Acetaminophen and hydrocodone

Name: Acetaminophen and hydrocodone

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and hydrocodone can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

Acetaminophen and hydrocodone dosing information

Usual Adult Dose for Pain:

Tablets:
Recommended dose:
Acetaminophen-hydrocodone 300 mg-5 mg: 1 to 2 tablets orally every 4 to 6 hours as needed
Acetaminophen-hydrocodone 300 mg-7.5 mg: 1 tablet orally every 4 to 6 hours as needed
Acetaminophen-hydrocodone 300 mg-10 mg: 1 tablet orally every 4 to 6 hours as needed
Maximum dose:
Acetaminophen-hydrocodone 300 mg-5 mg: 8 tablets daily
Acetaminophen-hydrocodone 300 mg-7.5 mg: 6 tablets daily
Acetaminophen-hydrocodone 300 mg-10 mg: 6 tablets daily

Liquid:
Recommended dose:
15 mL (acetaminophen-hydrocodone 325 mg-7.5 mg) orally every 4 to 6 hours as needed
Maximum dose: 6 tablespoonfuls daily

Comments:
Dosage should be adjusted according to severity of the pain and the response of the patient. Tolerance to hydrocodone can develop with continued use and the incidence of side effects is dose related.

Approved indication: For the relief of moderate to moderately severe pain

Usual Pediatric Dose for Pain:

Recommended dosing for children 2 to 18 years of age:

12 to 15 kg (27 to 34 lbs.)--about 2 to 3 years old:
Recommended dose: 3.75 mL orally every 4 to 6 hours
Maximum dose: 22.5 mL daily (in 6 divided doses)

16 to 22 kg (36 to 50 lbs.)--about 4 to 6 years old:
Recommended dose: 5 mL orally every 4 to 6 hours
Maximum dose: 30 mL daily (in 6 divided doses)

23 to 31 kg (51 to 69 lbs.)--about 7 to 9 years old:
Recommended dose: 7.5 mL orally every 4 to 6 hours
Maximum dose: 45 mL daily (in 6 divided doses)

32 to 45 kg (70 to 100 lbs.)--about 10 to 13 years old:
Recommended dose: 10 mL orally every 4 to 6 hours
Maximum dose: 60 mL daily (in 6 divided doses)

48 kg and up (101 lbs and up)--18 years to adult:
Recommended dose: 15 mL orally every 4 to 6 hours
Maximum dose: 90 mL daily (in 6 divided doses)

How should I take acetaminophen and hydrocodone?

Take acetaminophen and hydrocodone exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Measure the liquid form of this medication with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and hydrocodone. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. You may have withdrawal symptoms when you stop using acetaminophen and hydrocodone after using it over a long period of time. Do not stop using acetaminophen and hydrocodone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and hydrocodone.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.

Store acetaminophen and hydrocodone at room temperature away from moisture and heat.

Keep track of how many tablets have been used from each new bottle of this medicine. Hydrocodone is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Acetaminophen and hydrocodone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
  • shallow breathing, slow heartbeat;

  • feeling light-headed, fainting;

  • confusion, fear, unusual thoughts or behavior;

  • seizure (convulsions);

  • problems with urination; or

  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

  • feeling anxious, dizzy, or drowsy;

  • mild nausea, vomiting, upset stomach, constipation;

  • headache, mood changes;

  • blurred vision;

  • ringing in your ears; or

  • dry mouth.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect acetaminophen and hydrocodone?

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • antidepressants such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

If you are using any of these drugs, you may not be able to use acetaminophen and hydrocodone, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect acetaminophen and hydrocodone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

For the Consumer

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral syrup, oral tablet

Along with its needed effects, acetaminophen / hydrocodone 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 while taking acetaminophen / hydrocodone:

More common
  • Dizziness
  • lightheadedness
Incidence not known
  • Back, leg, or stomach pains
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blood in vomit
  • bluish lips or skin
  • chills
  • choking
  • cough or hoarseness
  • dark urine
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficult or troubled breathing
  • difficulty in passing urine (dribbling)
  • difficulty with breathing
  • difficulty with swallowing
  • fast heartbeat
  • fever
  • fever with or without chills
  • general body swelling
  • general feeling of tiredness or weakness
  • headache
  • irregular, fast or slow, or shallow breathing
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • nausea or vomiting
  • nosebleeds
  • not breathing
  • painful or difficult urination
  • pale or blue lips, fingernails, or skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • severe or continuing stomach pain
  • skin rash, hives, or itching
  • sore throat
  • sore tongue
  • sores, ulcers, or white spots on the lips or in the mouth
  • tightness in the chest
  • unable to speak
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / hydrocodone:

