Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET

Treatment of gastrointestinal symptoms of functional, non-ulcer dyspepsia (chronic gastritis) ie, sensation of bloating, early satiety, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension and Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) Delayed-Release Tablets are indicated for:

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

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. For those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) may be considered. Safety of treatment beyond 8 weeks in pediatric patients has not been established.

Maintenance Of Healing Of Erosive Esophagitis

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with GERD. Controlled studies did not extend beyond 12 months.

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is used to treat erosive esophagitis (damage to the esophagus from stomach acid caused by gastroesophageal reflux disease, or GERD) in adults and children who are at least 5 years old. Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is usually given for up to 8 weeks at a time while your esophagus heals.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is also used to treat Zollinger-Ellison syndrome and other conditions involving excess stomach acid.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is not for immediate relief of heartburn.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) may also be used for purposes not listed in this medication guide.

Adults: Recommended Dose: 50 mg daily (150-mg tab taken orally 3 times a day before meals). The dose may be reduced according to the patient's age and symptoms.

Duration of Treatment: In clinical studies, Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) has been administered up to 8 weeks.

Recommended Dosing Schedule

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.

Table 1: Recommended Dosing Schedule for Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET)

Administration Instructions

Directions for method of administration for each dosage form are presented in Table 2.

Table 2: Administration Instructions

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) Delayed-Release Tablets

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) Delayed-Release Tablets.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension in liquids other than apple juice, or foods other than applesauce.

Do not divide the 40 mg Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension -Oral Administration in Applesauce

• Open packet.
• Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES.
• Take within 10 minutes of preparation.
• Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension -Oral Administration in Apple Juice

• Open packet.
• Empty granules into a small cup or teaspoon containing one teaspoon of apple juice.
• Stir for 5 seconds (granules will not dissolve) and swallow immediately.
• To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension -Nasogastric (NG) Tube or Gastrostomy Tube Administration

For patients who have a nasogastric tube or gastrostomy tube in place, Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension can be given as follows:

• Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger.
• Connect the catheter tip of the syringe to a 16 French (or larger) tube.
• Hold the syringe attached to the tubing as high as possible while giving Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

  Oral Suspension to prevent any bending of the tubing.

• Empty the contents of the packet into the barrel of the syringe.
• Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe.

How supplied

Dosage Forms And Strengths

Delayed-Release Tablets

• 40 mg, yellow oval biconvex tablets imprinted with Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (brown ink) on one side
• 20 mg, yellow oval biconvex tablets imprinted with P20 (brown ink) on one side

For Delayed-Release

Oral Suspension

• 40 mg, pale yellowish to dark brownish, enteric-coated granules in a unit dose packet

Storage And Handling

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) sodium) Delayed-Release Tablets are supplied as 40 mg yellow, oval biconvex delayed-release tablets imprinted with Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (brown ink) on one side and are available as follows:

NDC 0008-0841-81, bottles of 90

NDC 0008-0841-99, carton of 10 Redipak® blister strips of 10 tablets each

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) sodium) Delayed-Release Tablets are supplied as 20 mg yellow oval biconvex delayed-release tablets imprinted with P20 (brown ink) on one side and are available as follows:

NDC 0008-0843-81, bottles of 90

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) sodium) For Delayed-Release

Oral Suspension

NDC 0008-0844-02, unit-dose carton of 30

Storage

Store Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) For Delayed-Release

Oral Suspension and Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) Delayed-Release Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Distributed by : Wyeth Pharmaceuticals Inc, A subsidiary of Pfizer Inc., Philadelphia, PA 19101. under license from Takeda GmbH D78467 Konstanz, Germany. Revised: December 2014

Hypersensitivity to Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) hydrochloride or any of the excipients of Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET).

Patients in whom an increase in gastrointestinal motility could be harmful eg, gastrointestinal hemorrhage, mechanical obstruction or perforation.

See also:
What is the most important information I should know about Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET)?

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

You should not use this medication if you are allergic to Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) or to any other benzimidazole medication such as albendazole (Albenza), or mebendazole (Vermox).

