Multi-Relax F.c. Tablets
COMPOSITION :
Each Multi-Relax 5 mg tablet contains: 5 mg Cyclobenzaprine hydrochloride.
Each Multi-Relax 10 mg tablet contains: 10 mg Cyclobenzaprine hydrochloride.
CLINICAL PHARMACOLOGY :
• Cyclobenzaprine HCI relieves skeletal muscle spasm of local origin without interfering with muscle function. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies indicate 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 contribute 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 (1jl) and alpha (a) motor systems.
• Cyclobenzaprine is well absoribed after oral administration.
• Cyclobenzaprine is eliminated quite slowly with a half life as long as one to three day lt is highly bound to plasma eroteins is
extensively metabolized primarily to glucuronidelike conjugates, and is excreted primarily via the kidneys. No sigrillicant effect on
plasma levels or bioavailability of cyclobenzaprine HCI or aspirin was noted when single or multiple doses of the two drugs were
administered concomitantly.
• Concomitant administration of cyclobenzaprine HCI and aspirin is usually well tolerated and no unexpected or serious clinical or
laboratory adverse effects have been observed.
INDICATIONS :
• Cyclobenzaprine HCI 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 Het has not been found effec tve In the rea ment of spasticity associated with cerebral or spinal cord disease or in children with cerebral palsy.
DOSAGE & ADMINISTRATION :
The usual dosage of cyclobenzaprine HCI is 5-10 mg 3 times a day; with a range of 20 to 40 mg a day in divided doses. Dosage should not exceed 60 mg a day.
SIDE EFFECTS :
Body as a Whole: Syncope, malaise.
Cardiovascular: Tachycardia, arrhythmia, vasodilatation ,palpitation , hypotension.
Digestiv : Vomiting anmexia djarrhea , gastrointestinal pain , gastritis , thirst , flatulence , edema of the tongue , abnormal liver
function and rare reports of hepatitis, jaundice, and cholestasis.
Hypersensitivity: Anaphylaxis, angioedema, pruritus, facial edema, urticaria, rash.
Musculoskeletal: Local weakness.
Nervous System and Psychiatric: Ataxia, vertigo, dysarthria, tremors, hypertqnia, convulsions, muscle twitching, disorientation, insomnia, depressed mood, abnormal sensations, anxiety, agitation, abnormal thinking and dreaming, hallucinations, excitement, paresthesia, diplopia.
Skin: Sweating.
Special Senses: Ageusia, tinnitus.
Urogenital: Urinary frequency and/or retention.
DRUG INTERACTIONS :
Cyclobenzaprine HCI may enhance the effects of alcohol, barbiturates, and other CNS depressants. Being structurally related
to tricyclic antidepressants, it may block the antihypertensive action of guanethidine and similarly acting compounds.
WARNINGS AND PRECAUTIONS :
• Cyclobenzaprineis structurally related to the tricyclic antidepressants, e.g., amitriptyline and imipramine. 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.
• Because of its atropine-like action, cyclobenzaprine HCI should be used with caution in patients with a history of urinary retention, angleclosure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
• Cyclobenzaprine HCI may impair mental and/or physical abilities required for performance of hazardous, tasks , such as operating machinary or driving a motor vehicle.
CONTRAINDICATIONS :
– Hypersensitivity to the drug.
– Concomitant use of monoamine oxidase inhibitors or within 14 days after their discontinuation.
– Acute recoveryphaseof myocardial infarction, and patients with arrhythmias, heart block or conduction disturibances, or congestive heart failure.
– Hyperthyroidism.
– Concomitant administration of drugs that prolong OT interval (especially in elderly).
PACKAGE :
Multi-Relax 5 mg: Packs of 20 F.C. Tablets.
Multi-Relax 10 mg: Packs of 10 F.C. Tablets – Packs of 20 F.C. Tablets.
Keep all medicines out of reach of children
Manufactured by :
Multi-Apex for Pharmaceutical Industries – S.A.E. – Badr City – Egypt.
