Codeine sulfate

Pronunciation

Generic Name: codeine sulfate (KOE-deen SUL-fate)
Brand Name: Generic only. No brands available.

Some children have had serious and sometimes fatal breathing problems when using codeine sulfate after surgery to remove tonsils or adenoids. Codeine sulfate should not be used in children to treat pain after surgery to remove tonsils or adenoids. Talk with your doctor for more information.


Codeine sulfate is used for:

Treating certain types of severe pain.

Codeine sulfate is a narcotic analgesic. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use codeine sulfate if:

  • you are allergic to any ingredient in codeine sulfate or to any codeine- or morphine-related medicine (eg, oxycodone)
  • you have a lack of muscle movement in the bowel (paralytic ileus) or high levels of carbon dioxide in the blood
  • you have a history of severe asthma or you are having an asthma attack
  • you have slow or shallow breathing
  • you are taking mixed agonist/antagonist analgesic medicines (eg, pentazocine, nalbuphine, butorphanol) or sodium oxybate (GHB)
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken an MAOI within the past 14 days
  • the patient is a child being treated for pain after surgery to remove tonsils or adenoids

Contact your doctor or health care provider right away if any of these apply to you.

Before using codeine sulfate:

Some medical conditions may interact with codeine sulfate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, epilepsy, or seizures
  • if you have a history of heart problems, low blood pressure, stomach or bowel problems (eg, inflammation, ulcer), pancreas problems (eg, inflammation), gallbladder problems (eg, gallstones), an enlarged prostate gland or other prostate problems, a blockage of your bladder or bowel, kidney or liver problems, adrenal gland problems (eg, Addison disease), or an underactive thyroid
  • if you have trouble breathing, a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea), scoliosis, or chronic obstructive pulmonary disease (COPD), or a cough that occurs with large amounts of mucus
  • if you are going through alcohol withdrawal or you have a history of alcohol or other substance abuse, mental or mood problems, or suicidal thoughts or behavior
  • if you are dehydrated, are in very poor health, or have had recent abdominal surgery

Some MEDICINES MAY INTERACT with codeine sulfate. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticholinergics (eg, scopolamine, bethanechol) because the risk of decreased bowel muscle movement and trouble urinating may be increased
  • HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), other narcotic pain medicines, phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of codeine sulfate's side effects, including low blood pressure and severe drowsiness
  • Cimetidine or sodium oxybate (GHB) because the risk of severe drowsiness, breathing problems, and seizures may be increased
  • Mixed agonist/antagonist analgesic medicines (eg, pentazocine, nalbuphine, butorphanol), naltrexone, quinidine, or rifampin because they may decrease codeine sulfate's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if codeine sulfate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use codeine sulfate:

Use codeine sulfate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Codeine sulfate may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • If codeine sulfate is no longer needed, check with your pharmacist for ways to properly dispose of codeine sulfate. Do not throw it in the trash.
  • If you miss a dose of codeine sulfate and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use codeine sulfate.

Important safety information:

  • Codeine sulfate may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use codeine sulfate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using codeine sulfate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Codeine sulfate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Do not take more than the recommended dose or use more often than prescribed without checking with your doctor.
  • Codeine sulfate may cause constipation. Check with your doctor to see if you should also take a stool softener or laxative to help decrease this effect.
  • Tell your doctor or dentist that you take codeine sulfate before you receive any medical or dental care, emergency care, or surgery.
  • Some patients may have a genetic trait that may cause codeine sulfate to enter their blood faster. This may increase the risk of side effects. Contact your doctor right away if you develop symptoms of overdose, even if you have not taken more than the recommended dose of codeine sulfate.
  • Codeine sulfate may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking codeine sulfate.
  • Use codeine sulfate with caution in the ELDERLY because they may be more sensitive to its effects, including severe drowsiness and breathing problems.
  • Codeine sulfate should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using codeine sulfate while you are pregnant. Codeine sulfate is found in breast milk. If you are or will be breast-feeding while you use codeine sulfate, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, codeine sulfate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if codeine sulfate stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking codeine sulfate. This is known as DEPENDENCE or addiction.

If you suddenly stop taking codeine sulfate, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of codeine sulfate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; lightheadedness; nausea; sweating; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fainting; fast or irregular heartbeat; mental or mood changes; numbness or pain of an arm or leg; seizures; severe drowsiness or dizziness; severe or persistent constipation or stomach pain; shortness of breath; slow or shallow breathing; sudden, severe headache or vomiting; trouble urinating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blue lips or nails; cold and clammy skin; coma; confusion; hallucinations; limp muscles; loss of consciousness; mood or mental changes; seizures; severe dizziness or drowsiness; slow heartbeat; slow or shallow breathing; sluggishness; small or large pupils.

Proper storage of codeine sulfate:

Store codeine sulfate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep codeine sulfate out of the reach of children and away from pets.

General information:

  • If you have any questions about codeine sulfate, please talk with your doctor, pharmacist, or other health care provider.
  • Codeine sulfate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take codeine sulfate or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about codeine sulfate. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to codeine sulfate. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using codeine sulfate.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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