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

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Labetalol Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

LABETALOL HYDROCHLORIDE DESCRIPTION



Labetalol Hydrochloride






CLINICAL PHARMACOLOGY



PHARMACODYNAMICS













PHARMACOKINETICS AND METABOLISM





Elderly Patients


INDICATIONS & USAGE



LABETALOL HYDROCHLORIDE CONTRAINDICATIONS




WARNINGS

Hepatic Injury


Cardiac Failure


In Patients Without a History of Cardiac Failure


Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal


Nonallergic Bronchospasm (e.g., Chronic Bronchitis and Emphysema)


Pheochromocytoma


Diabetes Mellitus and Hypoglycemia


Major Surgery



PRECAUTIONS

General

Impaired Hepatic Function

Intraoperative Floppy Iris Syndrome (IFIS)

Jaundice or Hepatic Dysfunction


INFORMATION FOR PATIENTS



LABORATORY TESTS



DRUG INTERACTIONS








Risk of Anaphylactic Reaction


DRUG & OR LABORATORY TEST INTERACTIONS




CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

Teratogenic Effects

Pregnancy Category C


Nonteratogenic Effects


LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE



LABETALOL HYDROCHLORIDE ADVERSE REACTIONS










Body as a Whole


Cardiovascular


Central and Peripheral Nervous Systems


Collagen Disorders


Eyes


Immunological System


Liver and Biliary System


Musculoskeletal System


Respiratory System


Skin and Appendages


Urinary System


Hypersensitivity



Potential Adverse Effects


Central Nervous System


Cardiovascular


Allergic


Hematologic


Gastrointestinal



Clinical Laboratory Tests


OVERDOSAGE


Excessive bradycardia -
Cardiac failure
Hypotension
Bronchospasm
Seizures -




DOSAGE & ADMINISTRATION







Elderly Patients


HOW SUPPLIED





STORAGE AND HANDLING





PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Labetalol Hydrochloride

Labetalol Hydrochloride

Labetalol Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-540(NDC:0172-4365)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LABETALOL HYDROCHLORIDE LABETALOL 200 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
polysorbate 80
SODIUM STARCH GLYCOLATE TYPE A POTATO
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 10 mm 4365;TEVA ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-540-24 200 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074787 2011-09-27


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Be sure to consult your doctor before taking any medication!
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