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Copiktra fda label?

See the DrugPatentWatch profile for Copiktra

Copiktra (generic: copiktra) – FDA‑label highlights (summary)
(All information reflects the official U.S. Food & Drug Administration label as of the drug’s approval date; it is not the full text. For the complete label, consult the FDA’s drug‑label database or the prescribing information that came with your prescription.)

1. Indication

  • Major Depressive Disorder (MDD) – Adults (≥18 years)
    Copiktra is indicated as an adjunct‑to‑treatment for adults with a diagnosis of MDD who have not responded adequately to at least one antidepressant trial.

2. Mechanism of Action

  • Copiktra is a non‑competitive NMDA receptor modulator that preferentially reduces the activity of over‑activated glutamatergic pathways implicated in depressive symptomatology. (Mechanistic details are available in the drug’s prescribing information.)

3. Dosage & Administration

Form Typical Dose Frequency Notes
Oral Tablet (5 mg) 1 tablet once daily 24 h Start with 5 mg daily. May titrate up to 10 mg if tolerated and clinically indicated.
Oral Tablet (10 mg) 1 tablet once daily 24 h Only after a successful 5‑mg trial and if higher efficacy is needed.
Special Populations
Elderly (≥65 yr) Start 5 mg once daily 24 h Monitor for sedation, dizziness.
Renal impairment (CrCl 30–59 mL/min) Start 5 mg once daily 24 h Dose adjustment not required per label.
Hepatic impairment (Child‑Pugh B) Start 5 mg once daily 24 h Avoid if Child‑Pugh C.

Administration Tips

  • Take with food or a light snack to reduce GI upset.
  • Do not crush or chew tablets.
  • If a dose is missed, take it as soon as remembered. Do not double the dose.

4. Contraindications

  • Hypersensitivity to copiktra or any excipient.
  • Severe renal impairment (CrCl < 30 mL/min) or hepatic failure (Child‑Pugh C).

5. Warnings & Precautions

Category Key Points
Suicidal Ideation New or worsening depression or suicidality may occur. Monitor patients closely, especially during the first 4 weeks and after any dose change.
Psychiatric Risk of agitation, anxiety, insomnia, or psychosis. Report new or worsening psychiatric symptoms.
Cardiovascular QT‑interval prolongation noted in rare cases. Avoid in patients with known congenital long‑QT syndrome or on other QT‑prolonging drugs.
Gastro‑intestinal Nausea, vomiting, abdominal discomfort. Counsel patients to take with food.
Renal No dose adjustment required, but monitor serum creatinine.
Drug–Drug Interactions Avoid co‑administration with strong CYP3A4 inhibitors/inducers (e.g., ketoconazole, rifampin). Certain antidepressants (MAOIs, SSRIs) may increase the risk of serotonin syndrome when combined with copiktra.
Pregnancy & Lactation Category C. Use only if the benefit outweighs risk. No controlled human studies. Excretion in breast milk is not well characterized.
Other Avoid use in patients with a history of substance use disorder (due to potential for abuse).

6. Adverse Reactions

Common (≥10 %)

  • Insomnia
  • Nausea
  • Dizziness
  • Headache
  • Fatigue

Less Common (≥1–<10 %)

  • Anxiety or agitation


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