Tekamlo

You should not take this medication if you are allergic to aliskiren or amlodipine, or if you are also using cyclosporine (Gengraf, Neoral, Sandimmune) or itraconazole (Sporanox).

If you have diabetes or kidney disease, you may not be able to take aliskiren and amlodipine if you are also taking any of the following heart or blood pressure medications:

• azilsartan (Edarbi, Edarbyclor), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), olmesartan (Benicar), valsartan (Diovan), telmisartan (Micardis); or
• benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik, Tarka).

To make sure you can safely take aliskiren and amlodipine, tell your doctor if you have any of these other conditions:

• 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 a blood pressure medication, such as benazepril (Lotensin), candesartan (Atacand), enalapril (Vasotec), lisinopril (Prinivil, Zestril), losartan (Cozaar, Hyzaar), olmesartan (Benicar, Azor), quinapril (Accupril), ramipril (Altace), telmisartan (Micardis, Twynsta), valsartan (Diovan, Exforge), and others.

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

It is not known whether this medication passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking aliskiren and amlodipine.

Tekamlo is part of the drug class:

• Dihydropyridine derivatives

Tekamlo may cause serious side effects:

• Harm to an unborn baby, causing injury or death
• Aliskiren, one of the medicines in Tekamlo, can cause swelling of your face, lips, tongue, throat, arms and legs, or the whole body. Get medical help right away and tell your doctor if you get any one or more of these symptoms. Serious allergic reactions can happen at any time while you are taking Tekamlo. 
• Low blood pressure (hypotension). Your blood pressure may get too low if you also take water pills, are on a low-salt diet, get dialysis treatments, have heart problems, or get sick with vomiting or diarrhea. Lie down if you feel faint or get dizzy. Call your doctor right away. 
• Possible increased chest pain or risk of heart attack.  It is rare, but when you first start taking Tekamlo or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room.

The most common side effects of Tekamlo include:

• Swelling of your lower legs

Common side effects of Tekamlo include:

• diarrhea
• cough
• dizziness
• flu-like symptoms
• tiredness
• high levels of potassium in the blood (hyperkalemia)

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of Tekamlo. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. 

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Aliskiren/amlodipine and certain other medicines may affect each other and cause side effects.

Especially tell your doctor if you take:

• a kind of medicine called angiotensin receptor blocker or angiotensin converting enzyme inhibitor
• water pills (also called “diuretics”)
• medicines for treating fungus or fungal infections
• cyclosporine (Gengraf, Neoral, Sandimmune), a medicine used to suppress the immune system
• potassium-containing medicines, potassium supplements, or salt substitutes containing potassium
• atorvastatin (Lipitor)
• non-steroidal anti-inflammatory drugs (like ibuprofen or naproxen)

Know your medicines. Keep a list of all your medicines. Show this list to your doctor or pharmacist when you get a new medicine. Your doctor or pharmacist will know what medicines are safe to take together.

In the U.S.

• Tekamlo

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Renin Inhibitor

Chemical Class: Amlodipine

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Tekamlo affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you have high blood sugar (diabetes), this medicine may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Have your blood pressure checked often. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• It is rare, but worse chest pain and heart attack can happen after Tekamlo is first started or after the dose is raised. The risk may be greater in people who have very bad heart blood vessel disease. Talk with the doctor.
• Talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
• If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
• If you are on a low-salt or salt-free diet, talk with your doctor.
• It may take a few weeks to see the full effect.
• Talk with your doctor before you drink alcohol.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
• If you are 65 or older, use this medicine with care. You could have more side effects.

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

• Take this medicine at the same time of day.
• Take with or without food. Always take with food or always take on an empty stomach.
• To gain the most benefit, do not miss doses.
• Keep taking Tekamlo 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 use 2 doses or extra doses.

     General Considerations

The recommended initial once-daily dose of Tekamlo is 150 mg/5 mg. Titrate as needed to a maximum of 300 mg/10 mg.

The blood pressure lowering effects are largely attained within 1 to 2 weeks. If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, titrate the dose to a maximum of Tekamlo 300 mg/10 mg once daily.

     Add-on Therapy

Use Tekamlo for patients not adequately controlled with aliskiren alone or amlodipine besylate (or another dihydropyridine calcium channel blocker) alone.

Switch a patient who experiences dose-limiting adverse reactions on either component alone to Tekamlo containing a lower dose of that component in combination with the other to achieve similar blood pressure reductions.

