Haloperidol description, usages, side effects, indications, overdosage, supplying and lots more!

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Haloperidol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Increased Mortality in Elderly Patients with Dementia-Related Psychosis
WARNINGS

HALOPERIDOL DESCRIPTION


Haloperidol



CLINICAL PHARMACOLOGY



INDICATIONS & USAGE




HALOPERIDOL CONTRAINDICATIONS



WARNINGS


Increased Mortality in Elderly Patients with Dementia-Related Psychosis
BOXED WARNING

Cardiovascular Effects


Tardive Dyskinesia




ADVERSE REACTIONS

Neuroleptic Malignant Syndrome (NMS)






Usage In Pregnancy



Combined Use of Haloperidol and Lithium


General





PRECAUTIONS






  • ●     with severe cardiovascular disorders, because of the possibility of transient hypotension and/or precipitation of anginal pain. Should hypotension occur and a vasopressor be required, epinephrine should not be used since haloperidol may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur. Instead, metaraminol, phenylephrine or norepinephrine should be used.
  • ●     receiving anticonvulsant medications, with a history of seizures, or with EEG abnormalities, because haloperidol may lower the convulsive threshold. If indicated, adequate anticonvulsant therapy should be concomitantly maintained.
  • ●     with known allergies, or with a history of allergic reactions to drugs.
  • ●     receiving anticoagulants, since an isolated instance of interference occurred with the effects of one anticoagulant (phenindione).











PREGNANCY

Non-teratogenic Effects



PEDIATRIC USE



GERIATRIC USE

Tardive DyskinesiaDOSAGE AND ADMINISTRATION

HALOPERIDOL ADVERSE REACTIONS


Cardiovascular Effects
WARNINGSPRECAUTIONS


CNS Effects


Dystonia


WITHDRAWAL EMERGENT NEUROLOGICAL SIGNS


TARDIVE DYSKINESIA




TARDIVE DYSTONIA


OTHER CNS EFFECTS


Body as a Whole
WARNINGS

Hematologic Effects


Liver Effects


Dermatologic Reactions


Endocrine Disorders


Gastrointestinal Effects


Autonomic Reactions


Respiratory Effects


Special Senses


Postmarketing Events


OVERDOSAGE

Manifestations
ADVERSE REACTIONS

Treatment


DOSAGE & ADMINISTRATION





Oral Administration






Children




Maintenance Dosage


Switchover Procedure


HOW SUPPLIED










STORAGE AND HANDLING






PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Haloperidol

Haloperidol

Haloperidol

Haloperidol TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-512(NDC:68382-080)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
HALOPERIDOL HALOPERIDOL 10 mg

Inactive Ingredients

Ingredient Name Strength
CALCIUM STEARATE
D&C YELLOW NO. 10
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
FD&C BLUE NO. 1
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
green 10 mm ZC;08 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-512-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077580 2011-09-15


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