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Zulbex Tablet

Generic Name(s): Rabeprazole

Why it's used

Zulbex Tablet is used for the short-term treatment and maintenance of healing, relief from symptoms of backflow of stomach acid in the food pipe (gastroesophageal reflux disease), and small intestine ulcer (duodenal ulcer). It is also used to treat small intestine bacterial infection (Helicobacter pylori), and cancer of stomach ulcer. It is a prescription medicine. This medicine works by preventing the amount of acid production in the stomach by blocking an organic enzyme (H+/K+ ATPase) system. This medicine helps by reducing acid secretions in the stomach. Zulbex is also used for the long-term treatment of overproduction of gastric acid (Zollinger-Ellison syndrome).
Zulbex Tablet may also be taken in combination with other medicines to treat certain conditions as recommended by the doctor. Zulbex Tablet is used together with Amoxicillin, or Clarithromycin to treat the stomach infection and small intestine ulcers caused by bacteria (Helicobacter pylori).
Proton Pump Inhibitors
Zulbex belongs to a class of medicines called Proton Pump Inhibitors. Proton-pump inhibitors (PPIs) are a group of medicines that significantly reduce stomach acid production. Excess acid production causes diseases related to the stomach and intestines. PPIs are used to treat such disorders.

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How to use

Follow directions on the product label, information guide, and provided by your doctor before using Zulbex. Eat this medicine as per your doctor's instructions.
Zulbex is eaten with or without food. Swallow the whole tablet without crushing, chewing or splitting it. Zulbex is eaten after the morning meal. When Zulbex is used in combination, tablets are taken twice a day, with the morning and evening meals, for 7 days.

Typical Dosage

The typical adult dose of Zulbex is 20 mg/day. The typical dose for children is 5-10 mg (<15 kg body weight/<33 lb) or 10-20 mg (>15 kg body weight/>33 lb) once daily for up to 12 weeks (for capsule). This medicine is commonly used for a period of 4 weeks for duodenal ulcer, 4 weeks for symptomatic gastroesophageal reflux disease (GERD), and 7 days for ulcer due to bacterial infection. There are no known habit-forming tendencies with this medicine.
Zulbex is to be used for longer periods of time. Zulbex may be taken for the long-term treatment of the overproduction of stomach acid (Zollinger-Ellison Syndrome) and reverse flow of stomach acid in the food pipe (Gastroesophageal reflux disease).
If using the delayed-release form of this medicine, do not crush or chew the medicine, unless indicated on the package. Crushing or chewing of the medicine can result in unpleasant taste resulting in patients not following the medicine schedule. Crushing or chewing can also release all of the medicine at once, resulting in a decrease of effectiveness and a possible increase in side-effects.

Talk to Your Doctor

Tell your doctor if your condition does not improve. Talk to your doctor if serious stomach problems.

Use in Children

If you are giving Zulbex Tablet to a child, be sure to use a product that is meant for use in children. Before giving this medicine, use the child's weight or age to find the right dose from the leaflet or product package. You can also read the dosage section of this page to know the correct dose for your child. Else, consult with your doctor and follow their recommendation.

Lab Tests

Before starting this medicine, your doctor may ask you to undergo certain medical or laboratory tests (Magnesium, and Antibiotic Susceptibility) to monitor for side-effects. After starting the medicine, your doctor should monitor you for these tests to make sure that you do not have side-effects of this medicine. Your doctor may require that certain tests be performed before using Zulbex Tablet. The doctor may ask you to have Magnesium test. Magnesium level should be checked before starting the treatment because low magnesium can happen in patients taking proton pump inhibitors. Your doctor may request Antibiotic Susceptibility test.

Storage

Store Zulbex Tablet at room temperature between 20°C to 25°C (68°F to 77°F), and away from moisture. Keep this medicine away from children and pets.
Medicines may be given for uses other than those listed in the medicine guide. Do not use Zulbex Tablet for symptoms for which it was not prescribed. Do not give Zulbex Tablet to others who may have similar symptoms as you. Self-medication can cause harm.

