Telmisartan and amlodipine

What is Telmisartan and amlodipine?

• Telmisartan and amlodipine (TWYNSTA) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product used to treat high blood pressure.

Telmisartan

Amlodipine

What are the uses of this medicine?

TWYNSTA is a prescription medicine that contains telmisartan and amlodipine. TWYNSTA tablets may be used to treat high blood pressure (hypertension):

• when one of these medicines (or a similar one) is not enough to lower your high blood pressure.
• as the first medicine to lower your high blood pressure if your doctor decides you are likely to need more than one medicine.

How does this medicine work?

Telmisartan:

• Telmisartan (tel" mi sar' tan) is an angiotensin II receptor blocker (ARB) used alone or in combination with other agents for therapy of hypertension.
• Telmisartan inhibits the renin-angiotensin system by blocking the angiotensin II type 1 receptor (AT1), which prevents the vasoconstriction and volume expansion induced by circulating angiotensin II which accounts for its potent antihypertensive activity.

Amlodipine:

• Amlodipine (am loe' di peen) belongs to the dihydropyridine class of calcium channel blockers and is used in the treatment of both hypertension and angina pectoris.
• Like other calcium channel blockers, amlodipine acts by blocking the influx of calcium ions into vascular smooth muscle and cardiac muscle cells during membrane depolarization.
• This action causes relaxation of vascular and arterial smooth muscle cells, resulting in arterial vasodilation and a decrease in cardiac work and oxygen consumption.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic (hypersensitive) to the active ingredients (telmisartan or amlodipine) or any of the other ingredients.
• with diabetes, if you are taking TWYNSTA you should not take aliskiren.

What drug interactions can this medicine cause?

TWYNSTA may affect the way other medicines work, and other medicines may affect how TWYNSTA works. Especially tell your doctor if you take:

• aliskiren
• digoxin (Lanoxin )
• lithium (Lithobid , lithium carbonate, lithium citrate)
• aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• other medicines that may be used to treat high blood pressure or a heart problem
• simvastatin (Zocor , Vytorin )
• water pills (diuretics)

Is this medicine FDA approved?

• Initial U.S. Approval: 2009

How should this medicine be used?

Recommended dosage:

• Substitute TWYNSTA for its individually titrated components for patients on amlodipine and telmisartan.
• TWYNSTA may also be given with increased amounts of amlodipine, telmisartan, or both, as needed.
• Use TWYNSTA tablets to provide additional blood pressure lowering for patients not adequately controlled with amlodipine (or another dihydropyridine calcium channel blocker) alone or with telmisartan (or another angiotensin receptor blocker) alone.
• Initiate with 40/5 mg or 80/5 mg once daily.
• Dosage may be increased after at least 2 weeks to a maximum dose of 80/10 mg once daily, usually by increasing one component at a time but both components can be raised to achieve more rapid control.
• Majority of antihypertensive effect is attained within 2 weeks.
• Initiate with 40/5 mg or 80/5 mg once daily.

Administration:

• Take TWYNSTA tablets exactly as your doctor tells you to take it.
• Your doctor will tell you how much TWYNSTA to take and when to take it. Your doctor may change your dose if needed.
• Take TWYNSTA one time each day at the same time.
• Take TWYNSTA tablets with or without food.
• If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
• If you take too much TWYNSTA, call your doctor or go to the nearest hospitalemergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets (mg aliskiren/mg valsartan): 150/160, 300/320.

This medicine is available in fallowing brand namesː

• Valturna

What side effects can this medication cause?

The most common side effects of this medicine include:

• swelling in your hands, ankles, or feet
• feeling like your heart is pounding or racing
• flushing or sudden redness of the face and neck
• dizziness
• back pain
• feeling tired or sleepy
• abdominal pain, nausea, or diarrhea
• low blood pressure or a sudden drop in blood pressure with fainting

TWYNSTA tablets may cause serious side effects, including:

• Injury or death to your unborn baby
• Low blood pressure (hypotension)
• get sick with vomiting or diarrhea
• If you feel faint or dizzy
• Kidney problems
• Heart problems or heart attack
• High potassium in the blood (hyperkalemia)
• Muscle rigidity, tremor and/or abnormal muscle movement
• Rare, serious allergic reactions may happen

What special precautions should I follow?

• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected,
• discontinue TWYNSTA as soon as possible.
• Hypotension may occur with TWYNSTA Correct any volume or salt depletion before initiating therapy. Observe for signs and symptoms of hypotension. Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.
• Titrate slowly in patients with hepatic or severe renal impairment.
• Heart failure may occur. Monitor for worsening.
• Avoid concomitant use with an ACE inhibitor.
• Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of TWYNSTA, particularly in patients with severe obstructive coronary artery disease.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Telmisartan overdose:

• The most likely manifestations of overdosage with telmisartan tablets would be hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.

Management:

• If symptomatic hypotension should occur, supportive treatment should be instituted.
• Telmisartan is not removed by hemodialysis.

Amlodipine overdose:

• peripheral vasodilation with marked hypotension and possibly a reflex tachycardia.

Management of overdosage:

• If massive overdose should occur, initiate active cardiac and respiratory monitoring.
• Frequent blood pressure measurements are essential.
• Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids.
• If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output.
• As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit

Can this medicine be used in pregnancy?

• TWYNSTA can cause harm or death to an unborn baby.
• Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
• If you get pregnant while taking TWYNSTA, tell your doctor right away.

Can this medicine be used in children?

• It is not known if TWYNSTA is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredients: telmisartan and amlodipine besylate
• Inactive ingredients: sodium hydroxide, povidone, meglumine, sorbitol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, corn starch, colloidal silicon dioxide, ferric oxide black, ferric oxide yellow and FD&C blue #1.

Who manufactures and distributes this medicine?

Distributed by:

• Boehringer Ingelheim Pharmaceuticals, Inc.
• Ridgefield, USA

Licensed from:

• Boehringer Ingelheim International GmbH, Ingelheim, Germany
• TWYNSTA® is a registered trademark of and used under license from Boehringe

What should I know about storage and disposal of this medication?

• Store TWYNSTA tablets at room temperature 68° to 77°F (20° to 25°C).
• Do not remove TWYNSTA tablets from blisters until right before you take them.
• Keep TWYNSTA tablets out of the light and away from moisture.

• Dailymed label info on Telmisartan and amlodipine
• FDA Telmisartan and amlodipine

Telmisartan and amlodipine Resources
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