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Codeine Sulfate

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Codeine Sulfate

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Selection of patients for treatment with codeine sulfate should be governed by the same principles that apply to the use of similar opioid analgesics. Physicians should 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.

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, addiction or diversion, including a prior history of abuse, addiction or diversion.

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 control 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 physician, other members of the healthcare team, the patient, and the caregiver/family.

Initiation of Therapy

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

The initial dose should be titrated based upon the individual patient's response to their initial dose of codeine. This dose can then be adjusted 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, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

HOW SUPPLIED

Dosage Forms And Strengths

Each 15 mg tablet for oral administration contains 15 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “15” debossed on the scored side and product identification number “54 613” debossed on the other side.

Each 30 mg tablet for oral administration contains 30 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “30” debossed on the scored side and product identification number “54 783” debossed on the other side.

Each 60 mg tablet for oral administration contains 60 mg of codeine sulfate, USP. It is a white, biconvex tablet scored on one side, with strength-indicating number “60” debossed on the scored side and product identification number “54 412” debossed on the other side.

Storage And Handling

Codeine Sulfate

15 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “15” debossed on the scored side and product identification number “54 613” debossed on the other side.

Unit dose, 25 tablets per blister card

NDC 0054-8155-24: 4 Cards per Carton

30 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “30” debossed on the scored side and product identification number “54 783” debossed on the other side.

Unit dose, 25 tablets per blister card

NDC 0054-4156-24: 4 Cards per Carton
NDC 0054-0244-25: Bottles of 100 Tablets

60 mg Tablet: white, biconvex tablets scored on one side, with strength-indicating number “60” debossed on the scored side and product identification number “54 412” debossed on the other side.

NDC 0054-4157-25: Bottles of 100 Tablets

Storage

Store at Controlled Room Temperature, 15° to 30°C (59° to 86°F).

Protect from moisture and light.

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

Blisters are not child-resistant. Use child-resistant closure if dispensing to outpatient.

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

Roxane Laboratories. Revised: August 2010

Last reviewed on RxList: 5/26/2011
This monograph has been modified to include the generic and brand name in many instances.

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