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PANTOPRAZOLE SODIUM

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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use pantoprazole sodium delayed-release tablets, USP safely and effectively. See full prescribing information for pantoprazole sodium delayed-release tablets, USP. Pantoprazole Sodium Delayed-Release Tablets, USP Initial U.S. approval: 2000 RECENT MAJOR CHANGESINDICATIONS AND USAGE Short-Term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD) (1.1) Maintenance of Healing of Erosive Esophagitis (1.2) Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (1.3) DOSAGE AND ADMINISTRATION Indication Dose Frequency See full prescribing information for administration instructions Short-Term Treatment of Erosive Esophagitis Associated With GERD ( 2.1 )   Adults 40 mg Once Daily for up to 8 wks Maintenance of Healing of Erosive Esophagitis ( 2.1 )   Adults 40 mg Once Daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome ( 2.1 )   Adults 40 mg Twice Daily DOSAGE FORMS AND STRENGTHS Delayed-Release Tablets, 20 mg and 40 mg (3) WARNINGS AND PRECAUTIONS Symptomatic response does not preclude presence of gastric malignancy (5.1) Atrophic gastritis has been noted with long-term therapy (5.2) Bone Fracture Side Effects For adult use (>2%) are headache, diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, and arthralgia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Wockhardt USA LLC. at 1-800-346-6854 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONS Do not co-administer with atazanavir or nelfinavir (7.1) Concomitant warfarin use may require monitoring  (7.2) May interfere with the absorption of drugs where gastric pH is important for bioavailability (7.3) May produce false-positive urine screen for THC (7.4)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION


1 INDICATIONS AND USAGE


1.1 Short-Term Treatment of Erosive Esophagitis Associated With Gastroesophageal Reflux Disease (GERD)



1.2 Maintenance of Healing of Erosive Esophagitis


1.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing Schedule


Table 1: Recommended Dosing Schedule for Pantoprazole Sodium Delayed-Release Tablets
Indication
Dose
Frequency
* For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium delayed-release tablets may be considered.

** Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.

Short-Term Treatment of Erosive Esophagitis Associated With GERD
  Adults 40 mg Once daily for up to 8 weeks*
Maintenance of Healing of Erosive Esophagitis
  Adults 40 mg Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
  Adults 40 mg Twice daily**

2.2 Administration Instructions


Table 2: Administration Instructions
Formulation
Route
Instructions*
* Patients should be cautioned that pantoprazole sodium delayed-release tablets should not be split, chewed, or crushed
Delayed-Release Tablets
Oral Swallowed whole, with or without food
Pantoprazole Sodium Delayed-Release Tablets, USP

3 DOSAGE FORMS AND STRENGTHS


  • 40 mg yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W434” (brown ink) on other side.
  • 20 mg yellow colored, biconvex oval shaped tablets plain on one side and imprinted with “W433” (brown ink) on other side.

4 CONTRAINDICATIONS

see Description (11)

5 WARNINGS AND PRECAUTIONS

5.1 Concurrent Gastric Malignancy

5.2 Atrophic Gastritis

H. pylori

5.3 Cyanocobalamin (Vitamin B-12) Deficiency


5.4 Bone Fracture

see Dosage and Administration (2) and Adverse Reactions (6.2)

5.5 Tumorigenicity

see Nonclinical Toxicology (13.1)

5.6 Interference with Urine Screen for THC

See Drug Interactions (7.4).

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience



Adults

2
Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2%
  Pantoprazole sodium delayed-release tablets (n=1473) %

Comparators (n=345) %

Placebo (n=82) %

Headache Diarrhea Nausea Abdominal pain Vomiting Flatulence Dizziness Arthralgia






12.2 8.8 7 6.2 4.3 3.9 3 2.8






12.8 9.6 5.2 4.1 3.5 2.9 2.9 1.4






8.5 4.9 9.8 6.1 2.4 3.7 1.2 1.2








Body as a Whole:

Gastrointestinal:

Hematologic:

Metabolic/Nutritional:

Musculoskeletal:

Nervous:

Skin and Appendages:

Special Senses:



Zollinger-Ellison Syndrome

6.2 Postmarketing Experience





Immune System Disorders:

Skin and Subcutaneous Tissue Disorders:

Musculoskeletal and Connective Tissue Disorders:

Renal and Urinary Disorders:

Hepatobiliary Disorders:

Psychiatric Disorders:

7 DRUG INTERACTIONS

7.1 Interference with Antiretroviral Therapy

Concomitant use of atazanavir or nelfinavir with proton pump inhibitors is not recommended. Coadministration of atazanavir or nelfinavir with proton pump inhibitors is expected to substantially decrease atazanavir or nelfinavir plasma concentrations and may result in a loss of therapeutic effect and development of drug resistance.

