Amlodipine and telmisartan

Name: Amlodipine and telmisartan

What is amlodipine and telmisartan?

Amlodipine is a calcium channel blocker. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Telmisartan is an angiotensin II receptor antagonist. Telmisartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Amlodipine and telmisartan is a combination medicine used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Amlodipine and telmisartan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about amlodipine and telmisartan?

Do not use this medicine if you are pregnant. It could harm the unborn baby. Stop using amlodipine and telmisartan and tell your doctor right away if you become pregnant.

If you have diabetes, do not use amlodipine and telmisartan together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).

What should I avoid while taking amlodipine and telmisartan?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking amlodipine and telmisartan, unless your doctor has told you to.

Amlodipine and telmisartan side effects

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

In rare cases, amlodipine and telmisartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have: unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • new or worsened chest pain;

  • pounding heartbeats or fluttering in your chest;

  • tremors, muscle stiffness or twitching; or

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement.

Common side effects may include:

  • swelling in your hands or feet;

  • fast or pounding heartbeats;

  • dizziness, drowsiness;

  • flushing (warmth, redness, or tingly feeling);

  • back pain; or

  • nausea, diarrhea, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Amlodipine and telmisartan dosing information

Usual Adult Dose for Hypertension:

Amlodipine 5 to 10 mg-Telmisartan 40 to 80 mg orally once a day

Maximum dose: Amlodipine 10 mg-Telmisartan 80 mg orally once a day

Comments:
-Correct volume and salt depletion before initiating therapy.
-Dose titration with the individual components is recommended before switching to this drug; treatment may be initiated with this drug if it is unlikely that blood pressure would be controlled with monotherapy; the usual starting dose for treatment initiation is amlodipine 5 mg-telmisartan 40 mg once a day.
-Patients who experience any dose limiting adverse reactions with amlodipine 10 mg monotherapy may be switched to amlodipine 5 mg-telmisartan 40 mg once a day to reduce the amlodipine dose without reducing the overall expected antihypertensive response.
-Start with a low initial amlodipine dose in patients 65 years or older; initial therapy with this drug is not recommended in patients 75 years or older.
-May increase dose after 2 weeks.

What other drugs will affect amlodipine and telmisartan?

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

  • digoxin;

  • a diuretic or "water pill";

  • lithium;

  • simvastatin (Zocor, Vytorin);

  • medicine to prevent organ transplant rejection--cyclosporine, tacrolimus;

  • an ACE inhibitor--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril; 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 amlodipine and telmisartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Liver Dose Adjustments

Liver dysfunction: Not recommended for initial therapy
Biliary obstructive disorder: Initiate at low doses and titrate slowly

Amlodipine / telmisartan Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Yes (amlodipine); Unknown (telmisartan) Excreted into animal milk: Yes (telmisartan)

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