Trust the safety of Prevacid®24HR for your frequent heartburn patients
Prevacid®24HR has been clinically proven to be safe and well tolerated.1,2
Hypersensitivity
Prevacid®24HR is contraindicated in patients who are hypersensitive to lansoprazole.
Drug interactions
- Warfarin
- Prescription antifungal or anti-yeast medicines
- Digoxin
- Theophylline
- Tacrolimus
- Atazanavir
Safety considerations
- Trouble or pain swallowing food
- Vomiting with blood
- Bloody or black stools
In the Drug Facts for Prevacid®24HR, consumers are advised to inform their health care provider prior to using Prevacid®24HR if they have:
- Liver disease
- Had heartburn over 3 months
- Heartburn with lightheadedness, sweating, or dizziness
- Chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck, or shoulders; or lightheadedness
- Frequent chest pain
- Frequent wheezing, particularly with heartburn
- Unexplained weight loss
- Nausea or vomiting
- Stomach pain
- Have heartburn that continues or worsens
- Need to take this product for more than 14 days
- Need to take more than 1 course of treatment every 4 months
PPIs and Plavix®
The FDA has issued safety information regarding the use of Plavix® (clopidogrel), Prilosec®, Prilosec OTC®, and private-label omeprazole that states concomitant use of omeprazole and clopidogrel should be avoided due to the effect on clopidogrel's active metabolite levels and anti-clotting activity.1 Note:
- The FDA does not have enough information about drug interactions between clopidogrel and PPIs other than omeprazole and esomeprazole to make specific recommendations about their coadministration1
- Other drugs that are potent inhibitors of the CYP 2C19 may have a similar effect and should be avoided in combination with clopidogrel1
Possible increased risk of osteoporosis-related fractures
The FDA is revising the labels of both prescription and OTC PPIs to notify users of the possible increased risk of fracture of the hip, wrist, and spine with prolonged and high-dose use of PPIs. It is important to weigh the known benefits against the potential risks when prescribing or recommending.2,3
Pregnancy
Women who are pregnant or breast-feeding are advised to ask a health care provider before using Prevacid®24HR.
Adverse Events
In all 3 clinical trials with Prevacid®24HR, the most frequently reported adverse events versus placebo over 14 days of treatment were: diarrhea (1.7% vs 0.4%), headache (1.2% vs 1.4%), nasopharyngitis (1.0% vs 0.7%), nausea (0.7% vs 0.7%), abdominal pain (0.5% vs 0.2%), and vomiting (0.5% vs 0.4%).1
Have questions about Prevacid®24HR?
* Prevacid® is indicated for many other acid-related conditions. For details on the full prescribing information for Prevacid, visit www.prevacid.com.
1 FDA. Drugs. Drug Safety and Availability. Postmarket Drug Safety Information for Patients and Providers. Information for Healthcare Professionals: Update to labeling of Clopidogrel Bisulfate (marketed as Plavix) to alert healthcare professionals about a drug interaction with omeprazole (marketed as Prilosec and Prilosec OTC). http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/
DrugSafetyInformationforHealthcareProfessionals/ucm190784.htm. Accessed September 21, 2010.
2. FDA Drug Safety Communication. Possible increased risk of fractures of the hip, wrist, and spine with the use of proton pump inhibitors. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformation
forPatientsandProviders/ucm213206.htm. Accessed September 21, 2010.
3. FDA Consumer Health Information. Possible increased risk of bone fractures with certain antacid drugs. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm21340.htm. Accessed September 21, 2010.
© 2009 Novartis Consumer Health, Inc.
