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Mounjaro 2.5 Mg Pfp 4X0.5 Ml

  • Manufacturer Name : LILLY ELI & CO
  • MFG # : 00002150680
  • NDC : 00002150680
  • Distributor Name : AmeriSource Bergen
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tirzepatide SUBCUT PEN INJCTR 2.5 MG/0.5

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind -
DESI2 Drug Ind NR
Drug Category -
Drug Category S
Drug Type Code 1
Drug Type Code S
FDA Approval Date 06/02/2022
FDA Approval Date 05/13/2022
FDA Therap Equiv NR
FDA Therap Equiv ML
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date 06/02/2022
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date -
Unit ML
Unit 2
Units Per Pkg 05/13/2022
Units Per Pkg 2
Active Ingredients 19067 tirzepatide
Active Ingredients 19067 tirzepatide
AHFS Class 68200600 INCRETIN MIMETICS
AHFS Class 68200600 INCRETIN MIMETICS
DEA Class NC
DEA Class NC
Dose Form PEN INJECTOR (ML)
Dose Form PEN INJECTOR (ML)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 83391 tirzepatide SUBCUT PEN INJCTR 2.5 MG/0.5
Gen Code and Des 83391 tirzepatide SUBCUT PEN INJCTR 2.5 MG/0.5
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 2.5MG
Strength 2.5MG
Common Brand Name COMMON BRAND NAME(S): Mounjaro
Common Brand Name COMMON BRAND NAME(S): Mounjaro
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. Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are not affected by these drugs. Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet. This medication may decrease the effectiveness of birth control pills especially when you first start treatment and when the dose is increased. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods for 4 weeks after starting this medication and for 4 weeks after each increase in dose of tirzepatide. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control pills are not working well.
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. Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are not affected by these drugs. Many drugs can affect your blood sugar, making it harder to control. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet. This medication may decrease the effectiveness of birth control pills especially when you first start treatment and when the dose is increased. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods for 4 weeks after starting this medication and for 4 weeks after each increase in dose of tirzepatide. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control pills are not working well.
Allocation Period -
Allocation Period -
Case Quantity 20
Case Quantity 20
Drug Form Pack Size 2
Drug Form Pack Size 2
Form PRE-FILLED PEN
Form PRE-FILLED PEN
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
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.
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 30 Refrige./DoNot Freez
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit EA
Unit Size 4X0.5
Unit Size 4X0.5
How to Use HOW TO USE: Read the Medication Guide and Instructions For Use provided by your pharmacist before you start using tirzepatide and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each week to lessen injury under the skin. Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once every 7 days. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. This medication may be used with or without meals. Use this medication regularly to get the most benefit from it. Remember to use it every 7 days. It may help to mark your calendar with a reminder. If needed, the day of weekly use may be changed as long as the time between two doses is at least 3 days. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended. Learn how to store and discard medical supplies safely. Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).
How to Use HOW TO USE: Read the Medication Guide and Instructions For Use provided by your pharmacist before you start using tirzepatide and each time you get a refill. Learn all preparation and usage instructions. If you have any questions, ask your doctor or pharmacist. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each week to lessen injury under the skin. Inject this medication under the skin in the thigh, abdomen, or upper arm as directed by your doctor, usually once every 7 days. The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. This medication may be used with or without meals. Use this medication regularly to get the most benefit from it. Remember to use it every 7 days. It may help to mark your calendar with a reminder. If needed, the day of weekly use may be changed as long as the time between two doses is at least 3 days. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended. Learn how to store and discard medical supplies safely. Tell your doctor if your condition does not get better or if it gets worse (your blood sugar is too high or too low).
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember if it is within 4 days after the missed dose. If it has been more than 4 days, skip the missed dose. Use your next dose on your regular day. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember if it is within 4 days after the missed dose. If it has been more than 4 days, skip the missed dose. Use your next dose on your regular day. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed. Lab and/or medical tests (such as kidney function, fasting blood glucose, hemoglobin A1c) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Do not share this medication with others. Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams. Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed. Lab and/or medical tests (such as kidney function, fasting blood glucose, hemoglobin A1c) should be done while you are using 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 (tir-ZEP-a-tide)
Phonetic Pronunciation (tir-ZEP-a-tide)
Precautions PRECAUTIONS: See also Warning section. Before using tirzepatide, 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: a certain eye problem (diabetic retinopathy), a disease of the pancreas (pancreatitis), gallbladder disease, kidney problems, stomach/intestinal disorders (such as gastroparesis, digestion problems). You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while using this medication because it can increase your risk of developing low blood sugar. It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin). It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: See also Warning section. Before using tirzepatide, 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: a certain eye problem (diabetic retinopathy), a disease of the pancreas (pancreatitis), gallbladder disease, kidney problems, stomach/intestinal disorders (such as gastroparesis, digestion problems). You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcohol while using this medication because it can increase your risk of developing low blood sugar. It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin). It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Swelling/redness/itching at the injection site, tiredness, loss of appetite, nausea, vomiting, upset stomach, diarrhea, or constipation 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. Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (such as decreased/blurred vision). Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain). Although tirzepatide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose(s) of your other diabetes medication(s) needs to be lowered. Drinking large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, headache, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Check with your doctor or pharmacist to find out what you should do if you miss a meal. Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased. 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: See also Warning section. Swelling/redness/itching at the injection site, tiredness, loss of appetite, nausea, vomiting, upset stomach, diarrhea, or constipation 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. Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes (such as decreased/blurred vision). Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain). Although tirzepatide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose(s) of your other diabetes medication(s) needs to be lowered. Drinking large quantities of alcohol, not getting enough calories from food, or doing unusually heavy exercise may also lead to low blood sugar. Symptoms may include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, headache, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, candy, or drinking a glass of fruit juice or non-diet soda. Check with your doctor or pharmacist to find out what you should do if you miss a meal. Symptoms of high blood sugar (hyperglycemia) include increased thirst/urination. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased. 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 in the refrigerator. Do not freeze. The medication may also be stored at room temperature but must be used within 21 days. 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 in the refrigerator. Do not freeze. The medication may also be stored at room temperature but must be used within 21 days. 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: Tirzepatide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. It lowers blood sugar by causing the release of your body's natural insulin and decreasing the amount of sugar your liver makes.
Uses USES: Tirzepatide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. It lowers blood sugar by causing the release of your body's natural insulin and decreasing the amount of sugar your liver makes.

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Mounjaro 2.5 Mg Pfp 4X0.5 Ml is manufactured by LILLY ELI & CO.
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