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Movantik 25 Mg Tab 30

  • Manufacturer Name : REDHILL BIOPHARMA INC.
  • MFG # : 57841130101
  • NDC : 57841130101
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind NR
DESI2 Drug Ind -
Drug Category S
Drug Category -
Drug Category -
Drug Type Code S
Drug Type Code S
Drug Type Code 1
FDA Approval Date 09/16/2014
FDA Approval Date 03/02/2015
FDA Approval Date 03/02/2015
FDA Therap Equiv TAB
FDA Therap Equiv TAB
FDA Therap Equiv NR
HCPCS -
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date -
Market Entry Date 03/02/2015
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date -
Termination Date 1
Unit 30
Unit TAB
Unit 30
Units Per Pkg 09/16/2014
Units Per Pkg 30
Units Per Pkg 09/16/2014
Active Ingredients 15864 naloxegol oxalate 135474491
Active Ingredients 15864 naloxegol oxalate 135474491
Active Ingredients 15864 naloxegol oxalate 135474491
AHFS Class 56920000 GI DRUGS, MISCELLANEOUS
AHFS Class 56920000 GI DRUGS, MISCELLANEOUS
AHFS Class 56920000 GI DRUGS, MISCELLANEOUS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 73336 naloxegol oxalate ORAL TABLET 25 MG
Gen Code and Des 73336 naloxegol oxalate ORAL TABLET 25 MG
Gen Code and Des 73336 naloxegol oxalate ORAL TABLET 25 MG
Inactive Ingredients 2272 mannitol 69658
Inactive Ingredients 2272 mannitol 69658
Inactive Ingredients 2272 mannitol 69658
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 25MG
Strength 25MG
Strength 25MG
Common Brand Name COMMON BRAND NAME(S): Movantik
Common Brand Name COMMON BRAND NAME(S): Movantik
Common Brand Name COMMON BRAND NAME(S): Movantik
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. Other medications can affect the removal of naloxegol from your body, which may affect how naloxegol works. Examples include adagrasib, azole antifungals (such as ketoconazole, itraconazole), clarithromycin, cobicistat, indinavir, nefazodone, nelfinavir, rifamycins (such as rifampin, rifabutin), ritonavir, tipranavir, among others.
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. Other medications can affect the removal of naloxegol from your body, which may affect how naloxegol works. Examples include adagrasib, azole antifungals (such as ketoconazole, itraconazole), clarithromycin, cobicistat, indinavir, nefazodone, nelfinavir, rifamycins (such as rifampin, rifabutin), ritonavir, tipranavir, among others.
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. Other medications can affect the removal of naloxegol from your body, which may affect how naloxegol works. Examples include adagrasib, azole antifungals (such as ketoconazole, itraconazole), clarithromycin, cobicistat, indinavir, nefazodone, nelfinavir, rifamycins (such as rifampin, rifabutin), ritonavir, tipranavir, among others.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 30
Drug Form Pack Size 30
Drug Form Pack Size 30
Form TABLET
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 30
Unit Size 30
Unit Size 30
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking naloxegol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth on an empty stomach at least 1 hour before or 2 hours after a meal, as directed by your doctor, usually once daily in the morning. If you are unable to swallow this medication whole, you may crush the tablets to a powder, mix in 4 ounces (120 milliliters) of water and drink immediately. Refill the glass with another 4 ounces of water, stir the contents and drink it. If you are giving this medication through a tube into the stomach (nasogastric tube), ask you health care professional for detailed instructions on how to properly mix and give it. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Naloxegol is used only for constipation caused by opioids. Stop using this medication when you stop taking opioid pain medication unless otherwise directed by your doctor. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Stop taking other laxatives before you start treatment with naloxegol. Your doctor may direct you to take other laxatives if your condition does not improve after 3 days of treatment with naloxegol. Ask your doctor for more details and follow your doctor's instructions carefully. Tell your doctor if your constipation lasts or gets worse.
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking naloxegol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth on an empty stomach at least 1 hour before or 2 hours after a meal, as directed by your doctor, usually once daily in the morning. If you are unable to swallow this medication whole, you may crush the tablets to a powder, mix in 4 ounces (120 milliliters) of water and drink immediately. Refill the glass with another 4 ounces of water, stir the contents and drink it. If you are giving this medication through a tube into the stomach (nasogastric tube), ask you health care professional for detailed instructions on how to properly mix and give it. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Naloxegol is used only for constipation caused by opioids. Stop using this medication when you stop taking opioid pain medication unless otherwise directed by your doctor. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Stop taking other laxatives before you start treatment with naloxegol. Your doctor may direct you to take other laxatives if your condition does not improve after 3 days of treatment with naloxegol. Ask your doctor for more details and follow your doctor's instructions carefully. Tell your doctor if your constipation lasts or gets worse.
