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Valsar Plus

Valsar Plus Adverse Reactions

amlodipine + valsartan

Manufacturer:

Tabros Pharma

Distributor:

EuroAsia
Full Prescribing Info
Adverse Reactions
Amlodipine and Valsartan combined therapy: Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall frequency of adverse reactions was neither dose-related nor related to gender, age, or race. In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the Amlodipine and Valsartan combined therapy treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with Amlodipine and Valsartan combined therapy were peripheral edema (0.4%), and vertigo (0.2%). Orthostatic events (orthostatic hypotension and postural dizziness) were seen in less than 1% of patients.
Post-marketing Experience: Amlodipine: Gynecomastia has been reported infrequently and a causal relationship is uncertain. Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
Valsartan: The following additional adverse reactions have been reported in post-marketing experience with valsartan: Blood and Lymphatic: There are very rare reports of thrombocytopenia.
Hypersensitivity: There are rare reports of angioedema.
Digestive: Elevated liver enzymes and very rare reports of hepatitis.
Renal: Impaired renal function.
Clinical Laboratory Tests: Hyperkalemia.
Dermatologic: Alopecia.
Vascular: Vasculitis Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
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