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Indomethacin (Indomethacin)

Trade Name : Indomethacin

Eon Labs, Inc.

CAPSULE, EXTENDED RELEASE

Strength 75 mg/1

INDOMETHACIN Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Indomethacin (Indomethacin) which is also known as Indomethacin and Manufactured by Eon Labs, Inc.. It is available in strength of 75 mg/1 per ml. Read more

Indomethacin (Indomethacin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
  • See full prescribing information for complete boxed warning.
  • 4n- 5.1
  • Indomethacin extended-release capsules are indicated for:
  • Indomethacin extended-release capsules are a nonsteroidal anti-inflammatory drug indicated for:
  • No data
  • Indomethacin Extended-Release Capsules, USP, 75 mg are supplied as green and clear capsules imprinted u201c720u201d.
  • Capsules: 75 mg ()
  • Indomethacin extended-release is contraindicated in the following patients:
  • No data
  • Hepatotoxicity
  • Hypertension
  • Heart Failure and Edema
  • Renal Toxicity
  • Anaphylactic Reactions
  • Exacerbation of Asthma Related to Aspirin Sensitivity
  • Serious Skin Reactions
  • Premature Closure of Fetal Ductus Arteriosus
  • Hematologic Toxicity
  • The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
  • In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving indomethacin immediate-release capsules than in the group taking indomethacin suppositories or placebo.
  • In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with indomethacin immediate-release capsules or suppositories was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.
  • The adverse reactions for indomethacin immediate-release capsules listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between indomethacin and these adverse reactions, some of which have been reported only rarely.
  • The adverse reactions reported with indomethacin immediate-release capsules may occur with use of the suppositories. In addition, rectal irritation and tenesmus have been reported in patients who have received the capsules.
  • Causal relationship unknown
  • Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians:
  • Cardiovascular
  • Thrombophlebitis
  • Hematologic
  • Although there have been several reports of leukemia, the supporting information is weak
  • Genitourinary
  • Urinary frequency A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group Au03b2 hemolytic streptococcus, has been described in persons treated with nonsteroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome.
  • Most common adverse reactions (incidence greater than or equal to 3%) are headache, dizziness, dyspepsia and nausea. ()
  • See for clinically significant drug interactions with indomethacin.
  • Table 2 Clinically Significant Drug Interactions with Indomethacin
  • Arrayn- Effects on Laboratory Tests
  • Indomethacin reduces basal plasma renin activity (PRA), as well as those elevations of PRA induced by furosemide administration, or salt or volume depletion. These facts should be considered when evaluating plasma renin activity in hypertensive patients.
  • False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.
  • Drugs that Interfere with Hemostasis (e.g. warfarin, aspirin, SSRIs/SNRIs)
  • ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers
  • ACE Inhibitors and ARBs
  • Diuretics
  • Digoxin
  • Pregnancy
  • Infertility
  • Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [].
  • Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 grams to 100 grams in adults, 1 gram to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdosage (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
  • For additional information about overdosage treatment contact a poison control center (1-800-222-1222).
  • Indomethacin extended-release capsules are nonsteroidal anti-inflammatory drugs. The chemical name is 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1-indole-3-acetic acid. The molecular weight is 357.8. Its molecular formula is C19H16ClNO4, and it has the following chemical structure.
  • Indomethacin is a white to yellow crystalline powder. It 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 extended-release capsule, for oral administration contains 75 mg of indomethacin.
  • In addition, each capsule contains the following inactive ingredients: D&C yellow No. 10 aluminum lake, FD&C blue No. 1 aluminum lake, ethylcellulose, lactose monohydrate, povidone, starch (corn), sucrose and talc.
  • The capsule shell contains the following ingredients: D&C Yellow #10, FD&C Green #3, gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide.
  • The edible imprinting ink contains the following ingredients: black iron oxide, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, propylene glycol, and shellac glaze.
  • No data
  • Carcinogenesis
  • In an 81-week chronic oral toxicity study in the rat at doses up to 1 mg/kg/day (0.05 times the MRHD on a mg/mbasis), indomethacin had no tumorigenic effect. Indomethacin produced no neoplastic or hyperplastic changes related to treatment in carcinogenic studies in the rat (dosing period 73 to 110 weeks) and the mouse (dosing period 62 to 88 weeks) at doses up to 1.5 mg/kg/day (0.04 times [mice] and 0.07 times [rats] the MRHD on a mg/mbasis, respectively).
  • Mutagenesis
  • Indomethacin did not have any mutagenic effect in bacterial tests and a series of tests including the host-mediated assay, sex-linked recessive lethals in Drosophila, and the micronucleus test in mice.
  • Impairment of Fertility
  • Indomethacin at dosage levels up to 0.5 mg/kg/day had no effect on fertility in mice in a two generation reproduction study (0.01 times the MRHD on a mg/mbasis) or a two litter reproduction study in rats (0.02 times the MRHD on a mg/mbasis).
