Zohydro

Zohydro ER (hydrocodone bitartrate) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. 

Limitations of Use

  • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Zohydro ER is not indicated as an as-needed (prn) analgesic.

Zohydro Description

Hydrocodone bitartrate is an opioid agonist and occurs as fine, white crystals, or as a crystalline powder. 

The chemical name is 4,5(alpha)-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5) or morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5 alpha)-, [R (R*, R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It has the following structural formula:

Zohydro ER (hydrocodone bitartrate) extended-release capsules are hard gelatin capsules for oral administration. Each Zohydro ER capsule contains either 10, 15, 20, 30, 40, or 50 mg of hydrocodone bitartrate USP and the following inactive ingredients: sugar spheres NF, hypromellose USP, ammonio methacrylate copolymer NF, silicon dioxide NF, and talc USP. The capsule shells collectively contain titanium dioxide, FD&C Blue #1, FD&C Red #40, FDA Yellow iron oxide, FD&C Red #3, FDA Black iron oxide, FDA Red iron oxide, and gelatin.

Zohydro Reviews

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by
Review:
This medication is long overdue, for years i have wondered why this has not been available. No acetaminophen. which greatly reducs liver damage. since it is dosed q12h these doses are not that high. For years I have seen hydrocodone/apap with the directions of 1-2 tablets q46h that could be up to 80mg of hydrocodone and 4000mg of acetaminophen.

Active Zohydro Ingredients

  1. Hydrocodone Bitartrate

Zohydro NDC Codes

NDC Quantity Package
43376-0210-10 100 Capsule 1 Bottle
43376-0215-10 100 Capsule 1 Bottle
43376-0220-10 100 Capsule 1 Bottle
43376-0230-10 100 Capsule 1 Bottle
43376-0240-10 100 Capsule 1 Bottle
43376-0250-10 100 Capsule 1 Bottle

Zohydro Structured Product Labels

SPL Manufacturer
cf68f7fe-30a9-4f1a-a3a4-6352dc436bbe Zogenix, Inc.

Zohydro Overview

Overall Rating
Medication Type
Prescription
Approval Date
Oct 25, 2013
DEA Schedule
Class 2

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