Olmetec Plus

Olmesartan medoxomil, hydrochlorothiazide.

Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) is available as film-coated tablets for oral administration in the following strength: Olmesartan medoxomil 20 mg equivalent to 20 mg Olmesartan Ph Eur and hydrochlorothiazide 12.5 mg equivalent to 12.5 mg Hydrochlorothiazide Ph Eur.
Olmesartan medoxomil-hydrochlorothiazide is a fixed-dose combination of the angiotensin II (AT₁ subtype) receptor antagonist, olmesartan medoxomil, and the thiazide, diuretic hydrochlorothiazide.
Olmesartan medoxomil: Olmesartan medoxomil is described chemically as (5-methyl-2-oxo-1, 3-dioxolen-4-yl)methyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl)-1, 1'-biphenyl-4-yl]methyl]-1H-imidazole-5-carboxylate. Alternatively, it can be described as 2,3-dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5-ylphenyl) benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate.
Its empirical formula is C₂₉H₃₀N₆O₆.
Olmesartan medoxomil is a prodrug which is hydrolyzed during absorption from the gastrointestinal tract to the active metabolite olmesartan (see Pharmacology under Actions).
Hydrochlorothiazide: Hydrochlorothiazide is described chemically as 6-chloro-3, 4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.
Its empirical formula is C₇H₈ClN₃O₄S₂.

