The 15 mg, 30 mg, 45 mg, 60 mg, and 90 mg tablets contain the following inactive ingredients: lactose monohydrate, ethyl cellulose, hypromellose, glyceryl behenate, and magnesium stearate. The 30 mg tablets also contain yellow ferric oxide.The 60 mg tablets also contain FD&C Blue #2 aluminum lake.In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration.

The starting dose for patients who are not opioid tolerant is hydrocodone bitartrate ER 20 mg orally every 24 hours.

Opioid tolerant patients 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, or an equianalgesic dose of another opioid.

Instruct patients to swallow hydrocodone bitartrate ER tablets whole; crushing, chewing or dissolving hydrocodone bitartrate ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2)].

Prolonged use of hydrocodone bitartrate ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.

Hydrocodone bitartrate extended-release (ER) tablets are supplied in 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg film-coated tablets for oral administration.

The tablet strengths describe the amount of hydrocodone per tablet as the bitartrate salt. Its chemical name is 4,5α-epoxy-3-methoxy-17methylmorphinan-6-one tartrate (1:1) hydrate (2:5).

• Limit dosages and durations to the minimum required.

• Follow patients for signs and symptoms of respiratory depression and sedation.

If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].