Olmesartan medoxomil

Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, 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 olmesartan medoxomil tablets. …

Indication Starting Dose Dose Range Adult Hypertension (2.1) 20 mg once daily 20 to 40 mg once daily Pediatric Hypertension (6 years of age and older) ( 2.2 ) 20 to

· 5 mg yellow coloured round shape film coated tablets debossed with OLM on one side & 5 on other side. · 20 mg white to off-white coloured, round shape film coated tablets debossed with OLM on one side & 20 on other side. · 40 mg white to off-white coloured,oval shape film coated tablets debossed with OLM on one side & 40 on other side. Tablets: 5 mg, 20 mg, and 40 mg

• The antihypertensive effects of olmesartan medoxomil tablets were evaluated in one randomized, double-blind clinical study
• In pediatric patients 1 to 16 years of age [see Clinical Studies ]
• The pharmacokinetics of olmesartan medoxomil tablets were evaluated
• In pediatric patients 1 to 16 years of age [see Clinical Pharmacology ]
• Olmesartan medoxomil tablets was generally well tolerated
• In pediatric patients, and the adverse experience profile was similar to that described for adults. …

Of the total number of hypertensive patients receiving olmesartan medoxomil tablets in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. No overall differences in effectiveness or safety were observed between elderly patients and younger patients. …

• Pregnancy : Advise female patients of childbearing age about the consequences of exposure to olmesartan medoxomil tablets during pregnancy
• Discuss treatment options with women planning to become pregnant
• Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions and Use in Specific Populations ]
• Lactation : Advise nursing women not to breastfeed during treatment with olmesartan medoxomil tablets [see Use in Specific Populations ]
• Hyperkalemia : Advise patients not to use potassium supplements or salt substitutes that contain potassium without consulting their healthcare provider [see Drug Interactions ]. …

• Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see Drug Interactions ]
• Do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes

Agents increasing potassium levels may lead to increase in serum potassium ( 7.1 ). NSAID use may lead to increased risk of renal impairment and loss of antihypertensive effect ( 7.2 ). Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.3 ). Lithium: Increases in serum lithium concentrations and lithium toxicity ( 7.4 ). Colesevelam hydrochloride: Consider administering olmesartan at least 4 hours before colesevelam hydrochloride dose ( 7.5 ). …

· Avoid fetal (in utero) exposure ( 5.1 ). · Use of olmesartan medoxomil tablets in children less than 1 year of age is not recommended.( 5.2 ). · Observe for signs and symptoms of hypotension in volume- or salt-depleted patients with treatment initiation ( 5.3 ). · Monitor for worsening renal function in patients with renal impairment ( 5.4 ). · Sprue-like enteropathy has been reported. Consider alternative antihypertensive therapy in cases where no other etiology is found ( 5.5 ). 5.1 Fetal Toxicity Olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. …

The most common adverse reaction in adults was dizziness (3%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary Olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension occurs, initiate supportive treatment. The dialyzability of olmesartan is unknown.

Storage Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.