Generic drug: hydrochlorothiazide and aliskiren
Brand name: Tekturna HCT
What is Tekturna HCT, and how does it work?
- aliskiren (Tekturna), a direct renin inhibitor (DRI)
- hydrochlorothiazide (HCTZ), a diuretic (water pill)
Aliskiren (Tekturna) reduces the effect of renin, and the harmful process that narrows blood vessels. Aliskiren also helps blood vessels relax and widen so blood pressure is lower. Hydrochlorothiazide reduces the amount of salt and water in your body so your blood pressure is lower.
Tekturna HCT may be used to lower high blood pressure in adults
- when 1 medicine to lower high blood pressure is not enough
- as the first medicine to lower high blood pressure if your doctor decides that you are likely to need more than 1 medicine
Tekturna HCT has not been studied in children under 18 years of age.
What are the side effects of Tekturna HCT?
- When pregnancy is detected, discontinue Tekturna HCT as soon as possible.
- Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Tekturna HCT may cause serious side effects:
- Harm to an unborn baby, causing injury or death.
- Severe Allergic Reactions and Angioedema (hypersensitivity). Aliskiren, one of the medicines in Tekturna HCT, can cause
- difficulty breathing or swallowing,
- tightness of the chest,
- general rash,
- vomiting, or
- abdominal pain (signs of a severe allergic reaction called anaphylactic reaction).
- Aliskiren can also cause
- swelling of the face,
- arms and legs, or
- the whole body (signs of angioedema).
- Stop taking Tekturna HCT and get medical help right away. Tell your doctor if you get any one or more of these symptoms. Angioedema can happen at any time while you are taking Tekturna HCT.
- 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.
- Renal Impairment or Failure. Aliskiren, one of the medicines in Tekturna HCT, may cause renal disorder with symptoms such as severely decreased urine output or decreased urine output (signs of renal impairment or failure).
- Tekturna HCT may affect your potassium levels. Your doctor will do blood tests to check your potassium levels.
- Allergic reactions: Hydrochlorothiazide, one of the medicines in Tekturna HCT, can cause allergic reactions.
- Active or Worsened Systemic Lupus Erythematosus (SLE). If you have SLE, tell your doctor right away if you get any new or worse symptoms.
Possible signs of SLE are facial rash, joint pain, muscle disorder, fever.
- Eye problems. One of the medicines in Tekturna HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Tekturna HCT. Tell your doctor right away if you have:
- Decrease in vision
- Eye pain
Common side effects of Tekturna HCT include:
- flu-like symptoms
- high levels of potassium in the blood (hyperkalemia)
Less common side effects include
- skin rash,
- severe skin reactions (signs may include severe blistering of the lips, eyes or mouth, rash with fever and skin peeling),
- liver disorder (signs may include nausea, loss of appetite, dark-colored urine, or yellowing of skin and eyes) and
- low level of sodium in the blood.
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 Tekturna HCT. 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.
What is the dosage for Tekturna HCT?
- The recommended once-daily doses of Tekturna HCT in order of increasing mean effect are 150/12.5 mg, 150/25 mg or 300/12.5 mg, and 300/25 mg.
- The antihypertensive effect of Tekturna HCT is largely manifested within 1 week, with maximal effects generally seen at around 4 weeks.
- If blood pressure remains uncontrolled after 2 to 4 weeks of therapy, the dose may be titrated up to a maximum of aliskiren 300 mg/HCTZ 25 mg.
- A patient whose blood pressure is not adequately controlled with aliskiren alone or hydrochlorothiazide alone may be switched to combination therapy with Tekturna HCT.
- The usual recommended starting dose is 150/12.5 mg once daily as needed to control blood pressure.
- The dose may be titrated up to a maximum of aliskiren 300 mg/hydrochlorothiazide 25 mg once daily.
- Tekturna HCT may be substituted for the individually titrated components.
- The usual recommended starting dose is 150/12.5 mg once daily as needed to control blood pressure. The dose may be titrated up to a maximum of aliskiren 300 mg/HCTZ 25 mg once daily.
- Tekturna HCT is not recommended for use as initial therapy in patients with intravascular volume depletion.
Relationship To Meals
- Patients should establish a routine pattern for taking Tekturna HCT with regard to meals. High-fat meals decrease absorption substantially.
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What drugs interact with Tekturna HCT?
No drug interaction studies have been conducted with Tekturna HCT and other drugs, although studies with the individual aliskiren and HCTZ components are described below.
- Avoid coadministration of cyclosporine with aliskiren.
