Flexor 10 mg

INDICATIONS

Cyclobenzaprine 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.

PHARMACOLOGY

Cyclobenzaprine, a centrally-acting skeletal muscle relaxant, is structurally related to tricyclic antidepressants, thus they share similar properties. It acts on the brain stem, decreasing tonic-somatic motor activities influencing both the α and δ motor systems. It is used as an adjunct in the symptomatic treatment of painful muscle spasms associated with musculoskeletal conditions.

DOSAGE & ADMINISTRATION

The usual dose is 5-10 mg three times daily given by mouth. The daily dose should not exceed 60 mg. Treatment for more than 2 or 3 weeks is not recommended.Dose in elderly: Therapy with Flexor in the elderly should be initiated with a 5 mg dose and titrated slowly upward.Dose in hepatic impairment: Flexor should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. The use of Flexor in subjects with moderate to severe impairment is not recommended.Pediatric use: Safety and effectiveness of Cyclobenzaprine Hydrochloride in pediatric patients below 15 years of age have not been established.

INTERACTION

Cyclobenzaprine Hydrochloride may have life-threatening interactions with MAO inhibitors. Cyclobenzaprine Hydrochloride may enhance the effects of alcohol, barbiturates, and other CNS depressants.

SIDE EFFECTS

The adverse reactions reported most frequently with Cyclobenzaprine Hydrochloride are drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions is lower in the surveillance program than in the controlled clinical studies.

PREGNANCY & LACTATION

Pregnancy category B. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Cyclobenzaprine Hydrochloride is administered to a nursing mother.

PRECAUTIONS & WARNINGS

Because of its atropine-like action, Cyclobenzaprine Hydrochloride 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.

THERAPEUTIC CLASS

Locally acting Skeletal Muscle Relaxants

STORAGE CONDITIONS

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.