     Replacement Therapy

Switch patients receiving aliskiren and amlodipine besylate from separate tablets to a single tablet of Tekamlo containing the same component doses. When substituting for individual components, increase the dose of one or both of the components if blood pressure control has not been satisfactory.

     Relationship to Meals

Patients should establish a routine pattern for taking Tekamlo, either with or without a meal. High-fat meals decrease absorption substantially [see Clinical Pharmacology (12.3)].

     Tekamlo

Tekamlo was studied in a total of 5549 patients with mild to moderate hypertension (diastolic blood pressure between 90 mmHg and 109 mmHg).

Aliskiren 150 mg and 300 mg and amlodipine besylate 5 mg and 10 mg were studied alone and in combination in an 8-week, randomized, double-blind, placebo-controlled, multifactorial study comparing the combinations 150 mg/5 mg, 150 mg/10 mg, 300 mg/5 mg and 300 mg/10 mg of aliskiren and amlodipine with their components and placebo. The combination of aliskiren and amlodipine resulted in placebo-adjusted decreases in systolic/diastolic blood pressure at trough of 14–17/9–11 mmHg compared to 4–9/3–5 mmHg for aliskiren alone and 9–14/6–8 mmHg for amlodipine alone.

Treatment with Tekamlo resulted overall in significantly greater reductions in diastolic and systolic blood pressure compared to the respective monotherapy components.

The antihypertensive effect of Tekamlo was similar in patients with and without diabetes, obese and non-obese patients, in patients 65 years of age or older and under 65 years of age, and in women and men.

A subgroup of 819 patients was studied with ambulatory blood pressure monitoring. The blood pressure lowering effect in the aliskiren/amlodipine group was maintained throughout the 24-hour period (see Figure 7 and Figure 8).

Figure 7: Mean Ambulatory Diastolic Blood Pressure (DBP) at Endpoint by Treatment and Hour

Figure 8: Mean Ambulatory Systolic Blood Pressure (SBP) at Endpoint by Treatment and Hour

Two additional double-blind, active-controlled studies of similar design were conducted in which Tekamlo was administered as initial therapy in patients with moderate to severe hypertension (SBP 160 mmHg to 200 mmHg). Patients were randomized to receive either combination aliskiren/amlodipine or amlodipine monotherapy. The initial dose of aliskiren/amlodipine was 150 mg/5 mg for 1 week with forced titration to 300 mg/10 mg for 7 weeks. The initial dose of amlodipine was 5 mg for 1 week with forced titration to 10 mg for 7 weeks. In one study of 443 black patients, at the primary endpoint of 8 weeks, the treatment difference between aliskiren/amlodipine and amlodipine was 5.2/3.8 mmHg. In the other study of 484 patients, at the primary endpoint of 8 weeks, the treatment difference between aliskiren/amlodipine and amlodipine was 7.1/3.8 mmHg.

The blood pressure lowering effects of Tekamlo are largely attained within 1 to 2 weeks.

There are no trials of the Tekamlo combination tablet demonstrating reductions in cardiovascular risk in patients with hypertension, but the amlodipine component has demonstrated such benefits.

     Aliskiren in Patients with Diabetes Treated with ARB or ACEI (ALTITUDE Study)

Patients with diabetes with renal disease (defined either by the presence of albuminuria or reduced GFR) were randomized to aliskiren 300 mg daily (n=4296) or placebo (n=4310). All patients were receiving background therapy with an ARB or ACEI. The primary efficacy outcome was the time to the first event of the primary composite endpoint consisting of cardiovascular death, resuscitated sudden death, nonfatal myocardial infarction, nonfatal stroke, unplanned hospitalization for heart failure, onset of end stage renal disease, renal death, and doubling of serum creatinine concentration from baseline sustained for at least 1 month. After a median follow-up of about 32 months, the trial was terminated early for lack of efficacy. Higher risk of renal impairment, hypotension and hyperkalemia was observed in aliskiren compared to placebo treated patients, as shown in the Table 1.

The risk of stroke (3.4% aliskiren versus 2.7% placebo) and death (8.4% aliskiren versus 8.0% placebo) were also numerically higher in aliskiren-treated patients.

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.

