Oxycodone and acetaminophen (Oral)

September 2nd, 2021 | drugs

Generic name: acetaminophen/oxycodone (a-seet-a-MIN-oh-fen, ox-i-KOE-done hye-droe-KLOR-ide)
Drug class: Narcotic analgesic combinations

Oral route(Tablet;Tablet, Extended Release)

Addiction, Abuse, and MisuseOxycodone/acetaminophen exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing oxycodone/acetaminophen, and monitor all patients regularly for the development of these behaviors or conditions .Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety .Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of oxycodone/acetaminophen. Monitor for respiratory depression, especially during initiation of oxycodone/acetaminophen or following a dose increase .Instruct patients to swallow oxycodone/acetaminophen ER tablets whole; crushing, chewing, or dissolving oxycodone/acetaminophen ER can cause rapid release and absorption of a potentially fatal dose of oxycodone Accidental IngestionAccidental ingestion of even one dose of oxycodone/acetaminophen, especially by children, can result in a fatal overdose of oxycodone .Neonatal Opioid Withdrawal SyndromeProlonged use of oxycodone/acetaminophen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .Cytochrome P450 3A4 InteractionThe concomitant use of Oxycodone/acetaminophen with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone/acetaminophen and any CYP3A4 inhibitor or inducer .HepatotoxicityAcetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of oxycodone/acetaminophen and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation .

Commonly used brand name(s)

In the U.S.

Endocet
Magnacet
Narvox
Percocet
Perloxx
Primalev
Roxicet
Roxilox
Tylox
Xartemix XR
Xolox

In Canada

oxyCODONE/ACET
Rivacocet
Teva-Oxycocet

Available Dosage Forms:

Tablet
Solution

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Oxycodone

Uses for oxycodone and acetaminophen

Oxycodone and acetaminophen combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Oxycodone and acetaminophen is available only with your doctor's prescription. Percocet® and Xartemis™ are available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

Before using oxycodone and acetaminophen

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 oxycodone and acetaminophen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxycodone and acetaminophen 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

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and acetaminophen combination in the pediatric population. Use of Xartemis™ is not recommended in children. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and acetaminophen combination extended-release tablet, solution, or tablet in the elderly. However, elderly patients are more likely to have age-related kidney, heart, lung, or liver problems, which may require caution and an adjustment in the dose for patients receiving oxycodone and acetaminophen.

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and acetaminophen combination capsules in the pediatric population. Safety and efficacy have not been established.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 oxycodone and acetaminophen, 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 oxycodone and acetaminophen 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.

Nalmefene
Naltrexone
Safinamide

Using oxycodone and acetaminophen 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.

