- What is codeine?
- Laboratory testing
- Possible side effects of codeine
- Special instructions for codeine
- What is this drug used for?
- What do I need to tell the doctor BEFORE my child takes this drug?
- What are some things I need to know or do while my child takes this drug?
- What are some side effects that I need to call my child’s doctor about right away?
- What are some other side effects of this drug?
- How is this drug best given?
- What do I do if my child misses a dose?
- How do I store and/or throw out this drug?
- General drug facts
- Consumer Information Use and Disclaimer
- Last Reviewed Date
- FDA Accepts Application for Promethazine/ Hydrocodone/ Acetaminophen Painkiller
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What is codeine?
Codeine is an opioid medicine used to treat pain. Codeine is also used to suppress cough. It is available as 15-mg, 30-mg, and 60-mg tablets. All are taken by mouth. Codeine also can be combined with other medicines, such as:
- Acetaminophen (Tylenol® with codeine), to control pain (available in liquid and tablet form)
- Guaifenesin, to suppress cough (available in liquid form)
- Promethazine, to suppress cough (available in liquid form)
An enzyme in the body called cytochrome P450 2D6 (CYP2D6) has the ability to break down certain medicines including codeine. A genetic test can be done to determine if your CYP2D6 breaks down medicines slower or faster than normal. If your body breaks down the medicine slower or faster than normal, you should avoid taking codeine. For information about CYP2D6 and its effect on codeine, talk with your doctor or pharmacist, and see “Do you know… Cytochrome P450 2D6 (CYP2D6) and medicines.” For more details, go to stjude.org/pg4kds.
Possible side effects of codeine
- Feeling drowsy
- Slower than normal rates of breathing
- Low blood pressure
Later (more than a day after treatment starts)
- Constipation (hard to have bowel movement)
- Itching and hives
- Feeling drowsy or very sleepy
- Feeling dizzy
- Nausea and vomiting
- Mood changes (feeling sadder or happier)
- Dry mouth
- Problems urinating
These are the most common side effects, but there may be others. Please report all side effects to the doctor or nurse.
In case of a severe side effect or reaction, call the doctor, nurse or pharmacist at 901-595-3300. If you are outside the Memphis area, dial toll-free 1-866-2STJUDE (1-866-278-5833), and press 0 once the call is connected.
Special instructions for codeine
- If you have any of the side effects listed above, most should get better after you have taken codeine for a few of days. Tell your doctor if the side effects get worse while you are taking this medicine. It may mean you need less codeine.
- If you are taking this medicine on a regular basis, do not stop taking it until the doctor tells you to do so. Stopping codeine without slowly decreasing the dose can lead to diarrhea, headache, sweating, muscle cramps, nausea, vomiting, or problems sleeping and resting.
- This medicine may cause you to feel dizzy and drowsy. Do not operate heavy equipment or drive a car until you see how this medicine affects you.
- If you have not slept well because of your pain, you may sleep more during the first few days of taking this medicine to “catch up” on missed sleep.
- If you are taking this medicine regularly, then you should drink more fluids and eat more fiber to help prevent constipation. Tell your doctor or nurse if you have not had a bowel movement in 3 to 5 days. You may need to take a stool softener or laxative to relieve your constipation.
- If you have taken codeine for a long time, at some point your doctor will slowly decrease your dose to wean you off the medicine. During this time, watch for a sudden onset of diarrhea, headache, sweating, muscle cramps, nausea, vomiting, or trouble sleeping and resting. If this occurs, call your doctor right away. It could mean your dose is being lowered too fast.
- If you are taking combined drugs (codeine plus acetaminophen, guaifenesin, or promethazine), you should avoid taking other medicines that contain acetaminophen, guaifenesin, or promethazine. For example, do not take acetaminophen (Tylenol®) while taking Tylenol with Codeine®. Taking both medicines at the same time could result in a Tylenol® dose that is too high.
- Other medicines can increase the drowsy feeling caused by codeine. These include:
- Alcohol (found in many over-the-counter cough and cold medicines),
- Diphenhydramine (over-the-counter Benadryl®);
- Diazepam or lorazepam;
- Antidepressants, such as amitriptyline; and
- Medicines used to treat seizures (such as carbamazepine, phenytoin, gabapentin, phenobarbital, and valproic acid).
- Always tell your doctor if you are taking any of these medicines, or if you start taking any new medicine while you are taking codeine.
This information from Lexicomp® explains what you need to know about this medication, including what it’s used for, how to take it, its side effects, and when to call your healthcare provider.
What is this drug used for?
- It is used to ease cold and flu signs.
What do I need to tell the doctor BEFORE my child takes this drug?
- If your child is allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
- If your child has any of these health problems: Asthma or other breathing problems like COPD (chronic obstructive pulmonary disease) or sleep apnea (breathing problems during sleep).