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How to take Zulbex

The dose and frequency of using Zulbex will depend on the following factors:
  • age of the patient
  • the weight of the patient
  • medicines recommended by the doctor
  • any other medicines being used
  • herbal supplements being used

Zulbex Dosage

Dosage for gastroesophageal reflux disease

Adult
  • Recommended: 20 mg/day for four to eight weeks

Dosage for maintenance of gastroesophageal reflux disease

Adult
  • Recommended: 20 mg/day

Dosage for symptoms of gastroesophageal reflux disease

Adult
  • Recommended: 20 mg/day for 4 weeks

Dosage for healing of small intestine ulcer

Adult
  • Recommended: 20 mg/day after the morning meal for up to four weeks

Dosage for overproduction of gastric acid (Zollinger-Ellison Syndrome)

Adult
  • Recommended: 60 mg/day

Dosage for short-term treatment for gastroesophageal reflux disease

Adult (12 years and older)
  • Recommended: 20 mg/day for up to 8 weeks

Dosage for backflow of stomach acid to the food pipe

Children (1 to 11 Years)
  • Recommended: 5mg/day (less than 15 kg (33 lb) body weight) for up to 12 weeks for capsule
  • Maximum: 10 mg/day
Children (1 to 11 Years)
  • Recommended: 10-20 mg/day (15 kg (33 lb) or greater body weight) body weight) for up to 12 weeks for capsule

Dosage for the stomach infection and small intestine ulcers

Adult
  • Recommended: Zulbex 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg for twice daily for 7 days

Minimum Age

1 year

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Delayed release tablet
Strength: 10 mg, 20 mg
Delayed release capsules
Strength: 5 mg,10 mg

Special Instructions

Delayed release capsule
The dose should be taken 30 minutes before a meal. Granules should not be crushed or chewed. Sprinkle the entire content of capsule on a small quantity of soft food (e.g., fruit, yogurt, applesauce) or liquid (apple juice or electrolyte solution for a child). The whole dose should be consumed within 15 minutes of preparation. Liquid or food should be at or below room temperature. Also, do not store the mixture for future use.

Missed Dose

A missed dose should be taken as early as you remember it. However, if the time for the next dose is almost there, then the missed dose should be skipped, and the regular dosing schedule should be continued. Avoid taking a double dose to make up for a missed dose.

Overdose

What to do if you overdose on Zulbex?
No specific antidote is available for an overdose of Zulbex. In this case, symptomatic (treatment according to the symptoms) and supportive therapy should be given.
If you think you have overdosed on Zulbex Tablet, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Zulbex

Before you use Zulbex, tell your doctor of your medical and health history including the following:
Before you use Zulbex Tablet, discuss with your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Tell your doctor if you are allergic any of the following substances: benzimidazoles.
The use of this medicine may change magnesium. Magnesium level should be checked before starting the treatment because low magnesium can happen in individuals who take a proton pump inhibitor medicine for at least three months.

Seizures

Zulbex Tablet can make you feel sleepy. Be careful when using any machinery, driving a vehicle, or doing any other activity that needs you to be fully alert. The consumption of alcohol with Zulbex Tablet can worsen the sleepiness. Zulbex Tablet may cause rarely seizures in some people. If you perform any activities where a loss of consciousness may cause harm to you (or others), you should discuss with your doctor.

Use in Pregnancy

The use of Zulbex during pregnancy should only be when required. Use this medicine in pregnancy only when the possible benefit justifies the possible risk of Zulbex to the fetus.

Use while Breastfeeding

It is not known if this medicine is safe for use in women who breastfeed. Consult with your doctor before you use Zulbex Tablet while breastfeeding. It is not known whether this medicine passes into breast milk.

Use while Conceiving

Consult with your doctor on the use of Zulbex, if you are trying to conceive.

Long-term Use

The long-term use of Zulbex may cause low levels of magnesium or vitamin B-12. It also increases the risk of bone fracture such as osteoporosis-related fractures of the wrist, hip or spine.

