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Rufinamide 40 Mg-Ml Oral Sus 460 Ml

PID UOM Price Qty
225310 UN
$2,074.05
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rufinamide ORAL ORAL SUSP 40 MG/ML

Product Properties:

Description N
Description -
Description N
DESI Drug Ind -; -
DESI Drug Ind -
DESI Drug Ind -; -
DESI2 Drug Ind AB
Drug Category USES: Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.
Drug Category USES: Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.
Drug Category -
Drug Type Code COMMON BRAND NAME(S): Banzel
Drug Type Code COMMON BRAND NAME(S): Banzel
Drug Type Code N
FDA Approval Date 11/02/2020
FDA Therap Equiv ML
HCPCS 1
HCPCS -
HCPCS 1
Market Entry Date -
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date (roo-FIN-a-mide)
Termination Date 1
Termination Date (roo-FIN-a-mide)
Unit 460
Units Per Pkg 04/23/2019
Active Ingredients 12301 rufinamide 106308445
Active Ingredients 12301 rufinamide 106308445
Active Ingredients 12301 rufinamide 106308445
AHFS Class 28129200 ANTICONVULSANTS, MISCELLANEOUS
AHFS Class 28129200 ANTICONVULSANTS, MISCELLANEOUS
AHFS Class 28129200 ANTICONVULSANTS, MISCELLANEOUS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form SUSPENSION, ORAL (FINAL DOSE FORM)
Dose Form SUSPENSION, ORAL (FINAL DOSE FORM)
Dose Form SUSPENSION, ORAL (FINAL DOSE FORM)
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 67131 rufinamide ORAL ORAL SUSP 40 MG/ML
Gen Code and Des 67131 rufinamide ORAL ORAL SUSP 40 MG/ML
Gen Code and Des 67131 rufinamide ORAL ORAL SUSP 40 MG/ML
Inactive Ingredients 2468 propylene glycol 57556; 2599 sorbitol 50704; 3203 paraben 99967
Inactive Ingredients 2468 propylene glycol 57556; 2599 sorbitol 50704; 3203 paraben 99967
Inactive Ingredients 2468 propylene glycol 57556; 2599 sorbitol 50704; 3203 paraben 99967
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 40MG-ML
Strength 40MG-ML
Strength 40MG-ML
Common Brand Name COMMON BRAND NAME(S): Banzel
Common Brand Name -
Common Brand Name -
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 are: orlistat, valproate. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as diazepam, triazolam, zolpidem), muscle relaxants, and opioid pain relievers (such as codeine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Drug Interaction -
Drug Interaction -
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 10
Case Quantity 10
Case Quantity 10
Drug Form Pack Size 460
Drug Form Pack Size 460
Drug Form Pack Size 460
Form SUSPENSION
Form SUSPENSION
Form SUSPENSION
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
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 460
Unit Size 460
Unit Size 460
How to Use -
How to Use -
How to Use HOW TO USE: Read the Medication Guide and, if available, the Instructions for Use provided by your pharmacist before you start using rufinamide and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with food as directed by your doctor, usually twice daily. The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. If you are using the suspension form of this medication, shake the bottle well before each dose. Measure each dose carefully with the provided oral dosing syringe. Do not use a household spoon because you may not get the correct dose. Rinse the syringe with tap water after each use. 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. It is very important to follow your doctor's dosing instructions exactly. It may take several weeks to reach the best dose for you and to get the full benefit from this medication. Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. This drug works best when the amount of medicine in your body is kept at a constant level. It is best to take rufinamide at evenly spaced intervals throughout the day and night. Do not stop taking this medication without consulting your doctor. Some conditions (such as seizures) may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Tell your doctor if your condition does not improve or worsens.
Missed Dose 460
Missed Dose 460
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 ML
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as liver function, complete blood counts) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes ML
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.
Overdose AB
Phonetic Pronunciation -
Phonetic Pronunciation -
Phonetic Pronunciation (roo-FIN-a-mide)
Precautions PRECAUTIONS: Before taking rufinamide, 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: family history of a certain heart problem (QT shortening in the EKG), kidney disease, liver disease, mental/mood disorders (such as depression, thoughts of suicide). This drug may make you dizzy or drowsy or blur your vision. It may also cause double vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Precautions -
Precautions -
Side Effects -
Side Effects -
Side Effects SIDE EFFECTS: Drowsiness, dizziness, loss of coordination, trouble walking, tiredness, headache, nausea, vomiting, loss of appetite, or blurred/double vision 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. A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself. 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: fever, swollen lymph nodes, 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. If using the suspension, store the bottle upright. Throw out the suspension within 90 days of first opening the bottle. 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 04/23/2019
Storage 04/23/2019
Uses -
Uses -
Uses USES: Rufinamide is used with other medications to prevent or control seizures (epilepsy) associated with Lennox-Gastaut syndrome (LGS). This medication is an anticonvulsant. Rufinamide is thought to work by acting on the sodium channels in the brain that carry excessive electrical charges that may cause seizures.

Frequently Asked Questions(FAQs)

The cost of RUFINAMIDE 40 MG-ML ORAL SUS 460 ML is $ 2074.05.
RUFINAMIDE 40 MG-ML ORAL SUS 460 ML is manufactured by Hikma Pharmaceuticals Plc.
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