Tekturna HCT (hydrochlorothiazide and aliskiren)

WARNING

FETAL TOXICITY

• 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,
  • hives,
  • general rash,
  • swelling,
  • itching,
  • dizziness,
  • vomiting, or
  • abdominal pain (signs of a severe allergic reaction called anaphylactic reaction).
  • Aliskiren can also cause
    • swelling of the face,
    • lips,
    • tongue,
    • throat,
    • 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:

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

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.

Protect your skin from the sun and undergo regular skin cancer screening, as one of the medicines in Tekturna HCT may cause non-melanoma skin cancer.

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.

Dose Selection

• 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.

Dose Titration

• 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.

Add-On Therapy

• 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.

Replacement Therapy

• Tekturna HCT may be substituted for the individually titrated components.

Initial Therapy

• 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.

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.

Aliskiren

Cyclosporine

• Avoid coadministration of cyclosporine with aliskiren.

Itraconazole

• 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.

Furosemide

• Oral coadministration of aliskiren and furosemide reduced exposure to furosemide. Monitor diuretic effects when furosemide is coadministered with aliskiren.

Hydrochlorothiazide (HCTZ)

• 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.

Lithium

• 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.

Ion-Exchange Resins

• Staggering the dosage of HCTZ and ion exchange resins (e.g., cholestyramine, colestipol) such that HCTZ is administered at least 4 hours before or 4 to 6 hours after the administration of resins would potentially minimize the interaction.

• 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.