Product Details
CYCLOBENZAPRINE HCL 15 MG ER CAP 60
Manufacturer: TEVA USA
MFG#: 00093-1920-06
NDC: 00093-1920-06
PID: 285141
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Product Properties:
| Description | - |
|---|---|
| Description | I |
| DESI Drug Ind | -; - |
| DESI Drug Ind | - |
| DESI2 Drug Ind | - |
| Drug Category | USES: Cyclobenzaprine is used short-term to treat muscle spasms. It is usually used along with rest and physical therapy. It works by helping to relax the muscles. This medication is not recommended for use in older adults because they may be at greater risk for side effects while using this drug. Ask the doctor or pharmacist for details. |
| Drug Category | I |
| Drug Type Code | 1 |
| Drug Type Code | COMMON BRAND NAME(S): Amrix |
| FDA Approval Date | 02/01/2007 |
| FDA Therap Equiv | NR |
| HCPCS | - |
| HCPCS | 1 |
| Market Entry Date | 10/02/2007 |
| Medical Coverage | - |
| Medical Coverage | - |
| Termination Date | (sye-klo-BENZ-uh-preen) |
| Termination Date | - |
| Unit | CAP |
| Units Per Pkg | 1 |
| Active Ingredients | 1678 cyclobenzaprine HCl 6202239 |
| Active Ingredients | 1678 cyclobenzaprine HCl 6202239 |
| AHFS Class | 12200400 CENTRALLY ACTING SKELETAL MUSCLE RELAXNT |
| AHFS Class | 12200400 CENTRALLY ACTING SKELETAL MUSCLE RELAXNT |
| DEA Class | NC |
| DEA Class | NC |
| Dose Form | CAPSULE, EXT RELEASE 24 HR |
| Dose Form | CAPSULE, EXT RELEASE 24 HR |
| Fine Line Class | 850085008510 All Rx Products |
| Fine Line Class | 850085008510 All Rx Products |
| Gen Code and Des | 62177 cyclobenzaprine HCl ORAL CAP ER 24H 15 MG |
| Gen Code and Des | 62177 cyclobenzaprine HCl ORAL CAP ER 24H 15 MG |
| Inactive Ingredients | 10141 red dye; 10143 yellow dye; 2549 gelatin 9000708; 2598 sucrose 57501 |
| Inactive Ingredients | 10141 red dye; 10143 yellow dye; 2549 gelatin 9000708; 2598 sucrose 57501 |
| OMP Family | - |
| OMP Family | - |
| Product Category | RX Pharmaceuticals |
| Product Category | RX Pharmaceuticals |
| Strength | 15MG ER |
| Strength | 15MG ER |
| Common Brand Name | COMMON BRAND NAME(S): Amrix |
| 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 include: tricyclic antidepressants (such as amitriptyline, imipramine). Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication. Before using this medication, report the use of drugs that increase serotonin, including street drugs (such as MDMA/"ecstasy"), St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), tramadol, among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), other muscle relaxants (such as carisoprodol, methocarbamol), or antihistamines (such as cetirizine, diphenhydramine). 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 | - |
| Allocation Period | - |
| Allocation Period | - |
| Case Quantity | 48 |
| Case Quantity | 48 |
| Drug Form Pack Size | 60 |
| Drug Form Pack Size | 60 |
| Form | CAPSULES |
| Form | CAPSULES |
| 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 | 10 Room Temperature |
| Temp Zone | 10 Room Temperature |
| Unit | EA |
| Unit | EA |
| Unit Size | 60 |
| Unit Size | 60 |
| How to Use | - |
| How to Use | HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking cyclobenzaprine and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole. Do not crush or chew the capsules. Doing so can release all of the drug at once, increasing the risk of side effects. If you have trouble swallowing the capsule, you may open the capsule and carefully sprinkle its contents on a tablespoon of applesauce. Swallow all of the mixture right away without chewing it. Then rinse your mouth with water and swallow the rinse liquid to make sure you have swallowed all of the medication. Do not prepare the mixture ahead of time for later use. Doing so may destroy the drug. The dosage is based on your medical condition and response to treatment. This medication should only be used short-term (for 3 weeks or less) unless directed by your doctor. 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. Tell your doctor if your condition lasts after 2 to 3 weeks or if it 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 | 1 |
| Notes | CAP |
| 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 condition unless your doctor directs you to do so. A different medication may be necessary in that case. |
| Overdose | NR |
| 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: fast/irregular heartbeat, fainting, severe drowsiness, trouble speaking, seizures, mental/mood changes (such as confusion, hallucinations). |
| Phonetic Pronunciation | - |
| Phonetic Pronunciation | (sye-klo-BENZ-uh-preen) |
| Precautions | PRECAUTIONS: Before taking cyclobenzaprine, 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: liver disease, overactive thyroid (hyperthyroidism), heart problems (such as irregular heartbeat, heart block, heart failure, recent heart attack), difficulty urinating (such as due to an enlarged prostate), glaucoma. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. 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). 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. It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding. |
| Precautions | - |
| Side Effects | SIDE EFFECTS: Drowsiness, dizziness, dry mouth, or tiredness 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: fast/irregular heartbeat, mental/mood changes (such as confusion, hallucinations). 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 | - |
| Storage | 02/01/2007 |
| 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: Cyclobenzaprine is used short-term to treat muscle spasms. It is usually used along with rest and physical therapy. It works by helping to relax the muscles. This medication is not recommended for use in older adults because they may be at greater risk for side effects while using this drug. Ask the doctor or pharmacist for details. |
| Uses | - |
Frequently Asked Questions (FAQs)
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CYCLOBENZAPRINE HCL 15 MG ER CAP 60 is manufactured by TEVA USA.
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