Pantoprazole Sodium Delayed-release: Package Insert and Label Information (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Gastric Malignancy

Advise patients to return to their healthcare provider if they have a suboptimal response or an early symptomatic relapse [see Warnings and Precautions (5.1)].

Acute Tubulointerstitial Nephritis

Advise patients to call their healthcare provider immediately if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Contraindications (4), Warnings and Precautions (5.2)].

Clostridium difficile- Associated Diarrhea

Advise patients to immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3)].

Bone Fracture

Advise patients to report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions (5.4)].

Severe Cutaneous Adverse Reactions

Advise patients to discontinue pantoprazole sodium and immediately call their healthcare provider for further evaluation [see Warnings and Precautions (5.5)].

Cutaneous and Systemic Lupus Erythematosus

Advise patients to immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.6)].

Cyanocobalamin (Vitamin B-12) Deficiency

Advise patients to report any clinical symptoms that may be associated with cyancobalamin deficiency to their healthcare provider if they have been receiving pantoprazole sodium for longer than 3 years [see Warnings and Precautions (5.7)].

Hypomagnesemia and Mineral Metabolism

Advise patients to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia, to their healthcare provider, if they have been receiving pantoprazole sodium for at least 3 months [see Warnings and Precautions (5.8)].

Drug Interactions

Instruct patients to inform their healthcare provider of any other medications they are currently taking, including rilpivirine-containing products [see Contraindications (4)], digoxin [see Warnings and Precautions (5.8)] and high dose methotrexate [see Warnings and Precautions (5.13)].

Pregnancy

Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)].

Administration

  • Do not split, crush, or chew pantoprazole sodium delayed-release tablets.
  • Swallow pantoprazole sodium delayed-release tablets whole, with or without food in the stomach.
  • Concomitant administration of antacids does not affect the absorption of pantoprazole sodium delayed-release tablets.
  • Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular scheduled time. Do not take 2 doses at the same time.

Manufactured for:

Lifestar Pharma LLC

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Made in India

Revised: July 2022, V-04

Dispense with Medication Guide available at:

www.lifestarpharma.com/medguide/pantoprazolesodiumtablets.pdf

SPL MEDGUIDE

Dispense with Medication Guide available at:

