Tekturna HCT

DRUG DESCRIPTION

Tekturna HCT is a fixed combination of aliskiren, an orally active, nonpeptide, direct renin inhibitor, and hydrochlorothiazide, a thiazide diuretic that is provided as tablets for oral administration.

Aliskiren

Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is

Aliskiren hemifumarate Structural Formula Illustration

Molecular formula: C30H53N3O60.5 C4H4O4

Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.8 (free base- 551.8). It is soluble in phosphate buffer, n-octanol, and highly soluble in water.

Hydrochlorothiazide

Hydrochlorothiazide USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-l,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide.

Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is

Tekturna HCT tablets are formulated for oral administration to contain aliskiren and hydrochlorothiazide, USP 150/12.5 mg, 150/25 mg, 300/12.5 mg and 300/25 mg. The inactive ingredients for all strengths of the tablets are colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide colorants, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide, and wheat starch.

What are the possible side effects of aliskiren (Tekturna)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • nausea with slow uneven heart rate and a weak pulse; or
  • swelling around your eyes.

Less serious side effects may be more likely to occur, such as:

  • stomach pain or upset, diarrhea,...

Read All Potential Side Effects and See Pictures of Tekturna HCT

What are the precautions when taking aliskren and hydrochlorothiazide tablets (Tekturna HCT)?

Before taking this product, tell your doctor or pharmacist if you are allergic to aliskiren or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine (anuria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: loss of too much body water (dehydration), kidney disease, liver disease, lupus, gout, untreated mineral imbalance (e.g., high/low potassium, low magnesium, high calcium), high levels of fats in the...

Read All Potential Precautions of Tekturna HCT


Tekturna HCT Consumer (continued)

SIDE EFFECTS: Dizziness, lightheadedness, diarrhea, blurred vision, or cough may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The hydrochlorothiazide in this product may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, extreme thirst, muscle cramps, weakness, fast/irregular heartbeat, nausea/vomiting, severe dizziness, confusion, unusual decrease in the amount of urine, fainting, seizures.

Tell your doctor immediately if any of these unlikely but serious side effects occur: joint pain, increased thirst/urination, decrease in vision, eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to aliskiren or hydrochlorothiazide; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine (anuria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: loss of too much body water (dehydration), kidney disease, liver disease, lupus, gout, untreated mineral imbalance (e.g., high/low potassium, low magnesium, high calcium), high levels of fats in the blood (cholesterol/triglycerides), certain recent nerve surgery (sympathectomy).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Significant loss of body water from too much sweating, vomiting, or diarrhea can also lower your blood pressure and worsen dizziness. Drink plenty of fluids to prevent these effects and dehydration. If your doctor has directed you to limit drinking fluids, consult your doctor for further instructions. Contact your doctor if you are unable to drink fluids or if you have persistent diarrhea/vomiting.

If you have diabetes, this product may change your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

This product may increase or decrease the potassium levels in your blood. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Older adults may be more sensitive to the effects of this product, especially dizziness and diarrhea.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

This medication passes into breast milk. Consult your doctor before breast-feeding.


Tekturna HCT Patient Information Including Side Effects

Brand Names: Tekturna HCT

Generic Name: hydrochlorothiazide and aliskiren (Pronunciation: HYE droe KLOR oh THYE a zide and a LIS ke rin)

  • What is hydrochlorothiazide and aliskiren (Tekturna HCT)?
  • What are the possible side effects of hydrochlorothiazide and aliskiren (Tekturna HCT)?
  • What is the most important information I should know about hydrochlorothiazide and aliskiren (Tekturna HCT)?
  • What should I discuss with my healthcare provider before taking hydrochlorothiazide and aliskiren (Tekturna HCT)?
  • How should I take hydrochlorothiazide and aliskiren (Tekturna HCT)?
  • What happens if I miss a dose (Tekturna HCT)?
  • What happens if I overdose (Tekturna HCT)?
  • What should I avoid while taking hydrochlorothiazide and aliskiren (Tekturna HCT)?
  • What other drugs will affect hydrochlorothiazide and aliskiren (Tekturna HCT)?
  • Where can I get more information?

What is hydrochlorothiazide and aliskiren (Tekturna HCT)?

Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Aliskiren is an anti-hypertensive (blood pressure lowering) medication. It works by decreasing substances in the body that narrow blood vessels and raise blood pressure.

The combination of hydrochlorothiazide and aliskiren is used to treat high blood pressure (hypertension).

Hydrochlorothiazide and aliskiren may also be used for other purposes not listed in this medication guide.

What are the possible side effects of hydrochlorothiazide and aliskiren (Tekturna HCT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • jaundice (yellowing of the skin or eyes);
  • easy bruising or bleeding;
  • feeling like you might pass out;
  • urinating less than usual, or not at all;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
  • dry mouth, increased thirst, drowsiness, confusion, increased urination, muscle pain or weakness, fast heart rate, or fainting.

Less serious side effects may include:

  • diarrhea, stomach pain, indigestion;
  • dizziness, spinning sensation;
  • blurred vision;
  • weakness;
  • joint pain;
  • runny or stuffy nose, sore throat; or
  • dry cough.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about hydrochlorothiazide and aliskiren (Tekturna HCT)?

Do not use this medication without telling your doctor if you are pregnant. Hydrochlorothiazide and aliskiren may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Do not use potassium supplements or salt substitutes while you are taking hydrochlorothiazide and aliskiren, unless your doctor has told you to.

There are many other medicines that can interact with hydrochlorothiazide and aliskiren. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

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