Olmetec

Olmetec

olmesartan

Manufacturer:

Pfizer
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Contents
Olmesartan medoxomil.
Action
Olmesartan medoxomil is a potent, orally active, selective angiotensin II receptor (type AT1) antagonist. It is expected to block all actions of angiotensin II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin II. The selective antagonism of the angiotensin II (AT1) receptors results in increased plasma renin levels and angiotensin I and II concentrations, and decreased plasma aldosterone concentrations.
Angiotensin II is the primary vasoactive hormone of the renin-angiotensin-aldosterone system and plays a significant role in the pathophysiology of hypertension via the type 1 (AT1) receptor.
In hypertension, olmesartan medoxomil causes a dose-dependent, long-lasting reduction in arterial blood pressure. There has been no evidence of first-dose hypotension, of tachyphylaxis during long-term treatment, or of rebound hypertension after cessation of therapy.
Once daily dosing with olmesartan medoxomil provides an effective and smooth reduction in blood pressure over the 24-hr dose interval. Once daily dosing produced similar decreases in blood pressure as twice daily dosing at the same total daily dose.
With continuous treatment, maximum reductions in blood pressure are achieved by 8 weeks after the initiation of therapy, although a substantial proportion of the blood pressure lowering effect is already observed after 2 weeks of treatment. When used together with hydrochlorothiazide, the reduction in blood pressure is additive and co-administration is well tolerated.
The effect of olmesartan on mortality and morbidity is not yet known.
Indications/Uses
Treatment of essential hypertension.
Dosage/Direction for Use
Recommended Starting Dose: 10 mg once daily. In patients whose blood pressure is not adequately controlled at this dose, the dose of olmesartan medoxomil may be increased to 20 mg once daily as the optimal dose. If additional blood pressure reduction is required, olmesartan medoxomil dose may be increased to a maximum of 40 mg daily or hydrochlorothiazide therapy may be added.
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. This should be borne in mind when considering changing the dose regimen for any patient.
In order to assist compliance, it is recommended that Olmetec be taken at about the same time each day, with or without food ie, breakfast time.
Elderly: The maximum dose in elderly patients is olmesartan medoxomil 20 mg once daily, owing to limited experience of higher dosages in this patient group.
Children and Adolescents: The safety and efficacy of olmesartan medoxomil have not been established in children and adolescents up to 18 years.
Renal Impairment: The maximum dose in patients with mild to moderate renal impairment (creatinine clearance 20-60 mL/min) is olmesartan medoxomil 20 mg 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.
Contraindications
Patients with biliary obstruction, 2nd and 3rd trimesters of pregnancy, lactation, and hypersensitivity to olmesartan medoxomil or any of the other excipients of Olmetec.
Use in pregnancy & lactation: There is no experience with the use of olmesartan medoxomil 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, olmesartan medoxomil is contraindicated during the 2nd and 3rd trimesters of pregnancy.
In addition, olmesartan medoxomil must not be used during the 1st trimester of pregnancy. If pregnancy occurs during therapy, olmesartan medoxomil must be discontinued as soon as possible.
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 Olmetec.
Special Precautions
Intravascular Volume Depletion: Symptomatic hypotension, especially after the 1st dose, may occur in patient who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhea or vomiting. Such conditions should be corrected before the administration of olmesartan medoxomil.
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 (eg, 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, azotaemia, oliguria or, rarely, acute renal failure. The possibility of similar effects cannot be excluded with angiotensin II receptor antagonists.
Renovascular 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.
Renal Impairment and Kidney Transplantation: When olmesartan medoxomil is used in patients with impaired renal function, periodic monitoring of serum potassium and creatinine levels is recommended. Use of olmesartan medoxomil is not recommended in patients with severe renal impairment (creatinine clearance <20 mL/min) (see Pharmacology: Pharmacokinetics under Actions and Dosage & Administration). There is no experience of the administration of olmesartan medoxomil in patients with a recent kidney transplant or in patients with end-stage renal impairment (ie, creatinine clearance <12 mL/min).
Hepatic Impairment: There is currently limited experience in patients with mild to moderate hepatic impairment and no experience in patients with severe hepatic impairment, therefore use of olmesartan medoxomil in these patient groups is not recommended.