www.lifestarpharma.com/medguide/pantoprazolesodiumtablets.pdf

MEDICATION GUIDE Pantoprazole Sodium Delayed-Release Tablets, USP (pan toe′ pra zole soe′dee um)
What is the most important information I should know about pantoprazole sodium delayed-release tablets? You should take pantoprazole sodium delayed-release tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Pantoprazole sodium delayed-release tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Pantoprazole sodium delayed-release tablets can cause serious side effects, including:
  • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including pantoprazole sodium delayed-release tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with pantoprazole sodium delayed-release tablets. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
  • Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
  • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
  • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including pantoprazole sodium delayed-release tablets, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun.
  • Low magnesium and other mineral levels in your body can happen in people who have taken pantoprazole sodium delayed-release tablets for at least 3 months. Tell your doctor if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
Talk to your doctor about your risk of these serious side effects. Pantoprazole sodium delayed-release tablets can have other serious side effects. See “What are the possible side effects of pantoprazole sodium delayed-release tablets?”
What are pantoprazole sodium delayed-release tablets? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. In adults, pantoprazole sodium delayed-release tablets are used for:
  • up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 weeks of pantoprazole sodium delayed-release tablets in patients whose EE does not heal.
  • maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD. It is not known if pantoprazole sodium delayed-release tablets are safe and effective when used for longer than 12 months for this purpose.
  • the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison Syndrome.
In children 5 years of age and older , pantoprazole sodium delayed-release tablets are used for:
  • up to 8 weeks for the healing and symptom relief of EE.
It is not known if pantoprazole sodium delayed-release tablets are safe if used longer than 8 weeks in children. Pantoprazole sodium delayed-release tablets are not for use in children under 5 years of age. It is not known if pantoprazole sodium delayed-release tablets are safe and effective in children for treatment other than EE.
Do not take pantoprazole sodium delayed-release tablets if you are:
  • allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in pantoprazole sodium delayed-release tablets. See the end of this Medication Guide for a complete list of ingredients.
  • taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) used to treat HIV-1 (Human Immunodeficiency Virus).
Before taking pantoprazole sodium delayed-release tablets, tell your doctor about all of your medical conditions, including if you:
  • have low magnesium levels, low calcium levels and low potassium levels in your blood.
  • are pregnant or plan to become pregnant. pantoprazole sodium delayed-release tablets may harm your unborn baby. Tell your doctor if you become pregnant or think you may be pregnant during treatment with pantoprazole sodium delayed-release tablets.
  • are breastfeeding or plan to breastfeed. pantoprazole sodium can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take pantoprazole sodium delayed-release tablets.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take methotrexate (Otrexup, Rasuvo, Trexall, XATMEP), digoxin (LANOXIN), or a water pill (diuretic).
How should I take pantoprazole sodium delayed-release tablets?
  • Take pantoprazole sodium delayed-release tablets exactly as prescribed by your doctor.
Pantoprazole sodium delayed-release tablets: o Do not split, chew, or crush pantoprazole sodium delayed-release tablets. o Swallow pantoprazole sodium delayed-release tablets whole, with or without food. o Tell your doctor if you are not able to swallow your pantoprazole sodium delayed-release tablet. o You may use antacids while taking pantoprazole sodium delayed-release tablets.
  • If you miss a dose of pantoprazole sodium delayed-release tablets, take it as soon as possible. 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 2 doses at the same time.
  • If you take too much pantoprazole sodium delayed-release tablets, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest emergency room.
What are the possible side effects of pantoprazole sodium delayed-release tablets? Pantoprazole sodium delayed-release tablets can cause serious side effects, including:
  • See “What is the most important information I should know about pantoprazole sodium delayed-release tablets?”
  • Low vitamin B-12 levels in your body can happen in people who have taken pantoprazole sodium delayed-release tablets for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B-12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
  • Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growths called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
  • Severe skin reactions. Pantoprazole sodium delayed-release tablets can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
    • Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
    • You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes. Stop taking pantoprazole sodium delayed-release tablets and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.
The most common side effects of pantoprazole sodium delayed-release tablets in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain. The most common side effects of pantoprazole sodium delayed-release tablets in children include: upper respiratory infection, headache, fever, diarrhea, vomiting, rash, and stomach-area (abdominal) pain. These are not all the possible side effects of pantoprazole sodium delayed-release tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store p antoprazole sodium delayed-release tablets? Store pantoprazole sodium delayed-release tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep pantoprazole sodium delayed-release tablets and all medicines out of the reach of children.
  • Bottles of 90s come in a child-resistant package.
General information about the safe and effective use of pantoprazole sodium delayed-release tablets. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pantoprazole sodium delayed-release tablets for a condition for which it was not prescribed. Do not give pantoprazole sodium delayed-release tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about pantoprazole sodium delayed-release tablets that is written for health professionals.
What are the ingredients in pantoprazole sodium delayed-release tablets? Active ingredient: pantoprazole sodium, USP Inactive ingredients in pantoprazole sodium delayed-release tablets: calcium stearate, crospovidone, hypromellose, ferric oxide red, ferrosoferric oxide black, mannitol, methacrylic acid- ethyl acrylate copolymer, polyethylene glycol, silicon dioxide, sodium carbonate, sucrose, talc, and triethyl citrate. Imprinting ink contains ammonium hydroxide, ferrosoferric oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: July 2022, V-04 For more information go to www.lifestarpharma.com or call 1-888-995-4337. This Medication Guide has been approved by the U.S. Food and Drug Administration. Brand listed are trademark of their respective owners.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70756-019-90

Pantoprazole Sodium Delayed-release Tablets, USP

40 mg

Swallow tablets whole. Do NOT

split, chew, or crush tablets.

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient

Rx only

90 Tablets

40-90
(click image for full-size original)

NDC 70756-019-12

Pantoprazole Sodium Delayed-release Tablets, USP

40 mg

Swallow tablets whole. Do NOT

split, chew, or crush tablets.

PHARMACIST: Dispense the

Medication Guide provided

separately to each patient

Rx only

1000 Tablets

40-1000
(click image for full-size original)
PANTOPRAZOLE SODIUM DELAYED-RELEASE pantoprazole sodium delayed-release tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70756-019
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PANTOPRAZOLE SODIUM (PANTOPRAZOLE) PANTOPRAZOLE 40 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA
BUTYL ALCOHOL
CALCIUM STEARATE
CROSPOVIDONE
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
HYPROMELLOSE 2910 (3 MPA.S)
ISOPROPYL ALCOHOL
MANNITOL
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM CARBONATE
SUCROSE
TALC
TRIETHYL CITRATE
Product Characteristics
Color BROWN (Light brown to brown) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code L9
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70756-019-90 90 TABLET in 1 BOTTLE None
2 NDC:70756-019-12 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215880 07/27/2022
Labeler — Lifestar Pharma LLC (080268943)
Registrant — Mankind Pharma Limited (915834068)
Establishment
Name Address ID/FEI Operations
Mankind Pharma Limited 916512493 MANUFACTURE (70756-019), ANALYSIS (70756-019), PACK (70756-019)

Revised: 08/2022 Lifestar Pharma LLC

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