Cyclobenzaprine hydrochloride is designated chemically as 3-(5H-dibenzo [a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:Each 5 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 5 mg Cyclobenzaprine hydrochloride.Each 10 mg Cyclobenzaprine hydrochloride tablet for oral administration contains 10 mg Cyclobenzaprine hydrochloride.Each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, carnauba wax, titanium dioxide, polyethylene glycol, and iron oxide yellow.In addition, 5 mg tablets also contain polyvinyl alcohol, talc, lecithin, and FD&C yellow # 6 / sunset yellow FCF aluminum lake.In addition, 10 mg tablets also contain D&C yellow # 10 aluminum lake, FD&C yellow # 6 aluminum lake and hypromellose.Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. (See Extended-release capsules are available in two strengths: 15 mg and 30 mg. Cyclobenzaprine hydrochloride tablets, USP 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, Ortho-McNeil Pharmaceutical)ULTRACET® (tramadol HCl and acetaminophen tablets, Ortho-McNeil Pharmaceutical)In rats treated with Cyclobenzaprine hydrochloride tablets, USP for up to 67 weeks at doses of approximately 5 to 40 times the maximum recommended human dose, pale, sometimes enlarged, livers were noted and there was a dose-related hepatocyte vacuolation with lipidosis. Concomitant administration of Cyclobenzaprine hydrochloride tablets, USP and naproxen or diflunisal was well tolerated with no reported unexpected adverse effects. Bottles of 15, NDC 43063-917-15. Less frequent manifestations include tremor, agitation, coma, ataxia, hypertension, slurred speech, confusion, dizziness, nausea, vomiting, and hallucinations.
The overall effectiveness of Cyclobenzaprine hydrochloride tablets, USP was similar to that observed in the double-blind controlled studies; the overall incidence of adverse effects was less (see 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 WARNINGS, below, and The incidence of drowsiness, the most frequent adverse reaction, was similar with both drugs.The efficacy of Cyclobenzaprine hydrochloride tablets, USP 5 mg was demonstrated in two seven-day, double-blind, controlled clinical trials enrolling 1405 patients. Cyclobenzaprine hydrochloride tablets, USP are available in 10 mg dosage strength.The 10 mg tablets are supplied as yellow colored film coated round shaped biconvex tablets debossed “K 7” on one side and plain on other side. This dosage can also vary from 20 mg to 40 mg per day, divided into multiple doses. However, the daily dosage should not exceed the maximum limit of 60 mg per day.
Take cyclobenzaprine exactly as your physician tells you to. Patients should be advised of the signs and symptoms of serotonin syndrome, and be instructed to seek medical care immediately if they experience these symptoms (see If signs of toxicity occur at any time during this period, extended monitoring is required. mononitrate extended-release tablets 30 and 60 mg (only doses evaluated acutely) demonstrated a significant increase from baseline in total treadmill time relative to placebo at 4 and 12 hours after the administration of the first dose. Ask doctors free.
August 27, 2020 These patients are generally more susceptible to drugs with potentially sedating effects, including cyclobenzaprine. Tricyclic antidepressants have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke.Cyclobenzaprine hydrochloride tablets, USP may enhance the effects of alcohol, barbiturates, and other CNS depressants.Because of its atropine-like action, Cyclobenzaprine hydrochloride tablets, USP 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.The plasma concentration of cyclobenzaprine is increased in patients with hepatic impairment (see
If consciousness is impaired, the airway should be secured prior to lavage and emesis is contraindicated.A maximal limb-lead QRS duration of ≥ 0.10 seconds may be the best indication of the severity of the overdose. Evidence suggests that the net effect of cyclobenzaprine is a reduction of tonic somatic motor activity, influencing both gamma (γ) and alpha (α) motor systems.Pharmacological studies in animals showed a similarity between the effects of cyclobenzaprine and the structurally related tricyclic antidepressants, including reserpine antagonism, norepinephrine potentiation, potent peripheral and central anticholinergic effects, and sedation. No well-controlled studies have been performed to indicate that Cyclobenzaprine hydrochloride tablets, USP enhance the clinical effect of aspirin or other analgesics, or whether analgesics enhance the clinical effect of Cyclobenzaprine hydrochloride tablets, USP in acute musculoskeletal conditions.Eight double-blind controlled clinical studies were performed in 642 patients comparing Cyclobenzaprine hydrochloride tablets, USP 10 mg, diazepam**, and placebo. Be sure not to double doses. Due to inconsistencies between the drug labels on DailyMed and the pill images provided by Based on individual patient response, the dose may be increased to 10 mg three times a day. Each endpoint consisted of a score on a 5-point rating scale (from 0 or worst outcome to 4 or best outcome). We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels.
Cyclobenzaprine hydrochloride tablets, USP are available in 10 mg dosage strength.