Abiraterone Acetate
Acepromazine
Alfentanil
Almotriptan
Alprazolam
Alvimopan
Amifampridine
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Anileridine
Aprepitant
Aripiprazole
Armodafinil
Asenapine
Atazanavir
Baclofen
Benperidol
Benzhydrocodone
Benzphetamine
Boceprevir
Bosentan
Bromazepam
Bromopride
Brompheniramine
Buprenorphine
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Ceritinib
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorpheniramine
Chlorpromazine
Chlorzoxazone
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clomipramine
Clonazepam
Clopidogrel
Clorazepate
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Darunavir
Delavirdine
Desipramine
Desmopressin
Desvenlafaxine
Dexamethasone
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Dibenzepin
Dichloralphenazone
Difenoxin
Dihydrocodeine
Diltiazem
Diphenhydramine
Diphenoxylate
Dolasetron
Donepezil
Doxepin
Doxylamine
Dronedarone
Droperidol
Duloxetine
Efavirenz
Eletriptan
Enflurane
Enzalutamide
Erdafitinib
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etravirine
Fenfluramine
Fentanyl
Flibanserin
Fluconazole
Fluoxetine
Fluphenazine
Flurazepam
Fluspirilene
Fluvoxamine
Fosamprenavir
Fosaprepitant
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furazolidone
Gabapentin
Gabapentin Enacarbil
Granisetron
Halazepam
Haloperidol
Halothane
Hexobarbital
Hydrocodone
Hydromorphone
Hydroxytryptophan
Hydroxyzine
Idelalisib
Imatinib
Imipramine
Indinavir
Iproniazid
Isocarboxazid
Isoflurane
Isoniazid
Itraconazole
Ivacaftor
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Lanreotide
Lasmiditan
Lefamulin
Lemborexant
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Lorazepam
Lorcaserin
Lorlatinib
Loxapine
Lumacaftor
Magnesium Oxybate
Meclizine
Melitracen
Melperone
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrimeprazine
Methylene Blue
Methylnaltrexone
Metoclopramide
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirtazapine
Mitotane
Moclobemide
Modafinil
Molindone
Moricizine
Morphine
Morphine Sulfate Liposome
Nafcillin
Nalbuphine
Nalorphine
Naloxone
Naratriptan
Nefazodone
Nelfinavir
Netupitant
Nevirapine
Nialamide
Nicomorphine
Nilotinib
Nitrazepam
Nitrous Oxide
Nortriptyline
Octreotide
Olanzapine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxazepam
Oxcarbazepine
Oxymorphone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paregoric
Paroxetine
Pentazocine
Pentobarbital
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenobarbital
Phenytoin
Pimozide
Piperacetazine
Pipotiazine
Piritramide
Pixantrone
Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
Posaconazole
Potassium Oxybate
Prazepam
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Promazine
Promethazine
Propofol
Protriptyline
Quazepam
Quetiapine
Ramelteon
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Ribociclib
Rifabutin
Rifampin
Rifapentine
Ritonavir
Rizatriptan
Samidorphan
Saquinavir
Scopolamine
Secobarbital
Selegiline
Selpercatinib
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sufentanil
Sulpiride
Sumatriptan
Suvorexant
Tapentadol
Telaprevir
Telithromycin
Temazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tilidine
Tizanidine
Tolonium Chloride
Topiramate
Tramadol
Tranylcypromine
Trazodone
Triazolam
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Tryptophan
Tucatinib
Venlafaxine
Verapamil
Vilazodone
Voriconazole
Vortioxetine
Voxelotor
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine

Using oxycodone and acetaminophen 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.

Acenocoumarol
Carbamazepine
Fosphenytoin
Lixisenatide
Phenytoin
St John's Wort
Warfarin
Zidovudine

Interactions with food/tobacco/alcohol

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 oxycodone and acetaminophen 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 oxycodone and acetaminophen, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Grapefruit Juice
Tobacco

Using oxycodone and acetaminophen 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 oxycodone and acetaminophen, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage

Proper use of oxycodone and acetaminophen

Take oxycodone and acetaminophen 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 oxycodone and acetaminophen is taken for a long time, it may become habit-forming and cause mental or physical dependence. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone and acetaminophen combination. Oxycodone and acetaminophen should also come with a Medication Guide. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

You may take oxycodone and acetaminophen with or without food.

Measure the oral liquid using the patient cup that comes with the package.

Swallow the extended-release tablet whole with water. Do not crush, break, chew, dissolve, snort, or inject it. Do not pre-soak, lick, or wet the tablet before placing it in your mouth. Do not give oxycodone and acetaminophen by feeding tubes.

Check with your doctor first before changing dosage forms (eg, capsules, extended-release tablets, tablets). These forms are very different from each other.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

Dosing

The dose of oxycodone and acetaminophen 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 oxycodone and acetaminophen. 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 moderate to moderately severe pain:
- For oral dosage form (capsules):
  - Adults—1 capsule every 6 hours as needed.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (extended-release tablets):
  - Adults—2 tablets every 12 hours as needed.
  - Children—Use is not recommended.
- For oral dosage form (solution):
  - Adults—5 milliliters (mL) or 1 teaspoon every 6 hours as needed. Your doctor may adjust the dose as needed. However, the dose is usually not more than 60 mL (12 teaspoons) per day.
  - Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
  - Adults—1 or 2 tablets every 6 hours as needed.
  - Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of oxycodone and acetaminophen, 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.

