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-TTS Side Effects, and Drug Interactions - Clonidine Patch
Catapres-TTS Side Effects, and Drug Interactions - Clonidine Patch
SIDE EFFECTS
Most systemic adverse
effects during therapy with clonidine film
have been mild and have tended to diminish with continued therapy.
In a 3-month, multiclinic
trial of clonidine film
in 101 hypertensive
patients, the most frequent systemic
reactions were dry mouth
(25 patients) and drowsiness (12 patients).
Transient localized
skin reactions, primarily
localized pruritus,
occurred in 51 patients. Twenty-six patients experienced localized
erythema. This erythema and pruritus
were more common in patients utilizing an adhesive overlay for the
entire 7-day treatment
period. Allergic contact
sensitization to clonidine film
was observed in 5 patients.
In additional clinical
experience contact
dermatitis resulting
in treatment discontinuation was observed in 128 of 673 patients
(about 19 in 100) after a mean
duration of treatment
of 37 weeks. The incidence
in white females was about
34 in 100; in white males
about 18 in 100; in black
females about 14 in 100; and in black
males about 8 in 100.
The following less frequent adverse experiences were also reported
in patients involved in the multiclinic trial with clonidine film.
Gastrointestinal: Constipation (1 patient); nausea
(1); and change in taste
(1).
Central Nervous System: Fatigue (6 patients); headache
(5); lethargy (3); sedation
(3); insomnia (2);
dizziness (2); and
nervousness (1).
Genitourinary: Impotence/sexual dysfunction
(2 patients).
Dermatological: Localized vesiculation
(7 patients); hyperpigmentation (5); edema
(3); excoriation
(3); burning (3); papules (1); throbbing
(1); blanching (1); and generalized macular rash
(1). In additional clinical
experience involving 3539 patients, less common dermatological reactions
have occurred, where a causal relationship to clonidine film
was not established: maculopapular skin
rash (10 cases); urticaria
(2 cases); angioedema
involving the face (2 cases),
one of which also involved the tongue.
Oro-otolaryngeal: Dry throat
(2 patients). In long experience
with oral Catapres, the
most common adverse reactions have been dry mouth (about 40%), drowsiness
(about 35%) and sedation
(about 8%). In addition,
the following adverse reactions have been reported less frequently:
Gastrointestinal: Nausea and vomiting, about 5 in
100 patients; anorexia
and malaise, each about 1 in 100; mild transient
abnormalities in liver
function tests, about
1 in 100; rare reports of hepatitis; parotitis, rarely.
Metabolic: Weight gain, about 1 in 100 patients;
gynecomastia, about 1 in 1000; transient
elevation of blood
glucose or serum
creatine phosphokinase, rarely.
Central Nervous System: Nervousness and agitation,
about 3 in 100 patients; mental
depression, about 1 in 100 and insomnia, about 5 in 1000. Vivid
dreams or nightmares, other behavioral changes, restlessness, anxiety,
visual and auditory hallucinations
and delirium have been
reported.
Cardiovascular: Orthostatic symptoms, about 3 in
100 patients; palpitations and tachycardia, and bradycardia, each
about 5 in 1000. Raynaud's phenomenon, congestive heart
failure, and electrocardiographic abnormalities (i.e., conduction
disturbances and arrhythmias) have been reported rarely. Rare cases
of sinus bradycardia
and atrioventricular
block have been reported,
both with and without the use of concomitant
digitalis.
Dermatological: Rash, about 1 in 100 patients; pruritus,
about 7 in 1000; hives; angioneurotic edema
and urticaria, about 5 in 100; alopecia, about 2 in 1000.
Genitourinary: Decreased sexual
activity, impotence
and loss of libido, about 3 in 100 patients; nocturia, about 1 in
100; difficulty in micturition, about 2 in 1000; urinary retention,
about 1 in 1000.
Other: Weakness, about 10 in 100 patients; fatigue,
about 4 in 100; headache, and discontinuation syndrome, each about
1 in 100; muscle or joint
pain, about 6 in 1000 and cramps of the lower limbs, about 3 in
1000. Dryness, burning of the eyes, blurred vision, dryness of the
nasal mucosa, pallor, weakly positive
Coombs' test, increased sensitivity to alcohol
and fever have been reported.
DRUG INTERACTIONS
If a patient receiving
clonidine is also taking tricyclic antidepressants, the effect
of clonidine may be reduced, thus necessitating an increase in dosage.
Clonidine may enhance the CNS-depressive effects of alcohol, barbiturates
or other sedatives. Amitriptyline in combination with clonidine
enhances the manifestation
of corneal lesions in rats (see DOSAGE
AND ADMINISTRATION, Toxicology).
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