Aliskiren and Amlodipine (Oral)

Designed to manage high blood pressure in adults, aliskiren and amlodipine is an oral medication commonly known as Tekamlo.

Overview

Aliskiren and amlodipine is a combination medicine which works to treat hypertension (high blood pressure). It is known in the US under the brand name Tekamlo and is administered in tablet form.

Aliskiren is a renin inhibitor. Renin is an enzyme which triggers a process which helps to regulate blood pressure by constricting the blood vessels. By blocking renin, aliskiren halts this process and dilates the blood vessels, which reduces blood pressure.

Amlodipine is a calcium channel block (CCB). It works on the movement of calcium in heart and blood vessel cells and helps to relax blood vessels while increasing the blood and oxygen supply to the heart. This reduces the workload of the heart.

Although aliskiren and amlodipine can be used separately, the combination of the two drugs helps to tackle hypertension more effectively. If hypertension is left untreated, it can lead to heart attack, heart disease, stroke and kidney failure. By reducing hypertension, aliskiren and amlodipine can help to reduce the risk of these life-threatening illnesses.

Drugs like aliskiren and amlodipine are designed to control hypertension, but they are unable to cure it completely. For this reason, they're designed for long-term use and many doctors will recommend that patients make lifestyle changes that will help to resolve hypertension. This might include losing weight, becoming more active, eating a more balanced diet, reducing salt intake, quitting smoking and reducing alcohol consumption. It's important that drastic lifestyle changes such as these are done with the approval and supervision of your doctor to ensure you don't put too much pressure on the body all at once. Ask your healthcare provider for advice on making safe, beneficial lifestyle changes that will support the effects of aliskiren and amlodipine.

Condition(s) treated?

  • Hypertension

Type of medicine?

  • Renin inhibitor
  • Calcium channel blocker (CCB)

Side Effects

Aliskiren and amlodipine can cause a series of unwanted side effects. Some are dangerous and should be reported to a doctor urgently, while others are minor and do not require medical attention. It's important to familiarize yourself with all potential side effects before you start taking the medication so that you can recognize and act on harmful side effects quickly.

Some of the most common harmful side effects include bloating or swelling of the feet, lower legs, arms, hands or face. It's also possible to develop tingling in the hands or feet, and to experience unusual rapid weight gain or loss. Rarer harmful side effects include blurred vision, dizziness or faintness when getting up from sitting or lying positions, unusual sweating and feeling more tired or weaker than usual. If you experience any of these side effects when taking aliskiren and amlodipine, tell your doctor urgently.

The following side effects are very rare, but have been reported by individuals taking aliskiren and amlodipine. If you notice any of these, report them to your doctor immediately:

  • Loss of appetite
  • Nausea
  • Pain in the abdomen or stomach
  • Light-colored stools
  • Diarrhea
  • Dark urine
  • Vomiting blood
  • Blistering or peeling skin
  • Hive-like swelling or rash on the skin
  • Red lesions on skin
  • Sores or ulcers on the lips or in the mouth
  • Unusually bad breath
  • Red, irritated eyes
  • Yellow eyes or skin
  • Chills
  • Fever
  • Dizziness
  • Headache
  • Cough
  • Sore throat
  • Pain in joints or muscles
  • Seizures

Some people experience an increase in stomach acid or a sour stomach when taking aliskiren and amlodipine. They may also develop itchy skin, feel a loss of strength, have occasional muscles cramps or feel mild discomfort in the stomach. In very rare instances, breast tissue may swell or become sore and this can occur in both men and women. These side effects are usually nothing to worry about but discuss them with your doctor if you feel concerned about them.

Sometimes side effects occur only while the body adjusts to a new medication. Your doctor may recommend that you wait a short time to find out if this is the case for you. If side effects persist and become bothersome, it may be possible to try a different treatment option or medication. Most medicines pose a risk of side effects, but the benefits of the drug usually outweigh the minor side effects. If the side effects cause major problems for you, it may be better to try a different drug.

If you notice any other side effects not listed here when taking aliskiren and amlodipine, tell your doctor about them. You can also report new side effects to the FDA.

Dosage

Aliskiren and amlodipine dosages vary depending on the patient in question and the severity of their hypertension. For adults, the typical starting dose is a single tablet contains 150 mg aliskiren and 5 mg amlodipine every day. However, doctors may increase the dose if they do not see the beneficial results they expect. The maximum dose for the drug is 300 mg aliskiren and 10 mg amlodipine once each day. Blood pressure is usually reduced within one to two weeks of starting the medication.

Sometimes aliskiren and amlodipine are prescribed to children, but the dosage will vary depending on their age, weight, height and the severity of their hypertension. Doctors will assess whether the drug is safe for the child and administer a dose which is most appropriate.

