At oral doses of up to 10 times the human dose, cyclobenzaprine did not adversely affect the reproductive performance or fertility of male or female rats. Cyclobenzaprine did not demonstrate mutagenic activity in the male mouse at dose levels of up to 20 times the human dose. Cyclobenzaprine is structurally and pharmacologically related to tricyclic antidepressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds. Tell your doctor if you are pregnant robaxin vs flexeril which is stronger or plan to become pregnant during treatment with Flexeril. It is unknown if Flexeril passes into breast milk or if it could harm a nursing baby.
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. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. For most patients, the recommended dose of Flexeril is 5 mg three times a day. In light of these findings, therapy with FLEXERIL in the elderly should be initiated with a 5 mg dose and titrated slowly upward. Analysis of the data from controlled studies shows that FLEXERIL produces clinical improvement whether or not sedation occurs. All patients suspected of an overdose with FLEXERIL should receive gastrointestinal decontamination.
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. A post-marketing surveillance program was carried out in 7607 patients with acute musculoskeletal disorders, and included 297 patients treated with FLEXERIL 10 mg for 30 days or longer. The overall effectiveness of FLEXERIL was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less (see ADVERSE REACTIONS). The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Safety and effectiveness of FLEXERIL in pediatric patients below 15 years of age have not been established.
The patient should rinse their mouth to ensure that they have swallowed all the contents. Eight double-blind controlled clinical studies were performed in 642 patients comparing FLEXERIL 10 mg, diazepam, and placebo. Muscle spasm, local pain and tenderness, limitation of motion, and restriction in activities of daily living were evaluated. In three of these studies there was a significantly greater improvement with FLEXERIL than with diazepam, while in the other studies the improvement following both treatments was comparable.
If signs of toxicity occur at any time during this period, extended monitoring is required. Monitoring of plasma drug levels should not guide management of the patient. Dialysis is probably of no value because of low plasma concentrations of the drug. In a pharmacokinetic study of sixteen subjects with hepatic impairment (15 mild, 1 moderate per Child-Pugh score), both AUC and Cmax were approximately double the values seen in the healthy control group. Based on the findings, FLEXERIL should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward.
Cyclobenzaprine is a centrally acting skeletal muscle relaxant structurally related to tricyclic antidepressants. Cyclobenzaprine relieves skeletal muscle spasms of local origin without interfering with muscle function. In preclinical research, cyclobenzaprine reduced skeletal muscle hyperactivity. Research indicates that it primarily acts within the central nervous system in the brain stem. Cyclobenzaprine is a centrally acting skeletal muscle relaxant structurally related to tricyclic antidepressants. Cyclobenzaprine is a tricyclic amine salt that works in the central nervous system (CNS) as a depressant that reduces muscle hyperactivity.
The elderly may also be more at risk for CNS adverse events such as hallucinations and 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. In such patients FLEXERIL should be initiated with a 5 mg dose and titrated slowly upward. In order to protect against the rare but potentially critical manifestations described above, obtain an ECG and immediately initiate cardiac monitoring. Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination. Observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.
I want to spread the knowledge and educate the readers as much as possible about various health issues which are diffusing the world. You are encouraged to report negative side effects of prescription drugs to the FDA. Secondary endpoints included a physician’s evaluation of the presence and extent of palpable muscle spasm. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Other potential effects of overdosage include any of the symptoms listed under ADVERSE REACTIONS.