Indomethacin (Page 4 of 5)

OVERDOSAGE

The following symptoms may be observed following overdosage: nausea, vomiting, intense headache, dizziness, mental confusion, disorientation, or lethargy. There have been reports of paresthesias, numbness and convulsions.

Treatment is symptomatic and supportive. The stomach should be emptied as quickly as possible if the ingestion is recent. If vomiting has not occurred spontaneously, the patient should be induced to vomit with syrup of ipecac. If the patient is unable to vomit, gastric lavage should be performed. Once the stomach has been emptied, 25 g or 50 g of activated charcoal may be given. Depending on the condition of the patient, close medical observation and nursing care may be required. The patient should be followed for several days because gastrointestinal ulceration and hemorrhage have been reported as adverse reactions of indomethacin. Use of antacids may be helpful.

DOSAGE & ADMINISTRATION

Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.

Indomethacin is available as 25 mg and 50 mg capsules.

Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.

Pediatric Use

Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).

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.

HOW SUPPLIED

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

The 25 mg capsules are size ‘3’ hard gelatin capsules, with opaque light green cap imprinted with ‘H’ and opaque light green body imprinted with ‘103’, containing white to off-white powder.

Bottles of 30 capsules NDC 65977-5042-0

Bottles of 100 capsules NDC 65977-5042-1

Bottles of 500 capsules NDC 65977-5042-2

Bottles of 1000 capsules NDC 65977-5042-3

The 50 mg capsules are size ‘1’ hard gelatin capsules, with opaque light green cap imprinted with ‘H’ and opaque light green body imprinted with ‘104’, containing white to off-white powder.

Bottles of 30 capsules NDC 65977-5043-0

Bottles of 100 capsules NDC 65977-5043-1

Bottles of 500 capsules NDC 65977-5043-2

Bottles of 1000 capsules NDC 65977-5043-3

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.

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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. 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: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:

• 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.

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

• Aspirin is an NSAID medicine but it does not increase the chance of a heart attack.

Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also

cause ulcers in the stomach and intestines.

• Some of these NSAID medicines are sold in lower doses without a prescription (over-

the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs

for more than 10 days.

NSAID medicines that need a prescription

Generic Name Trade name
CelecoxibDiclofenacDiflunisal EtodolacFenoprofen FlurbiprofenIbuprofenIndomethacinKetoprofen Ketorolac MefenamicAcidMeloxicam NabumetoneNaproxen OxaprozinPiroxicamSulindacTolmetin CelebrexCataflam, Voltaren, Arthrotec (combined with misoprostol) DolobidLodine, Lodine XLNalfon, Nalfon 200AnsaidMotrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)Indocin, Indocin SR, Indo-Lemmon, IndomethaganOruvailToradolPonstelMobicRelafenNaprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole)DayproFeldeneClinorilTolectin, Tolectin DS, Tolectin 600

* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAIDS label warns that long term continuous use may increase the risk of heart attack or stroke.

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

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