INDOMETHACIN- indomethacin capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

INDOMETHACIN (UNII: XXE1CET956) (INDOMETHACIN - UNII:XXE1CET956)

Disponível em:

Proficient Rx LP

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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). Indomethacin has been found effective in active stages of the following: Indomethacin is contraindicated in patients with known hypersensitivity to indomethacin or the excipients (see DESCRIPTION). Indomethacin should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic/anaphylactoid reactions to NSAIDs have been reported in such patients (see WARNINGS - Anaphylactic/Anaphylactoid Reactions, and PRECAUTIONS - Preexisting Asthma). Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Resumo do produto:

Indomethacin capsules are supplied containing 25 mg of indomethacin, USP. The 25mg capsule is a hard-shell gelatin capsule with an opaque pink cap and an opaque white body debossed with “HP/10” on both the body and cap. They are supplied in bottles of 20 as follows: NDC 63187-290-20 bottle of 20 NDC 63187-290-30 bottle of 30 NDC 63187-290-60 bottle of 60 NDC 63187-290-90 bottle of 90 Store at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature]. Protect from light. Rx Only 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 for: Heritage Pharmaceuticals, Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Made in India Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 DRUGS/PY/05 13 1523 ______________________________________________________________________________ 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: 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)? NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? 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: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription Celecoxib Celebrex Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol) Diflunisal Dolobid Etodolac Lodine, Lodine XL Fenoprofen Nalfon, Nalfon 200 Flurbiprofen Ansaid Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone) Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethegan Ketoprofen Oruvail Ketorolac Toradol Mefenamic Acid Ponstel Meloxicam Mobic Nabumetone Relafen Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (copackaged with lansoprazole) Oxaprozin Daypro Piroxicam Feldene Sulindac Clinoril Tolmetin Tolectin, Tolectin DS, Tolectin 600 Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Heritage Pharmaceuticals, Inc. Eatontown, NJ 07724 1.866.901.DRUG (3784) Made in India Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 DRUGS/PY/05 13 1523

Status de autorização:

New Drug Application

Características técnicas

INDOMETHACIN- INDOMETHACIN CAPSULE
PROFICIENT RX LP
----------
INDOMETHACIN CAPSULES, USP01/14- REV 05
RX ONLY
BOXED WARNINGS
DESCRIPTION
Indomethacin Capsules, USP for oral administration contain either 25
mg or 50 mg of indomethacin and
the following inactive ingredients: D & C Red #28, FD&C Blue #1, FD&C
Red #3, gelatin, lactose
monohydrate, magnesium stearate, povidone, pregelatinized starch,
silicon dioxide, sodium lauryl
sulfate, starch and titanium dioxide. Indomethacin is a non-steroidal
anti-inflammatory indole derivative
designated chemically as
1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indole-3-acetic acid.
Indomethacin 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. The structural formula is:
C19H16CLNO4 M.W. 357.79
C19H16ClNO4 M.W. 357.79
C19H16ClNO4 M.W. 357.79
CLINICAL PHARMACOLOGY
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits antipyretic and analgesic
properties. Its mode of action, like that of other anti-inflammatory
drugs, is not known. However, its
CARDIOVASCULAR RISK
• NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of
use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be
at a greater risk. (See WARNINGS .)
• Indomethacin is contraindicated for the treatment of
peri-operative pain in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS ).
GASTROINTESTINAL RISK
• NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
bleeding, ulceration, and perforation of the stomach or intestines,
which can be fatal. These
events can occur at any time during use and without warning symptoms.
Elderly patients are
at greater risk for serious gastrointestinal events. (See WARNINGS .)
therapeutic action is not due to pituitary-adrenal stimulation.