Minds On Meds

Mental Health Medications

Antipsychotics

Navane, Page 2

Navane (thiothixene) is a thioxanthene derivative. Navane possesses certain chemical and pharmacological similarities to the piperazine phenothiazines and differences from the aliphatic group of phenothiazines. It is effective in the management of schizophrenia.

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, levarterenol 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

Navane (thiothixene) Capsules

Bottles of 100’s: 1 mg (NDC 0049-5710-66)
2 mg (NDC 0049-5720-66)
5 mg (NDC 0049-5730-66)
10 mg (NDC 0049-5740-66)
20 mg (NDC 0049-5770-66)

Rx only

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LAB-0251-4.0
January 2008

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).
NAVANE
thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-5710
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
gelatin
titanium dioxide
Yellow 10
Yellow 6
Blue 1
Green 3
Red 3
lactose
magnesium stearate
sodium lauryl sulfate
starch
Product Characteristics
Color orange, yellow Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Navane;Roerig;571
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-5710-66 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
NAVANE
thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-5720
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
gelatin
titanium dioxide
Yellow 10
Yellow 6
Blue 1
Green 3
Red 3
lactose
magnesium stearate
sodium lauryl sulfate
starch
Product Characteristics
Color blue (Blue-Green) , yellow Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Navane;Roerig;572
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-5720-66 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
NAVANE
thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-5730
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
gelatin
titanium dioxide
Yellow 10
Yellow 6
Blue 1
Green 3
Red 3
lactose
magnesium stearate
sodium lauryl sulfate
starch
Product Characteristics
Color orange, white Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Navane;Roerig;573
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-5730-66 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
NAVANE
thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-5740
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
gelatin
titanium dioxide
Yellow 10
Yellow 6
Blue 1
Green 3
Red 3
lactose
magnesium stearate
sodium lauryl sulfate
starch
Product Characteristics
Color blue (Light Blue) , white Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code Navane;Roerig;574
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-5740-66 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
NAVANE
thiothixene capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-5770
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Thiothixene (Thiothixene) Thiothixene 20 mg
Inactive Ingredients
Ingredient Name Strength
gelatin
titanium dioxide
Yellow 10
Yellow 6
Blue 1
Green 3
Red 3
lactose
magnesium stearate
sodium lauryl sulfate
starch
Product Characteristics
Color blue (Light Blue) , green (Light Green) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code Navane;Roerig;577
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-5770-66 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
NAVANE
thiothixene solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-5750
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Thiothixene (Thiothixene) Thiothixene 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
alcohol
cherry flavor
dextrose
passion fruit flavor
sorbitol solution
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-5750-47 120 mL (120 MILLILITER) in 1 BOTTLE, DROPPER None
Labeler — Roerig

Revised: 02/2008 Roerig