- If your child has porphyria.
- If your child is very sleepy.
- If your child has taken certain drugs for depression or certain other health problems in the last 14 days. This includes isocarboxazid, phenelzine, or tranylcypromine. Very high blood pressure may happen.
- If your child is taking or will be taking another drug like this one.
- If your child is breast-feeding a baby. Be sure your child does not breast-feed while taking this drug.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Do not give your child more of this drug than what the doctor told you to give. Giving more of this drug than you are told may raise the chance of very bad side effects.
- Do not have your child use longer than you have been told by your child’s doctor.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with your child’s doctor before giving your child other drugs and natural products that may slow your child’s actions.
- Avoid giving your child other products that have paracetamol (acetaminophen) in them. Check labels closely. Too much paracetamol (acetaminophen) may cause liver problems.
- This drug has paracetamol (acetaminophen) in it. Liver problems have happened with paracetamol. Sometimes, this has led to liver transplant or death. Most of the time, problems happened in people taking more than 4,000 mg (milligrams) of paracetamol in a day. People were also often taking more than 1 drug that had paracetamol.
- Follow the directions exactly. Do not give your child more paracetamol (acetaminophen) in a day than directed. If you do not know how much paracetamol (acetaminophen) you can give to your child in a day, ask your child’s doctor or pharmacist. Call your child’s doctor right away if you have given your child too much paracetamol (acetaminophen) in a day even if your child feels well.
- Talk with the doctor if your child has seizures or has ever had seizures.
- If your child is allergic to sulfites, talk with your child’s doctor. Some products have sulfites in them.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- This drug may affect allergy skin tests. Be sure the doctor and lab workers know your child takes this drug.
- Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.
- Use with care in children. Talk with the doctor.
- Do not give this drug to a child younger than 12 years old without first checking with the doctor.
If your child is pregnant:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
What are some side effects that I need to call my child’s doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- A heartbeat that does not feel normal.
- Not able to pass urine or change in how much urine is passed.
- Very bad dizziness or passing out.
- Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
- Feeling confused.
- Low mood (depression).
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Feeling sleepy.
- Blurred eyesight.
- Dry mouth.
- Dry nose.
- Upset stomach or throwing up.
- Feeling nervous and excitable.
- Not able to sleep.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
How is this drug best given?
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Give this drug with or without food. Give with food if it causes an upset stomach.
- Have your child drink lots of noncaffeine liquids every day unless told to drink less liquid by your child’s doctor.
What do I do if my child misses a dose?
- If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
How do I store and/or throw out this drug?
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Consumer Information Use and Disclaimer
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
Last Reviewed Date
FDA Accepts Application for Promethazine/ Hydrocodone/ Acetaminophen Painkiller
The FDA has accepted for review a new drug application for CL-108 (Charleston Laboratories/Daiichi Sankyo) for the relief of moderate-to-severe pain while preventing or reducing the associated opioid-induced nausea and vomiting. CL-108 is a fixed-dose, immediate-release, bilayered tablet with a rapid-release layer containing 12.5 mg of promethazine and a second layer containing 7.5 mg of hydrocodone and 325 mg of acetaminophen.
The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of January 31, 2017.
The new drug application for CL-108 was supported by two pivotal randomized, double-blind, placebo- and active-controlled phase 3 clinical studies, one after oral surgery (molar removal) and the other after bunionectomy surgery, as well as by an additional phase 3 open-label, actual-use safety study in patients with moderate-to-severe acute pain or “flares” associated with osteoarthritis of the knee or hip. More than 1,000 patients have been enrolled in the CL-108 phase 3 clinical trial program. A human abuse-liability study has also been conducted.
Source: Charleston Laboratories; June 14, 2016.
Publicado em 23 de agosto de 2018
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It is not known whether promethazine HClpromethazine hydrochlorideis excreted in human milkBecause many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from promethazine hydrochloride tabletsa decision should be made whether to discontinue nursing or to discontinue the drugtaking into account the importance of the drug to the mother.
Along with its liquid formpromethazine can be administered orally as a tabletthrough the rectum as a suppository and intravenously by injectionBut injection problems have linked the drug to severe tissue injuriesincluding gangrene.
The safety of promethazine for long-term treatment of allergic rhinitis has not been established.
PROMETHAZINE HYDROCHLORIDE TABLETS USP SHOULD NOT BE USED IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE BECAUSE OF THE POTENTIAL FOR FATAL RESPIRATORY DEPRESSION.
Keep this medication in the carton or container it came intightly closedand out of reach of childrenStore promethazine tablets and liquid at room temperature and away from excess heat and moisturenot in the bathroomStore promethazine suppositories in the refrigeratorProtect the medication from light.
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