Azilsartan Medoxomil
Indications
Azilsartan Medoxomil is indicated for the
treatment of hypertension to lower blood pressure. Lowering blood
pressure reduces the risk of fatal and nonfatal cardiovascular events,
primarily stroke and myocardial infarction. Azilsartan Medoxomil may be
used either alone or in combination with other antihypertensive agents.
Pharmacology
Azilsartan Medoxomil, a prodrug, is
hydrolyzed to Azilsartan in the gastrointestinal tract during
absorption. Azilsartan is a selective AT1 subtype angiotensin II
receptor antagonist. Azilsartan blocks the vasoconstrictor and
aldosterone secreting effects of angiotensin II by selectively blocking
the binding of angiotensin II to the AT1 receptor in many tissues, such
as vascular smooth muscle and the adrenal gland.
Dosage & Administration
The recommended dose in adults is 80 mg
taken orally once daily. Consider a Starting dose of 40 mg for patients
who are treated with high doses of diuretics. If blood pressure is not
controlled with Azilsartan alone, additional blood pressure reduction
can be achieved by taking Azilsartan with other antihypertensive agents.
Interaction
No drug interactions have been observed in
studies of Azilsartan Medoxomil or Azilsartan given with amlodipine,
antacids, chlorthalidone, digoxin, fluconazole, glyburide, ketoconazole,
metformin, pioglitazone and warfarin. The antihypertensive effect of
Azilsartan may be attenuated by the non-steroidal anti-inflammatory
drugs including selective COX-2 inhibitors. Dual blockade of the RAS
with angiotensin receptor blockers, ACE inhibitors or aliskiren is
associated with increased risks of hypotension, hyperkalemia and changes
in renal function.
Contraindications
It is contraindicated to co-administer Aliskiren with Azilsartan in patients with Diabetes.
Side Effects
The most common adverse reaction in adults
is diarrhea. The other side effects are nausea, asthenia, fatigue,
muscle spasm, dizziness and cough.
Pregnancy & Lactation
Pregnancy Category D. The risk to the fetus
increases if Azilsartan Medoxomil is administered during the second or
third trimesters of pregnancy. It is not known whether Azilsartan
Medoxomil is excreted in human milk, as many drugs are excreted in human
milk and 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.
Precautions & Warnings
Use of Azilsartan Medoxomil during the
second and third trimesters of pregnancy reduces fetal renal function
and increases fetal and neonatal morbidity and death. In patients who
are intravascularly volume-depleted (e.g., those treated with high-dose
diuretics), symptomatic hypotension may occur. Changes in renal function
including renal failure has been reported in renal impaired patient.
Use in Special Populations
Safety and effectiveness in pediatric patients under 18 years of ages have not been established.
Overdose Effects
Limited data are available related to
overdose in humans. In the event of and overdose, supportive therapy
should be instituted as dictated by the patient’s clinical status.
Azilsartan is not dialyzable.
Therapeutic Class
Angiotensin-ll receptor blocker
Storage Conditions
keep in a dry place away from light and heat. Keep out of the reach of children.
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