Medication info

Reyataz Capsule 200 mg (Atazanavir Sulfate)

Prescription medicationOralApproval withdrawn
Ingredient · strength
Atazanavir Sulfate›227.79mg / 1 capsule
Manufacturer / importer
BMS Pharmaceutical Korea Ltd.
Appearance
A blue opaque capsule filled with white-yellowish granules
Packaging
60 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 200410363 · Approved 2004.08.17

This product's status changed to Approval withdrawn on 2024.05.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of HIV-1 infection in combination with other antiretroviral agents
Who takes it
Adults · Children
Adult dose
This medicine should be taken with food. The recommended oral dose of this medicine varies depending on the patient's treatment history and concomitant medications. It may need to be taken separately when used with an H2-receptor antagonist or a proton pump inhibitor. When this medicine is used with buffered or enteric-coated didanosine formulations, it should be taken with food 2 hours before or 1 hour after didanosine. Use of this medicine without ritonavir is not recommended in treatment-experienced patients who have failed to achieve viral suppression. The safety and efficacy of using this medicine with ritonavir at doses of 100mg or more once daily have not been established. Higher doses of ritonavir may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and are therefore not recommended. The recommended dose for treatment-naive patients is this medicine 300mg and ritonavir 100mg once daily (taken together with food). The recommended dose for treatment-naive patients who do not tolerate ritonavir well is this medicine 400mg (without ritonavir) once daily with food. When used with the following medicines, this medicine 300mg and ritonavir 100mg once daily (taken together with food) The dose of the H2-receptor antagonist should not exceed the equivalent of famotidine 40mg twice daily. This medicine 300mg and ritonavir 100mg should be administered at the same time as the H2-receptor antagonist and/or at least 10 hours after administration of the H2-receptor antagonist. For patients who do not tolerate ritonavir well, this medicine 400mg should be administered once daily with food at least 2 hours before and at least 10 hours after taking the H2-receptor antagonist. In these patients, a single dose of the H2-receptor antagonist should not exceed the equivalent of famotidine 20mg, and the total daily dose should not exceed the equivalent of famotidine 40mg. The dose of the proton pump inhibitor should not exceed the equivalent of omeprazole 20mg and should be administered approximately 12 hours before taking this medicine 300mg and ritonavir 100mg. If this medicine is coadministered with efavirenz, this medicine 400mg (two 200mg capsules) and ritonavir 100mg should be taken together once daily with food, and efavirenz should be taken on an empty stomach, preferably at bedtime. Dosage for treatment-experienced patients: this medicine 300mg and ritonavir 100mg once daily (taken together with food) Whenever an H2-receptor antagonist is used in patients taking this medicine and ritonavir, the dose of the H2-receptor antagonist should not exceed the equivalent of famotidine 20mg twice daily. This medicine and ritonavir should be administered at the same time as the H2-receptor antagonist and/or at least 10 hours after administration of the H2-receptor antagonist. If taking an H2-receptor antagonist, this medicine 300mg and ritonavir 100mg once daily (taken together with food) If taking both tenofovir disoproxil fumarate and an H2-receptor antagonist, this medicine 400mg and ritonavir 100mg once daily (taken together with food) Proton pump inhibitors should not be used in treatment-experienced patients taking this medicine. Efavirenz: Coadministration of efavirenz and this medicine is not recommended in treatment-experienced patients because it reduces atazanavir exposure. No dose adjustment of this medicine is required in patients with renal impairment, including those with severe renal impairment who are not receiving hemodialysis. For treatment-naive patients with end-stage renal disease receiving hemodialysis, administer this medicine 300mg and ritonavir 100mg. This medicine should not be used in treatment-experienced patients with end-stage renal disease who are receiving hemodialysis. Use with caution in patients with mild to moderate hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh Class B) who have not previously experienced virologic failure, a dose reduction to 300mg once daily should be considered. This medicine should not be used in patients with severe hepatic impairment (Child-Pugh Class C). Use of this medicine/ritonavir has not been studied in patients with hepatic impairment and is therefore not recommended.
Child dose
Ages 13 years and older and 18 years and younger: The recommended daily dose of this medication is determined by body weight and should not exceed the adult dose. This medication must be taken with food. 15kg to less than 35kg: this medication 200mg and ritonavir 100mg; administer once daily with food 35kg or more: this medication 300mg and ritonavir 100mg; administer once daily with food Body weight 40kg or more: The recommended dose for treatment-naive patients who do not tolerate ritonavir well is this medication 400mg (without ritonavir) once daily with food. Body weight 40kg or more: Patients receiving concomitant tenofovir disoproxil fumarate, an H2-receptor antagonist, or a proton pump inhibitor must not receive this medication alone without ritonavir. There are insufficient data on the recommended dosage for patients younger than 13 years of age receiving this medication without ritonavir. There are insufficient data on the recommended dosage for patients weighing less than 40kg who are receiving concomitant tenofovir disoproxil fumarate, an H2-receptor antagonist, or a proton pump inhibitor.

