Arbitel80 mg

Hypertension

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

Cardiovascular Risk Reduction

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

• ACE inhibitors (e.g., ramipril): Combining Arbitel 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 Arbitel is generally not recommended.
• Aliskiren: Concomitant use of Arbitel 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 Arbitel can raise blood potassium levels (hyperkalemia), particularly in patients with kidney disease, heart failure, or diabetes; periodic monitoring of serum potassium is advised during Arbitel therapy.
• NSAIDs (e.g., ibuprofen) and COX-2 inhibitors: Regular use with Arbitel may reduce the blood-pressure-lowering effect of Arbitel and can worsen kidney function, especially in elderly, volume-depleted, or renally impaired patients.
• Lithium: Arbitel can increase blood lithium levels and the risk of lithium toxicity; lithium levels should be monitored closely when lithium is used together with Arbitel.
• Digoxin: Arbitel can increase peak and trough digoxin concentrations; digoxin levels should be monitored when digoxin is used together with Arbitel.

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 Arbitel: 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 Arbitel: severe dizziness, fainting, or syncope, particularly after the first dose or in patients who are dehydrated
• Signs of high potassium (hyperkalemia) while taking Arbitel: muscle weakness, irregular heartbeat
• Signs of kidney problems while taking Arbitel: 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 Arbitel: yellowing of skin or eyes, dark urine
• Unexplained muscle pain, tenderness, or weakness while taking Arbitel (very rare reports of rhabdomyolysis)
• Signs of anaphylaxis or severe allergic/skin reactions to Arbitel

Pregnancy

Arbitel is contraindicated during pregnancy. Drugs that act directly on the renin-angiotensin system, including Arbitel, can cause injury and even death to the developing fetus. When Arbitel is used in the second and third trimesters, Arbitel 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 Arbitel are more limited, and available epidemiologic studies have not clearly distinguished a specific pattern of malformation from other antihypertensive medicines; however, because Arbitel carries no established safe window during pregnancy, Arbitel 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 Arbitel. If continued exposure to Arbitel has occurred, serial ultrasound examinations are recommended, and newborns exposed to Arbitel in utero should be monitored for low blood pressure, low urine output, and high potassium.

Breastfeeding

There is no published human data on whether Arbitel passes into breast milk or on the effects of Arbitel 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 Arbitel therapy, particularly while nursing a newborn or preterm infant. Mothers who need an antihypertensive medicine while breastfeeding should discuss alternatives to Arbitel with their doctor.

• Fetal toxicity: Arbitel 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 Arbitel, 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 Arbitel, and initiate Arbitel under medical supervision in such patients.
• Hyperkalemia: Arbitel can raise blood potassium levels, particularly in patients with kidney impairment, diabetes, or heart failure, or when Arbitel 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, Arbitel 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 Arbitel therapy.
• Hepatic impairment: Arbitel is eliminated mainly through the bile, so patients with hepatic impairment or biliary obstruction should be started on a lower dose of Arbitel with close monitoring, since plasma levels of Arbitel can rise substantially.
• Dual blockade of the renin-angiotensin system: Combining Arbitel 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 Arbitel and the pediatric limitations of Arbitel are described in the Pregnancy and Lactation and Pediatric Uses sections.

Limited data are available on Arbitel overdose in humans. The most likely effects of a Arbitel overdose are related to the blood-pressure-lowering action of Arbitel and include hypotension (low blood pressure) and dizziness; a fast, or less commonly slow, heart rate may also occur. If an overdose of Arbitel 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 Arbitel overdose is supportive, based on the symptoms present; Arbitel is not removed from the body by hemodialysis.

Store Arbitel 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 Arbitel tablets in their original blister pack and remove a Arbitel tablet only immediately before it is taken, since Arbitel tablets are sensitive to moisture. Keep Arbitel out of the reach of children. Always check the product label for the specific storage instructions applicable to the marketed brand or pack of Arbitel.

Children

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

Elderly

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

Renal Impairment

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

Hepatic Impairment

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

Pregnant and Breastfeeding Women

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

Arbitel 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 Arbitel. The full blood-pressure-lowering effect of Arbitel typically develops within about 4 weeks of starting or adjusting the dose of Arbitel. When Arbitel is used for cardiovascular risk reduction in high-risk patients, Arbitel is intended for long-term use as directed by a specialist. The duration of Arbitel therapy should be determined by a healthcare professional based on blood pressure response, tolerability, and overall cardiovascular risk, and Arbitel 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 Arbitel have not been established in children and adolescents under 18 years of age, and the FDA label for Arbitel states this explicitly; no pediatric dose of Arbitel 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 Arbitel specifically, and any pediatric use of Arbitel would be off-label and should only be undertaken by a pediatric specialist with individualized dosing of Arbitel and close monitoring. Infants exposed to Arbitel in utero require monitoring after birth for hypotension, oliguria (reduced urine output), and hyperkalemia, as noted in Pregnancy and Lactation.