Flexeril Cyclobenzaprine Hcl: Uses, Dosage, Side Effects, Interactions, Warning

by | Jul 25, 2023 | Blog |

Flexeril Cyclobenzaprine Hcl: Uses, Dosage, Side Effects, Interactions, Warning

Data sources include IBM Watson Micromedex (updated 3 Sep 2023), Cerner Multum™ (updated 28 Aug 2023), ASHP (updated 10 Aug 2023) and others. In light of these findings, therapy with FLEXERIL in the elderly should be initiated with a 5 mg dose and titrated slowly upward. Cyclobenzaprine caused slight to moderate increase in heart rate in animals.

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Each endpoint consisted of a score on a 5-point rating scale (from 0 or worst outcome to 4 or best outcome). 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.

FDA Drug Information

All patients suspected of an overdose with FLEXERIL should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated. For most patients, the recommended dose of Flexeril is 5 mg three times a day. Secondary endpoints included a physician’s evaluation of the presence and extent of palpable muscle spasm.

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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. 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. 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.

Related treatment guides

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. 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.

In such patients FLEXERIL should be initiated with a 5 mg dose and titrated slowly upward. 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).

  • 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.
  • 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.
  • Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
  • Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitor drugs.
  • This should include large volume gastric lavage followed by activated charcoal.

Safety and effectiveness of FLEXERIL in pediatric patients below 15 years of age have not been established. Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. FLEXERIL may enhance the effects of alcohol, barbiturates, and other CNS depressants. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Flexeril.

Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function, and Use in the Elderly). Our Flexeril (cyclobenzaprine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Because cyclobenzaprine is closely related to the tricyclic antidepressants, some of which are known to be excreted in human milk, caution should be exercised when FLEXERIL is administered to a nursing woman. Because of its atropine-like action, FLEXERIL should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.

Dialysis is probably of no value because of low plasma concentrations of the drug. The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs. 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. The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Hepatic Impairment).

Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation. Hyperpyretic crisis seizures, and deaths have occurred in patients receiving cyclobenzaprine (or structurally similar tricyclic antidepressants) flexeril class drug concomitantly with MAO inhibitor drugs. In the higher dose groups this microscopic change was seen after 26 weeks and even earlier in rats which died prior to 26 weeks; at lower doses, the change was not seen until after 26 weeks.