Codar D

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

Get emergency medical help if a child taking this medicine has breathing problems, blue lips, or severe drowsiness, or if you cannot wake the child up from sleep.

Stop using codeine and pseudoephedrine and call your doctor at once if you have:

• severe dizziness or drowsiness;
• weak or shallow breathing;
• severe restlessness or nervousness;
• severe constipation;
• pounding heartbeats or fluttering in your chest;
• painful or difficult urination; or
• little or no urinating.

Common side effects may include:

• mild drowsiness;
• dryness of your eyes, nose, and mouth;
• blurred vision;
• nausea, vomiting, diarrhea, constipation;

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 FDA at 1-800-FDA-1088.

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.

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.

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.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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

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

• It is used to treat nose stuffiness.
• It is used to relieve coughing.

Use Codar D as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine. If there is none, ask the pharmacist for a device to measure Codar D.

What do I do if I miss a dose?

• If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Codar D is taken on an as needed basis. Do not take more often than told by the doctor.

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 doctor or get medical help right away if you have 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Chest pain or pressure or a fast heartbeat.
• Trouble breathing, slow breathing, or shallow breathing.
• Noisy breathing.
• Feeling very sleepy.
• Feeling confused.
• A heartbeat that does not feel normal.
• Hallucinations (seeing or hearing things that are not there).
• Mood changes.
• Seizures.
• Very bad belly pain.
• Very bad headache.
• Trouble passing urine.
• Shakiness.
• Change in eyesight.
• Very upset stomach or throwing up.
• Very hard stools (constipation).
• Feeling very tired or weak.

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

Administration advice:
-Take orally with or without food
-Oral measuring devices should be provided to ensure accuracy in dosing; a household teaspoon should not be considered an accurate measuring device

Storage requirements:
-Protect from moisture and light

General:
-Patients who are ultra-rapid metabolizers of codeine due to a CYP450 2D6 polymorphism, will convert codeine more rapidly and completely to morphine resulting in unexpectedly high morphine levels, which may be life-threatening.
-Codeine use is contraindicated in the postoperative period in children who have undergone tonsillectomy and/or adenoidectomy.

Monitoring:
-Cardiovascular: Monitor for signs of hypotension, especially in those whose blood pressure is compromised
-Respiratory: Monitor for respiratory depression
-Gastrointestinal: Monitor for constipation and decreased bowel motility in post-operative patients.
-Patients should be monitored for the development of addiction, abuse, or misuse.

Patient advice:
-Patients should understand that codeine use can result in addiction, abuse, and misuse; recommended doses should not be exceeded.
-Patients should understand that this product is for temporary relief of cough; if cough persists for longer than 1 week, recurs, or is accompanied by fever, rash, or persistent headache, a health care professional should be consulted.
-Patients should understand risks of life-threatening respiratory depression and when this risk is greatest; patients should be aware that a genetic mutation may result in greater codeine toxicity in some patients; breastfed infants of women who have this genetic mutation are also at risk.
-Women who are breastfeeding, pregnant, or planning to become pregnant should speak to their healthcare provider before using this product.
-This drug may cause drowsiness, dizziness, or impair thinking or motor skills; patients should avoid driving or operating machinery until adverse effects are determined.
-Concomitant use of alcohol, sedatives, and tranquilizers may increase drowsiness; patients should avoid alcohol and consult with their healthcare provider regarding concomitant use of other CNS depressants.
-Pseudoephedrine may cause sleeplessness, especially if it is taken up to several hours before going to bed.

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. -Pseudoephedrine should be avoided during the first trimester.

In rats, codeine has been shown to be embryolethal and fetotoxic at maternally toxic doses. In rats and rabbits administered doses ranging from 5 to 120 mg/kg during the period of organogenesis, teratogenicity was not observed. Prolonged use of opioids during pregnancy has resulted in babies being born physically dependent. Opioids administered to mothers shortly before delivery may result in some degree of newborn respiratory depression, especially with higher doses. In rabbits and rats, pseudoephedrine in doses of 35 and 50 times the human daily dose, respectively, have not produced teratogenic effects. Limited data in human pregnancy has shown an elevated risk of gastroschisis (defective closure of the abdominal wall) with first-trimester use; vascular disruption has been postulated as the etiology. There are no adequate and well controlled studies in pregnant women.