Tekamlo contains a combination of aliskiren and amlodipine. 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.

Amlodipine belongs to a group of medicines called calcium channel blockers. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Tekamlo is used to treat high blood pressure (hypertension).

Tekamlo may also be used for purposes not listed in this medication guide.

Do not use Tekamlo if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

If you have diabetes, you should not use Tekamlo together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

You should not take Tekamlo if you are also using cyclosporine or itraconazole.

Before you take Tekamlo, tell your doctor if you have kidney or liver disease, congestive heart failure, coronary artery disease, an electrolyte imbalance (such as low potassium or magnesium), if you are on a low-salt diet, or if you have ever had an allergic reaction to a blood pressure medication.

Keep using Tekamlo as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Take Tekamlo exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food, but take it the same way every time.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you feel very dizzy.

Your blood pressure will need to be checked often.

Your chest pain may become worse when you first start taking Tekamlo, or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

If you need surgery or medical tests, tell the doctor ahead of time that you are using Tekamlo. You may need to stop using the medicine for a short time.

Keep using Tekamlo as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store in the original container at room temperature, away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial or add-on therapy: 150 mg/5 mg orally once a day. Titrate as needed up to a maximum of 300 mg/10 mg.

The blood pressure lowering effect is largely attained within 1 to 2 weeks.

Maximum dose: 300 mg/10 mg

Comments:
-The combination product may be substituted for patients receiving aliskiren and amlodipine from separate tablets.
-Tablets should be taken the same way each day, either with or without a meal. (High-fat meals decrease absorption of aliskiren substantially).

Usual Geriatric Dose for Hypertension:

Exposure to aliskiren and amlodipine is increased in elderly patients. Lower initial doses of aliskiren-amlodipine should be considered.

You should not take Tekamlo if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine or itraconazole.

If you have diabetes, you should not use Tekamlo together with certain heart or blood pressure medicines, such as:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Azar, Benicar), valsartan (Diovan, Exforge, Tribenzor), telmisartan (Micardis); or

• benazepril (Lotensin), captopril (Capoten, Capozide), enalapril (Vasotec, Vasoretic), fosinopril (Monopril), lisinopril (Prinivil, Zestoretic, Zestril), moexipril (Uniretic, Univasc), perindopril (Aceon), quinapril (Accupril, Accuretic), ramipril (Altace), or trandolapril (Mavik, Tarka).

You may also need to avoid taking these medicines with Tekamlo if you have kidney disease.

To make sure Tekamlo is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);

• liver disease;

• congestive heart failure;

• coronary artery disease (hardened arteries);

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• if you are on a low-salt diet; or

• if you have ever had an allergic reaction to an ACE inhibitor heart or blood pressure medicine (benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, trandolapril).

FDA pregnancy category D. Do not use Tekamlo if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether aliskiren and amlodipine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Tekamlo.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking Tekamlo with a high-fat meal, which can make it harder for your body to absorb aliskiren.

Do not use salt substitutes or potassium supplements while taking this medicine, unless your doctor has told you to.

Avoid drinking alcohol. It can further lower your blood pressure and may increase some of the side effects of Tekamlo.

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.

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

Call your doctor at once if you have:

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

• chest pain or pressure, pain spreading to your jaw or shoulder;

• little or no urinating; or

• high potassium - slow heart rate, weak pulse, muscle weakness, tingly feeling.

Common Tekamlo side effects may include:

• swelling in your hands, ankles, or feet;

• dizziness, tired feeling;

• cough;

• diarrhea;

• stomach pain, upset stomach; or

• flu symptoms (fever, chills, body aches).

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.