TIZANIDINE HYDROCHLORIDE (Page 4 of 4)

DRUG ABUSE AND DEPENDENCE

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 transient signs of withdrawal at doses > 35 times the maximum recommended human dose on a mg/m2 basis. These transient withdrawal signs (increased locomotion, body twitching, and aversive behavior toward the observer) were not reversed by naloxone administration.

OVERDOSAGE

One significant overdosage of tizanidine has been reported. Attempted suicide bya 46 year-old male with multiple sclerosis resulted in coma very shortly after the ingestion of one-hundred 4 mg tizanidine tablets. Pupils were not dilated and nystagmus was not present. The patient had marked respiratory depression with Cheyne-Stokes respiration. Gastric lavage and forced diuresis with furosemide and mannitol were instituted. The patient recovered several hours later without sequelae. Laboratory findings were normal.

Should overdose occur, basic steps to ensure the adequacy of an airway and the monitoring of cardiovascular and respiratory systems should be undertaken. For the most recent information concerning the management of overdose, contact a poison control center.

DOSAGE AND ADMINISTRATION

A single dose of 8 mg of tizanidine reduces muscle tone in patients with spasticity for a period of several hours. The effect peaks at approximately 1 to 2 hours and dissipates between 3 to 6 hours. Effects are dose-related.

Although single doses of less than 8 mg have not been demonstrated to be effective in controlled clinical studies, the dose-related nature of tizanidine’s common adverse events make it prudent to begin treatment with single oral doses of 4 mg. Increase the dose gradually (2 to 4 mg steps) to optimum effect (satisfactory reduction of muscle tone at a tolerated dose).

The dose can be repeated at 6 to 8 hour intervals, as needed, to a maximum of three doses in 24 hours. The total daily dose should not exceed 36 mg.

Experience with single doses exceeding 8 mg and daily doses exceeding 24 mg is limited. There is essentially no experience with repeated, single, daytime doses greater than 12 mg or total daily doses greater than 36 mg (see WARNINGS).

HOW SUPPLIED

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)


Rx Only
Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachepalli — 502 325 INDIA
Repackaged by:
Rebel Distributors
Thousand Oaks, CA 91320

Package Label
(click image for full-size original)
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-126(NDC:64720-106)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIZANIDINE HYDROCHLORIDE (TIZANIDINE) TIZANIDINE 2 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE (White) Score 2 pieces
Shape ROUND (round) Size 9mm
Flavor Imprint Code cor;106
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-126-28 28 TABLET (TABLET) in 1 BOTTLE None
2 NDC:21695-126-30 30 TABLET (TABLET) in 1 BOTTLE None
3 NDC:21695-126-90 90 TABLET (TABLET) in 1 BOTTLE None
4 NDC:21695-126-72 120 TABLET (TABLET) in 1 BOTTLE None
5 NDC:21695-126-78 180 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076347 02/06/2007
TIZANIDINE HYDROCHLORIDE tizanidine hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:21695-127(NDC:64720-138)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIZANIDINE HYDROCHLORIDE (TIZANIDINE) TIZANIDINE 4 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
ANHYDROUS LACTOSE
SILICON DIOXIDE
STARCH, CORN
STEARIC ACID
Product Characteristics
Color WHITE (White) Score 4 pieces
Shape ROUND (round) Size 9mm
Flavor Imprint Code cor;138
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21695-127-14 14 TABLET (TABLET) in 1 BOTTLE None
2 NDC:21695-127-15 15 TABLET (TABLET) in 1 BOTTLE None
3 NDC:21695-127-30 30 TABLET (TABLET) in 1 BOTTLE None
4 NDC:21695-127-60 60 TABLET (TABLET) in 1 BOTTLE None
5 NDC:21695-127-90 90 TABLET (TABLET) in 1 BOTTLE None
6 NDC:21695-127-72 120 TABLET (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076347 02/06/2007
Labeler — Rebel Distributors (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors 118802834 relabel, repack

Revised: 12/2009 Rebel Distributors

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