Dosing and uses of Azor (amlodipine-olmesartan)
Adult dosage forms and strengths
amlodipine/olmesartan
tablet
- 5mg/20mg
- 5mg/40mg
- 10mg/20mg
- 10mg/40mg
Hypertension
5 mg/20 mg PO qDay intially; may increasedose after 1-2 weeks; not to exceed 10 mg/40 mg
May be adminsitered concomitantly with other antihypertensive agents
Pediatric dosage forms and strengths
Safety and efficacy not established
Azor (amlodipine-olmesartan) adverse (side) effects
>10%
Peripheral edema (11%)
Frequency not defined
Palpitation
Nocturia
Urinary frequency
Orthostatic hypotension
Pruritus
Rash
Postmarketing Reports
Acute renal failure
Anaphylactic reactions
Angioedema
Diarrhea
Hepatic enzyme elevations
Jaundice
Rhabdomyolysis
Warnings
Black box warnings
Discontinue as soon as possible when pregnancy is detected; affects renin-angiotensin system causing oligohydramnios, which may result in fetal injury and/or death
Contraindications
Hypersensitivity to olmesartan, amlodipine or other ingredients
Pregnancy (2nd/3rd trimesters): Significant risk of fetal and neonatal morbidity & mortality
Anuria
Do not coadminister with aliskiren in patients with diabetes mellitus
Also see individual monographs:
- amlodipine
- olmesartan
Cautions
Dual blockade of the renin angiotensin system with ARBs, ACE inhibitors, or aliskiren associated with increased risk for hypotension, hyperkalemia, and renal function changes (including acute renal failure) compared to monotherapy
Increased angina and/or myocardial infarction reported with initiation or dosing titration of dihydropyridine calcium channel blockers
Olmesartan may be associated with deterioration of renal function and/or increased in serum creatinine in patients with low renal blood flow
Intestinal problems (ie, sprue-like enteropathy) reported with olmesartan; symptoms may include severe, chronic diarrhea with substantial weight loss
Use caution in heart failure, severe aortic stenosis (amlodipine), hepatic impairment, renal artery stenosis, or hypertrophic cardiomyopathy
Pregnancy and lactation
Pregnancy category: C (1st trimester); D (2nd & 3rd trimesters). During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.
Lactation: It is not known whether the amlodipine or olmesartan are excreted in human milk. 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.
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
