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Protonix is indicated for the treatment of conditions where a reduction of gastric acid secretion is required, such as the following:

• Duodenal ulcer

  
  

• Gastric ulcer

  
  

• Reflux esophagitis

  
  

• Symptomatic gastro-esophageal reflux disease (such as, acid regurgitation and heartburn).

  
  

• Prevention of gastrointestinal lesions induced by non-steroidal anti-inflammatory drugs (NSAIDs) in patients with a need for continuous NSAID treatment, who have increased risk to develop NSAID-associated upper gastrointestinal lesions.

  
  

• H. pylori associated duodenal ulcer. Protonix, in combination with clarithromycin and either amoxicillin or metronidazole, is indicated for the treatment of patients with an active duodenal ulcer who are H. pylori positive. Clinical trials using combinations of Protonix with appropriate antibiotics have indicated that such combinations are successful in eradicating H. pylori.

  
  

For the maintenance treatment of patients with reflux esophagitis and the resolution of symptoms associated with reflux esophagitis, such as heartburn, regurgitation and dyspepsia, 20 mg or 40 mg Protonix once daily have been used for 3 years in controlled clinical trials. In continuous maintenance treatment 20 mg Protonix has been used in a limited number of patients for up to eight years.

No dose adjustment is recommended based on age. The daily dose used in elderly patients, as a rule, should not exceed the recommended dosage regimens.

The safety and effectiveness of Protonix in children have not yet been established.

Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see Dosage Forms, Composition and Packaging.

When gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with Protonix is instituted since treatment with Protonixmay alleviate symptoms and delay diagnosis.

Effects of long-term treatment include hypergastrinemia, possible enterochromaffin-like (ECL) cell hyperplasia and carcinoid formation in the stomach, adenomas and carcinomas in the liver and neoplastic changes in the thyroid.

In the rat, the mechanism leading to the formation of gastric carcinoids is considered to be due to the elevated gastrin level occurring during chronic treatment. Similar observations have also been made after administration of other acid secretion inhibitors.

Short-term and long-term treatment with Protonixin a limited number of patients up to 6 years have not resulted in any significant pathological changes in gastric oxyntic exocrine cells.

The daily dose in patients with severe liver disease should, as a rule, not exceed 20 mg Protonix. See Action and Clinical Pharmacology, Special Populations and Conditions.

The daily dose used in renal insufficient patients, as a rule, should not exceed the recommended dosage regimens. See Action and Clinical Pharmacology, Special Populations and Conditions.

Protonix for Special Populations

There are no adequate or well-controlled studies in pregnant women. Protonixshould not be administered to pregnant women unless the expected benefits outweigh the potential risks to the fetus.

Limited data is available around Protonix in nursing women. Protonix excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose. The clinical relevance of this finding is not known. Protonixshould not be given to nursing mothers unless its use is believed to outweigh the potential risks to the infant.

The safety and effectiveness of Protonix in children have not yet been established.

No dose adjustment is recommended based on age. The daily dose used in elderly patients, as a rule, should not exceed the recommended dosage regimens.

Protonix (Protonix) is well tolerated. Most adverse events have been mild and transient showing no consistent relationship with treatment. Adverse events have been recorded during controlled clinical investigations in over 13 000 patients exposed to Protonixas the single therapeutic agent for treatment of conditions requiring acid suppression.

The following adverse events (the most frequently reported) have been reported in individuals receiving Protonix therapy (40 mg once daily) in controlled clinical trials of at least 6 months duration: headache (2.1%), diarrhea (1.6%), nausea (1.2%).

The following adverse reactions considered possibly, probably, or definitely related by the investigator have been reported in individuals receiving Protonix therapy (20 mg or 40 mg once daily) in long-term clinical trials (duration of at least 6 months). There were a limited number of H. pylori positive patients in these studies and therefore, definitive conclusions with regard to long-term consequences of H. pylori infection and acid suppressive treatment on gastric inflammation in this sub-group cannot be made. See Table 1.

diarrhea, flatulence, abdominal pain, abdominal pain upper, abdominal distension, gastric polyps, loose stools, frequent bowel movements, eructation, dyspepsia, nausea, vomiting, constipation.

fatigue.

alanine aminotransferase increased, aspartate aminotransferase increased, liver function tests abnormal, transaminases increased.

hyperglycaemia.

headache, dizziness, vertigo.

pruritus, rash.

visual disturbance.

libido decreased.

blood pressure increased, hypertension, ECG abnormal.

flatulence, abdominal distension, abdominal pain, abdominal pain upper, loose stools, esophageal reflux aggravated, gastric polyps, abdominal discomfort, abdominal tenderness, constipation, eructation, vomiting, dyspepsia, gastroesophageal reflux, esophagitis.

fatigue, peripheral edema, pyrexia.

alanine aminotransferase increased, aspartate aminotransferase increased, liver function tests abnormal, transaminases increased.

hypertriglyceridaemia.

appetite decreased, weight increase.

dysgeusia, dizziness, migraine, vertigo.

cough.

pruritus, rash.

mouth dry, vision blurred.

neoplasm.

