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
Catapres Indications, Dosage, Storage, Stability - Clonidine
Catapres Indications, Dosage, Storage, Stability - Clonidine
INDICATIONS
Tablet
Clonidine hydrochloride
is indicated in the treatment
of hypertension. Clonidine hydrochloride
may be employed alone or concomitantly with other antihypertensive agents.
Epidural Injection
Epidural clonidine HCl is indicated in combination with opiates for the
treatment of severe pain
in cancer patients that is
not adequately relieved by opioid
analgesics alone. Epidural clonidine is more likely to be effective in
patients with neuropathic pain
than somatic or visceral pain
(see CLINICAL STUDIES.)
The safety of this drug product
has only been established in a highly selected group
of cancer patients, and only
after an adequate trial of opioid analgesia. Other use is of unproven
safety and is not recommended. In a rare patient,
the potential benefits may
outweigh the known risks (see WARNINGS.)
DOSAGE AND ADMINISTRATION
Tablet
Adults: The dose
of clonidine hydrochloride
must be adjusted according to the patient's individual blood
pressure response. The following
is a general guide to its administration.
Initial Dose: 0.1 mg tablet
twice daily (morning and bedtime). Elderly patients may benefit
from a lower initial dose.
Maintenance Dose: Further increments of 0.1 mg per
day may be made if necessary until the desired response
is achieved. Taking the larger portion of the oral
daily dose at bedtime may minimize
transient adjustment effects
of dry mouth and drowsiness.
The therapeutic doses
most commonly employed have ranged from 0.2 mg to 0.6 mg per
day given in divided doses. Studies have indicated that 2.4 mg is the
maximum effective daily dose,
but doses as high as this have rarely been employed.
Renal Impairment: Dosage must be adjusted according to
the degree of impairment,
and patients should be carefully monitored. Since only a minimal amount
of clonidine is removed during routine hemodialysis,
there is no need to give supplemental
clonidine following dialysis.
Toxicology: In several studies, oral clonidine hydrochloride
produced a dose-dependent increase in the incidence and severity of spontaneously
occurring retinal degeneration
in albino rats treated for
six months or longer. Tissue distribution
studies in dogs and monkeys revealed that clonidine hydrochloride
was concentrated in the choroid
of the eye. In view of the retinal
degeneration observed
in rats, eye examinations were
performed in 908 patients prior to the start of clonidine hydrochloride
therapy, who were then examined
periodically thereafter. In 353 of these 908 patients, examinations were
performed for periods of 24 months or longer. Except for some dryness
of the eyes, no drug-related abnormal
ophthalmologic findings were recorded and clonidine hydrochloride did
not alter retinal function
as shown by specialized tests such as the electroretinogram
and macular dazzle. In rats, clonidine hydrochloride in combination with
amitriptyline produced corneal lesions within 5 days.
Epidural Injection
The recommended starting dose
of epidural clonidine HCl
for continuous epidural infusion
is 30 mcg/hr. Although dosage
may be titrated up or down depending on pain
relief and occurrence of adverse
events, experience with
dosage rates above 40 mcg/hr is limited.
Familiarization with the continuous epidural
infusion device
is essential. Patients receiving epidural
clonidine from a continuous infusion
device should be closely monitored for the first few days to assess their
response.
Dosage for Impaired Renal Function: Dosage should be adjusted
according to the degree of
renal impairment, and patients
should be carefully monitored. Since only a minimal
amount of clonidine is removed during routine hemodialysis,
there is no need to give supplemental
clonidine following dialysis.
Epidural clonidine HCl must not be used with a preservative.
HOW SUPPLIED
Tablet
Store below 86°F (30°).
Dispense in tight, light-resistant container.
Epidural Injection
Store at controlled room temperature
15°-30°C (59°-86°F). Preservative Free. Discard
unused portion.
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