Pantoprazole Sodium (Page 8 of 9)
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 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 [see Dosage and Administration ( 2)] . Pantoprazole was well tolerated at these dose levels for prolonged periods (greater than 2 years in some patients).
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Pantoprazole Sodium Delayed-Release Tablets, USP are supplied as 20 mg white to off-white, oval-shaped coated tablet, imprinted in black with “18” on one side and are available as follows:
Overbagged with 10 tablets per bag, NDC 55154-4346-0
Storage
Store Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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)] .
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 ( 5.5)] .
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 for longer than 3 years [see Warnings and Precautions ( 5.6)] .
Hypomagnesemia
Advise patients to report any clinical symptoms that may be associated with hypomagnesemia to their healthcare provider, if they have been receiving Pantoprazole for at least 3 months [see Warnings and Precautions ( 5.7)] .
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 ( 5.7)] and high dose methotrexate [see Warnings and Precautions ( 5.12)] .
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.
This product’s label may have been updated. For current full prescribing information, call 1-855-361-3993.
Manufactured for:
AvKARE
Pulaski, TN 38478
Distributed By:
Cardinal Health
Dublin, OH 43017
L58064270224
Mfg. Rev. 12/20
AV 01/21 (P)
MEDICATION GUIDE
Pantoprazole (pan toe’ pra zole) Sodium Delayed-Release Tablets, USP |
What is the most important information I should know about Pantoprazole? You should take Pantoprazole exactly as prescribed, at the lowest dose possible and for the shortest time needed. Pantoprazole may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Pantoprazole can cause serious side effects, including:
Talk to your doctor about your risk of these serious side effects. Pantoprazole can have other serious side effects. See “What are the possible side effects of Pantoprazole?” |
What is Pantoprazole? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. In adults, Pantoprazole is used for:
In children 5 years of age and older, Pantoprazole is used for:
Pantoprazole is not for use in children under 5 years of age. It is not known if Pantoprazole is safe and effective in children for treatment other than EE. |
Do not take Pantoprazole if you are:
|
Before taking Pantoprazole, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all of 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?
|
What are the possible side effects of Pantoprazole? Pantoprazole can cause serious side effects, including:
The most common side effects of Pantoprazole in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain. The most common side effects of Pantoprazole 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. 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 Pantoprazole? Store Pantoprazole at room temperature between 59° to 86°F (15° to 30°C). Keep Pantoprazole and all medicines out of the reach of children. |
General information about the safe and effective use of Pantoprazole. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Pantoprazole for a condition for which it was not prescribed. Do not give Pantoprazole 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 that is written for health professionals. |
What are the ingredients in Pantoprazole? Active ingredient: pantoprazole sodium sesquihydrate Inactive ingredients in Pantoprazole Sodium Delayed-Release Tablets: crospovidone, glyceryl dibehenate, hypromellose, lactose monohydrate, methacrylic acid copolymer dispersion, talc, titanium dioxide, and triethyl citrate. The 20 mg tablet also contains black iron oxide, isopropyl alcohol, and propylene glycol. For more information, call 1-855-361-3993. |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
This product’s label may have been updated. For more information, call 1-855-361-3993.
Manufactured for:
AvKARE
Pulaski, TN 38478
Distributed By:
Cardinal Health
Dublin, OH 43017
L58064270224
Mfg. Rev. 12/20
AV 01/21 (P)
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