Spravato 28mg (Esketamine) Nasal Spray

(25 customer reviews)

$220.00

Esketamine nasal spray is used along with another antidepressant, taken by mouth, to manage treatment-resistant depression (TRD; depression that does not improve with treatment) in adults. It is also used along with another antidepressant, taken by mouth, to treat depressive symptoms in adults with major depressive disorder (MDD) and suicidal thoughts or actions. Esketamine is in a class of medications called NMDA receptor antagonists. It works by changing the activity of certain natural substances in the brain.

Dissociation: The most common psychological effects of SPRAVATO were dissociative or perceptual changes (including distortion of time, space and illusions), derealization and depersonalization (61% to 84% of SPRAVATO -treated patients developed dissociative or perceptual changes). Given its potential to induce dissociative effects, carefully assess patients with psychosis before administering SPRAVATO; treatment should be initiated only if the benefit outweighs the risk.

Because of the risks of dissociation, patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause prolonged drowsiness, mental changes (eg, confusion about identity, place, and time, feeling of unreality, sense of detachment from self or body), or high blood pressure. Your doctor will check for these effects for at least 2 hours after each treatment session.

Esketamine nasal spray may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may make you drowsy, confused, or have problems with thinking clearly. Do not drive or do anything else that could be dangerous until the next day after a restful sleep or until you know how this medicine affects you. You may also need someone to drive you home after treatment with this medicine.

This medicine may cause bladder problems, including ulcerative or interstitial cystitis. Check with your doctor right away if you have bloody or cloudy urine, difficult, burning, or painful urination, or a frequent urge to urinate.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away. Try it with Blantons

To use the nasal device:

  • This medicine is for use only inside the nose. Do not get any of it into your eyes or on your skin. If it does get on these areas, rinse it off right away.
  • Gently blow your nose to clear the nostrils before you use the first device only.
  • Hold the device upright between your thumb and first 2 fingers. Do not press the plunger.
  • Tilt your head back slightly.
  • Insert the device tip into the first nostril. The nose rest should touch the skin between the nostrils.
  • Close the other nostril, then firmly press the plunger all the way up as you slowly breathe through your nose. Sniff gently after spraying.
  • Repeat the steps for the other nostril.
  • If you need to use another device, wait 5 minutes after each device to allow the medicine to be absorbed.
  • If liquid drips down from your nose, dab it with a tissue. Do not blow your nose.

Description

Table 1: Recommended dosing for Spravato in adults <65 years with treatment-resistant Major Depressive Disorder
Induction phase

Maintenance phase

Weeks 1-4 :Starting day 1 dose: 56 mg

Subsequent doses: 56 mg or 84 mg twice a week

Weeks 5-8 :56 mg or 84 mg once weekly

 

From Week 9:

56 mg or 84 mg every 2 weeksP Por once weekly

Evidence of therapeutic benefit should be evaluated at the end of induction phase to determine need for continued treatment. The need for continued treatment should be re-examined periodically.

 

Table 2: Recommended dosing for Spravato in adults ≥ 65 years with treatment-resistant Major Depressive Disorder
Induction phase

Maintenance phase

Weeks 1-4:Starting day 1 dose: 28 mg

Subsequent doses: 28 mg, 56 mg or 84 mg twice a week, all dose changes should be in 28 mg increments

Weeks 5-8:28 mg, 56 mg or 84 mg once weekly, all dose changes should be in 28 mg increments

 

From Week 9:

28 mg, 56 mg or 84 mg every 2 weeksP Por once weekly, all dose changes should be in 28 mg increments

Evidence of therapeutic benefit should be evaluated at the end of induction phase to determine need for continued treatment. The need for continued treatment should be reexamined periodically.

The recommended dosage of Spravato for adult patients (<65 years) is 84 mg twice per week for 4 weeks. Dosage reduction to 56 mg should be made based on tolerability. After 4 weeks of treatment with Spravato, the oral antidepressant (AD) therapy should be continued, per clinical judgement.

In these patients, treatment with Spravato should be part of the comprehensive clinical care plan.

Food and liquid intake recommendations prior to administration

Since some patients may experience nausea and vomiting after administration of Spravato, patients should be advised not to eat for at least 2 hours before administration and not to drink liquids at least 30 minutes prior to administration

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