Teana20 mg

Hypertension

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

Cardiovascular Risk Reduction

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

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

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

Pregnancy

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

Breastfeeding

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

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

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

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

Children

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

Elderly

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

Renal Impairment

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

Hepatic Impairment

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

Pregnant and Breastfeeding Women

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

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