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
Capoten Side Effects, and Drug Interactions - Captopril
Capoten Side Effects, and Drug Interactions - Captopril
SIDE EFFECTS
Reported incidences are based on clinical trials involving
approximately 7000 patients.
Renal
About one of 100 patients developed proteinuria (see WARNINGS).
Each of the following has been reported in approximately 1
to 2 of 1000 patients and are of uncertain relationship to drug use: renal insufficiency,
renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency.
Hematologic
Neutropenia/agranulocytosis has occurred (see WARNINGS).
Cases of anemia, thrombocytopenia, and pancy-topenia have been reported.
Dermatologic
Rash, often with pruritus, and sometimes with fever, arthralgia,
and eosinophilia, occurred in about 4 to 7 (depending on renal status and dose)
of 100 patients, usually during the first four weeks of therapy. It is usually
maculopapular, and rarely urticarial. The rash is usually mild and disappears
within a few days of dosage reduction, short-term treatment with an anti-histaminic
agent, and/or discontinuing therapy; remission may occur even if captopril is
continued. Pruritus, without rash, occurs in about 2 of 100 patients. Between
7 and 10 percent of patients with skin rash have shown an eosinophilia and/or
positive ANA titers. A reversible associated pemphigoid-like lesion, and photo-sensitivity,
have also been reported.
Flushing or pallor has been reported in 2 to 5 of 1000 patients.
Cardiovascular
Hypotension may occur; see WARNINGS
and PRECAUTIONS [Drug
Interactions] for discussion of hypoten-sion with captopril therapy.
Tachycardia, chest pain, and palpitations have each been observed
in approximately 1 of 100 patients.
Angina pectoris, myocardial infarction, Raynaud’s syndrome,
and congestive heart failure have each occurred in 2 to 3 of 1000 patients.
Dysgeusia
Approximately 2 to 4 (depending on renal status and dose) of
100 patients developed a diminution or loss of taste per-ception. Taste impairment
is reversible and usually self-limited (2 to 3 months) even with continued drug
administration. Weight loss may be associated with the loss of taste.
Angioedema
Angioedema involving the extremities, face, lips, mucous membranes,
tongue, glottis or larynx has been reported in approximately one in 1000 patients.
Angioedema involving the upper airways has caused fatal airway obstruction.(See
WARNINGS: Head and Neck Angioedema, Intestinal
Angioedema and PRECAUTIONS: Information
for Patients.)
Cough
Cough has been reported in 0.5-2% of patients treated with
captopril in clinical trials (see PRECAUTIONS:
General, Cough).
The following have been reported in about 0.5 to 2 percent
of patients but did not appear at increased frequency compared to placebo or
other treatments used in controlled trials: gastric irritation, abdominal pain,
nausea, vomiting, diarrhea, anorexia, constipation, aphthous ulcers, peptic
ulcer, dizziness, headache, malaise, fatigue, insomnia, dry mouth, dyspnea,
alopecia, pares-thesias.
Other clinical adverse effects reported since the drug was
marketed are listed below by body system. In this setting, an incidence or causal
relationship cannot be accurately determined.
Body as a whole: Anaphylactoid reactions (see WARNINGS:
Anaphylactoid and possible related reactions and PRECAUTIONS:
Hemodialysis).
General
Asthenia, gynecomastia.
Cardiovascular
Cardiac arrest, cerebrovascular accident/insufficiency, rhythm
disturbances, orthostatic hypotension, syncope.
Dermatologic
Bullous pemphigus, erythema multiforme (including Stevens-Johnson
syndrome), exfoliative dermatitis.
Gastrointestinal
Pancreatitis, glossitis, dyspepsia.
Hematologic
Anemia, including aplastic and hemolytic.
Hepatobiliary
Jaundice, hepatitis, including rare cases of necrosis, cholestasis.
Metabolic
Symptomatic hyponatremia.
Musculoskeletal
Myalgia, myasthenia.
Nervous/Psychiatric
Ataxia, confusion, depression, nervousness, somnolence.
Respiratory
Bronchospasm, eosinophilic pneumonitis, rhinitis.
Special Senses
Blurred vision.
Urogenital
Impotence.
As with other ACE inhibitors, a syndrome has been reported
which may include: fever, myalgia, arthralgia, interstitial nephritis, vasculitis,
rash or other dermatologic manifestations, eosinophilia and an elevated ESR.
