ALZOR Olmesartan Medoxomil 40mg Film-Coated Tablet 1's

Adults: The recommended starting dose of Olmesartan medoxomil in adult patients who are not salt or volume depleted is 20 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of Olmesartan medoxomil may be increased to a maximum of 40 mg once daily. The antihypertensive effect of Olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. Olmesartan medoxomil can be taken with or without food. It is recommended that Olmesartan medoxomil be taken at about the same time each day.
Volume or salt depleted patients: In patients who are salt and/or volume depleted, the recommended starting dose is 10 mg (1/2 20 mg tablet) once daily. Treatment should commence under close medical supervision.
Elderly: The maximum dose in elderly patients is 20 mg Olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group.
Renal impairment: The maximum dose in patients with mild to moderate renal impairment (creatinine clearance of 20-60 mL/min) is 20 mg Olmesartan medoxomil once daily, owing to limited experience of higher dosages in this patient group. The use of Olmesartan medoxomil in patients with severe renal impairment (creatinine clearance <20 mL/min) is not recommended, since there is only limited experience in this patient group.
Hepatic impairment: The use of Olmesartan medoxomil is not recommended in patients with hepatic impairment, since there is only limited experience in this patient group.
Children and adolescents: The safety and efficacy of Olmesartan medoxomil has not been established in children and adolescents up to 18 years of age.

 

Overdosage

May be taken with or without food.

 

Patients who are hypersensitive to any component of this product. Second and third trimesters of pregnancy. Lactation. Biliary obstruction.

 

Intravascular volume depletion: Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or salt depleted. Such conditions should be corrected before the administration of Olmesartan medoxomil. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. A transient hypotensive response is not a contraindication to further treatment, which usually can be continued without difficulty once the blood pressure has stabilized.
Renovasular hypertension: There is an increased risk of severe hypotension and 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-aldosterone system.
Other conditions with stimulation of the renin-angiotensin-aldosterone system: In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other drugs that affect this system has been associated with acute hypotension, azotemia, oliguria or, rarely, acute renal failure. The possibility of similar effects cannot be excluded with angiotensin II receptor antagonists.

 

Use In Pregnancy & Lactation

In double-blind, placebo-controlled monotherapy studies, the overall incidence of treatment-emergent adverse events was 42.4% on Olmesartan medoxomil and 40.9% on placebo. In placebo-controlled monotherapy studies, the only adverse drug reaction that was unequivocally related to treatment was dizziness (2.5% incidence on Olmesartan medoxomil and 0.9% on placebo).
In long-term (2-year) treatment, the incidence of withdrawals due to adverse events on Olmesartan medoxomil 10-20 mg once daily was 3.7%. The following adverse events have been reported across all clinical trials with Olmesartan medoxomil (including trials with active as well as placebo control), irrespective of causality or incidence relative to placebo. They are listed under headings of frequency: Common (≥1/100, <1/10) dizziness, bronchitis, cough, pharyngitis, rhinitis, abdominal pain, diarrhea, dyspepsia, gastroenteritis, nausea, arthritis, back pain, skeletal pain, hematuria, UTI, chest pain, fatigue, influenza-like symptoms, peripheral oedema, pain. Uncommon (≥1/1,000, <1/100) Vertigo, angina pectoris, rash. Rare (≥1/10,000, <1/1,000) Hypotension.
Laboratory Parameters: In placebo-controlled monotherapy studies, the incidence was somewhat higher on Olmesartan medoxomil compared with placebo for hypertriglyceridaemia (2.0% versus 1.1%) and for raised creatine phosphokinase (1.3% versus 0.7%). Laboratory adverse events reported across all clinical trials with Olmesartan medoxomil (including trials without a placebo control), irrespective of causality or incidence relative to placebo, included: increased creatine phosphokinase, hypertriglyceridaemia, hyperuricaemia, hyperkalaemia and liver enzyme elevations.
Post-Marketing Experience: Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.

 

Olmesartan has no clinically relevant inhibitory effects on in vitro human cytochrome P450 enzymes 1A1/2, 2A6, 2C8/9, 2C19, 2D6, 2E1 and 3A4, and has 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 metabolized by the previously-mentioned cytochrome P450 enzymes are expected.
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 (e.g. heparin) may lead to increases in serum potassium. Such concomitant use is therefore not recommended.
Other antihypertensive medications: The blood pressure lowering effect of Olmesartan medoxomil 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.
Antacids: After treatment with antacid (aluminium magnesium hydroxide), a modest reduction in bioavailability of Olmesartan was observed.

 

Storage

Action

Angiotensin II Antagonists