Disclaimer:

Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.

Cyclobenzaprine Hydrochloride

×

Overview

What is Fexmid?

Fexmid (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5-dibenzo[]cyclohepten-5-ylidene)--dimethyl-1-propanamine hydrochloride, and has the following structural formula:

Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.



What does Fexmid look like?



What are the available doses of Fexmid?

Sorry No records found.

What should I talk to my health care provider before I take Fexmid?

Sorry No records found

How should I use Fexmid?

Fexmid is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.

Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.

Fexmid should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.

For most patients, the recommended dose of cyclobenzaprine HCl is 5 mg three times a day. Based on individual patient response, the dose may be increased to either 7.5 mg or 10 mg three times a day. Use of Fexmid for periods longer than two or three weeks is not recommended. (See )

Less frequent dosing should be considered for hepatically impaired or elderly patients (see , and ).


What interacts with Fexmid?

Sorry No Records found


What are the warnings of Fexmid?

Array

The development of a potentially life-threatening serotonin syndrome has been reported with Cyclobenzaprine Hydrochloride when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The concomitant use of Fexmid with MAO inhibitors is contraindicated (see ). Serotonin syndrome symptoms may include mental status changes (e.g., confusion, agitation, hallucinations), autonomic instability (e.g., diaphoresis, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g., tremor, ataxia, hyperreflexia, clonus, muscle rigidity), and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Treatment with Fexmid and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated. If concomitant treatment with Fexmid and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).

Fexmid is closely related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. In short term studies for indications other than muscle spasm associated with acute musculoskeletal conditions, and usually at doses somewhat greater than those recommended for skeletal muscle spasm, some of the more serious central nervous system reactions noted with the tricyclic antidepressants have occurred (see , below, and ).

Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.

Fexmid may enhance the effects of alcohol, barbiturates, and other CNS depressants.


What are the precautions of Fexmid?

Sorry No Records found


What are the side effects of Fexmid?

Sorry No records found


What should I look out for while using Fexmid?

Hypersensitivity to any component of this product.

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) concomitantly with MAO inhibitor drugs.

Acute recovery phase of myocardial infarction, and patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.

Hyperthyroidism


What might happen if I take too much Fexmid?

Although rare, deaths may occur from overdosage with Fexmid. Multiple drug ingestion (including alcohol) is common in deliberate cyclobenzaprine overdose. Signs and symptoms of toxicity may develop rapidly after Fexmid overdose; therefore, hospital monitoring is required as soon as possible. The acute oral LD of cyclobenzaprine HCl is approximately 338 and 425 mg/kg in mice and rats, respectively.

Manifestations

The most common effects associated with cyclobenzaprine overdose are drowsiness and tachycardia. Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations. Rare but potentially critical manifestations of overdose are cardiac arrest, chest pain, cardiac dysrhythmias, severe hypotension, seizures, and neuroleptic malignant syndrome. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of cyclobenzaprine toxicity.

Other potential effects of overdosage include any of the symptoms listed under .

Management

General

As management of overdose is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment.

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. Dialysis is probably of no value because of low plasma concentrations of the drug.

Gastrointestinal Decontamination

All patients suspected of an overdose with Fexmid 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.

Cardiovascular

A maximal limb-lead QRS duration of ≥0.10 seconds may be the best indication of the severity of the overdose. Serum alkalinization, to a pH of 7.45 to 7.55, using intravenous sodium bicarbonate and hyperventilation (as needed), should be instituted for patients with dysrhythmias and/or QRS widening. A pH>7.60 or a pCO<20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type 1A and 1C antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).

CNS

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.

Psychiatric Follow-Up

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.

Pediatric Management

The principles of management of child and adult overdosages are similar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.


How should I store and handle Fexmid?

Fexmid (cyclobenzaprine hydrochloride tablets USP, 7.5 mg) are round, white, film-coated tablets imprinted and supplied in bottles of 100 (NDC 59630-950-10).Pharmacist:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:Shionogi Inc.Florham Park, NJ 07932 USA Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USARevised: October 2014FEX-PI-3                    184152-3Fexmid (cyclobenzaprine hydrochloride tablets USP, 7.5 mg) are round, white, film-coated tablets imprinted and supplied in bottles of 100 (NDC 59630-950-10).Pharmacist:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:Shionogi Inc.Florham Park, NJ 07932 USA Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USARevised: October 2014FEX-PI-3                    184152-3Fexmid (cyclobenzaprine hydrochloride tablets USP, 7.5 mg) are round, white, film-coated tablets imprinted and supplied in bottles of 100 (NDC 59630-950-10).Pharmacist:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:Shionogi Inc.Florham Park, NJ 07932 USA Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USARevised: October 2014FEX-PI-3                    184152-3Fexmid (cyclobenzaprine hydrochloride tablets USP, 7.5 mg) are round, white, film-coated tablets imprinted and supplied in bottles of 100 (NDC 59630-950-10).Pharmacist:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:Shionogi Inc.Florham Park, NJ 07932 USA Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USARevised: October 2014FEX-PI-3                    184152-3Fexmid (cyclobenzaprine hydrochloride tablets USP, 7.5 mg) are round, white, film-coated tablets imprinted and supplied in bottles of 100 (NDC 59630-950-10).Pharmacist:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Manufactured for:Shionogi Inc.Florham Park, NJ 07932 USA Manufactured by:Actavis Laboratories FL, Inc.Fort Lauderdale, FL 33314 USARevised: October 2014FEX-PI-3                    184152-3