7.2 Coumarin Anticoagulants

There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including pantoprazole sodium delayed-release tablets, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin concomitantly should be monitored for increases in INR and prothrombin time.

7.3 Drugs for Which Gastric pH Can Affect Bioavailability

Pantoprazole causes long-lasting inhibition of gastric acid secretion. Therefore, pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g., ketoconazole, ampicillin esters, and iron salts).

8 USE IN SPECIFIC POPULATIONS


8.1 Pregnancy

Pregnancy CategoryB





see Nonclinical Toxicology (13.2)

8.3 Nursing Mothers

Pantoprazole and its metabolites are excreted in the milk of rats. Pantoprazole 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. Many drugs which are excreted in human milk have a potential for serious adverse reactions in nursing infants. Based on the potential for tumorigenicity shown for pantoprazole in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

8.4 Pediatric Use

The effectiveness of pantoprazole sodium delayed-release tablets for treating symptomatic GERD in pediatric patients has not been established. Information describing use in pediatric patients with erosive esophagitis associated with GERD is approved for Wyeth Pharmaceuticals Inc.'s pantoprazole sodium delayed-release tablets.  However, due to Wyeth Pharmaceuticals Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.



8.5 Geriatric Use

In short-term U.S. clinical trials, erosive esophagitis healing rates in the 107 elderly patients (≥ 65 years old) treated with pantoprazole sodium delayed-release tablets were similar to those found in patients under the age of 65. The incidence rates of adverse reactions and laboratory abnormalities in patients aged 65 years and older were similar to those associated with patients younger than 65 years of age.

8.6 Gender

Erosive esophagitis healing rates in the 221 women treated with pantoprazole sodium delayed-release tablets in U.S. clinical trials were similar to those found in men. In the 122 women treated long-term with pantoprazole sodium delayed-release tablets 40 mg or 20 mg, healing was maintained at a rate similar to that in men. The incidence rates of adverse reactions were also similar for men and women.

8.7 Patients with Hepatic Impairment

Doses higher than 40 mg/day have not been studied in patients with hepatic impairment [ ]. see Clinical Pharmacology (12.3)

10 OVERDOSAGE





11 DESCRIPTION

The active ingredient in pantoprazole sodium delayed-release tablets, USP is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]1 -benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C H F N NaO S x 1.5 H O, with a molecular weight of 432.4. The structural formula is: Pantoprazole sodium sesquihydrate, USP is a white to off-white powder and is racemic. Pantoprazole has weakly basic and acidic properties. Pantoprazole sodium sesquihydrate, USP is freely soluble in water and practically insoluble in hexane. The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8. Pantoprazole sodium is supplied as a delayed-release tablet for oral administration, available in 2 strengths (40 mg and 20 mg). Each delayed-release tablet contains 45.1 mg or 22.56 mg of pantoprazole sodium sesquihydrate USP (equivalent to 40 mg or 20 mg pantoprazole, respectively) with the following inactive ingredients: aerosil 200, calcium stearate, colloidal silicon dioxide, mannitol, pregelatinized starch, shellac glaze, sodium carbonate anhydrous, sodium starch glycolate and talc. Each delayed-release tablet contains ammonium hydroxide, eudragit L 100-55, FD and C Blue #2, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 4000, polyethylene glycol 6000, propylene glycol, sodium hydroxide, titanium dioxide and triethyl citrate as the coating ingredients. Pantoprazole sodium delayed-release tablets USP, 20 mg and 40 mg, meet USP Dissolution Test 3. H 16 14 2 3 4 2
PANTOPRAZOLE SODIUM








12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

++++

12.2 Pharmacodynamics





Table 4: Effect of Single Daily Doses of Oral Pantoprazole on Intragastric pH
  –––––––—––––––––Median pH on day 7—–––––––––––––
Time Placebo 20 mg 40 mg 80 mg
* Significantly different from placebo

# Significantly different from 20 mg

8 a.m. - 8 a.m. (24 hours)
1.3 2.9* 3.8*# 3.9*#
8 a.m. - 10 p.m. (Daytime)
1.6 3.2* 4.4*# 4.8*#
10 p.m. - 8 a.m. (Nighttime)
1.2 2.1* 3* 2.6*










see Nonclinical Toxicology (13.1)

12.3 Pharmacokinetics

max

maxmax


max

max








14


max





max








in vivo

In vivoin vivo





see Drug Interactions (7.2)




