Generic Name: phenylephrine/promethazine (fen-ill-EF-rin/proe-METH-a-zeen)
Brand Name: Generic only. No brand names available.
Phenylephrine/promethazine should not be used in children younger than 2 years old. Potentially fatal side effects (eg, difficult or slowed breathing, drowsiness leading to coma) may occur in this age group when taking phenylephrine/promethazine.
Caution should be used when using phenylephrine/promethazine in children 2 years of age and older. The lowest possible dose should be used in this age group and should not be used with other medicines that cause slowed breathing.
Phenylephrine/promethazine is used for:
Relieving congestion, sneezing, runny nose, nasal or throat itching, and itchy or watery eyes caused by colds, hay fever, or other allergic conditions. It may also be used for other conditions as determined by your doctor.
Phenylephrine/promethazine is a phenothiazine antihistamine and decongestant combination. The antihistamine works by blocking histamine, which decreases the symptoms of allergies. The decongestant works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.
Do NOT use phenylephrine/promethazine if:
- you are allergic to any ingredient in phenylephrine/promethazine
- you have severe central nervous system depression or are in a coma
- you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems
- you are taking droxidopa, furazolidone, or have taken a monoamine oxidase (MAOI) (eg, phenelzine) in the last 14 days
- you are also taking astemizole, cisapride, terfenadine, or tramadol
Contact your doctor or health care provider right away if any of these apply to you.
Before using phenylephrine/promethazine:
Some medical conditions may interact with phenylephrine/promethazine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of nervous system problems, bone marrow depression, heart problems, a blood disease, blood pressure problems, blood vessel problems, liver problems, stomach problems (eg, ulcer), a blockage of your bladder or bowel, an enlarged prostate, diabetes, Parkinson disease, seizures, Reye syndrome, adrenal gland problems (eg, pheochromocytoma), an overactive thyroid, seizures, stroke, glaucoma, or increased eye pressure, or you are at risk for glaucoma
- if you are addicted to alcohol or regularly consume large amounts of alcohol
Some MEDICINES MAY INTERACT with phenylephrine/promethazine. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), astemizole, cisapride, general anesthetics (eg, thiopental), methyldopa, terfenadine, or tramadol because side effects, such as low blood pressure and seizures, may occur
- Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of phenylephrine/promethazine's side effects
- Digoxin, droxidopa, or haloperidol because risk of irregular heartbeat or heart attack may be increased
- Bromocriptine, lithium, meperidine, metrizamide, naltrexone, polypeptide antibiotics (eg, actinomycin), or trazodone because the risk of their side effects may be increased by phenylephrine/promethazine
- Epinephrine, guanadrel, guanethidine, levodopa, mecamylamine, methyldopa, pergolide, or reserpine because their effectiveness may be decreased by phenylephrine/promethazine
This may not be a complete list of all interactions that may occur. Ask your health care provider if phenylephrine/promethazine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use phenylephrine/promethazine:
Use phenylephrine/promethazine as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take phenylephrine/promethazine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- If you miss a dose of phenylephrine/promethazine 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.
Ask your health care provider any questions you may have about how to use phenylephrine/promethazine.
Important safety information:
- Phenylephrine/promethazine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use phenylephrine/promethazine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using phenylephrine/promethazine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
- If your symptoms do not get better within 7 days of if you develop a high fever, check with your doctor.
- Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by phenylephrine/promethazine. 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.
- Phenylephrine/promethazine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to phenylephrine/promethazine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Diabetes patients - Phenylephrine/promethazine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Check with your doctor before taking diet or appetite control medicines while you are taking phenylephrine/promethazine.
- If you have trouble sleeping, talk to your doctor or pharmacist about the best time of day to take phenylephrine/promethazine.
- Phenylephrine/promethazine has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Use phenylephrine/promethazine with caution in the ELDERLY; they may be more sensitive to the effects of phenylephrine/promethazine.
- Phenylephrine/promethazine should not be used in CHILDREN younger than 2 years old. Serious, and sometimes fatal, side effects (difficult or slowed breathing, drowsiness leading to coma) have occurred when phenylephrine/promethazine has been used in children in this age group.
- Phenylephrine/promethazine should be used with extreme caution in CHILDREN 2 years of age or older. The lowest effective dose should be used in children 2 years of age and older.
- PREGNANCY and BREAST-FEEDING: It is not known if phenylephrine/promethazine can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using phenylephrine/promethazine while you are pregnant. Phenylephrine/promethazine is found in breast milk. If you are or will be breast-feeding while you use phenylephrine/promethazine, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of phenylephrine/promethazine:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; drowsiness; dry mouth, throat, or nose; headache; nausea; nervousness; occasional blurred vision; sleepiness; stomach upset; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fast heartbeat; hallucinations; sensitivity to light; severe nervousness; tremors; uncontrolled muscle movements; yellowing of skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include enlarged pupils; fast, slow, or irregular heartbeat; fever; flushing; hallucinations; loss of consciousness; nightmares; rapid breathing; seizures; shortness of breath; sweating; trouble breathing; severe or persistent drowsiness or dizziness; restlessness.Proper storage of phenylephrine/promethazine:
Store phenylephrine/promethazine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep phenylephrine/promethazine out of the reach of children and away from pets.
- If you have any questions about phenylephrine/promethazine, please talk with your doctor, pharmacist, or other health care provider.
- Phenylephrine/promethazine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take phenylephrine/promethazine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about phenylephrine/promethazine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to phenylephrine/promethazine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using phenylephrine/promethazine.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.