Codeine (Codeine Sulfate) - Indications and Dosage

INDICATIONS AND USAGE

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.

DOSAGE FORMS AND STRENGTHS

Each 15 mg tablet for oral administration contains 15 mg of codeine sulfate. 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. 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. 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.

HOW SUPPLIED/STORAGE AND HANDLING

Codeine Sulfate

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 54868-2541-0: Bottles of 10 Tablets

NDC 54868-2541-1: Bottles of 30 Tablets

NDC 54868-2541-2: Bottles of 60 Tablets

Storage

Store at Controlled Room Temperature, 15º to 30ºC (59º to 86ºF).

Protect from moisture and light.

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

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

PATIENT COUNSELING INFORMATION

• Advise patients that codeine sulfate is a narcotic pain reliever and may be habit forming. It should be taken only as directed.
• The dose of codeine sulfate should not be adjusted without consulting with your physician.
• Advise patients that codeine may cause drowsiness, dizziness, or lightheadedness and may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery.
• Patients started on codeine sulfate or patients whose dose has been adjusted should refrain from any potentially dangerous activity until it is established that they are not adversely affected. Advise patients not to combine codeine sulfate with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
• Advise patients that codeine sulfate is a potential drug of abuse, and should be protected from theft. It should never be given to anyone other than the individual for whom it was prescribed.
• Advise patients to keep codeine sulfate in a secure place out of the reach of children. When codeine sulfate is no longer needed the unused tablets should be destroyed by flushing down the toilet.
• Advise patients of the potential for severe constipation when taking codeine sulfate; appropriate laxatives and/or stool softeners as well as other appropriate treatments should be initiated from the onset of therapy.
• Advise patients of the most common adverse events that may occur while taking codeine sulfate: drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, constipation, and sweating.
• Advise patients that some people have a genetic variation that results in their liver changing codeine into morphine more rapidly and completely than other people. These people are more likely to have higher-than-normal levels of morphine in their blood after taking codeine, which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Nursing mothers should be advised to watch for signs of morphine toxicity in their infants which includes increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby's doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).
• If patients have been receiving treatment with codeine sulfate for more than a few weeks and cessation of therapy is indicated, they should be counseled on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. The physician should provide a dose schedule to accomplish a gradual discontinuation of the medication.
• Women of childbearing potential who become or are planning to become pregnant should consult a physician prior to initiating or continuing therapy with codeine sulfate.
• Safe use in pregnancy has not been established. Prolonged use of opioid analgesics during pregnancy may cause fetal/neonatal physical dependence, and neonatal withdrawal may occur.

  10005657/01 Revised July 2009

  © RLI, 2009