Promethazine and codeine (Oral route)

Pronunciation:

proe-METH-a-zeen hye-droe-KLOR-ide, KOE-deen FOS-fate

Brand Names:

Phenergan w/Codeine

Dosage Forms:

Solution
Syrup

Warnings:

Oral route(Solution)

Life-threatening respiratory depression and death have occurred in children who received codeine. Most of the reported cases occurred following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Promethazine hydrochloride and codeine phosphate oral solution is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of promethazine hydrochloride and codeine phosphate oral solution in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.Postmarketing cases of respiratory depression, including fatalities have been reported with use of promethazine in pediatric patients. Children may be particularly sensitive to the additive respiratory depressant effects when promethazine is combined with other respiratory depressants, including codeine.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol

Oral route(Syrup)

Promethazine and codeine use is contraindicated in pediatric patients younger than 6 years. Concomitant use of promethazine products with other 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 and/or adenoidectomy and had evidence of being ultrarapid metabolizers of codeine due to CYP2D6 polymorphism. Concomitant use of opioids and benzodiazepines may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol .

Classifications:

Therapeutic—

Antitussive, Opioid/Antihistamine Combination

Pharmacologic—

Promethazine

Chemical—

Promethazine

Uses of This Medicine:

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.

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:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
Furazolidone
Iproniazid
Isocarboxazid
Levoketoconazole
Linezolid
Magnesium Oxybate
Mesoridazine
Methylene Blue
Moclobemide
Nalmefene
Naltrexone
Nialamide
Ozanimod
Phenelzine
Pimozide
Piperaquine
Potassium Citrate
Potassium Oxybate
Procarbazine
Rasagiline
Safinamide
Samidorphan
Saquinavir
Selegiline
Sodium Oxybate
Sparfloxacin
Terfenadine
Thioridazine
Toloxatone
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
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
Azithromycin
Baclofen
Belladonna
Bemetizide
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Biperiden
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Bumetanide
Buprenorphine
Bupropion
Buserelin
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Canrenoate
Canrenone
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Cenobamate
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chloroquine
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Cimetidine
Cinacalcet
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clofazimine
Clomipramine
Clonazepam
Clopamide
Clopidogrel
Clorazepate
Clothiapine
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabrafenib
Daridorexant
Darifenacin
Darunavir
Dasatinib
Degarelix
Delamanid
Delavirdine
Delorazepam
Desipramine
Deslorelin
Desmopressin
Desvenlafaxine
Deutetrabenazine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Dicyclomine
Difenoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxylamine
Dronedarone
Droperidol
Duloxetine
Efavirenz
Elagolix
Eletriptan
Encorafenib
Enflurane
Entrectinib
Enzalutamide
Epinephrine
Eplerenone
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etozolin
Etrasimod
Etravirine
Fedratinib
Fenfluramine
Fentanyl
Fesoterodine
Fexinidazole
Fingolimod
Flavoxate
Flecainide
Flibanserin
Fluconazole
Flunitrazepam
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Formoterol
Fosamprenavir
Fosaprepitant
Foscarnet
Fosnetupitant
Fosphenytoin
Fospropofol
Fostemsavir
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Glucagon
Glycopyrrolate
Glycopyrronium Tosylate
Gonadorelin
Goserelin
Granisetron
Halazepam
Halofantrine
Haloperidol
Halothane
Hexobarbital
Histrelin
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydroflumethiazide
Hydromorphone
Hydroxychloroquine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Ibutilide
Idelalisib
Iloperidone
Imatinib
Imipramine
Indapamide
Indinavir
Inotuzumab Ozogamicin
Ipratropium
Isoflurane
Isradipine
Itraconazole
Ivabradine
Ivacaftor
Ivosidenib
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lacosamide
Lapatinib
Larotrectinib
Lasmiditan
Lefamulin
Lemborexant
Lenacapavir
Lenvatinib
Letermovir
LetibotulinumtoxinA-wlbg
Leuprolide
Levocetirizine
Levofloxacin
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Loxapine
Lumacaftor
Lumefantrine
Macimorelin
Magnesium Oxybate
Mavacamten
Meclizine
Medazepam
Mefloquine
Melitracen
Melperone
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaclazepam
Metaxalone
Methacholine
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methyclothiazide
Metoclopramide
Metolazone
Metrizamide
Metronidazole
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Mobocertinib
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Moxifloxacin
Nafarelin
Nafcillin
Nalbuphine
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Nordazepam
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Oliceridine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Osilodrostat
Osimertinib
Oxaliplatin
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxycodone
Oxymorphone
Ozanimod
Pacritinib
Palbociclib
Paliperidone
Palonosetron
Panobinostat
Papaveretum
Paregoric
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenobarbital
Phenytoin
Pimavanserin
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Pirenzepine
Piretanide
Piritramide
Pitolisant
Polythiazide
Ponesimod
Porfimer
Posaconazole
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Procainamide
Procarbazine
Prochlorperazine
Procyclidine
Promazine
Promethazine
Propafenone
Propantheline
Propiverine
Propofol
Protriptyline
Quazepam
Quetiapine
Quinethazone
Quinidine
Quinine
Quizartinib
Ramelteon
Ranitidine
Ranolazine
Relugolix
Remifentanil
Remimazolam
Remoxipride
Revefenacin
Ribociclib
Rifabutin
Rifampin
Rifapentine
Ritonavir
Rizatriptan
Rolapitant
Ropeginterferon Alfa-2b-njft
Saquinavir
Scopolamine
Secobarbital
Secretin Human
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sibutramine
Siponimod
Sodium Oxybate
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Spironolactone
St John's Wort
Stramonium
Sufentanil
Sulpiride
Sumatriptan
Sunitinib
Suvorexant
Tacrolimus
Tapentadol
Telaprevir
Telavancin
Telithromycin
Temazepam
Terbinafine
Terodiline
Tetrabenazine
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tilidine
Tiotropium
Tizanidine
Tolonium Chloride
Tolterodine
Topiramate
Toremifene
Torsemide
Tramadol
Trazodone
Triamterene
Triazolam
Trichlormethiazide
Triclabendazole
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Triptorelin
Tropicamide
Trospium
Tryptophan
Umeclidinium
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Verapamil
Vilanterol
Vilazodone
Vinflunine
Voclosporin
Voriconazole
Vortioxetine
Voxelotor
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuclopenthixol
Zuranolone

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 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 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. 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.

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 While Using This Medicine:

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 of This Medicine:

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.

Last Updated: 4/24/2024

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