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Generic Flexeril

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Product Name Price Shipping Total Order
Cyclobenzaprine 10mg (Gen. for Flexeril) 120 Tabs $149 free $149 Order
Cyclobenzaprine 10mg (Gen. for Flexeril) 180 Tabs $169 free $169 Order

Cyclobenzaprine is a muscle relaxant. It works by blocking nerve impulses (or pain sensations) that are sent to your brain.

Cyclobenzaprine ( Generic Flexeril )
Cyclobenzaprine ( Generic Flexeril )

Cyclobenzaprine is used together with rest and physical therapy to treat skeletal muscle conditions such as pain or injury.

Cyclobenzaprine may also be used for purposes not listed in this medication guide.

Important Information

You should not use cyclobenzaprine if you have an allergy to the medication, a certain type of thyroid disorder (hyperthyroidism), heart block, congestive heart failure, a heart rhythm disorder, or you have recently had a heart attack.

Do not use cyclobenzaprine if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine.

Cyclobenzaprine Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: B

Embryofetal development in rats and rabbits given approximately 3 and 15 times, respectively, the maximum recommended human dose (MRHD) was not adversely effected. Dams receiving this drug at doses 3 times or more the MRHD during pregnancy and lactation, had pups with decreased body weight and survival. There are no adequate and controlled studies in pregnant women.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
adversely

Cyclobenzaprine Breastfeeding Warnings

This drug has been shown to be excreted in rat milk and achieve concentrations in the milk which are 50% of those in the rat maternal plasma. As this drug is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, use caution especially when other drugs that cause sedation are used simultaneously.

Caution is recommended.

Cyclobenzaprine Levels and Effects while Breastfeeding

Summary of Use during Lactation

Amounts of cyclobenzaprine in milk appear to be very small and two infants apparently tolerated the drug in milk well. If cyclobenzaprine is required by the mother, it is not a reason to discontinue breastfeeding. Monitor the infant for (drowsiness, adequate weight gain, and developmental milestones), especially in neonates and preterm infants and when using combinations of sedating drugs.

Drug Levels

Maternal Levels. Two mothers were taking chronic cyclobenzaprine therapy. One mother was taking 5 mg once daily for temporomandibular joint pain and the other mother was taking 10 mg twice daily for fibromyalgia pain. Each collected milk at 0, 1, 2, 4, 6, 8 and 12 hours after a dose. After the 5 mg dose, the peak milk level was 6.6 mcg/L and the average level was 2.2 mcg/L. After the 10 mg dose, the peak milk level was 24.5 mcg/L and the average level was 10.3 mcg/L. These amounts resulted in the respective infant dosages of 0.3 mcg/kg and 0.7 mcg/kg daily. In both cases, the weight-adjusted dosage was 0.5% of the maternal dosage.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Two mothers were taking chronic cyclobenzaprine therapy. One mother was taking 5 mg once daily for temporomandibular joint pain and the other mother was taking 10 mg twice daily for fibromyalgia pain. The latter mother was also taking unspecified antidepressants, levothyroxine, zolpidem, alprazolam and famotidine. Both mothers were breastfeeding their infants (extent not stated). Neither infant had any noticeable adverse reaction such as sedation.[1]

A search was performed of the shared database of all U.S. poison control centers for the time period of 2001 to 2017 for calls regarding medications and breastfeeding. Of 2319 calls in which an infant was exposed to a substance via breastmilk, 7 were classified as resulting in a major adverse effect, and one of these involved cyclobenzaprine. A 16-day-old infant was exposed to cyclobenzaprine, acetaminophen and oxycodone in breastmilk. The infant was admitted to the hospital in a noncritical care unit for bradycardia, hypotension, and respiratory arrest. The dosages and extent of breastfeeding were not reported and the infant survived.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Before taking this medicine

You should not use cyclobenzaprine if you are allergic to it, or if you have:

  • hyperthyroidism;
  • heart block, heart rhythm disorder, congestive heart failure; or
  • if you have recently had a heart attack.

Cyclobenzaprine is not approved for use by anyone younger than 15 years old.

Do not use cyclobenzaprine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

Some medicines can interact with cyclobenzaprine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure cyclobenzaprine is safe for you, tell your doctor if you have:

  • thyroid disease;
  • liver disease;
  • glaucoma;
  • enlarged prostate; or
  • problems with urination.

It is not known whether cyclobenzaprine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Older adults may be more sensitive to the effects of this medicine.

How should I take cyclobenzaprine?

Cyclobenzaprine is usually taken taken for up to 2 or 3 weeks. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Follow your doctor’s dosing instructions very carefully.

Swallow the capsule whole and do not crush, chew, break, or open it.

Call your doctor if your symptoms do not improve after 3 weeks, or if they get worse.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Muscle Spasm

Immediate-release:
Initial dose: 5 mg orally 3 times a day
-May increase to 10 mg orally 3 times a day based on individual patient response
Duration of therapy: Up to 3 weeks

Extended-release:
Initial dose: 15 mg orally once a day
-May increase to 30 mg orally based on individual patient response
Duration of therapy: Up to 3 weeks

Comments:
-Duration of therapy should be limited to 2 to 3 weeks.
-Response is measured by relief of muscle spasm and its associated signs and symptoms, namely pain, tenderness, and limitation of motion.

Use: As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Usual Geriatric Dose for Muscle Spasm

Immediate-release:
Initial dose: 5 mg orally up to 3 times a day
Duration of therapy: Duration of therapy: Up to 3 weeks

Extended-release: Not recommended

Comments:
-Due to higher plasma levels in elderly patients, less frequent dosing should be considered.
-Extended-release capsules are not recommended in elderly patients.
-Duration of therapy should be limited to 2 to 3 weeks.

Use: As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Usual Pediatric Dose for Muscle Spasm

15 years and older:
Immediate-release:
Initial dose: 5 mg orally 3 times a day
-May increase to 10 mg orally 3 times a day based on individual patient response
Duration of therapy: Up to 3 weeks

Extended-release: Safety and effectiveness has not been established

Comments:
-Duration of therapy should be limited to 2 to 3 weeks.
-Response is measured by relief of muscle spasm and its associated signs and symptoms, namely pain, tenderness, and limitation of motion.

Use: As an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Immediate-release:
Mild hepatic impairment:
-Initial dose: 5 mg orally; titrate slowly upward

Moderate to severe hepatic impairment: Not recommended

Extended-release: Not recommended

Precautions

Safety and efficacy of immediate-release product have not been established in patients younger than 15 years.

Safety and efficacy of extended-release product have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of cyclobenzaprine can be fatal.

Overdose symptoms may include severe drowsiness, vomiting, fast heartbeats, tremors, agitation, or hallucinations.

What should I avoid while taking cyclobenzaprine?

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Avoid drinking alcohol. Dangerous side effects could occur.

Cyclobenzaprine side effects

Get emergency medical help if you have signs of an allergic reaction to cyclobenzaprine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have:

  • fast or irregular heartbeats;
  • chest pain or pressure, pain spreading to your jaw or shoulder; or
  • sudden numbness or weakness (especially on one side of the body), slurred speech, balance problems.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults.

Common cyclobenzaprine side effects may include:

  • drowsiness, tiredness;
  • headache, dizziness;
  • dry mouth; or
  • upset stomach, nausea, constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Along with its needed effects, cyclobenzaprine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cyclobenzaprine:

Rare

      • Clumsiness or unsteadiness
      • confusion
      • fainting
      • mental depression
      • problems in urinating
      • ringing or buzzing in the ears
      • skin rash, hives, or itching occurring without other symptoms of an allergic reaction listed above
      • unusual thoughts or dreams
      • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking cyclobenzaprine:

Symptoms of overdose

      • Convulsions (seizures)
      • drowsiness (severe)
      • dry, hot, flushed skin
      • fast or irregular heartbeat
      • hallucinations (seeing, hearing, or feeling things that are not there)
      • increase or decrease in body temperature
      • troubled breathing
      • unexplained muscle stiffness
      • unusual nervousness or restlessness (severe)
      • vomiting (occurring together with other symptoms of overdose)

Some side effects of cyclobenzaprine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

    • Blurred vision
    • dizziness, drowsiness, or lightheadedness
    • dryness of the mouth

Less common or rare

    • Bloated feeling or gas, indigestion, nausea or vomiting, or stomach cramps or pain
    • constipation
    • diarrhea
    • excitement or nervousness
    • frequent urination
    • general feeling of discomfort or illness
    • headache
    • muscle twitching
    • numbness, tingling, pain, or weakness in hands or feet
    • pounding heartbeat
    • problems in speaking
    • trembling
    • trouble sleeping
    • unpleasant taste or other taste changes
    • unusual muscle weakness
    • unusual tiredness
What other drugs will affect cyclobenzaprine?

Using cyclobenzaprine with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your other medicines, especially:

  • MAO inhibitors, such as isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, or tranylcypromine;
  • Any antidepressant or anxiety medications;
  • bupropion (Zyban, for smoking cessation or Wellbutrin, for depression);
  • meperidine;
  • tramadol;
  • verapamil;
  • cold or allergy medicine that contains an antihistamine (Benadryl and others);
  • medicine to treat Parkinson’s disease;
  • medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
  • medicine to treat overactive bladder; or
  • bronchodilator asthma medication.

This list is not complete. Other drugs may interact with cyclobenzaprine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

For more generic flexeril, please check Cyclobenzaprine forums

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