Product Details

Relieves skeletal muscle spasm associated with acute, painful musculoskeletal conditions. Does not interfere with muscle function.

Cyclobenzaprine hydrochloride, USP is a white to off-white crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons.

Indications and Usage

Cyclobenzaprine hydrochloride tablets, USP are recommended in addition 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.

Tablets should only be used for short periods (up to 2 to 3 weeks). Prolonged use has not been shown to be adequately effective because muscle spasm due to acute, painful musculoskeletal conditions is generally short and longer therapy is usually not warranted.

Dosage and Administration

Recommended dose is 5 mg three times a day. Based on individual patient, the dose may be increased to 7.5 or 10 mg three times a day. Use of this medication is not recommended for periods longer than 2-3 weeks.

Information for the Patient

Cyclobenzaprine hydrochloride, especially when used with alcohol or other CNS depressants, may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. 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 hydrochloride tablets should be initiated with a 5 mg dose and titrated slowly upward.

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of cyclobenzaprine hydrochloride and other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or monoamine oxidase (MAO) inhibitors. 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 WARNINGS, and see PRECAUTIONS, Drug Interactions).

Warnings

Use for pregnant women, nursing mothers, the elderly and pediatric use is cautioned and this drug should only be used for these patients if clearly needed.

Always check with your healthcare provider if you experience any side effects or adverse reactions.