داروساز ایرانی

Contraindications

Known hypersensitivity to pantoprazole, any other ingredient in the formulation, or other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, omeprazole, rabeprazole).

Warnings/Precautions

Sensitivity Reactions

Anaphylaxis

Anaphylaxis has been reported with the use of IV pantoprazole sodium. Immediate medical intervention and drug discontinuance are required if anaphylaxis or other severe hypersensitivity reaction occurs.

General Precautions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

GI Effects

Symptomatic response to therapy with pantoprazole does not preclude the presence of gastric neoplasm. Because of the chronic nature of the disease, there may be a potential for prolonged administration of pantoprazole in patients with erosive esophagitis; in long-term animal studies, pantoprazole caused rare types of GI tumors, although the relevance of these findings to humans is unknown.

Atrophic gastritis occasionally has been noted in gastric corpus biopsy specimens from patients receiving long-term treatment with pantoprazole, especially those infected with Helicobacter pylori.

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia). For further precautionary information about this adverse effect, see Community-acquired Pneumonia under Cautions: Respiratory Effects, in Omeprazole 56:28.36.

Musculoskeletal Effects

Findings from several observational studies suggest that therapy with proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., one year or longer), may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The magnitude of risk is unclear; causality has not been established. (See Cautions: Musculoskeletal Effects, in Omeprazole 56:28.36.) The US Food and Drug Administration (FDA) is continuing to evaluate this safety concern. Although controlled studies are required to confirm these findings, patients should receive proton-pump inhibitors at the lowest effective dosage and for the shortest possible time appropriate for their clinical condition. Individuals who are at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D and should have their bone health assessed and managed according to current standards of care.

Glass Vial Breakage

The manufacturer and the US Food and Drug Administration (FDA) have received reports of glass vial breakage during attempts to connect pantoprazole sodium vials to spiked IV system adapters. Such breakage may be a safety issue for health-care personnel (e.g., pharmacists, nurses) attempting to connect these system components either manually or with mechanical assistance, but is not considered by the manufacturer to be a quality issue for pantoprazole sodium for injection. Although the manufacturer is reviewing the use of pantoprazole sodium vials with such systems in order to understand the problem, the manufacturer has not performed studies with these systems to date and currently does not recommend use of spiked IV system adapters with pantoprazole sodium vials. The manufacturer of pantoprazole sodium states that if a decision is made to use spiked adapters, the manufacturer of the adapters should be contacted to provide assistance.

Injection Site Reactions

Injection site reactions, including thrombophlebitis and abscess, have been associated with IV administration of pantoprazole.

Hepatic Effects

Mild, transient elevations of serum ALT (SGPT) have been reported with oral pantoprazole therapy. Serum ALT increases exceeding 3 times the upper limit of normal occurred in 0.4% of patients receiving pantoprazole 40 mg daily in short-term studies.

Edetate Disodium Content

Pantoprazole sodium for injection contains edetate disodium (disodium EDTA), which is a potent metal ion (e.g., zinc) chelator. Zinc supplementation should be considered during IV pantoprazole therapy in patients who are prone to zinc deficiency and caution should be exercised when IV pantoprazole is used concomitantly with other IV preparations that contain edetate disodium.

Cyanocobalamin Malabsorption

Hypochlorhydria or achlorhydria resulting from daily treatment with acid-suppressive drugs over a long period (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin. Cyanocobalamin deficiency has been reported rarely. The possibility of such malabsorption should be considered if manifestations of cyanocobalamin deficiency occur.

Laboratory Test Interferences

Cannabinoid Tests

False-positive results for urine screening tests for tetrahydrocannabinol (THC) have been reported in patients receiving proton-pump inhibitors, including pantoprazole. An alternative confirmatory test should be considered to verify positive urine THC screening results in these patients.

Specific Populations

Pregnancy

Category B. (See Users Guide.)

Lactation

Pantoprazole is distributed into milk; discontinue nursing or the drug because of potential risk in nursing infants.

Pediatric Use

Safety and efficacy in children younger than 18 years of age have not been established.

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults. No dosage adjustment is necessary in geriatric patients.

Common Adverse Effects

Adverse effects occurring in 1% or more of patients receiving pantoprazole delayed-release tablets for up to 8 weeks and more frequently than in those receiving placebo include diarrhea and hyperglycemia. Adverse effects occurring in 1% or more of patients receiving pantoprazole delayed-release tablets for up to 12 months and more frequently than in those receiving ranitidine include headache, abdominal pain, and abnormal liver function test results. The adverse effect profile of pantoprazole delayed-release oral suspension is similar to that of the delayed-release tablets.

Adverse effects occurring in more than 1% of patients receiving IV pantoprazole and that generally had an unclear relationship to the drug include headache, injection site reaction (including thrombophlebitis and abscess), abdominal pain, constipation, dyspepsia, nausea, diarrhea, insomnia, dizziness, and rhinitis. In general, IV or oral administration of the drug has been well tolerated in both short- and long-term studies.

۹ - Saunders Nursing Drug Handbook 2010 (Saunders-Dx™) | Version: 12.0.3/2009.11.25

Side Effects

RARE (less than 2%): Diarrhea, headache, dizziness, pruritus, rash.