Mitosan40 mg

Hypertension

Mitosan is indicated for the treatment of essential hypertension in adults. Mitosan may be used alone or in combination with other antihypertensive medicines when blood pressure is not adequately controlled on Mitosan alone. This is an established, guideline-supported use of Mitosan.

Cardiovascular Risk Reduction

Mitosan is also indicated to reduce the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older who are at high risk of cardiovascular events (for example, due to coronary artery disease, peripheral arterial disease, stroke, transient ischaemic attack, or high-risk diabetes with evidence of end-organ damage) and who are unable to take ACE inhibitors. This use of Mitosan is guideline-supported and specialist-directed, and is not a routine first-line use of Mitosan in the general hypertensive population.

After oral administration, Telmisartan is absorbed with peak plasma concentrations of Telmisartan reached within about 0.5 to 1 hour. The absolute bioavailability of Telmisartan is dose-dependent, ranging from approximately 42% at a 40 mg dose to 58% at a 160 mg dose, and food modestly reduces the absorption of Telmisartan. Telmisartan is more than 99.5% bound to plasma proteins and has a large volume of distribution. Telmisartan is metabolized by conjugation to a pharmacologically inactive acyl glucuronide and is not significantly metabolized by the cytochrome P450 enzyme system. Telmisartan is eliminated primarily unchanged via biliary excretion into the feces (over 97%), with less than 1% excreted in urine; the terminal elimination half-life of Telmisartan is approximately 24 hours, which supports once-daily dosing of Telmisartan.

• Take Mitosan by mouth once daily, at about the same time each day.
• Mitosan can be taken with or without food.
• Swallow the Mitosan tablet with a glass of water; do not crush or chew Mitosan unless advised by a healthcare professional.
• Keep Mitosan in its original blister pack until just before taking it, as Mitosan tablets are sensitive to moisture.
• If a dose of Mitosan is missed, take Mitosan as soon as remembered; if it is almost time for the next dose, skip the missed dose of Mitosan rather than doubling up.
• Continue taking Mitosan as prescribed even when feeling well, since blood pressure control with Mitosan requires regular use.
• Do not stop taking Mitosan without consulting a doctor, especially if pregnancy is suspected (see Pregnancy and Lactation).

• ACE inhibitors (e.g., ramipril): Combining Mitosan with an ACE inhibitor increases the risk of low blood pressure, high potassium, and reduced kidney function without added cardiovascular benefit (dual blockade of the renin-angiotensin system); this combination with Mitosan is generally not recommended.
• Aliskiren: Concomitant use of Mitosan with aliskiren is not recommended, and is specifically avoided in patients with diabetes, because of an increased risk of hyperkalemia, hypotension, and reduced kidney function.
• Potassium-sparing diuretics, potassium supplements, or potassium-containing salt substitutes: Using these with Mitosan can raise blood potassium levels (hyperkalemia), particularly in patients with kidney disease, heart failure, or diabetes; periodic monitoring of serum potassium is advised during Mitosan therapy.
• NSAIDs (e.g., ibuprofen) and COX-2 inhibitors: Regular use with Mitosan may reduce the blood-pressure-lowering effect of Mitosan and can worsen kidney function, especially in elderly, volume-depleted, or renally impaired patients.
• Lithium: Mitosan can increase blood lithium levels and the risk of lithium toxicity; lithium levels should be monitored closely when lithium is used together with Mitosan.
• Digoxin: Mitosan can increase peak and trough digoxin concentrations; digoxin levels should be monitored when digoxin is used together with Mitosan.

