OLINVYK Solution for injection Ref.[10350] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

The active ingredient in OLINVYK is oliceridine, an opioid agonist. Oliceridine fumarate is a white to lightly-colored solid that is sparingly soluble in water. The chemical name for oliceridine fumarate is [(3-methoxythiophen-2-yl)methyl]({2-[(9R)9(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine fumarate, and the molecular formula is C22H30N2O2S·C4H4O4. The theoretical average molecular mass is 502.62 (fumarate salt) and 386.55 (free base).

The structural formula of oliceridine fumarate is:

OLINVYK (oliceridine) injection is a clear, colorless, sterile, preservative-free solution, pH 6.4 to 7.4, in a glass vial for intravenous use.

Each milliliter of the solution contains 1.0 mg of oliceridine free base (1.3 mg of oliceridine fumarate salt), as well as L-histidine and mannitol, in water for injection.

Dosage Forms and Strengths

Injection: clear, colorless, sterile, preservative-free solution for intravenous use supplied as follows:

  • 1 mg/mL, equivalent to 1.3 mg/mL oliceridine fumarate salt, in single-dose, 2 mL, clear glass vials with gray plastic flip-off caps
  • 2 mg/2 mL (1 mg/mL), equivalent to 2.6 mg/2 mL (1.3 mg/mL) oliceridine fumarate salt, in single-dose, 2 mL, clear glass vials with orange plastic flip-off caps
  • 30 mg/30 mL (1 mg/mL), equivalent to 39 mg/30 mL (1.3 mg/mL) oliceridine fumarate salt, in single-patient-use, 30 mL, clear glass vials with purple plastic flip-off caps. For PCA Use Only.
How Supplied

OLINVYK (oliceridine) injection is a clear, colorless, preservative free solution for intravenous use supplied as follows:

NDC# 71308-011-10: 1 mg/mL, sterile solution in single-dose, 2 mL clear glass vials with gray stoppers topped with overseals with gray plastic flip-off caps (carton of 10 vials)

NDC# 71308-021-10: 2 mg/2 mL (1 mg/mL), sterile solution in single-dose, 2 mL clear glass vials with gray stoppers topped with overseals with orange plastic flip-off caps (carton of 10 vials)

NDC# 71308-301-10: 30 mg/30 mL (1 mg/mL), sterile solution in single-patient-use, 30 mL clear glass vials with gray stoppers topped with overseals with purple plastic flip-off caps (carton of 10 vials). For PCA Use Only.

Drugs

Drug Countries
OLINVYK United States
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