Aliskiren & Hydrochlorothiazide

Aliskiren/hydrochlorothiazide is a prescription medication used to treat high blood pressure (hypertension). It is a single tablet containing two medications, aliskiren and hydrochlorothiazide. Aliskiren belongs to a group of drugs called renin inhibitors, which work by reducing renin production in the body to reduce blood pressure. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics, which work by stopping reabsorption of salt into your body. This prevents fluid from building up in the body.

Aliskiren/hydrochlorothiazide is a prescription medicine used to treat high blood pressure (hypertension).

Aliskiren & Hydrochlorothiazide may be found in some form under the following brand names:

• Tekturna HCT

Aliskiren/hydrochlorothiazide may cause serious side effects:

• Injury or death to an unborn baby. See "Drug Precautions" and FDA Warning.
• 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. Drinking alcohol and taking certain medicines (barbiturates or narcotics) can cause low blood pressure to get worse. Lie down if you feel faint or dizzy, and call your doctor right away.
• Angioedema. Aliskiren can cause swelling of the 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. Angioedema can happen at any time while you are taking aliskiren/hydrochlorothiazide.
• Active or worsened Systemic Lupus Erythematosus (SLE). If you have SLE, tell your doctor right away if you get any new or worse symptoms.
• Eye problems. One of the medicines in aliskiren/hydrochlorothiazide can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting aliskiren/hydrochlorothiazide. Tell your doctor right away if you have:
              ▪ Decrease in vision
              ▪ Eye pain

Common side effects of aliskiren/hydrochlorothiazide include:

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

Other less common side effects include skin rash.

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 aliskiren/hydrochlorothiazide. For a complete list of side effects, 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. Especially tell your doctor if you are taking:

• a kind of medicine called angiotensin receptor blocker or angiotensin converting enzyme inhibitor
• atorvastatin (medicine to lower cholesterol in your blood)
• water pills (also called “diuretics”)
• medicines for treating fungus or fungal infections
• cyclosporine (a medicine used to suppress the immune system)
• potassium-containing medicines, potassium supplements, or salt substitutes containing potassium
• cholestyramine (for example; Questran, Questran Light, Cholestyramine Light, Locholest Light, Locholest, Prevalite) (medicines to lower the cholesterol in your blood)
• colestipol (for example; Colestipol hydrochloride, Colestid, Flavored Colestid) (medicines to lower the cholesterol in your blood)
• medicines to treat diabetes, including insulin
• lithium, a medicine used in some types of depression. Do not take if you are taking lithium.
• Nonsteroidal anti-inflammatory (NSAIDs) medicines. Ask your doctor if you are not sure if you are taking one of these medicines.
• blood thinners
• barbiturate or narcotic medicines. Ask your doctor if you are not sure if you are taking one of these medicines.

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

Do not take aliskiren/hydrochlorothiazide:

• If you get pregnant, stop taking aliskiren/hydrochlorothiazide and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options for your high blood pressure. 
• If you have diabetes and are taking a kind of medicine called an angiotensin-receptor-blocker or angiotensin-converting-enzyme-inhibitor. 
• If you make very little or no urine due to kidney problems. 
• If you are allergic to any of its ingredients. 
• This medication may cause dizziness and tiredness. Do not drive or operate heavy machinery until you know how aliskiren/hydrochlorothiazide affects you.

Tell your doctor about all your medical conditions, including whether you:

• have kidney problems
• are pregnant or planning to become pregnant. 
• have any allergies or asthma
• have liver problems
• have systemic lupus erythematosus (SLE). Aliskiren/hydrochlorothiazide can make your SLE active or worse.
• have ever had a reaction called angioedema, to an ACE inhibitor medicine. Angioedema causes swelling of the face, lips, tongue, throat, arms and legs, and may cause difficulty breathing.
• are breast-feeding. It is not known if aliskiren/hydrochlorothiazide passes into your breast milk.

Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Aliskiren/hydrochlorothiazide can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking aliskiren/hydrochlorothiazide, tell your doctor right away.

• Take aliskiren/hydrochlorothiazide exactly as prescribed by your doctor. It is important to take aliskiren/hydrochlorothiazide every day to control your blood pressure.
• Take aliskiren/hydrochlorothiazide once each day, about the same time each day.
• Take aliskiren/hydrochlorothiazide the same way everyday, either with or without a meal.
• Your doctor may change your dose of aliskiren/hydrochlorothiazide if needed.
• If you miss a dose of aliskiren/hydrochlorothiazide, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
• If you take too much aliskiren/hydrochlorothiazide, call your doctor or a Poison Control Center, or go to the nearest hospital emergency room.

If you take too much aliskiren/hydrochlorothiazide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If aliskiren/hydrochlorothiazide is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store aliskiren/hydrochlorothiazide tablets at room temperature between 59°F-86°F (15°C-30°C).
• Keep aliskiren/hydrochlorothiazide in the original prescription bottle in a dry place. Do not remove the desiccant (drying agent) from the bottle.
• Keep aliskiren/hydrochlorothiazide and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue aliskiren/hydrochlorothiazide as soon as possible. 
• Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.