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
- Worldwide Labeling Safety Report: Dyskinesia and Dyskinesia Tardive and Thiothixene, (16Apr02).
- Worldwide Labeling Safety Report: Neuroleptic Malignant Syndrome and Thiothixene, (16Apr02).
- Worldwide Labeling Safety Report: Hyperprolactinemia and Thiothixene, (16Apr02).
- 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).
- Worldwide Labeling Safety Report: Drug Interaction and Thiothixene, (09May02).
- McEvoy GK, Miller JL, Snow EK, et al. AHFS Drug Information. American Society of Health- System Pharmacists, Inc., p. 2334-2336, (2002).
- 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
Thiothixene Capsules, USP 1 mg 1000’s counts
Thiothixene Capsules, USP 2 mg 100’s counts
Thiothixene Capsules, USP 2 mg 1000’s counts
Thiothixene Capsules, USP 2 mg Unit dose blister packages of 100 (10 cards of 10 capsules each)
Thiothixene Capsules, USP 5 mg 100’s counts
Thiothixene Capsules, USP 5 mg 1000’s counts
Thiothixene Capsules, USP 5 mg Unit dose blister packages of 100 (10 cards of 10 capsules each)
Thiothixene Capsules, USP 10 mg 100’s counts
Thiothixene Capsules, USP 10 mg 1000’s counts
Thiothixene Capsules, USP 10 mg Unit dose blister packages of 100 (10 cards of 10 capsules each)
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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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