Brand names: Olmesartan Medoxomil / Amlodipine Besylate / Hydrochlorothiazide
Thiazide Diuretic
Route: Oral
FDA Black Box Warning
BOXED WARNING WARNING: FETAL TOXICITY When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. ( 5.1 , 8.1) Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus. ( 5.1 , 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible ( 5.1 ), 8.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 , 8.1 ).
Contraindications
4 CONTRAINDICATIONS Because of the hydrochlorothiazide component, olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets is contraindicated in patients with anuria, hypersensitivity to any component, or hypersensitivity to other sulfonamide-derived drugs. Do not coadminister aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets in patients with diabetes [ see Drug Interactions ( 7.2 ) ]. Anuria: Hypersensitivity to sulfonamide-derived drugs ( 4 ). Do not coadminister aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with diabetes ( 4 ).
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary Olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets 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 [ see Clinical Considerations ] . Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue olmesartan medoxomil, amlodipine and hydrochlorothiazide tablets as soon as possible. Consider alternative antihypertensive therapy during pregnancy. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Olmesartan medoxomil Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotensio
15 interactions on record
Contraindicated in patients with diabetes. Avoid in patients with renal impairment (GFR <60 ml/min). Dual RAS blockade increases risks of hypotension, hyperkalemia, and acute renal failure.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Amlodipine increases exposure to cyclosporine, requiring monitoring.
Source: NLP:olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Increases serum lithium concentrations and may cause lithium toxicity.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
COX-2 inhibitors may result in deterioration of renal function including acute renal failure in elderly, volume-depleted, or renal-compromised patients. May attenuate antihypertensive effect.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
NSAIDs may lead to increased risk of renal impairment and loss of antihypertensive effect. In elderly, volume-depleted, or renal-compromised patients, may result in deterioration of renal function including acute renal failure.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
May lead to increased risk of renal impairment, loss of antihypertensive effect, and deterioration of renal function including possible acute renal failure.
Source: NLP:olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Amlodipine increases exposure to tacrolimus, requiring monitoring.
Source: NLP:olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Amlodipine ( 7.2 ): Limit simvastatin to 20 mg daily when coadministered. Increased amlodipine exposure when coadministered with CYP3A inhibitors Hydrochlorothiazide ( 7.3 ): Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. Closely monitor blood pressure, renal function and electrolytes in patients on olmesartan medoxomil, amlodipine and hydrochlorothiazide and other agents that affect the RAS.
Source: FDA drug label - olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Reduces absorption of hydrochlorothiazide, decreasing its therapeutic effect.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Reduces systemic exposure and peak plasma concentration of olmesartan. Administer olmesartan at least 4 hours before colesevelam hydrochloride.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Reduces absorption of hydrochlorothiazide, decreasing its therapeutic effect.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Increased amlodipine exposure when coadministered with CYP3A inhibitors Hydrochlorothiazide ( 7.3 ): Antidiabetic drugs: Dosage adjustment of antidiabetic may be required. Closely monitor blood pressure, renal function and electrolytes in patients on olmesartan medoxomil, amlodipine and hydrochlorothiazide and other agents that affect the RAS. Do not co-administer aliskiren with olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with diabetes [See Contraindications (4) ].
Source: FDA drug label - olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
7 DRUG INTERACTIONS Olmesartan medoxomil ( 7.1 ): Nonsteroidal anti-inflammatory drugs (NSAIDS): May lead to increased risk of renal impairment and loss of antihypertensive effect. Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. 7.1 Drug Interactions with Olmesartan Medoxomil Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including olmesartan medoxomil, may result in deterioration of renal function, including possible acute renal failure.
Source: FDA drug label - olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Limit simvastatin to 20 mg daily when coadministered with amlodipine.
Source: NLP:olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose. Use with Colesevelam Hydrochloride: Concurrent administration of bile acid sequestering agent colesevelam hydrochloride reduces the systemic exposure and peak plasma concentration of olmesartan. Administration of olmesartan at least 4 hours prior to colesevelam hydrochloride decreased the drug interaction effect.
Source: FDA drug label - olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide