Codeine Sulfate

DRUG DESCRIPTION

Chemically, codeine is Morphinan-6-ol,7,8-didehydro-4,5-epoxy-3-methoxy-17-methyl-(5a,6a)-, sulfate (2:1) (salt), trihydrate. Its empirical formula is C18H21NO3 and its molecular weight is 299.36.

Its structure is as follows:

Codeine sulfate Structural Formula Illustration

Each tablet contains 15, 30, or 60 mg of codeine sulfate and the following inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, and stearic acid.

What are the possible side effects of codeine ()?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, agitation, hallucinations, unusual thoughts or behavior;
  • seizure (convulsions); or
  • problems with urination.

Less serious side effects include:

  • feeling...

Read All Potential Side Effects and See Pictures of Codeine Sulfate

What are the precautions when taking codeine (Codeine Sulfate)?

Before taking codeine, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., morphine, hydrocodone, oxycodone); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, carbon dioxide retention), a certain bowel disease (paralytic ileus), severe infectious diarrhea (e.g., Clostridium difficile-associated diarrhea), intoxication with medications that can cause drowsiness...

Read All Potential Precautions of Codeine Sulfate


Codeine Sulfate Consumer (continued)

SIDE EFFECTS: Nausea commonly occurs with the use of codeine and usually goes away after the first few doses. Consult your doctor or pharmacist about ways to decrease nausea (e.g., antihistamines, taking with food, lying down for 1-2 hours with as little head movement as possible).

Lightheadedness, dizziness, drowsiness, dry mouth, flushing, vomiting, constipation, and sweating may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, mental/mood changes (e.g., agitation, confusion, restlessness), fast/slow/irregular heartbeat, fainting, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), hives, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking codeine, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain medications (e.g., morphine, hydrocodone, oxycodone); or if you have any other allergies. This product may contain inactive ingredients (such as sulfites found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, carbon dioxide retention), a certain bowel disease (paralytic ileus), severe infectious diarrhea (e.g., Clostridium difficile-associated diarrhea), intoxication with medications that can cause drowsiness or slow/shallow breathing (e.g., alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: abdominal problems (e.g., gallbladder disease, pancreatitis, ulcerative colitis), adrenal gland problems (e.g., Addison's disease), brain disorders (e.g., seizures, head injury, tumor, increased intracranial pressure), heart problems (e.g., irregular heartbeat, low blood pressure), kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia, emphysema), personal or family history of regular drug/alcohol abuse, mental/mood disorders (e.g., toxic psychosis), spinal problem (kyphoscoliosis), underactive thyroid (hypothyroidism), difficulty urinating (e.g., enlarged prostate, urethral stricture).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing, drowsiness, and difficulty urinating.

This medication should be used only when clearly needed during pregnancy. It is not recommended for use for long periods or in high doses near the expected delivery date because of the potential for harm to your unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell your doctor immediately if your infant develops increased sleepiness, difficulty feeding, or trouble breathing. Discuss the risks and benefits with your doctor before breast-feeding.


Codeine Sulfate Patient Information Including Side Effects

Brand Names:

Generic Name: codeine (Pronunciation: KOE deen)

  • What is codeine ?
  • What are the possible side effects of codeine ?
  • What is the most important information I should know about codeine ?
  • What should I discuss with my healthcare provider before taking codeine ?
  • How should I take codeine ?
  • What happens if I miss a dose ?
  • What happens if I overdose ?
  • What should I avoid while taking codeine ?
  • What other drugs will affect codeine ?
  • Where can I get more information?

What is codeine ?

Codeine is in a group of drugs called narcotic pain medicines.

Codeine is used to treat mild to moderate pain.

Codeine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of codeine ?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • feeling light-headed, fainting;
  • confusion, agitation, hallucinations, unusual thoughts or behavior;
  • seizure (convulsions); or
  • problems with urination.

Less serious side effects include:

  • feeling dizzy or drowsy;
  • nausea, vomiting, constipation;
  • sweating;
  • headache;
  • trouble sleeping (insomnia);
  • loss of interest in sex;
  • dry mouth;
  • blurred vision; or
  • mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about codeine ?

Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are taking codeine. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more than your prescribed dose of codeine. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Codeine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Do not stop using codeine suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

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