Thiothixene (Page 3 of 3)

DOSAGE & ADMINISTRATION

Dosage of thiothixene capsules should be individually adjusted depending on the chronicity and severity of the symptoms of schizophrenia. In general, small doses should be used initially and gradually increased to the optimal effective level, based on patient response.
Some patients have been successfully maintained on once a day thiothixene capsule therapy.
The use of thiothixene capsules in children under 12 years of age is not recommended because safe conditions for its use have not been established.
In milder conditions, an initial dose of 2 mg three times daily is recommended. If indicated, a subsequent increase to 15 mg/day total daily dose is often effective.
In more severe conditions, an initial dose of 5 mg twice daily is recommended. The usual optimal dose is 20 mg to 30 mg daily. If indicated, an increase to 60 mg/day total daily dose is often effective. Exceeding a total daily dose of 60 mg rarely increases the beneficial response.

OVERDOSAGE

Manifestations include muscular twitching, drowsiness and dizziness. Symptoms of gross overdosage may include CNS depression, rigidity, weakness, torticollis, tremor, salivation, dysphagia, hypotension, disturbances of gait, or coma.
Treatment
Essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under careful observation and maintain an open airway, since involvement of the extrapyramidal system may produce dysphagia and respiratory difficulty in severe overdosage. If hypotension occurs, the standard measures for managing circulatory shock should be used (I.V. fluids and/or vasoconstrictors).
If a vasoconstrictor is needed, norepinephrine and phenylephrine are the most suitable drugs. Other pressor agents, including epinephrine, are not recommended, since phenothiazine derivatives may reverse the usual pressor action of these agents and cause further lowering of blood pressure.
If CNS depression is marked, symptomatic treatment is indicated. Extrapyramidal symptoms may be treated with antiparkinson drugs.
There are no data on the use of peritoneal or hemodialysis, but they are known to be of little value in phenothiazine intoxication.

HOW SUPPLIED

Thiothixene Capsules, USP are available containing 1 mg, 2 mg, 5 mg or 10 mg of thiothixene, USP.

Thiothixene, USP 1 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a blue opaque body filled with white to off-white powder. The capsule is imprinted “014” on the cap and “novitium” on the body in black ink. They are available as below:

NDC 70954-014-10 Bottle of 100 capsules

NDC 70954-014-20 Bottle of 1000 capsules

Thiothixene, USP 2 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a yellow opaque body filled with white to off-white powder. The capsule is imprinted “015” on the cap and “novitium” on the body in black ink. They are available as below:

NDC 70954-015-10 Bottle of 100 capsules

NDC 70954-015-20 Bottle of 1000 capsules

NDC 70954-015-40 Unit dose blister packages of 100 (10 cards of 10 capsules each)

Thiothixene, USP 5 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a white opaque body filled with white to off-white powder. The capsule is imprinted “016” on the cap and “novitium” on the body in black ink. They are available as below:

NDC 70954-016-10 Bottle of 100 capsules

NDC 70954-016-20 Bottle of 1000 capsules

NDC 70954-016-40 Unit dose blister packages of 100 (10 cards of 10 capsules each)

Thiothixene, USP 10 mg capsule is a size 4 hard gelatin capsule with a caramel opaque cap and a peach opaque body filled with white to off-white powder. The capsule is imprinted “017” on the cap and “novitium” on the body in black ink. They are available as below:

NDC 70954-017-10 Bottle of 100 capsules

NDC 70954-017-20 Bottle of 1000 capsules

NDC 70954-017-40 Unit dose blister packages of 100 (10 cards of 10 capsules each)

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

Preserve in tight, light-resistant container as defined in the USP.

REFERENCES

  1. Worldwide Labeling Safety Report: Dyskinesia and Dyskinesia Tardive and Thiothixene, (16Apr02).
  2. Worldwide Labeling Safety Report: Neuroleptic Malignant Syndrome and Thiothixene, (16Apr02).
  3. Worldwide Labeling Safety Report: Hyperprolactinemia and Thiothixene, (16Apr02).
  4. Ereshefsky L, Saklad SR, Watanabe MD, et al. Thiothixene Pharmacokinetic Interactions: A Study of Hepatic Enzyme Inducers, Clearance Inhibitors, and Demographic Variables. Journal of Clinical Psychopharmacology, 11(5):296–301, (1991).
  5. Worldwide Labeling Safety Report: Drug Interaction and Thiothixene, (09May02).
  6. McEvoy GK, Miller JL, Snow EK, et al. AHFS Drug Information. American Society of Health- System Pharmacists, Inc., p. 2334-2336, (2002).
  7. Worldwide Labeling Safety Report: Menstrual Disorder and Thiothixene, (16Apr02).