Fetal/Neonatal Morbidity and Mortality
See WARNINGS: Fetal/Neonatal
Morbidity and Mortality.
Altered Laboratory Findings
Serum Electrolytes: Hyperkalemia: small increases
in serum potassium, especially in patients with renal impairment (see PRECAUTIONS).
Hyponatremia
particularly in patients receiving a low sodium diet or concomitant
diuretics.
BUN/Serum Creatinine
Transient elevations of BUN or serum cre-atinine especially
in volume or salt depleted patients or those with renovascular hypertension
may occur. Rapid reduction of longstanding or markedly elevated blood pressure
can result in decreases in the glomerular filtration rate and, in turn, lead
to increases in BUN or serum creatinine.
Hematologic
A positive ANA has been reported.
Liver Function Tests
Elevations of liver transaminases, alkaline phosphatase,and
serum bilirubin have occurred.
DRUG INTERACTIONS
Hypotension — Patients on Diuretic Therapy: Patients
on diuretics and especially those in whom diuretic therapy was recently instituted,
as well as those on severe dietary salt restriction or dialysis, may occasionally
experience a precipitous reduction of blood pressure usually within the first
hour after receiving the initial dose of captopril.
The possibility of hypotensive effects with captopril can be
minimized by either discontinuing the diuretic or increasing the salt intake
approximately one week prior to initiation of treatment with CAPOTEN (captopril
tablets, USP) or initiating therapy with small doses (6.25 or 12.5 mg). Alternatively,
provide medical supervision for at least one hour after the initial dose. If
hypotension occurs, the patient should be placed in a supine position and, if
necessary, receive an intravenous infusion of normal saline. This transient
hypotensive response is not a contraindication to further doses which can be
given without difficulty once the blood pressure has increased after volume
expansion.
Agents Having Vasodilator Activity: Data on the effect
of concomitant use of other vasodilators in patients receiving CAPOTEN for heart
failure are not available; therefore, nitroglycerin or other nitrates (as used
for management of angina) or other drugs having vasodilator activity should,
if possible, be discontinued before starting CAPOTEN. If resumed during CAPOTEN
therapy, such agents should be administered cautiously, and perhaps at lower
dosage.
Agents Causing Renin Release
Captopril’s effect will be augmented by antihypertensive agents
that cause renin release. For example, diuretics (e.g., thiazides) may activate
the renin-angiotensin-aldosterone system.
Agents Affecting Sympathetic Activity
The sympathetic nervous system may be especially important
in supporting blood pressure in patients receiving captopril alone or with diuretics.
Therefore, agents affecting sympathetic activity (e.g., ganglionic blocking
agents or adrenergic neuron blocking agents) should be used with caution. Beta-adrenergic
blocking drugs add some further antihypertensive effect to captopril, but the
overall response is less than additive.
Agents Increasing Serum Potassium
Since captopril decreases aldosterone production, elevation
of serum potassium may occur. Potassium-sparing diuretics such as spironolactone,
triamterene, or amiloride, or potassium supplements should be given only for
documented hypokalemia, and then with caution, since they may lead to a significant
increase of serum potassium. Salt substitutes containing potassium should also
be used with caution.
Inhibitors Of Endogenous Prostaglandin Synthesis
It has been reported that indomethacin may reduce the antihypertensive
effect of captopril, especially in cases of low renin hypertension. Other nonsteroidal
anti-inflammatory agents (e.g., aspirin) may also have this effect.
Lithium
Increased serum lithium levels and symptoms of lithium toxicity
have been reported in patients receiving concomitant lithium and ACE inhibitor
therapy. These drugs should be coad-ministered with caution and frequent monitoring
of serum lithium levels is recommended. If a diuretic is also used, it may increase
the risk of lithium toxicity.
Cardiac Glycosides
In a study of young healthy male subjects no evidence of a
direct pharmacokinetic captopril-digoxin interaction could be found.
Loop Diuretics: Furosemide administered concurrently
with cap-topril does not alter the pharmacokinetics of captopril in renally
impaired hypertensive patients.
Allopurinol
In a study of healthy male volunteers no significant pharmacokinetic
interaction occurred when captopril and allop-urinol were administered concomitantly
for 6 days.
Drug/Laboratory Test Interaction
Captopril may cause a false-positive urine test for acetone.
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