Olsart40 mg

Hypertension (Established Use)

Olsart is indicated for the treatment of hypertension (high blood pressure) in adults, to lower blood pressure. Lowering blood pressure with Olsart reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and heart attacks. Olsart may be used alone or in combination with other antihypertensive medicines.

Hypertension in Children (Established Use, Age 6–16 Years)

Olsart is indicated for the treatment of hypertension in children aged 6 to 16 years. Olsart has not been shown to be effective for lowering blood pressure in children younger than 6 years, and Olsart must not be given to infants younger than 1 year of age.

Guideline Positioning

The 2017 ACC/AHA hypertension guideline lists angiotensin II receptor blockers such as Olsart among the first-line drug classes for initial antihypertensive therapy, alongside thiazide-type diuretics, ACE inhibitors, and calcium channel blockers. Whether Olsart or another first-line agent is most appropriate for a given patient is decided by the treating physician.

Each tablet contains Olmesartan Medoxomil as the active ingredient, available in strengths of 10 mg, 20 mg, and 40 mg.

Olsart is a prescription medicine used to treat high blood pressure (hypertension) in adults and in children aged 6 years and older. Olsart belongs to a group of medicines called angiotensin II receptor blockers (ARBs), which work by relaxing blood vessels so blood can flow more easily. By lowering blood pressure, Olsart helps reduce the long-term risk of serious problems such as stroke and heart attack. Olsart is taken by mouth, usually once a day, and is normally used as a long-term, ongoing treatment rather than a short course. Olsart should only be used under the guidance of a registered physician, who will decide the right dose for each patient.

Antihypertensive (Angiotensin II Receptor Blocker)

Olmesartan Medoxomil is an ester prodrug that is rapidly and completely bioactivated by ester hydrolysis during absorption from the gastrointestinal tract; the active moiety produced from Olmesartan Medoxomil selectively blocks the binding of angiotensin II to the AT1 receptor in vascular smooth muscle, preventing the vasoconstrictor and aldosterone-secreting effects of angiotensin II. The active metabolite of Olmesartan Medoxomil has more than a 12,500-fold greater affinity for the AT1 receptor than for the AT2 receptor and does not inhibit ACE (kininase II), the enzyme that generates angiotensin II and also degrades bradykinin. The blood-pressure-lowering effect of Olmesartan Medoxomil is dose-related across the 2.5 mg to 40 mg range, and the absolute bioavailability of Olmesartan Medoxomil is approximately 26%, with peak plasma concentrations reached 1 to 2 hours after dosing. Olmesartan Medoxomil is highly bound to plasma proteins (99%), is eliminated with a terminal half-life of approximately 13 hours, and reaches steady-state levels within 3 to 5 days of once-daily dosing, with elimination occurring through both renal and biliary/fecal routes.

• Take Olsart exactly as prescribed by your doctor, at about the same time each day.
• Olsart may be taken with or without food.
• Swallow the Olsart tablet whole with a glass of water; do not crush or chew unless your doctor advises otherwise.
• If a dose of Olsart is missed, take it as soon as remembered; if it is almost time for the next dose, skip the missed dose and continue the regular schedule. Do not take a double dose.
• Do not stop taking Olsart without consulting your doctor, even if you feel well, since high blood pressure often has no symptoms.
• Keep taking Olsart and attend follow-up visits so your doctor can monitor your blood pressure and kidney function.

• Dual blockade of the renin-angiotensin system (ACE inhibitors or aliskiren): Combining Olsart with an ACE inhibitor or with aliskiren increases the risk of hypotension, hyperkalemia, and changes in kidney function compared with use of Olsart alone; aliskiren must not be co-administered with Olsart in patients with diabetes.
• Lithium: Concomitant use of Olsart with lithium has been reported to increase serum lithium concentrations and cause lithium toxicity; serum lithium levels should be monitored closely if Olsart and lithium are used together.
• NSAIDs, including COX-2 inhibitors: In elderly patients, volume-depleted patients, or those with reduced kidney function, taking an NSAID with Olsart may worsen kidney function, including rare acute kidney failure, and may reduce the blood-pressure-lowering effect of Olsart.
• Potassium-sparing diuretics, potassium supplements, and potassium-containing salt substitutes: Because Olsart inhibits the renin-angiotensin system, using it together with these products can raise serum potassium (hyperkalemia); periodic monitoring of serum electrolytes is advised.
• Digoxin and warfarin: No clinically significant interaction has been reported between Olsart and either digoxin or warfarin.

Common Side Effects

The most commonly reported side effect of Olsart in clinical trials was dizziness. Other side effects reported with Olsart at rates similar to placebo included headache, back pain, diarrhea, fatigue, and upper respiratory symptoms such as bronchitis, pharyngitis, rhinitis, sinusitis, and flu-like symptoms.

Serious Side Effects – Seek Medical Attention

• Signs of an allergic reaction: swelling of the face, lips, tongue, or throat, or difficulty breathing, may indicate angioedema or an anaphylactic reaction to Olsart and require emergency care.
• Signs of high potassium (hyperkalemia): muscle weakness, irregular heartbeat, or tingling can occur with Olsart, especially when combined with certain other medicines.
• Signs of kidney problems: a marked decrease in urination or swelling can indicate acute kidney injury related to Olsart, particularly in patients with pre-existing kidney disease, heart failure, or dehydration.
• Severe, chronic diarrhea with significant weight loss: this may indicate sprue-like enteropathy associated with Olsart; see Precautions and Warnings for full details.
• Unexplained muscle pain, tenderness, or weakness: rare cases of rhabdomyolysis have been reported with Olsart.

