Prozart Plus Special Precautions

Hypersensitivity: Angioedema.
Hepatic Renal Impairment: Losartan and Hydrochlorothiazide is not recommended for patients with hepatic impairment or severe renal impairment (creatinine clearance <30 mL/minute).
Losartan: Renal Function Impairment: As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported in susceptible individuals; these changes in renal function may be reversible upon discontinuation of therapy.
Hydrochlorothiazide: Hypotension and electrolyte/fluid imbalance: As with all antihypertensive therapy, symptomatic hypotension may occur in some patients. Patients should be observed for clinical signs of fluid and electrolyte imbalance (e.g., Volume depletion, hyponatremia, hypochloremic alkalosis, hypomagnesemia or hypokalemia) which may occur during inter current diarrhea or vomiting.
Periodic determination of serum electrolytes should be performed at appropriate intervals in such patients.
Metabolic and endocrine effects: Thiazide therapy may impair glucose tolerance. Dosage adjustment of antidiabetic agents, including insulin, may be required.
Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out test for parathyroid function.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Thiazide therapy may precipitate hyperuricemia and/or gout in certain patients. Because Losartan decreases uric acid, Losartan in combination with Hydrochlorothiazide attenuates the diuretic-induced hyperuricemia.
Impaired hepatic function: Based on pharmacokinetic data which demonstrates significantly increased plasma concentrations of Losartan in cirrhotic patients, a lower dose should be considered for patients with impaired liver function.
Use in Pregnancy: When used in pregnancy during the 2nd and 3rd trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Losartan and Hydrochlorothiazide should be discontinued as soon as possible.
Although there is no experience with the use of Losartan and Hydrochlorothiazide in pregnant women, animal studies with Losartan Potassium have demonstrated fetal and neonatal injury and death, the mechanism of which is believed to be pharmacologically mediated through effects on the renal perfusion, which is dependent upon the development of the renin-angiotensin system, begins in the 2nd trimester; thus, risk to the fetus increases if losartan and hydrochlorothiazide is administered during 2nd or 3rd trimesters of pregnancy.
Thiazides cross the placental barrier and appear in cord blood. The routine use of diuretics in otherwise healthy pregnant women is not recommended and exposes mother and fetus to unnecessary hazard including fetal and neonatal jaundice, thrombocytopenia and possibly other adverse reactions which have occurred in the adult. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Use in Lactation: It is not known whether Losartan is excreted in the milk, but significant levels of Losartan and its active metabolite were shown to be present in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Use in Children: Safety and effectiveness in the children have not been established.
Use in Elderly: In clinical studies, there were no clinically significant differences in the efficacy and safety profiles of Losartan and Hydrochlorothiazide in older (>65 years) and younger patients (<65 years).
Of the total number of patients receiving Losartan Potassium in controlled clinical studies, 391 patients (19%) were 65 years and over, whole 37 patients 92%) were 75 years and over. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.