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
Atacand Side Effects, and Drug Interactions - Candesartan Cilexetil
Atacand Side Effects, and Drug Interactions - Candesartan Cilexetil
SIDE EFFECTS
ATACAND has been evaluated for safety in more than 3600 patients subjects
including more than 3260 patients treated for hypertension. About 600
of these patients were studied for at least six months and about 200 for
more than at least one year. In
general treatment with ATACAND
was well tolerated. The overall incidence
of adverse events reported with ATACAND was similar to placebo.
The rate of withdrawals due
to adverse events in all trials in patients (7510 total) was 3.3% of (i.e.
108 of 3260) patients treated with candesartan cilexetil as monotherapy
and 3.5% of (i.e. 39 of 1106) patients treated with placebo. In
placebo-controlled trials
discontinuation of therapy
due to clinical adverse events
occurred in 2.4% of (i.e. 57 of 2350) patients treated with ATACAND and
3.4% of (i.e. 35 of 1027) patients treated with placebo.
The most common reasons for discontinuation of therapy
with ATACAND were headache
(0.6%) and dizziness (0.3%).
The adverse experiences that occurred in placebo
controlled clinical trials in at least 1% of patients treated with ATACAND
and at a higher incidence in candesartan cilexetil (n = 2350) than
placebo (n = 1027) patients
included back pain
(3% vs. 2%), dizziness (4%
vs. 3%), upper respiratory tract
infection (6% vs. 4%), pharyngitis
(2% vs. 1%), and rhinitis (2% vs. 1%).
The following adverse experiences occurred in placebo
controlled clinical trials at a more than 1% rate
but at about the same or greater incidence in patients receiving placebo
compared to candesartan cilexetil: fatigue, peripheral
edema, chest
pain, headache,
bronchitis, coughing, sinusitis,
nausea, abdominal
pain, diarrhea,
vomiting, arthralgia,
albuminuria.
Other potentially important adverse events that have been reported whether
or not attributed to treatment
with an incidence of 0.5%
or greater from the more than 3200 patients worldwide treated with ATACAND
are listed below. It cannot be determined whether these events were causally
related to ATACAND.
- Body as a Whole: asthenia, fever;
- Central and Peripheral Nervous System: paraesthesia,
vertigo;
- Gastrointestinal System Disorder: dyspepsia, gastroenteritis;
- Heart Rate and Rhythm Disorders: tachycardia, palpitation;
- Metabolic and Nutritional Disorders: creatine phosphokinase
increased, hyperglycemia,
hypertriglyceridemia, hyperuricemia;
- Musculoskeletal System Disorders: myalgia;
- Platelet Bleeding Clotting Disorders: epistaxis;
- Psychiatric Disorders: anxiety, depression,
somnolence;
- Respiratory System Disorders: dyspnea;
- Skin and Appendages Disorders: rash, sweating increased;
- Urinary System Disorders: hematuria.
Other reported events seen less frequently included angina
pectoris myocardial infarction and angioedema. Adverse events occurred
at about the same rates in men and women older and younger patients
and black and nonblack patients.
Post-Marketing Experience
The following have been very rarely reported in post-marketing
experience:
- Digestive: Abnormal hepatic function and hepatitis.
- Hematologic: Neutropenia, leukopenia, and agranulocytosis.
- Metabolic and Nutritional Disorders: Hyperkalemia, hyponatremia./li>
- Renal: Renal impairment, renal failure.
- Skin and Appendages Disorders: Pruritis and urticaria.
Rare reports of rhabdomyolysis have been reported in patients receiving
angiotensin II receptor blockers.
Laboratory Test Findings
In controlled clinical trials
clinically important changes in standard
laboratory parameters were
rarely associated with the administration
of ATACAND.
Creatinine Blood Urea Nitrogen: Minor increases in blood
urea nitrogen (BUN) and serum
creatinine were observed
infrequently.
Hyperuricemia: Hyperuricemia was rarely found (19 or 0.6%
of 3260 patients treated with candesartan cilexetil and 5 or 0.5% of 1106
patients treated with placebo).
Hemoglobin and Hematocrit: Small decreases in hemoglobin
and hematocrit (mean decreases of approximately 0.2 grams/dL and 0.5 volume percent, respectively) were
observed in patients treated with ATACAND alone, but were rarely of clinical
importance. Anemia, leukopenia,
and thrombocytopenia
were associated with withdrawal of one patient
each from clinical trials.
Potassium: A small increase (mean increase of 0.1 mEq/L)
was observed in patients treated with
ATACAND alone but was rarely of clinical
importance. One patient from
a congestive heart failure
trial was withdrawn for hyperkalemia
(serum potassium 7.5 mEq/L). This patient
was also receiving spironolactone.
Liver Function Tests: Elevations of liver
enzymes and or serum bilirubin were observed infrequently. Five patients
assigned to candesartan cilexetil in clinical
trials were withdrawn because of abnormal
liver chemistries. All had elevated
transaminases. Two had mildly elevated total bilirubin but one of these
patients was diagnosed with Hepatitis A.
DRUG INTERACTIONS
See WARNINGS, CONTRAINDICATIONS
and PRECAUTIONS sections for information
on drug interactions.
No significant drug
interactions have been reported in studies of candesartan cilexetil given
with other drugs such as glyburide
nifedipine digoxin warfarin
hydrochlorothiazide and oral
contraceptives in healthy
volunteers. Because candesartan is not metabolized by the cytochrome
P450 system and has no effects
on P450 enzymes, interactions with drugs that inhibit or are metabolized
by those enzymes would not be expected.
Lithium: Reversible increases in serum lithium concentrations and toxicity
have been reported during concomitant administration of lithium with ACE inhibitors,
and with some angiotensin II receptor antagonists. An increase in serum lithium
concentration has been reported during concomitant administration of lithium with ATACAND,
so careful monitoring of serum lithium levels is recommended during concomitant use.
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