Hyperkalaemia: As with other angiotensin II antagonists and ACE inhibitors, hyperkalaemia may occur during treatment with olmesartan medoxomil, especially in the presence of renal impairment and/or heart failure (see Interactions). Close monitoring of serum potassium levels in at risk patients is recommended.
Lithium: As with other angiotensin II receptor antagonists, the combination of lithium and olmesartan medoxomil is not recommended.
Aortic or Mitral Valve Stenosis, or Obstructive Hypertrophic Cardiomyopathy: As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Primary Aldosteronism: Patients with primary aldosteronism generally will not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin system. Therefore, the use of olmesartan medoxomil is not recommended in such patients.
Ethnic Differences: As with all other angiotensin II antagonists, the blood pressure lowering effect of olmesartan medoxomil is somewhat less in Black patients than in non-Black patients, possibly because of a higher prevalence of low-renin status in the Black hypertensive population.
Others: As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic heart disease or ischaemic cerebrovascular disease could result in a myocardial infarction or stroke.
Effects on the Ability to Drive or Operate Machinery: The effect of olmetec tablets on the ability to drive has not been specifically studied. With respect to driving vehicles or operating machines. It should be taken into account that occasionally dizziness or fatigue may occur in patients taking antihypertensive therapy.
Use In Pregnancy & Lactation
There is no experience with the use of olmesartan medoxomil 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, olmesartan medoxomil is contraindicated during the 2nd and 3rd trimesters of pregnancy.
In addition, olmesartan medoxomil must not be used during the 1st trimester of pregnancy. If pregnancy occurs during therapy, olmesartan medoxomil must be discontinued as soon as possible.
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 Olmetec.
Adverse Reactions
Common: Dizziness, bronchitis, cough, pharyngitis, rhinitis, abdominal pain, diarrhoea, dyspepsia, gastroenteritis, nausea, arthritis, back pain, skeletal pain, haematuria, urinary tract infection, chest pain, fatigue, influenza-like symptoms, peripheral oedema and pain.
Uncommon: Vertigo, angina pectoris, rash. Rare : hypotension.
Post-Launch Experience: In addition, as with other angiotensin II antagonists, headache has been observed. In very rare cases, hypersensitivity reactions (pruritus, urticaria, angioedema), peripheral oedema, vomiting, diarrhea, anaphylactic reaction, acute renal failure, myalgia and asthenic condition eg, asthenia, fatigue, lethargy, malaise have been reported.
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% vs 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: Metabolic and Nutritional Disorders: Common: Increased creatine phosphokinase, hypertriglyceridaemia, hyperuricaemia. Rare: Hyperkalaemia.
Liver and Biliary Disorders: Common: Liver enzyme elevations.
Drug Interactions
Effects of Other Medicinal Products on Olmesartan Medoxomil: 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 Antihypertensives: The blood pressure-lowering effect of olmesartan medoxomil can be increased by concomitant use of other antihypertensives medications.
Nonsteroidal Anti-inflammatory Drugs (NSAIDs): NSAIDs (including acetylsalicylic acid at doses >3 g/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 (aluminum magnesium hydroxide), a modest reduction in bioavailability of olmesartan was observed.
Co-administration of warfarin and digoxin had no effect on the pharmacokinetics of olmesartan.
Effects of Olmesartan Medoxomil on Other Medicinal Products: Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin-coverting enzyme inhibitors and angiotensin II antagonists. Therefore, use of olmesartan medoxomil 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 aluminum hydroxide), hydrochlorothiazide and pravastatin. No clinically relevant interactions were observed and in particular olmesartan medoxomil 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 P-450 enzymes 1A1/2, 2A6, 2C8/9, 2C19, 2D6, 2E1 and 3A4, and had no or minimal inducing effects on rat cytochrome P-450 activities. Therefore in vivo interaction studies with known cytochrome P-450 enzyme inhibitors and inducers were not conducted, and no clinically relevant interactions between olmesartan and drugs metabolised by the above cytochrome P-450 enzymes are expected.
Storage
Store at 25°-30°C temperature.
Shelf-Life: 3 years.
MIMS Class
Angiotensin II Antagonists
ATC Classification
C09CA08 - olmesartan medoxomil ; Belongs to the class of angiotensin II receptor blockers (ARBs). Used in the treatment of cardiovascular disease.
Presentation/Packing
Tab 20 mg (white, circular, with C14 embossed on one side) x 30's. 40 mg (white, oval, with C15 embossed on one side) x 30's.
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