  • Indomethacin has been shown to be an effective anti-inflammatory agent, appropriate for long-term use in rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis.
  • Indomethacin extended-release affords relief of symptoms; it does not alter the progressive course of the underlying disease.
  • Indomethacin extended-release suppresses inflammation in rheumatoid arthritis as demonstrated by relief of pain, and reduction of fever, swelling and tenderness. Improvement in patients treated with indomethacin for rheumatoid arthritis has been demonstrated by a reduction in joint swelling, average number of joints involved, and morning stiffness; by increased mobility as demonstrated by a decrease in walking time; and by improved functional capability as demonstrated by an increase in grip strength. Indomethacin extended-release may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. In such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effects.
  • Indomethacin Extended-Release Capsules, USP, for oral administration, are available as
  • Arrayn- 75 mg
  • Green and clear capsules, imprinted u201cE 720u201d and are supplied as
  • NDC 0185-0720-60 bottles of 60 (as unit of use)
  • NDC 0185-0720-01 bottles of 100
  • NDC 0185-0720-05 bottles of 500
  • NDC 0185-0720-10 bottles of 1000
  • Arrayn- Storage
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Protect from moisture.
  • KEEP TIGHTLY CLOSED.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide) that accompanies each prescription dispensed. Inform patients, families, or their caregivers of the following information before initiating therapy with indomethacin extended-release capsules and periodically during the course of ongoing therapy.
  • Cardiovascular Thrombotic Events
  • Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [].
  • Gastrointestinal Bleeding, Ulceration, and Perforation
  • Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [].
  • Hepatotoxicity
  • Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, diarrhea, jaundice, right upper quadrant tenderness, and u201cflu-likeu201d symptoms). If these occur, instruct patients to stop indomethacin extended-release capsules and seek immediate medical therapy [].
  • Heart Failure and Edema
  • Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [].
  • Anaphylactic Reactions
  • Inform patients of the signs of an anaphylactic reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients to seek immediate emergency help if these occur [and)].
  • Serious Skin Reactions
  • Advise patients to stop indomethacin extended-release capsules immediately if they develop any type of rash and to contact their healthcare provider as soon as possible [].
  • Female Fertility
  • Advise females of reproductive potential who desire pregnancy that NSAIDs, including indomethacin extended-release capsules, may be associated with a reversible delay in ovulation [].
  • Fetal Toxicity
  • Inform pregnant women to avoid use of indomethacin extended-release capsules and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus [].
  • Avoid Concomitant Use of NSAIDs
  • Inform patients that the concomitant use of indomethacin extended-release capsules with other NSAIDs or salicylates (e.g., diflunisal, salsalate) is not recommended due to the increased risk of gastrointestinal toxicity, and little or no increase in efficacy [see and]. Alert patients that NSAIDs may be present in u201cover-the-counteru201d medications for treatment of colds, fever, or insomnia.
  • Use of NSAIDs and Low-Dose Aspirin
  • Inform patients not to use low-dose aspirin concomitantly with indomethacin until they talk to their healthcare provider [].
  • Manufactured for
  • Sandoz Inc.
  • Princeton, NJ 08540
  • Manufactured by
  • Epic Pharma, LLC
  • Laurelton, NY 11413
  • OS8695
  • Rev. April 2019
  • MF0720REV04/19
  • Arrayn- for
  • Arrayn- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
  • What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
  • NSAIDs can cause serious side effects, including:
  • Do not take NSAIDs right before or after a heart surgery called a u201ccoronary artery bypass graft (CABG).u201d
  • Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
  • The risk of getting an ulcer or bleeding increases with:
  • NSAIDs should only be used:
  • What are NSAIDs?
  • NSAIDs 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 NSAIDs?
  • Do not take NSAIDs:
  • Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. n- Do not start taking any new medicine without talking to your healthcare provider first.
  • What are the possible side effects of NSAIDs?
  • NSAIDs can cause serious side effects, including:
  • See u201cWhat is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?u201d
  • Get emergency help right away if you get any of the following symptoms:
  • Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
  • If you take too much of your NSAID, call your healthcare provider or get medical help right away.
  • These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Other information about NSAIDs
  • General information about the safe and effective use of NSAIDs
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.
  • If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
  • For more information, go to or call 1-800-525-8747.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Manufactured for
  • Sandoz Inc.
  • Princeton, NJ 08540
  • Manufactured by
  • Epic Pharma, LLC
  • Laurelton, NY 11413
  • OS8695
  • Rev. July 2016
  • MF0720REV07/16
  • NDC
  • Indomethacin
  • Extended-Release
  • Capsules, USP
  • 75 mg
  • PHARMACIST:
  • Rx only
  • 60 Capsules
  • Sandoz

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