Label Changes for:
Tekturna (aliskiren) Tablets
October 2011
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February, June and October 2011
October 2011
USE IN SPECIAL POPULATIONS
Geriatric Use
- Of the total number of patients receiving aliskiren in clinical studies, 1,275 (19%)..... Blood pressure response and adverse effects were generally similar to those in younger patients.
June 2011
*eye problems
WARNINGS AND PRECAUTIONS
Acute Myopia and Secondary Angle-Closure Glaucoma
- Hydrochlorothiazide, a sulfonamide, can cause an idosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
Cyclosporine or Itraconazole
- Aliskiren: When aliskiren was given with cyclosporine or itraconazole, the blood concentrations of aliskiren were significantly increased. Avoid concomitant use of aliskiren with cyclosporine or intraconazole
ADVERSE REACTIONS
Post-Marketing Experience
- Blood creatinine increased
DRUG INTERACTIONS
Aliskiren
- Cyclosporine: Avoid co-administration of cyclosporine with aliskiren.
- Itraconazole: Avoid co-administration of itraconazole with aliskiren.
Patient Labeling
What are the possible side effects of Tekturna HCT?
- 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
February2011
WARNINGS and PRECAUTIONS
- Aliskiren-... Avoid concomitant use of aliskiren with cyclosporine or itraconazole
Drug Interactions
- Aliskiren-Cyclosporine: Avoid co-administration of cyclosporine with aliskiren. Itraconazole: Avoid co-administration of itraconazole with aliskiren.
ADVERSE REACTIONS
Postmarketing Experience
- Blood creatinine increased