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is not for immediate relief of heartburn symptoms.

Take this medication for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) should not be taken together with atazanavir (Reyataz) or nelfinavir (Viracept). Tell your doctor if you are taking either of these medications to treat HIV or AIDS.

Some conditions must be treated long-term with Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET). The chronic use of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) has caused stomach cancer in animal studies, but it is not known if this medication would have the same effects in humans. Talk with your doctor about your specific risk of developing stomach cancer.

Long-term treatment with Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) may also make it harder for your body to absorb vitamin B-12, resulting in a deficiency of this vitamin. Talk with your doctor if you need long-term Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) treatment and you have concerns about vitamin B-12 deficiency.

Use Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension refilled.
• Take Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension by mouth on an empty stomach about 30 minutes before a meal.
• Do not crush or chew Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension.
• Do not divide the contents of the packet to make a smaller dose.
• Only mix Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension with applesauce or apple juice. Do not mix with water or other liquids or foods.
• If you are mixing Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension with applesauce, sprinkle the contents of the packet onto 1 teaspoonful of applesauce. Swallow within 10 minutes after mixing. Take sips of water to make sure the granules are washed down into the stomach.
• If you are mixing Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension with apple juice, empty the contents of the packet into a small cup containing 5 mL (1 teaspoonful) apple juice. Stir for 5 seconds and then swallow immediately. To be sure you receive all the medicine, rinse the container once or twice with apple juice and swallow immediately.
• If the patient is taking Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension through a nasogastric (NG) tube or gastric tube, follow the instructions for use in the extra patient leaflet.
• You may take antacids while you are using Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension if you are directed to do so by your doctor.
• Continue to take Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension even if you feel well. Do not miss any doses.
• If you miss a dose of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) suspension.

Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is used to treat heartburn, feeling of stomach fullness and bloating, upper abdominal pain, nausea, vomiting and loss of appetite (anorexia).

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is used to treat certain stomach and esophagus problems (such as acid reflux). It works by decreasing the amount of acid your stomach makes. This medication relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. It helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) belongs to a class of drugs known as proton pump inhibitors (PPIs).

OTHER USES: This section contains uses of this drug that are not listed in the approved US professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat and prevent stomach and intestinal ulcers.

How to use Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET)

Read the Medication Guide provided by your pharmacist before you start taking Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Dosage and length of treatment are based on your medical condition and response to treatment.

If you are taking the tablets, you may take them with or without food. Swallow the tablets whole. Do not split, crush, or chew the medication. Doing so may destroy the drug.

If you are taking the granules, take your dose 30 minutes before a meal. To take it by mouth, open the packet and mix the granules in applesauce or apple juice. Do not mix with other foods or liquids. Do not crush or chew the granules. Sprinkle the granules on 1 teaspoon (5 milliliters) of applesauce and swallow all of the mixture right away (within 10 minutes). Follow with sips of water. Or you can mix the granules with 1 teaspoon (5 milliliters) of apple juice in a small cup, stir for 5 seconds, and swallow all of the mixture right away. To make sure you take the entire dose, rinse the cup once or twice with apple juice to mix any remaining granules, and swallow the juice. Do not prepare the mixture ahead of time for later use.

If you are giving the granules through a tube into the stomach (nasogastric or gastric tube), ask your health care professional for detailed instructions on how to properly mix and give it.

If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) at least 30 minutes before sucralfate.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.

Tell your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.

Metabolic interactions are not expected since Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is primarily metabolized by flavine monooxygenase and not by CYP450.

No changes in protein-binding have been seen with co-administration of warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine and nicardipine hydrochloride.

Since Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) has gastrokinetic effects it could influence the absorption of concomitantly orally administered drugs. Particular caution should be taken with drugs with a narrow therapeutic index, sustained-release or enteric-coated formulations.

Antiulcer drugs eg, cimetidine, ranitidine, teprenone and cetraxate do not affect the prokinetic action of Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET).

Anticholinergic drugs may reduce the action of Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET).

