TIZANIDINE tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

TIZANIDINE HYDROCHLORIDE (UNII: B53E3NMY5C) (TIZANIDINE - UNII:6AI06C00GW)

Tilgængelig fra:

Direct Rx

INN (International Name):

TIZANIDINE HYDROCHLORIDE

Sammensætning:

TIZANIDINE 4 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Tizanidine is a central alpha-2-adrenergic agonist indicated for the management of spasticity. Because of the short duration of therapeutic effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important [see Dosage and Administration (2.1)]. Tizanidine is contraindicated in patients taking potent inhibitors of CYP1A2, such as fluvoxamine or ciprofloxacin [see Drug Interactions (7.1, 7.2)]. 8.1 Pregnancy Pregnancy Category C Tizanidine has not been studied in pregnant women. Tizanidine should be given to pregnant women only if the benefit outweighs the risk to the unborn fetus. Reproduction studies performed in rats at a dose of 3 mg/kg, equal to the maximum recommended human dose on a mg/m2 basis, and in rabbits at 30 mg/kg, 16 times the maximum recommended human dose on a mg/m2 basis, did not show evidence of teratogenicity. Tizanidine at doses that are equal to and up to 8 times the maximum recommended human dose on a mg/m2 basis increas

Produkt oversigt:

16.2 Tizanidine Tablets Tizanidine Tablets, USP 2 mg are available for oral administration as white to off-white, round, scored tablets, imprinted “APO” over “TI-2” on one side and plain with a bisect score on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-0251-1) Bottles of 150 (NDC 60505-0251-3) Bottles of 1000 (NDC 60505-0251-2) Tizanidine Tablets, USP 4 mg are available for oral administration as white to off-white, round, scored tablets, imprinted “APO” over “TI-4” on one side and plain with a quadrisect score on the other side. They are supplied as follows: Bottles of 100 (NDC 60505-0252-1) Bottles of 150 (NDC 60505-0252-3) Bottles of 1000 (NDC 60505-0252-2) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TIZANIDINE- TIZANIDINE TABLET
DIRECT RX
----------
TIZANIDINE
1 INDICATIONS AND USAGE
Tizanidine is a central alpha-2-adrenergic agonist indicated for the
management of spasticity. Because
of the short duration of therapeutic effect, treatment with tizanidine
should be reserved for those daily
activities and times when relief of spasticity is most important [see
Dosage and Administration (2.1)].
2 DOSAGE AND ADMINISTRATION
2.1 DOSING INFORMATION
Tizanidine tablets may be prescribed with or without food. Once the
formulation has been selected and
the decision to take with or without food has been made, this regimen
should not be altered.
Food has complex effects on tizanidine pharmacokinetics, which differ
with the different formulations.
Tizanidine capsules and tizanidine tablets are bioequivalent to each
other under fasting conditions (more
than 3 hours after a meal), but not under fed conditions (within 30
minutes of a meal). These
pharmacokinetic differences may result in clinically significant
differences when switching
administration of tablet and capsules and when switching
administration between the fed or fasted state.
These changes may result in increased adverse events, or delayed or
more rapid onset of activity,
depending upon the nature of the switch. For this reason, the
prescriber should be thoroughly familiar
with the changes in kinetics associated with these different
conditions [see Clinical Pharmacology
(12.3)].
The recommended starting dose is 2 mg. Because the effect of
tizanidine peaks at approximately 1 to 2
hours post-dose and dissipates between 3 to 6 hours post-dose,
treatment can be repeated at 6 to 8 hour
intervals, as needed, to a maximum of three doses in 24 hours.
Dosage can be gradually increased by 2 mg to 4 mg at each dose, with 1
to 4 days between dosage
increases, until a satisfactory reduction of muscle tone is achieved.
The total daily dose should not
exceed 36 mg. Single doses greater than 16 mg have not been studied.
2.2 DOSING IN PATIENTS WITH RENAL IMPAIRMENT
Tizanidine sh