PROTONIX safety information
- PROTONIX is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria.
- In adults, symptomatic response to therapy does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.
- Acute interstitial nephritis has been observed in patients taking PPIs including PROTONIX. This may occur during any PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue PROTONIX if acute interstitial nephritis develops.
- PPI therapy, like PROTONIX, may be associated with increased risk of Clostridium difficile associated diarrhea.
- PPI therapy, like PROTONIX, may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
- Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including PROTONIX, mostly cutaneous; events have occurred as new onset or exacerbation of existing disease. Discontinue PROTONIX and refer to specialist for evaluation.
- Daily long-term use (e.g. longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin (Vitamin B-12).
- In clinical trials of adult patients, the most frequently reported adverse reactions (>2%) with PROTONIX Delayed-Release Tablets were headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia.
- In clinical trials of pediatric patients 1 to 16 years of age, the most frequently reported adverse reactions (>4%) with PROTONIX were URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.
- Concomitant use of atazanavir or nelfinavir and proton pump inhibitors is not recommended.
- Patients treated with PPIs and warfarin concomitantly should be monitored for increases in INR and prothrombin time.
- Due to its effects on gastric acid secretion, PROTONIX can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. The absorption of drugs such as ketoconazole, ampicillin esters, atazanavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease.
- Concomitant use of PPIs with high doses of methotrexate may elevate and prolong serum levels of methotrexate, possibly leading to methotrexate toxicity.
- PROTONIX is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.
- PROTONIX is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.
- PROTONIX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Terms and Conditions
By participating in the PROTONIX Savings Card Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- As per federal and some state laws, the Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs, including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”)
- The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs which reimburse you for the entire cost of your prescription drugs
- Patients must be 18 or older
- You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
- Eligible patients may pay a minimum of $4 per prescription fill. By using the Card, eligible patients will receive a savings of up to $70 per fill off of their co-pay or out-of-pocket costs. The Card is good for a maximum savings of $840 per year ($70 per month x 12 months). The Card limits your prescription cost to $4, subject to a $70 maximum monthly benefit. Thus, if your co-pay or out-of-pocket cost is more than $74, you will save $70 off of your co-pay or total out-of-pocket costs. [Example: If your co-pay or out-of-pocket costs are $100, you will pay $30 ($100-$70 = $30).] If your co-pay or out-of-pocket costs are no more than $74, you pay $4. For a mail-order 3-month prescription, your total maximum savings may be $210 ($70 x 3)
- The Card is not valid for Massachusetts residents whose prescriptions are covered, in whole or in part, by third-party insurance, or where otherwise prohibited by law
- The Card cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
- The Card will be accepted only at participating pharmacies
- The Card is not health insurance
- This offer is good only in the U.S. and Puerto Rico
- The Card is limited to one per person during this offering period and is not transferable
- Pfizer reserves the right to rescind, revoke, or amend the program without notice
- No membership fees. The Card and Program expire on 12/31/18
Visit PROTONIX.com for more information about PROTONIX. For help with the PROTONIX Savings Card Program, call 1-855-807-7901 or write: Pfizer, ATTN: PROTONIX, PO Box 4938, Warren, NJ 07059-6600.
Under license from Takeda, D78467 Konstanz, Germany