Aliskiren/amlodipine

What is Aliskiren/amlodipine?

• Aliskiren/amlodipine (Tekamlo) is a combination of aliskiren, a renin inhibitor, and amlodipine, a dihydropyridine calcium channel blocker, used for the treatment of hypertension, to lower blood pressure.

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Aliskiren

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Amlodipine

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Amlodipine 3D ball

What are the uses of this medicine?

Aliskiren/amlodipine (Tekamlo) is a prescription medicine that may be used:

• as the first medicine to lower your high blood pressure if your doctor decides that you are likely to need more than one medicine.
• to treat your high blood pressure when one medicine to lower your high blood pressure has not worked well enough.
• if you are already taking the medicines aliskiren and amlodipine to treat your high blood pressure.

Tekamlo contains:

• aliskiren, a direct renin inhibitor (DRI)
• amlodipine, a calcium channel blocker (CCB)

How does this medicine work?

Aliskiren:

• Aliskiren is a direct inhibitor of renin and acts to inhibit its ability to convert angiotensinogen to angiotensin 1, an early step in the renin-angiotensin system pathway.
• By inhibiting renin and the subsequent production of angiotensin II and aldosterone release, aliskiren results in a decrease in peripheral vasoconstriction and increase in sodium excretion.
• Aliskiren is effective in lowering blood pressure and can be used alone or in combination with other antihypertensive medications, including other inhibitors of the renin-angiotensin system such as the angiotensin converting enzyme (ACE) inhibitors and the angiotensin receptor blockers (ARBs).

Amlodipine:

• Amlodipine 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 with:

• diabetes

What drug interactions can this medicine cause?

• Avoid concomitant use with Cyclosporine.
• Avoid concomitant use with Itraconazole.
• NSAIDS use may lead to increased risk of renal impairment and loss of antihypertensive effect of Tekamlo.
• If simvastatin is co-administered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin.

Is this medicine FDA approved?

• Initial U.S. Approval: 2010

How should this medicine be used?

Recommended dosage:

• The recommended initial once-daily dose of Tekamlo is 150 mg/5 mg. Titrate as needed to a maximum of 300 mg/10 mg.
• If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, titrate the dose to a maximum of Tekamlo 300 mg/10 mg once daily.
• The blood pressure lowering effect is largely attained within 1-2 weeks.

Administration:

• Take Tekamlo exactly as prescribed by your doctor. It is important to take Tekamlo every day
• to control your blood pressure.
• Take Tekamlo one time a day, about the same time each day.
• Take Tekamlo the same way every day, either with or without a meal.
• Your doctor may change your dose of Tekamlo if needed. Do not change the amount of
• Tekamlo you take without talking to your doctor.
• If you miss a dose of Tekamlo, take it as soon as you remember. If it is close to your next
• dose, do not take the missed dose. Just take the next dose at your regular time.
• If you take too much Tekamlo, call your doctor or a Poison Control Center, or go to the
• nearest hospital emergency room.

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

This medicine is available in fallowing doasage form:

• As Tablets (aliskiren/amlodipine): 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg, 300 mg/10 mg.

This medicine is available in fallowing brand namesː

• Tekamlo

What side effects can this medication cause?

The most common side effects of this medicine include:

• Swelling of your lower legs

Common side effects of Tekamlo include:

• diarrhea
• cough
• dizziness
• flu-like symptoms
• tiredness
• high levels of potassium in the blood (hyperkalemia)

Tekamlo may cause serious side effects:

• Harm to an unborn baby, causing injury or death
• Low blood pressure (hypotension)
• Possible increased chest pain or risk of heart attack

What special precautions should I follow?

• Avoid concomitant use with ARBs or ACEI in patients with renal impairment (GFR<60 mL/min).
• Tekamlo is contraindicated in patients with diabetes who are receiving ARBs or ACEI because of the increased risk of renal impairment, hyperkalemia, and hypotension.
• Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with aliskiren and has necessitated hospitalization and intubation. Discontinue Tekamlo immediately in patients who develop angioedema and do not readminister.
• Hypotension may occur in volume- and/or salt-depleted patients. Correct imbalances before initiating therapy with Tekamlo.
• Increased angina or myocardial infarction with calcium channel blockers may occur upon dosage initiation or increase.
• Monitor renal function periodically in patients treated with Tekamlo. Changes in renal function, including acute renal failure, can be caused by drugs that affect the renin-angiotensin system. Consider withholding or discontinuing therapy in patients who develop a clincally significant decrease in renal function.
• Caution should be exercised when administering Tekamlo to patientsn with severe hepatic impairment.
• Avoid concomitant use of aliskiren with cyclosporine or intraconazole.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension

Management of overdosage:

• If symptomatic hypotension should occur, provide supportive treatment.
• Aliskiren is poorly dialyzed.
• Therefore, hemodialysis is not adequate to treat aliskiren overexposure.

Can this medicine be used in pregnancy?

• 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.
• Tekamlo can cause harm or death to an unborn baby.

Can this medicine be used in children?

• Safety and effectiveness of Tekamlo in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredients: Aliskiren hemifumarate and amlodipine
• Inactive ingredients: Colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron

oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.

Who manufactures and distributes this medicine?

Distributed by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey

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

• Store Tekamlo tablets at room temperature between 59oF to 86oF (15oC to 30oC).
• Keep the original prescription bottle and store in a dry place.
• Protect Tekamlo from heat and moisture.

• Dailymed label info on Aliskiren/amlodipine
• FDA Aliskiren/amlodipine

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