Description
Promethazine and codeine combination is used to relieve cough, runny or stuffy nose, sneezing, or other symptoms caused by allergies or the common cold.
Promethazine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. It can sometimes close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Codeine belongs to the group of medicine called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Syrup
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Use of promethazine and codeine combination is not recommended in children younger than 6 years of age for syrup or in children younger than 12 years of age for oral solution, because of the increased risk of respiratory depression.
Promethazine and codeine combination should not be used to relieve pain after surgery to remove tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of promethazine and codeine combination in the elderly. However, elderly patients are more likely to have unwanted effects (eg, confusion, drowsiness) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Bromopride
- Calcium Oxybate
- Cisapride
- Dronedarone
- Isocarboxazid
- Levoketoconazole
- Linezolid
- Magnesium Oxybate
- Mavorixafor
- Mesoridazine
- Methylene Blue
- Moclobemide
- Naltrexone
- Ozanimod
- Phenelzine
- Pimozide
- Piperaquine
- Potassium Citrate
- Potassium Oxybate
- Procarbazine
- Rasagiline
- Safinamide
- Samidorphan
- Saquinavir
- Selegiline
- Sodium Oxybate
- Sparfloxacin
- Terfenadine
- Thioridazine
- Tranylcypromine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acepromazine
- Aclidinium
- Adagrasib
- Alfentanil
- Alfuzosin
- Almotriptan
- Alosetron
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anagrelide
- Anileridine
- Apalutamide
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Baclofen
- Bedaquiline
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aminolevulinic Acid
- Belladonna
- Belladonna Alkaloids
- Betel Nut
- Evening Primrose
- Midodrine
- Phenylalanine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
- Grapefruit Juice
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison's disease (an adrenal problem) or
- Brain tumors, history of or
- Breathing or lung problems (eg, sleep apnea) or
- Drug abuse or dependence or
- Enlarged prostate or
- Glaucoma, narrow-angle or
- Head injury, history of or
- Hypothyroidism (underactive thyroid) or
- Nerve and muscle disease or
- Obesity (overweight) or
- Stomach or bowel problems (eg, blockage, peptic ulcer, ulcerative colitis) or
- Surgery (eg, stomach, bowel, urinary tract), recent or
- Trouble urinating or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Bone marrow problems (eg, agranulocytosis, leukopenia) or
- Heart or blood vessel disease or
- Hypotension (low blood pressure) or
- Kidney disease or
- Liver disease or
- Seizures, history of—Use with caution. May make these conditions worse.
- Lung disease or breathing problems (eg, asthma) or
- Surgery in children (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.
Proper Use
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming and cause mental or physical dependence.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For relief of symptoms caused by allergies or the common cold:
- For oral dosage form (solution):
- Adults and children 12 years of age and older—5 milliliters (mL) (1 teaspoonful) every 4 to 6 hours. Do not take more than 30 mL in 24 hours.
- Children younger than 12 years of age—Use is not recommended.
- For oral dosage form (syrup):
- Adults and children 12 years of age and older—5 milliliters (mL) (1 teaspoonful) every 4 to 6 hours. Do not take more than 30 mL in 24 hours.
- Children 6 to 11 years of age—2.5 to 5 mL (0.5 to 1 teaspoonful) every 4 to 6 hours. Do not take more than 30 mL in 24 hours.
- Children younger than 6 years of age—Use is not recommended.
- For oral dosage form (solution):
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm
Precautions
It is very important that your doctor check your or your child's progress while taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.
If your condition does not improve or becomes worse, check with your doctor.
Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there may be too much morphine in the body and more side effects from morphine than usual. Children may be especially sensitive to this effect. Do not give this medicine to:
- Children younger than 12 years of age.
- Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
- Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).
If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to morphine overdose in the nursing baby and cause very serious side effects.
For nursing mothers taking this medicine:
- Talk to your doctor if you have any questions about taking codeine or about how this medicine may affect your baby.
- Call your doctor if you become extremely tired and have difficulty caring for your baby.
- Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
- Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you or your child are using this medicine.
Promethazine may increase your risk for convulsions (seizures). It may also cause dystonia (movement disorder). This is more likely in sick children with diarrhea. Talk to your doctor if you have any concerns.
Check with your doctor right away if you or your child are having convulsions, difficulty in breathing, fast heartbeat, high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
If you think you or your child may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include extreme sleepiness, confusion, shallow breathing, hallucinations, nausea, vomiting, pinpoint pupils of the eyes, pale or blue lips, fingernails, or skin, or seizures.
Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.
This medicine may make your skin more sensitive to sunlight. Use sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
This medicine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Incidence not known
- Bluish lips or skin
- chills
- clay-colored stools
- cold sweats
- confusion
- cough
- dark urine
- decrease in the frequency of urination
- decrease in the urine volume
- diarrhea
- difficult or troubled breathing
- difficulty in passing urine (dribbling)
- dizziness
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- feeling of warmth
- fever
- headache
- high fever
- hives or welts, itching, or rash
- increased sweating
- irregular, fast or slow, or shallow breathing
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- loss of bladder control
- nausea
- noisy breathing
- not breathing
- painful urination
- pale or blue lips, fingernails, or skin
- rectal bleeding
- redness of the face, neck, arms, and occasionally, upper chest
- redness of the skin
- seeing, hearing, or feeling things that are not there
- seizures
- severe muscle stiffness
- shakiness in the legs, arms, or hands
- stomach pain
- sweating
- tightness in the chest
- tiredness
- trembling or shaking of the hands or feet
- unpleasant breath odor
- unusual tiredness or weakness
- unusually pale skin
- vomiting of blood
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Cold, clammy skin
- dry mouth
- fainting
- no blood pressure or pulse
- no muscle tone or movement
- pinpoint pupils (black part of the eye)
- stopping of the heart
- unconsciousness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Bad dreams
- blurred or loss of vision
- confusion as to time, place, or person
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty having a bowel movement
- disturbed color perception
- double vision
- drowsiness
- false or unusual sense of well-being
- halos around lights
- hearing loss
- holding false beliefs that cannot be changed by fact
- increased sensitivity of the skin to sunlight
- night blindness
- overbright appearance of lights
- redness or other discoloration of the skin
- relaxed and calm feeling
- severe sunburn
- sleepiness
- trouble sleeping
- tunnel vision
- unusual excitement, nervousness, or restlessness
- vomiting
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
CON-XXXXXXXX
