Relax
Chlorzoxazone-Paracetamol
Composition :
Each capsule contains:
Active Ingredients:
Chlorzoxazone
Paracetamol
Inactive Ingredients:
PVP K 90, Talc, Aerosil 200 & Magnesium stearate.
PharmaceutkaI form :
Hard gelatin capsule.
Pharmacological Actions :
– Chlorzoxazone is a centrally acting skeletal muscle relaxant. It acts primarily at the spinal cord level and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. This results in reduced skeletal muscle spasm, relief of pain and increased mobility of involved muscles.
– Paracetamol has analgesic and antipyretic properties. It is as potent as aspirin in inhibiting prostaglandin synthesis in the CNS. The analgesic action of paracetamol adds to that which results secondarily from muscle relaxation.
– Relax® capsule offers quick relief of pain and restores mobility
even in severe painful spasms of the skeletal muscles. Rel (aspirin free) is used safely with patients allergic to aspirin, in hemophilia and upper 01 disease (e.g. ulcer, gastritis).
Pharmacokinetics :
– Chlorwxazone is rapidly absorbed and can be detected in serum within 0.5 hour. It reaches its peak blood levels, in about I to 2 hours. Its onset of action is I hour. Chlorzoxazone is rapidly metabolized and excreted in urine. primarily as a glucuronide conjugate. Its half-life is about 60 minutes.
– Paracetamol is rapidly and completely absorbed from the GI tract with peak plasma concentrations within 0.5 to 2 hours. It is relatively and uniformly distributed throughout most body fluids. It is extensively metabolized and excreted in urine primarily as inactive glucuronide and sulphate conjugates. The half-llfe in plasma is about 2 hours.
indications :
Relax@ capsule is indicated for the relief of severe skeletal muscle spasm associated with acute painful musculoskeletal conditions as: low back pain, cervical root and disc syndromes, sprains and strains, myalgias, torticollis, tension headaches, traumatic muscle injuries and fibrositis.
Dosage and Administration :
The usual adult dosage is one capsule to be taken 3 or 4 times
daily.
N.B. Take with food or water if 01 upset occurs.
Contralndicatlons :
• Relax@ capsule Is contra-indicated with known sensitivity to
any of its components.
• Avoid in patients with liver disease.
Side Effects :
Occasional GL disturbances, dizziness, nausea, Iightheadedness or drowsiness, malaise, or overstimulation may be noted. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone.
Drug interactions :
Alcohol and other CNS depressants: They cause drowsiness that may be additive to that induced by chlorzoxazone, They also may increase the potential of hepatotoxicity of paracetamol.
Pregnancy and Lactation :
Safety of chlorzoxazone during pregnancy or lactation has not been established. Use only when clearly needed and when the potential benefits outweigh the potential hazards.
Precautions and Warnings :
– Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorwxazone. The mechanism is unknown but appears to be idiosyncratic and un redictabl~. Facto~redis sing patients to this rare event are no own.signs, and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develops. chlorzoxazone use should be discontinued if a patient develops abnormal liver enzymes ( e.g. AST, ALT, alkaline phosphatase, and bilirubin ). The
concomitant use of alcohol or other central nervous system depressants may have an additive effect.
– If a sensitivity reaction occurs such as: urticaria, redness, or itching of the skin, the medicine should be stopped.
– If any signs or symptoms suggestive of liver dysfunction are
observed, the medicine should be discontinued. Dosages in excess of the recommended ones may cause severe liver damage.
– Patients suffering from kidney disease should take this medicine
under medical supervision.
Storage :
Store at temperature not exceeding 30°C.
Package :
Carton box of 1 , 2, 3, 5 or 10 (AL/PVC) strips, each contains 10
capsules and an lnner leaflet
Instructions to patients :
– A medicament. it is a product that affects your health, and
consumption without need or without medical consultation is dangerous for you.
– Follow strictly the instructions of your doctor prescription, and
the instructions of the pharmacist sold the medicament. as they are experienced with its benefits and risks, do not interrupt or repeat the treatment course by yourself.
– Keep all medicines out of reach of children
Product of :
ALFACURE PHARMACEUTICALS
Factory: Badr City. Cairo. Egypt.
