FULL PRESCRIBING INFORMATION:

CONTENTS *

INDICATIONS AND USAGE

  1. Acromegaly

  2. Carcinoid Tumors

  3. Vasoactive Intestinal Peptide Tumors (VIPomas)

  4. Important Limitations of Use

DOSAGE AND ADMINISTRATION

  1. Acromegaly

  2. Carcinoid Tumors and VIPomas

  3. Special Populations: Renal Impairment

  4. Special Populations: Hepatic Impairment - Cirrhotic Patients

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

  1. Cholelithiasis and Gallbladder Sludge

  2. Hyperglycemia and Hypoglycemia

  3. Thyroid Function Abnormalities

  4. Cardiac Function Abnormalities

  5. Nutrition

  6. Monitoring: Laboratory Tests

  7. Drug Interactions

ADVERSE REACTIONS

  1. Clinical Study Experience

  2. Post Marketing Experience 7 DRUG INTERACTIONS

    CyclosporineInsulin and Oral Hypoglycemic DrugsBromocriptineOther Concomitant Drug TherapyDrug Metabolism Interactions

USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

    Nursing MothersPediatric UseGeriatric UseRenal ImpairmentHepatic Impairment - Cirrhotic Patients

OVERDOSAGE

DESCRIPTION

CLINICAL PHARMACOLOGY

  1. Mechanism of Action

  2. Pharmacodynamics

  3. Pharmacokinetics

NONCLINICAL TOXICOLOGY

  1. Carcinogenesis, Mutagenesis, Impairment of Fertility

  2. Reproductive Toxicology Studies

CLINICAL STUDIES

  1. Acromegaly

  2. Carcinoid Syndrome

HOW SUPPLIED/STORAGE AND HANDLING