Zoltab indications
Zoltab is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Zoltab.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.
It may be used alone or in combination with other antihypertensive agents.
Zoltab description
Zoltab 10 mg Tablet: Each tablet contains 10 mg of Zoltab.
Zoltab 20 mg Tablet: Each tablet contains 20 mg of Zoltab.
Zoltab 40 mg Tablet: Each tablet contains 40 mg of Zoltab.
Zoltab (Zoltab), a prodrug, which is hydrolysed to the active metabolite olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist.
Zoltab 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.
Zoltab is a white to light yellowish-white powder or crystalline powder with a molecular weight of 558.59. It is practically insoluble in water and sparingly soluble in methanol.
Zoltab dosage
Adults: Dosage must be individualized. The usual recommended starting dose of Zoltab is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. If additional blood pressure reduction is required, Zoltab dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added.
The antihypertensive effect of Zoltab is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. This should be borne in mind when considering changing the dose regimen for any patient.
Elderly: No adjustment of dosage is generally required in the elderly. If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored.
Renal Impairment: Dosage of Zoltab should be individualized in patients with renal impairment.
The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20–60 mL/min) is 20 mg Zoltab once daily, owing to limited experience of higher dosages in this patient group. The use of Zoltab in patients with severe renal impairment (creatinine clearance <20 mL/min) is not recommended, since there is only limited experience in this patient group.
There is no experience in the use of Zoltab in patients requiring dialysis.
Hepatic Impairment: No adjustment of dosage recommendations is required for patients with mild hepatic impairment. In patients with moderate hepatic impairment, an initial dose of 10 mg Zoltab once daily is recommended and the maximum dose should not exceed 20 mg once daily. Close monitoring of blood pressure and renal function is advised in hepatically-impaired patients who are already receiving diuretics and/or other antihypertensive agents. There is no experience of Zoltab in patients with severe hepatic impairment, therefore use is not recommended in this patient group. Zoltab should not be used in patients with biliary obstruction.
Children: The safety and efficacy of Zoltab in children and adolescents below 18 years has not been established. No data are available.
Administration: In order to assist compliance, it is recommended that Zoltab tablets be taken at about the same time each day, with or without food, for example at breakfast time.
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet should not be chewed.
Zoltab interactions
Zoltab
No significant drug interactions were reported in studies in which Zoltab was co-administered with hydrochlorothiazide, digoxin or warfarin in healthy volunteers. The bioavailability of olmesartan was not significantly altered by the co-administration of antacids [Al(OH)3/Mg(OH)2]. Zoltab 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 those enzymes are not expected.
Hydrochlorothiazide
When administered concurrently the following drugs may interact with thiazide diuretics:
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.
Other Antihypertensive Drugs– additive effect or potentiation.
Cholestyramine and Colestipol Resins– absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the hydrochlorothiazide and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively.
Corticosteroids, ACTH– intensified electrolyte depletion, particularly hypokalemia.
Pressor Amines (e.g. Norepinephrine)– possible decreased response to pressor amines but not sufficient to preclude their use.
Skeletal Muscle Relaxants, Non depolarizing (e.g. Tubocurarine)– possible increased responsiveness to the muscle relaxant.
Lithium– should not generally be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparation with Zoltab-hydrochlorothiazide.
Non-steroidal Anti-inflammatory Drugs– in some patients the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Zoltab-hydrochlorothiazide tablets and non-steroidal anti-inflammatory agents are used concomitantly, the patients should be observed closely to determine if the desired effect of the diuretic is obtained
Zoltab side effects
Zoltab has been evaluated for safety in >3,825 patients/subjects, including >3,275 patients treated for hypertension in controlled trials. This experience included about 900 patients treated for at least 6 months and >525 for at least 1 year. Treatment with Zoltab was well tolerated, with an incidence of adverse events similar to placebo. Events generally were mild, transient and had no relationship to the dose of Zoltab.
The overall frequency of adverse events was not dose-related. Analysis of gender, age and race groups demonstrated no differences between Zoltab- and placebo-treated patients. The rate of withdrawals due to adverse events in all trials of hypertensive patients was 2.4% (ie, 79/3,278) of patients treated with Zoltab and 2.7% (ie, 32/1,179) of control patients. In placebo-controlled trials, the only adverse event that occurred in >1% of patients treated with Zoltab and at a higher incidence versus placebo was dizziness (3% vs 1%).
The following adverse events occurred in placebo-controlled clinical trials at an incidence of >1% of patients treated with Zoltab, but also occurred at about the same or greater incidence in patients receiving placebo: Back pain, bronchitis, increased creatine phosphokinase, diarrhea, headache, hematuria, hyperglycemia, hypertriglyceridemia, influenza-like symptoms, pharyngitis, rhinitis and sinusitis.
The incidence of cough was similar in placebo (0.7%) and Zoltab (0.9%) patients. Other (potentially important) adverse events that have been reported with an incidence of >0.5%, whether or not attributed to treatment, in the >3,100 hypertensive patients treated with Zoltab monotherapy in controlled or open-label trials are listed as follows: Body as a Whole: Chest pain, peripheral edema.
Central and Peripheral Nervous System: Vertigo.
Gastrointestinal: Abdominal pain, dyspepsia, gastroenteritis, nausea.
Heart Rate and Rhythm Disorders: Tachycardia.
Metabolic and Nutritional Disorders: Hypercholesterolemia, hyperlipemia, hyperuricemia.
Musculoskeletal: Arthralgia, arthritis, myalgia.
Skin and Appendages: Rash.
Facial edema was reported in 5 patients receiving Zoltab. Angioedema has been reported with other angiotensin II antagonists.
Laboratory Test Findings: In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of Zoltab.
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.
Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Five patients (0.1%) assigned to Zoltab and 1 patient (0.2%) assigned to placebo in clinical trials were withdrawn because of abnormal liver chemistries (transaminases or total bilirubin). Of the 5 Zoltab patients, 3 had elevated transaminases, which were attributed to alcohol use, and 1 had a single elevated bilirubin value, which normalized while treatment continued.
Clinical Trial Experience: Dizziness has been reported commonly (≥1%, <10% incidence) in clinical trials with Zoltab.
Post-Launch Experience: 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, increased hepatic enzymes and blood creatinine, hyperkalaemia, myalgia and asthenic conditions eg, asthenia, fatigue, lethargy, malaise. Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
Zoltab contraindications
Hypersensitivity to Zoltab or to any of the excipients of Zoltab.
Biliary obstruction.
Do not co-administer aliskiren with Zoltab in patients with diabetes.
Use in pregnancy: There is no experience with the use of Zoltab in pregnant women. However, drugs that act directly on the renin-angiotensin system administered during the 2nd and 3rd trimesters of pregnancy have been reported to cause foetal and neonatal injury (hypotension, renal dysfunction, oliguria and/or anuria, oligohydramnios, skull hypoplasia, intrauterine growth retardation, lung hypoplasia, facial abnormalities, limb contracture) and even death.
Thus, as for any drug in this class, Zoltab is contraindicated during the 2nd and 3rd trimesters of pregnancy. In addition, Zoltab must not be used during the 1st trimester. If pregnancy occurs during therapy, Zoltab must be discontinued as soon as possible.
Use in lactation: Olmesartan is excreted in the milk of lactating rats, but it is not known whether olmesartan is excreted in human milk. Mothers must not breastfeed if they are taking Zoltab.
Active ingredient matches for Zoltab:
Olmesartan medoxomil in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| 20 mg x 10's | |
| Zoltab 20mg TAB / 10 | |
| Zoltab 40mg TAB / 10 | |
| ZOLTAB tab 20 mg x 10's (Intas) | $ 0.83 |
| ZOLTAB tab 40 mg x 10's (Intas) | $ 1.52 |
| Zoltab 20mg TAB / 10 | |
| Zoltab 40mg TAB / 10 | |
List of Zoltab substitutes (brand and generic names): | |
| Plaunac (Italy) | |
| PMS-Olmesartan (Canada) | |
| Restelox (Mexico) | |
| Revival (Poland) | |
| RiteMED Olmesartan (Philippines) | |
| RiteMED Olmesartan FC tab 20 mg 30's (RiteMED) | |
| Sandoz Olmesartan (Canada) | |
| Santini (Romania) | |
| Sarten (Czech Republic) | |
| Tansidor (Bulgaria) | |
| Tanzidor (Bulgaria) | |
| Tensar (Bulgaria) | |
| Tensar FC tab 80 mg 5 x 6's (Healthcare Pharma) | |
| Tensonit (Argentina) | |
| Tenzar (Slovakia) | |
| triolmezest 40 Tablet | |
| triolmezest 40 Tablet (Sun Pharmaceutical Industries Ltd.) | $ 0.22 |
| Vivactra (Bulgaria) | |
| Votum (Germany, Switzerland) | |
| Tablet, Film-Coated; Oral; Olmesartan Medoxomil 10 mg (Berlin-chemie) | |
| Tablet, Film-Coated; Oral; Olmesartan Medoxomil 20 mg (Berlin-chemie) | |
| Tablet, Film-Coated; Oral; Olmesartan Medoxomil 40 mg (Berlin-chemie) | |
| Tablets, Film-Coated; Oral; Olmesartan Medoxomil 10 mg (Berlin-chemie) | |
| Tablets, Film-Coated; Oral; Olmesartan Medoxomil 20 mg (Berlin-chemie) | |
| Tablets, Film-Coated; Oral; Olmesartan Medoxomil 40 mg (Berlin-chemie) | |
| Votum 10mg (Switzerland) | |
| Votum 20mg (Switzerland) | |
| Votum 40mg (Switzerland) | |
| Win BP | |
| Win BP 40 mg Tablet (Piramal Healthcare) | $ 0.17 |
| Win BP 20 mg Tablet (Piramal Healthcare) | $ 0.12 |
| Win-BP (India) | |
| Win-BP 20mg TAB / 10 (AHPL) | $ 1.06 |
| Win-BP 40mg TAB / 10 (AHPL) | $ 1.59 |
| 20 mg x 10's (AHPL) | $ 0.96 |
| 40 mg x 10's (AHPL) | $ 1.45 |
| WIN-BP tab 20 mg x 10's (AHPL) | $ 1.06 |
| WIN-BP tab 40 mg x 10's (AHPL) | $ 1.59 |
| Win-BP AM (India) | |
| Win-BP AM Olmesartan medoxomil 20 mg, Amlodipine 5 mg. TAB / 10 (AHPL) | $ 1.20 |
| Win-BP AM Olmesartan medoxomil 40 mg, Amlodipine 5 mg. TAB / 10 (AHPL) | $ 1.81 |
| WIN-BP AM tab 10's (AHPL) | $ 1.81 |
| Xirtam | |
| Xirtam 20 mg Tablet (Bayer India Ltd) | $ 0.09 |
| Xirtam 40 mg Tablet (Bayer India Ltd) | $ 0.15 |
| XIRTAM 20 MG TABLET 1 strip / 10 tablets each (Bayer India Ltd) | $ 0.92 |
| XIRTAM 40 MG TABLET 1 strip / 10 tablets each (Bayer India Ltd) | $ 1.63 |
| Xirtam 20mg Tablet (Bayer India Ltd) | $ 0.10 |
| Xirtam 40mg Tablet (Bayer India Ltd) | $ 0.17 |
See 633 substitutes for Zoltab | |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