See also:
What other drugs will affect Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET)?

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) is metabolized through the cytochrome P450 system, primarily the CYP2C19 and CYP3A4 isozymes, and subsequently undergoes Phase II conjugation.

Based on studies evaluating possible interactions of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) with other drugs, no dosage adjustment is needed with concomitant use of the following: theophylline, cisapride, antipyrine, caffeine, carbamazepine, diazepam (and its active metabolite, desmethyldiazepam), diclofenac, naproxen, piroxicam, digoxin, ethanol, glyburide, an oral contraceptive (levonorgestrel/ethinyl estradiol), metoprolol, nifedipine, phenytoin, warfarin, midazolam, clarithromycin, metronidazole, or amoxicillin. Clinically relevant interactions of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) with other drugs with the same metabolic pathways are not expected. Therefore, when coadministered with Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET), adjustment of the dosage of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) or of such drugs may not be necessary. There was also no interaction with concomitantly administered antacids. There have been postmarketing reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET), 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.

Because of profound and long lasting inhibition of gastric acid secretion, Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (eg, ketoconazole, ampicillin esters, and iron salts).

Laboratory Tests

There have been reports of false-positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving most proton pump inhibitors, including Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET). An alternative confirmatory method should be considered to verify positive results.

Clinical Trials: In clinical trials (phase I-III), Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) hydrochloride was well-tolerated and no serious adverse reactions were reported. A total of 19 adverse drug reactions in 14 patients were reported out of 572 cases with an incidence of 2.4%. The majority of these adverse reactions occurring in >1 patient consisted of diarrhea in 4 cases (0.7%), headache in 2 cases (0.3%) and abdominal pain in 2 cases (0.3%).

Abnormal laboratory findings observed in the trials include decreased white blood cells (leukocytopenia) in 4 cases (0.7%), increased prolactin in 2 cases (0.3%).

Post Marketing Experience: The following adverse events have been reported in patients receiving Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) hydrchloride.

Blood and Lymphatic System Disorders: Leukopenia and thrombocytopenia.

Immune System Disorders: Anaphylactoid reaction.

Endocrine Disorders: Increased prolactin level and gynecomastia.

Nervous System Disorders: Dizziness, headache and tremor.

Gastrointestinal Disorders: Diarrhea, constipation, abdominal pain, increased saliva and nausea.

Hepatobiliary Disorders: Jaundice.

Skin and Subcutaneous Tissue Disorders: Rash, redness and itching.

Investigations: Increased aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase (SGOT)], alanine aminotransferase (ALT) [serum glutamic pyruvic transaminase (SGPT)], γ-glutamyl transpeptidase (γ-GTP), alkaline phosphatase and bilirubin.

See also:
What are the possible side effects of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET)?

The adverse reaction profiles for Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) sodium) For Delayed-Release

Oral Suspension and Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) sodium) Delayed-Release Tablets are similar.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adults

Safety in nine randomized comparative US clinical trials in patients with GERD included 1,473 patients on oral Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) (20 mg or 40 mg), 299 patients on an H2-receptor antagonist, 46 patients on another proton pump inhibitor, and 82 patients on placebo. The most frequently occurring adverse reactions are listed in Table 3.

Table 3: Adverse Reactions Reported in Clinical Trials of Adult Patients with GERD at a Frequency of > 2%

Additional adverse reactions that were reported for Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) in clinical trials with a frequency of ≤ 2% are listed below by body system:

Body as a Whole: allergic reaction, pyrexia, photosensitivity reaction, facial edema

Gastrointestinal: constipation, dry mouth, hepatitis

Hematologic: leukopenia, thrombocytopenia

Metabolic/Nutritional: elevated CK (creatine kinase), generalized edema, elevated triglycerides, liver enzymes elevated

Musculoskeletal: myalgia

Nervous: depression, vertigo

Skin and Appendages: urticaria, rash, pruritus

Special Senses: blurred vision

Pediatric Patients

Safety of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three clinical trials. Safety trials involved pediatric patients with EE; however, as EE is uncommon in the pediatric population, 249 pediatric patients with endoscopically-proven or symptomatic GERD were also evaluated. All adult adverse reactions to Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) are considered relevant to pediatric patients. In patients ages 1 year through 16 years, the most commonly reported ( > 4%) adverse reactions include: URI, headache, fever, diarrhea, vomiting, rash, and abdominal pain.