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking naloxegol and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth on an empty stomach at least 1 hour before or 2 hours after a meal, as directed by your doctor, usually once daily in the morning. If you are unable to swallow this medication whole, you may crush the tablets to a powder, mix in 4 ounces (120 milliliters) of water and drink immediately. Refill the glass with another 4 ounces of water, stir the contents and drink it. If you are giving this medication through a tube into the stomach (nasogastric tube), ask you health care professional for detailed instructions on how to properly mix and give it. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Naloxegol is used only for constipation caused by opioids. Stop using this medication when you stop taking opioid pain medication unless otherwise directed by your doctor. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details. Stop taking other laxatives before you start treatment with naloxegol. Your doctor may direct you to take other laxatives if your condition does not improve after 3 days of treatment with naloxegol. Ask your doctor for more details and follow your doctor's instructions carefully. Tell your doctor if your constipation lasts or gets worse.
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.
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.
Notes NOTES: Do not share this medication with others.
Notes NOTES: Do not share this medication with others.
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.
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-OX-ee-gol)
Phonetic Pronunciation (nal-OX-ee-gol)
Phonetic Pronunciation (nal-OX-ee-gol)
Precautions PRECAUTIONS: Before taking naloxegol, 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: stomach/intestinal blockage, stomach/intestinal ulcers or tumors, bowel disease (such as Crohn's, diverticulitis), kidney disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, naloxegol should be used only when clearly needed. This medication may cause opioid withdrawal in a pregnant woman and her unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. This medication may cause opioid withdrawal in a nursing infant. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking naloxegol, 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: stomach/intestinal blockage, stomach/intestinal ulcers or tumors, bowel disease (such as Crohn's, diverticulitis), kidney disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, naloxegol should be used only when clearly needed. This medication may cause opioid withdrawal in a pregnant woman and her unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. This medication may cause opioid withdrawal in a nursing infant. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking naloxegol, 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: stomach/intestinal blockage, stomach/intestinal ulcers or tumors, bowel disease (such as Crohn's, diverticulitis), kidney disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, naloxegol should be used only when clearly needed. This medication may cause opioid withdrawal in a pregnant woman and her unborn baby. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. This medication may cause opioid withdrawal in a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Pain in the stomach/abdomen, diarrhea, or gas may occur. 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. Opiate withdrawal symptoms may occur in some people. Tell your doctor right away if any of these withdrawal symptoms occur: sweating, chills, pain in the stomach/abdomen, diarrhea, yawning, mental/mood changes (such as anxiety/irritability). This drug may rarely cause a serious tear in the stomach or intestinal wall (perforation). If you notice any of the following unlikely but serious side effects, get medical help right away: severe stomach/abdominal pain that doesn't go away, fever, dizziness/fainting, nausea/vomiting. 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: Pain in the stomach/abdomen, diarrhea, or gas may occur. 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. Opiate withdrawal symptoms may occur in some people. Tell your doctor right away if any of these withdrawal symptoms occur: sweating, chills, pain in the stomach/abdomen, diarrhea, yawning, mental/mood changes (such as anxiety/irritability). This drug may rarely cause a serious tear in the stomach or intestinal wall (perforation). If you notice any of the following unlikely but serious side effects, get medical help right away: severe stomach/abdominal pain that doesn't go away, fever, dizziness/fainting, nausea/vomiting. 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: Pain in the stomach/abdomen, diarrhea, or gas may occur. 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. Opiate withdrawal symptoms may occur in some people. Tell your doctor right away if any of these withdrawal symptoms occur: sweating, chills, pain in the stomach/abdomen, diarrhea, yawning, mental/mood changes (such as anxiety/irritability). This drug may rarely cause a serious tear in the stomach or intestinal wall (perforation). If you notice any of the following unlikely but serious side effects, get medical help right away: severe stomach/abdominal pain that doesn't go away, fever, dizziness/fainting, nausea/vomiting. 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.
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 treat constipation caused by opioid medications in people with ongoing pain that is not caused by cancer. It blocks the effect of opioids on the gut without blocking the effect on pain. Naloxegol belongs to a class of drugs known as opioid antagonists.
Uses USES: This medication is used to treat constipation caused by opioid medications in people with ongoing pain that is not caused by cancer. It blocks the effect of opioids on the gut without blocking the effect on pain. Naloxegol belongs to a class of drugs known as opioid antagonists.
Uses USES: This medication is used to treat constipation caused by opioid medications in people with ongoing pain that is not caused by cancer. It blocks the effect of opioids on the gut without blocking the effect on pain. Naloxegol belongs to a class of drugs known as opioid antagonists.

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Movantik 25 Mg Tab 30 is manufactured by REDHILL BIOPHARMA INC..
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