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NALTREXONE 50 MG TAB 100

  • Manufacturer Name : SPECGX LLC/GENERIC
  • MFG # : 00406117001
  • NDC : 00406117001
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind -
DESI2 Drug Ind AB
Drug Category NJ
Drug Category N
Drug Type Code 1
Drug Type Code N
FDA Approval Date 08/23/1999
FDA Approval Date 08/23/1999
FDA Therap Equiv AB
FDA Therap Equiv TAB
HCPCS -
HCPCS -
Market Entry Date 08/23/1999
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date 1
Unit 1
Unit TAB
Units Per Pkg 1
Units Per Pkg 08/23/1999
Active Ingredients 1615 naltrexone HCl 16676292
Active Ingredients 1615 naltrexone HCl 16676292
AHFS Class 28100000 OPIATE ANTAGONISTS; 92040000 ALCOHOL DETERRENTS
AHFS Class 28100000 OPIATE ANTAGONISTS; 92040000 ALCOHOL DETERRENTS
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 4518 naltrexone HCl ORAL TABLET 50 MG
Gen Code and Des 4518 naltrexone HCl ORAL TABLET 50 MG
Inactive Ingredients 2432 lactose 64044515; 2537 povidone 9003398
Inactive Ingredients 2432 lactose 64044515; 2537 povidone 9003398
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 50MG
Strength 50MG
Common Brand Name COMMON BRAND NAME(S): Revia
Common Brand Name COMMON BRAND NAME(S): Revia
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: dextromethorphan, diarrhea medication (such as diphenoxylate), disulfiram, opioid pain or cough relievers (such as codeine, hydrocodone), thioridazine. This medication may interfere with certain laboratory tests (including drug tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: dextromethorphan, diarrhea medication (such as diphenoxylate), disulfiram, opioid pain or cough relievers (such as codeine, hydrocodone), thioridazine. This medication may interfere with certain laboratory tests (including drug tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 100
Drug Form Pack Size 100
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 20 Cool-Store Cont Temp
Temp Zone 20 Cool-Store Cont Temp
Unit EA
Unit EA
Unit Size 100
Unit Size 100
How to Use HOW TO USE: Take this medication by mouth with or without food, usually 50 milligrams once daily or as directed by your doctor. This medication may be given as part of a program where a health care professional will watch you take the medication. In this case, your doctor may order a higher dose (100-150 milligrams) to be taken every 2-3 days to make it easier to schedule clinic visits. Naltrexone may be taken with food or antacids if stomach upset occurs. A urine test should be done to check for recent opiate drug use. Your doctor may give you another medication (naloxone challenge test) to check for opiate use. Do not use any opiates for at least 7 days before starting naltrexone. You may need to stop certain opiate drugs (such as methadone) 10 to 14 days before starting naltrexone. Dosage is based on your medical condition and response to treatment. Your doctor may start you at a lower dose and monitor you for any side effects or withdrawal symptoms before increasing your dose. Take this medication as directed. Do not increase your dose, take it more often, or stop taking it without your doctor's approval. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if you start using drugs or alcohol again.
How to Use HOW TO USE: Take this medication by mouth with or without food, usually 50 milligrams once daily or as directed by your doctor. This medication may be given as part of a program where a health care professional will watch you take the medication. In this case, your doctor may order a higher dose (100-150 milligrams) to be taken every 2-3 days to make it easier to schedule clinic visits. Naltrexone may be taken with food or antacids if stomach upset occurs. A urine test should be done to check for recent opiate drug use. Your doctor may give you another medication (naloxone challenge test) to check for opiate use. Do not use any opiates for at least 7 days before starting naltrexone. You may need to stop certain opiate drugs (such as methadone) 10 to 14 days before starting naltrexone. Dosage is based on your medical condition and response to treatment. Your doctor may start you at a lower dose and monitor you for any side effects or withdrawal symptoms before increasing your dose. Take this medication as directed. Do not increase your dose, take it more often, or stop taking it without your doctor's approval. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if you start using drugs or alcohol again.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (nal-TREX-one hye-droe-KLOR-ide)
Phonetic Pronunciation (nal-TREX-one hye-droe-KLOR-ide)
Precautions PRECAUTIONS: Before taking naltrexone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or recent use (in the last 7 to 14 days) of any type of opioid drug (such as morphine, methadone, buprenorphine), kidney disease, liver disease. You should carry or wear medical identification stating that you are taking this drug so that appropriate treatment can be given in a medical emergency. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). After stopping naltrexone treatment, you may be more sensitive to lower doses of opioids, increasing your risk of possibly life-threatening side effects from the opioid (such as decreased breathing, loss of consciousness). This medication blocks the effects of opiate drugs (including heroin) and similar drugs (opioids). However, large doses of heroin or opioids can overcome this block. Trying to overcome this block is very dangerous and may cause serious injury, loss of consciousness, and death. Make sure you completely understand and accept the risks and benefits of using this medication. Follow your doctor's instructions closely. Before having surgery or any medical treatment, tell your doctor or dentist that you are taking this medication. