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PROMETHAZINE W/CODEINE SYRUP
Ingredient Name: PROMETHAZINE (proe-METH-a-zeen) and CODEINE (KOE-deen)
Drug Manufacturer: ACTAVIS MID
Common Uses: This medicine is a phenothiazine antihistamine and narcotic cough suppressant combination used to treat cough and to relieve runny nose, sneezing, or other upper respiratory symptoms due to colds or allergies. It may also be used for other conditions as determined by your doctor.
Before Using This Medicine: WARNING: THIS MEDICINE MAY CAUSE SEVERE AND SOMETIMES FATAL BREATHING PROBLEMS in children. DO NOT USE THIS MEDICINE in children under 6 years old. Do not give this medicine 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. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking sodium oxybate. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticholinergics (such as scopolamine), barbiturates (such as phenobarbital), cimetidine, haloperidol, HIV protease inhibitors (such as indinavir), levodopa, local anesthetics (such as lidocaine), meperidine, monoamine oxidase inhibitors (MAOIs) (such as phenelzine), naltrexone, narcotic pain medicines (such as morphine), pergolide, quinidine, rifampin, risperidone, or tricyclic antidepressants (such as amitriptyline). DO NOT START OR STOP any medicine without doctor or pharmacist approval. INFORM YOUR DOCTOR of any other medical conditions including chronic cough, cough that occurs with large amounts of mucus, or a history of kidney, liver, thyroid, or bone marrow problems; lung or breathing problems (such as chronic bronchitis, or slow, shallow breathing); gallbladder problems; diabetes; glaucoma or increased pressure in the eye; heart or blood vessel problems; low blood pressure; enlarged prostate; bladder problems (such as blockage); stomach or bowel problems (such as blockage or inflammation); ulcers; recent stomach, bowel, or bladder surgery; seizures; blood problems (such as porphyria); allergies; pregnancy; or breast-feeding. INFORM YOUR DOCTOR if you have poor health; dehydration problems; recent head or brain injury; brain tumor or increased pressure in the brain; infection in the brain or nervous system; fever; or Reye Syndrome. Tell your doctor if you have a history of Addison or Parkinson disease, chronic constipation, mental or mood problems, suicidal thoughts or actions, or alcohol or other substance abuse. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe drowsiness, certain lung or breathing problems (such as asthma, sleep apnea, or chronic obstructive pulmonary disease), diarrhea due to antibiotic use or food poisoning, or a fever and a productive cough. USE OF THIS MEDICINE IS NOT RECOMMENDED if the patient is a child and has just had surgery to remove tonsils or adenoids. Use of this medicine in children under age 6 is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if youhave any questions or concerns about using this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. USE A MEASURING DEVICE marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure this dose. This medicine may be taken on an empty stomach or with food. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE 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.
Cautions: DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to any ingredient in this product, to any codeine-related medicine (such as hydrocodone or oxycodone), or to a phenothiazine (such as chlorpromazine). A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain medicine contains a codeine-related medicine, contact your doctor or pharmacist. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS including certain enzyme levels and certain pregnancy tests. Make sure laboratory personnel and your doctors know you use this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. AVOID ALCOHOL while you are using this medicine. THIS MEDICINE WILL ADD TO THE EFFECTS of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants. This medicine may cause drowsiness, dizziness, or blurred vision. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. THIS MEDICINE MAY CAUSE DIZZINESS, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness. THIS MEDICINE MAY CAUSE increased sensitivity to the sun. Avoid exposure to the sun or sunlamps until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. A SERIOUS AND SOMETIMES FATAL effect called neuroleptic malignant syndrome (NMS) has been associated with this medicine. 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. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine especially confusion and drowsiness. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. Using this medicine for a long period of time or in high doses during pregnancy may result in fetal or newborn dependence or toxicity. Discuss anyquestions or concerns with your doctor. THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include blurred vision; constipation; dizziness; drowsiness; dry mouth, nose, or throat; headache; nausea; vomiting; or tiredness or weakness. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience persistent blurred vision; other vision changes; excitability; change in the amount of urine produced; or difficulty urinating. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal thoughts; agitation; confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; hoarseness; loss of coordination; mood or mental changes; seizures; severe or persistent dizziness, headache, or lightheadedness; severe or persistent drowsiness, tiredness, or weakness; slow or irregular breathing; tremors; uncontrolled muscle movements; muscle pain or stiffness; unusual bruising or bleeding; unusual sweating; or yellowing of the eyes or skin. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other side effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold or clammy skin, coma, dilated or pinpoint pupils, exaggerated reflexes, limp or rigid muscles, loss of consciousness, severe drowsiness, seizures, severe dizziness, slow or difficult breathing, and slow or irregular heartbeat.
Additional Information: IF YOUR COUGH CONTINUES for more than 5 days, or if you develop a high fever or persistent headache, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets.
Copyright 2012 Wolters Kluwer Health, Inc.
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