Zoltab Dosage

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Dosage of Zoltab in details

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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

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Interaction studies have only been performed in adults.

Effects of Other Medicinal Products on Zoltab: Potassium Supplements and Potassium Sparing Diuretics: Based on experience with the use of other drugs that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other drugs that may increase serum potassium levels (eg heparin) may lead to increases in serum potassium. Such concomitant use is therefore not recommended.

Other Antihypertensive Medications: The blood pressure lowering effect of Zoltab can be increased by concomitant use of other antihypertensive medications.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): NSAIDs (including acetylsalicylic acid at doses >3g/day and also COX-2 inhibitors) and angiotensin-II receptor antagonists may act synergistically by decreasing glomerular filtration. The risk of the concomitant use of NSAIDs and angiotensin II antagonists is the occurrence of acute renal failure. Monitoring of renal function at the beginning of treatment should be recommended as well as regular hydration of the patient.

Additionally, concomitant treatment can reduce the antihypertensive effect of angiotensin II receptor antagonists, leading to their partial loss of efficacy.

Other Compounds: After treatment with antacid (aluminium magnesium hydroxide), a modest reduction in bioavailability of olmesartan was observed. Coadministration of warfarin and digoxin had no effect on the pharmacokinetics of olmesartan.

Effects of Zoltab On Other Medicinal Products: Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors and angiotensin II antagonists. Therefore use of Zoltab and lithium in combination is not recommended. If use of the combination proves necessary, careful monitoring of serum lithium levels is recommended.

Other Compounds: Compounds which have been investigated in specific clinical studies in healthy volunteers include warfarin, digoxin, an antacid (magnesium aluminium hydroxide), hydrochlorothiazide and pravastatin. No clinically relevant interactions were observed and in particular Zoltab had no significant effect on the pharmacokinetics or pharmacodynamics of warfarin or the pharmacokinetics of digoxin.

Olmesartan had no clinically relevant inhibitory effects on in vitro human cytochrome P450 enzymes 1A1/2, 2A6, 2C8/9, 2C19, 2D6, 2E1 and 3A4, and had no or minimal inducing effects on rat cytochrome P450 activities. Therefore in vivo interaction studies with known cytochrome P450 enzyme inhibitors and inducers were not conducted, and no clinically relevant interactions between olmesartan and drugs metabolised by the above cytochrome P450 enzymes are expected.


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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