Ingredients

Importer
BMS Pharmaceutical Korea Ltd.

Efficacy & effects

Treatment of HIV-1 infection in combination with other antiretroviral agents

  • HIV-1 infection
View approved original text

This medication is effective in the treatment of HIV-1 infection when used in combination with other antiretroviral agents. It helps to suppress viral replication as part of combination therapy, thereby protecting immune function and slowing the progression of infection. This contributes to improving the patient's health status and enhancing their quality of life. Therefore, it is actively used for the treatment of HIV-1 infection.

How to take

Adult dose

This medicine should be taken with food. The recommended oral dose of this medicine varies depending on the patient's treatment history and concomitant medications. It may need to be taken separately when used with an H2-receptor antagonist or a proton pump inhibitor. When this medicine is used with buffered or enteric-coated didanosine formulations, it should be taken with food 2 hours before or 1 hour after didanosine. Use of this medicine without ritonavir is not recommended in treatment-experienced patients who have failed to achieve viral suppression. The safety and efficacy of using this medicine with ritonavir at doses of 100mg or more once daily have not been established. Higher doses of ritonavir may alter the safety profile of atazanavir (cardiac effects, hyperbilirubinemia) and are therefore not recommended. The recommended dose for treatment-naive patients is this medicine 300mg and ritonavir 100mg once daily (taken together with food). The recommended dose for treatment-naive patients who do not tolerate ritonavir well is this medicine 400mg (without ritonavir) once daily with food. When used with the following medicines, this medicine 300mg and ritonavir 100mg once daily (taken together with food) The dose of the H2-receptor antagonist should not exceed the equivalent of famotidine 40mg twice daily. This medicine 300mg and ritonavir 100mg should be administered at the same time as the H2-receptor antagonist and/or at least 10 hours after administration of the H2-receptor antagonist. For patients who do not tolerate ritonavir well, this medicine 400mg should be administered once daily with food at least 2 hours before and at least 10 hours after taking the H2-receptor antagonist. In these patients, a single dose of the H2-receptor antagonist should not exceed the equivalent of famotidine 20mg, and the total daily dose should not exceed the equivalent of famotidine 40mg. The dose of the proton pump inhibitor should not exceed the equivalent of omeprazole 20mg and should be administered approximately 12 hours before taking this medicine 300mg and ritonavir 100mg. If this medicine is coadministered with efavirenz, this medicine 400mg (two 200mg capsules) and ritonavir 100mg should be taken together once daily with food, and efavirenz should be taken on an empty stomach, preferably at bedtime. Dosage for treatment-experienced patients: this medicine 300mg and ritonavir 100mg once daily (taken together with food) Whenever an H2-receptor antagonist is used in patients taking this medicine and ritonavir, the dose of the H2-receptor antagonist should not exceed the equivalent of famotidine 20mg twice daily. This medicine and ritonavir should be administered at the same time as the H2-receptor antagonist and/or at least 10 hours after administration of the H2-receptor antagonist. If taking an H2-receptor antagonist, this medicine 300mg and ritonavir 100mg once daily (taken together with food) If taking both tenofovir disoproxil fumarate and an H2-receptor antagonist, this medicine 400mg and ritonavir 100mg once daily (taken together with food) Proton pump inhibitors should not be used in treatment-experienced patients taking this medicine. Efavirenz: Coadministration of efavirenz and this medicine is not recommended in treatment-experienced patients because it reduces atazanavir exposure. No dose adjustment of this medicine is required in patients with renal impairment, including those with severe renal impairment who are not receiving hemodialysis. For treatment-naive patients with end-stage renal disease receiving hemodialysis, administer this medicine 300mg and ritonavir 100mg. This medicine should not be used in treatment-experienced patients with end-stage renal disease who are receiving hemodialysis. Use with caution in patients with mild to moderate hepatic impairment. For patients with moderate hepatic impairment (Child-Pugh Class B) who have not previously experienced virologic failure, a dose reduction to 300mg once daily should be considered. This medicine should not be used in patients with severe hepatic impairment (Child-Pugh Class C). Use of this medicine/ritonavir has not been studied in patients with hepatic impairment and is therefore not recommended.

