Aliskiren and hydrochlorothiazide

• If you have an allergy to aliskiren, hydrochlorothiazide, or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a sulfa (sulfonamide) allergy, talk with your doctor.
• If you are taking any of these drugs: Cyclosporine, dofetilide, or itraconazole.
• If you are not able to pass urine.
• If you have kidney disease.
• If you have high blood sugar (diabetes) or kidney disease and are taking certain drugs for high blood pressure or your heart. Talk with your doctor.
• If you are breast-feeding. Do not breast-feed while you take aliskiren and hydrochlorothiazide.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take aliskiren and hydrochlorothiazide with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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

• Take with or without food. Always take with food or always take on an empty stomach.
• Take aliskiren and hydrochlorothiazide at the same time of day.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• To gain the most benefit, do not miss doses.
• This medicine may cause you to pass urine more often. To keep from having sleep problems, try to take before 6 pm.
• 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 take 2 doses at the same time or extra doses.

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.
• Feeling tired or weak.
• Cough.
• Loose stools (diarrhea).
• Flu-like signs.

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:

Tekturna HCT:

150/12.5: Aliskiren 150 mg and hydrochlorothiazide 12.5 mg

150/25: Aliskiren 150 mg and hydrochlorothiazide 25 mg

300/12.5: Aliskiren 300 mg and hydrochlorothiazide 12.5 mg

300/25: Aliskiren 300 mg and hydrochlorothiazide 25 mg

• Antihypertensive
• Diuretic, Thiazide
• Renin Inhibitor

Refer to adult dosing.

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

CrCl <30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling; however, limited data suggests no adjustment necessary for aliskiren (Vaidyanathan 2007). Risk of hyperkalemia is increased and progressive renal impairment may occur with aliskiren (use with caution). Hydrochlorothiazide is usually ineffective when CrCl <30 mL/minute and is contraindicated in patients who are anuric.

ESRD (requiring hemodialysis): There are no dosage adjustments provided in the manufacturer’s labeling; however, no dosage adjustment necessary for aliskiren (Khadzhynov 2012). Risk of hyperkalemia is increased with chronic aliskiren therapy; use with extreme caution. Hydrochlorothiazide is usually ineffective when CrCl <30 mL/minute and is contraindicated in patients who are anuric.

Applies to aliskiren / hydrochlorothiazide: oral tablet

Along with its needed effects, aliskiren / hydrochlorothiazide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking aliskiren / hydrochlorothiazide:

• Chills
• cough
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

• Difficulty with swallowing
• dizziness
• fast heartbeat
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in the chest

Get emergency help immediately if any of the following symptoms of overdose occur while taking aliskiren / hydrochlorothiazide:

• Coma
• confusion
• decreased urine output
• drowsiness
• dry mouth
• fainting
• increase in heart rate
• increased thirst
• irregular heartbeat
• irritability
• lightheadedness
• muscle cramps
• numbness, tingling, pain, or weakness in the hands or feet
• rapid breathing
• seizures
• sunken eyes
• swelling of the face, ankles, or hands
• trembling
• weak pulse
• weakness and heaviness of the legs
• wrinkled skin

Some side effects of aliskiren / hydrochlorothiazide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty with moving
• feeling of constant movement of self or surroundings
• lack or loss of strength
• muscle stiffness
• sensation of spinning

Patients should establish a routine pattern for taking aliskiren-hydrochlorothiazide, either with or without a meal. High-fat meals decrease absorption of aliskiren substantially.

Animal studies with aliskiren have revealed evidence of fetotoxicity. Animal studies with hydrochlorothiazide have failed to reveal evidence of fetal harm. 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.

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.