Hydrocodone bitartrate extended-release capsules are:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them.
- A long acting (extended-release) 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.
- Not to be taken on an “as needed” basis.
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Important information about hydrocodone bitartrate extended-release capsules:
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Get emergency help or call 911 right away if you take too much hydrocodone bitartrate extended-release capsules (overdose). When you first start taking hydrocodone bitartrate extended-release capsules, 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 the emergency treatment of an opioid overdose.
- Taking hydrocodone bitartrate extended-release capsules 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.
- Never give anyone else your hydrocodone bitartrate extended-release capsules. They could die from taking it. Selling or giving away hydrocodone bitartrate extended-release capsules is against the law.
- Store hydrocodone bitartrate extended-release capsules 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 hydrocodone bitartrate extended-release capsules if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or narrowing of the stomach or intestines.
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Before taking hydrocodone bitartrate extended-release capsules, tell your healthcare provider if you have a history of:
- head injury, seizures
- problems urinating
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.
Tell your healthcare provider if you:
- are noticing your pain getting worse. If your pain gets worse after you take hydrocodone bitartrate extended-release capsules, do not take more of hydrocodone bitartrate extended-release capsules without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking hydrocodone bitartrate extended-release capsules.
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are pregnant or planning to become pregnant. Use of hydrocodone bitartrate extended-release capsules for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
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are breastfeeding. Not recommended during treatment with hydrocodone bitartrate extended-release capsules. It may harm your baby.
- are living in a household where there are small children or someone who has abused street or prescription drugs.
- are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking hydrocodone bitartrate extended-release capsules with certain other medicines can cause serious side effects that could lead to death.
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When taking hydrocodone bitartrate extended-release capsules:
- Do not change your dose. Take hydrocodone bitartrate extended-release capsules exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
- Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.
- Swallow hydrocodone bitartrate extended-release capsules whole. Do not cut, break, chew, crush, dissolve, snort, or inject hydrocodone bitartrate extended-release capsules because this may cause you to overdose and die.
Call your healthcare provider if the dose you are taking does not control your pain.
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Do not stop taking hydrocodone bitartrate extended-release capsules without talking to your healthcare provider.
- Dispose of expired, unwanted, or unused hydrocodone bitartrate extended-release capsules by taking your drug to an authorized DEA-registered collector or drug take-back program. If one is not available, you can dispose of hydrocodone bitartrate extended-release capsules by mixing the product with dirt, cat litter, or coffee grounds; placing the mixture in a sealed plastic bag, and throwing the bag in your trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
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While taking hydrocodone bitartrate extended-release capsules DO NOT:
- Drive or operate heavy machinery, until you know how hydrocodone bitartrate extended-release capsules affects you. Hydrocodone bitartrate extended-release capsules can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with hydrocodone bitartrate extended-release capsules may cause you to overdose and die.
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The possible side effects of hydrocodone bitartrate extended-release capsules are:
- 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:
- trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when you are 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 hydrocodone bitartrate extended-release capsules. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.
Product of USA
Distributed by:
Alvogen, Inc.
Morristown, NJ 07960 USA
For more information, call Alvogen at 1-866-770-3024. |