Generic Name: promethazine/codeine (proe-METH-a-zeen/KOE-deen)
Brand Name: Generic only. No brands available.
Promethazine/codeine syrup may cause severe and sometimes fatal breathing problems in children. Do NOT use promethazine/codeine syrup in children younger than 6 years old. Do not give promethazine/codeine syrup with any other medicines that can cause breathing problems.
Some children have had serious and sometimes fatal breathing problems when using codeine after surgery to remove tonsils or adenoids. Talk with your doctor for more information.
Promethazine/codeine syrup is used for:
Treating cough and other upper respiratory symptoms caused by allergies or the common cold. It may also be used for other conditions as determined by your doctor.
Promethazine/codeine syrup is a phenothiazine antihistamine and narcotic cough suppressant combination. The antihistamine works by blocking the action of histamine to reduce the symptoms of an allergic reaction, such as runny nose and sinus drainage. The cough suppressant works in the brain to decrease the cough reflex.
Do NOT use promethazine/codeine syrup if:
- you are allergic to any ingredient in promethazine/codeine syrup, any other codeine-related medicine (eg, oxycodone), or phenothiazines (eg, chlorpromazine)
- you have severe drowsiness
- you have certain lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], sleep apnea) or if you have a fever and a productive cough
- you have diarrhea caused by food poisoning or antibiotic use
- you are taking sodium oxybate (GHB)
- the patient is a child and has just had surgery to remove tonsils or adenoids
Contact your doctor or health care provider right away if any of these apply to you.
Before using promethazine/codeine syrup:
Some medical conditions may interact with promethazine/codeine syrup. 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 a history of heart problems, low blood pressure, blood problems (eg, porphyria), bone marrow problems, or blood vessel problems
- if you have a history of seizures, liver or kidney problems, diabetes, increased pressure in the eye (eg, glaucoma), Parkinson disease, Addison disease, or an underactive thyroid
- if you have a history of an enlarged prostate; bladder problems (eg, blockage); stomach or bowel problems (eg, inflammation, blockage); gallbladder problems; chronic constipation; ulcer; or have had recent stomach, bowel, or bladder surgery
- if you are dehydrated, are in poor health, or have or recently have had a fever, any head injury, brain injury or tumor, increased pressure in the brain, infection of the brain or nervous system, or Reye syndrome
- if you have a chronic cough, lung or breathing problems (eg, chronic bronchitis, slow or shallow breathing), or if your cough occurs with large amounts of mucus
- if you have a history of alcohol or other substance abuse, mental or mood problems, or suicidal thoughts or attempts
Some MEDICINES MAY INTERACT with promethazine/codeine syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Barbiturates (eg, phenobarbital), cimetidine, meperidine, narcotics (eg, morphine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because the risk of severe drowsiness or serious breathing problems may be increased
- Haloperidol because the risk of irregular heartbeat may be increased
- Local anesthetics (eg, lidocaine) because the risk of seizures may be increased
- Anticholinergics (eg, scopolamine), HIV protease inhibitors (eg, indinavir), or monoamine oxidase inhibitors (MAOIs) (eg, phenelzine) because they may increase the risk of promethazine/codeine syrup's side effects
- Naltrexone, quinidine, rifampin, or risperidone because they may decrease promethazine/codeine syrup's effectiveness
- Levodopa or pergolide because their effectiveness may be decreased by promethazine/codeine syrup
This may not be a complete list of all interactions that may occur. Ask your health care provider if promethazine/codeine syrup 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 promethazine/codeine syrup:
Use promethazine/codeine syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take promethazine/codeine syrup by mouth with or without food.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you miss a dose of promethazine/codeine syrup and you are taking 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 promethazine/codeine syrup.
Important safety information:
- Promethazine/codeine syrup may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use promethazine/codeine syrup 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 promethazine/codeine syrup without checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- Promethazine/codeine syrup 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 for longer than prescribed without checking with your doctor.
- If cough persists for more than 5 days or is accompanied by a high fever, contact your health care provider. A persistent cough could be a sigh of a serious condition.
- Do not use promethazine/codeine syrup for a cough with a lot of mucous. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.
- Promethazine/codeine syrup may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to promethazine/codeine syrup. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by promethazine/codeine syrup. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
- Diabetes patients - Promethazine/codeine syrup may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Tell your doctor or dentist that you take promethazine/codeine syrup before you receive any medical or dental care, emergency care, or surgery.
- Promethazine/codeine syrup may interfere with certain lab tests, including certain enzyme levels and certain pregnancy tests. Be sure your doctor and lab personnel know you are taking promethazine/codeine syrup.
- Use promethazine/codeine syrup with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion and drowsiness.
- Promethazine/codeine syrup should not be used in CHILDREN younger than 6 years old; serious, and sometimes fatal, breathing problems have occurred when promethazine/codeine syrup has been used in these children.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using promethazine/codeine syrup during pregnancy. Using promethazine/codeine syrup for a long period of time or in high doses during pregnancy may result in fetal or newborn dependence or toxicity. Discuss any questions or concerns with your doctor. Promethazine/codeine syrup is found in breast milk. If you are or will be breast-feeding while you use promethazine/codeine syrup, check with your doctor. Discuss any possible risks to your baby.
When used for long periods of time or at high doses, promethazine/codeine syrup 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 promethazine/codeine syrup stops working well. Do not take more than prescribed.
Some people who use promethazine/codeine syrup for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking promethazine/codeine syrup suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea and vomiting; pain; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; or trouble sleeping.
Possible side effects of promethazine/codeine syrup:
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:
Seek medical attention right away if any of these SEVERE side effects occur:
Blurred vision; constipation; dizziness; drowsiness; dry mouth, throat, or nose; headache; nausea; tiredness or weakness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; agitation; change in the amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of coordination; mood or mental changes; muscle pain or stiffness; overexcitement; seizures; severe drowsiness; severe or persistent blurred vision, dizziness, headache, or lightheadedness; slow or irregular breathing; symptoms of infection (eg, fever, chills); tremors; uncontrolled muscle movements (eg, movements of the arms, legs, tongue, eyes); unusual bruising or bleeding; unusual sweating; vision problems; yellowing of the skin or eyes.
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 cold or clammy skin; coma; dilated or pinpoint pupils; exaggerated reflexes; limp or rigid muscles; loss of consciousness; seizures; severe dizziness; severe drowsiness; slow or difficult breathing; slow or irregular heartbeat.Proper storage of promethazine/codeine syrup:
Store promethazine/codeine syrup at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep promethazine/codeine syrup out of the reach of children and away from pets.
- If you have any questions about promethazine/codeine syrup, please talk with your doctor, pharmacist, or other health care provider.
- Promethazine/codeine syrup 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 promethazine/codeine syrup 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 promethazine/codeine syrup. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to promethazine/codeine syrup. 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 promethazine/codeine syrup.
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.