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Fosfomycin Tromethamine 3 Gm Grn

  • Manufacturer Name : ASCEND LABORATO
  • MFG # : 67877074957
  • NDC : 67877074957
  • Distributor Name : AmeriSource Bergen
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fosfomycin tromethamine ORAL PACKET 3 G

Product Properties:

Description -
Description N
Description N
DESI Drug Ind -; -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: This medication is an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections) in women. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Fosfomycin should not be used to treat infections outside the bladder (such as kidney infections).
Drug Category USES: This medication is an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections) in women. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Fosfomycin should not be used to treat infections outside the bladder (such as kidney infections).
Drug Type Code COMMON BRAND NAME(S): Monurol
Drug Type Code COMMON BRAND NAME(S): Monurol
Drug Type Code 1
FDA Approval Date 10/21/2021
FDA Therap Equiv AB
HCPCS 1
HCPCS 1
HCPCS -
Market Entry Date 11/12/2021
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date (FOS-foe-MYE-sin troe-METH-a-meen)
Termination Date (FOS-foe-MYE-sin troe-METH-a-meen)
Unit GM
Units Per Pkg 3
Active Ingredients 4468 fosfomycin tromethamine 78964859
Active Ingredients 4468 fosfomycin tromethamine 78964859
Active Ingredients 4468 fosfomycin tromethamine 78964859
AHFS Class 8360000 URINARY ANTI-INFECTIVES
AHFS Class 8360000 URINARY ANTI-INFECTIVES
AHFS Class 8360000 URINARY ANTI-INFECTIVES
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form PACKET (EA)
Dose Form PACKET (EA)
Dose Form PACKET (EA)
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 21871 fosfomycin tromethamine ORAL PACKET 3 G
Gen Code and Des 21871 fosfomycin tromethamine ORAL PACKET 3 G
Gen Code and Des 21871 fosfomycin tromethamine ORAL PACKET 3 G
Inactive Ingredients 2598 sucrose 57501; 2600 saccharin 81072
Inactive Ingredients 2598 sucrose 57501; 2600 saccharin 81072
Inactive Ingredients 2598 sucrose 57501; 2600 saccharin 81072
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 3GM
Strength 3GM
Strength 3GM
Common Brand Name -
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Monurol
Drug Interaction -
Drug Interaction -
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: metoclopramide, probenecid.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 72
Case Quantity 72
Case Quantity 72
Drug Form Pack Size 1
Drug Form Pack Size 1
Drug Form Pack Size 1
Form GRANULES
Form GRANULES
Form GRANULES
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
Orange Book AA Products in conventional dosage forms not presenting bioequivalence problems.
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 -
Unit Size -
Unit Size -
How to Use -
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking fosfomycin. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually 1 packet (sachet) as a single dose. Mix this drug with water before taking it. Pour the contents of 1 packet (sachet) into a half glass (4 ounces or 120 milliliters) of cold water and stir to dissolve. Do not use warm or hot water. Drink all of the mixture right away. Your symptoms should get better within 2 to 3 days. Tell your doctor if you do not get better after 3 days or if you get worse.
How to Use -
Missed Dose 3
Missed Dose MISSED DOSE: Not applicable.
Missed Dose 3
Notes GM
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to. Lab and/or medical tests (such as urine culture) may be done while you are taking this medication. Keep all medical and lab appointments.
Notes GM
Overdose AB
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. Symptoms of overdose may include: hearing loss, metallic taste.
Overdose AB
Phonetic Pronunciation -
Phonetic Pronunciation -
Phonetic Pronunciation (FOS-foe-MYE-sin troe-METH-a-meen)
Precautions -
Precautions -
Precautions PRECAUTIONS: Before taking fosfomycin, 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: kidney disease. If you develop symptoms of a kidney infection (such as pain in your side or lower back area, fever, chills), contact your doctor right away. Your doctor may change your treatment. 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. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). This product may contain sugar and/or aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely. Fosfomycin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using fosfomycin before having any immunizations/vaccinations. 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. This drug passes into breast milk in small amounts, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Diarrhea, nausea, headache, vaginal discomfort, or dizziness 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: vision changes, unusual weakness. This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. 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 -
Storage 10/21/2021
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 10/21/2021
Uses -
Uses USES: This medication is an antibiotic used to treat bladder infections (such as acute cystitis or lower urinary tract infections) in women. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections. Fosfomycin should not be used to treat infections outside the bladder (such as kidney infections).
Uses -

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