Aliskiren and amlodipine can be taken either with or without food, but you should aim to take the medication at roughly the same time and in the same way each day. This might help to reduce the risk of side effects. If you miss a dose, take it as soon as you remember and continue with your usual dosing schedule. If when you remember it is almost time for your next dose, simply skip the missed dose and take the next one at the usual time, then continue with your original dosing schedule.

All blood pressure medications like aliskiren and amlodipine are designed for long-term use. They help to control blood pressure, but they do not cure it. It is usually advisable to continue taking the medicine even after your blood pressure has returned to normal because stopping the medicine could cause harmful side effects or simply result in your blood pressure returning to a high level. Only stop taking aliskiren and amlodipine under the advice of your doctor.

Interactions

Aliskiren and amlodipine should not be taken concurrently with ARBs (angiotensin receptor blockers) or ACEIs (angiotensin-converting enzyme inhibitors) by patients with diabetes or renal impairment. Doing so could lead to kidney damage which might result in hospitalization.

NSAIDs (non-steroidal anti-inflammatory agents) may reduce the antihypertensive effects of aliskiren, but they may still be used together. In patients who are elderly or volume-depleted (meaning that they have reduced fluid throughout the body) or who have renal failure, the concurrent use of NSAIDs and aliskiren may lead to a decrease in renal function and in worst cases could lead to acute renal failure. The effects are reversible, but these patients should be closely monitored if taking both NSAIDs and aliskiren.

Cyclosporine, a drug used to prevent organ rejection in people who have had heart, liver or kidney transplants, should not use aliskiren and amlodipine concurrently. Cyclosporine dramatically increases the effects of aliskiren which can lead to a dramatic drop in blood pressure and cause hyperkalemia, which means the potassium levels in the blood become very high. This can lead to kidney failure, irregular heartbeat, muscle paralysis and cardiac arrest.

Itraconazole, a medication used to treat fungal infections, should be avoided when taking aliskiren and amlodipine. This medication can also heighten the effects of aliskiren and increase the risk of hyperkalemia. Furthermore, itraconazole interacts with amlodipine and cause a wide range of side effects, such as irregular heartbeat, fluid retention, severely low blood pressure and heart failure.

It is also not recommended to take aliskiren and amlodipine with the following medications. Be sure to tell your doctor if you are taking any of the following drugs:

  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Candesartan
  • Captopril
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Fosinopril
  • Irbesartan
  • Lisinopril
  • Losartan
  • Moexipril
  • Olmesartan Medoxomil
  • Perindopril
  • Quinapril
  • Ramipril
  • Telmisartan
  • Trandolapril
  • Valsartan

The following medicines are not recommended for use with aliskiren and amlodipine but your doctor may allow you to continue taking both if the benefits of both drugs outweigh the risk of interactions. In some cases, they may adjust the dosages of some medications or give extra instruction as to the time of day that you should take them, or they may find alternative treatments for some conditions.

  • Amiodarone
  • Atazanavir
  • Ceritinib
  • Clarithromycin
  • Clopidogrel
  • Conivaptan
  • Dantrolene
  • Digoxin
  • Domperidone
  • Droperidol
  • Eliglustat
  • Idelalisib
  • Lacosamide
  • Piperaquine
  • Simeprevir
  • Simvastatin
  • Tacrolimus
  • Tegafur
  • Telaprevir

Finally, the following medicines might increase the risk of you having certain side effects, which may cause your doctor to choose alternative drugs or treatment options. However, if the benefits of all medications outweigh the risk of side effects, your doctor may continue to prescribe the medicines with adjusted dosages or administration instructions, or they may simply monitor your condition more closely.

  • Furosemide
  • Indinavir
  • Rifampin

Warnings

Certain pre-existing medical conditions might affect the behavior of aliskiren and amlodipine and could lead to an increased risk of side effects or health complications. Always ensure that your doctor is aware of all other health problems you're suffering with, particularly the ones outlined below.

History of airway surgery

If you've had surgery on your airways in the past (in the nose, mouth or throat) you could be at an increased risk of angioedema when taking aliskiren and amlodipine. Angioedema is swelling of the face, lips, tongue, throat, arms or legs.

History of angioedema

If you've had angioedema in the past, you're at an increased risk of developing the condition again when using aliskiren and amlodipine.

Congestive heart failure or history of heart attack

Individuals who have suffered from heart attack of congested heart failure may be at an increased risk of developing kidney problems when taking aliskiren and amlodipine.

Diabetes or kidney problems

People with diabetes or kidney problems are more likely to develop hyperkalemia (high blood potassium levels) when taking aliskiren and amlodipine, which is a life-threatening condition. Furthermore, diabetic patients who are taking ACEIs or ARBs should never take aliskiren and amlodipine due to dangerous interactions of the drugs.

Electrolyte or fluid imbalances

People with electrolyte imbalances - such as high potassium or low sodium levels - or with fluid imbalances may not be able to take aliskiren and amlodipine because the medication could worsen their condition.

