Zomoland

Therapeutic Group: Muscle Relaxants Chemical Composition: Chlorzoxazone + Paracetamol License by : Unipharma Dosage form: Capsules
Information about Zomoland

CHEMICAL COMPOSITION:

Each Capsule contains: Chlorzoxazone 250 mg and Paracetamol 300 mg.

 

PHARMACOLOGICAL CLASSIFICATION

Muscle Relaxants & Cholinesterase Inhibitors.

 

Mechanism of action:

Chlorzoxazoneis a centrally acting muscle relaxant, which exerts its effect at the level of the spinal cord and sub-cortical areas of the brain to inhibit multisynapticreflex arcs responsible for skeletal muscle spasm. Paracetamol has an analgesic effect on skeletal muscle.

 

Pharmacokinetics:


Absorption:

-Chlorzoxazoneis completely absorbed after oral administration and peak plasma concentrations are achieved after 1 to 2 hours.

-Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral doses.

 

Distribution: Binding to plasma proteins is minimal at therapeutic concentrations.

 

Metabolism: Chlorzoxazone and paracetamol are metabolized in the liver.

 

Excretion:

-Chlorzoxazone is excreted in urine. The elimination half-life of Chlorzoxazone is about 1 hour.


- Paracetamol is excreted in urine. The elimination half-life of paracetamol is about 1 to 3 hours.

 

 INDICATIONS:

It is indicated for treating pain and spasm of the skeletal muscles in:

- Sprains and strains

- Myalgia

- Torticollis

- Tension headache

- Traumatic muscle damage

- Lumbago

- Spondylarthrosis

- Cervical root syndrome

 

CONTRAINDICATIONS:

Hypersensitivity to any of the components

 

ADVERSE REACTIONS:

Irritations of the gastrointestinal tract, somnolence,vertigo, headaches, nausea, over-excitability may sometimes occur. Allergic skin phenomena such as eruptions, petechiae, and ecchymosis are also known to occur, but angioneurotic oedemas or anaphylactic reactions are extremely rare.

 

 DRUG INTERACTIONS:

-The risk of paracetamol hepatic toxicity may be increased in patients receiving other potentially hepatotoxic drugs.

-The absorption of paracetamol may be accelerated by drugs such as metoclopramide.


-Excretion maybe affected and plasma concentrations altered when given with probenecid.

-Cholestramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.

-Caution should be taken with drugs that cause drowsiness such as: certain antihistamines,anti-seizure drugs, medicines for sleep or anxiety, other muscle relaxants,narcotic pain relievers, psychiatric medicines.

-The CNS effects of chlorzoxazone may be enhanced by concomitant use of other central nervous system depressants.

 

WARNINGS AND PRECAUTIONS:

-Caution is advised with patients known to be hypersensitive to drugs.

-Color change of the urine, due to a phenolic metabolite of Chlorzoxazone may occur.

-Serious hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. Drug must be discontinued immediately and a physician consulted if any Signs and/or symptoms of hepatotoxicity occur such as fever, rash,anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine or jaundice.

-Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes.

-The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

-Caution should be taken into consideration when driving vehicles.

 

PREGNANCY and LACTATION:

It is not recommended during pregnancy or lactation.

 

 

DOSAGE and ADMINISTRATION:

2 capsules 3 times daily after meals

 

 OVERDOSAGE:

Following overdose there might be gastrointestinal disturbances, drowsiness, dizziness,headache, malaise and sluggishness followed by marked loss of muscle tone, hypotension and respiratory depression. Paracetamol overdose may cause liver failure.

Treatment consists of emptying the stomach by lavage or emesis, followed by administration of activated charcoal.

Administration of N-Acetylcysteine or Methionine may be required as a paracetamol antidote.

 

STORAGE CONDITIONS: Store below 30°C , protect frommoisture.

 

PACKAGE: Pack of 20 Capsules.