Commonly Used Brand Name(s)Anexsia, Ceta Plus, Co-Gesic, Dolorex Forte, Hycet, Lorcet, Lortab, Maxidone, Norco, Stagesic, Vicodin HP, Zydone
Therapeutic ClassificationsOpioid/Acetaminophen Combination
QUICK LINKS
- Blackbox Warning
- Overview
- Proper Use
- Dosing
- Missed Dose
- Use & Storage
- Before Using
- Allergies
- Pediatric
- Geriatric
- Pregnancy
- Breast Feeding
- Drug Interactions
- Other Interactions
- Other Medical Problems
- Precautions
- Chemical Classifications
Blackbox WarningTOP
Acetaminophen 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 mg/day, and often involve more than one acetaminophen-containing product .
Oral route (Tablet)Hydrocodone bitartrate and acetaminophen has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors and conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of hydrocodone bitartrate and acetaminophen, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen. Prolonged use of hydrocodone bitartrate and acetaminophen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Monitor patients receiving hydrocodone bitartrate and acetaminophen and any CYP3A4 inhibitor or inducer for signs of respiratory depression or sedation. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death, most often with the use of acetaminophen at doses that exceed 4000 mg/day, and involving more than 1 acetaminophen-containing product. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation .
OverviewTOP
Hydrocodone and acetaminophen combination is used to relieve moderate to moderately severe pain.
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.
Hydrocodone belongs to the group of medicines called narcotic 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 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.
This medicine is available only with your doctor's prescription.
Proper UseTOP
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.
This medicine should come with a Medication Guide and patient information leaflet. Read the information carefully. 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.
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).
DosingTOP
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 moderately severe pain:
- For oral dosage form (capsules):
- Adults—1 or 2 capsules every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 capsules per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (elixir):
- Adults and children 14 years of age and older and weighing 46 kg and more—11.25 milliliters (mL) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL per day.
- Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL per day.
- Children 7 to 9 years of age and weighing 23 to 31 kg—5.6 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL per day.
- Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL per day.
- Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (7.5 milligrams [mg] per 325 mg per 15 mL solution):
- Adults and children 14 years of age and older and weighing 46 kg and more—15 milliliters (mL) or 1 tablespoonful every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 90 mL (6 tablespoonfuls) per day.
- Children 10 to 13 years of age and weighing 32 to 45 kg—10 mL (2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 60 mL (12 teaspoonfuls) per day.
- Children 7 to 9 years of age and weighing 23 to 31 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 45 mL (9 teaspoonfuls) per day.
- Children 4 to 6 years of age and weighing 16 to 22 kg—5 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 30 mL (6 teaspoonfuls) per day.
- Children 2 to 3 years of age and weighing 12 to 15 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- 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 increase 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 and 1/4 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 67.5 mL (13 and 1/2 teaspoonfuls) per day.
- Children 10 to 13 years of age and weighing 32 to 45 kg—7.5 mL (1 and 1/2 teaspoonfuls) every 4 to 6 hours as needed. Your doctor may increase 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 to 31 kg—5.6 mL (1 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 33.6 mL (6 and 1/2 teaspoonfuls) per day.
- Children 4 to 6 years of age and weighing 16 to 22 kg—3.75 mL (3/4 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 22.5 mL (4 and 1/2 teaspoonfuls) per day.
- Children 2 to 3 years of age and weighing 12 to 15 kg—2.8 mL (1/2 teaspoonful) every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 16.8 mL (3 and 1/4 teaspoonfuls) per day.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For oral dosage form (5 milligrams [mg] per 325 mg tablets):
- Adults—
- Lortab®: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 12 tablets per day.
- Norco®: 1 or 2 tablets every 4 to 6 hours as needed. Your doctor may increase your dose as needed. However, the dose is usually not more than 8 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 (7.5 mg per 325 mg tablets):
- Adults—
- Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase 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 325 mg tablets):
- Adults—
- Lortab®: 1 tablet every 4 to 6 hours as needed. Your doctor may increase 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 (capsules):
Missed DoseTOP
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.
Use & StorageTOP
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.
Flush any unused Norco® tablets down the toilet.
Before UsingTOP
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:
AllergiesTOP
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.
PediatricTOP
Appropriate studies have not been performed on the relationship of age to the effects of hydrocodone and acetaminophen 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 oral solution in children. However, safety and efficacy have not been established in children younger than 2 years of age.
GeriatricTOP
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 liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydrocodone and acetaminophen combination in order to avoid potentially serious side effects.
PregnancyTOP
| Pregnancy Category | Explanation | |
|---|---|---|
| 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. |
Breast FeedingTOP
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 InteractionsTOP
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.
- Nalmefene
- Naltrexone
- Safinamide
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.