The following adverse reactions considered possibly, probably, or definitely related by the investigator have been reported in individuals receiving Protonix therapy (20 mg or 40 mg once daily) in short-term clinical trials (duration of up to 3 months).

diarrhea, flatulence, nausea, constipation, abdominal pain.

headache, dizziness.

pruritus.

In addition, the following adverse events considered unrelated, or unlikely related by the investigator have been reported in individuals receiving Protonix therapy (20 mg or 40 mg once daily) in short-term and long-term clinical trials.

influenza like illness, headache, diarrhea.

bronchitis, nausea, back pain, abdominal pain upper, upper respiratory tract infection, nonaccidental injury, sinusitis, abdominal pain, dizziness, arthralgia, vomiting, pharyngitis, chest pain, gastroenteritis, dyspepsia, urinary tract infection, eructation, pyrexia, cough, depression, hypertension, pain in limb, constipation, fatigue, operation, neck pain, nasopharyngitis, alanine aminotransferase increased, hemorrhoids, pain, flatulence, viral infection, hypertriglyceridaemia, toothache, hypersensitivity, rash, abdominal pain lower, pneumonia, abdominal distension, dyspnoea, muscle cramp, rhinitis, peripheral edema, tonsillitis, angina pectoris, cholelithiasis, sinus congestion, influenza, vertigo, insomnia, infection, osteoarthritis, hypercholesterolaemia, pruritis, eczema, sleep disorder, migraine, aspartate aminotransferase increased, hyperglycemia, musculoskeletal discomfort, blood triglycerides increased, myocardial infarction, tendonitis, weight increased, rectal hemorrhage, cystitis, nasal congestion, arthritis, contusion, abdominal discomfort, enteritis.

The following Serious Adverse Events regardless of causality were reported with a frequency of <0.1% in either 20 mg or 40 mg: sepsis.

A total of 1217 patients were treated with triple combination therapy including Protonixand two antibiotics. Adverse events noted at a frequency of greater than or equal to 1% when Protonixwas used in combination with antibiotics for the eradication of an H. pylori infection included the following:

In combination with clarithromycin and metronidazole (n=725):

Protonix in the Body as a Whole

headache (1.8%), tiredness (1.1%).

dizziness (1.4%).

diarrhea (4.8%), nausea (3.7%), upper abdominal pain (1.9%), tongue pain (1.2%), loose stools (1.0%), buccal inflammation (1.0%).

hepatic enzymes increased (1.2%).

bitter taste (4.0%), metallic taste (2.1%).

In combination with amoxicillin and clarithromycin (n=492):

headache (1.8%), pain (1.0%).

exanthema (1.2%).

diarrhea (10.0%), bitter taste (3.0%), upper abdominal pain (1.4%), nausea (1.2%).

Regardless of the combination regimen, the most frequently reported events were gastrointestinal system disorders, followed by autonomic nervous system disorders and “body as a whole”, or generalized disorders.

Please refer to the Hepatobiliary Disorders and the Laboratory Parameters portions of the Adverse Reaction; Action and Clinical Pharmacology, Special Populations and Conditions; and Warnings and Precautions, Hepatic/Biliary/Pancreatic.

The following adverse events were reported in post-marketing use and causal relation to Protonixtreatment could not be ruled out:

allergic reactions such as skin rash. Very rare cases of angioedema, severe skin reactions such as Stevens-Johnson Syndrome, erythema multiforme, toxic epidermal necrolysis, and photosensitivity. Isolated cases of alopecia, acne, maculopapular rash, urticaria, exfoliative dermatitis.

hypokinesia, disturbances in vision (blurred vision). Rare cases of somnolence, insomnia; in isolated cases vertigo, tremor, tinnitus, paresthesia, nervousness, photophobia.

anterior ischemic optic neuropathy.

occasionally upper abdominal pain, flatulence; rare cases of increased appetite, dry mouth, nausea/vomiting, constipation, dyspeptic symptoms, acid eructation, pancreatitis, increased salivation.

isolated cases of hematuria and impotence. Interstitial nephritis.

in rare cases, increased liver enzymes (transaminases, γ-GT), elevated triglycerides.

pancytopenia, isolated cases of eosinophilia. Very rare cases of leukopenia, and thrombocytopenia.

speech disorder, very rare cases of peripheral edema, increased body temperature.

very rare cases of severe hepatocellular damage leading to jaundice with or without hepatic failure.

anaphylactic reactions including anaphylactic shock.

elevated creatine phosphokinase, in rare cases, myalgia and arthralgia. In very rare cases rhabdomyolysis.

confusion, very rare cases of mental depressio