Capoten mylan tablet
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Capoten mylan tablet may be used as
initial
therapy for patients with normal renal
function, in whom the risk is relatively low. In patients with impaired
renal function, particularly those with collagen vascular disease,
captopril should be reserved for hypertensives who have either
developed unacceptable side effects on other drugs, or have failed to
respond satisfactorily to drug combinations.
Reductions of blood pressure are usually maximal 60 to 90 minutes after
oral administration of an individual dose of Capoten mylan
tablet. The duration of effect is dose related. The reduction
in blood pressure may be progressive, so to achieve maximal therapeutic
effects, several weeks of therapy may be required. The blood pressure
lowering effects of captopril and thiazide-type diuretics are additive.
In contrast, captopril and beta-blockers have a less than additive
effect.
Capoten mylan tablet is indicated to
improve
survival following myocardial
infarction in clinically stable patients with left ventricular
dysfunction manifested as an ejection fraction ≤40% and to reduce the
incidence of overt heart failure and subsequent hospitalizations for
congestive heart failure in these patients.
The reductions in hemoglobin and hematocrit values in rats and mice
were only significant at 1 year and returned to normal with continued
dosing by the end of the study. Marked anemia was seen at all dose
levels (8 to 30 times MRHD) in dogs, whereas moderate to marked
leukopenia was noted only at 15 and 30 times MRHD and thrombocytopenia
at 30 times MRHD. The anemia could be reversed upon discontinuation of
dosing. Bone marrow suppression occurred to a varying degree, being
associated only with dogs that died or were sacrificed in a moribund
condition in the 1 year study.
Placebo controlled studies of 12 weeks duration in patients who did not
respond adequately to diuretics and digitalis show no tolerance to
beneficial effects on ETT; open studies, with exposure up to 18 months
in some cases, also indicate that ETT benefit is maintained. Clinical
improvement has been observed in some patients where acute hemodynamic
effects were minimal. In patients with
either normal or low blood pressure, who have been vigorously treated
with diuretics and who may be hyponatremic and/or hypovolemic, a
starting dose of 6.25 or 12.5 mg tid may minimize the magnitude or
duration of the hypotensive effect (see WARNINGS: Hypotension); for
these patients, titration to the usual daily dosage can then occur
within the next several days.
In two multicenter, double-blind, placebo controlled studies, a total
of 235 normotensive patients with insulin-dependent diabetes mellitus,
retinopathy and microalbuminuria (20-200 µg/ min) were randomized
to placebo or Capoten mylan tablet (50 mg bid) and
followed for up to 2 years. Capoten mylan tablet
delayed the progression to overt nephropathy (proteinuria ≥ 500 mg/day)
in both studies (risk reduction 67% to 76%; P < 0.05). Capoten
tablet also reduced the albumin excretion rate. However, the
long term clinical benefit of reducing the progression from
microalbuminuria to proteinuria has not been established.
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
tablet
(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.
Total urinary proteins greater than 1 g per day were seen in about 0.7
percent of patients receiving captopril. About 90 percent of affected
patients had evidence of prior renal disease or received relatively
high doses of captopril (in excess of 150 mg/day), or both. The
nephrotic syndrome occurred in about one-fifth of proteinuric Capoten
drug patients.
In most cases, proteinuria subsided or cleared within six months
whether or not captopril was continued. Parameters of renal function,
such as BUN and creatinine, were seldom altered in the patients with
proteinuria.
Studies in rats and cats indicate that Capoten mylan tablet
does not cross the blood-brain barrier to any significant extent.
Contact your doctor or health care provider right away if any of these
apply to you.
Before using Capoten:
Some medical conditions may interact with Capoten mylan tablet.
Tell your doctor or pharmacist if you have any medical conditions,
especially if any of the following apply to you:
if you are taking any prescription or
nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines or other
substances
if you have swelling of the lips, eyes, or tongue;
bone marrow depression; decreased blood flow to the heart or brain;
high blood potassium levels; low blood sodium levels; thickening of the
skin; kidney disease, transplant, or dialysis; heart problems; lupus;
an autoimmune disease; or are on a sodium-restricted diet.
This may not be a complete list of all interactions that may occur. Ask
your health care provider if Capoten mylan tablet may
interact with other medicines that you take. Check with your health
care provider before you start, stop, or change the dose of any
medicine.
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