Aliskiren/amlodipine
What is Aliskiren/amlodipine?[edit | edit source]
- 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.
What are the uses of this medicine?[edit | edit source]
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?[edit | edit source]
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 ?[edit | edit source]
This medicine cannot be used in patients with:
What drug interactions can this medicine cause?[edit | edit source]
- 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?[edit | edit source]
- Initial U.S. Approval: 2010
How should this medicine be used?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
Symptoms of overdosage may include:
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?[edit | edit source]
- 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?[edit | edit source]
- Safety and effectiveness of Tekamlo in pediatric patients have not been established.
What are the active and inactive ingredients in this medicine?[edit | edit source]
- 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?[edit | edit source]
Distributed by:
- Novartis Pharmaceuticals Corporation
- East Hanover, New Jersey
What should I know about storage and disposal of this medication?[edit | edit source]
- 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.
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