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:

Rebel Distributors

INN (Mezinárodní Name):

TIZANIDINE HYDROCHLORIDE

Složení:

TIZANIDINE 2 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Tizanidine 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 ). Tizanidine is contraindicated in patients with known hypersensitivity to tizanidine hydrochloride or its ingredients. Geriatric Use Tizanidine should be used with caution in elderly patients because clearance is decreased four-fold. Pediatric Use There are no adequate and well-controlled studies to document the safety and efficacy of tizanidine in children. Abuse potential was not evaluated in human studies. Rats were able to distinguish tizanidine from saline in a standard discrimination paradigm, after training, but failed to generalize the effects of morphine, cocaine, diazepam, or phenobarbital to tizanidine. Monkeys were shown to self-administer tizanidine in a dose-dependent manner, and abrupt cessation of tizanidine produced transie

Přehled produktů:

Tizanidine hydrochloride tablets 2 mg are supplied as white to off white, oval, flat, beveled edged tablets embossed with "R179" on one side and "bisecting score" on other side. The tablets are available in bottles of 28, 30, 90, 120 and 180. They are supplied as follows: Bottles of 28 (NDC 21695-126-28) Bottles of 30 (NDC 21695-126-30) Bottles of 90 (NDC 21695-126-90) Bottles of 120 (NDC 21695-126-72) Bottles of 180 (NDC 21695-126-78) Tizanidine hydrochloride tablets 4 mg are supplied as white to off white, oval, flat, beveled edged tablets embossed with "R180" on one side and "quadrisecting score" on other side. The tablets are available in bottles of 14, 15, 30, 60, 90 and 120. They are supplied as follows: Bottles of 14 (NDC 21695-127-14) Bottles of 15 (NDC 21695-127-15) Bottles of 30 (NDC 21695-127-30) Bottles of 60 (NDC 21695-127-60) Bottles of 90 (NDC 21695-127-90) Bottles of 120 (NDC 21695-127-72)

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

TIZANIDINE HYDROCHLORIDE - TIZANIDINE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS
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TIZANIDINE HYDROCHLORIDE
PHARMACOKINETIC DIFFERENCES BETWEEN TIZANIDINE HYDROCHLORIDE
CAPSULES AND TIZANIDINE HYDROCHLORIDE TABLETS:
TIZANIDINE HYDROCHLORIDE CAPSULES ARE NOT BIOEQUIVALENT TO
TIZANIDINE HYDROCHLORIDE 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 HCl (tizanidine) 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 CIN S•HCl, its molecular
weight is 290.2 and its structural
formula is:
Tizanidine hydrochloride is supplied as 2 and 4 mg tablets for oral
administration. Tizanidine
hydrochloride 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 inactive
ingredients, microcrystalline cellulose, anhydrous lactose, colloidal
silicon dioxide, 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 dru