If you miss a dose of Percocet®, skip the missed dose and go back to your regular dosing schedule.

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.

Oxycodone and acetaminophen combination can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong narcotic pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.

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 oxycodone and acetaminophen

It is very important that your doctor check your progress while you are taking oxycodone and acetaminophen, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal it.

Oxycodone and acetaminophen 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. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of these medicines while you are using oxycodone and acetaminophen.

Oxycodone and acetaminophen 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.

Do not use oxycodone and acetaminophen if you are using or have used an MAO inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days. Using these medicine together may cause serious unwanted effects.

Oxycodone and acetaminophen may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using oxycodone and acetaminophen.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

Oxycodone and acetaminophen may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how oxycodone and acetaminophen affects you.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with oxycodone and acetaminophen. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using oxycodone and acetaminophen.

Oxycodone and acetaminophen may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using oxycodone and acetaminophen.

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.

If you have been using oxycodone and acetaminophen regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as stomach cramps, anxiety, fever, irritability, nausea, restlessness, runny nose, sweating, tremors, or trouble with sleeping.

Using oxycodone and acetaminophen while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using oxycodone and acetaminophen.

For nursing mothers:

Talk to your doctor if you have any questions about taking oxycodone or about how oxycodone and acetaminophen 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.

Before you have any medical tests, tell the medical doctor in charge that you are taking oxycodone and acetaminophen. The results of some tests may be affected by oxycodone and acetaminophen.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of oxycodone and acetaminophen may reduce infertility (unable to have children). Talk with your doctor before using oxycodone and acetaminophen if you plan to have children.

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.

Oxycodone and acetaminophen 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:

More common

Black, tarry stools
chills
dark urine
dizziness
fever
headache
itching, skin rash
light-colored stools
loss of appetite
nausea
stomach pain
unpleasant breath odor
unusual tiredness or weakness
vomiting of blood
yellow eyes or skin

Rare

Cough
fever with or without chills
general feeling of tiredness or weakness
hoarseness
lower back or side pain
painful or difficult urination
sore throat
sores, ulcers, or white spots on the lips or in the mouth
unusual bleeding or bruising

Incidence not known

Back, leg, or stomach pains
bleeding gums
bloating
blood in the urine or stools
blue lips and fingernails
blurred vision
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
cloudy urine
clumsiness
confusion
constipation
coughing that sometimes produces a pink frothy sputum
decreased awareness or responsiveness
decreased frequency or amount of urine
difficult, fast, noisy breathing
difficulty in passing urine (dribbling)
difficulty with swallowing
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
dry mouth
extremely shallow or slow breathing
fainting
fast or deep breathing
fast, slow, irregular, pounding, or racing heartbeat
feeling of warmth
general body swelling
hives or welts
increased sweating
increased thirst
indigestion
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
lightheadedness
muscle aches, tremors, or weakness
nervousness
nosebleeds
pains in the stomach, side, or abdomen, possibly radiating to the back
pale skin
pinpoint red spots on the skin
pounding in the ears
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
rapid, deep or shallow breathing
redness of the face, neck, arms, and occasionally, upper chest
restlessness
seizures
severe constipation
severe sleepiness
severe vomiting
skin blisters
sleepiness
stomach cramps
sunken eyes
sweating
swelling of the face, fingers, lower legs, or ankles
thirst
tightness in the chest
tiredness
trouble breathing
vomiting
weakness or heaviness of the legs
weight gain

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Bluish lips or skin
change in consciousness
cold, clammy skin
extreme sleepiness
general feeling of discomfort or illness
loss of consciousness
low blood pressure or pulse
slow breathing
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: