Concomitant administration of cyclobenzaprine HCl and naproxen or diflunisal was well tolerated with no reported unexpected adverse effects.
However combination therapy of cyclobenzaprine HCl with naproxen was associated with more side effects than therapy with naproxen alone, primarily in the form of drowsiness. No well-controlled studies have been performed to indicate that cyclobenzaprine HCl enhances the clinical effect of aspirin or other analgesics, or whether analgesics enhance the clinical effect of cyclobenzaprine HCl in acute musculoskeletal conditions.
Clinical Studies Eight double-blind controlled clinical studies were performed in patients comparing cyclobenzaprine HCl tablets, USP 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 cyclobenzaprine HCl than with diazepam, while in the other studies the improvement following both treatments was comparable.
Although the frequency and severity of adverse reactions observed in patients treated with cyclobenzaprine HCl were comparable to those observed in patients treated with diazepam, dry mouth was observed more frequently in patients treated with cyclobenzaprine HCl and dizziness more frequently in those treated with diazepam. The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs. The efficacy of cyclobenzaprine HCl tablets, USP 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1, patients.
Primary endpoints for both trials were determined by patient-generated data and included global impression of change, medication helpfulness, and relief from starting backache. Each endpoint consisted of a score on a 5-point rating scale from 0 or worst outcome to 4 or best outcome. Comparison of cyclobenzaprine HCl tablets, USP 5 mg and placebo groups in both trials established the statistically significant superiority of the 5 mg dose for all three primary endpoints at day 8 and, in the study comparing 5 and 10 mg, at day 3 or 4 as well.
Physician-assessed secondary endpoints also showed that cyclobenzaprine HCl tablets, USP 5 mg was associated with a greater reduction in palpable muscle spasm than placebo. Analysis of the data from controlled studies shows that cyclobenzaprine HCl produces clinical improvement whether or not sedation occurs. Surveillance Program A post-marketing surveillance program was carried out in 7, patients with acute musculoskeletal disorders, and included patients treated with cyclobenzaprine HCl tablets, USP 10 mg for 30 days or longer.
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. If you cannot swallow the capsule whole, you may open the capsule and sprinkle the contents over one tablespoon of applesauce.
Swallow the mixture right away without chewing. Rinse the mouth to make sure all of the medicine have been swallowed. Do not save any of the mixture to use later. Dosing TOP The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.
The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Serotonin syndrome symptoms may include mental status changes e. Treatment with Cyclobenzaprine Hydrochloride and any concomitant serotonergic agents should be discontinued immediately if the above reactions occur and supportive symptomatic treatment should be initiated.
Cyclobenzaprine is closely related to the tricyclic antidepressants, e. Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. Precautions General Because of its atropine-like action, Cyclobenzaprine HCl 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.
These patients are generally more susceptible to drugs with potentially sedating effects, including Cyclobenzaprine. Cyclobenzaprine HCl should be used with caution in subjects with mild hepatic impairment starting with a 5 mg dose and titrating slowly upward. In the elderly, the frequency and severity of adverse events associated with the use of Cyclobenzaprine, with or without concomitant medications, is increased.
In elderly patients, Cyclobenzaprine HCl should be initiated with a 5 mg dose and titrated slowly upward. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases see WARNINGS. Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol. 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. Cyclobenzaprine did not affect the onset, incidence or distribution of neoplasia in an week study in the mouse or in a week study in the rat.
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.
Pregnancy Pregnancy Category B Reproduction studies have been performed in rats, mice and rabbits at doses up to 20 times the human dose, and have revealed no evidence of impaired fertility or harm to the fetus due to Cyclobenzaprine HCl.
Should certain beverages, foods and other products be avoided when I take Cyclobenzaprine Hydrochloride? What are the possible drug interactions of Cyclobenzaprine Hydrochloride? How will Cyclobenzaprine Hydrochloride work in my body? How should Cyclobenzaprine Hydrochloride be taken? How to reduce the risk of Cyclobenzaprine Hydrochloride drug interactions and side effects? Note The health and medical information provided here is intended to supplement and not substitute for the expertise and judgment of your physician, pharmacists or other health care professional.
Related Searches Lose Weight. Nervous System and Psychiatric: Nursing Mothers It is not known whether this drug is excreted in human milk. Drug accumulates when dosed three times a day, reaching steady-state within 10mg at plasma concentrations about four-fold higher than after a single dose. The abrupt termination of prolonged use can also cause side effects, including nausea, headache and malaise. Cyclobenzaprine belongs to the family of medications known as muscle relaxants. Abrupt cessation of treatment after prolonged administration rarely may produce nausea, headache, and malaise. Do not use more than directed. Cyclobenzaprine caused slight to tablet increase in heart rate in animals, cyclobenzaprine 10mg tablet.
Surveillance Program A post-marketing cyclobenzaprine program was carried out in patients with acute musculoskeletal disorders, and included patients treated with cyclobenzaprine 10mg for 30 days or longer. Contraindications Hypersensitivity to any component of this product. When Not To Use This medicine is not right for everyone. There are, however, no adequate and well-controlled studies in pregnant women. Treatment with Cyclobenzaprine Hydrochloride and any concomitant serotonergic agents should be discontinued 10mg if the above reactions occur and supportive symptomatic treatment should be initiated, cyclobenzaprine 10mg tablet. Missed Dose If you miss a dose, take it as soon 10mg you remember. The tablet of drowsiness, the most frequent adverse reaction, cyclobenzaprine 10mg tablet, was similar with both tablets. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly cyclobenzaprine. Taking MAO inhibitors with this medication may cause a serious azelastine 137 price fatal drug interaction.
No significant effect on plasma levels or bioavailability of cyclobenzaprine HCl or aspirin was noted when single or multiple doses of the two drugs were administered concomitantly. Notes Do not share this medication with others. Miscellaneous Concerns You should avoid cyclobenzaprine if you are allergic to it. Before Using TOP In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. Concomitant use of monoamine oxidase MAO inhibitors or within 14 days after their discontinuation. It can cause euphoria, diaphoresis sweatingdiplopia double visioncyclobenzaprine 10mg tablet, tinnitus ringing in the ears and frequent urination. Hepatic Impairment In a cefaclor capsules 250mg study of sixteen subjects with hepatic impairment 15 mild, 1 moderate per Child-Pugh scoreboth AUC and Cmax were approximately double the values seen in the healthy control group, cyclobenzaprine 10mg tablet. The dosage is based on your tablet condition and response to treatment. It is ineffective in muscle spasm due to central nervous system disease. Lance JW, Anthony M. In elderly patients, cyclobenzaprine hydrochloride tablets should be initiated with a 5 mg dose and titrated slowly upward. Properly discard this product when it is expired or no longer cyclobenzaprine. Vomiting; anorexia; diarrhea; gastrointestinal pain; gastritis; thirst; flatulence; edema of the tongue; abnormal liver function and rare reports of hepatitis, jaundice and cholestasis. MedlinePlus says that it can cause chest pain, convulsions, seizures, trouble breathing and dysphagia trouble swallowing. Serum alkalinization, to a pH of 7. Comparison of cyclobenzaprine HCl tablets, USP 5 mg and placebo groups in both trials established the statistically significant superiority of the 5 mg dose for all three primary endpoints at day 8 and, in 10mg study comparing 5 and 10 mg, at day 3 or 4 as well. Always consult your health care professional before using this, or any other, drug.
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