Avsar Plus

Serious Warnings

• Black Box Warning: FETAL TOXICITY: Valsartan, a component of this fixed-dose combination, can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Oligohydramnios, which may result, is associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue this medication as soon as possible. There is no acceptable alternative to an Angiotensin Receptor Blocker (ARB) in pregnancy. All women of childbearing age should be counseled about the potential risks to the fetus and the importance of using effective contraception while taking this medication. If pregnancy occurs, the medication must be immediately discontinued, and an appropriate alternative antihypertensive therapy should be initiated.
• Several critical warnings are associated with the use of valsartan, amlodipine, and hydrochlorothiazide.
• Symptomatic hypotension may occur, especially in patients who are volume-depleted (e.
• g.
• , those on high-dose diuretics or with severe diarrhea/vomiting).
• Renal function should be monitored periodically, as valsartan can cause renal impairment, particularly in patients with pre-existing renal disease, severe congestive heart failure, or renal artery stenosis.
• Hydrochlorothiazide may exacerbate or activate systemic lupus erythematosus and can cause acute transient myopia and acute angle-closure glaucoma, necessitating immediate discontinuation.
• Electrolyte disturbances, including hypokalemia, hyponatremia, and hypercalcemia, are possible due to the diuretic component and require regular monitoring.
• Hyperuricemia and precipitation of gout attacks can occur.
• Patients with severe hepatic impairment should use this medication with caution, as amlodipine metabolism may be prolonged.
• Dual blockade of the Renin-Angiotensin-Aldosterone System (RAAS) with ARBs, ACE inhibitors, or aliskiren is associated with an increased risk of hypotension, hyperkalemia, and renal impairment and is generally not recommended, especially in diabetic patients or those with moderate to severe renal impairment (contraindicated with aliskiren).