Indomethacin

Hetero Drugs Ltd.,

FULL PRESCRIBING INFORMATION: CONTENTS*

• BOXED WARNING
• INDOMETHACIN DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• INDOMETHACIN CONTRAINDICATIONS
• WARNINGS
  • Cardiovascular Effects
  • Gastrointestinal Effects
  • Renal Effects
  • Anaphylactic / Anaphylactoid Reactions
  • Skin Reactions
  • Pregnancy
  • Ocular Effects
  • Central Nervous System Effects
• PRECAUTIONS
  • General Precautions
  • Information for Patients
  • Laboratory Tests
  • Drug Interactions
  • Drug & OR Laboratory Test Interactions
  • Carcinogenesis & Mutagenesis & Impairment Of Fertility
  • Pregnancy
  • Labor & Delivery
  • Nursing Mothers
  • Pediatric Use
  • Geriatric Use
• INDOMETHACIN ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

INDOMETHACIN DESCRIPTION

C₁₉H₁₆ClNO₄       M.W. 357.79

Indomethacin, USP is practically insoluble in water and sparingly soluble in alcohol. It has a pKa of 4.5 and is stable in neutral or slightly acidic media and decomposes in strong alkali.

Each capsule for oral administration contains 25 mg or 50 mg of indomethacin and the following inactive ingredients: lactose monohydrate, sodium lauryl sulphate, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate. The hard gelatin shell consists of gelatin, titanium dioxide USP, FD & C Blue 1, D & C Yellow 10. The capsules are printed with black ink containing black iron oxide E172 dye. 

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

INDOMETHACIN CONTRAINDICATIONS

WARNINGS

Cardiovascular Effects

Gastrointestinal Effects

Renal Effects

Anaphylactic / Anaphylactoid Reactions

Skin Reactions

Pregnancy

Ocular Effects

Central Nervous System Effects

PRECAUTIONS

General Precautions

Information for Patients

WARNINGS: Cardiovascular Effects

WARNINGS: Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation







WARNINGS

Laboratory Tests

Drug Interactions

WARNINGS: Renal Effects

Drug & OR Laboratory Test Interactions

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Pregnancy

Labor & Delivery

Nursing Mothers

Pediatric Use

Geriatric Use

WARNINGS , Gastrointestinal Effects: Risk of Ulceration, Bleeding, and PerforationDOSAGE AND ADMINISTRATIONWARNINGS: Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation

ADVERSE REACTIONS

WARNINGS: Renal Effects

INDOMETHACIN ADVERSE REACTIONS

Incidence greater than 1%

GASTROINTESTINAL






CENTRAL NERVOUS SYSTEM






SPECIAL SENSES


CARDIOVASCULAR


METABOLIC


INTEGUMENTARY


HEMATOLOGIC


HYPERSENSITIVITY


GENITOURINARY


MISCELLANEOUS

Incidence  less than 1%

GASTROINTESTINAL













CENTRAL NERVOUS SYSTEM


















SPECIAL SENSES





CARDIOVASCULAR







METABOLIC








INTEGUMENTARY










HEMATOLOGIC









HYPERSENSITIVITY











GENITOURINARY






MISCELLANEOUS



Causal Relationship Unknown



Cardiovascular:

Hematologic:

Genitourinary:

PRECAUTIONS: General

OVERDOSAGE

DOSAGE & ADMINISTRATION

WARNINGS







Pediatric Use

WARNINGS

Adult Use















PRECAUTIONS: Geriatric Use

HOW SUPPLIED

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light.



PHARMACIST:

SPL MEDGUIDE

INDOMETHACIN CAPSULES USP

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
See the end of this Medication Guide for a list of prescription NSAID medicines

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.




NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:




The chance of a person getting an ulcer or bleeding increases with:







NSAID medicines should only be used:





What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?






Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
 
Do not take an NSAID medicine:




Tell your healthcare provider: 


Keep a
       list of your medicines to show to your healthcare provider and pharmacist.
NSAID medicines should not be used by pregnant women late in their pregnancy
Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? 

serious side effects include:

Other side effects include:

•   heart attack  •   stroke •   high blood pressure •   heart failure from body swelling (fluid Retension) •   kidney problems including kidney failure •   bleeding and ulcers in the stomach and intestine •   low red blood cells (anemia) •   life-threatening skin reactions •   life-threatening allergic reactions •   liver problems including liver failure •   asthma attacks in people who have asthma

•  stomach pain •  constipation •  diarrhea •  gas •  heartburn •  nausea •  vomiting •  dizziness

Get emergency help right away if you have any of the following symptoms:






Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:












Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)








NSAID medicines that need a prescription

Generic Name

Trade name

Celecoxib Diclofenac Diflunisal  Etodolac Fenoprofen  Flurbiprofen Ibuprofen Indomethacin Ketoprofen  Ketorolac  MefenamicAcid Meloxicam    Nabumetone Naproxen  Oxaprozin Piroxicam Sulindac Tolmetin

Celebrex Cataflam, Voltaren, Arthrotec (combined with  misoprostol)  Dolobid Lodine, Lodine XL Nalfon, Nalfon 200 Ansaid Motrin, Tab-Profen, Vicoprofen*(combined with hydrocodone), Combunox (combined with oxycodone) Indocin, Indocin SR, Indo-Lemmon, Indomethagan Oruvail Toradol Ponstel Mobic Relafen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole) Daypro Feldene Clinoril Tolectin, Tolectin DS, Tolectin 600

^*

This Medication Guide has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Indomethacin Indomethacin CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:65977-5042 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDOMETHACIN INDOMETHACIN 25 mg Inactive Ingredients Ingredient Name Strength lactose monohydrate SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO COLLOIDAL SILICON DIOXIDE MAGNESIUM STEARATE GELATIN titanium dioxide FD&C BLUE NO. 1 D&C YELLOW NO. 10 FERROSOFERRIC OXIDE Product Characteristics Color Size Imprint Code Shape GREEN 16 mm H;103 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65977-5042-0 30 in 1 BOTTLE 2 NDC:65977-5042-1 100 in 1 BOTTLE 3 NDC:65977-5042-2 500 in 1 BOTTLE 4 NDC:65977-5042-3 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091240 2011-04-12

Indomethacin Indomethacin CAPSULE Product Information Product Type Human prescription drug label Item Code (Source) NDC:65977-5043 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength INDOMETHACIN INDOMETHACIN 50 mg Inactive Ingredients Ingredient Name Strength lactose monohydrate SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO COLLOIDAL SILICON DIOXIDE MAGNESIUM STEARATE GELATIN titanium dioxide FD&C BLUE NO. 1 D&C YELLOW NO. 10 FERROSOFERRIC OXIDE Product Characteristics Color Size Imprint Code Shape GREEN 19 mm H;104 CAPSULE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65977-5043-0 30 in 1 BOTTLE 2 NDC:65977-5043-1 100 in 1 BOTTLE 3 NDC:65977-5043-2 500 in 1 BOTTLE 4 NDC:65977-5043-3 1000 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091240 2011-04-12