Tekturna HCT

Name: Tekturna HCT

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-4hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is


Molecular formula: C30H53N3O6 • 0.5 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-1,2,4-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.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

How should I take hydrochlorothiazide and aliskiren?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take this medicine with or without food, but take it the same way every time.

You may have 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.

Your blood pressure will need to be checked often.

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

If you need surgery or medical tests, tell the surgeon ahead of time that you are using hydrochlorothiazide and aliskiren. You may need to stop using the medicine for a short time.

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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Hydrochlorothiazide and aliskiren side effects

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

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • little or no urination;

  • eye pain, vision problems;

  • low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement;

  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

  • lupus-like symptoms--joint pain with fever, skin sores, butterfly-shaped skin rash on your cheeks and nose, numbness or pale appearance of your fingers or toes;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • dizziness, tired feeling;

  • cough;

  • joint pain;

  • diarrhea; or

  • flu symptoms (fever, chills, body aches).

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

Uses For Tekturna HCT

Aliskiren and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure will reduce the risk of strokes and heart attacks.

Aliskiren is a renin inhibitor. It works by blocking an enzyme in the body that is necessary to produce a substance that causes blood vessels to tighten. As a result, the blood vessels relax and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

This medicine is available only with your doctor's prescription.

Before Using Tekturna HCT

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of aliskiren and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aliskiren and hydrochlorothiazide combination in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Candesartan
  • Captopril
  • Dofetilide
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Fosinopril
  • Irbesartan
  • Lisinopril
  • Losartan
  • Moexipril
  • Olmesartan Medoxomil
  • Perindopril
  • Quinapril
  • Ramipril
  • Telmisartan
  • Trandolapril
  • Valsartan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Amphetamine
  • Amtolmetin Guacil
  • Arsenic Trioxide
  • Aspirin
  • Benzphetamine
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Choline Salicylate
  • Clonixin
  • Cyclophosphamide
  • Cyclosporine
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • Dextroamphetamine
  • Diclofenac
  • Diflunisal
  • Digitalis
  • Digitoxin
  • Digoxin
  • Dipyrone
  • Droperidol
  • Droxicam
  • Eliglustat
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Flecainide
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Indomethacin
  • Itraconazole
  • Ketanserin
  • Ketoprofen
  • Ketorolac
  • Levomethadyl
  • Lisdexamfetamine
  • Lithium
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Methamphetamine
  • Methotrexate
  • Metildigoxin
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Ouabain
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Proscillaridin
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Simeprevir
  • Sodium Salicylate
  • Sotalol
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aminolevulinic Acid
  • Bepridil
  • Carbamazepine
  • Cholestyramine
  • Furosemide
  • Ginkgo
  • Gossypol
  • Licorice
  • Rifampin
  • Topiramate

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Airway surgery, history of—At risk for severe complications from angioedema (swelling of the face, lips, tongue, throat, arms, or legs).
  • Angioedema, history of—May increase the risk of this condition occurring again.
  • Anuria (not able to pass urine) or
  • Diabetes patients who are also taking certain blood pressure medicines such as angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) or
  • Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.
  • Asthma, history of—May increase likelihood of having an allergic reaction.
  • Diabetes or
  • Kidney problems—May increase risk of having high potassium in the blood.
  • Electrolyte imbalance (e.g., high or low levels of calcium, magnesium, potassium, or sodium in the body) or
  • Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
  • Glaucoma, secondary angle closure or
  • Gout or
  • Hyperlipidemia (high cholesterol or fats in the blood) or
  • Liver disease or
  • Myopia, acute (changes in the eyeball causing vision problems) or
  • Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
  • Heart failure, severe
  • Heart attack, history—Use may lead to kidney problems.

Important information

You should not use Tekturna HCT if you are unable to 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 tell your doctor right away.

If you have diabetes, you should not use Tekturna HCT together with certain heart or blood pressure medicines (such as Accupril, Benicar, Capoten, Cozaar, Diovan, Lotensin, Mavik, Prinivil, Vasotec, and many others).

Before you take Tekturna HCT, tell your doctor if you have asthma, low or high levels of potassium in your blood, kidney or liver disease, glaucoma, gout, lupus, diabetes, or an allergy to sulfa drugs or penicillin.

You should not use Tekturna HCT if you are allergic to aliskiren or hydrochlorothiazide, if you are unable to urinate, or if you are also using itraconazole (Sporanox) or cyclosporine (Gengraf, Neoral, Sandimmune). FDA pregnancy category D. Do not use Tekturna HCT if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant.

Do not use potassium supplements or salt substitutes while you are taking Tekturna HCT, unless your doctor has told you to. It may take up to 4 weeks for this medication to control your blood pressure. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

You should not use Tekturna HCT 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 Tekturna HCT 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.

To make sure Tekturna HCT is safe for you, tell your doctor if you have:

  • kidney 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 Tekturna HCT if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Hydrochlorothiazide and aliskiren can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

It is not known whether hydrochlorothiazide and aliskiren passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Tekturna HCT is not approved for use by anyone younger than 18 years old.

Tekturna HCT dosing information

Usual Adult Dose for Hypertension:

Initial dose: 150 mg-12.5 mg or 150 mg-25 mg once daily

Maximum dose: Aliskiren-hydrochlorothiazide 300/25 mg orally daily

Comments:
-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).

What should I avoid while taking Tekturna HCT?

If you also take cholestyramine or colestipol, avoid taking these medicines within 4 hours before or 4 hours after you take Tekturna HCT.

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

Avoid taking Tekturna HCT with a high-fat meal, which can make it harder for your body to absorb aliskiren.

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 Tekturna HCT.

(web3)