Symptoms of overdose
  • Bloody or cloudy urine
  • change in consciousness
  • chest pain or discomfort
  • cold and clammy skin
  • decreased awareness or responsiveness
  • extreme drowsiness
  • general feeling of discomfort or illness
  • increased sweating
  • irregular heartbeat
  • lightheadedness, dizziness, or fainting
  • loss of consciousness
  • no blood pressure or pulse
  • no muscle tone or movement
  • not breathing
  • severe sleepiness
  • slow or irregular heartbeat
  • stopping of heart
  • sudden decrease in the amount of urine
  • unconsciousness
  • unpleasant breath odor

Some side effects of acetaminophen / hydrocodone 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
  • sleepiness
Incidence not known
  • Belching
  • changes in mood
  • difficulty having a bowel movement (stool)
  • 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

For Healthcare Professionals

Applies to acetaminophen / hydrocodone: oral capsule, oral elixir, oral liquid, oral solution, oral tablet

General

The adverse effects of hydrocodone are generally similar to the adverse effects observed with other narcotic analgesics. Acetaminophen is generally well-tolerated when administered in therapeutic doses.[Ref]

Nervous system

One study has suggested that the respiratory depression caused by hydrocodone may be of benefit in the treatment of dyspnea related to chronic obstructive pulmonary disease and restrictive lung disease. However, the potential for the precipitation of respiratory insufficiency makes such use of hydrocodone hazardous and such use should be undertaken, if at all, only with extreme caution.[Ref]

Nervous system side effects of hydrocodone include mental depression, dizziness, lightheadedness, respiratory depression (which is sometimes fatal), stupor, delirium, somnolence, agitation, and dysphoria.[Ref]

Other

Other side effects have included withdrawal symptoms, after either abrupt cessation or fast tapering of narcotic analgesics. Such symptoms may include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting, and sweating.[Ref]

Hepatic

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

The adverse effects of hydrocodone may be more likely and more severe in patients with liver disease.[Ref]

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis have been reported in alcoholic patients. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.[Ref]

Gastrointestinal

Gastrointestinal side effects with the use of acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely.

Gastrointestinal side effect including nausea, vomiting, constipation, and dry mouth are relatively common effects of narcotic analgesics.[Ref]

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Genitourinary

Genitourinary side effects including ureteral spasm, spasm of vesicle sphincters, and urinary retention have been reported.[Ref]

Dermatologic

Dermatologic side effects including narcotic-induced rashes have been reported. General erythematous skin rashes associated with acetaminophen have been reported, but are rare. A rare case of bullous erythema associated with acetaminophen has been reported. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).[Ref]

Renal

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases.

The adverse effects of hydrocodone may be more likely and more severe in patients with renal insufficiency.[Ref]

Renal side effects of acetaminophen are rare and include acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, from chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.[Ref]

Hypersensitivity

Hypersensitivity side effects to acetaminophen have been reported rarely.[Ref]

Respiratory

Respiratory side effects have included a case of eosinophilic pneumonia which has been associated with acetaminophen.[Ref]

Metabolic

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

Some side effects of acetaminophen / hydrocodone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Usual Pediatric Dose for Pain

Recommended dosing for children 2 to 18 years of age:

12 to 15 kg (27 to 34 lbs.)--about 2 to 3 years old:
Recommended dose: 3.75 mL orally every 4 to 6 hours
Maximum dose: 22.5 mL daily (in 6 divided doses)

16 to 22 kg (36 to 50 lbs.)--about 4 to 6 years old:
Recommended dose: 5 mL orally every 4 to 6 hours
Maximum dose: 30 mL daily (in 6 divided doses)

23 to 31 kg (51 to 69 lbs.)--about 7 to 9 years old:
Recommended dose: 7.5 mL orally every 4 to 6 hours
Maximum dose: 45 mL daily (in 6 divided doses)

32 to 45 kg (70 to 100 lbs.)--about 10 to 13 years old:
Recommended dose: 10 mL orally every 4 to 6 hours
Maximum dose: 60 mL daily (in 6 divided doses)

48 kg and up (101 lbs and up)--18 years to adult:
Recommended dose: 15 mL orally every 4 to 6 hours
Maximum dose: 90 mL daily (in 6 divided doses)

Upsides

  • May be used to relieve moderate-to-moderately severe pain unresponsive to other treatment options.
  • The combination is more effective than either drug alone.
  • Both drugs last for a similar length of time in the body which makes them appropriate to be given together.
  • Available in tablet and oral solution forms.
  • Has been FDA-approved for use in children; however, because of its high potential for addiction, acetaminophen/hydrocodone should only be given to children if there are no other alternatives.
  • Generic acetaminophen/hydrocodone is available.
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