Trifluoperazine Hydrochloride (Page 4 of 4)

DOSAGE AND ADMINISTRATION-ADULTS

Dosage should be adjusted to the needs of the individual. The lowest effective dosage should always be used. Dosage should be increased more gradually in debilitated or emaciated patients. When maximum response is achieved, dosage may be reduced gradually to a maintenance level. Because of the inherent long action of the drug, patients may be controlled on convenient b.i.d. administration; some patients may be maintained on once a day administration.

When trifluoperazine hydrochloride is administered by intramuscular injection, equivalent oral dosage may be substituted once symptoms have been controlled.

Note: Although there is little likelihood of contact dermatitis due to the drug, persons with known sensitivity to phenothiazine drugs should avoid direct contact.

Elderly Patients

In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored, and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

Non-Psychotic Anxiety

Usual dosage is 1 mg or 2 mg twice daily. Do not administer at doses of more than 6 mg per day or for longer than 12 weeks.

Schizophrenia

Oral

Usual starting dosage is 2 mg to 5 mg b.i.d. (Small or emaciated patients should always be started on the lower dosage.)

Most patients will show optimum response on 15 mg or 20 mg daily, although a few may require 40 mg a day or more. Optimum therapeutic dosage levels should be reached within 2 or 3 weeks.

DOSAGE AND ADMINISTRATION-SCHIZOPHRENIA IN CHILDREN

Dosage should be adjusted to the weight of the child and severity of the symptoms. These dosages are for children, ages 6 to 12, who are hospitalized or under close supervision.

Oral

The starting dosage is 1 mg administered once a day or b.i.d. Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome.

While it is usually not necessary to exceed dosages of 15 mg daily, some older children with severe symptoms may require higher dosages.

HOW SUPPLIED

For psychiatric patients who are hospitalized under close supervision.

The 5 mg tablets are lavender, film-coated, round, unscored tablets debossed with T5 on one side of the tablet and M on the other side. They are available as follows:

NDC: 70518-2106-00

PACKAGING: 30 in 1 BLISTER PACK

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

DRUG: Trifluoperazine Hydrochloride

GENERIC: trifluoperazine hydrochloride

DOSAGE: TABLET, FILM COATED

ADMINSTRATION: ORAL

NDC: 70518-2106-0

COLOR: purple

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: M;T5

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • TRIFLUOPERAZINE HYDROCHLORIDE 5mg in 1

INACTIVE INGREDIENT(S):

  • SILICON DIOXIDE
  • CROSCARMELLOSE SODIUM
  • HYPROMELLOSE, UNSPECIFIED
  • LACTOSE MONOHYDRATE
  • MAGNESIUM STEARATE
  • MICROCRYSTALLINE CELLULOSE
  • POLYDEXTROSE
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • STARCH, CORN
  • SODIUM LAURYL SULFATE
  • TITANIUM DIOXIDE
  • TRIACETIN
  • D&C RED NO. 30
  • FD&C BLUE NO. 2
  • FD&C YELLOW NO. 6
Remedy_Label
(click image for full-size original)
TRIFLUOPERAZINE HYDROCHLORIDE
trifluoperazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2106(NDC:0378-2405)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIFLUOPERAZINE HYDROCHLORIDE (TRIFLUOPERAZINE) TRIFLUOPERAZINE 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIACETIN
D&C RED NO. 30
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
Product Characteristics
Color purple (lavender) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code M;T5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2106-0 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040209 05/23/2019
Labeler — REMEDYREPACK INC. (829572556)

Revised: 07/2021 REMEDYREPACK INC.

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