Aliskiren

Name: Aliskiren

Aliskiren FDA Warning

WARNING: FETAL TOXICITY

  • When pregnancy is detected, discontinue this medication as soon as possible. 
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

What other drugs will affect aliskiren?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • cyclosporine;

  • any heart or blood pressure medicines;

  • a diuretic or "water pill";

  • a potassium supplement such as K-Dur, Klor-Con;

  • salt substitutes that contain potassium;

  • antifungal medicine--itraconazole, ketoconazole;

  • cholesterol medication--atorvastatin, simvastatin, Lipitor, Zocor; or

  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with aliskiren, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Commonly used brand name(s)

In the U.S.

  • Tekturna

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Renin Inhibitor

How is this medicine (Aliskiren) best taken?

Use aliskiren as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food. Always take with food or always take on an empty stomach.
  • Take this medicine at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Keep taking aliskiren as you have been told by your doctor or other health care provider, even if you feel well.
  • Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are some other side effects of Aliskiren?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Cough.
  • Loose stools (diarrhea).
  • Back pain.
  • Flu-like signs.
  • Headache.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Tekturna: 150 mg, 300 mg

Pharmacologic Category

  • Renin Inhibitor

Dietary Considerations

May be taken with or without food; however, a high-fat meal reduces absorption. Consistent administration with regards to meals is recommended.

ALERT U.S. Boxed Warning

Fetal toxicity

When pregnancy is detected, discontinue aliskiren as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus.

Usual Adult Dose for Hypertension

Initial: 150 mg orally once a day
Maintenance: the dosage may be increased to 300 mg daily if blood pressure is not adequately controlled.

Comments:
-The antihypertensive effect is substantially attained by 2 weeks.
-Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).
Aliskiren may be used alone or in combination with other antihypertensive agents.

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 mL/min or greater): No adjustment recommended
Severe renal dysfunction (CrCl 30 mL/min or less): Not recommended

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