Drug Catalog - Product Detail
CYCLOBENZAPRINE TABS 7.5MG 100CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 57237-0266-01 | RISING PHARMACEUTICALS | 100 | 7.5MG | TABLET |
PACKAGE FILES
Generic Name
CYCLOBENZAPRINE HYDROCHLORIDE
Substance Name
CYCLOBENZAPRINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA071611
Description
DESCRIPTION Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. It has a melting point of 217°C, and a pK a 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 H -dibenzo[ a,d ]cyclohepten-5-ylidene)- N,N -dimethyl-1-propanamine hydrochloride, and has the following structural formula: Cyclobenzaprine hydrochloride tablets, USP are available for oral administration as 7.5 mg tablets. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide. 567d0e01-c789-45ff-a45a-dcca4ace9b92
How Supplied
HOW SUPPLIED Cyclobenzaprine Hydrochloride Tablets, USP 7.5 mg are round, white, film-coated tablets imprinted WATSON and 3330 supplied in bottles of 100 (NDC 57237-266-01). Dispense in a well-closed container with child-resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Manufactured for: Citron Pharma LLC East Brunswick, NJ 08816 Issued: June 2016 PIC26601-00 234110
Indications & Usage
INDICATIONS AND USAGE Cyclobenzaprine HCl 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. Cyclobenzaprine HCl 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. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.
Dosage and Administration
DOSAGE AND ADMINISTRATION 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 cyclobenzaprine HCl for periods longer than two or three weeks is not recommended. (See INDICATIONS AND USAGE . ) Less frequent dosing should be considered for hepatically impaired or elderly patients (see PRECAUTIONS, Impaired Hepatic Function , and Use in the Elderly ).