Promethazine with Codeine

Promethazine with Codeine is a combination medicine used to treat cold or allergy symptoms like a runny nose, sneezing, and cough.

Promethazine with Codeine contains an opioid (narcotic) cough medicine, and it may be habit-forming.

Promethazine with Codeine may also be used for reasons not mentioned in this medication guide.

Follow the instructions on your prescription label and read all medication guides. Never use this medicine in larger amounts or for longer than prescribed. Take this medicine only until your symptoms go away.

Never share opioid medicine with anyone else, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a secure place where others cannot access it. Selling or giving away opioid medicine is illegal.

Measure liquid medicine precisely. Use the dosing syringe that comes with it, or use a medicine dose-measuring device (not a kitchen spoon). Rinse the measuring device after each use.

Call your doctor if your symptoms do not get better after 5 days of treatment.

If you need surgery or medical tests, inform the surgeon or doctor if you have taken a cough or cold medicine in the past few days.

Store at room temperature, away from moisture, heat, and light. Keep track of your medicine. Be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover medication. Just one dose can lead to death in someone using this medicine accidentally or improperly. Read and carefully follow the instructions provided with this medicine on how to safely dispose of any unused portion.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol or with other drugs that cause drowsiness or slow your breathing.

You should not use Promethazine with Codeine if you are allergic to codeine or promethazine, or if you have:

• asthma or severe breathing problems;
• a stomach or bowel obstruction (including paralytic ileus);
• narrow-angle glaucoma; or
• if you are unable to urinate.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Promethazine with Codeine is not approved for use by anyone younger than 12 years old.

Do not give this medicine to anyone younger than 18 years old who recently had surgery to remove the tonsils or adenoids.

Tell your doctor if you have ever had:

• lung disease or breathing problems;
• a head injury, brain tumor, or seizure;
• constipation, a bowel obstruction, or stomach problems;
• problems with your bile duct, pancreas, or adrenal gland;
• an enlarged prostate or urination problems;
• uncontrolled muscle spasms;
• a blood cell disorder;
• neuroleptic malignant syndrome (a severe nervous system reaction);
• liver or kidney disease;
• low blood pressure;
• a drug addiction; or
• if you have a fever and cough with mucus.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.

Do not breast-feed. Codeine can pass into breast milk and may cause drowsiness, breathing problems, or death in a nursing baby.

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

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue lips, or if you are hard to wake up.

Promethazine with Codeine may cause serious side effects. Stop using Promethazine with Codeine and call your doctor right away if you have:

• noisy breathing, sighing, shallow breathing;
• extreme drowsiness, confusion, feeling weak or limp;
• uncontrolled muscle movements in your face, neck, arms, or legs;
• feeling light-headed, like you might faint;
• a seizure;
• adrenal gland problems—nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
• severe nervous system reaction—very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors.

Seek medical attention immediately if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects of Promethazine with Codeine may include:

• dry mouth, nausea, vomiting, constipation;
• confusion, dizziness, headache;
• drowsiness, lack of energy;
• tremors, coordination problems;
• feeling anxious, restless, nervous, or irritable;
• urination problems;
• sweating; or
• shortness of breath.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Since Promethazine with Codeine is used as needed, you may not have a regular dosing schedule. If you miss a dose and it’s almost time for your next one, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A codeine overdose can be fatal, especially in a child or anyone using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

Avoid driving or operating machinery until you know how Promethazine with Codeine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Do not drink alcohol. Dangerous side effects or death could occur.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications--opioid pain medicine or prescription cough medicine;
• a sedative like Valium--diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing--a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness; or
• drugs that affect serotonin levels in your body--a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may affect Promethazine with Codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.