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DULOXETINE delayed-release capsules USP(六)
2017-07-19 02:47:25 来源: 作者: 【 】 浏览:18126次 评论:0
ch as Linezolid or Methylene Blue
 
Do not start duloxetine delayed-release capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4)]. 

In some cases, a patient already receiving duloxetine delayed-release capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine delayed-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine delayed-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.4)].

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine delayed-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.4)].
 
3 DOSAGE FORMS AND STRENGTHS
 
Duloxetine Delayed-Release Capsules, USP are available as: 

20 mg size '4' hard gelatin capsule having light blue cap and body, imprinted as '20 mg' on the body and '1109' on the cap with black ink, containing off white to reddish brown colored pellets.

30 mg size '3' hard gelatin capsule having blue cap and milky white body, imprinted as '30 mg' on the body with black ink and '1110' on the cap with white ink, containing off white to reddish brown colored pellets.

60 mg size '1' hard gelatin capsule having opaque blue cap and yellow body, imprinted as '60 mg' on the body and '1111' on the cap with white ink, containing off white to reddish brown colored pellets.

4 CONTRAINDICATIONS
Monoamine Oxidase Inhibitors (MAOIs) — The use of MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4)]. 

Starting duloxetine delayed-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9) and Warnings and Precautions (5.4)]. 

5 WARNINGS AND PRECAUTIONS
5.1 Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults
 
Patie

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