OUR PRODUCTS
- Each delayed-release capsule contains 30 mg Dexalansoprazole.
- Each delayed-release capsule contains 60 mg Dexalansoprazole.
• Patients with hypersensitivity to any of the components of the preparation
• Patients receiving products containing rilpivirine.
• Antiretrovirals:
The effect of PPIs on antiretroviral drugs is variable, the clinical significance and the mechanisms underlying these interactions are not always known.
Decreased exposure to certain antiretroviral drugs (eg rilpivirine, atazanavir, nelfinavir) when used with dexlansoprazole may reduce the antiviral effect and promote the development of drug resistance.
Increased exposure to other antiretroviral drugs (eg saquinavir) when used concomitantly with dexlansoprazole may increase the toxicity of antiretroviral drugs.
There are other antiretroviral drugs that do not lead to clinically relevant interactions with dexlansoprazole.
• Warfarin: Increased INR and prothrombin time in patients receiving proton pump inhibitors with warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
• Methotrexate: Concomitant use of proton pump inhibitors with methotrexate (primarily in high doses) may elevate and prolong serum concentrations of methotrexate and/or the hydroxymethotrexate metabolite, potentially leading to methotrexate toxicity. No formal drug interaction studies have been conducted for high doses of methotrexate with proton pump inhibitors
• Digoxin: It may lead to an increase in the concentration of digoxin.
• Drugs that depend on gastric pH for absorption (eg iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole / itraconazole): Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
• Tacrolimus: Increased potential exposure to tacrolimus, especially in transplant patients who have moderate or poor metabolism by CYP2C19.
Interactions with examinations for neuroendocrine tumors: CgA levels increase secondary to PPI-induced decrease in gastric acidity. An increased CgA level may lead to false positive results in diagnostic investigations of neuroendocrine tumors.
• Interaction with secretin stimulation tests: hyperresponsiveness in gastrin secretion in response to the secretion stimulation test, incorrectly indicating the presence of a gastrinoma.
• CYP2C19 or CYP3A4 Inducers: Decreased exposure to dexlansoprazole when used concomitantly with strong inducers.
• CYP2C19 or CYP3A4 Inhibitors: Increased exposure to dexlansoprazole is expected when used concomitantly with strong inhibitors
- Healing of erosive esophagitis: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
- Maintain healing of erosive esophagitis: for up to 6 months.
- Non-erosive gastroesophageal reflux disease: For the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
- Recommended dosage for patients 12 years of age or older:
• Healing of erosive esophagitis: one delayed-release capsule of 60 mg once daily for 8 weeks.
• Healing of erosive esophagitis and maintaining gastric acidity: One 30 mg capsule once daily, controlled studies of no longer than 6 months in adults and 16 weeks in patients 12-17 years of age.
• Esophageal reflux disease without any symptoms: one 30 mg capsule daily for 4 weeks.
Dosage Adjustment in Patients with Hepatic Impairment Recovering from Erosive Esophagitis: For patients with moderate hepatic impairment, the recommended dose is 30 mg daily for 8 weeks. It is not recommended for use in patients with severe hepatic impairment.
- Consult your doctor immediately if any of the following side effects occur while taking dexlansoprazole:
Feeling of burning, itching, or numbness, chest pain or discomfort, tightness or heaviness, persistent stomach pain, diarrhea, difficulty breathing or difficulty breathing, fast or irregular heartbeat, rapid heartbeat or pulse, fever headache, Incoherent speech Joint pain, stiffness, or swelling, Dizziness, Muscle pain, cramps, or weakness, Nausea, Numbness or tingling in the hands, feet, or lips, Pain or discomfort in the arms, jaw, leg, back, or neck, Pounding in the ears, Rash Skin and hives, shaking in the legs, arms, hands or feet, sweating, swelling of the eyelids, face, lips, hands or feet, watery or bloody diarrhea
- Vitamin B12 deficiency: Decreases the amount of acid in your stomach. Stomach acid is necessary for the proper absorption of vitamin B12.
- Low levels of magnesium in the body: This problem can be serious. Low magnesium can occur in some people who take proton pump inhibitor medication for at least 3 months. If a drop in magnesium levels occurs, it is usually after a year of treatment. You may or may not have symptoms of magnesium deficiency
- Vigolans 30 mg Delayed-release capsule................(10/2021)
- Vigolans 60 mg Delayed-release capsule……….……(11/2021)
A carton box contains two blisters, inside each one 10 delayed-release capsules.