Manufactured by:

Novitium Pharma LLC

70 Lake Drive, East Windsor

New Jersey 08520

Issued: 08/2020

LB4233-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Thiothixene Capsules, USP 1 mg 100’s counts

1mg
(click image for full-size original)

Thiothixene Capsules, USP 1 mg 1000’s counts
1mg1000
(click image for full-size original)

Thiothixene Capsules, USP 2 mg 100’s counts
2mg100
(click image for full-size original)

Thiothixene Capsules, USP 2 mg 1000’s counts
2mg1000
(click image for full-size original)

Thiothixene Capsules, USP 2 mg Unit dose blister packages of 100 (10 cards of 10 capsules each)
blister2
(click image for full-size original)
carton2
(click image for full-size original)


Thiothixene Capsules, USP 5 mg 100’s counts
5mg100
(click image for full-size original)

Thiothixene Capsules, USP 5 mg 1000’s counts
5mg1000
(click image for full-size original)

Thiothixene Capsules, USP 5 mg Unit dose blister packages of 100 (10 cards of 10 capsules each)
blister5
(click image for full-size original)
carton5
(click image for full-size original)

Thiothixene Capsules, USP 10 mg 100’s counts
10mg100
(click image for full-size original)

Thiothixene Capsules, USP 10 mg 1000’s counts

10mg1000
(click image for full-size original)

Thiothixene Capsules, USP 10 mg Unit dose blister packages of 100 (10 cards of 10 capsules each)

blister10
(click image for full-size original)
carton10
(click image for full-size original)

THIOTHIXENE thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-014
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THIOTHIXENE (THIOTHIXENE) THIOTHIXENE 1 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
D&C RED NO. 28
Product Characteristics
Color BROWN (Caramel (Opaque Cap)) , BLUE ((Opaque Body)) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 014;novitium
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-014-10 100 CAPSULE in 1 BOTTLE None
2 NDC:70954-014-20 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211642 04/05/2019
THIOTHIXENE thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-015
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THIOTHIXENE (THIOTHIXENE) THIOTHIXENE 2 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
GELATIN
SHELLAC
D&C YELLOW NO. 10
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN (Caramel (Opaque Cap)) , YELLOW ((Opaque Body)) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 015;novitium
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-015-10 100 CAPSULE in 1 BOTTLE None
2 NDC:70954-015-20 1000 CAPSULE in 1 BOTTLE None
3 NDC:70954-015-40 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70954-015-30)
3 NDC:70954-015-30 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70954-015-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211642 04/05/2019
THIOTHIXENE thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-016
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THIOTHIXENE (THIOTHIXENE) THIOTHIXENE 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
CROSCARMELLOSE SODIUM
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color BROWN (Caramel (Opaque Cap)) , WHITE ((Opaque Body)) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 016;novitium
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-016-10 100 CAPSULE in 1 BOTTLE None
2 NDC:70954-016-20 1000 CAPSULE in 1 BOTTLE None
3 NDC:70954-016-40 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70954-016-30)
3 NDC:70954-016-30 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70954-016-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211642 04/05/2019
THIOTHIXENE thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70954-017
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
THIOTHIXENE (THIOTHIXENE) THIOTHIXENE 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
TITANIUM DIOXIDE
GELATIN
SHELLAC
PROPYLENE GLYCOL
AMMONIA
POTASSIUM HYDROXIDE
FERROSOFERRIC OXIDE
Product Characteristics
Color PINK (Peach (Opeque Body)) , BROWN (Caramel (Opaque Cap)) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 017;capsule
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70954-017-10 100 CAPSULE in 1 BOTTLE None
2 NDC:70954-017-20 1000 CAPSULE in 1 BOTTLE None
3 NDC:70954-017-40 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70954-017-30)
3 NDC:70954-017-30 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (70954-017-40)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211642 04/05/2019
Labeler — Novitium Pharma LLC (080301870)
Establishment
Name Address ID/FEI Operations
Novitium Pharma LLC 080301870 MANUFACTURE (70954-014), MANUFACTURE (70954-015), MANUFACTURE (70954-016), MANUFACTURE (70954-017), PACK (70954-014), PACK (70954-015), PACK (70954-016), PACK (70954-017)

Revised: 09/2020 Novitium Pharma LLC

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