Common Side Effects

• Upper respiratory tract infection-like symptoms (cough, sore throat)
• Back pain
• Sinusitis
• Diarrhea
• Dizziness or headache
• Fatigue
• Nausea or indigestion
• Muscle cramps

Serious Side Effects - Seek Medical Attention

• Signs of angioedema while taking Mitosan: swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing (rare, but can be life-threatening; fatal cases have been reported)
• Symptoms of significant low blood pressure while taking Mitosan: severe dizziness, fainting, or syncope, particularly after the first dose or in patients who are dehydrated
• Signs of high potassium (hyperkalemia) while taking Mitosan: muscle weakness, irregular heartbeat
• Signs of kidney problems while taking Mitosan: reduced urination, swelling, unusual tiredness (risk of acute renal failure, especially with pre-existing kidney disease, heart failure, or dehydration)
• Signs of liver problems while taking Mitosan: yellowing of skin or eyes, dark urine
• Unexplained muscle pain, tenderness, or weakness while taking Mitosan (very rare reports of rhabdomyolysis)
• Signs of anaphylaxis or severe allergic/skin reactions to Mitosan

Pregnancy

Mitosan is contraindicated during pregnancy. Drugs that act directly on the renin-angiotensin system, including Mitosan, can cause injury and even death to the developing fetus. When Mitosan is used in the second and third trimesters, Mitosan has been associated with oligohydramnios (low amniotic fluid), fetal lung hypoplasia, skeletal deformations, skull hypoplasia, fetal kidney failure (anuria), and neonatal death. Data on first-trimester exposure to Mitosan are more limited, and available epidemiologic studies have not clearly distinguished a specific pattern of malformation from other antihypertensive medicines; however, because Mitosan carries no established safe window during pregnancy, Mitosan should be discontinued as soon as pregnancy is confirmed and should not be restarted. Women who are pregnant or planning pregnancy should discuss alternative antihypertensive options with their doctor instead of continuing Mitosan. If continued exposure to Mitosan has occurred, serial ultrasound examinations are recommended, and newborns exposed to Mitosan in utero should be monitored for low blood pressure, low urine output, and high potassium.

Breastfeeding

There is no published human data on whether Mitosan passes into breast milk or on the effects of Mitosan on a breastfed infant. Because this information is not available, and because alternative antihypertensive medicines with more breastfeeding safety data exist, breastfeeding is generally not recommended during Mitosan therapy, particularly while nursing a newborn or preterm infant. Mothers who need an antihypertensive medicine while breastfeeding should discuss alternatives to Mitosan with their doctor.

• Fetal toxicity: Mitosan can cause fetal injury and death when used during pregnancy; see Pregnancy and Lactation for full details.
• Symptomatic hypotension: Excessive low blood pressure may occur with Mitosan, especially in patients who are volume- or salt-depleted (e.g., from diuretic use, a low-salt diet, vomiting, or diarrhea); correct volume depletion before starting Mitosan, and initiate Mitosan under medical supervision in such patients.
• Hyperkalemia: Mitosan can raise blood potassium levels, particularly in patients with kidney impairment, diabetes, or heart failure, or when Mitosan is combined with potassium-sparing agents; periodic monitoring of serum potassium is advised (see Interactions).
• Renal function changes: As with other drugs that affect the renin-angiotensin system, Mitosan may worsen kidney function in patients whose kidney function depends on this system (e.g., severe heart failure or renal artery stenosis); renal function should be monitored during Mitosan therapy.
• Hepatic impairment: Mitosan is eliminated mainly through the bile, so patients with hepatic impairment or biliary obstruction should be started on a lower dose of Mitosan with close monitoring, since plasma levels of Mitosan can rise substantially.
• Dual blockade of the renin-angiotensin system: Combining Mitosan with an ACE inhibitor or aliskiren increases the risk of hypotension, hyperkalemia, and reduced kidney function without added benefit and is generally not recommended (see Interactions).
• Pregnancy and pediatric limitations: The pregnancy contraindication of Mitosan and the pediatric limitations of Mitosan are described in the Pregnancy and Lactation and Pediatric Uses sections.

