By: IPR Pharmaceuticals, Inc., Carolina, PR 00984 Cumulative effects of the drug may develop in patients with impaired renal function.Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.Lithium generally should not be given with thiazides (See In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur.
In most patients studied, onset of antihypertensive activity was seen at one hour after oral administration of an individual dose of lisinopril, with peak reduction of blood pressure achieved by six hours. Hyperglycemia may occur with thiazide diuretics. This is more likely to occur in patients with pre-existing renal impairment.
In patients with renal disease, thiazides may precipitate azotemia. Infants with histories of in utero exposure to ACE inhibitors should be closely observed for hypotension, oliguria, and hyperkalemia. Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. *Calculations assume a human weight of 50 kg and human body surface area of 1.62mLisinopril was not mutagenic in the Ames microbial mutagen test with or without metabolic activation.
These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Treatment is symptomatic and supportive. Although any chloride deficit is generally mild and usually does not require specific treatment, except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis. Suggested measures include induction of emesis and/or gastric lavage, and correction of dehydration, electrolyte imbalance and hypotension by established procedures.Following a single oral dose of 20 g/kg no lethality occurred in rats and death occurred in one of 20 mice receiving the same dose. (See PRECAUTIONS .) Therapy with Zestoretic should be discontinued and the patient observed closely. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
(See WARNINGS .) The diuretic should, if possible, be discontinued for two to three days before beginning therapy with lisinopril to reduce the likelihood of hypotension (See WARNINGS). imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. When pregnancy is detected, ZESTORETIC should be discontinued as soon as possible.
Based on urinary recovery, the mean extent of absorption of lisinopril is approximately 25 percent, with large intersubject variability (6%-60%) at all doses tested (5-80 mg). Adverse experiences occurring in greater than one percent of patients treated with lisinopril plus hydrochlorothiazide in controlled clinical trials are shown below. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.
In most patients, the antihypertensive effect of ZESTORETIC was sustained for at least 24 hours.
Perform serial ultrasound examinations to assess the intra-amniotic environment.
On a mg/kg basis, the doses used were up to 625 times (in mice), 188 times (in rats), and 0.6 times (in rabbits) the maximum recommended human dose.Teratogenicity studies were conducted in mice and rats with up to 90 mg/kg/day of lisinopril (56 times the maximum recommended human dose) in combination with 10 mg/kg/day of hydrochlorothiazide (2.5 times the maximum recommended human dose). Tell your doctor right away if you have any serious side effects, including: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat), signs of kidney problems (such as change in the amount of urine), decrease in vision, eye pain.
No specific information is available on the treatment of overdosage with ZESTORETIC. The overall incidence of syncope may be reduced by proper titration of the individual components.
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. It is chemically described as (S)-1-[
Adverse experiences that have occurred have been limited to those that have been previously reported with lisinopril or hydrochlorothiazide.