Loxapine (Page 3 of 3)

OVERDOSAGE

Signs and symptoms of overdosage will depend on the amount ingested and individual patient tolerance. As would be expected from the pharmacologic actions of the drug, the clinical findings may range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression, and unconsciousness. The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind. Renal failure following loxapine overdosage has also been reported.
The treatment of overdosage is essentially symptomatic and supportive. Early gastric lavage and extended dialysis might be expected to be beneficial. Centrally-acting emetics may have little effect because of the antiemetic action of loxapine. In addition, emesis should be avoided because of the possibility of aspiration of vomitus. Avoid analeptics, such as pentylenetetrazol, which may cause convulsions. Severe hypotension might be expected to respond to the administration of norepinephrine or phenylephrine. EPINEPHRINE SHOULD NOT BE USED SINCE ITS USE IN A PATIENT WITH PARTIAL ADRENERGIC BLOCKADE MAY FURTHER LOWER THE BLOOD PRESSURE. Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson agents or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated. Additional measures include oxygen and intravenous fluids.

DOSAGE AND ADMINISTRATION

Loxapine is administered, usually in divided doses, two to four times a day. Daily dosage (in terms of base equivalents) should be adjusted to the individual patient’s needs as assessed by the severity of symptoms and previous history of response to antipsychotic drugs.

Oral Administration

Initial dosage of 10 mg twice daily is recommended, although in severely disturbed patients initial dosage up to a total of 50 mg daily may be desirable. Dosage should then be increased fairly rapidly over the first seven to ten days until there is effective control of symptoms of schizophrenia. The usual therapeutic and maintenance range is 60 mg to 100 mg daily. However, as with other drugs used to treat schizophrenia, some patients respond to lower dosage and others require higher dosage for optimal benefit. Daily dosage higher than 250 mg is not recommended.

Maintenance Therapy

For maintenance therapy, dosage should be reduced to the lowest level compatible with symptom control; many patients have been maintained satisfactorily at dosages in the range of 20 to 60 mg daily.

HOW SUPPLIED

Loxapine Capsules, USP are available in the following strengths:
Loxapine succinate, USP 6.8 mg equivalent to 5 mg loxapine, black ink, hard shell capsules Size 2, opaque, with dark green body and cap imprinted with “E525 ” on cap and body, are supplied in bottles of 100 NDC# 35573-436-02.
Loxapine succinate, USP 13.6 mg equivalent to 10 mg loxapine, black ink, hard shell capsules Size 2, opaque, yellow cap and dark green body imprinted with “E526 ” on cap and body are supplied in bottles of 100 NDC# 35573-437-02.
Loxapine succinate, USP 34.0 mg equivalent to 25 mg loxapine, black ink, hard shell capsules Size 2, opaque, with light green cap and dark green body imprinted with “E527 ” on cap and body, are supplied in bottles of 100 NDC# 35573-438-02.
Loxapine succinate, USP 68.0 mg equivalent to 50 mg loxapine, black ink, hard shell capsules Size 2, opaque, with light blue cap and dark green body imprinted with “E528 ” on cap and body, are supplied in bottles of 100 NDC# 35573-439-02.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure, as required.
Manufactured by:
Elite Laboratories, Inc.
Northvale, NJ 07647 USA
Manufactured for:
Burel Pharmaceuticals, LLC
Mason, OH 45040 USA
IN0540Revised 09/21

PRINCIPAL DISPLAY PANEL

Loxapine Succinate 5mg
(click image for full-size original)

NDC# 35573-436-02
Loxapine Capsules USP
5 mg
100 Capsules Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loxapine Succinate 10mg
(click image for full-size original)

NDC# 35573-437-02
Loxapine Capsules USP
10 mg
100 Capsules Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loxapine Succinate 25mg
(click image for full-size original)

NDC# 35573-438-02
Loxapine Capsules USP
25 mg
100 Capsules Rx Only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Loxapine Succinate 50mg
(click image for full-size original)

NDC# 35573-439-02
Loxapine Capsules USP
50 mg
100 Capsules Rx Only

LOXAPINE loxapine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-436
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loxapine Succinate (Loxapine) Loxapine 5 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
Hypromellose, Unspecified
Lactose Monohydrate
Magnesium Stearate
Titanium Dioxide
Fd&C Blue No. 1
Fd&C Yellow No. 6
Shellac
Ferrosoferric Oxide
Butyl Alcohol
Propylene Glycol
Fd&C Blue No. 2–Aluminum Lake
Fd&C Blue No. 1 Aluminum Lake
D&C Yellow No. 10
Fd&C Red No. 40
Product Characteristics
Color GREEN (Dark Green) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code E525
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35573-436-02 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076868 05/01/2021
LOXAPINE loxapine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-437
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loxapine Succinate (Loxapine) Loxapine 10 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
Hypromellose, Unspecified
Lactose Monohydrate
Magnesium Stearate
Titanium Dioxide
Fd&C Blue No. 1
Fd&C Yellow No. 6
Shellac
Ferrosoferric Oxide
Butyl Alcohol
Propylene Glycol
Fd&C Blue No. 2–Aluminum Lake
Fd&C Blue No. 1 Aluminum Lake
Ferric Oxide Yellow
D&C Yellow No. 10
Fd&C Red No. 40
Product Characteristics
Color GREEN (Dark Green Body) , YELLOW (Yellow Cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code E526
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35573-437-02 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076868 05/01/2021
LOXAPINE loxapine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-438
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loxapine Succinate (Loxapine) Loxapine 25 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
Hypromellose, Unspecified
Lactose Monohydrate
Magnesium Stearate
Titanium Dioxide
Fd&C Blue No. 1
Shellac
Ferrosoferric Oxide
Butyl Alcohol
Propylene Glycol
Fd&C Blue No. 2–Aluminum Lake
Fd&C Blue No. 1 Aluminum Lake
Ferric Oxide Yellow
D&C Yellow No. 10
Fd&C Red No. 40
Product Characteristics
Color GREEN (Dark Green Body) , GREEN (Light Green Cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code E527
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35573-438-02 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076868 05/01/2021
LOXAPINE loxapine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35573-439
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Loxapine Succinate (Loxapine) Loxapine 50 mg
Inactive Ingredients
Ingredient Name Strength
Silicon Dioxide
Hypromellose, Unspecified
Lactose Monohydrate
Magnesium Stearate
Titanium Dioxide
Fd&C Blue No. 1
Shellac
Ferrosoferric Oxide
Butyl Alcohol
Propylene Glycol
Fd&C Blue No. 2–Aluminum Lake
Fd&C Blue No. 1 Aluminum Lake
Ferric Oxide Yellow
D&C Yellow No. 10
Fd&C Red No. 40
Product Characteristics
Color GREEN (Dark Green Body) , BLUE (Light Blue Cap) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code E528
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35573-439-02 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076868 05/01/2021
Labeler — Burel Pharmaceuticals, LLC (609436204)
Registrant — Elite Laboratories, Inc. (785398728)
Establishment
Name Address ID/FEI Operations
Elite Laboratories, Inc. 785398728 manufacture (35573-436), manufacture (35573-437), manufacture (35573-438), manufacture (35573-439), pack (35573-436), pack (35573-437), pack (35573-438), pack (35573-439)

Revised: 10/2020 Burel Pharmaceuticals, LLC

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