olmesartan medoxomil and hydrochlorothiazide
Pharmaranks rates Olmesartan Medoxomil and Hydrochlorothiazide 3.6/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Olmesartan Medoxomil and Hydrochlorothiazide is a combination medicine containing Hydrochlorothiazide and Olmesartan Medoxomil.
Hydrochlorothiazide and Olmesartan Medoxomil · by Micro Labs
Generic of Benicar Hct
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Hydrochlorothiazide and Olmesartan Medoxomil
- Form
- Tablet
- Strength
- Hydrochlorothiazide 12.5MG; Olmesartan Medoxomil 20MG · Hydrochlorothiazide 12.5MG; Olmesartan Medoxomil 40MG · Hydrochlorothiazide 25MG; Olmesartan Medoxomil 40MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Micro Labs
- Half-life
- about 6 to 15 hours (the label reports a range, not a single number) (how long it stays in your system)
- What the pharmacy pays
- ~$0.91 for 30 — not your price
- FDA application
- ANDA206371
- FDA boxed warning
- Yes — see the boxed warning
What is Olmesartan Medoxomil and Hydrochlorothiazide?
From the FDA label:Olmesartan medoxomil and hydrochlorothiazide tablets are combination of an angiotensin II receptor antagonist (AT 1 subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ). Olmesartan medoxomil is 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[ p -( o -1 H -tetrazol-5-ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C 29 H 30 N 6 O 6 and its structural formula is: Olmesartan medoxomil is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2 H -1,2,4-benzo-thiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C 7 H 8 ClN 3 O 4 S 2 and its structural formula is: Hydrochlorothiazide is a white, or practically white, practically odourless, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution. Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: hydroxypropylcellulose, hypromellose, lactose…
How to use
The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40 /25 mg if necessary. The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with HCT monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40 /25 mg if necessary. Patients titrated to the individual components (olmesartan and hydrochlorothiazide) may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide tablets. Recommended starting dose in patients not adequately controlled with olmesartan monotherapy, 40/12.5 mg ( 2 ) Recommended starting dose in patients not adequately controlled with hydrochlorothiazide monotherapy, 20/12.5 mg ( 2 ) Adjust dose after 2 to 4 weeks, as needed, to a maximum of 40 mg / 25 mg olmesartan / hydrochlorothiazide ( 2 )
Side effects
The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide tablets are described elsewhere: Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] Electrolyte and Metabolic Imbalances [see Warnings and Precautions (5.5) ] Acute Myopia and Secondary Angle-Closure Glaucoma [see Warnings and Precautions (5.6) ] Systemic Lupus Erythematosus [see Warnings and Precautions (5.7) ] Sprue-Like Enteropathy [see Warnings and Precautions (5.8) ] Most common adverse reactions (incidence ≥2%) are nausea, hyperuricemia, dizziness, and upper respiratory infection ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-332-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Olmesartan medoxomil and hydrochlorothiazide The concomitant use of olmesartan medoxomil and hydrochlorothiazide was evaluated for safety in 1243 hypertensive patients. Treatment with olmesartan medoxomil and…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible [see Warnings and Precautions (5.1) ] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) ] . WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible ( 5.1 ). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus ( 5.1 ).
