Aliskiren and amlodipine

aliskiren and amlodipine comes with a patient information insert. Read the information carefully and make sure you understand it before taking aliskiren and amlodipine. Ask your doctor if you have any questions.

In addition to the use of aliskiren and amlodipine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that aliskiren and amlodipine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Take aliskiren and amlodipine the same way every day. This means take it at the same time and take it consistently with or without food.

Dosing

The dose of aliskiren and amlodipine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of aliskiren and amlodipine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—At first, one tablet containing 150 milligrams (mg) of aliskiren and 5 mg of amlodipine once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 300 mg of aliskiren and 10 mg of amlodipine once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of aliskiren and amlodipine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the tablets in its original container in a dry place.

• 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 aliskiren and amlodipine 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 aliskiren and amlodipine 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
• Signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• Very bad dizziness or passing out.
• Chest pain that is new or worse.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Trouble swallowing.
• Stiff muscles, shakiness, or muscle movements that are not normal.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

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).
• Flu-like signs.
• 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.

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

Tablet, oral:

Tekamlo 150/5: Aliskiren 150 mg and amlodipine 5 mg [DSC]

Tekamlo 150/10: Aliskiren 150 mg and amlodipine 10 mg [DSC]

Tekamlo 300/5: Aliskiren 300 mg and amlodipine 5 mg [DSC]

Tekamlo 300/10: Aliskiren 300 mg and amlodipine 10 mg [DSC]

• Tekamlo [DSC]

Hypertension: Oral: Note: Dosage must be individualized. Prior to initiation, correct hypovolemia and/or closely monitor volume status in patients on concurrent diuretics during treatment initiation.

Initial therapy or add on therapy: Initial: Aliskiren 150 mg/amlodipine 5 mg once daily; may titrate after 2 to 4 weeks of therapy. Maximum: Aliskiren 300 mg/amlodipine 10 mg per day.

Replacement therapy: Substitute for the individually titrated components. Maximum: Aliskiren 300 mg/amlodipine 10 mg per day.

CrCl ≥30 mL/minute: No dosage adjustment necessary.

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling; however, no dosage adjustment is necessary for aliskiren (limited data) or amlodipine (Doyle 1989; Vaidyanathan 2007). Risk of hyperkalemia and progressive renal impairment may occur with aliskiren; use with caution.

ESRD (requiring hemodialysis): There are no dosage adjustments provided in the manufacturer’s labeling; however, no dosage adjustment is necessary for aliskiren (limited data) or amlodipine (Khadzhynov 2012; Kungys 2003). Risk of hyperkalemia is increased with chronic aliskiren therapy; use with extreme caution.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from heat and moisture. Dispense in original container.

This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus. US FDA pregnancy category: Not assigned Risk Summary: Use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. Comments: Adequate methods of contraception should be encouraged.

Animal studies with aliskiren have revealed evidence of fetotoxicity. Animal studies with amlodipine have revealed increased intrauterine deaths, decreased litter size, and prolonged gestation and labor. In humans, use of drugs that act on RAS during the second and third trimesters can cause the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations including skull hypoplasia, hypotension, and death. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.