34

34

12.4 Pharmacogenomics





13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility









in vitroin vitroin vivoin vitroin vitroin vitroin vivo

13.2 Animal Toxicology and/or Pharmacology




14 CLINICAL STUDIES

14.1 Erosive Esophagitis (EE) Associated with Gastroesophageal Reflux Disease (GERD)

Adult Patients

Table 5: Erosive Esophagitis Healing Rates (Per Protocol)
–––––––––––Pantoprazole Sodium Delayed-Release Tablets––––––––––– Placebo
Week 10 mg daily (n = 153)
20 mg daily (n = 158)
40 mg daily (n = 162)
(n = 68)
(p < 0.001) pantoprazole sodium delayed-release tablets versus placebo +

* (p < 0.05) versus 10 mg or 20 mg pantoprazole sodium delayed-release tablets

# (p < 0.05) versus 10 mg pantoprazole sodium delayed-release tablets

4 45.6% + 58.4% # + 75% * + 14.3%
8 66% + 83.5 % # + 92.6% * + 39.7%
H. pylori




Table 6: Erosive Esophagitis Healing Rates (Per Protocol)

––––Pantoprazole Sodium Delayed-Release Tablets–––––
Nizatidine
Week 20 mg daily (n = 72)
40 mg daily (n = 70)
150 mg twice daily (n = 70)
(p < 0.001) pantoprazole sodium delayed-release tablets versus nizatidine +
4 61.4% + 64% + 22.2%
8 79.2% + 82.9% + 41.4%
H. pylori




14.2 Long-Term Maintenance of Healing of Erosive Esophagitis


Table 7: Long-Term Maintenance of Healing of Erosive Gastroesophageal Reflux Disease (GERD Maintenance): Percentage of Patients Who Remained Healed
  Pantoprazole Sodium Delayed-Release Tablets 20 mg daily
Pantoprazole Sodium Delayed-Release Tablets 40 mg daily
Ranitidine 150 mg twice daily
* (p < 0.05 vs. ranitidine)

# (p < 0.05 vs. pantoprazole sodium delayed-release tablets 20 mg)

Note: Pantoprazole sodium delayed-release tablet 10 mg was superior (p < 0.05) to ranitidine in Study 2, but not Study 1.

Study 1
n = 75 n = 74 n = 75
Month 1 Month 3 Month 6 Month 12



91* 82* 76* 70*


99* 93*# 90*# 86*#


68 54 44 35


Study 2
n = 74 n = 88 n = 84
Month 1 Month 3 Month 6 Month 12


89* 78* 72* 72*


92*# 91*# 88*# 83*


62 47 39 37



Table 8: Number of Episodes of Heartburn (mean ± SD)
    Pantoprazole Sodium Delayed-Release Tablet 40 mg daily
Ranitidine 150 mg twice daily
* (p < 0.001 vs. ranitidine, combined data from the two US studies)
Month 1 Daytime Nighttime
5.1 ± 1.6* 3.9 ± 1.1*
18.3 ± 1.6 11.9 ± 1.1
Month 12 Daytime Nighttime
2.9 ± 1.5* 2.5 ± 1.2*
17.5 ± 1.5 13.8 ± 1.3

14.3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

In a multicenter, open-label trial of 35 patients with pathological hypersecretory conditions, such as Zollinger-Ellison syndrome, with or without multiple endocrine neoplasia-type I, pantoprazole sodium delayed-release tablets successfully controlled gastric acid secretion. Doses ranging from 80 mg daily to 240 mg daily maintained gastric acid output below 10 mEq/h in patients without prior acid-reducing surgery and below 5 mEq/h in patients with prior acid-reducing surgery. Doses were initially titrated to the individual patient needs, and adjusted in some patients based on the clinical response with time [ ]. Pantoprazole sodium delayed-release tablet was well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients).

see Dosage and Administration (2)

17 PATIENT COUNSELING INFORMATION

See FDA-Approved Patient Labeling.

Patient Counseling
  • Caution patients that pantoprazole sodium delayed-release tablets, should not be split, crushed, or chewed.
  • Tell patients that pantoprazole sodium delayed-release tablets, USP should be swallowed whole, with or without food in the stomach.
  • Let patients know that concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets, USP.
FDA-Approved Patient LabelingPATIENT INFORMATION




What is pantoprazole sodium?



