Sevitan20 mg

Hypertension (Established Use)

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

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

Sevitan is indicated for the treatment of hypertension in children aged 6 to 16 years. Sevitan has not been shown to be effective for lowering blood pressure in children younger than 6 years, and Sevitan 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 Sevitan among the first-line drug classes for initial antihypertensive therapy, alongside thiazide-type diuretics, ACE inhibitors, and calcium channel blockers. Whether Sevitan 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.

Sevitan is a prescription medicine used to treat high blood pressure (hypertension) in adults and in children aged 6 years and older. Sevitan 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, Sevitan helps reduce the long-term risk of serious problems such as stroke and heart attack. Sevitan is taken by mouth, usually once a day, and is normally used as a long-term, ongoing treatment rather than a short course. Sevitan 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 Sevitan exactly as prescribed by your doctor, at about the same time each day.
• Sevitan may be taken with or without food.
• Swallow the Sevitan tablet whole with a glass of water; do not crush or chew unless your doctor advises otherwise.
• If a dose of Sevitan 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 Sevitan without consulting your doctor, even if you feel well, since high blood pressure often has no symptoms.
• Keep taking Sevitan 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 Sevitan with an ACE inhibitor or with aliskiren increases the risk of hypotension, hyperkalemia, and changes in kidney function compared with use of Sevitan alone; aliskiren must not be co-administered with Sevitan in patients with diabetes.
• Lithium: Concomitant use of Sevitan with lithium has been reported to increase serum lithium concentrations and cause lithium toxicity; serum lithium levels should be monitored closely if Sevitan 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 Sevitan may worsen kidney function, including rare acute kidney failure, and may reduce the blood-pressure-lowering effect of Sevitan.
• Potassium-sparing diuretics, potassium supplements, and potassium-containing salt substitutes: Because Sevitan 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 Sevitan and either digoxin or warfarin.

Common Side Effects

The most commonly reported side effect of Sevitan in clinical trials was dizziness. Other side effects reported with Sevitan 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 Sevitan and require emergency care.
• Signs of high potassium (hyperkalemia): muscle weakness, irregular heartbeat, or tingling can occur with Sevitan, 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 Sevitan, 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 Sevitan; see Precautions and Warnings for full details.
• Unexplained muscle pain, tenderness, or weakness: rare cases of rhabdomyolysis have been reported with Sevitan.

Pregnancy

Sevitan is contraindicated in pregnancy. Drugs that act on the renin-angiotensin system, including Sevitan, can cause injury and even death to the developing fetus when used during pregnancy. Use of Sevitan 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, Sevitan 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 Sevitan in utero should be closely monitored for low blood pressure, low urine output, and high potassium.

Breastfeeding

It is not known whether Sevitan 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 Sevitan, taking into account the importance of Sevitan to the mother.

• Sprue-like enteropathy: Sevitan has been associated with severe, chronic diarrhea accompanied by substantial weight loss, sometimes developing months to years after starting Sevitan 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 Sevitan and has not been established with other angiotensin II receptor blockers. If a patient taking Sevitan develops these symptoms and no other cause is found, Sevitan should be discontinued; symptoms have improved after stopping Sevitan in reported cases.
• Fetal toxicity: Sevitan 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 Sevitan 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 Sevitan, or Sevitan should be started under close medical supervision.
• Impaired renal function: As with other drugs that affect the renin-angiotensin system, Sevitan 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 Sevitan.
• Hyperkalemia: Sevitan may raise serum potassium levels; periodic monitoring of electrolytes is advised, especially when Sevitan is combined with potassium-sparing diuretics, potassium supplements, or salt substitutes.
• Infants younger than 1 year: Sevitan 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 Sevitan. Based on the pharmacologic action of Sevitan, 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 Sevitan 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 Sevitan overdose is supportive, based on the patient's symptoms, and may include monitoring of blood pressure and heart function; it is not known whether Sevitan can be removed from the body by dialysis.

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

Children

Sevitan is approved for the treatment of hypertension in children aged 6 to 16 years, with dosing based on body weight; see Dosage. Sevitan has not been shown to be effective in children younger than 6 years, and Sevitan 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 Sevitan have been observed between elderly and younger patients, although greater sensitivity in some older individuals cannot be ruled out; no initial dose adjustment of Sevitan is required based on age alone.

Renal Impairment

Blood levels of Sevitan are increased in patients with reduced kidney function, and no initial dose adjustment of Sevitan 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 Sevitan.

Hepatic Impairment

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

Pregnant and Breastfeeding Women

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

Sevitan 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 Sevitan is determined by a doctor based on ongoing blood pressure response and overall cardiovascular risk, and Sevitan 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.

Sevitan is indicated for the treatment of hypertension in children 6 to 16 years of age; dosing of Sevitan 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 Sevitan has not been established in children younger than 6 years. Sevitan must not be given to infants younger than 1 year of age, because renin-angiotensin system blockade with Sevitan can adversely affect kidney development that is still ongoing in the first year of life. Children taking Sevitan should be monitored by a pediatrician for blood pressure control, growth, and kidney function.