Heart disease, blood vessel disease or heart valve conditions

Conditions affecting the heart, heart valves and blood vessels, such as obstructive coronary artery disease or aortic stenosis, may be worsened with the use of aliskiren and amlodipine. The risk of heart attack and chest pain increases in patients with these conditions.

Liver disease

People with liver disease will not process aliskiren and amlodipine out of the body as quickly as those with a healthy liver. This could result in the medicine having a heightened impact on the body which might cause blood pressure to become too low.

Pregnancy and breastfeeding

Aliskiren and amlodipine is a category D drug for pregnancy, which means that it poses a risk to the fetus. Research has found that during the second and third trimesters, the drug can reduce renal function of the fetus which may risk the life of the fetus. It may also risk the normal development of the fetus. Generally speaking, aliskiren and amlodipine should be discontinued as soon as a woman becomes pregnant.

However, managing the blood pressure of the mother during pregnancy is vital for the health of both her and the fetus. If the risk of high blood pressure and the benefits of aliskiren and amlodipine far outweigh the potential risk to the fetus, aliskiren and amlodipine may still be recommended if it is deemed a lifesaving treatment for the mother. In these instances, the fetus should be monitored closely and frequently throughout pregnancy. After the mother has given birth, the infant should be monitored closely for signs of hypotension (low blood pressure), oliguria (decreased urine output) and hyperkalemia (high blood potassium).

It isn't clear whether aliskiren and amlodipine is excreted in breast milk, and if so what effects it may have on a nursing infant. For this reason, aliskiren and amlodipine is not recommended for mothers who are breastfeeding. However, if the health risks faced by the mother are very severe and if other treatments for the management of hypertension aren't possible, the drug may be prescribed if the benefits far outweigh the potential risks to the infant.

Use of potassium supplements

Since aliskiren and amlodipine can lead to an increase in potassium levels, it's important to avoid using supplements which contain potassium. If you do take supplements with potassium or you use salt substitutes which contain the mineral, consult your doctor before continuing use of them after being prescribed aliskiren and amlodipine.

Managing dizziness

Aliskiren and amlodipine can cause dizziness and lightheadedness. Do not operate machinery or drive until you know how the drug affects you and you feel alert enough to do so safely. Although alcohol doesn't interact with aliskiren and amlodipine, it can worsen dizziness, so it is wise to avoid or limit alcoholic beverages while taking this medication.

Allergic reaction

If you have had an allergic reaction to either aliskiren or amlodipine in the past, to any other ingredients in aliskiren and amlodipine tablets, or to similar medications, tell your doctor before taking the medication.

Signs of allergic reaction include swelling of the mouth, tongue, lips, and throat, rash or lesions on the skin and tightening in the chest. If you notice any of these symptoms, seek emergency care.

Storage

Aliskiren and amlodipine tablets should be stored in a closed container at room temperature. They should be kept away from direct light, heat, and moisture. Avoid storing the medication in the bathroom, as the heat and humidity from the bath or shower could destroy the drugs. It is usually wise to keep the tablets in their original container and to retain the information leaflet for your future reference.

Medications like aliskiren and amlodipine should always be kept out of reach of children and pets. It is safest to keep them in a secure container which has a childproof safety cap. Keep the container up and away from the ground where they could be within easy reach of children or pets.

If you have expired aliskiren and amlodipine tablets or have a stock of tablets that you no longer use, ask your healthcare provider how to dispose of them safely. You should never throw unused or expired medicine in the trash, down the toilet or down the drains, as they could be harmful to the environment.

Summary

Aliskiren and amlodipine is a combination drug sold under the brand name Tekamlo in the US. It is designed to manage hypertension and works by relaxing blood vessels, increasing blood and oxygen supply to the heart and reducing the workload of the heart. It is not a cure for hypertension but is instead designed for long-term management of the condition.

Patients are usually advised to adopt lifestyle changes to reduce their blood pressure and improve overall health while taking aliskiren and amlodipine. This might include losing weight, eating less salt and a more balanced diet, quitting smoking and reducing alcohol intake.

Aliskiren and amlodipine is not suitable for people with reduced renal function if they are also taking NSAIDs, ACEIs or ARBs. It also shouldn't be taken concurrently with either cyclosporine or itraconazole. People with preexisting health conditions such as liver disease, heart disease, angioedema, electrolyte imbalances and history of heart attack may be at an increased risk of health complications or side effects when taking aliskiren and amlodipine.

The most common side effects of aliskiren and amlodipine are itchy skin, stomach upset or sour stomach, and mild muscle cramps. Usually, these do not require medical attention and dissipate after a short time. If the medication causes swelling of the extremities, blurred vision, rash, chest pain and sweating, consult a doctor as soon as possible.

Aliskiren and amlodipine doses vary from patient to patient, but they usually range between 150-300 mg aliskiren and 5-10 mg amlodipine. The drug is administered in a combination tablet which should be taken once each day at around the same time, either with or without food.

Resources
Last Reviewed:
December 10, 2017
Last Updated:
April 05, 2018