Hydrochlorothiazide and aliskiren

Hydrochlorothiazide is a type of diuretic (water pill). Aliskiren is a medicine that helps lower blood pressure.

Hydrochlorothiazide and aliskiren is a combination medicine used to treat high blood pressure (hypertension).

Hydrochlorothiazide and aliskiren may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

You can take hydrochlorothiazide and aliskiren with or without food, but make sure to take it the same way each time. Do not take this medicine with a high-fat meal, as it can make it harder for your body to absorb aliskiren.

You may experience very low blood pressure while taking hydrochlorothiazide and aliskiren. Call your doctor if you are sick with vomiting or diarrhea, or if you feel light-headed.

It may take up to 4 weeks for your blood pressure to improve. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to take blood pressure medicine for the rest of your life.

Your blood pressure will need to be monitored frequently.

Your doctor may also check your skin since hydrochlorothiazide can increase your risk of developing non-melanoma skin cancer. Ask your doctor about skin symptoms to look out for.

If you need surgery or medical tests, inform the surgeon in advance that you are using hydrochlorothiazide and aliskiren. You may need to stop taking the medicine for a short period.

Store at room temperature away from moisture and heat.

Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

You should not use hydrochlorothiazide and aliskiren if you cannot urinate, or if you are allergic to sulfa drugs.

Do not use if you are pregnant. If you become pregnant, stop taking this medicine and inform your doctor immediately.

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

You should not use this medicine if you are allergic to aliskiren or hydrochlorothiazide, or if:

• you are unable to urinate; or
• you are allergic to sulfa drugs.

If you have diabetes, you should not use hydrochlorothiazide and aliskiren 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 hydrochlorothiazide and aliskiren if you have kidney disease.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease;
• low or high levels of potassium in your blood;
• asthma or allergies;
• systemic lupus erythematosus (SLE);
• glaucoma;
• gout;
• diabetes; or
• an allergy to penicillin.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Hydrochlorothiazide and aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using this medicine.

Hydrochlorothiazide and aliskiren is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction (hives, vomiting, severe stomach pain, dizziness, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Hydrochlorothiazide and aliskiren may cause serious side effects. Call your doctor immediately if you have:

• a light-headed feeling, like you might faint;
• little or no urination;
• eye pain, vision problems;
• high potassium level--nausea, weakness, tingling feeling, chest pain, irregular heartbeats, loss of movement;
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or feeling limp;
• low sodium level --headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
• lupus-like symptoms--muscle or joint pain, fever, and a rash or patchy skin color that gets worse in sunlight.

Common side effects of hydrochlorothiazide and aliskiren may include:

• dizziness, feeling tired;
• high potassium;
• cough;
• joint pain;
• diarrhea; or
• flu symptoms (fever, chills, body aches).

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Hypertension:

Initial dose: 150 mg-12.5 mg or 150 mg-25 mg once dailyMaximum dose: Aliskiren-hydrochlorothiazide 300/25 mg orally dailyComments:-The combination product may be substituted for patients receiving aliskiren and hydrochlorothiazide 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).

Take the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at the same time.

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

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

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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.

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

If you take cholestyramine or colestipol, take your hydrochlorothiazide and aliskiren dose 4 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your other medicines, especially:

• cyclosporine;
• lithium;
• any heart or blood pressure medicines;
• a diuretic or "water pill";
• insulin or oral diabetes medicine;
• a potassium supplement such as K-Dur, Klor-Con;
• salt substitutes that contain potassium;
• antifungal medicine--itraconazole, ketoconazole;
• cholesterol medication--atorvastatin, cholestyramine, colestipol, simvastatin, Lipitor, Vytorin, Zocor; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect hydrochlorothiazide and aliskiren, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.