Warnings
Important safety information
Hypotension: Correct volume-depletion prior to administration. ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 ) Observe for signs of fluid or electrolyte imbalance. ( 5.4 ) Acute angle-closure glaucoma ( 5.5 ) Sprue-like enteropathy has been reported. Consider discontinuation of olmesartan medoxomil and hydrochlorothiazide tablets in cases where no other etiology is found ( 5.7 ) 5.1 Fetal Toxicity Pregnancy Category D 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. Resulting oligohydramnios can be 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 olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible [see Use in Specific Populations (8.1) ] . Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations (8.1) ] . 5.2 Hypotension in Volume or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients ( e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with olmesartan medoxomil and hydrochlorothiazide tablets. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. When electrolyte and fluid imbalances have been corrected, olmesartan medoxomil and hydrochlorothiazide tablets usually can be continued without difficulty. A transient hypotensive response is not a contraindication to further treatment. 5.3 Impaired Renal Function Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin-angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system ( e.g. , patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on olmesartan medoxomil and hydrochlorothiazide tablets. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on olmesartan medoxomil and hydrochlorothiazide tablets [see Drug Interactions (7) ] . 5.4 Hypersensitivity Reactions Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history. 5.5 Electrolyte and Metabolic Imbalances Olmesartan medoxomil and hydrochlorothiazide tablets contain hydrochlorothiazide which can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. Olmesartan medoxomil and hydrochlorothiazide tablets also contain olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically. Hydrochlorothiazide may alter glucose tolerance and raise serum levels of cholesterol and triglycerides. Hyperuricemia may occur or frank gout may be precipitated in patients receiving thiazide therapy. Hydrochlorothiazide decreases urinary calcium excretion and may cause elevations of serum calcium. Monitor calcium levels. 5.6 Acute Myopia and Secondary Angle-Closure Glaucoma Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. 5.7 Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. 5.8 Sprue-Like Enteropathy Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Consider discontinuation of olmesartan medoxomil and hydrochlorothiazide tablets in cases where no other etiology is identified.
Who should not take Olmesartan Medoxomil and Hydrochlorothiazide
Olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated: In patients with hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets [see Adverse Reactions (6.1 , 6.2) ] In patients with anuria [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] For coadministration with aliskiren in patients with diabetes [see Drug Interactions (7.4) ] . Hypersensitivity to any component of olmesartan medoxomil and hydrochlorothiazide tablets ( 4 ) Anuria ( 4 ) Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide tablets in patients with diabetes. ( 4 )
Overdose — what happens if you take too much
Olmesartan medoxomil Limited data are available related to overdosage of olmesartan medoxomil in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension should occur, supportive treatment should be initiated. The dialyzability of olmesartan is unknown. No lethality was observed in acute toxicity studies in mice and rats given single oral doses up to 2000 mg/kg olmesartan medoxomil. The minimum lethal oral dose of olmesartan medoxomil in dogs was greater than 1500 mg/kg. Hydrochlorothiazide The most common signs and symptoms of hydrochlorothiazide overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established. The oral LD 50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Lithium: Risk of lithium toxicity ( 7.2 ) Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): Reduced diuretic, natriuretic and antihypotensive effects; increased risk of renal toxicity ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.4 ) Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ) Antidiabetic drugs: Dosage adjustment may be required ( 7.6 ) Cholestyramine and colestipol: Reduced absorption of thiazides ( 7.6 ) 7.1 Agents Increasing Serum Potassium Coadministration of olmesartan medoxomil and hydrochlorothiazide tablets with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use. 7.3 Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) Olmesartan medoxomil 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. These effects are usually reversible. Monitor renal function periodically in patients receiving olmesartan medoxomil and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including olmesartan medoxomil may be attenuated by NSAIDs including selective COX-2 inhibitors. Hydrochlorothiazide In some patients the administration of a NSAID can reduce the diuretic, natriuretic, and antihypertensive effects of thiazide diuretics. Therefore, monitor blood pressure closely. 7.4 Dual Blockade of the Renin Angiotensin System 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 (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on olmesartan medoxomil and hydrochlorothiazide tablets and other agents that affect the RAS. Do not co-administer aliskiren with olmesartan medoxomil and hydrochlorothiazide tablets in patients with diabetes [see Contraindications (4) ] . Avoid use of aliskiren with olmesartan medoxomil and hydrochlorothiazide tablets in patients with renal impairment (GFR <60 ml/min). 7.5 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. Consider administering olmesartan at least 4 hours before the colesevelam hydrochloride dose [see Clinical Pharmacology (12.3) ] . 7.6 The Use of Hydrochlorothiazide with Other Drugs When administered concurrently the following drugs may interact with thiazide diuretics: Antidiabetic drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required. Ion exchange resins: Staggering the dosage of hydrochlorothiazide and ion exchange resins (e.g., cholestyramine, colestipol) such that hydrochlorothiazide is administered at least 4 hours before or 4 – 6 hours after the administration of resins would potentially minimize the interaction [see Clinical Pharmacology (12.3) ] . Corticosteroids, ACTH: Intensified electrolyte depletion, particularly hypokalemia.
