Brand Name
US Brand Name
Anexsia
Ceta Plus
Co-Gesic
Dolorex Forte
Hycet
Lorcet
Lortab
Maxidone
Norco
Stagesic
Vicodin HP
Zydone
Description
Hydrocodone 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. Although rare, use of acetaminophen has been reported to lead to liver transplantation and death, usually at high doses and when multiple acetaminophen-containing products have been used.
Hydrocodone belongs to the group of medicines called opioid analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.
When hydrocodone 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 opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Solution
- Tablet
- Elixir
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
Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and acetaminophen combination capsules and tablets in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen combination oral liquid in children 2 years of age and older. However, safety and efficacy have not been established in children younger than 2 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone and acetaminophen combination in the elderly. However, elderly patients are more likely to have confusion and drowsiness, and age-related lung, liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone and acetaminophen combination.
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.
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.
- Isocarboxazid
- Naltrexone
- Safinamide
- Samidorphan
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
- Acepromazine
- Aclidinium
- Alfentanil
- Almotriptan
- Alprazolam
- Amantadine
- Amifampridine
- Amiloride
- Amineptine
- Amiodarone
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Amprenavir
- Anileridine
- Apalutamide
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Asenapine
- Atazanavir
- Atropine
- Avacopan
- Baclofen
- Belladonna
- Belzutifan
- Bemetizide
- Bendroflumethiazide
- Benperidol
- Bentazepam
- Benzphetamine
- Benzthiazide
- Benztropine
- Berotralstat
- Biperiden
- Boceprevir
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.
- Acenocoumarol
- Desflurane
- Fosphenytoin
- Lixisenatide
- Mavacamten
- Phenytoin
- Warfarin
- Zidovudine
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
- Tobacco
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.
- Cabbage
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 (adrenal gland problem) or
- Alcohol use disorder history of or
- Brain tumor, or history of or
- Breathing or lung problems (eg, asthma, apnea, COPD, emphysema, hypoxia) or
- Cor pulmonale (serious heart condition) or
- Depression or
- Drug use disorder or dependence, or history of or
- Head injuries, or history of or
- Increased pressure in the head or
- Hypothyroidism (an underactive thyroid) or
- Problems with passing urine or
- Prostatic hypertrophy (enlarged prostate, BPH) or
- Seizures, history of—Use with caution. May increase risk for more serious side effects.
- Asthma, acute or severe or
- Lung or breathing problems (eg, respiratory depression), severe or
- Stomach or bowel blockage (eg, paralytic ileus), known or suspected—Should not be used in patients with these conditions.
- Hypotension (low blood pressure) or
- Pancreatitis (swelling of the pancreas) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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. 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) or cause an overdose. Large amounts of acetaminophen may cause liver damage.
It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of hydrocodone and acetaminophen combination. This medicine should also come with a Medication Guide and patient information leaflet. 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.
Measure the oral liquid with a marked measuring spoon, oral syringe, dropper, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
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), as this may increase the risk for serious liver problems. For patients who have a liver condition, the daily maximum limit for acetaminophen use may be lower than 4 grams. Talk to your doctor if you have questions about this.
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 moderate to severe pain:
- For oral dosage form (10 milligrams [mg] per 325 mg per 15 mL solution):
- Adults—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
- Children 14 years of age and older and weighing 46 kg and more—11.25 mL (2 ¼ teaspoonfuls) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 67.5 mL (13 ½ teaspoonfuls) per day.
- Children 10 to 13 years of age and weighing 32 kg to 45 kg—7.5 mL (1 ½ teaspoonfuls) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
- Children 7 to 9 years of age and weighing 23 kg to 31 kg—5.6 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 33.6 mL (6 ½ teaspoonfuls) per day.
- Children 4 to 6 years of age and weighing 16 kg to 22 kg—3.75 mL (¾ teaspoonful) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 22.5 mL (4 ½ teaspoonfuls) per day.
- Children 2 to 3 years of age and weighing 12 kg to 15 kg—2.8 mL (½ teaspoonful) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 16.8 mL (3 ¼ teaspoonfuls) per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults—
- Norco® 5/325 (5 milligrams [mg] per 325 mg tablets): 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 8 tablets per day.
