Proton Pump Inhibitor

Short-term treatment of erosive esophagitis associated with GERD

B

No adequate and well-controlled studies have been done in pregnant women. Use in pregnancy only if clearly needed. Pantoprazole and its metabolites are excreted in the milk of rats. It is unknown if pantoprazole is excreted in human milk. Do not use in women who are breast-feeding.

Hypersensitivity to pantoprazole or any component

Symptomatic response does not preclude gastric malignancy; not indicated for maintenance therapy; safety and efficacy for use beyond 16 weeks have not been established; safety and efficacy in pediatric patients have not been established

1% to 10%:

Cardiovascular: Chest pain

Central nervous system: Pain, migraine, anxiety, dizziness

Endocrine & metabolic: Hyperglycemia (1%), hyperlipidemia

Gastrointestinal: Diarrhea (4%), constipation, dyspepsia, gastroenteritis, nausea, rectal disorder, vomiting

Genitourinary: Urinary frequency, urinary tract infection

Hepatic: Liver function test abnormality increased SGPT

Neuromuscular & skeletal: Weakness, back pain, neck pain, arthralgia, hypertonia

Respiratory: Bronchitis, increased cough, dyspnea, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection

Miscellaneous: Flu syndrome, infection

<1%: Rash, allergic reaction, fever, generalized edema, neoplasm, angina pectoris, arrhythmia, congestive heart failure, ECG abnormality, hemorrhage, hypertension, hypotension, myocardial ischemia, palpitation, retinal vascular disorder, syncope, tachycardia, thrombosis, vasodilation, anorexia, aphthous stomatitis, colitis, dry mouth, duodenitis, dysphagia, gastrointestinal carcinoma, gastrointestinal hemorrhage, gastrointestinal moniliasis, gingivitis, glossitis, halitosis, increased appetite, mouth ulceration, oral moniliasis, rectal hemorrhage, stomach ulcer, stomatitis, tongue discoloration, diabetes mellitus, glycosuria, goiter,cholecystitis, cholelithiasis, cholestatic jaundice, hepatitis, increased alkaline phosphatase, increased transaminases, ecchymosis, eosinophilia, anemia, leukocytosis, leukopenia, thrombocytopenia, dehydration, gout, arthritis, bone pain, bursitis, leg cramps, neck rigidity, myalgia, tenosynovitis, confusion, convulsion, depression, dysarthria, hallucinations, hyperkinesia, decreased libido, nervousness, neuralgia, neuritis, paresthesia, decrease reflexes, somnolence, tremor, vertigo, asthma, epistaxis, laryngitis, pneumonia, voice alteration, acne, alopecia, contact dermatitis, dry skin, eczema, fungal dermatitis, herpes simplex, herpes zoster, lichenoid dermatitis, maculopapular rash, pain, pruritus, skin ulcer, sweating, urticaria, abnormal vision, amblyopia, cataract, deafness, diplopia, ear pain, extraocular palsy, glaucoma, otitis externa, taste perversion, tinnitus, albuminuria, balanitis, breast pain, cystitis, dysmenorrhea, dysuria, epididymitis, hematuria, impotence, kidney calculus, kidney pain, nocturia, pyelonephritis, scrotal edema, urethritis, impaired urination, vaginitis, anaphylaxis, angioedema, anterior ischemic optic neuropathy, erythema mulitforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, pancreatitis, hypokinesia, speech disorder, increased salivation, vertigo, increased creatinine, hypercholesterolemia, hyperuricemia

Treatment of an overdose would include appropriate supportive treatment. No adverse events were seen with ingestions of 400 and 600 mg doses. Pantoprazole is not removed by hemodialysis.

CYP2C19 and 3A4 enzyme substrate

Store at 15°C to 30°C (59°F to 77°F)

Suppresses gastric acid secretin by inhibiting the parietal cell H+/K+ ATP pump

Absorption: Well absorbed

Distribution: V_d: 11-24 L

Protein binding: 98% primarily to albumin

Metabolism: Extensively metabolized; CYP2C19 (demethylation), CYP3A4. No evidence that metabolites have pharmacologic activity.

Bioavailability: 77%

Half-life: 1 hour

Time to peak: 2.5 hours after oral ingestion

Elimination: Urine (71%) and feces (18%)

Adults: Oral: 40 mg every day for up to 8 weeks; an additional 8 weeks may be used in patients who have not healed after an 8-week course

Dosage adjustment in hepatic impairment: Dosage adjustment is not required for mild to moderate impairment. Specific guidelines are not available for patients with severe hepatic impairment.

Elderly: Dosage adjustment not required

Take with or without food

No information available to require special precautions

No effects or complications reported

Take with or without food. Do not split, chew or crush tablet; take at a similar time every day; inform prescriber if you are or intend to be pregnant; discontinue breast-feeding prior to starting this medicine.

Tablets should be swallowed whole; not chewed, crushed, or split. Do not administer via a nasogastric or feeding tube. Assess other medications the patient may be taking where absorption may be altered by a change in gastric pH (itraconazole, ketoconazole, iron salts, ampicillin esters).

Tablet: 40 mg