Pharmacologic Category: Angiotensin II Receptor Blocker and Diuretics.
Pharmacology: Pharmacodynamics: Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor antagonist. Angiotensin II is the principal pressor agent of the renin-angiotensin system with effects that include vasoconstriction, stimulation of the synthesis and release of aldosterone, cardiac stimulation and renal reabsorption of sodium. Olmesartan blocks the vasoconstrictor effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT₁ receptors in vascular smooth muscle. Its action is therefore, independent of the pathway of angiotensin II synthesis.
Oral doses of olmesartan medoxomil 2.5 to 40 mg inhibited the pressor response to exogenous angiotensin I infusion.
Plasma concentrations of angiotensin I, angiotensin II and plasma renin activity increased after single or repeated administration of olmesartan medoxomil to healthy subjects or hypertensive patients. Olmesartan medoxomil administration had little effect on plasma levels of aldosterone.
Hydrochlorothiazide is a thiazide diuretic. The mechanism of the antihypertensive effect of thiazide diuretics is not fully known. Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts. The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity and increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium. The renin-aldosterone link is mediated by angiotensin II and therefore, co-administration of an angiotensin II receptor antagonist tends to reverse the potassium loss associated with thiazide diuretics. With hydrochlorothiazide, onset of diuresis occurs at about 2 hours and peak effect occurs at about 4 hours post-dose, whilst the action persists for approximately 6-12 hrs.
The combination of olmesartan medoxomil and hydrochlorothiazide produces additive reductions in blood pressure which generally increase with the dose of each component. Withdrawal of olmesartan medoxomil therapy, with or without concomitant hydrochlorothiazide therapy, did not result in rebound hypertension.
Pharmacokinetics: Concomitant administration of olmesartan medoxomil and hydrochlorothiazide had no clinically-relevant effects on the pharmacokinetics of either component in healthy subjects.
Absorption and Distribution: Olmesartan medoxomil: Following oral administration, olmesartan medoxomil is rapidly metabolized to its pharmacologically active metabolite, olmesartan. The mean absolute bioavailability of olmesartan from a tablet formulation was found to be about 26%.
The mean peak plasma concentration of olmesartan is reached within about 2 hrs after oral dosing with olmesartan medoxomil, and olmesartan plasma concentrations increase approximately linearly with increasing single or repeated oral doses over the therapeutic range.
Food has no clinically-relevant effect on the bioavailability of olmesartan.
No clinically relevant gender-related differences in the pharmacokinetics of olmesartan have been observed.
Olmesartan is highly bound to plasma protein (>99%). The mean volume of distribution after intravenous dosing is in the range of 16-29 L.
In rats, olmesartan crossed the blood-brain barrier poorly, if at all. Olmesartan crossed the placental barrier in rats and was distributed to the fetus. Olmesartan was distributed to milk at low levels in rats.
Hydrochlorothiazide: Following oral administration of olmesartan medoxomil and hydrochlorothiazide in combination, the median time to peak concentrations of hydrochlorothiazide was 1.5 to 2 hours after dosing. Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83-1.14 L/kg.
Metabolism and Elimination: Olmesartan medoxomil: Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, there is virtually no further metabolism of olmesartan. Approximately 30% to 50% of the systematically absorbed drug is excreted in the urine whilst the remainder is excreted in feces (via the bile).
Depending on ethnic origin, the terminal elimination half-life of olmesartan varied between 6 and 15 hours. Steady state was reached after the first few doses and no further accumulation was evident with repeated dosing. Renal clearance was approximately 0.5-0.7 L/h.
Hydrochlorothiazide: Hydrochlorothiazide is not metabolized in man and is excreted almost entirely as unchanged drug in urine. About 60% of the oral dose is eliminated as unchanged drug within 48 hours. Renal clearance is about 250-300 mL/min. The terminal elimination half-life of hydrochlorothiazide is 10-15 hours.
Pharmacokinetics in Special Populations: Elderly: In Caucasian patients, the olmesartan AUC at steady state was increased by about 33% in elderly patients. These increases in bioavailability corresponded to reductions in renal clearance of about 30% in elderly.
Renal Impairment: In patients with renal insufficiency, serum concentrations of olmesartan were elevated compared to subjects with normal renal function. After repeated dosing, the AUC was approximately tripled in patients with severe renal impairment (creatinine clearance <20 mL/min).
The pharmacokinetics of olmesartan in patients undergoing hemodialysis has not been studied.
Hepatic Impairment: Mean olmesartan AUC after single oral administration to patients with moderate hepatic impairment was increased by about 48% compared with healthy controls (total group), or by about 60% when compared with matched controls only.
Olmesartan Pharmacokinetic Interactions: No significant pharmacokinetic interactions were observed in studies in which olmesartan medoxomil was co-administered with digoxin or warfarin in healthy volunteers. The bioavailability of olmesartan was not significantly affected by antacid (aluminum magnesium hydroxide). Olmesartan medoxomil is not metabolized by the cytochrome P450 system and has no effects on P450 enzymes; thus, interactions with drugs that inhibit, induce or are metabolized by these enzymes are not expected.
Drug Interaction with Bile Acid Sequestering Agent Colesevelam: Concomitant administration of 40 mg olmesartan medoxomil and 3750 mg colesevelam hydrochloride in healthy subjects resulted in 28% reduction in C_max and 39% reduction in AUC of olmesartan. Lesser effects, 4% and 15% reduction in C_max and AUC respectively, were observed when olmesartan medoxomil was administered 4 hours prior to colesevelam hydrochloride (see Interactions).
Toxicology: Preclinical Safety Data: The toxic potential of olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) combinations was evaluated in repeated dose oral toxicity studies for up to six months in rats and dogs. Most observations were due to the pharmacological activity of the combination and there were no findings that would preclude administration to humans at the therapeutic dosage level.
Olmesartan medoxomil-hydrochlorothiazide in a ratio of 20:12.5 was negative in the bacterial reverse mutation test up to the maximum recommended plate concentration for the standard assays. Olmesartan medoxomil and hydrochlorothiazide were tested individually and in combination ratios of 40:12.5, 20:12.5 and 10:12.5, for clastogenic activity in the in vivo Chinese hamster lung chromosomal aberration assay. As expected, a positive response was seen for each component and combination ratio. However, no synergism in clastogenic activity was detected between olmesartan medoxomil and hydrochlorothiazide at any combination ratio. Olmesartan medoxomil-hydrochlorothiazide in a ratio of 20:12.5, administered orally, tested negative in the in vivo mouse bone marrow erythrocyte micronucleus assay at administered doses of up to 1935 mg/kg olmesartan medoxomil plus 1209 mg/kg hydrochlorothiazide.
The carcinogenic potential of olmesartan medoxomil-hydrochlorothiazide was not investigated since there was no evidence of relevant carcinogenic effects of the two individual components under conditions relevant to clinical use.
There was no evidence of teratogenicity in mice or rats treated with olmesartan medoxomil-hydrochlorothiazide combinations. As expected with this class of drug, fetal toxicity was observed in rats, as evidenced by significantly reduced fetal body weights, when treated with olmesartan medoxomil-hydrochlorothiazide combinations during gestation (see Use in Pregnancy & Lactation).
Studies of the effects of olmesartan medoxomil-hydrochlorothiazide on fertility have not been conducted but studies with the individual components found no adverse effects on fertility in rodents.
Other Clinical Trials: The Randomized Olmesartan And Diabetes Microalbuminuria Prevention (ROADMAP) clinical study included 4447 patients with type 2 diabetes, normoalbuminuria and at least one additional cardiovascular risk factor. Patients were randomized to olmesartan 40 mg daily or placebo. The trial met its primary endpoint, delayed onset of microalbuminuria. For the secondary endpoints, which the study was not designed to formally assess, cardiovascular events occurred in 96 patients (4.3%) with olmesartan and in 94 patients (4.2%) with placebo. The incidence of cardiovascular mortality was higher with olmesartan compared to placebo treatment (15 patients [0.67%] vs. 3 patients [0.14%][HR=4.94, 95% CI=1.43-17.06]), but the risk of non-fatal myocardial infarction was lower with olmesartan (HR 0.64, 95% CI 0.35, 1.18).

Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) is indicated for the treatment of hypertension.
Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) is indicated for use in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or hydrochlorothiazide alone.

Usual Adult Dose: Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) is administered once daily, with or without food.
When clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Elderly: No initial dosage adjustment is recommended for elderly patients.
Renal impairment: Olmesartan medoxomil-hydrochlorothiazide is not recommended for use in patients with more severe renal disease (creatinine clearance <30 mL/min).
Hepatic impairment: No initial dosage adjustment is necessary in patients with hepatic impairment.
Children: The safety and efficacy of olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) have not been established in children and adolescents.

No specific information is available on the effects or treatment of olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) overdosage. Only limited data relevant to overdosage with olmesartan medoxomil in humans are available. The most likely effect of olmesartan medoxomil overdosage is hypotension. Overdosage with hydrochlorothiazide is associated with electrolyte depletion (hypokalemia, hypochloremia) and dehydration resulting from excessive diuresis. The most common signs and symptoms of overdosage are nausea and somnolence. Hypokalemia may accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides. In the event of overdosage with olmesartan medoxomil-hydrochlorothiazide, treatment should be supportive.
No information is available regarding the dialysability of olmesartan or hydrochlorothiazide.

Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) is contraindicated in patients who are hypersensitive to any active or inactive component of the tablet, such as microcrystalline cellulose, low-substituted hydroxypropylcellulose, lactose monohydrate, hydroxypropylcellulose, magnesium stearate, talc, hypromellose, titanium dioxide, yellow iron oxide and red iron oxide or who are hypersensitive to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived drug).
Olmesartan medoxomil-hydrochlorothiazide is contraindicated in patients with anuria, because of the hydrochlorothiazide component.
Patients who become pregnant should discontinue the use of olmesartan medoxomil-hydrochlorothiazide as soon as possible (see Use in Pregnancy & Lactation).
Do not co-administer aliskiren with olmesartan medoxomil-hydrochlorothiazide in patients with diabetes (see Interactions).