- Norco® 7.5/325 (7.5 mg per 325 mg tablets): 1 tablet every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 tablets per day.
- Norco® 10/325 (10 mg per 300 mg tablets): 1 tablet every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 tablets per day.
- Generic: Dose depends on the strength of the tablet and must be determined by your doctor.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For oral dosage form (10 mg per 300 mg tablets):
- Adults—1 tablet every 4 to 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 tablets per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (10 milligrams [mg] per 325 mg per 15 mL 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.
If you miss a dose of hydrocodone and acetaminophen oral solution or Norco®, 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.
Hydrocodone can cause serious unwanted effects or fatal overdose if taken by children, pets, or adults who are not used to strong opioid pain medicines. Make sure you store the medicine in a safe and secure place to prevent others from getting it.
Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid 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 using this medicine, 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 or your child should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine 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.
It is against the law and dangerous for anyone else to use your medicine. Keep your unused tablets in a safe and secure place.
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 opioids, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), 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 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.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary. Signs of an overdose include: dark urine, difficult or trouble 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 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 this medicine.
This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
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.
Call your doctor right away if you have worsening of pain, increased sensitivity to pain, or new pain after taking this medicine. These may be symptoms of opioid-induced hyperalgesia and allodynia.
This medicine may cause serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
This medicine may cause a serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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 this medicine.
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 dizziness or lightheadedness.
This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Using opioids for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child 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.
Before you or your child have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of certain tests may be affected by this medicine.
Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you or your child 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, including stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.
Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight.
For nursing mothers taking this medicine:
- Talk to your doctor if you have any questions about taking this medicine or about how this medicine may affect your baby. This medicine may be present in your breast milk and passed to 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 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.
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 this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine 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.
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
- Dizziness
- lightheadedness
Incidence not known
- Agitation
- back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- blood in vomit
- bluish lips or skin
- chest tightness
- chills
- choking
- confusion
- cough
- dark urine
- darkening of the skin
- decrease in the frequency of urination
- decrease in urine volume
- diarrhea
- difficult or trouble breathing
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- fainting
- fast heartbeat
- fever
- fever with or without chills
- general body swelling
- general feeling of tiredness or weakness
- headache
- hoarseness
- increased sensitivity to pain
- irregular, fast or slow, or shallow breathing
- joint or muscle pain
- light-colored stools
- loss of appetite
- lower back or side pain
- mental depression
- nausea
- nosebleeds
- not breathing
- overactive reflexes
- painful or difficult urination
- pale or blue lips, fingernails, or skin
- pinpoint red spots on the skin
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red irritated eyes
- red skin lesions, often with a purple center
- restlessness
- severe or continuing stomach pain
- shivering
- skin rash, hives, or itching
- sore throat
- sore tongue
- sores, ulcers, or white spots on the lips or in the mouth
- sweating
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- unable to speak
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- worsening of pain
- yellow eyes and skin
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Bloody or cloudy urine
- change in consciousness
- chest pain or discomfort
- cold and clammy skin
- coughing that sometimes produces a pink frothy sputum
- decreased awareness or responsiveness
- difficult or trouble breathing
- extreme drowsiness
- general feeling of discomfort or illness
- increased sweating
- irregular, fast or slow, or shallow breathing
- irregular heartbeat
- lightheadedness, dizziness, or fainting
- loss of consciousness
- no blood pressure or pulse
- no muscle tone or movement
- not breathing
- pale or blue lips, fingernails, or skin
- severe sleepiness
- slow or irregular heartbeat
- stopping of heart
- sudden decrease in the amount of urine
- swelling in the legs and ankles
- unpleasant breath odor
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:
More common
- Drowsiness
- relaxed and calm feeling
- sleepiness
Incidence not known
- Belching
- changes in mood
- difficulty having a bowel movement
- fear or nervousness
- feeling of indigestion
- hearing loss
- impaired hearing
- pain in the chest below the breastbone
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
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.
DRG-20074089
