It is unknown if Flexeril passes into breast milk or if it could harm a nursing baby. You can also manage your communication preferences by updating your account at anytime.
In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines or, if these are ineffective, other anticonvulsants (e.g. phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in close consultation with a poison control center. For most patients, the recommended dose of FLEXERIL is 5 mg three times a day. Based on individual patient response, the dose may be increased to 10 mg three times a day.
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The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies. The efficacy of FLEXERIL 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1405 patients. One study compared FLEXERIL 5 mg and 10 mg t.i.d. to placebo; and a second study compared FLEXERIL 5 mg and 2.5 mg t.i.d. to placebo. Primary endpoints for both trials were determined by patient-generated data and included global impression of change, medication helpfulness, and relief from starting backache.
You are encouraged to report negative side effects of prescription drugs to the FDA. Other potential effects of overdosage include any of the symptoms listed under ADVERSE REACTIONS. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase.
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Use of FLEXERIL for periods longer than two or three weeks is not recommended. Analysis of the data from controlled studies shows that FLEXERIL produces clinical improvement whether or not sedation occurs. As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Pharmacologic similarities among the tricyclic drugs require that certain withdrawal symptoms be considered when FLEXERIL is administered, even though they have not been reported to occur with this drug.
The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly). The elderly may also be more at risk for CNS adverse events such as hallucinations and flexeril otc confusion, cardiac events resulting in falls or other sequelae, drug-drug and drug-disease interactions. For these reasons, in the elderly, cyclobenzaprine should be used only if clearly needed.
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Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies indicate that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems. Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease.
Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
- It is unknown if Flexeril passes into breast milk or if it could harm a nursing baby.
- The plasma concentration of cyclobenzaprine is increased in the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Elderly).
- Dialysis is probably of no value because of low plasma concentrations of the drug.
- Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated.
- Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.
Multiple drug ingestion (including alcohol) is common in deliberate cyclobenzaprine overdose. As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity may develop rapidly after cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible. The acute oral LD50 of FLEXERIL is approximately 338 and 425 mg/kg in mice and rats, respectively.
FDA Drug Information
These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine. FLEXERIL should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward. Due to the lack of data in subjects with more severe hepatic insufficiency, the use of FLEXERIL in subjects with moderate to severe impairment is not recommended.