Drug Notebook

FDA Alerts

  • May cause fetal and neonatal morbidity and mortality if used during pregnancy. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
  • If pregnancy is detected, discontinue aliskiren as soon as possible.

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aliskiren
(a LIS ke rin)

What is aliskiren?
Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure. Aliskiren is used to treat high blood pressure (hypertension). Aliskiren may also be used for purposes other than those listed in this medication guide.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Tekturna 150MG Tablets NOVARTIS30/$74.18 or 90/$211.95
Tekturna 300MG Tablets NOVARTIS30/$93.27 or 90/$267.11

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What are the possible side effects of aliskiren?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;

  • nausea with slow uneven heart rate and a weak pulse; or

  • swelling around your eyes.

Less serious side effects may be more likely to occur, such as:

  • stomach pain or upset, diarrhea, heartburn;

  • itching or skin rash;

  • headache, dizziness, tired feeling;

  • back pain, joint pain or swelling; or

  • stuffy nose, sore throat, cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take aliskiren?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Take aliskiren with a full glass of water. You may take aliskiren with or without food, but take it the same way every time. If you take aliskiren with meals, avoid high-fat foods. They can make it harder for your body to absorb aliskiren.

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What is the most important information I should know about aliskiren?
Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Aliskiren could cause birth defects in the baby if you take the medication during pregnancy, especially during the last 6 months. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment. Before you take aliskiren, tell your doctor if you have kidney disease, gout, diabetes, heart disease, or if you are on a low-salt diet.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect aliskiren?
The following drugs can interact with aliskiren. Tell your doctor if you are using any of these: furosemide (Lasix); antibiotics such as clotrimazole (Mycelex Troche), fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral); a potassium supplement such as K-Dur, Klor-Con; salt substitutes that contain potassium; or a diuretic (water pill). This list is not complete and there may be other drugs not listed that can affect aliskiren. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Aliskiren has been assigned to pregnancy categories C (use during first trimester) and D (use during second and third trimesters) by the FDA. Animal data have failed to reveal evidence of teratogenicity. However, fetal birth weight was affected after daily doses of 50 mg/kg/day (approximately 3.2 times the maximum recommended human dose). Drugs acting directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Use of aliskiren is considered contraindicated during pregnancy.

Drugs that act directly on the renin-angiotensin-aldosterone (RAA) system can cause fetal and neonatal morbidity and death when administered during pregnancy. Several dozen cases have been reported in the world literature in patients who were taking similar drugs, angiotensin converting enzyme (ACE) inhibitors. A committee of the National Institutes of Health has recommended that these drugs be avoided during pregnancy. When pregnancy is detected or expected, aliskiren should be discontinued as soon as possible. The use of drugs that act directly on the RAA system during the second and third trimesters has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the use of these drugs. These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester.

There are no data on the excretion of aliskiren into human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the nursing mother.

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Who should NOT use this medication?

Manufacturer states that there are no contraindications to use of aliskiren.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an aliskiren overdose may include feeling light-headed or fainting.

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What should I discuss with my health care provider before taking aliskiren?
Do not use this medication if you are allergic to aliskiren. Before using aliskiren, tell your doctor if you are allergic to any drugs, or if you have: kidney disease (or if you are on dialysis); gout; diabetes; heart disease; or if you are on a low-salt diet. If you have any of these conditions, you may need a dose adjustment or special tests to safely take aliskiren. FDA pregnancy category D. This medication may be harmful to an unborn baby. Do not use this medication without telling your doctor if you are pregnant or planning a pregnancy. Aliskiren could cause birth defects in the baby if you take the medication during pregnancy, especially during the last 6 months. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

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Can I stop taking the medication if I feel better?
Even though you may feel better you should not stop taking your high blood pressure medication without first checking with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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