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Prescription Medications

Indomethacin (Page 6 of 6)

Adult Use

Dosage Recommendations for Active Stages of the Following:

  1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
    Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
    In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
    If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
    If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
    Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
    As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
  2. Acute painful shoulder (bursitis and/or tendinitis).
    Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
  3. Acute gouty arthritis.
    Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.

HOW SUPPLIED

Indomethacin capsules USP are available containing either 25 mg or 50 mg of indomethacin, USP.

The 50 mg capsule is a size ‘1’ two piece opaque green hard gelatin capsules imprinted with ‘G302’ on body and ‘G’ on cap filled with white to off-white granular powder. They are available as follows:

Bottles of 15 capsules NDC 35356-697-15

Bottles of 21 capsules NDC 35356-697-21

Bottles of 30 capsules NDC 35356-697-30

Bottles of 50 capsules NDC 35356-697-50

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

Protect from light.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

PHARMACIST: Dispense a Medication Guide with each prescription.

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115www.glenmarkgenerics.com

May 2010

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. This chance increases:

  • with longer use of NSAID medicines.
  • in people who have heart disease.

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:

  • can happen without warning symptoms
  • may cause death

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

  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

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

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.

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

Serious side effects include:

  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • 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

Other side effects include:

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

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

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

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

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Glenmark Generics Inc., USA at 1 (888)721-7115.

Image of Label

Image of Label
(click image for full-size original)

INDOMETHACIN indomethacin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-697(NDC:68462-302)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
INDOMETHACIN (INDOMETHACIN) INDOMETHACIN 50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
ALCOHOL
ISOPROPYL ALCOHOL
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
GELATIN
D&C YELLOW NO. 10
HYPROMELLOSES
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code G302;G
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:35356-697-15 15 CAPSULE in 1 BOTTLE None
2 NDC:35356-697-21 21 CAPSULE in 1 BOTTLE None
3 NDC:35356-697-30 30 CAPSULE in 1 BOTTLE None
4 NDC:35356-697-50 50 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091276 12/22/2010
Labeler — Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 831276758 repack

Revised: 07/2012 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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