Volume or Salt Depleted Patients: In patients with an activated renin-angiotensin system such as volume and/or salt depleted patients (e.g. those being treated with high doses of diuretics), symptomatic hypotension may occur following the initiation of treatment with olmesartan medoxomil-hydrochlorothiazide.
Impaired Renal Function: In patients whose renal function may depend predominantly on the activity of the renin-angiotensin system (e.g. patients with severe congestive heart failure), treatment with drugs that affect this system has been associated with azotemia, oliguria or, rarely, acute renal failure.
There is an increased risk of renal insufficiency when patients with bilateral renal artery stenosis (or stenosis of the artery to a single functioning kidney) are treated with medicinal products that affect the renin-angiotensin system.
Thiazide diuretics are not recommended in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia.
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.
Sprue-like Enteropathy: Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan medoxomil, exclude other etiologies. Consider discontinuation of olmesartan medoxomil-hydrochlorothiazide in cases where no other etiology is identified.
Hepatic Impairment: Minor alterations of fluid and electrolyte balance during thiazide therapy may precipitate hepatic coma in patients with impaired hepatic function or progressive liver disease.
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.
Systemic Lupus Erythematosus: Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Lithium: Use of lithium in combination with diuretics is not recommended (see Interactions).
Metabolic and Endocrine Effects: Thiazide therapy may impair glucose tolerance. In diabetic patients, dosage adjustments of insulin or oral hypoglycemic agents may be required (see Interactions). Latent diabetes mellitus may become manifest during thiazide therapy.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy.
Hyperuricemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy.
Electrolyte Imbalance: As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalemia, hyponatremia and hypochloremic alkalosis). Warning signs or symptoms of fluid or electrolyte imbalance include dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances, such as nausea or vomiting (see Adverse Reactions).
Hypokalemia may develop with the use of thiazide diuretics, especially in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH.
Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) also contains olmesartan, a drug that inhibits the renin-angiotensin system (RAS). Drugs that inhibit the RAS can cause hyperkalemia. Monitor serum electrolytes periodically.
Chloride deficit is generally mild and usually does not require treatment.
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesemia.
Non-melanoma Skin Cancer: An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC)and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC.
Patients taking Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of HCTZ may also need to be reconsidered in patients who have experienced previous NMSC.
Effects on Ability to Drive and Use Machines: No data available.
Use in Pregnancy & Lactation: See Use in Pregnancy & Lactation regarding use in pregnancy and lactation.

Pregnancy: There is no experience with the use of olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) in pregnant women. Studies in mice and rats using olmesartan medoxomil-hydrochlorothiazide combinations do not indicate a teratogenic effect, but fetotoxicity has been shown in rats. Thiazides cross the placental barrier and appear in cord blood. They may cause fetal electrolyte disturbances and possible other reactions that have occurred in adults. Cases of neonatal thrombocytopenia, or fetal or neonatal jaundice have been reported with maternal thiazide therapy.
If pregnancy occurs during therapy, olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) should be discontinued as soon as possible.
If olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) is used during pregnancy, or if the patient becomes pregnant while taking olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) the patient should be apprised of the potential hazard to a fetus. Should exposure to olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) have occurred from the second trimester forward, ultrasound examinations of the renal function and of the skull are recommended. Newborns exposed to angiotensin II antagonists in utero must be closely monitored for the occurrence of hypotension, oliguria, and hyperkalemia.
Lactation: It is not known whether olmesartan is excreted in human milk, but olmesartan is secreted at low concentrations in the milk of lactating rats. Thiazides appear 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.

