Children should not use products that contain codeine after certain surgeries (including tonsil/adenoid removal). Also, for children younger than 12 years, do not use codeine to treat cough or pain unless specifically directed by the doctor. Some children are more sensitive to codeine and have had very serious (rarely fatal) breathing problems such as slow/shallow breathing (see also Side Effects section). Talk with your doctor or pharmacist about the risks and benefits of this medication.Who should not take codeine sulfate?
See also Warning section.
This medication is used to treat mild to moderate pain. It acts on certain centers in the brain and spinal cord to give you pain relief. Codeine is a narcotic pain reliever related to morphine.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
Codeine may also be used to control a cough.
Take this medication by mouth as directed by your doctor. Pain medications work best when taken at the first signs of pain. If you wait until the pain has worsened, the medication may not work as well. The dosage is based on your medical condition and response to therapy. For children, the dosage is also based on weight.
If you are using the liquid form, read the Medication Guide provided by your pharmacist before you start taking codeine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
If so directed by your doctor, you may also use long-acting narcotic medications for ongoing pain. In that case, this medication might be used when needed for sudden attacks of "breakthrough" pain. Also follow your doctor's or pharmacist's instructions for the safe use of non-narcotic pain relievers (e.g., acetaminophen, ibuprofen). Ask your doctor or pharmacist if you have any questions about your treatment.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, runny nose, watering eyes, trouble sleeping, severe abdominal/muscle pain, nausea, vomiting, rapid breathing, and fast heartbeat) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.
Though it is very unlikely to occur, this medication can also be habit-forming and may result in abnormal drug-seeking behavior (addiction). Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.
When used for a long time, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Inform your doctor if your pain persists or worsens.
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 (such as 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 right away if you have any serious side effects, including: mental/mood changes (such as agitation, restlessness), fast/slow/irregular heartbeat, vision changes, severe stomach/abdominal pain, change in the amount of urine.
Get medical help right away if you have any very serious side effects, including: fainting, seizures.
Codeine is changed into a strong narcotic drug (morphine) in your body. In some people, this change happens faster and more completely than usual, which increases the risk of very serious side effects. Get medical help right away if you notice any of the following: slow/shallow breathing, unusual drowsiness/difficulty waking up, confusion.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), 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.
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/abdominal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus, gallbladder disease, pancreatitis, ulcerative colitis), adrenal gland problems (such as Addison's disease), brain disorders (such as seizures, head injury, tumor), heart problems (such as irregular heartbeat, low blood pressure), kidney disease, liver disease, breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), personal or family history of regular drug/alcohol abuse, mental/mood disorders (such as toxic psychosis), difficulty urinating (such as enlarged prostate).
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.
Some children may be more sensitive to very serious side effects of this drug, such as extreme sleepiness, confusion, or slow/shallow/noisy breathing. (See also Warning section.)
Older adults may be more sensitive to the side effects of this drug, especially confusion, dizziness, drowsiness, and slow/shallow breathing.
Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Also, using it for a long time or in high doses near the expected delivery date may harm the unborn baby. To lessen the risk, take the smallest effective dose for the shortest possible time. Tell the doctor right away if you notice any symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea.
This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor right away if your infant develops increased sleepiness, trouble breast-feeding, trouble breathing, or unusual limpness. Discuss the risks and benefits with your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: certain pain medications (mixed narcotic agonist-antagonists such as butorphanol/nalbuphine), narcotic antagonists (such as naltrexone).
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and other narcotic pain relievers (such as morphine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
This medication may interfere with certain laboratory tests (including amylase and lipase tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow/shallow breathing, slow heartbeat, cold/clammy skin, loss of consciousness.
Do not share this medication with others. It is against the law.
This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in those cases.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.
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