PANTOPRAZOLE SODIUM: Package Insert and Label Information (Page 5 of 6)

14.2 Long-Term Maintenance of Healing of Erosive Esophagitis

Two independent, multicenter, randomized, double-blind, comparator-controlled trials of identical design were conducted in adult GERD patients with endoscopically confirmed healed EE to demonstrate efficacy of pantoprazole sodium delayed-release tablets in long-term maintenance of healing. The two US studies enrolled 386 and 404 patients, respectively, to receive either 10 mg, 20 mg, or 40 mg of pantoprazole sodium delayed-release tablets once daily or 150 mg of ranitidine twice daily. As demonstrated in Table 10, pantoprazole sodium delayed-release tablets 40 mg and 20 mg were significantly superior to ranitidine at every timepoint with respect to the maintenance of healing. In addition, pantoprazole sodium delayed-release tablet 40 mg was superior to all other treatments studied.

Table 10: 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 Tablets40 mg daily	Ranitidine150 mg twice daily
Study 1	n = 75	n = 74	n = 75
Month 1	91*	99*	68
Month 3	82*	93*#	54
Month 6	76*	90*#	44
Month 12	70*	86*#	35
Study 2	n = 74	n = 88	n = 84
Month 1	89*	92*#	62
Month 3	78*	91*#	47
Month 6	72*	88*#	39
Month 12	72*	83*	37

* (p < 0.05 vs. ranitidine)

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

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

Pantoprazole sodium delayed-release tablet 40 mg was superior to ranitidine in reducing the number of daytime and nighttime heartburn episodes from the first through the twelfth month of treatment. Pantoprazole sodium delayed-release tablets 20 mg, administered once daily, was also effective in reducing episodes of daytime and nighttime heartburn in one trial, as presented in Table 11.

Table 11: Number of Episodes of Heartburn (mean ± SD)

	Pantoprazole Sodium Delayed-Release Tablets 40 mg daily		Ranitidine 150 mg twice daily
Month 1	Daytime	5.1 ± 1.6*	18.3 ± 1.6
	Nighttime	3.9 ± 1.1*	11.9 ± 1.1
Month 12	Daytime	2.9 ± 1.5*	17.5 ± 1.5
	Nighttime	2.5 ± 1.2*	13.8 ± 1.3

^* (p < 0.001 vs. ranitidine, combined data from the two US studies)

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 [see Dosage and Administration (2)]. Pantoprazole sodium delayed-release tablet 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 for delayed-release oral suspension is supplied as pale yellowish to dark brownish, enteric-coated granules containing 40 mg pantoprazole in a unit-dose packet. Pantoprazole sodium for delayed-release oral suspension is supplied as child-resistant sachets as follows:

NDC 62756-071-64, unit-dose carton of 30.

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
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 for delayed-release oral suspension 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 delayed-release oral suspension 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 delayed-release oral suspension 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 for delayed-release oral suspension.
• Pantoprazole sodium for delayed-release oral suspension packet is a fixed dose and cannot be divided to make a smaller dose.
• Take pantoprazole sodium for delayed-release oral suspension approximately 30 minutes before a meal.
• Administer pantoprazole sodium for delayed-release oral suspension in apple juice or applesauce, as described in the Instructions for Use. Do not administer in water, other liquids, or foods.
• For patients with a nasogastric (NG) or gastrostomy tube, pantoprazole sodium for delayed-release oral suspension can be administered with apple juice, as described in the Instructions for Use.
• 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.

MEDICATION GUIDE

Dispense with Medication Guide available at: https://www.sunpharma.com/usa/products

MEDICATION GUIDE Pantoprazole Sodium (pan-TOE-pra-zole SOE-dee-um) for Delayed-Release Oral Suspension

What is the most important information I should know about pantoprazole sodium for delayed-release oral suspension? You should take pantoprazole sodium for delayed-release oral suspension exactly as prescribed, at the lowest dose possible and for the shortest time needed. Pantoprazole sodium for delayed-release oral suspension may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.Pantoprazole sodium for delayed-release oral suspension 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 for delayed-release oral suspension, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with pantoprazole sodium for delayed-release oral suspension. 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 for delayed-release oral suspension, 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 for delayed-release oral suspension 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 for delayed-release oral suspension can have other serious side effects. See “What are the possible side effects of pantoprazole sodium for delayed-release oral suspension?”

