Codeine sulfate solution

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 solution after surgery to remove tonsils or adenoids. Codeine sulfate solution 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 solution is used for:

Treating mild to moderately severe pain in certain patients.

Codeine sulfate solution is an opioid (narcotic) analgesic. It works in the brain and nervous system to decrease pain.

Do NOT use codeine sulfate solution if:

  • you are allergic to any ingredient in codeine sulfate solution
  • you have known or suspected bowel blockage (paralytic ileus)
  • you have difficult or slowed breathing, hypercarbia or hypercapnia (high blood levels of carbon dioxide), or severe asthma, or you are having an asthma attack
  • you are taking mixed agonist/antagonist analgesic medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine) or sodium oxybate (GHB)
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or you have taken one 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.

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Before using codeine sulfate solution:

Some medical conditions may interact with codeine sulfate solution. 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 had an allergic reaction to any other narcotic pain reliever (eg, hydromorphone, morphine, oxycodone)
  • if you have severe drowsiness or have recently had any head or brain injury, growths in the brain (eg, lesions, tumors), increased pressure in the head, infection of the brain or nervous system, or seizures (eg, epilepsy)
  • if you have a history of heart problems (eg, cor pulmonale), low blood pressure, low blood volume, an enlarged prostate gland or other prostate problems, urinary blockage or trouble urinating, adrenal gland problems (eg, Addison disease), curvature of the spine, low blood oxygen levels (hypoxia), hypercapnia or hypercarbia, dehydration, or thyroid problems
  • if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea)
  • if you have liver or kidney problems, gallbladder problems (eg, gallstones), pancreas problems (eg, pancreatitis), or stomach or bowel problems (eg, inflammation, pseudomembranous colitis, ulcer), or if you have had recent stomach or bowel surgery
  • if you have a personal or family history of alcohol or other substance abuse or dependence, mental or mood problems (eg, depression), or suicidal thoughts or behavior
  • if you drink alcohol or have symptoms of alcohol withdrawal
  • if you have stomach pain; if you are in poor health; if you are constipated; if you will be having surgery; or if you are in shock caused by heart problems, blood vessel problems, or severe bleeding
  • if your health care provider has told you that you are a "rapid metabolizer"

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

  • Anticholinergics (eg, scopolamine, oxybutynin) because the risk of trouble urinating and severe constipation may be increased
  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Amiodarone, azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, erythromycin), MAOIs (eg, phenelzine), protease inhibitors (eg, boceprevir, ritonavir), quinidine, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of codeine sulfate solution's side effects
  • Other narcotic pain medicines (eg, morphine, oxycodone) or sodium oxybate (GHB) because the risk of severe drowsiness may be increased
  • Carbamazepine, mixed agonist/antagonist analgesic medicines (eg, buprenorphine, butorphanol, nalbuphine, pentazocine), naltrexone, phenytoin, or rifampin because they may decrease codeine sulfate solution's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if codeine sulfate solution 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 solution:

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

  • Codeine sulfate solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get codeine sulfate solution refilled.
  • Codeine sulfate solution may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Always use the measuring device that comes with codeine sulfate solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you have been taking codeine sulfate solution regularly, do NOT suddenly stop taking it without checking with your doctor. If you have been taking codeine sulfate solution for more than a few weeks and your doctor tells you to stop taking it, your dose may need to be gradually lowered, as directed by your doctor, to avoid side effects.
  • If codeine sulfate solution is no longer needed, dispose of the unused solution as soon as possible by flushing it down the toilet. You may also check with your pharmacist for other ways to dispose of codeine sulfate solution.
  • Codeine sulfate solution is usually used as needed. If you forget to take a dose of codeine sulfate solution and you still have pain, take it when you remember as directed by your doctor. Do not take 2 doses at once.

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

Important safety information:

  • Codeine sulfate solution may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use codeine sulfate solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using codeine sulfate solution.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using codeine sulfate solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Codeine sulfate solution may cause dizziness, light-headedness, 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, use more often than prescribed, or use for longer than prescribed without checking with your doctor.
  • Codeine sulfate solution may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use codeine sulfate solution.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take codeine sulfate solution before you receive any medical or dental care, emergency care, or surgery.
  • If a child accidentally takes codeine sulfate solution, seek emergency medical attention right away.
  • Some patients may have a genetic trait that may cause codeine sulfate solution 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 solution.
  • Codeine sulfate solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking codeine sulfate solution.
  • Use codeine sulfate solution with caution in the ELDERLY because they may be more sensitive to its effects, especially severe drowsiness and breathing problems.
  • Codeine sulfate solution 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 solution while you are pregnant. Codeine sulfate solution is found in breast milk. If you are or will be breast-feeding while you use codeine sulfate solution, check with your doctor. Discuss any possible risks to your baby.

When used for long periods of time or at high doses, codeine sulfate solution 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 solution 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 solution. This is known as DEPENDENCE or addiction.

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

Possible side effects of codeine sulfate solution:

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; light-headedness; nausea; sleepiness; sweating; 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, jaw, or arm pain; confusion; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe or persistent constipation or stomach pain; severe or persistent drowsiness or dizziness; shortness of breath; slow, shallow, or difficult breathing; sudden, severe nausea or vomiting; tremor; trouble urinating; vision changes.

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 bluish skin or nails; chest pain; cold and clammy skin; coma; difficult, slow, or shallow breathing; fainting; limp muscles; seizures; severe dizziness or drowsiness; slow or irregular heartbeat; small or large pupils.

Proper storage of codeine sulfate solution:

Store codeine sulfate solution 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 solution out of the reach of children and away from pets.

General information:

  • If you have any questions about codeine sulfate solution, please talk with your doctor, pharmacist, or other health care provider.
  • Codeine sulfate solution 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 solution 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 solution. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to codeine sulfate solution. 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 solution.

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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