TIZANDINE tablet

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Direct_Rx

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

16.2 Tizanidine Tablets Tizanidine (tizanidine hydrochloride) tablets, USP are available as white to off-white, round, flat, bevel edged uncoated tablets containing 2 mg or 4 mg of tizanidine. Tizanidine tablets USP, 2 mg are debossed with "U" and "168" on one side and bisecting score on other side. Bottles of 150: Bottles of 500: Bottles of 1,000: Tizanidine tablets USP, 4 mg are debossed with "U" and "169" on one side and quadrisecting score on other side. Bottles of 150: Bottles of 300: Bottles of 500: Bottles of 1,000: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container [see USP].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

TIZANDINE- TIZANDINE TABLET
DIRECT_RX
----------
TIZANIDINE
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)].
2.1 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 should be used with caution in patients with renal
insuf