Zulbex Side-effects

The following side-effects may commonly occur when using Zulbex Tablet. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
The following side-effects may commonly occur in children when using Zulbex Tablet. Discuss with your doctor if any of these side-effects last for a long time or are severe:
Rarely, the use of Zulbex Tablet may cause the following side-effects:
The following severe side-effects may also occur when using Zulbex Tablet:
  • Blood and lymphatic system disorder
    Symptoms: decreased white blood cells (leukopenia), increased white blood cells (leukocytosis), low levels of thrombocytes, low levels of neutrophils, decreased red blood cells, white blood cells and platelets count (pancytopenia) deficiency red blood cells
  • Immune system disorders such as an allergic reaction
    Symptoms: sudden swelling of the face, difficulty breathing, low blood pressure fainting
    This medicine should be stopped if these symptoms occur.
  • Metabolism and nutrition disorder
    Symptoms: loss of appetite (anorexia), low levels of magnesium, low sodium level in the blood excess of ammonia in the blood (hyperammonemia)
  • Symptoms: depression, confusion disturbance in mental abilities (delirium)
  • Stomach and intestine disorder
    Symptoms: inflammation of the stomach (gastritis), swelling and sores inside the mouth inflammation of the large intestine (microscopic colitis)
  • Liver disorder
    Symptoms: inflammation of the liver (hepatitis), yellowing of the skin (jaundice) loss of brain function due to liver failure (hepatic encephalopathy)
  • Musculoskeletal connective tissue and bone disorder
    Symptoms: muscles breakdown (rhabdomyolysis)
  • Life-threatening drug-induced skin reaction
  • Lung infection (interstitial pneumonia)
  • Central nervous system disorder
    Symptoms: seizures
Your doctor has prescribed this medicine because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious cases of side-effects. This page does not contain a complete list of all possible side-effects.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Use In Combination With Antibacterial Agents

Patients who are allergic to antibacterial agents (clarithromycin and amoxicillin) should take precaution when using with Zulbex.

Stomach Cancer (Gastric Malignancy)

Treatment with Zulbex does not prevent the presence of stomach ulcers in these patients.

Magnesium Deficiency

Patients on prolonged treatment (at least three months or years) or who are taking Zulbex with digoxin or may cause the deficiency of magnesium are at an increased risk. This may cause harmful effects like seizures, muscle spasm, increase or decrease in heartbeat, dizziness, disturbance in mental abilities and fatigue. Treatment of low magnesium level in the blood can be improved by magnesium replacement or discontinuation of Zulbex.

Use With Methotrexate

When Zulbex is used with methotrexate, it may increase the level of methotrexate in the blood. In case of high dose intake of methotrexate, a temporary withdrawal of Zulbex should be considered.

Stomach And Intestinal Infection

Patients who are taking Zulbex are at an increased risk. Zulbex increases the count of bacteria in the stomach and intestine. It may increase the risk of infection caused by Salmonella, Campylobacter and Clostridium difficile.

Interference With Laboratory Tests

Increased Chromogranin A (protein) level may interfere with the test for both neural and endocrine cancer (neuroendocrine tumors). To avoid this interference, Zulbex should be discontinued for at least 5 days before chromogranin A measurements.

Subacute Cutaneous Lupus Erythematosus

Zulbex may cause subacute cutaneous lupus erythematosus, lesion and pain in a joints (arthralgia). Immediate medical help and discontinuation of proton pump inhibitors should be considered on the occurrence of lesions and pain in joints (arthralgia).

Use With Warfarin

Use of Zulbex with warfarin increases the levels of blood parameters such as blood clotting time which may lead to abnormal bleeding and may cause a fatality. Blood parameters should be monitored in patients taking Zulbex with warfarin.

Inflammation Within The Kidneys

Patients who are taking Zulbex are at an increased risk. Zulbex may cause inflammation in the kidneys which lead to unknown harmful allergic reactions in the body. If a patient develops inflammation in the kidneys, discontinue the use of Zulbex.