Child dose

Ages 13 years and older and 18 years and younger: The recommended daily dose of this medication is determined by body weight and should not exceed the adult dose. This medication must be taken with food. 15kg to less than 35kg: this medication 200mg and ritonavir 100mg; administer once daily with food 35kg or more: this medication 300mg and ritonavir 100mg; administer once daily with food Body weight 40kg or more: The recommended dose for treatment-naive patients who do not tolerate ritonavir well is this medication 400mg (without ritonavir) once daily with food. Body weight 40kg or more: Patients receiving concomitant tenofovir disoproxil fumarate, an H2-receptor antagonist, or a proton pump inhibitor must not receive this medication alone without ritonavir. There are insufficient data on the recommended dosage for patients younger than 13 years of age receiving this medication without ritonavir. There are insufficient data on the recommended dosage for patients weighing less than 40kg who are receiving concomitant tenofovir disoproxil fumarate, an H2-receptor antagonist, or a proton pump inhibitor.

Precautions

This medication can cause serious side effects or drug interactions that may be life-threatening when taken with other medications, so it must be taken under the guidance of a healthcare professional. Some patients may experience cardiac conduction abnormalities, particularly an increase in the PR interval on the electrocardiogram, so caution is needed for patients with heart disease or previous electrocardiogram abnormalities. Patients with diabetes or those with hyperglycemia may experience a worsening of blood glucose levels while taking this medication, so careful blood glucose management is necessary. Patients with a history of allergic reactions to the components of this medication, or those contraindicated from taking specific medications, should not use this medication. Patients with impaired liver function or those infected with hepatitis B or C viruses should undergo regular liver function tests before and during treatment due to the risk of liver function deterioration. Patients with kidney disease or impaired kidney function should conduct kidney function tests before and after taking this medication, and if any kidney-related abnormalities are found, they should consult a specialist. During treatment, adverse symptoms such as rashes, jaundice, nausea, vomiting, and diarrhea may occur; any severe or persistent symptoms should be reported to healthcare professionals immediately. This medication has a high potential for drug interactions, particularly with heart medications, anticoagulants, certain antidepressants, anticonvulsants, antibiotics, and steroids, so all medications being taken should be disclosed to healthcare professionals. When taken with antacids or gastrointestinal medications, the effectiveness of this medication may be reduced, so it should be taken at spaced intervals. Patients who are pregnant, breastfeeding, children, or the elderly should consult a doctor before using this medication. It is important to undergo regular blood tests and liver function tests to check for any adverse reactions during treatment with this medication. If symptoms such as sudden muscle pain, fever, bleeding, or difficulty breathing occur while taking this medication, a healthcare facility should be visited immediately.

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and should ideally be kept in a cool place between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

A blue opaque capsule filled with white-yellowish granules

Package unit

60 capsules/bottle

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.