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SPRAVATO(esketamine)nasal spray(四)
2019-03-07 02:32:32 来源: 作者: 【 】 浏览:14426次 评论:0
nds with the Cmax) and subsequently as clinically warranted.
• If blood pressure is decreasing and the patient appears clinically stable for at least two hours,the patient may be discharged at the end of the post-dose monitoring period; if not, continueto monitor [see Warnings and Precautions (5.6)].
Food and Liquid Intake Recommendations Prior to AdministrationBecause some patients may experience nausea and vomiting after administration of SPRAVATO[see Adverse Reactions (6.1)], advise patients to avoid food for at least 2 hours beforeadministration and to avoid drinking liquids at least 30 minutes prior to administration.
Nasal Corticosteroid or Nasal DecongestantPatients who require a nasal corticosteroid or nasal decongestant on a dosing day shouldadminister these medications at least 1 hour before SPRAVATO [see Clinical Pharmacology(12.3)].
2.2 Recommended Dosage
Administer SPRAVATO in conjunction with an oral antidepressant (AD).
The recommended dosage for SPRAVATO is shown in Table 1. Dosage adjustments should bemade based on efficacy and tolerability. Evidence of therapeutic benefit should be eva luated atthe end of the induction phase to determine need for continued treatment.
Table 1: Recommended Dosage for SPRAVATO
Adults
Induction Phase Weeks 1 to 4:
Administer twice per week
Day 1 starting dose: 56 mg
Subsequent doses: 56 mg or
84 mg
Maintenance Phase Weeks 5 to 8:
Administer once weekly 56 mg or 84 mg
Week 9 and after:
Administer every 2 weeks or
once weekly* 56 mg or 84 mg
* Dosing frequency should be individualized to the least frequent dosing to maintain remission/response.
2.3 Administration Instructions
SPRAVATO is for nasal use only. The nasal spray device delivers a total of 28 mg ofesketamine. To prevent loss of medication, do not prime the device before use. Use 2 devices(for a 56 mg dose) or 3 devices (for an 84 mg dose), with a 5-minute rest between use of eachdevice. Follow these administration instructions and read the Instructions for Use beforeadministration:
2.4 Post-Administration Observation
During and after SPRAVATO administration at each treatment session, observe the patient for atleast 2 hours until the patient is safe to leave [see Warnings and Precautions (5.1, 5.2, 5.6, 5.8)].
Before SPRAVATO administration, instruct patients not to engage in potentially hazardousactivities, such as driving a motor vehicle or operating machinery, until the next day after arestful sleep.
2.5 Missed Treatment Session(s)
If a patient misses treatment sessions and there is worsening of depression symptoms, perclinical judgement, consider returning to the patient’s previous dosing schedule (i.e., every twoweeks to once weekly, weekly to twice weekly; see Table 1).
3 DOSAGE FORMS AND STRENGTHS
Nasal Spray: 28 mg of esketamine per device. Each nasal spray device delivers two sprayscontaining a total of 28 mg esketamine.
4 CONTRAINDICATIONS
SPRAVATO is contraindicated in patients with:
• Aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial, andperipheral arterial vessels) or arteriovenous malformation [see Warnings and Precautions(5.5)]
• History of intracerebral hemorrhage [see Warnings and Precautions (5.5)]
• Hypersensitivity to esketamine, ketamine, or any of the excipients.
5 WARNINGS AND PRECAUTIONS
5.1 Sedation
In clinical trials, 49% to 61% of SPRAVATO-treated patients developed sedation based on
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