A-Z Drug Facts > Pantoprazole Sodium

Pantoprazole Sodium

Pronouncation: (pahn-TOE-prazz-ole SO-dee-uhm)
Class: Proton Pump Inhibitor

Trade Names:
Protonix
- Tablets, delayed-release 40 mg
- Tablets, delayed-release 20 mg

Trade Names:
Protonix IV
- Powder for Injection 40 mg/vial

Panto IV (Canada)
Pantoloc (Canada)

Pharmacology

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Suppresses gastric acid secretion by blocking acid (proton) pump within gastric parietal cells.

Pharmacokinetics

Absorption

Rapid. C _max is 2.5 mcg/mL (oral) and 5.52 mcg/mL (IV); bioavailability is approximately 77% (oral). T _max is 2.5 h. Oral administration with food may delay absorption up to 2 h or longer.

Distribution

Pantoprazole distributes mainly in extracellular fluid. Vd is 11 to 23.6 L. Protein binding is approximately 98%, mainly albumin.

Metabolism

Pantoprazole is extensively metabolized in the liver through CYP-450. The main metabolic pathway is demethylation by CYP2C19 and oxidation by CYP3A4. No evidence of metabolites with pharmacologic activity. CYP2C19 displays genetic polymorphism because of deficiency in some populations (3% of white and black patients, 17% to 23% of Asian patients); these patients are known to be slow metabolizers of pantoprazole.

Elimination

Urine (71%), feces (18%); no renal excretion of unchanged drug. The t _½ is 1 h, and 3.5 to 10 h in slow metabolizers. Total Cl is 7.6 to 14 L/h.

Duration

More than 24 h.

Special Populations

Hepatic Function Impairment

With oral administration, there is an increase in serum elimination t _½ from 7 to 9 h; AUC increases by 5- to 7-fold. No dosage adjustment is necessary.

Elderly

Moderate increase in AUC (43%) and C _max (26%). No dosage adjustment is recommended.

Gender

Oral administration produces a modest increase in AUC and C _max in women. No dosage adjustment is recommended.

Indications and Usage

Oral

Short-term (no more than 8 wk) treatment in the healing and symptomatic relief of erosive esophagitis associated with gastroesophageal reflux disease (GERD); long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome; maintenance of healing of erosive esophagitis.

IV

Short-term (7- to 10-day) treatment of GERD, as an alternative to oral therapy in patients unable to continue oral pantoprazole; hypersecretory conditions associated with Zollinger-Ellison syndrome or other neoplastic conditions.

Contraindications

Standard considerations.

Dosage and Administration

Treatment of Erosive Esophagitis
Adults

PO 40 mg/day for up to 8 wk; an additional 8-wk course of treatment may be considered in patients who have not healed after 8 wk.

Adults

IV 40 mg/day for 7 to 10 days.

Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome
Adults

PO Recommended starting dose is 40 mg twice daily, adjusting the dose to the patient's needs and continuing therapy as long as clinically indicated. IV 80 mg every 12 h; based upon individual patient needs, the dose may be increased to 80 mg every 8 h.

Maintenance of Healing of Erosive Esophagitis
Adults

PO 40 mg/day.

General Advice

Tablets

• May be used concomitantly with antacids.
• Administer without regard to meals but administer with food if GI upset occurs.
• Instruct patient to swallow tablet whole and not to split, chew, or crush the tablet.

