DESCRIPTION

DESCRIPTION:
MOVAX chemically Tizanidine Hydrochloride is a centrally acting a2 agonist which is a
skeletal muscle relaxant. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-
benzothiodiazole hydrochloride
Tizanidine molecular formula is C9H8CIN5S-HCl, its molecular weight is 290.2gm
Movax is an agonist at a2- adrenergic receptors sites and presumably reduces spasticity
by increasing presynaptic inhibition of motor neurons. The effects of Movax (Tizanidine) are
greatest on polysynaptic pathways. The overall effect of these actions is thought to reduce
facilitation of spinal motor neurons

COMPOSITION:

Each tablet contains:
Tizanidine Hydrochloride USP equivalent to Tizanidine…..2mg

Each tablet contains:

Tizanidine Hydrochloride USP equivalent to Tizanidine.….4mg

PHARMACOLOGICAL PROPERTIES:

Absorption and bioavailability:
Tizanidine is rapidly and almost completely absorbed, reaching peak plasma concentration
in approx. 1hour. Although Tizanidine is well absorbed, the absolute oral bioavailability of
Tizanidine is  about 30-40% due to extensive first pass metabolism

Distribution:

Tizanidine is only about 30% bound to plasma proteins
Metabolism:
Tizanidine undergoes rapid and extensive metabolism in the liver. Tizanidine metabolites
are not known to be active
Elimination:
Excretion primarily is via renal route (approx. 70% of the administered dose). The elimination
half-life of Tizanidine from plasma is 2-4hours in patients
Concomitant food intake has no influence on the pharmacokinetic profile of Tizanidine
tablets

THERAPEUTIC INDICATIONS:

Painful muscle spasms:
Associated with static and functional disorders of the spine (cervical and lumbar syndromes)
Following surgery e.g. for herniated intervertebral disc or osteoarthritis of the hip
Muscular spasms associated with accidental trauma
Spasticity due to neurological disorders:
Like Multiple sclerosis, chronic myelopathy, degenerative spinal cord diseases, cerebrovascular
accidents and cerebral palsy

DOSAGE AND ADMINISTRATION:

For oral administration:
The effect of Movax (Tizanidine) on spasticity is maximum within 2-3 hours of dosing and
it has a relatively short duration of action. The timing and frequency of dosing should
therefore be tailored to the individual and Movax (Tizanidine) should be given in divided
doses, up to 3-4 times daily, depending on the patient's needs. There is considerable
variation in response between patients so careful titration is necessary. Care should be taken
not to exceed the dose producing the desired therapeutic effect. It is usual to start with a
single dose of 2mg increasing by 2mg increments at not less than half-weekly intervals
The total daily dose should not exceed 36mg, although it is usually not necessary to exceed
24mg daily

Elderly:

Experience in the elderly is limited and use of Tizanidine is not recommended unless the
benefit of treatment clearly outweighs the risk. Pharmacokinetic data suggest that renal
clearance in the elderly may be decreased by up to three folds

Children:

Experience with Tizanidine in patients under the age of 18years is limited Movax (Tizanidine)
is not recommended for use in children
Patients with Renal impairment:
In patients with renal insufficiency (creatinine clearance <25mL/min) treatment should be
started with 2mg once daily with slow titration to achieve the effective dose. Dosage increases
should be in increments of no more than 2mg according to tolerability and effectiveness
It is advisable to slowly increase the once-daily dose before increasing the frequency of
administration. Renal function should be monitored as appropriate in these patients..

Patients with Hepatic Impairment:

Movax (Tizanidine) is contra-indicated in patients with significantly impaired hepatic function
Or as directed by the physician

CONTRA-INDICATIONS:

Hypersensitivity to Tizanidine or any other component of the product. The use of Movax
(Tizanidine) in patients with significantly impaired hepatic function is contra-indicated,
because Tizanidine is extensively metabolised by the liver

PRECAUTIONS:

Use in Renal Impairment:
Patients with renal impairment may require lower doses and therefore caution should be
exercised when using Movax (Tizanidine) in these patients
Liver Function:
Hepatic dysfunction has been reported in association with Tizanidine. It is recommended
that liver function tests should be monitored monthly for the first four months in all patients
and in those who develop symptoms suggestive of liver dysfunction such as unexplained
nausea, anorexia or tiredness. Treatment with Tizanidine should be discontinued if serum
levels of SGPT and/or SGOT are persistently above three times the upper limit of normal
range

INTERACTIONS:

As Movax (Tizanidine) may induce hypotension it may potentiate the effect of antihypertensive
drugs, including diuretics, and caution should therefore be exercised in patients receiving
blood pressure lowering drugs. Caution should also be exercised when Movax (Tizanidine)
is used concurrently with ß-blocking drugs or digoxin as the combination may potentiate
hypotension or bradycardia
Caution should be exercised when Movax (Tizanidine) is prescribed with drugs known to
increase the QT interval
Alcohol or sedatives may enhance the sedative action of Movax (Tizanidine)

PREGNANCY & LACTATION:

Pregnancy Category C. The safety of Movax (Tizanidine) in pregnancy has not been
established and its safety in breast-fed infants of mothers receiving Movax (Tizanidine) is
not known. Therefore Movax (Tizanidine) should not be used in pregnant or nursing mothers
unless the likely benefit clearly outweighs the risk

ADVERSE EFFECTS:

The most frequently reported adverse events occurring in association with Movax (Tizanidine)
include drowsiness, fatigue, dizziness, somnolence, dry mouth, nausea, gastrointestinal
disturbances, muscle weakness, insomnia, sleep disorder, hypotension and a reduction in
blood pressure. With slow upward titration of the dose of Movax (Tizanidine) these effects
are usually not severe enough to require discontinuation of treatment. Increases in hepatic
serum transaminases, which are reversible on stopping treatment, have occurred. Infrequent
cases of acute hepatitis have been reported. Muscle weakness has been reported infrequently,
although in controlled clinical trials it was clearly demonstrated that Movax (Tizanidine) does
not adversely affect muscle strength. Allergic reactions (e.g. pruritus and rash) have rarely
been reported

OVER DOSE:

Symptoms: Nausea, vomiting, hypotension, dizziness, somnolence, miosis, restlessness,
respiratory distress, coma
Treatment: General supportive measures are indicated and an attempt should be made to
remove uningested drug from the gastro-intestinal tract using gastric lavage or activated
charcoal. The patient should be well hydrated. Further treatment should be symptomatic

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