May 25, 2017
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(aliskiren and amlodipine) Tablets, for Oral Administration




Tekamlo is a single tablet for oral administration of aliskiren hemifumarate (an orally active, nonpeptide, potent direct renin inhibitor) and amlodipine besylate (a dihydropyridine calcium channel blocker).

Aliskiren Hemifumarate

Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is:

Aliskiren hemifumarate - Structural Formula Illustration 1

Molecular formula: C30H53N3O6 • 0.5 C4H4O4

Aliskiren hemifumarate is a white to slightly yellowish powder with a molecular weight of 609.8 (free base551.8). It is highly soluble in water, and freely soluble in methanol, ethanol and isopropanol.

Amlodipine Besylate

Amlodipine besylate, USP is chemically described as 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(ochlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate, and its structural formula is:

Amlodipine Besylate - Structural Formula Illustration 2

Molecular formula: C20H25CIN2O5•C6H6O3S

Amlodipine besylate is a white to pale yellow crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol.

Tekamlo tablets are formulated for oral administration to contain aliskiren hemifumarate and amlodipine besylate providing for the following available combinations: 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg and 300 mg/10 mg aliskiren/amlodipine. The inactive ingredients for all strengths of the tablets may contain colloidal silicon dioxide, crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.

What are the possible side effects of this drug (Tekamlo)?

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

Call your doctor at once if you have a serious side effect such as:

  • swelling in your hands, ankles, or feet;
  • feeling like you might pass out;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple...

Read All Potential Side Effects and See Pictures of Tekamlo »

What are the precautions when taking aliskiren and amlodipine tablets (Tekamlo)?

Before taking this product, tell your doctor or pharmacist if you are allergic to aliskiren or amlodipine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, kidney disease, liver disease, severe loss of body water and minerals (dehydration), certain heart valve conditions (aortic/mitral stenosis).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Too much sweating, diarrhea, or vomiting may cause...

Read All Potential Precautions of Tekamlo »

Last reviewed on RxList: 1/30/2017
This monograph has been modified to include the generic and brand name in many instances.

Tekamlo - User Reviews

Tekamlo User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Tekamlo sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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