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
Combipres Indications, Dosage, Storage, Stability - Clonidine
Combipres Indications, Dosage, Storage, Stability - Clonidine
INDICATIONS
AND USES
CLORPRES™ (clonidine hydrochloride USP/chlorthalidone USP) is indicated in
the treatment of hypertension. 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.
DOSAGE AND ADMINISTRATION
The dosage must be determined by individual titration. (See INDICATIONS
AND
USAGE.)
Chlorthalidone is usually initiated at a dose of 25 mg once daily and may be
increased to 50 mg if the response is insufficient after a suitable trial.
Clonidine hydrochloride is usually initiated at a dose of 0.1 mg twice daily.
Elderly patients may benefit from a lower initial dose. Further increments of
0.1 mg/day may be made if necessary until the desired response is achieved.
The therapeutic doses most commonly employed have ranged from 0.2 to 0.6 mg
per day in divided doses.
One CLORPRES™ (clonidine hydrochloride/chlorthalidone) Tablet administered
once or twice daily can be used to administer a minimum of 0.1 mg clonidine
hydrochloride and 15 mg chlorthalidone to a maximum of 0.6 mg clonidine hydrochloride
and 30 mg chlorthalidone.
HOW SUPPLIED
CLORPRES™ (clonidine hydrochloride and chlorthalidone) Tablets, USP are available
containing:
0.1 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP
or
0.2 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP
or
0.3 mg clonidine hydrochloride, USP and 15 mg chlorthalidone, USP
The 0.1 mg/15 mg product is a yellow, round, scored tablet marked with M1.
They are available as follows:
NDC 62794-001-01
bottles of 100 tablets
The 0.2 mg/15 mg product is a yellow, round, scored tablet marked with M27.
They are available as follows:
NDC 62794-027-01
bottles of 100 tablets
The 0.3 mg/15 mg product is a yellow, round, scored tablet marked with M72.
They are available as follows:
NDC 62794-072-01
bottles of 100 tablets
STORE AT CONTROLLED ROOM TEMPERATURE 15° to 30° C (59° to 86°F).
AVOID EXCESSIVE HUMIDITY.
Dispense in a tight, light-resistant container as defined in the USP using
a child-resistant closure.
Rx only
BERTEK PHARMACEUTICALS INC.
Sugar Land, TX 77478
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