Chlorcyclizine and codeine

Codeine can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Ask a doctor before giving this medicine to a child younger than 12 years old. Do not give this medicine to anyone under 18 who recently had surgery to remove the tonsils or adenoids.

You should not use antihistamine medication to make a child sleepy.

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.

In some people, codeine breaks down rapidly in the liver and reaches higher than normal levels in the body. This can cause dangerously slow breathing and may cause death, especially in a child.

Ask a doctor before giving this medicine to a child younger than 12 years old.

Medicines that contain codeine should not be used in anyone under 18 who recently had surgery to remove the tonsils or adenoids.

To make sure this medicine is safe for you, tell your doctor if you have:

• any type of breathing problem (asthma, COPD);

• glaucoma;

• enlarged prostate, urination problems;

• cough with mucus, or cough caused by emphysema or chronic bronchitis;

• heart disease, high blood pressure; or

• a thyroid disorder.

Using chlorcyclizine and codeine during pregnancy could harm the unborn baby. Ask a doctor before using this medicine if you are pregnant.

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

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 other person 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 drinking alcohol.

Ask a doctor or pharmacist before using any other cold, allergy, cough, or sleep medicine. Many combination medicines contain antihistamines or decongestants. Taking certain products together can cause you to get too much of a certain drug.

This medicine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking chlorcyclizine and codeine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with chlorcyclizine and codeine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Data not available

The US FDA has issued a Drug Safety Communication restricting use of prescription codeine pain and cough medicines in children less than 12 years. This update follows previous communications evaluating the potential risks of codeine. Children less than 12 years appear to be at the greatest risk of codeine associated serious adverse events including slowed or difficult breathing and death. The FDA is considering additional regulatory action for over the counter (OTC) combination cough and cold products containing codeine. At this time, it appears prudent to avoid codeine use in all children less than 12 years and avoid use in adolescents between 12 and 18 years who are obese, or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule V

Codeine has been shown to be embryolethal and fetotoxic in the hamster, rat, and mouse at doses of approximately 2 to 4 times the maximum recommended human dose. Maternally toxic doses (7 times the maximum recommended human dose) were associated with evidence of resorptions and incomplete ossification, including meningioencephalocele and cranioschisis. In the rabbit model, embryotoxicity and fetotoxicity were not observed. 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. There is no animal data available on chlorcyclizine. There are no controlled data in human pregnancy. Chronic use of opioids may cause reduced fertility; it is unknown whether these effects are reversible.

Benefit should outweigh risk US FDA pregnancy category: Not formally assigned a pregnancy category Comments: Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.