Skip to main content

June 10: VDP Formulary, CAD, MCO Search Realignment Now Active

Dot gov

Official websites use the Texas HHS logo.
The Texas HHS logo means this is an official website of Texas Health and Human Services.

HTTPS

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

1. Dosage

In August 2014, the Drug Enforcement Administration published a final ruling to reschedule hydrocodone combination products from Schedule III to Schedule II due to their high potential of abuse. Beginning October 6, 2014, all hydrocodone combination products will be Schedule II. Single-entity hydrocodone products were already classified as Schedule II1.

Hydrocodone bitartrate, as combination therapy, is FDA-approved as an opioid antitussive and analgesic used for the relief of cough and moderate to moderately severe pain for which alternative treatments are inadequate2-10. Hydrocodone bitartrate is available in fixed combinations with non-opiate drugs (e.g., acetaminophen, chlorpheniramine, homatropine, ibuprofen)2,4-7,10. This drug should be given in the smallest effective dose and as infrequently as possible to minimize the development of tolerance and physical dependence. Hydrocodone bitartrate is available in the United States as a single entity, extended-release tablet (Hysingla ER), formulated with abuse-deterrent beads properties and as generic extended-release capsules2,8,9. This hydrocodone product is FDA-approved for managing pain requiring daily, long-term, around-the-clock opiate therapy for which alternative treatments are inadequate2,8,9.

The use of hydrocodone when prescribed by multiple physicians will be reviewed.

Hydrocodone/acetaminophen combination products containing greater than 325 mg of acetaminophen have been discontinued due to increased potential for liver toxicity.

Table 1. Recommended Adult Hydrocodone Dosages: Monotherapy2,3,8,9
Drug/IndicationDosage Forms/StrengthsUsual Dosage RegimenMaximum Recommended Dose
Analgesic hydrocodone extended-release tablet (Hysingla ER, generics)20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg extended-release, abuse-deterrent tablets20 mg to 120 mg every 24 hoursmaximum dose not defined; doses should be titrated per patient to maximize analgesia and minimize adverse drug reactions
Table 2. Recommended Adult Hydrocodone Dosages: Combination Therapy2,4-7,10
Drug/IndicationDosage Forms/StrengthsUsual Dosage RegimenMaximum Recommended Dose
Analgesic hydrocodone bitartrate/ acetaminophen (Lortab, Norco, generics)5 mg/300 mg, 7.5 mg/300 mg, 10 mg/300 mg, 2.5 mg/325 mg, 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg tablets; 7.5 mg/325 mg/15 ml or 10 mg/325 mg/15 ml solution; 10 mg/300 mg/15 ml elixir2.5-10 mg every 4-6 hours as needed60 mg/4000 mg daily*
Analgesic hydrocodone bitartrate/ ibuprofen (Vicoprofen, Ibudone, Reprexain, generics)2.5 mg/200 mg, 5 mg/200 mg, 7.5 mg/200 mg, 10 mg/200 mg tablets2.5-10 mg every 4-6 hours as needed5 tablets per day [maximum hydrocodone dose (10mg/200 mg): 50 mg daily]**
Antitussive hydrocodone bitartrate/homatropine (Hydromet, generics)5 mg/1.5 mg/5ml solution or 5 mg/1.5 mg tablet5 mg every 4-6 hours as needed30 mg/ 9 mg daily daily
Antitussive hydrocodone polistirex/chlorpheniramine polistirex (TussiCaps)10 mg/ 8 mg extended-release capsules1 capsule every 12 hours20 mg/16 mg every 24 hours
Antitussive hydrocodone polistirex/chlorpheniramine polistirex (Tussionex Pennkinetic, generics)10 mg/8 mg+/5 ml extended-release oral suspension10 mg/8 mg+ every 12 hours20 mg/16 mg+ daily

Legend:

  • *dosage limit based on maximum acetaminophen daily dose; varies by product
  • **short-term use (less than 10 days) recommended
  • +dosed as hydrocodone bitartrate and chlorpheniramine maleate