  • Up to 8 weeks for short-term treatment of acid-related damage to the lining of the esophagus (erosive esophagitis) caused by gastroesophageal reflux disease (GERD). If needed, your doctor may prescribe an additional 8 weeks of pantoprazole sodium delayed-release tablets.
  • Maintain healing of acid-related damage to the lining of the esophagus and helps prevent return of heartburn symptoms caused by GERD. Pantoprazole sodium delayed-release tablets have not been studied for treatment lasting longer than 1 year
  • Treating a rare condition called Zollinger-Ellison Syndrome, where the stomach makes more than the normal amount of acid




Who should not take pantoprazole sodium delayed-release tablets, USP?

  • allergic to any of the ingredients in pantoprazole sodium delayed-release tablets. See the end of this leaflet for a complete list of ingredients in pantoprazole sodium delayed-release tablets.
  • allergic to any proton pump inhibitor (PPI). If you do not know if your medicines are PPIs, please ask your doctor.
What should I tell my doctor before taking pantoprazole sodium delayed-release tablets, USP?

Before taking pantoprazole sodiumdelayed-release tablets, tell your doctor about all your medical conditions, including if you are:
  • pregnant, think you may be pregnant, or are planning to become pregnant. It is not known if pantoprazole sodium delayed-release tablets will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • breastfeeding or planning to breastfeed. Pantoprazole sodium delayed-release tablets may pass into your milk. Talk with your doctor about the best way to feed your baby if you take pantoprazole sodium delayed-release tablets.  


  • Warfarin (Coumadin , Athrombin -K , Jantoven , Panwarfin )
  • Ketoconazole (Nizoral )
  • Atazanavir (Reyataz ), Nelfinavir (Viracept )
  • Iron supplements
  • Ampicillin antibiotics


How should I take pantoprazole sodium delayed-release tablets, USP?
  • Take pantoprazole sodium delayed-release tablets exactly as prescribed by your doctor.
  • Do not change your dose or stop pantoprazole sodium delayed-release tablets without talking to your doctor.
  • If you forget to take a dose of pantoprazole sodium delayed-release tablets, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose at your regular time. Do not take two doses to try to make up for a missed dose.
  • If you take too much pantoprazole sodium delayed-release tablets, call your doctor right away.
  • See the Patient Instructions for Use at the end of this leaflet for detailed instructions about:
    • how to take pantoprazole sodium delayed-release tablets .
What are the possible side effects of pantoprazole sodium delayed-release tablets, USP?


  • Stomach lining weakening with long-term use
  • Vitamin B-12 deficiency
  • Serious allergic reactions. Tell your doctor if you get any of the following symptoms with pantoprazole sodium delayed-release tablets
    • rash
    • face swelling
    • throat tightness
    • difficult breathing



  • Headache
  • Diarrhea
  • Nausea
  • Stomach pain
  • Vomiting
  • Gas
  • Dizziness
  • Pain in your joints

  • Upper respiratory infection
  • Headache
  • Fever
  • Diarrhea
  • Vomiting
  • Rash
  • Stomach pain






How should I store pantoprazole sodium delayed-release tablets, USP?

  • Store pantoprazole sodium delayed-release tablets at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature].
  • Keep pantoprazole sodium delayed-release tablets and all medicines out of the reach of children.  
General Information






What are the ingredients in pantoprazole sodium delayed-release tablets, USP?

Active ingredient:

Inactive ingredients in pantoprazole sodium delayed-release tablets, USP:

Patient Instructions for Use
Pantoprazole sodium delayed-release tablets, USP
  • You can take pantoprazole sodium delayed-release tablets with food or on an empty stomach.  
  • Swallow pantoprazole sodium delayed-release tablets whole.
  • If you have trouble swallowing a pantoprazole sodium delayed-release tablet 40 mg tablet, you can take two 20 mg tablets instead.
  • Do not split, chew or crush pantoprazole sodium delayed-release tablets.


Manufactured by:



Distributed by:






PANTOPRAZOLE SODIUM DR

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM

PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:50436-8102(NDC:64679-433)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM PANTOPRAZOLE 20 mg

Inactive Ingredients

Ingredient Name Strength
mannitol
STARCH, CORN
SILICON DIOXIDE
SODIUM CARBONATE
CALCIUM STEARATE
talc
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide
POLYETHYLENE GLYCOL 4000
FERRIC OXIDE YELLOW
FD&C BLUE NO. 2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
SODIUM HYDROXIDE
TRIETHYL CITRATE
polyethylene glycol 400
polyethylene glycol 6000
SHELLAC
FERROSOFERRIC OXIDE
ferric oxide red
propylene glycol
HYPROMELLOSES

Product Characteristics

Color Size Imprint Code Shape
yellow (yellow) 9 mm W433 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50436-8102-2 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091231 2011-01-19


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