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Official Information about Flexeril

Generic Name: cyclobenzaprine hydrochloride

Dosage Form: tablet, film coated

Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt with the empirical formula C20H21N • HCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa 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-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:

Each tablet for oral administration contains 10 mg Cyclobenzaprine Hydrochloride, USP.

Each tablet has the following inactive ingredients: anhydrous lactose, carnauba wax, corn starch, crospovidone, hypromellose, magnesium stearate, pregelatinized starch, polyethylene glycol, polysorbate 80, titanium dioxide, D&C yellow #10, FD&C Blue #2,& FD&C yellow#6.

Magnesium stearate, also called octadecanoic acid, magnesium salt, is a white substance which is solid at room temperature. It has the chemical formula Mg(C18H35O2)2. It is a salt containing two equivalents of stearate (the anion of stearic acid) and one magnesium cation (Mg2+). Magnesium stearate melts at about 120 °C, is not soluble in water, and is generally considered safe for human consumption at levels below 2500 mg/kg per day. In 1979, FDA’s Subcommittee on GRAS (generally recognized as safe) Substances (SCOGS) reported, “There is no evidence in the available information on … magnesium stearate … that demonstrates, or suggests reasonable grounds to suspect, a hazard to the public when they are used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future.” Magnesium stearate data from WikiPedia.Org.

Flexeril – Clinical Pharmacology

Cyclobenzaprine HCl relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease.

Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies show that cyclobenzaprine does not act at the neuromuscular junction or directly on skeletal muscle. Such studies show that cyclobenzaprine acts primarily within the central nervous system at brain stem as opposed to spinal cord levels, although its action on the latter may give to its overall skeletal muscle relaxant activity. 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. Cyclobenzaprine caused slight to moderate increase in heart rate in animals.

Cyclobenzaprine is well absorbed after oral administration,but there is a large intersubject variation in plasma levels cyclobenzaprine is eliminated quite slowly with a half-life as long as one to three is highly bound to plasma protein,is extensively metabolised primarily to glucuronide-like conjugates, and is excreted primarily via the kidneys

No significant effect on plasma levels or bioavailability of cyclobenzaprine hydrochloride or aspirin was noted when single or multiple doses of the two medicines were administered concomitantly.concomitant administration of cyclobenzaprine hydrochloride and aspirin is usually well tolerated and no unexpected or serious clinical or laboratory adverse effects have been studies have been performed to write down whether cyclobenzaprine enhances the clinical effect of aspirin or other analgesics,or whetheranalgesics enhance the clinical effect of cyclobenzaprine in acute musculoskeletal conditions.

Clinical Studies

Controlled clinical studies show that cyclobenzaprine hydrochloride significantly improves the signs and symptoms of skeletal muscle spasm as compared with placebo.The clinical responses include improvement in muscle spasm as determined by palpation,reduction in localpain and tenderness,increased range of motion,and less restriction in activities of daily living.When daily observations were made,clinical improvement was observed as early as the first day of therapy.

Eight double-blind controlled clinical studies were performed in 642 patients comparing cyclobenzaprine hydrochloride, 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 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 were comparable to those observed in patients treated with diazepam, dry mouth was observed more often in patients treated with cyclobenzaprine and dizziness more frequently in those treated with diazepam. The incidence of drowsiness, the most frequent adverse reaction, was similar with both medicines.

Analysis of the data from controlled studies shows that cyclobenzaprine produces clinical improvement whether or not sedation occurs.

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Official Information about Flexeril