TIZANIDINE HYDROCHLORIDE tablet

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Keltman Pharmaceuticals Inc.

INN (Mezinárodní Name):

TIZANIDINE HYDROCHLORIDE

Složení:

TIZANIDINE HYDROCHLORIDE 4 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Tizanidine hydrochloride is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION). Concomitant use of tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated. Significant alterations of pharmacokinetic parameters of tizanidine including increased AUC, t1/2 , Cmax , increased oral bioavailability and decreased plasma clearance have been observed with concomitant administration of either fluvoxamine or ciprofloxacin. This pharmacokinetic interaction can result in potentially serious adverse events (see WARNINGS and CLINICAL PHARMACOLOGY: Drug Interactions). Tizanidine tablets are contraindicated in patients with known hypersensitivity to tizanidine or its ingredients. Abuse potential was not evaluated in human studies. Rats were able to distinguish tizanidine from saline in

Přehled produktů:

Tizanidine Tablets, USP are available containing 4 mg of tizanidine, USP. Tizanidine hydrochloride tablets 2 mg are white, round compressed tablets debossed cor above the bisect and 106 below the bisect on one side and the other side is plain. The 4 mg tablets are white, round, scored tablets debossed with cor on one side of the tablet and 724 scored on the other side. They are supplied by Keltman Pharmaceuticals Inc. as follows: Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured and Distributed by: Corepharma, LLC. Middlesex, NJ 08846 This Product was Repackaged For: Keltman Pharmaceuticals Inc. 1 Lakeland Square, Suite A Flowood, MS 39232 United States

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

TIZANIDINE HYDROCHLORIDE - TIZANIDINE HYDROCHLORIDE TABLET
KELTMAN PHARMACEUTICALS INC.
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TIZANIDINE HYDROCHLORIDE TABLETS
PHARMACOKINETIC DIFFERENCES BETWEEN TIZANIDINE CAPSULES AND
TIZANIDINE TABLETS:
TIZANIDINE CAPSULES ARE NOT BIOEQUIVALENT TO TIZANIDINE TABLETS IN
THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH
THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (SEE
PHARMACOKINETICS AND DOSAGE AND ADMINISTRATION).
DESCRIPTION
Tizanidine hydrochloride is a centrally acting α -adrenergic agonist.
Tizanidine hydrochloride, USP is
a white to off-white, fine crystalline powder, which is odorless or
with a faint characteristic odor.
Tizanidine is slightly soluble in water and methanol; solubility in
water decreases as the pH increases.
Its chemical name is
5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole
hydrochloride.
Tizanidine’s molecular formula is C H ClN S·HCl, its molecular
weight is 290.2 and its structural
formula is:
Tizanidine tablets, USP are supplied 4 mg tablets for oral
administration. Tizanidine tablets are
composed of the active ingredient, tizanidine hydrochloride (2.288 mg
equivalent to 2 mg tizanidine
base and 4.576 mg equivalent to 4 mg tizanidine base), and the
following inactive ingredients: anhydrous
lactose, colloidal silicon dioxide, microcrystalline cellulose,
pregelatinized Starch and stearic acid.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Tizanidine is an agonist at α -adrenergic receptor sites and
presumably reduces spasticity by increasing
presynaptic inhibition of motor neurons. In animal models, tizanidine
has no direct effect on skeletal
muscle fibers or the neuromuscular junction, and no major effect on
monosynaptic spinal reflexes. The
effects of tizanidine are greatest on polysynaptic pathways. The
overall effect of these actions is
thought to reduce facilitation of spinal motor neurons.
The imidazoline chemical structure of tizanidine is related to that of
the anti-hypertensive drug
2
9
8
5
2
clonidine and other α -adrenergic a