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Generic Name(S): hydrocodone-acetaminophen
Xodol® is supplied as follows:
5 mg/300 mg
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White, capsule-shaped, bisected tablets, debossed “5” score “300” on one side and “TP” on the other side.
7.5 mg/300 mg
Xodol Oral Tablet 7.5 mg/300 mg
White, capsule-shaped, bisected tablets, debossed “7.5” score “300” on one side and “TP” on the
other side.
10 mg/300 mg
Xodol Oral Tablet 10 mg/300 mg
White, capsule-shaped, bisected tablets, debossed “10” score “300” on one side and “TP” on the other side.
STORAGE: Store at 20° to 25°C
(68° to 77°F). [See USP Controlled Room Temperature].
PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure.
A Schedule III Narcotic
Uses
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.
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Intended Use of Xodol
Xodol, or the combination of hydrocodone bitartrate and acetaminophen, was initially developed as an alternative treatment for severe pain. When non-opioid pain relievers aren’t working as expected, Xodol tablets are prescribed to help manage pain. Like many opioids, Xodol works by blocking pain receptors in the brain and providing temporary relief.
How Xodol Is Taken
Take Xodol exactly as directed by your doctor or pharmacist.
Xodol is usually taken by mouth in the form of a white tablet. A single, adult dose is one-or-two 5 mg/ 300 mg tablets that usually last four-to-six hours. Medical experts recommend taking the hydrocodone-acetaminophen combination with a glass of water, with or without food.
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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 often, 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.
This product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. Patients known to be hypersensitive
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to other opioids may exhibit cross sensitivity to hydrocodone.
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.
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DOSAGE AND ADMINISTRATION
Dosage should be adjusted according to the severity of the pain and the response of the patient.
However, it should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
Xodol® 5/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg): The
usual adult dosage is one or two tablets every four to six hours as needed for pain.
Xodol® 7.5/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/300 mg): The
usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage
should not exceed 6 tablets.
Xodol® 10/300 (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/300 mg): The
usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage
should not exceed 6 tablets.
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Xodol side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Xodol and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
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Xodol may cause serious side effects. Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops;
- a light-headed feeling, like you might pass out;
- liver problems–nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- low cortisol levels– nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; o
- high levels of serotonin in the body–agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects include:
- dizziness, drowsiness, feeling tired;
- nausea, vomiting, stomach pain;
- constipation; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
Warnings
MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.
Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.
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Before taking this medicine
You should not use Xodol if you are allergic to acetaminophen or hydrocodone, or if you have:
- severe asthma or breathing problems; or
- a blockage in your stomach or intestines.
Tell your doctor if you have ever had:
- breathing problems, sleep apnea (breathing stops during sleep);
- liver disease;
- a drug or alcohol addiction;
- kidney disease;
- a head injury or seizures;
- urination problems; or
- problems with your thyroid, pancreas, or gallbladder.
If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on opioids may need medical treatment for several weeks.
Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.
How should I take Xodol?
Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if you feel an increased urge to use more of this medicine.
Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away this medicine is against the law.
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Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.
You should not stop using this medicine suddenly. Follow your doctor’s instructions about tapering your dose.
Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.
What happens if I miss a dose?
Since Xodol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.
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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include nausea, vomiting, sweating, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.
Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don’t wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.
Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.
What should I avoid while taking Xodol?
Avoid driving or operating machinery until you know how Xodol will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.
Do not drink alcohol. Dangerous side effects or death could occur.
Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen (sometimes abbreviated as APAP). Taking certain medications together can lead to a fatal overdose.
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What other drugs will affect Xodol?
You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.
Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
- cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic (“water pill”);
- medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
- other opioids–opioid pain medicine or prescription cough medicine;
- a sedative like Valium–diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
- drugs that make you sleepy or slow your breathing–a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
- drugs that affect serotonin levels in your body–a stimulant, or medicine for depression, Parkinson’s disease, migraine headaches, serious infections, or nausea and vomiting.
This list is not complete. Other drugs may affect Xodol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. for sale
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