布地奈德缓释胶囊(Tarpeyo)的用法用量:用药指南,剂量调整,特殊人群用药

Budesonide extended-release capsules (Tarpeyo) are indicated for reducing the loss of kidney function in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

Usage and dosage of Budesonide sustained-release capsules (Tarpeyo)

1. Recommended treatment course

The recommended course of treatment is 9 months.

2. Dosage

Take 16 mg orally once a day. When treatment is discontinued, reduce the dose to 8 mg once daily during the last 2 weeks of treatment.

3. How to take the medicine

Swallow the tablet whole in the morning, at least 1 hour before meals. Do not open, crush or chew.

4. Treatment of missed doses

If you miss a dose, please take the prescribed dose at the next scheduled time. Do not double your next dose.

5. Dosage forms and specifications

Sustained-release capsules, each containing 4 mg of budesonide. White-coated opaque capsules with black "CAL104MG" printed on the capsule body.

6. Overdose

There are few reports of acute toxicity and/or death following corticosteroid overdose. If acute overdose occurs and there is no specific antidote, treatment includes supportive and symptomatic care.

The pictures come from public channels (such as the official website of the FDA, the official website of the original drug manufacturer, etc.) and are for reference only.

Drug interactions of Budesonide extended-release capsules (Tarpeyo)

1. Budesonide is a substrate of CYP3A4. Avoid coadministration with strong CYP3A4 inhibitors; such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine.

2. Avoid ingesting grapefruit juice while taking budesonide sustained-release capsules. Ingestion of grapefruit juice, which inhibits CYP3A4 activity, may increase systemic exposure of budesonide.

Special Population Use of Budesonide Extended-Release Capsules (Tarpeyo)

1. Pregnancy

Existing data on oral budesonide in pregnant women from published case series, epidemiological studies, and reviews have not identified significant drug-related risks of birth defects, miscarriage, or other adverse maternal or fetal outcomes. IgA nephropathy poses risks to the mother and fetus. Infants exposed to corticosteroids in utero, including budesonide, are at risk for developing adrenal insufficiency.

2. Lactation

Breastfeeding is not expected to result in significant infant exposure to budesonide, lactation studies have not been conducted with oral budesonide, and there is no information on the effects of this drug on breastfed infants or on milk production.

The developmental and health benefits of breastfeeding should be weighed against the mother's clinical need for budesonide and any potential adverse effects on the breastfed infant from budesonide extended-release capsules or underlying maternal disease.

3. Use in children

The safety and effectiveness of budesonide in pediatric patients have not been established.

4. Use in the Elderly

Clinical studies of budesonide did not include a sufficient number of subjects aged 65 and over to determine whether their responses were different from those of younger subjects.

Other reported clinical experience has not found differences in response between older and younger patients. In general, dose selection in elderly patients should be cautious, reflecting a greater frequency of decreased hepatic, renal, or cardiac function as well as concurrent illness or other drug therapy.

5. Hepatic insufficiency

Patients with moderate to severe hepatic impairment (Child-Pugh class B and C, respectively) may be at higher risk for cortical hyperfunction and adrenal axis suppression due to increased systemic exposure of budesonide.

Avoid use in patients with severe hepatic impairment (Child-Pugh Class C).

Monitor patients with moderate hepatic impairment (Child-Pugh class B) for signs and/or increased symptoms of cortical hyperactivity.