Hydrocodone 10mg/325mg

Hydrocodone 10mg/325mg

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M367 (Acetaminophen and Hydrocodone Bitartrate 325 mg / 10 mg)

Pill with imprint M367 is White, Capsule-shape and has been identified as Acetaminophen and Hydrocodone Bitartrate 325 mg / 10 mg. It is supplied by Mallinckrodt Pharmaceuticals.

Acetaminophen/hydrocodone is used in the treatment of back pain; pain; cough and belongs to the drug class narcotic analgesic combinations. Risk cannot be ruled out during pregnancy. Acetaminophen/hydrocodone 325 mg / 10 mg is classified as a Schedule 2 controlled substance under the Controlled Substance Act (CSA).

Acetaminophen and Hydrocodone Bitartrate

Imprint
M367
Strength
325 mg / 10 mg
Color
White
Size
15.00 mm
Shape
Capsule-shape
Availability
Prescription only
Drug Class
Narcotic analgesic combinations
Pregnancy Category
C – Risk cannot be ruled out
CSA Schedule
2 – High potential for abuse
Inactive Ingredients
magnesium stearate, microcrystalline cellulose, corn starch, silicon dioxide, stearic acid
Acetaminophen / hydrocodone Side Effects

For the Consumer

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

Warning

Oral route (Solution)

Hydrocodone bitartrate and acetaminophen oral solution 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. 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 Risk Evaluation and Mitigation Strategy (REMS) for these products. 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 oral solution, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen. Prolonged use of hydrocodone bitartrate and acetaminophen oral solution 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 oral solution 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.

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. 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 Risk Evaluation and Mitigation Strategy (REMS) for these products. 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.

Side effects requiring immediate medical attention

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

  • 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
  • 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
  • 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
  • tightness in the chest
  • trembling or shaking
  • twitching
  • unable to speak
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting
  • 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
  • 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

Side effects not requiring immediate medical attention

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 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
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Hydrocodone 10mg/325mg

Hydrocodone 10mg/325mg: This combination medication is used to relieve moderate to severe pain. It contains an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen). Hydrocodone works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever.

How to use Hydrocodone-Acetaminophen

See also Warning section.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

If you are using a liquid form of this medication, use a medication measuring device to carefully measure the prescribed dose. Do not use a household spoon because you may not get the correct dose.

The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other pain relievers (such as ibuprofen, naproxen) may also be prescribed. Ask your doctor or pharmacist about using this product safely with other drugs.

Suddenly stopping this medication may cause withdrawal, especially if you have used it for a long time or in high doses. To prevent withdrawal, your doctor may lower your dose slowly. Tell your doctor or pharmacist right away if you have any withdrawal symptoms such as restlessness, mental/mood changes (including anxiety, trouble sleeping, thoughts of suicide), watering eyes, runny nose, nausea, diarrhea, sweating, muscle aches, or sudden changes in behavior.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Take this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your pain does not get better or if it gets worse.

Side Effects

Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).

Get medical help right away if you have any very serious side effects, including: fainting, seizure, slow/shallow breathing, severe drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Additional Information

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Pack of 5, Single

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