Description
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DOSAGE AND ADMINISTRATION
Daily doses of ZOHYDRO ER, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.
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Patients considered opioid-tolerant are those taking, 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.
CONTRAINDICATIONS
Significant respiratory depression.
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
Known or suspected gastrointestinal obstruction, including paralytic ileus.
Hypersensitivity to hydrocodone or to any other components of ZOHYDRO
ER.
WARNINGS AND PRECAUTIONS
ZOHYDRO ER contains hydrocodone, a Schedule II controlled substance. As an opioid, it exposes users to the risks of addiction, abuse, and misuse. Because extended-release products such as it deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.
ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
• Addiction, Abuse, and Misuse [see Warnings and Precautions.
• Life-Threatening Respiratory Depression [see Warnings and Precautions.
• Neonatal Opioid Withdrawal Syndrome
• Interactions with Benzodiazepines and Other CNS Depressants.
• Adrenal Insufficiency.
• Severe Hypotension.
• Gastrointestinal Adverse Reactions.
• Seizures.
• Withdrawal
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