Applies to aliskiren / amlodipine: oral tablet

Cardiovascular

Aliskiren:
Rare (less than 0.1%): Hypotension

Amlodipine:
Common (1% to 10%): palpitations
Uncommon (0.1% to 1%): Arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, postural hypotension, tachycardia, vasculitis
Rare (less than 0.1%): Myocardial infarction, angina[Ref]

Dermatologic

Aliskiren:
Common (1% to 10%): Rash
Rare (less than 0.1%): Angioedema (involving the face, hands, or whole body)
Postmarketing reports: Severe cutaneous adverse reactions (including Stevens Johnson syndrome and toxic epidermal necrolysis)

Amlodipine:
Common (1% to 10%): Rash, erythematous rash
Uncommon (0.1% to 1%): Angioedema, erythema multiforme, increased sweating, maculopapular rash, pruritus
Rare (less than 0.1%): Alopecia, dermatitis, skin discoloration, skin dryness, urticaria, lichen planus, telangiectasia[Ref]

Endocrine

Amlodipine:
Postmarketing reports: Gynecomastia[Ref]

Gastrointestinal

Aliskiren:
Common (1% to 10%): Diarrhea, abdominal pain, dyspepsia, gastroesophageal reflux (these side effects appear to be dose related)
Postmarketing reports: Nausea, vomiting

Amlodipine:
Common (1% to 10%): Nausea, dysphagia, abdominal pain
Uncommon (0.1% to 1%): Anorexia, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gingival hyperplasia, pancreatitis, vomiting
Rare (less than 0.1%): Gastritis, increased appetite, loose stools, taste perversion, dysgeusia[Ref]

Genitourinary

Amlodipine:
Uncommon (0.1% to 1%): Micturition disorder, micturition frequency, nocturia
Rare (less than 0.1%): Dysuria, polyuria[Ref]

Hematologic

Amlodipine:
Uncommon (0.1% to 1%): Leukopenia, purpura, thrombocytopenia[Ref]

Hypersensitivity

Aliskiren:
Frequency not reported: Angioedema (face, hands, and body) with or without respiratory symptoms
Postmarketing reports: Angioedema

Amlodipine:
Uncommon (0.1% to 1%): Allergic reaction[Ref]

Hepatic

Amlodipine:
Postmarketing reports: Jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis)-Some cases were severe enough to require hospitalization[Ref]

Metabolic

Aliskiren:
Uncommon (0.1% to 1%): Elevated uric acid, gout, renal stones
Postmarketing reports: Peripheral edema, hyponatremia

Amlodipine:
Uncommon (0.1% to 1%): Hyperglycemia, thirst, weight loss, weight gain
Very rare (less than 0.01%): Acute porphyria exacerbation
Frequency not reported: New-onset diabetes[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Asthenia, rigors

Amlodipine:
Common (1% to 10%): Myalgia
Uncommon (0.1% to 1%): Arthralgia, arthrosis, muscle cramps
Rare (less than 0.1%): Hypertonia, muscle weakness, twitching, ataxia[Ref]

Nervous system

Aliskiren:
Frequency not reported: Headache, dizziness, fatigue, episodes of tonic-clonic seizures with loss of consciousness

Amlodipine:
Common (1% to 10%): Headache, dizziness, somnolence
Uncommon (0.1% to 1%): Hypoesthesia, paresthesia, peripheral neuropathy, postural dizziness, syncope, tinnitus, tremor
Rare (less than 0.1%): Migraine[Ref]

Ocular

Amlodipine:
Uncommon (0.1% to 1%): Abnormal vision, conjunctivitis, diplopia, eye pain
Rare (less than 0.1%): Abnormal visual accommodation, xerophthalmia[Ref]

Psychiatric

Amlodipine:
Rare (less than 0.1%): Abnormal dreams, anxiety, depersonalization, depression, insomnia, nervousness, agitation, amnesia, apathy[Ref]

Renal

Amlodipine:
Rare (less than 0.1%): Interstitial nephritis[Ref]

Respiratory

Aliskiren:
Frequency not reported: Nasopharyngitis, upper respiratory tract infection, cough

Amlodipine:
Common (1% to 10%): Epistaxis
Uncommon (0.1% to 1%): Dyspnea
Rare (less than 0.1%): Coughing, rhinitis
Postmarketing reports: Pulmonary edema was reported during a study of patients with NYHA Class III or IV heart failure without clinical symptoms or objective evidence of underlying ischemic disease.[Ref]

Other

Rare (less than 0.1%): Parosmia
Frequency not reported: Tinnitus[Ref]

Some side effects of Tekamlo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.