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Methadone Hydrochloride Oral Concentrate, USP, CII
(Intensol™)
(METH-a-done)
Rx Only
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Methadone Hydrochloride Intensol™ is:
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- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
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- A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
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- Not for use to treat pain that is not around-the-clock.
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- Also used to manage drug addiction.
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Important information about Methadone Hydrochloride Intensol™:
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Get emergency help or call 911 right away if you take too much Methadone Hydrochloride Intensol™(overdose). When you first start taking Methadone Hydrochloride Intensol™, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for emergency treatment of opioid overdose.
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- Taking Methadone Hydrochloride Intensol™ with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
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- Never give anyone else your Methadone Hydrochloride Intensol™. They could die from taking it. Selling or giving away Methadone Hydrochloride Intensol™ is against the law.
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- Store Methadone Hydrochloride Intensol™ securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.
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Do not take Methadone Hydrochloride Intensol™ if you have:
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- Severe asthma, trouble breathing, or other lung problems.
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- A bowel blockage or have narrowing of the stomach or intestines.
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Before taking Methadone Hydrochloride Intensol™, tell your healthcare provider if you have a history of:
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- head injury, seizures
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- liver, kidney, thyroid problems
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- problems urinating
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- heart rhythm problems (Long QT syndrome)
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- pancreas or gallbladder problems
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- abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
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Tell your healthcare provider if you are:
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Pregnant or plan to become pregnant. If you take Methadone Hydrochloride Intensol™ while pregnant, your baby may have symptoms of opioid withdrawal or respiratory depression at birth. Talk to your doctor if you are pregnant or plan to become pregnant.
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Breastfeeding. Methadone passes into breast milk and may harm your baby.
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- Living in a household where there are small children or someone who has abused street or prescription drugs.
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- Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Methadone Hydrochloride Intensol™ with certain other medicines may cause serious side effects.
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When taking Methadone Hydrochloride Intensol™:
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- Do not change your dose. Take Methadone Hydrochloride Intensol™ exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
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- Do not take more than your prescribed dose in 24 hours. If you take Methadone Hydrochloride Intensol™ for pain and miss a dose, take Methadone Hydrochloride Intensol™ as soon as possible and then take your next dose 8 or 12 hours later as directed by your healthcare provider. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
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- If you take Methadone Hydrochloride Intensol™ for opioid addiction and miss a dose, take your next dose the following day as scheduled. Do not take extra doses. Taking more than the prescribed dose may cause you to overdose because Methadone Hydrochloride Intensol™ build up in your body over time.
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- Do not crush, dissolve, snort or inject Methadone Hydrochloride because this may cause you to overdose and die.
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Call your healthcare provider if the dose you are taking does not control your pain.
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Do not stop taking Methadone Hydrochloride Intensol™ without talking to your healthcare provider.
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- Dispose of expired, unwanted, or unused Methadone Hydrochloride Intensol™ by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
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While taking Methadone Hydrochloride Intensol™ DO NOT:
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- Drive or operate heavy machinery, until you know how Methadone Hydrochloride Intensol™ affect you. Methadone Hydrochloride Intensol™ can make you sleepy, dizzy, or lightheaded.
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- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Methadone Hydrochloride Intensol™ may cause you to overdose and die.
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The possible side effects of Methadone Hydrochloride Intensol™ are:
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- Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
Get emergency medical help or call 911 right away if you have:
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- Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.
These are not all the possible side effects of Methadone Hydrochloride Intensol™. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go todailymed.nlm.nih.gov.
Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07724
For more information, please call 1-800-962-8364.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
C50000748/xx
Revised November 2023
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