- Avoid coadministration of itraconazole with aliskiren.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)
- In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors with agents that affect the RAAS, including aliskiren, may result in deterioration of renal function, including possible acute renal failure.
- These effects are usually reversible. Monitor renal function periodically in patients receiving aliskiren and NSAID therapy.
- The antihypertensive effect of aliskiren may be attenuated by NSAIDs.
Dual Blockade Of The Renin-Angiotensin-Aldosterone System (RAAS)
- The concomitant use of aliskiren with other agents acting on the RAAS such as ACEIs or ARBs is associated with an increased risk of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.
- Most patients receiving the combination of two drugs that inhibit the renin-angiotensin system do not obtain any additional benefit compared to monotherapy.
- In general, avoid combined use of aliskiren with ACE inhibitors or ARBs, particularly in patients with CrCl less than 60 mL/min.
- Monitor blood pressure, renal function, and electrolytes in patients on aliskiren and other agents that affect the RAAS.
- The concomitant use of aliskiren with an ARB or an ACEI in diabetic patients is contraindicated.
- Oral coadministration of aliskiren and furosemide reduced exposure to furosemide. Monitor diuretic effects when furosemide is coadministered with aliskiren.
- When administered concurrently, the following drugs may interact with thiazide diuretics.
Antidiabetic Drugs (Oral Agents And Insulin)
- Dosage adjustment of the antidiabetic drug may be required.
- Diuretic agents increase the risk of lithium toxicity. Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists.
- Monitoring of serum lithium levels is recommended during concomitant use.
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) And COX-2 Selective Agents
- When Tekturna HCT and NSAIDs are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Is Tekturna HCT safe to use while pregnant or breastfeeding?
- Inform female patients of childbearing age about the consequences of exposure to Tekturna HCT during pregnancy.
- Discuss treatment options with women planning to become pregnant.
- Advise patients to report pregnancies to their physicians as soon as possible.
- Advise nursing women that breastfeeding is not recommended during treatment with Tekturna HCT.
Tekturna HCT (hydrochlorothiazide and aliskiren) contains 2 prescription medicines in 1 tablet that work together to lower blood pressure. Serious side effects of Tekturna HCT include potentially causing harm to an unborn baby (injury or death), severe allergic reactions, angioedema (hypersensitivity), low blood pressure (hypotension), renal impairment or failure, affected potassium levels, allergic reactions, active or worsened Systemic Lupus Erythematosus (SLE), and eye problems.
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High Blood Pressure (Hypertension)
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
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Second Source WebMD Medical Reference
Things to Know About High Blood Pressure Treatment
High blood pressure (hypertension) means high pressure (tension) in the arteries. Treatment for high blood pressure include lifestyle modifications (alcohol, smoking, coffee, salt, diet, exercise), drugs and medications such as ACE inhibitors, angiotensin receptor blockers, beta blockers, diuretics, calcium channel blockers (CCBs), alpha blockers, clonidine, minoxidil, and Exforge.
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Portal hypertension is most commonly caused by cirrhosis, a disease that results from scarring of the liver. Other causes of portal hypertension include blood clots in the portal vein, blockages of the veins that carry the blood from the liver to the heart, and a parasitic infection called schistosomiasis. Symptoms of portal hypertension include varices (enlarged veins), vomiting blood, blood in the stool, black and tarry stool, ascites (abnormal fluid collection within the peritoneum, the sac that contains the intestines within the abdominal cavity), confusion and lethargy, splenomegaly or enlargement of the spleen, and decreased white blood cell counts.
Hypertension-Induced Chronic Kidney Disease
Hypertension-induced chronic kidney disease (CKD) is a long-standing kidney condition that develops over time due to persistent or uncontrolled high blood pressure (hypertension).
Can High Blood Pressure Hurt My Eyes?
Unfortunately, yes. Suffering from untreated or poorly controlled high blood pressure for a long time can be detrimental to your eyes. Several eye diseases are directly or indirectly caused by high blood pressure (hypertension).
What Is High Blood Pressure (Hypertension)?
High blood pressure or hypertension is when the blood pressure readings consistently range from 140 or higher for systolic or 90 or higher for diastolic. Blood pressure readings above 180/120 mmHg are dangerously high and require immediate medical attention.
High Blood Pressure Symptoms
Most people with high blood pressure have no signs or symptoms, even if blood pressure readings reach dangerously high levels. In some patients, symptoms may include fatigue, headaches, dizziness, confusion, sweating, chest pain and vision problems.
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