Pantoprazole Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Pantoprazole Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

PANTOPRAZOLE SODIUM DESCRIPTION


Pantoprazole Sodium





CLINICAL PHARMACOLOGY

Pharmacokinetics
CLINICAL PHARMACOLOGY, Pharmacokinetics, Metabolism

Absorption


Distribution


Metabolism


Elimination


Special Populations

Geriatric


Pediatric


Gender


Renal Impairment


Hepatic Impairment


Drug-Drug Interactions


Pharmacodynamics

Mechanism of Action


Antisecretory Activity





Serum Gastrin Effects




Enterochromaffin-Like (ECL) Cell Effects



Other Effects



Clinical Studies


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











Long-Term Maintenance of Healing of Erosive Esophagitis







Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome



INDICATIONS & USAGE

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


Maintenance of Healing of Erosive Esophagitis


Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome


PANTOPRAZOLE SODIUM CONTRAINDICATIONS



PRECAUTIONS

General





INFORMATION FOR PATIENTS



DRUG INTERACTIONS






CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY









PREGNANCY

Teratogenic Effects

Pregnancy Category B


NURSING MOTHERS



PEDIATRIC USE


Use in Women


GERIATRIC USE



Laboratory Tests


PANTOPRAZOLE SODIUM ADVERSE REACTIONS





























Postmarketing Reports











Laboratory Values


OVERDOSAGE





DOSAGE & ADMINISTRATION

Treatment of Erosive Esophagitis


Maintenance of Healing of Erosive Esophagitis


Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome





HOW SUPPLIED


















STORAGE AND HANDLING



INFORMATION FOR PATIENTS



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 Labeling
PATIENT 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 (CoumadinAthrombin -KJantovenPanwarfin
  • ●     Ketoconazole (Nizoral
  • ●     Atazanavir (ReyatazNelfinavir (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












How should I store pantoprazole sodium delayed-release tablets, USP?
  • ●     Store pantoprazole sodium delayed-release tablets at 20(68
  • ●     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

  • ●     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.



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Pantoprazole Sodium

Pantoprazole Sodium

Pantoprazole Sodium

Pantoprazole Sodium TABLET, DELAYED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-851(NDC:64679-434)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM PANTOPRAZOLE 40 mg

Inactive Ingredients

Ingredient Name Strength
mannitol
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 12 mm W434 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-851-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091231 2011-12-02


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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