Nefecon Dosage/Direction for Use

Posology: The recommended dose is 16 mg once daily in the morning, at least one hour before a meal, for 9 months. When treatment is to be discontinued, the dose should be reduced to 8 mg once daily for 2 weeks of therapy; the dose may be reduced to 4 mg once daily for an additional 2 weeks, at the discretion of the treating physician.
Re-treatment may be considered at the discretion of the treating physician. Safety and efficacy of treatment with subsequent courses of Nefecon have not been established.
If the patient forgets to take Nefecon, the patient should take Nefecon the next day, in the morning as usual. The patient should not double the daily dose to make up for a missed dose.
Special populations: Elderly: Experience of the use of Nefecon in the elderly is limited. However, from the clinical data available, the efficacy and safety of Nefecon are expected to be similar to that of other age groups studied.
Hepatic impairment: The safety and efficacy of Nefecon capsules in patients with hepatic impairment have not been studied.
Nefecon is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C). See Contraindications, Precautions, and Pharmacology: Pharmacokinetics under Actions.
Renal impairment: The pharmacokinetics of budesonide are not expected to be altered in patients with renal impairment.
Paediatric population: The safety and efficacy of Nefecon capsules in children and adolescents below 18 years of age have not yet been established. No data are available.
Method of administration: Nefecon is for oral use. The modified-release hard capsules should be swallowed whole with water in the morning, at least 1 hour before a meal (see Pharmacology: Pharmacokinetics under Actions). The capsules must not be opened, crushed or chewed, as it could affect the release profile.