Zohydro Er (Hydrocodone Bitartrate)


Zohydro Er (Hydrocodone Bitartrate)


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What is Zohydro Er (Hydrocodone Bitartrate)?

Zohydro Er (Hydrocodone Bitartrate) extended-release capsules are hard gelatin capsules for oral administration. 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).

DOSAGE AND ADMINISTRATION of Zohydro Er (Hydrocodone Bitartrate)

Important Dosage And Administration Information

ZOHYDRO ER (hydrocodone bitartrate) should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of

Daily doses of ZOHYDRO ER, a single dose of greater than 40 mg, or a total daily dose of greater than 80 mg, are only for use in patients in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with ZOHYDRO ER and adjust the dosage accordingly.

Instruct patients to swallow ZOHYDRO ER capsules whole. Crushing, chewing, or dissolving the beads in ZOHYDRO ER capsules will result in uncontrolled delivery of hydrocodone and can lead to overdose or death. ZOHYDRO ER is administered orally twice daily (every 12 hours).

SIDE EFFECTS of Zohydro Er

The following serious adverse reactions are discussed elsewhere in the labeling:

  • Addiction, Abuse, and Misuse
  • Life-Threatening Respiratory Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Interactions with Benzodiazepines and Other CNS Depressants
  • Adrenal Insufficiency
  • Severe Hypotension
  • Gastrointestinal Adverse Reactions
  • Seizures
  • Withdrawal

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Additional information


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