- Acepromazine
- Alfentanil
- Almotriptan
- Alprazolam
- Amineptine
- Amisulpride
- Amitriptyline
- Amitriptylinoxide
- Amobarbital
- Amoxapine
- Amphetamine
- Anileridine
- Aprepitant
- Aripiprazole
- Asenapine
- Atazanavir
- Baclofen
- Benperidol
- Benzphetamine
- Boceprevir
- Bromazepam
- Bromopride
- Brompheniramine
- Buprenorphine
- Buspirone
- Butabarbital
- Butorphanol
- Carbinoxamine
- Carisoprodol
- Carphenazine
- Ceritinib
- Chloral Hydrate
- Chlordiazepoxide
- Chlorpheniramine
- Chlorpromazine
- Chlorzoxazone
- Citalopram
- Clarithromycin
- Clobazam
- Clomipramine
- Clonazepam
- Clorazepate
- Clozapine
- Cocaine
- Codeine
- Conivaptan
- Cyclobenzaprine
- Dasabuvir
- Desipramine
- Desmopressin
- Desvenlafaxine
- Dexmedetomidine
- Dextroamphetamine
- Dextromethorphan
- Dezocine
- Diazepam
- Dibenzepin
- Dichloralphenazone
- Difenoxin
- Dihydrocodeine
- Diltiazem
- Diphenhydramine
- Diphenoxylate
- Dolasetron
- Donepezil
- Doxepin
- Doxylamine
- Dronedarone
- Droperidol
- Duloxetine
- Eletriptan
- Enflurane
- Erythromycin
- Escitalopram
- Estazolam
- Eszopiclone
- Ethchlorvynol
- Ethopropazine
- Ethylmorphine
- Fentanyl
- Flibanserin
- Fluconazole
- Fluoxetine
- Fluphenazine
- Flurazepam
- Fluspirilene
- Fluvoxamine
- Fosaprepitant
- Fospropofol
- Frovatriptan
- Furazolidone
- Granisetron
- Halazepam
- Haloperidol
- Halothane
- Hexobarbital
- Hydromorphone
- Hydroxytryptophan
- Hydroxyzine
- Idelalisib
- Imatinib
- Imipramine
- Indinavir
- Iproniazid
- Isocarboxazid
- Isoflurane
- Isoniazid
- Itraconazole
- Ketamine
- Ketazolam
- Ketobemidone
- Ketoconazole
- Levomilnacipran
- Levorphanol
- Linezolid
- Lisdexamfetamine
- Lithium
- Lofepramine
- Lopinavir
- Lorazepam
- Lorcaserin
- Loxapine
- Meclizine
- Melitracen
- Melperone
- Meperidine
- Mephobarbital
- Meprobamate
- Meptazinol
- Mesoridazine
- Metaxalone
- Methadone
- Methamphetamine
- Methdilazine
- Methocarbamol
- Methohexital
- Methotrimeprazine
- Methylene Blue
- Midazolam
- Milnacipran
- Mirtazapine
- Moclobemide
- Molindone
- Moricizine
- Morphine
- Morphine Sulfate Liposome
- Nalbuphine
- Naratriptan
- Nefazodone
- Nelfinavir
- Netupitant
- Nialamide
- Nicomorphine
- Nitrazepam
- Nitrous Oxide
- Nortriptyline
- Olanzapine
- Ombitasvir
- Ondansetron
- Opipramol
- Opium
- Opium Alkaloids
- Orphenadrine
- Oxazepam
- Oxycodone
- Oxymorphone
- Palonosetron
- Papaveretum
- Paregoric
- Paritaprevir
- Paroxetine
- Pentazocine
- Pentobarbital
- Perampanel
- Perazine
- Periciazine
- Perphenazine
- Phenelzine
- Phenobarbital
- Piperacetazine
- Pipotiazine
- Piritramide
- Pixantrone
- Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
- Posaconazole
- Prazepam
- Primidone
- Procarbazine
- Prochlorperazine
- Promazine
- Promethazine
- Propofol
- Protriptyline
- Quazepam
- Quetiapine
- Ramelteon
- Rasagiline
- Remifentanil
- Remoxipride
- Ritonavir
- Rizatriptan
- Saquinavir
- Secobarbital
- Selegiline
- 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
- Venlafaxine
- Verapamil
- Vilazodone
- Voriconazole
- Vortioxetine
- Zaleplon
- Ziprasidone
- Zolmitriptan
- Zolpidem
- Zopiclone
- Zotepine
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
- Carbamazepine
- Fosphenytoin
- Lixisenatide
- Phenytoin
- Warfarin
- Zidovudine
Other InteractionsTOP
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 ProblemsTOP
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 abuse, history of or
- Brain tumor, or history of or
- Breathing or lung problems (eg, asthma, apnea, chronic obstructive pulmonary disease [COPD], cor pulmonale, emphysema, hypoxia) or
- CNS depression or
- Drug dependence, especially narcotic abuse or dependence, or history of or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Head injuries, or history of or
- Increased pressure in the head or
- Hypothyroidism (an underactive thyroid) or
- Problems with passing urine—Use with caution. May increase risk for more serious side effects.
- Hypotension (low blood pressure) or
- Pancreatitis (inflammation 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.
- Lung disease or breathing problems, severe or
- Stomach or bowel blockage—Should not be used in patients with these conditions.
PrecautionsTOP
It is very important that your doctor check the progress of you or your child while 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.
Do not use this medicine if you are using or have used an MAO inhibitor (eg, Eldepryl®, Marplan®, Nardil®, 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. People who are addicted to drugs might want to steal this medicine.
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 (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.
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 this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis 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 this medicine.
This medicine may make you dizzy, drowsy, or lightheaded. 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.
Using narcotics 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, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.
Using this medicine while you are pregnant may cause the neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your child has the following symptoms: an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, sneezing, weight loss, vomiting, yawning, or failure to gain weight.
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.
