
combined with 15 mg hydrochlorothiazide
in bottles of 100 (NDC 0003-0384-50). Tablets are white
with distinct orange mottling; they are biconvex
ovals with a bisect bar.
50 mg captopril
combined with 25 mg hydrochlorothiazide
in bottles of 100 (NDC 0003-0390-50). Tablets are peach-colored and may
show slight mottling; they are
biconvex ovals with a bisect
bar.
STORAGE
Keep bottles tightly closed (protect from moisture); do not store above
86° F.
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