Label Changes for:
Diovan HCT (valsartan/hydrochloriothiazide) Tablets
December 2011
Changes have been made to the PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010, June and December 2011
December 2011
DRUG INTERACTIONS
Valsartan
- CYP 450 Interactions: In vitro metabolism studies indicate that CYP 450 mediated drug interactions between valsartan and co-administered drugs are unlikely because of the low extent of metabolism
- Transporters: The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Co-administration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
- Non-Steroidal Anti-Inflammatory Agents 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, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including valsartan, may result in deterioration of renal function, including possible acute renal failure…
PATIENT INFORMATION
“Tell your doctor about all the medicines you take”
- like ibuprofen or naproxen
June 2011
* eye problems
WARNINGS AND PRECAUTIONS
Acute Myopia and Secondary Angle-Closure Glaucoma
- Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic 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.
PATIENT INFORMATION
What are the possible side effects of Diovan HCT?
Eye Problems. One of the medicines in Diovan HCT can cause eye problems that may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting Diovan HCT. Tell your doctor right away if you have:
- decrease in vision
- eye pain
April 2010
ADVERSE REACTIONS
Postmarketing Experience
- Dermatologic: Alopecia
- Vascular: Vasculitis
- Nervous System: Syncope
DRUG INTERACTIONS
Hydrochlorothiazide
- Carbamazepine: May lead to symptomatic hyponatremia
Valsartan
- CYP 450 Interactions: In vitro metabolism studies indicate that CYP 450 mediated drug interactions between valsartan and co-administered drugs are unlikely because of low extent of metabolism.
- Transporters: The results from an in vitro study with human liver tissue indicate that valsartan is a substrate of the hepatic uptake transporter OATP1B1 and the hepatic efflux transporter MRP2. Co-administration of inhibitors of the uptake transporter (rifampin, cyclosporine) or efflux transporter (ritonavir) may increase the systemic exposure to valsartan.
