Codeine, phenylephrine, and promethazine (Oral route)
KOE-deen FOS-fate, fen-il-EF-rin hye-droe-KLOR-ide, proe-METH-a-zeen hye-droe-KLOR-ide
- Promethazine VC With Codeine
Promethazine hydrochloride/phenylephrine hydrochloride/codeine phosphate use is contraindicated in pediatric patients under 6 years of age. Concomitant use of promethazine products with respiratory depressants has an association with respiratory depression, and sometimes death, in pediatric patients. Postmarketing cases of respiratory depression, including fatalities, have been reported with a wide range of weight-based promethazine doses in pediatric patients younger than 2 years. Respiratory depression and death have occurred in children who received codeine following tonsillectomy or adenoidectomy and had evidence of being ultrarapid metabolizers of codeine due to CYP2D6 polymorphism. Concomitant use of benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, or death. Avoid concomitant use .
Antitussive, Opioid/Antihistamine/Decongestant Combination
Uses of This Medicine:
Codeine, phenylephrine, and promethazine combination is used to treat for the temporary relief of cough or stuffy nose caused by allergies or the common cold.
Codeine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain. Phenylephrine is a decongestant. It works by narrowing the blood vessels and leads to clearing of the nasal congestion.
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.
When codeine is used for a long time or in large doses, it may become habit-forming, causing mental or physical dependence. Physical dependence may lead to withdrawal side effects when you stop taking the medicine.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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:
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.
Use of codeine, phenylephrine, and promethazine combination in children younger than 6 years of age is not recommended. It should not be used to relieve pain after the surgical removal of tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of codeine, phenylephrine, and promethazine combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving codeine, phenylephrine, and promethazine combination.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
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.
- Methylene Blue
- Sodium Oxybate
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.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Chloral Hydrate
- Inotuzumab Ozogamicin
- Iobenguane I 123
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Secretin Human
- Sodium Oxybate
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- St John's Wort
- Tolonium Chloride
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 Alkaloids
- Betel Nut
- Evening Primrose
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 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.
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 or
- Alcohol abuse, or history of or
- Bladder blockage or
- Brain tumor or
- Breathing problems (eg, COPD, sleep apnea) or
- Depression or
- Drug dependence, especially with narcotics, or history of or
- Enlarged prostate or
- Head injury or
- Thyroid problems or
- Trouble urinating or
- Weakened physical condition—Use with caution. May increase risk for more serious side effects.
- Asthma or
- Hypertension (high blood pressure) or
- Peripheral vascular insufficiency or
- Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.
- Bone marrow problems (eg, agranulocytosis, leukopenia) or
- Diabetes or
- Heart or blood vessel problems (eg, arteriosclerosis) or
- Hypotension (low blood pressure) or
- Kidney disease or
- Liver disease (eg, cholestatic jaundice) or
- Narrow-angle glaucoma or
- Seizures, or history of or
- Stomach or bowel problems (eg, bowel blockage, peptic ulcer, ulcerative colitis) or
- Surgery (eg, stomach, urinary tract), recent—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).
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.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
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 oral dosage forms (elixir or syrup):
- For symptoms of cough or stuffy nose caused by allergies:
- Adults and children 12 years of age and older—5 milliliters (mL) or 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 (half 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 symptoms of cough or stuffy nose caused by allergies:
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.
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.
Precautions While Using This Medicine:
It is very important that your doctor check your progress while you or your child are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.
If your or your child's symptoms do not improve or become worse, check with your doctor right away.
Do not use this medicine if you or your child is also using an MAO inhibitor (such as Eldepryl®, Marplan®, Nardil®, or Parnate®).
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 have extreme drowsiness, sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect.
If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a 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 more than 4 hours at a time.
- Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") 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.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you or your child are using this medicine.
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 or stool softeners, 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 make you dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Check with your doctor right away if you or your child are having convulsions, difficulty with 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).
Make sure any doctor or dentist who treats you knows that you are using this medicine. You or your child may need to stop using this medicine several days before you have surgery or medical tests.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
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 of This Medicine:
- Incidence not known
- Abdominal or stomach pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- chest pain
- clay-colored stools
- cold sweats
- dark urine
- decrease in the frequency of urination
- decrease in urine volume
- difficult or troubled breathing
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up from lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- high fever
- increased sweating
- irregular, fast or slow, or shallow breathing
- loss of appetite
- loss of bladder control
- nausea or vomiting
- painful or difficult urination
- pale or blue lips, fingernails, or skin
- pinpoint red spots on the skin
- pounding in the ears
- rash or itching
- severe muscle stiffness
- shakiness in the legs, arms, hands, or feet
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trembling or shaking of the hands or feet
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusually pale skin
- vomiting of blood
- yellow eyes or skin
- More common
- Incidence not known
- blurred or loss of vision
- confusion about identity, place, and time
- disturbed color perception
- double vision
- dry mouth
- false or unusual sense of well-being
- halos around lights
- increased sensitivity of the skin to sunlight
- night blindness
- overbright appearance of lights
- redness or other discoloration of the skin
- relaxed and calm
- seeing, hearing, or feeling things that are not there
- severe sunburn
- sleepiness or unusual drowsiness
- trouble sleeping
- tunnel vision
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:
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:
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.
Last Updated: 9/4/2017