Limited data are available on Mitosan overdose in humans. The most likely effects of a Mitosan overdose are related to the blood-pressure-lowering action of Mitosan and include hypotension (low blood pressure) and dizziness; a fast, or less commonly slow, heart rate may also occur. If an overdose of Mitosan is suspected, contact a doctor, hospital emergency department, or a poison control service immediately. Do not induce vomiting unless specifically directed to do so by a healthcare professional or poison control service. Treatment of Mitosan overdose is supportive, based on the symptoms present; Mitosan is not removed from the body by hemodialysis.

Store Mitosan tablets at room temperature (around 25°C/77°F; brief excursions between 15-30°C/59-86°F are permitted), protected from moisture and light. Keep Mitosan tablets in their original blister pack and remove a Mitosan tablet only immediately before it is taken, since Mitosan tablets are sensitive to moisture. Keep Mitosan out of the reach of children. Always check the product label for the specific storage instructions applicable to the marketed brand or pack of Mitosan.

Children

The safety and effectiveness of Mitosan have not been established in patients under 18 years of age, and no pediatric dose of Mitosan has been defined. See Pediatric Uses for further detail.

Elderly

No overall differences in the effectiveness or safety of Mitosan were observed between elderly and younger adult patients in clinical trials, and no initial dose adjustment of Mitosan is required based on age alone; however, individual sensitivity to the blood-pressure-lowering effects of Mitosan may be greater in some older patients.

Renal Impairment

No dosage adjustment of Mitosan is required for patients with mild to moderate renal impairment. Mitosan is not removed by hemodialysis. Patients with severe renal impairment or those on dialysis should be monitored closely during Mitosan therapy, as changes in renal function may occur, particularly if renal function depends on the renin-angiotensin system.

Hepatic Impairment

Mitosan is eliminated mainly through biliary excretion, so plasma levels of Mitosan increase substantially in patients with hepatic impairment or obstructive biliary disease. Mitosan should be used with caution and started at a lower dose in these patients, with close monitoring.

Pregnant and Breastfeeding Women

Mitosan is contraindicated in pregnancy and is generally not recommended during breastfeeding; see Pregnancy and Lactation for full detail.

Mitosan is generally used long-term for the ongoing control of high blood pressure, since hypertension usually requires continuous treatment rather than a short course of Mitosan. The full blood-pressure-lowering effect of Mitosan typically develops within about 4 weeks of starting or adjusting the dose of Mitosan. When Mitosan is used for cardiovascular risk reduction in high-risk patients, Mitosan is intended for long-term use as directed by a specialist. The duration of Mitosan therapy should be determined by a healthcare professional based on blood pressure response, tolerability, and overall cardiovascular risk, and Mitosan should not be stopped abruptly without medical advice.

Telmisartan selectively blocks the binding of angiotensin II to the AT1 receptor found in vascular smooth muscle and the adrenal gland. By blocking this receptor, Telmisartan prevents the vasoconstriction and aldosterone-secreting effects of angiotensin II, resulting in relaxation of blood vessels and a lowering of blood pressure. Telmisartan has more than 3,000-fold greater affinity for the AT1 receptor than the AT2 receptor, and Telmisartan does not inhibit the angiotensin-converting enzyme (ACE) or affect bradykinin breakdown.

The safety and effectiveness of Mitosan have not been established in children and adolescents under 18 years of age, and the FDA label for Mitosan states this explicitly; no pediatric dose of Mitosan has been defined. Current guideline-level pediatric hypertension recommendations (e.g., from the American Academy of Pediatrics) list angiotensin II receptor blockers as one of several acceptable classes of initial antihypertensive medicine in children and adolescents, alongside ACE inhibitors, long-acting calcium channel blockers, and thiazide diuretics. However, this class-level guideline support does not equate to established pediatric labeling for Mitosan specifically, and any pediatric use of Mitosan would be off-label and should only be undertaken by a pediatric specialist with individualized dosing of Mitosan and close monitoring. Infants exposed to Mitosan in utero require monitoring after birth for hypotension, oliguria (reduced urine output), and hyperkalemia, as noted in Pregnancy and Lactation.