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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?
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What should I talk to my health care provider before I take Fexmid?
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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?
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What are the warnings of Fexmid?
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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?
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What are the side effects of Fexmid?
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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
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Estimates of mean oral bioavailability of cyclobenzaprine range from 33% to 55%. Cyclobenzaprine exhibits linear pharmacokinetics over the dose range 2.5 mg to 10 mg, and is subject to enterohepatic circulation. It is highly bound to plasma proteins. Drug accumulates when dosed three times a day, reaching steady-state within 3-4 days at plasma concentrations about four-fold higher than after a single dose. At steady state in healthy subjects receiving 10 mg t.i.d. (n=18), peak plasma concentration was 25.9 ng/mL (range, 12.8-46.1 ng/mL), and area under the concentration-time (AUC) curve over an 8-hour dosing interval was 177 ng.hr/mL (range, 80-319 ng.hr/mL).
Cyclobenzaprine is extensively metabolized, and is excreted primarily as glucuronides via the kidney. Cytochromes P-450 3A4, 1A2, and, to a lesser extent, 2D6, mediate N-demethylation, one of the oxidative pathways for cyclobenzaprine. Cyclobenzaprine is eliminated quite slowly, with an effective half-life of 18 hours (range 8-37 hours; n=18); plasma clearance is 0.7 L/min.
The plasma concentration of cyclobenzaprine is generally higher in the elderly and in patients with hepatic impairment. (See and
)
Non-Clinical Toxicology
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
Fexmid may have life-threatening interactions with MAO inhibitors (see ). Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. 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 may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.
____________________________________________________________________ ULTRAM (tramadol HCl tablets, PriCar, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.) ULTRACET (tramadol HCl and acetaminophen tablets, Ortho-McNeil-Janssen Pharmaceuticals, Inc.)_____________________________________________________________________
Because of its atropine-like action, Fexmid 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.
Incidence of most common adverse reactions in the 2 double-blind, placebo-controlled 5 mg studies (incidence of > 3% on cyclobenzaprine HCl 5 mg):
Adverse reactions which were reported in 1% to 3% of the patients were: abdominal pain, acid regurgitation, constipation, diarrhea, dizziness, nausea, irritability, mental acuity decreased, nervousness, upper respiratory infection, and pharyngitis.
The following list of adverse reactions is based on the experience in 473 patients treated with cyclobenzaprine HCl 10 mg in additional controlled clinical studies, 7607 patients in the postmarketing surveillance program, and reports received since the drug was marketed. The overall incidence of adverse reactions among patients in the surveillance program was less than the incidence in the controlled clinical studies.
The adverse reactions reported most frequently with cyclobenzaprine HCl were drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions was lower in the surveillance program than in the controlled clinical studies:
Among the less frequent adverse reactions, there was no appreciable difference in incidence in controlled clinical studies or in the surveillance program. Adverse reactions which were reported in 1% to 3% of the patients were: fatigue/tiredness, asthenia, nausea, constipation, dyspepsia, unpleasant taste, blurred vision, headache, nervousness, and confusion.
The following adverse reactions have been reported in postmarketing experience or with an incidence of less than 1% of patients in clinical trials with the 10 mg tablet:
Body as a Whole:
Cardiovascular:
Digestive:
Hypersensitivity:
Musculoskeletal:
Nervous System and Psychiatric:
Skin:
Special Senses:
Urogenital:
________________________________________________________________________________________________________
Causal Relationship Unknown
Other reactions, reported rarely for cyclobenzaprine HCl under circumstances where a causal relationship could not be established or reported for other tricyclic drugs, are listed to serve as alerting information to physicians:
Body as a Whole:
Cardiovascular:
Digestive:
Endocrine:
Hematic and Lymphatic:
Metabolic, Nutritional and Immune:
Musculoskeletal:
Nervous System and Psychiatric:
Respiratory:
Skin:
Urogenital:
To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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