Injection

• For IV administration only. Not for intradermal, subcutaneous, IM, or intra-arterial administration.
• Infuse prescribed dose through a dedicated line or Y-site over a period of 2 min or 15 min (7 mL/min) as ordered. Flush IV line before and after administration of pantoprazole with dextrose 5% injection, sodium chloride 0.9% injection, or lactated Ringer's injection.
• For 2-min infusion of 40 mg dose, reconstitute 1 vial of powder for injection with 10 mL of sodium chloride 0.9% injection to produce a solution with a final concentration of 4 mg/mL. Infuse total volume over a period of 2 min.
• For 2-min infusion of 80 mg dose, reconstitute each of 2 vials of powder for injection with 10 mL of sodium chloride 0.9% injection to produce a solution with a final concentration of 4 mg/mL. Infuse total volume from both vials IV over a period of 2 min.
• For 15-min infusion of 40 mg dose, reconstitute 1 vial with 10 mL of 0.9% sodium chloride injection. Further dilute (admix) with 100 mL dextrose 5% injection, sodium chloride 0.9% injection, or lactated Ringer's injection to a total volume of 110 mL, producing a solution with a final concentration of approximately 0.4 mg/mL.
• For 15-min infusion of 80 mg dose, reconstitute each of 2 vials with 10 mL of sodium chloride 0.9% injection. Combine contents of 2 vials and further dilute (admix) with 80 mL dextrose 5% injection, sodium chloride 0.9% injection, or lactated Ringer's injection to a total volume of 100 mL, producing a solution with a final concentration of approximately 0.8 mg/mL.
• Do not administer if particulate matter, cloudiness, or discoloration noted.
• Discard any unused reconstituted or admixed solution. Do not save for future use.

Storage/Stability

Store tablets at controlled room temperature (59° to 86°F). Store powder for injection in refrigerator (36° to 46°F). Protect powder for injection from light. Do not freeze reconstituted solution. Reconstituted solution may be stored for up to 2 h at room temperature prior to further dilution. Admixed solution may be stored for up to 22 h at room temperature prior to IV infusion. Neither reconstituted solution nor admixed solution need to be protected from light.

Drug Interactions

Drugs depending on gastric pH for bioavailability (eg, ampicillin, cyanocobalamin, ketoconazole, iron salts)

Absorption of these drugs may be affected.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Migraine (at least 1%).

CNS

Headache (9%); insomnia (1%); anxiety, asthenia, increased dizziness, hypertonia (at least 1%); anterior ischemic optic neuropathy, confusion, hypokinesia, speech disorder, increased salivation, tinnitus, vertigo (postmarketing).

Dermatologic

Rash (2%); severe dermatologic reactions (eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) (postmarketing).

EENT

Pharyngitis, rhinitis (at least 1%); blurred vision (postmarketing).

GI

Diarrhea (6%); flatulence, abdominal pain (4%); nausea, vomiting (2%); eructation (1%); constipation, dyspepsia, gastroenteritis, GI disorder, vomiting (at least 1%); pancreatitis (postmarketing).

Genitourinary

Rectal disorder, urinary frequency, UTI (at least 1%); interstitial nephritis (postmarketing).

Hematologic-Lymphatic

Pancytopenia (postmarketing).

Hepatic

Abnormal LFTs, increased ALT (2%); hepatocellular damage leading to jaundice and hepatic failure (postmarketing).

Lab Tests

Elevated CPK (postmarketing).

Local

Injection site reactions (including abscess, thrombophlebitis) (at least 1%).

Metabolic-Nutritional

Hyperglycemia (1%); hyperlipidemia (at least 1%).

Musculoskeletal

Arthralgia, back pain, neck pain (at least 1%).

Respiratory

Bronchitis, cough, dyspnea, sinusitis, upper respiratory tract infection (at least 1%).

Miscellaneous

Chest pain, flu syndrome, infection, pain (at least 1%); anaphylaxis, angioedema, rhabdomyolysis (postmarketing).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Patient Information

• Advise patient or caregiver that injection will be prepared and administered by a health care professional and is used temporarily when oral therapy is not feasible.
• Instruct patient to take each dose without regard to meals but to take with food if stomach upset occurs.
• Instruct patient to swallow tablet whole and not to split, crush, or chew the tablet.
• Remind patient that pantoprazole is to be taken every day and not as needed or only when symptoms are present.
• Remind patient that antacids may be taken concurrently with pantoprazole.
• Instruct patient to report any of the following to health care provider: bloody or coffee ground vomit; black tarry stools; recurrent heartburn; recurrent indigestion or abdominal pain; increasing need for antacid use; or bothersome side effects (eg, headache, constipation, gas).

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