For safety information in patients less than 1 year of age see Use in Specific Populations.

Additional adverse reactions that were reported for Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) in pediatric patients in clinical trials with a frequency of ≤ 4% are listed below by body system:

Body as a Whole: allergic reaction, facial edema

Gastrointestinal: constipation, flatulence, nausea

Metabolic/Nutritional: elevated triglycerides, elevated liver enzymes, elevated CK (creatine kinase)

Musculoskeletal: arthralgia, myalgia

Nervous: dizziness, vertigo

Skin and Appendages: urticaria

The following adverse reactions seen in adults in clinical trials were not reported in pediatric patients in clinical trials, but are considered relevant to pediatric patients: photosensitivity reaction, dry mouth, hepatitis, thrombocytopenia, generalized edema, depression, pruritus, leukopenia, and blurred vision.

Zollinger-Ellison Syndrome

In clinical studies of Zollinger-Ellison Syndrome, adverse reactions reported in 35 patients taking Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) 80 mg/day to 240 mg/day for up to 2 years were similar to those reported in adult patients with GERD.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These adverse reactions are listed below by body system:

General Disorders and Administration Conditions: asthenia, fatigue, malaise

Hematologic: pancytopenia, agranulocytosis

Hepatobiliary Disorders: hepatocellular damage leading to jaundice and hepatic failure

Immune System Disorders: anaphylaxis (including anaphylactic shock)

Infections and Infestations: Clostridium difficile associated diarrhea

Investigations: weight changes

Metabolism and Nutritional Disorders: hyponatremia, hypomagnesemia

Musculoskeletal Disorders: rhabdomyolysis, bone fracture

Nervous: ageusia, dysgeusia

Psychiatric Disorders: hallucination, confusion, insomnia, somnolence

Renal and Urinary Disorders: interstitial nephritis

Skin and Subcutaneous Tissue Disorders: severe dermatologic reactions (some fatal), including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN, some fatal), and angioedema (Quincke's edema)

Each film-coated tablet also contains the following inactive ingredients: Lactose, cornstarch, carmellose, light anhydrous silicic acid, magnesium stearate, hydroxypropylmethylcellulose 2910 (6 mm²/s), macrogol 6000, titanium oxide and carnauba wax.

The film-coated tablet is formulated to provide immediate release.

Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) hydrochloride is N-(4-(2(dimethylamino)ethoxy)benzyl)-3,4-dimethoxybenzamide hydrochloride. Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) hydrochloride is a substituted benzamide. It has an empirical formula of C₂0H₂₆N₂O₄·HCl and a molecular weight of 394.89 g/mol.

Itopride (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) hydrochloride is a white to pale yellowish white crystal or crystalline powder. It is odorless and has a bitter taste. It is very soluble in water, freely soluble in methanol or in glacial acetic acid, sparingly soluble in ethanol and practically insoluble in acetic anhydride or in ether. The pH of the solution is 4-5. The melting point is 193°-198°C.

Each 20-mg tablet contains Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) sodium sesquihydrate 22.6 mg equivalent to Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) 20 mg.

Pantoprazole (Pantoprazole 40MG + ITOPRIDE 150MG SR TABLET) also contains the following excipients: Crospovidone, yellow iron oxide E172, hypromellose 2910, methylacrylic acid-ethyl acrylate copolymer (1:1), polysorbate 80, sodium carbonate, titanium dioxide E171, triethyl citrate; mannitol (approximately 0.0036 BU), povidone K90, calcium stearate, povidone K25, propylene glycol, sodium lauryl sulfate; printing ink (for tablets only); microcrystalline cellulose, povidone, sodium dodecyl sulfate.