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking naltrexone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: current or recent use (in the last 7 to 14 days) of any type of opioid drug (such as morphine, methadone, buprenorphine), kidney disease, liver disease. You should carry or wear medical identification stating that you are taking this drug so that appropriate treatment can be given in a medical emergency. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). After stopping naltrexone treatment, you may be more sensitive to lower doses of opioids, increasing your risk of possibly life-threatening side effects from the opioid (such as decreased breathing, loss of consciousness). This medication blocks the effects of opiate drugs (including heroin) and similar drugs (opioids). However, large doses of heroin or opioids can overcome this block. Trying to overcome this block is very dangerous and may cause serious injury, loss of consciousness, and death. Make sure you completely understand and accept the risks and benefits of using this medication. Follow your doctor's instructions closely. Before having surgery or any medical treatment, tell your doctor or dentist that you are taking this medication. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Nausea, headache, dizziness, anxiety, tiredness, and trouble sleeping may occur. In a small number of people, mild opiate withdrawal symptoms may occur, including abdominal cramps, restlessness, bone/joint pain, muscle aches, and runny nose. If any of these effects last or get worse, tell your doctor or pharmacist promptly. 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. Sudden opiate withdrawal symptoms can occur within minutes after taking naltrexone. Tell your doctor right away if any of these withdrawal symptoms occur: abdominal cramps, nausea/vomiting, diarrhea, joint/bone/muscle aches, mental/mood changes (such as anxiety, confusion, extreme sleepiness, visual hallucinations), runny nose. Naltrexone has rarely caused serious liver disease. The risk is increased when larger doses are used. Discuss the risks and benefits with your doctor. Stop using this medication and tell your doctor right away if you develop symptoms of liver disease, including: nausea/vomiting that doesn't stop, severe stomach/abdominal pain, dark urine, yellowing eyes/skin. 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. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Nausea, headache, dizziness, anxiety, tiredness, and trouble sleeping may occur. In a small number of people, mild opiate withdrawal symptoms may occur, including abdominal cramps, restlessness, bone/joint pain, muscle aches, and runny nose. If any of these effects last or get worse, tell your doctor or pharmacist promptly. 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. Sudden opiate withdrawal symptoms can occur within minutes after taking naltrexone. Tell your doctor right away if any of these withdrawal symptoms occur: abdominal cramps, nausea/vomiting, diarrhea, joint/bone/muscle aches, mental/mood changes (such as anxiety, confusion, extreme sleepiness, visual hallucinations), runny nose. Naltrexone has rarely caused serious liver disease. The risk is increased when larger doses are used. Discuss the risks and benefits with your doctor. Stop using this medication and tell your doctor right away if you develop symptoms of liver disease, including: nausea/vomiting that doesn't stop, severe stomach/abdominal pain, dark urine, yellowing eyes/skin. 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. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: This medication is used to prevent people who have been addicted to certain drugs (opiates) from taking them again. It is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes). This medication must not be used in people currently taking opiates, including methadone. Doing so can cause sudden withdrawal symptoms. Naltrexone belongs to a class of drugs known as opiate antagonists. It works in the brain to prevent opiate effects (such as feelings of well-being, pain relief). It also decreases the desire to take opiates. Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it. This medication is also used to treat alcohol abuse. It can help people drink less alcohol or stop drinking altogether. It also decreases the desire to drink alcohol when used with a treatment program that includes counseling, support, and lifestyle changes.
Uses USES: This medication is used to prevent people who have been addicted to certain drugs (opiates) from taking them again. It is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes). This medication must not be used in people currently taking opiates, including methadone. Doing so can cause sudden withdrawal symptoms. Naltrexone belongs to a class of drugs known as opiate antagonists. It works in the brain to prevent opiate effects (such as feelings of well-being, pain relief). It also decreases the desire to take opiates. Ask your doctor or pharmacist if you should have naloxone available to treat opioid overdose. Teach your family or household members about the signs of an opioid overdose and how to treat it. This medication is also used to treat alcohol abuse. It can help people drink less alcohol or stop drinking altogether. It also decreases the desire to drink alcohol when used with a treatment program that includes counseling, support, and lifestyle changes.

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NALTREXONE 50 MG TAB 100 is manufactured by SPECGX LLC/GENERIC.
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