Tekturna HCT (aliskiren/hydrochlorothiazide) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2010 and April 2012

 

April 2012

Summary View

 

• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations…

• Tekturna HCT is contraindicated in patients with diabetes who are receiving ARBs or ACEI because of the increased risk of renal impairment, hyperkalemia, and hypotension
• Avoid use of Tekturna HCT with ARBs or ACEI in patients with moderate renal impairment (GFR <60 ml/min).

Impaired Renal Function

• Monitor renal function periodically in patients treated with Tekturna HCT. Changes in renal fuction, includingacute renal failure, can be caused by drugs that affect the renin-angiotensin system…

Serum Electrolyte Abnormalities

• in patients with hypertension not concomitantly treated with an ARB or ACEI…

• Monitor serum potassium periodically in patients receiving aliskiren. Drugs that affect the renin-angiotensin system can cause hyperkalemia. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes, combination use with ARBs or ACEI [see Contraindications (4), Warnings (5.2), and Clinical Trials (14.4)], NSAIDs, or potassium supplements or potassium sparing diuretics.

• Hydrochlorothiazide can cause hypokalemia and hyponatremia. Hypomagnesemia can result in hypokalemia which appears difficult to treat despite potassium repletion.

ADVERSE REACTIONS

Clinical Trials Experience

• These data do not include information from the ALTITUDE study which evaluated the use of aliskiren in combination with ARBs or ACEI

Clinical Laboratory Test Abnormalities

• in patients with hypertension not concomitantly treated with an ARB or ACEI.
• Blood Urea Nitrogen (BUN)/Creatinine:In patients with hypertension not concomitantly treated with an ARB or ACEI, elevations

PATIENT COUNSELING INFORMATION

• If you have diabetes and are taking a kind of medicine called an angiotens inreceptor- blocker or angiotensin-converting-enzyme-inhibitor .

• a kind of medicine called angiotensin receptor blocker or angiotensin converting enzyme inhibitor

• high levels of potassium in the blood (hyperkalemia)

 

May 2010 

Summary View

 

WARNINGS AND PRECAUTIONS

Head and Neck Angioedema

• Aliskiren Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with Tekturna and has necessitated hospitalization and intubation. This may occur at any time during treatment and has occurred in patients with and without a history of angioedema with ACE inhibitors or angiotensin receptor antagonists. If angioedema involves the throat, tongue, glottis or larynx, or if the patient has a history of upper respiratory surgery, airway obstruction may occur and be fatal. Patients who experience these effects, even without respiratory distress, require prolonged observation since treatment with antihistamines and corticosteroids may not be sufficient to prevent respiratory involvement. Prompt administration of subcutaneous epinephrine solution 1:1000 (0.3 to 0.5 ml) and measures to ensure a patient airway may be necessary.
• Discontinue Tekturna immediately in patients who develop angioedema, and do not readminister.