Azisan 80 mg (Tablet)

Indications

• Treatment of hypertension
• Lowering blood pressure
• Prevention of fatal and nonfatal cardiovascular events
• Strokes
• Myocardial infarction

Pharmacology

• Formation of angiotensin II from angiotensin I
• Principal pressor agent of the renin-angiotensin system
• Vasoconstriction
• Stimulation of aldosterone synthesis and release
• Cardiac stimulation
• Renal reabsorption of sodium
• Selective blocking of AT1 receptor
• Inhibition of angiotensin II synthesis
• Increased plasma renin activity and angiotensin II circulating levels
• Plasma aldosterone concentrations decreased
• Metabolism to active metabolite in gastrointestinal tract
• Peak plasma concentrations reached within 1.5 to 3 hours
• Highly bound to human plasma proteins
• Distribution across blood-brain and placental barriers
• Metabolism by CYP2C9

Dosage & Administration

• Recommended dose in adults: 80 mg orally once daily
• Consider 40 mg starting dose for patients on high diuretic doses
• Additional blood pressure reduction with other antihypertensive agents

Interaction

• No observed drug interactions with listed medications
• Potential attenuation by non-steroidal anti-inflammatory drugs

Contraindications

• Co-administration of Aliskiren with Azilsartan in patients with diabetes

Side Effects

• Common adverse reaction: diarrhea
• Other side effects: nausea, asthenia, fatigue, muscle spasm, dizziness, cough

Pregnancy & Lactation

• Pregnancy Category D
• Increased risk to fetus in second or third trimesters
• Unknown excretion in human milk
• Potential adverse effects on nursing infant

Precautions & Warnings

• Reduced fetal renal function in second and third trimesters
• Symptomatic hypotension in intravascularly volume-depleted patients
• Changes in renal function including renal failure in renal impaired patients

Use in Special Populations

• Neonatal effects with in utero exposure
• Necessity for supporting blood pressure and renal function in neonates
• Safety and effectiveness not established in pediatric patients under 18 years of age
• No dose adjustment for elderly patients
• Likelihood of abnormally high serum creatinine values in those age 75 or older
• No differences in safety or effectiveness observed between elderly and younger patients
• No dose adjustment in mild-to-severe renal impairment or end-stage renal disease
• Increased likelihood of abnormally high serum creatinine values in moderate to severe renal impairment
• No dose adjustment for mild or moderate hepatic impairment
• No studies in severe hepatic impairment

Overdose Effects

• Limited data on overdose in humans
• Supportive therapy as dictated by clinical status
• Non-dialyzable

Therapeutic Class

• Angiotensin-II receptor blocker

Storage Conditions

• Keep in a dry place away from light and heat
• Keep out of the reach of children

Related Brands

• Adarbi 40 mg (Tablet) - nipro-jmi-pharma-ltd
• Azisan 40 mg (Tablet) - renata-limited