Thursday, October 27, 2016

aliskiren and hydrochlorothiazide


a-lis-KYE-ren, hye-droe-klor-oh-THYE-a-zide


Oral route(Tablet)

Avoid use in pregnancy. 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 .



Commonly used brand name(s)

In the U.S.


  • Tekturna HCT

Available Dosage Forms:


  • Tablet

Therapeutic Class: Antihypertensive


Pharmacologic Class: Renin Inhibitor


Chemical Class: Thiazide


Uses For aliskiren and hydrochlorothiazide


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. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.


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


aliskiren and hydrochlorothiazide is available only with your doctor's prescription.


Before Using aliskiren and hydrochlorothiazide


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 aliskiren and hydrochlorothiazide, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to aliskiren and hydrochlorothiazide 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 CategoryExplanation
All TrimestersDStudies 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 aliskiren and hydrochlorothiazide, 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 aliskiren and hydrochlorothiazide 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.


  • Dofetilide

Using aliskiren and hydrochlorothiazide 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.


  • Acetyldigoxin

  • Arsenic Trioxide

  • Cyclosporine

  • Deslanoside

  • Digitalis

  • Digitoxin

  • Digoxin

  • Droperidol

  • Flecainide

  • Itraconazole

  • Ketanserin

  • Levomethadyl

  • Lithium

  • Metildigoxin

  • Ouabain

  • Proscillaridin

  • Sotalol

Using aliskiren and hydrochlorothiazide 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.


  • Alacepril

  • Apazone

  • Aspirin

  • Benazepril

  • Bepridil

  • Bromfenac

  • Captopril

  • Carbamazepine

  • Celecoxib

  • Chlorpropamide

  • Cholestyramine

  • Cilazapril

  • Cyclophosphamide

  • Delapril

  • Diclofenac

  • Diflunisal

  • Enalapril

  • Enalaprilat

  • Enalapril Maleate

  • Etodolac

  • Fenoprofen

  • Flurbiprofen

  • Fosinopril

  • Ginkgo

  • Glipizide

  • Gossypol

  • Ibuprofen

  • Ibuprofen Lysine

  • Imidapril

  • Indomethacin

  • Ketoprofen

  • Ketorolac

  • Licorice

  • Lisinopril

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Moexipril

  • Nabumetone

  • Naproxen

  • Nepafenac

  • Oxaprozin

  • Pentopril

  • Perindopril

  • Piroxicam

  • Quinapril

  • Ramipril

  • Rifampin

  • Salicylic Acid

  • Salsalate

  • Spirapril

  • Sulindac

  • Temocapril

  • Tolmetin

  • Topiramate

  • Trandolapril

  • Zofenopril

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 aliskiren and hydrochlorothiazide 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 aliskiren and hydrochlorothiazide, 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 aliskiren and hydrochlorothiazide. Make sure you tell your doctor if you have any other medical problems, especially:


  • Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—May increase the risk of this condition occurring again.

  • Anuria (not able to pass urine) or

  • Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

  • Asthma, history of—May cause side effects to become worse.

  • Dehydration or

  • Hyponatremia (low sodium in the blood) or

  • Hypovolemia (low blood volume)—Use with caution. These conditions may cause the blood pressure to fall too low with aliskiren and hydrochlorothiazide.

  • Electrolyte imbalance or

  • Hypotension (low blood pressure) or

  • Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of aliskiren and hydrochlorothiazide


aliskiren and hydrochlorothiazide should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.


In addition to the use of aliskiren and hydrochlorothiazide, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.


Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.


Remember that aliskiren and hydrochlorothiazide will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.


You may take aliskiren and hydrochlorothiazide with or without food. High-fat meals may affect absorption of aliskiren and hydrochlorothiazide.


Dosing


The dose of aliskiren and hydrochlorothiazide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of aliskiren and hydrochlorothiazide. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For high blood pressure:
      • Adults—One tablet once a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 300 milligrams (mg) of aliskiren and 25 mg of hydrochlorothiazide once a day.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of aliskiren and hydrochlorothiazide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using aliskiren and hydrochlorothiazide


It is very important that your doctor check your progress at regular visits to make sure aliskiren and hydrochlorothiazide is working properly and to check for unwanted effects.


Using aliskiren and hydrochlorothiazide while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.


Stop using aliskiren and hydrochlorothiazide and call your doctor right away if you have swelling of the face, arms, legs, eyes, lips, or tongue, or problems with swallowing or breathing. These are symptoms of a condition called angioedema.


Dizziness, lightheadedness, or fainting may occur after the first dose, especially if you have been taking a diuretic (water pill). Make sure you know how you react to the medicine before you drive, use machines, or do other things that could be dangerous if you are dizzy or not alert.


Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.


Check with your doctor if you become sick while taking aliskiren and hydrochlorothiazide, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water, possibly resulting in low blood pressure.


Hyperkalemia (high potassium in the blood) may occur while you are using aliskiren and hydrochlorothiazide. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs. Do not use salt substitutes containing potassium without first checking with your doctor.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


aliskiren and hydrochlorothiazide Side Effects


Along with its needed effects, a medicine 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:


Less common
  • 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

Incidence not known
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Coma

  • confusion

  • decreased urine output

  • dizziness

  • drowsiness

  • dry mouth

  • fainting

  • fast or irregular heartbeat

  • increase in heart rate

  • increased thirst

  • irritability

  • lightheadedness

  • mood changes

  • muscle cramps

  • numbness, tingling, pain, or weakness in the hands or feet

  • rapid breathing

  • seizures

  • shortness of breath

  • sunken eyes

  • swelling of the face, ankles, or hands

  • trembling

  • weak pulse

  • weakness and heaviness of the legs

  • wrinkled skin

Some side effects 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:


Less common
  • Difficulty with moving

  • feeling of constant movement of self or surroundings

  • lack or loss of strength

  • muscle stiffness

  • sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


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

See also: aliskiren and hydrochlorothiazide side effects (in more detail)



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More aliskiren and hydrochlorothiazide resources


  • Aliskiren and hydrochlorothiazide Side Effects (in more detail)
  • Aliskiren and hydrochlorothiazide Dosage
  • Aliskiren and hydrochlorothiazide Use in Pregnancy & Breastfeeding
  • Aliskiren and hydrochlorothiazide Drug Interactions
  • Aliskiren and hydrochlorothiazide Support Group
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