What is pantoprazole sodium for delayed-release oral suspension? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. In adults, pantoprazole sodium for delayed-release oral suspension is 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 for delayed-release oral suspension 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 for delayed-release oral suspension is 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 for delayed-release oral suspension is used for: up to 8 weeks for the healing and symptom relief of EE. It is not known if pantoprazole sodium for delayed-release oral suspension is safe if used longer than 8 weeks in children.Pantoprazole sodium for delayed-release oral suspension is not for use in children under 5 years of age. It is not known if pantoprazole sodium for delayed-release oral suspension is safe and effective in children for treatment other than EE.

Do not take pantoprazole sodium for delayed-release oral suspension if you are: allergic to pantoprazole sodium, any other PPI medicine, or any of the ingredients in pantoprazole sodium for delayed-release oral suspension. 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 for delayed-release oral suspension, 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 for delayed-release oral suspension may harm your unborn baby. Tell your doctor if you become pregnant or think you may be pregnant during treatment with pantoprazole sodium for delayed-release oral suspension. are breastfeeding or plan to breastfeed. Pantoprazole can pass into your breast milk. Talk with your doctor about the best way to feed your baby if you take pantoprazole sodium for delayed-release oral suspension. 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 for delayed-release oral suspension? Take pantoprazole sodium for delayed-release oral suspension exactly as prescribed by your doctor. Do not split, chew, or crush pantoprazole sodium for delayed-release oral suspension. Take pantoprazole sodium for delayed-release oral suspension about 30 minutes before a meal. Pantoprazole sodium for delayed-release oral suspension should only be given by mouth mixed in apple juice or applesauce or through a nasogastric (NG) tube or gastrostomy tube mixed in apple juice. Do not mix pantoprazole sodium for delayed-release oral suspension in liquids other than apple juice or foods other than applesauce. Do not divide a packet of pantoprazole sodium for delayed-release oral suspension to make a smaller dose. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and take pantoprazole sodium for delayed-release oral suspension by mouth in applesauce or apple juice or how to mix and give the suspension through an NG tube or gastrostomy tube mixed in apple juice. If you miss a dose of pantoprazole sodium for delayed-release oral suspension, 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 for delayed-release oral suspension, 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 for delayed-release oral suspension? Pantoprazole sodium for delayed-release oral suspension can cause serious side effects, including: See “What is the most important information I should know about pantoprazole sodium for delayed-release oral suspension?” Low vitamin B-12 levels in your body can happen in people who have taken pantoprazole sodium for delayed-release oral suspension 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 for delayed-release oral suspension 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 for delayed-release oral suspension 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 for delayed-release oral suspension in adults include: headache, diarrhea, nausea, stomach-area (abdominal) pain, vomiting, gas, dizziness, and joint pain. The most common side effects of pantoprazole sodium for delayed-release oral suspension 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 for delayed-release oral suspension. 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 sodium for delayed-release oral suspension? Pantoprazole sodium for delayed-release oral suspension comes in a child-resistant package. Store pantoprazole sodium for delayed-release oral suspension at room temperature between 68°F to 77°F (20°C to 25°C).Keep pantoprazole sodium for delayed-release oral suspension and all medicines out of the reach of children.

General information about the safe and effective use of pantoprazole sodium for delayed-release oral suspension. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use pantoprazole sodium for delayed-release oral suspension for a condition for which it was not prescribed. Do not give pantoprazole sodium for delayed-release oral suspension 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 for delayed-release oral suspension that is written for health professionals.

What are the ingredients in pantoprazole sodium for delayed-release oral suspension ? Active ingredient: pantoprazole sodium sesquihydrate Inactive ingredients: calcium stearate, crospovidone, ferric oxide yellow, hydroxypropyl cellulose, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, and triethyl citrate For more information, call 1-800-818-4555.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2022