How long does Hydrochlorothiazide and Olmesartan Medoxomil stay in your body?
The elimination half-life of hydrochlorothiazide and olmesartan medoxomil is about 6 to 15 hours (the label reports a range, not a single number) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma ELIMINATION half-life. Plasma levels fall bi-exponentially: other FDA labels for hydrochlorothiazide combination products describe a distribution phase of roughly 2 hours before the ~10-hour (6-15 h) elimination phase — the elimination figure is the one given here. Hydrochlorothiazide is NOT a prodrug and is NOT metabolized, so there is no active metabolite that outlasts the parent; more than 95% of the absorbed dose is excreted unchanged in urine. Kidney impairment: the label states plainly that in patients with renal disease plasma concentrations are increased and the elimination half-life is PROLONGED — it does not quantify by how much. The label does not state a different half-life for older adults or for liver impairment, so no number should be assumed for those groups. Absorption (not elimination) is reduced in congestive heart failure. This is a pharmacokinetic figure about how long the drug stays in plasma; it is not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — HYDROCHLOROTHIAZIDE capsule, Clinical Pharmacology (Pharmacokinetics and Metabolism).
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Olmesartan Medoxomil and Hydrochlorothiazide rated?
- pharmaranks gives Olmesartan Medoxomil and Hydrochlorothiazide a composite score of 3.6 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Olmesartan Medoxomil and Hydrochlorothiazide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.91 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Olmesartan Medoxomil and Hydrochlorothiazide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Olmesartan Medoxomil and Hydrochlorothiazide. To pay less, Olmesartan Medoxomil and Hydrochlorothiazide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Olmesartan Medoxomil and Hydrochlorothiazide?
- Olmesartan Medoxomil and Hydrochlorothiazide is marketed by Micro Labs. You can see Micro Labs's full profile, rating, and other products on pharmaranks.
- Is Olmesartan Medoxomil and Hydrochlorothiazide a brand-name or generic drug?
- Olmesartan Medoxomil and Hydrochlorothiazide is a generic medication; its active ingredient is Hydrochlorothiazide and Olmesartan Medoxomil. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Olmesartan Medoxomil and Hydrochlorothiazide available over the counter?
- No. Olmesartan Medoxomil and Hydrochlorothiazide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Olmesartan Medoxomil and Hydrochlorothiazide come in?
- Olmesartan Medoxomil and Hydrochlorothiazide is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Olmesartan Medoxomil and Hydrochlorothiazide FDA-registered?
- Olmesartan Medoxomil and Hydrochlorothiazide is on record with the U.S. FDA under application number ANDA206371. You can verify this on its official FDA label.
- Has Olmesartan Medoxomil and Hydrochlorothiazide been recalled by the FDA?
- Olmesartan Medoxomil and Hydrochlorothiazide has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Olmesartan Medoxomil and Hydrochlorothiazide safe?
- There's no single safe-or-not verdict. pharmaranks gives Olmesartan Medoxomil and Hydrochlorothiazide a recall-safety score of 72/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Olmesartan Medoxomil and Hydrochlorothiazide?
- Olmesartan Medoxomil and Hydrochlorothiazide's side effects are taken directly from its FDA label. From the label: The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide tablets are described elsewhere: Hypotension in Volume- or Salt-Depleted Patients [see Warnings and Precautions (5.2) ] Impaired Renal Function [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions [see Warn… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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72/100