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What is codeine and promethazine?
Codeine is a narcotic. It is a pain reliever and a cough suppressant. Promethazine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in your body. The combination of codeine and promethazine is used to treat cold or allergy symptoms such as runny nose, sneezing, and cough. Codeine and promethazine may also be used for other purposes not listed in this medication guide.

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What are the possible side effects of codeine and promethazine?

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.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• restless muscle movements in your eyes, tongue, jaw, or neck, tremor (uncontrolled shaking);

• shallow breathing, slow heartbeat;

• feeling like you might pass out;

• jaundice (yellowing of the skin or eyes);

• confusion, agitation, hallucinations, unusual thoughts or behavior;

• seizure (convulsions);

• urinating less than usual or not at all; or

• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing.

Less serious side effects may include:

• dizziness, drowsiness, sleepiness;

• feeling restless, nervous, or anxious;

• blurred vision, ringing in your ears;

• constipation, mild nausea or vomiting;

• warmth, redness, or tingly feeling under your skin;

• sleep problems (insomnia);

• increased sweating;

• dry mouth; 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.

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How should I take codeine and promethazine?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Contact your doctor if your symptoms do not improve within a few days of using codeine and promethazine. Store this medication at room temperature away from moisture, heat, and light.

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What is the most important information I should know about codeine and promethazine?
Tell your doctor about all of your medical conditions before you start taking this medication. You should not use this medication if you are allergic to codeine or promethazine, or if you have asthma or other lung disease. Codeine may be habit-forming and should be used only by the person it was prescribed for. Codeine and promethazine 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.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect codeine and promethazine?
Many drugs can interact with codeine and promethazine. Below is just a partial list. Tell your doctor if you are using: sedatives or anxiety medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion); antidepressants such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); narcotic pain medicines such as meperidine (Demerol), morphine (MS Contin, MSIR), propoxyphene (Darvon, Darvocet), hydrocodone (Lortab, Vicodin), oxycodone (Percocet, Percodan), fentanyl (Duragesic), codeine (Fiorinal, Fioricet, Tylenol #3);

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Codeine-promethazine has been assigned to pregnancy category C by the FDA. Codeine is the only narcotic analgesic which has shown a statistically significant association with teratogenicity (involving respiratory tract malformations) at the time of this writing. Like other narcotics, codeine rapidly crosses the placenta. Neonatal codeine withdrawal has occurred even in infants whose mothers were taking codeine at cough suppressant doses for as little as ten days prior to delivery. Promethazine taken within two weeks of delivery may inhibit platelet aggregation in the newborn. There are no controlled data in human pregnancy. Codeine-promethazine is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

Codeine is excreted into human milk in small amounts. Several small series and one small retrospective study suggest that codeine may be causative in episodes of apnea, bradycardia and cyanosis in the first week of life. The FDA issued a Public Health Advisory about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. Codeine is nevertheless considered compatible with breast-feeding by the American Academy of Pediatrics. There are no data on the excretion of promethazine into human milk. However, passage of the drug into breast milk is expected.

The FDA issued a Public Health Advisory regarding a very rare, but serious, side effect. This may occur in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. When codeine enters the body and is metabolized, it changes to morphine, which relieves pain. Many factors affect codeine metabolism, including a person's genetic make-up. Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people. Nursing mothers taking codeine may also have higher morphine levels in their breast milk. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. In most cases, it is not known if someone is an ultra-rapid metabolizer of codeine. When prescribing codeine-containing drugs to nursing mothers, it is recommended that the lowest effective dose be used for the shortest period of time. It is also recommended that the mother-infant pairs be closely monitored. There is an FDA cleared test for determining a patient's CYP450 2D6 genotype. The test is not routinely used in clinical practice but is available through a number of different laboratories. The results of this test predict that a person can convert codeine to morphine at a faster rate than average, resulting in higher morphine levels in the blood. When levels of morphine are too high, patients have an increased risk of adverse events.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of this medication may fatal. Overdose symptoms include dizziness, extreme drowsiness, dry mouth, nausea, vomiting, cold and clammy skin, weak pulse, shallow breathing, fainting, seizure (convulsions), or breathing that stops.

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What should I discuss with my doctor before taking codeine and promethazine?
You should not use this medication if you are allergic to codeine, phenylephrine, or promethazine, or if you have high blood pressure, a blood vessel disorder, or asthma. Before taking codeine and promethazine, tell your doctor if you are allergic to any drugs, or if you have: epilepsy or other seizure disorder; asthma, COPD, sleep apnea, or other breathing disorders; glaucoma; a stomach ulcer or digestive obstruction; a weak immune system; Addison's disease; enlarged prostate, urination problems;

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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