Olmesartan medoxomil-hydrochlorothiazide: In clinical trials, the overall frequency of adverse events on olmesartan medoxomil-hydrochlorothiazide was similar to that on placebo. The rate of discontinuation due to adverse events on olmesartan medoxomil-hydrochlorothiazide was low (2%) and no higher than on placebo.
Dizziness was reported more frequently on olmesartan medoxomil-hydrochlorothiazide than on placebo.
Laboratory findings: In clinical trials, clinically important changes in standard laboratory parameters were rarely associated with olmesartan medoxomil-hydrochlorothiazide.
Minor increases in mean uric acid, blood urea nitrogen and creatinine values and minor decreases in mean hemoglobin and hematocrit values were observed during treatment with olmesartan medoxomil-hydrochlorothiazide.
Olmesartan medoxomil: Clinical Trial Experience: Dizziness has been reported commonly (≥1% <10% incidence) in clinical trials with olmesartan medoxomil.
In post-launch experience, adverse drug reactions which have been reported very rarely (<0.01% incidence) are: peripheral edema, headache, cough, abdominal pain, nausea, vomiting, diarrhea, sprue-like enteropathy, anaphylactic reaction, rash, pruritus, angioedema, acute renal failure, hepatic enzymes increased, blood creatinine increased, hyperkalemia, myalgia and asthenic conditions, such as asthenia, fatigue, lethargy, malaise.
Hydrochlorothiazide: Adverse events reported with other hydrochlorothiazide preparations are as follows: Gastrointestinal system disorders: Gastric irritation, sialadenitis, pancreatitis.
Hepatobiliary disorders: Jaundice (intrahepatic cholestatic jaundice).
Eye disorders: Xanthopsia, transient blurred vision.
Blood and lymphatic system disorders: Leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia.
Skin and subcutaneous tissue disorders: Photosensitivity reactions, urticaria, necrotizing angiitis (vasculitis, cutaneous vasculitis), anaphylactic reactions, toxic epidermal necrolysis.
General disorders: Fever.
Respiratory system disorders: Respiratory distress (including pneumonitis and pulmonary edema).
Renal and urinary disorders: Renal dysfunction, interstitial nephritis.
Musculoskeletal disorders: Muscle spasms, weakness.
Nervous system disorders: Restlessness.
Neoplasms benign, malignant and unspecified (including cysts and polyps): Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer, especially squamous cell carcinoma in white patients with increasing cumulative doses¹.
Laboratory findings: Hyperglycemia, glycosuria, hyperuricemia, electrolyte imbalance (including hyponatremia and hypokalemia), increases in cholesterol and triglycerides.
¹Non-melanoma skin cancer and hydrochlorothiazide containing olmesartan products (Veeva Document number: VV-PVG-010758).

General: Other antihypertensive agents: The blood pressure lowering effect of Olmesartan medoxomil-hydrochlorothiazide (Olmetec Plus) can be increased by concomitant use of other antihypertensive medications.
Olmesartan medoxomil: Use with Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists, including olmesartan. Monitor serum lithium levels during concomitant use.
Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor antagonists, ACE inhibitors or aliskiren is associated with increased risks of hypotension, hyperkalemia and changes in renal function (including acute renal failure) compared to monotherapy. Monitor blood pressure, renal function and electrolytes in patients on olmesartan and other agents that affect the RAS.
Use with Aliskiren: Do not co-administer aliskiren with olmesartan medoxomil in patients with diabetes (see Contraindications) because dual use is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAIDs and ARBs may act synergistically by decreasing glomerular filtration. The concomitant use of NSAIDs and ARBs may increase the risk of worsening renal function.
Additionally, the antihypertensive effect of ARBs, including olmesartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors.
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 (see Pharmacology under Actions).
Hydrochlorothiazide: Alcohol, Barbiturates or Narcotics: Potentiation of orthostatic hypotension may occur.
Antidiabetic Drugs (oral agents and insulin): Dosage adjustment of the antidiabetic drug may be required (see Precautions).
Cholestyramine and Colestipol Resins: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Corticosteroids and ACTH: Patients taking corticosteroids or ACTH are at a greater risk of hypokalemia (see Precautions).
Pressor Amines (e.g. noradrenaline = norepinephrine): The effect of pressor amines may be decreased.
Non-depolarizing Skeletal Muscle Relaxants (e.g. Tubocurarine): The effect of non-depolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
Lithium: Renal clearance of lithium is reduced by thiazides and consequently the risk of lithium toxicity may be increased. Therefore, use of olmesartan medoxomil-hydrochlorothiazide and lithium in combination is not recommended (see Precautions). If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Non-steroidal Anti-inflammatory Drugs: The administration of non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients.

Store at temperatures not exceeding 30°C.

Angiotensin II Antagonists / Diuretics

C09DA08 - olmesartan medoxomil and diuretics ; Belongs to the class of angiotensin II receptor blockers (ARBs) in combination with diuretics. Used in the treatment of cardiovascular disease.

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