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Codeine (Codeine Sulfate) - Indications and Dosage



Codeine sulfate is an opioid analgesic indicated for the management of mild to moderately severe pain where the use of an opioid analgesic is appropriate.


Selection of patients for treatment with codeine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.

Individualization of Dosage

As with any opioid drug product, adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of codeine sulfate, attention should be given to the following:

  • the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;
  • the reliability of the relative potency estimate used to calculate the equivalent codeine sulfate dose needed;
  • the patient's degree of opioid tolerance;
  • the general condition and medical status of the patient;
  • concurrent medications;
  • the type and severity of the patient's pain;
  • risk factors for abuse or addiction, including a prior history of abuse and addiction.

The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Continual re-evaluation of the patient receiving codeine sulfate is important, with special attention to the maintenance of pain management and the relative incidence of side effects associated with therapy. During chronic therapy, especially for noncancer-related pain, the continued need for the use of opioid analgesics should be re-assessed as appropriate.

During periods of changing analgesic requirements, including initial titration, frequent contact is recommended between the physician, other members of the healthcare team, the patient, and the caregiver/family.

Initiation of Therapy

The usual adult dosage is 15 mg to 60 mg (2.5 mL to 10 mL) repeated up to every four hours as needed for pain. The maximum 24 hour dose is 360 mg.

Titrate the dose based upon the individual patient's response to their initial dose of codeine. Adjust the dose to an acceptable level of analgesia taking into account the improvement in pain intensity and the tolerability of the codeine by the patient.

It should be kept in mind, however, that tolerance to codeine sulfate can develop with continued use and that the incidence of untoward effects is dose-related. Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain and are associated with an appreciably increased incidence of undesirable side effects.

Cessation of Therapy

When the patient no longer requires therapy with codeine sulfate, gradually taper the dose to prevent signs and symptoms of withdrawal in the physically dependent patient.


Each 5 mL of clear, reddish-orange to orange codeine sulfate oral solution contains codeine sulfate, USP 30 mg. The concentration of the 30 mg per 5 mL solution is 6 mg/mL.


Codeine Sulfate Oral Solution

Codeine Sulfate Oral Solution, 30 mg per 5 mL is a clear, reddish-orange to orange solution available as follows:

NDC 68094-760-62
2.5 mL per unit dose cup
Thirty (30) cups per shipper

NDC 68094-761-62
5 mL per unit dose cup
Thirty (30) cups per shipper


Store at controlled room temperature, 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F).

Protect from light and moisture.

Dispense in well-closed container as defined in the USP/NF.

All opioids, including codeine sulfate, are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

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