Vitamin B-12 Deficiency

Patients who are taking Zulbex are at an increased risk. Long-term (more than 3 years) use of acid-suppressing agents may lead to vitamin B-12 deficiency due to the absence of hydrochloric acid in the stomach. Diagnosis should be considered if these clinical symptoms persist.

Bacteria (Clostridium difficile) Associated Diarrhea

Patients who are taking Zulbex are at an increased risk. The use of Zulbex with clarithromycin or amoxicillin may cause bacteria associated diarrhea. Patients with bacteria associated diarrhea should take the lowest dose of Zulbex for short period of time.

Bone Fracture

Patients with bone weakness related fractures are at an increased risk when using Zulbex for the longer period of time or taking its high doses. Long-term use or high doses of Zulbex may increase the risk of fractures of the wrist, hip, or spine. Patients with bone weakness related fractures should take the lowest dose of Zulbex for the shorter duration of time. Also, patients should have an adequate intake of calcium and vitamin D.

Interactions with Zulbex

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Zulbex Tablet. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Anticoagulant

Zulbex Tablet may interact with Anticoagulant such as warfarin, which is used to treat blood clots. The use of Zulbex with warfarin increases the blood clotting time which may lead to abnormal bleeding and can be possibly fatal. Patients should be monitored for blood clotting parameters (INR and prothrombin time) when using both medicines together.

Immunosuppressant

There may be an interaction of Zulbex with Immunosuppressant such as cyclosporine, which is used during organ transplantation. Zulbex reduces the metabolism of cyclosporine which may lead to an increased level of cyclosporine in the blood.

Antifungal Drugs

Zulbex Tablet interacts with Antifungal Drugs such as ketoconazole and itraconazole, which are used to treat fungal infection. Zulbex may decrease the level of antifungal drugs in the blood. Special monitoring of patients is required who are taking Zulbex with ketoconazole and itraconazole. If required, the dose may be adjusted in such patients.

Cardiac glycoside

Special instructions need to be followed while taking this medicine along with Cardiac glycoside such as digoxin, which is used to treat heart disease. Zulbex may increase the absorption of digoxin and the combined use may cause low magnesium level. Magnesium level should be checked before and during the treatment with Zulbex.

Mycophenolate Mofetil

Your doctor's guidelines may need to be followed while taking this medicine along with Mycophenolate Mofetil, which is used during organ transplantation. Using Zulbex with mycophenolate mofetil increases stomach pH which may decrease the absorption of mycophenolate mofetil. Special precautions are required in the transplant patients taking mycophenolate mofetil with Zulbex.

Antiretroviral Drug

Zulbex Tablet may interact with Antiretroviral Drug such as atazanavir, which is used to treat human immunodeficiency virus (HIV) infection. Zulbex may decrease the level of atazanavir in the blood and thereby reduce the effectiveness of atazanavir. Use of atazanavir and Zulbex is not recommended.

Antineoplastics

There may be an interaction of Zulbex with Antineoplastic such as erlotinib, which is used in the treatment of cancer. Zulbex may decrease the absorption of erlotinib.

Antimetabolite

Zulbex Tablet interacts with Antimetabolite such as methotrexate, which is used to treat cancer. The use of Zulbex with methotrexate may increase the levels of methotrexate in blood. In case of high dose intake of methotrexate, a temporary withdrawal of proton pump inhibitors should be considered.

Antibiotics

Special instructions need to be followed while taking this medicine along with Antibiotics such as amoxicillin and clarithromycin, which are used to treat bacterial infections. The combined use of amoxicillin and clarithromycin with Zulbex may increase the levels of Zulbex and 14-hydroxyclarithromycin in the blood and this may cause harmful reactions.

Iron Salts

Your doctor's guidelines may need to be followed while taking this medicine along with Iron Salt, which is used to treat anemia. Zulbex may decrease the absorption of iron salts.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Zulbex is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.

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