Pregnancy

Olsart is contraindicated in pregnancy. Drugs that act on the renin-angiotensin system, including Olsart, can cause injury and even death to the developing fetus when used during pregnancy. Use of Olsart during the second and third trimesters reduces fetal renal function, which can lead to oligohydramnios (low amniotic fluid), fetal lung hypoplasia, skull hypoplasia, fetal renal impairment or anuria, and increased fetal and neonatal illness or death. If pregnancy is detected during treatment, Olsart should be discontinued as soon as possible, and the patient should be switched to an alternative antihypertensive medicine considered safer in pregnancy under a doctor's guidance. A newborn who was exposed to Olsart in utero should be closely monitored for low blood pressure, low urine output, and high potassium.

Breastfeeding

It is not known whether Olsart passes into human breast milk. Because of the potential for serious adverse effects in a nursing infant, a decision should be made, in consultation with a doctor, whether to discontinue breastfeeding or discontinue Olsart, taking into account the importance of Olsart to the mother.

• Sprue-like enteropathy: Olsart has been associated with severe, chronic diarrhea accompanied by substantial weight loss, sometimes developing months to years after starting Olsart and occasionally serious enough to require hospitalization. Intestinal biopsies in affected patients have often shown villous atrophy resembling celiac disease (sprue-like enteropathy), but tests for celiac disease are typically negative. This reaction has been specifically linked to Olsart and has not been established with other angiotensin II receptor blockers. If a patient taking Olsart develops these symptoms and no other cause is found, Olsart should be discontinued; symptoms have improved after stopping Olsart in reported cases.
• Fetal toxicity: Olsart can cause fetal harm when used in pregnancy; see Pregnancy and Lactation for full details.
• Hypotension in volume- or salt-depleted patients: Symptomatic low blood pressure may occur after starting Olsart in patients who are volume- or salt-depleted (for example, from diuretic use, dietary salt restriction, vomiting, or diarrhea); volume depletion should be corrected before starting Olsart, or Olsart should be started under close medical supervision.
• Impaired renal function: As with other drugs that affect the renin-angiotensin system, Olsart can be associated with a decline in kidney function, particularly in patients with renal artery stenosis, severe heart failure, or volume depletion; kidney function should be monitored periodically during treatment with Olsart.
• Hyperkalemia: Olsart may raise serum potassium levels; periodic monitoring of electrolytes is advised, especially when Olsart is combined with potassium-sparing diuretics, potassium supplements, or salt substitutes.
• Infants younger than 1 year: Olsart must not be given to infants younger than 1 year of age because of the risk to the developing kidneys; see Use in Special Populations.

There is limited clinical experience with overdose of Olsart. Based on the pharmacologic action of Olsart, the most likely effects of an overdose are low blood pressure (hypotension) and a fast heart rate (tachycardia); a slow heart rate (bradycardia) could occur from excessive parasympathetic (vagal) stimulation. If an overdose of Olsart is suspected, do not induce vomiting unless specifically directed to do so by a doctor or poison control center. Contact emergency medical services or a poison control center immediately. Treatment of an Olsart overdose is supportive, based on the patient's symptoms, and may include monitoring of blood pressure and heart function; it is not known whether Olsart can be removed from the body by dialysis.

Store according to the storage instructions on the product label of the specific Olsart brand, generally at controlled room temperature away from excess heat, moisture, and direct light. Keep Olsart out of the reach and sight of children, and do not use Olsart after the expiry date printed on the pack.

Children

Olsart is approved for the treatment of hypertension in children aged 6 to 16 years, with dosing based on body weight; see Dosage. Olsart has not been shown to be effective in children younger than 6 years, and Olsart must not be given to infants younger than 1 year of age because of risk to developing kidneys.

Elderly

No overall differences in the effectiveness or safety of Olsart have been observed between elderly and younger patients, although greater sensitivity in some older individuals cannot be ruled out; no initial dose adjustment of Olsart is required based on age alone.

Renal Impairment

Blood levels of Olsart are increased in patients with reduced kidney function, and no initial dose adjustment of Olsart is required for moderate-to-marked renal impairment, but these patients should be monitored closely for changes in kidney function and potassium levels while taking Olsart.

Hepatic Impairment

Blood levels of Olsart are increased in patients with moderate liver impairment; no initial dose adjustment of Olsart is recommended, but such patients should be monitored during treatment with Olsart.

Pregnant and Breastfeeding Women

See Pregnancy and Lactation for full information on the use of Olsart in these populations.

Olsart is typically used as a long-term, ongoing (chronic) treatment for hypertension, since high blood pressure usually requires continuous control rather than a short course of therapy. The duration of treatment with Olsart is determined by a doctor based on ongoing blood pressure response and overall cardiovascular risk, and Olsart should not be stopped abruptly without medical advice.

Antihypertensive; Angiotensin II Receptor Blocker (ARB); Renin-Angiotensin System (RAS) Inhibitor

Olmesartan Medoxomil is an ester prodrug that is converted to its active form during absorption; the active form of Olmesartan Medoxomil selectively blocks the binding of angiotensin II to the AT1 receptor found in vascular smooth muscle and other tissues, thereby blocking the vasoconstricting and aldosterone-secreting effects of angiotensin II. Olmesartan Medoxomil does not inhibit ACE (kininase II) and does not affect bradykinin breakdown.

Olsart is indicated for the treatment of hypertension in children 6 to 16 years of age; dosing of Olsart in this group is based on body weight (10 mg to 20 mg once daily for children weighing 20 kg to less than 35 kg, and 20 mg to 40 mg once daily for children weighing 35 kg or more). The effectiveness of Olsart has not been established in children younger than 6 years. Olsart must not be given to infants younger than 1 year of age, because renin-angiotensin system blockade with Olsart can adversely affect kidney development that is still ongoing in the first year of life. Children taking Olsart should be monitored by a pediatrician for blood pressure control, growth, and kidney function.