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YTIDICA (PANTAPROZOLE 40MG)

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Medical uses

Pantoprazole is used for short-term treatment of erosion and ulceration of the oesophagus caused by gastroesophageal reflux disease. Initial treatment is generally of eight weeks' duration, after which another eight-week course of treatment may be considered if necessary. ^[1] It can be used as a maintenance therapy for long-term use after initial response is obtained. Pantoprazole may also be used in combination with antibiotics to treat ulcers caused by Helicobacter pylori.When treating H. pylori ulcers, pantoprazole is given twice daily, ^[3] in contrast to gastroesophageal reflux disease, where it is usually given once daily. Typical treatment courses for H. pylori range from 10 to 14 days.

Adverse effects

Infection: Stomach acid plays a role in killing ingested bacteria. Use of pantoprazole may increase the chance of developing infections such as pneumonia, particularly in hospitalized patients.

Common

Gastrointestinal: abdominal pain (3%), diarrhea (4%), flatulence (4%)
Neurologic: headache (5%)

Serious

Gastrointestinal: atrophic gastritis, Clostridium difficile diarrhea
Hematologic: thrombocytopenia (less than 1%)
Immunologic: Stevens-Johnson syndrome, toxic epidermal necrolysis
Musculoskeletal: Muscle disorders, bone fracture and infection, Clostridium difficile infection, osteoporosis-related hip fracture, rhabdomyolysis
Renal: interstitial nephritis (rare)
Nutrition: may reduce the absorption of important nutrients, vitamins and minerals, as well as medications, leaving users at increased risk for pneumonia^[5]
Cardiovascular: increase in a chemical that suppresses the production of nitric oxide by 25% in humans, which has proven to relax and protect arteries and veins, causes blood vessels to constrict, a development that could lead to a number of cardiovascular problems if continued for a prolonged time^[5]

Pharmacology

Pantoprazole is metabolized in the liver by the cytochrome P450 system.Metabolism mainly consists of demethylation by CYP2C19 followed by sulfation. Another metabolic pathway is oxidation by CYP3A4. Pantoprazole metabolites are not thought to have any pharmacological significance. Pantoprazole is relatively free of drug interactions; ^[7] however, it may alter the absorption of other medications that depend on the amount of acid in the stomach, such as ketoconazole or digoxin. Generally inactive at the acidic pH of stomach, thus it is usually given with a prokinetic drug. Pantoprazole binds irreversibly to H+K+ATPase (proton pumps) and suppresses the secretion of acid. As it binds irreversibly to the pumps, new pumps have to be made before acid production can be resumed. The drug's plasma half-life is about 2 hours.

Pharmacokinetics

Absorption

Bioavailability: (oral, delayed release tablets), about 77%
Effect of food: (oral, delayed-release tablets), AUC and C_max no effect, T_max variable, absorption delayed, no net effect
Effect of food: (oral, for-delayed-release suspension), administer 30 minutes before a meal
T_max, oral, delayed-release suspension: 2.0 to 2.5 h
T_max, oral, delayed-release tablets: 2.5 h
T_max, oral,delayed-release tablets: 1.5 to 2.0 hours (pediatrics)

Distribution

Protein binding: about 98% to primarily albumin
Vd, extensive metabolizers (IV): about 11 to 23.6 l
Vd, pediatrics (oral): 0.21 to 0.43 l/kg.

Metabolism

Hepatic; cytochrome P450 CYP2C19; minor metabolism from CYP3A4, 2D6, and 2C9

Excretion

Fecal: (oral or IV, normal metabolizers), 18%
Renal: (oral or IV, normal metabolizers), about 71%, none as unchanged
Dialyzable: no (hemodialysis)
Total body clearance: (IV) 7.6 to 14 l/hour.
Total body clearance: (oral, pediatrics) 0.18 to 2.08 l/h/kg

Elimination half-life

Oral or IV, 1 hour
Oral or IV, slow metabolizers, 3.5 to 10 hours
Pediatrics, 0.7 to 5.3 hours

Check with your health care provider before you start, stop, or change the dose of any medicine.