Avivavasc 5/160 mg 28 tablets
Composition
Valsartan 160 mg / Amlodipine 5 mg
Indication
-Hypertension
Avivavasc (amlodipine and valsartan) is indicated for the treatment of hypertension, to lower blood pressure.
-Avivavasc may be used in patients whose blood pressure is not adequately controlled on either monotherapy.
-Avivavasc may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals.
Dosage and Administration
Dose once daily. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of one 10/ 320 mg tablet once daily as needed to control blood pressure.
Avivavasc may be administered with other anti hypertensive agents.
Initial Therapy
A patient may be initiated on Avivavasc if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose is Avivavasc 5/ 160 mg once daily in patients who are not volume-depleted.
Contraindications
Do not use in patients with known hypersensitivity to any component.
The concomitant use of Avivavasc with Aliskiren- containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml /min /1.73 m*).
Precautions
-Fetal Toxicity
Avivavasc can cause fetal harm when administered to a pregnant woman. When pregnancy is detected, discontinue Avivavasc as soon as possible.
-Hypotension
Treatment with Avivavasc should start under close medical supervision.
-Initiate therapy cautiously in patients with heart failure or recent myocardial infarction and in patients undergoing surgery or dialysis.
-Risk of Myocardial Infarction or Increased Angina
Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
-Hyperkalemia
Drugs that inhibit the rennin-angiotensin system can cause hyperglycemia.
-Avivavasc contains lactose
Side Effects
Amlodipine
Gynecomastia has been reported infrequently.
Jaundice and hepatic enzyme elevations
Valsartan:
Hypersensitivity: Angioedema has been reported.
Digestive: Elevated liver enzymes and reports of hepatitis
Musculoskeletal: Rhabdomyolysis
Renal: Impaired renal function, renal failure
Dermatologic: Alopecia, bullous dermatitis
Blood and Lymphatic: Thrombocytopenia
Vascular: Vasculitis
Storage Method:
Store at temperature not exceeding 30°C in a dry place.
Package
Carton box contains 4 strips each of 7 tablets and insert leaflet.