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Indomethacin 25mg 30 Caps

INDICATIONS:

It is indicated for active stages: Osteoarthritis (hands, fingers, osteoarthritis, knee osteoarthritis, and spinal cord), rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis and gout.

For acute inflammation and pain accompanied by: Dental, bursitis, tendinitis, synovitis, tenosynovitis, capsulitis, shoulder pain, back pain and sciatica, premenstrual syndrome, dysmenorrhea.

In Orthopaedics: Helping in the postoperative orthopedic pain and inflammation after reduction and immobilization of fractures and dislocations.

Human Pharmacokinetics: It is a potent inhibitor of prostaglandin synthesis that provides anti-inflammatory and analgesic efficacy.

Indomethacin is well absorbed by the digestive tract and its bioavailability is nearly 100%. About 90% of the drug is absorbed within the first 4 hours without altering the presence of food. Analgesic response in gouty arthritis begins between 2 and 4 hours post administration of indomethacin, but the best response observed in about 4 days.

After a single oral dose of 25, 50 or 75 mg, the maximum plasma concentration was 1.54, 2.65 and 4.92 mcg / ml, respectively, and was reached in two hours. Distribution half life of indomethacin is 2 to 8 hours. Plasma concentrations required to achieve a therapeutic effect are 1 mcg / ml.

Binds to plasma proteins in 99%. Spread good for all body fluids and passes slowly in the synovial fluid and 5 hours after administration on this site concentrations are equal to the plasma to later be increased in synovial fluid and decrease in plasma and is found in low concentration in breast milk, brain tissue, saliva and placenta. It crosses the blood-brain and placental barriers.

Is extensively metabolized in the liver (microsomal enzymes) by O-demethylation and N-deacetylation resulting three inactive metabolites.

Is eliminated by the kidneys in 60%, almost 26% as unchanged drug and the remainder as metabolites. Via the gut is removed approximately 33% (1.5% in unchanged form) and presents a significant enterohepatic circulation. Breast milk is removed and elimination t ½ is on average 4.5 hours.

Pharmacodynamics inhibiir cyclooxygenase indomethacin, blocked the arachidonic acid cascade thus reducing the formation of prostaglandins, known for his extensive involvement in the inflammatory process.

Also, the endometrium that emerges when menstruating triggers the formation of arachidonic acid and prostaglandin F2 alpha which causes smooth muscle contraction and uterine vessels, and sensitized allogeneic recipients thereby increasing pain is present.

To get rid of this material is released into the circulation in large quantities, the overall effects are associated with dysmenorrhea such as diarrhea, nausea, flushing, and lightheadedness.

Hypersensitivity to indomethacin.

History of asthma, urticaria, rhinitis or allergy to aspirin or other NSAIDs.

Pregnancy and lactation.

Indomethacin association diflunisal. Perioperative coronary bypass.

WARNINGS: Although rare, Indomethacin may raise the possibility of triggering cardiovascular thrombotic events, heart attacks, strokes and increase with time of use, or in patients with a history and presence of cardiovascular risk factors.

Must be used with greater care in elderly patients, as increased age appears to increase the likelihood of side effects.

Like other NSAIDs, indomethacin may irritate the gastrointestinal tissue, you should not administer to patients with active peptic ulcer or a history of recurrent gastrointestinal ulcer.

There are no security of employment of children under 12 years. Children treated with indomethacin should be carefully monitored and they should do periodic studies of liver function at appropriate intervals. There have been reports of fatal hepatotoxicity. Advise patients that if they experience drowsiness should not drive a motor vehicle or perform hazardous activities requiring alertness.

Indomethacin should be used with caution in patients with psychiatric disorders, epilepsy and Parkinson's, as in some cases may aggravate these conditions. Caution in patients on lithium therapy by administering indomethacin (see Interactions and other gender).

RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION: Not recommended for Stratasin * during pregnancy or breastfeeding, because indomethacin was found in the placenta and in breast milk. Indomethacin may promote fetal ductus arteriosus closure.

ADVERSE REACTIONS: They are related to the dose used.

The side effects that occur most frequently are:

Gastrointestinal: Nausea, anorexia, vomiting, epigastric distress, abdominal pain, constipation or diarrhea.

During indomethacin treatment were observed single or multiple ulcerations, including perforation and bleeding (esophagus, stomach, duodenum, small intestine or large intestine).

There are reports of gastrointestinal hemorrhage without appreciable ulceration and perforation of the sigmoid preexisting lesions (diverticulum, carcinoma, etc.).

CNS: headache may occur, sometimes accompanied by dizziness or lightheadedness, at the beginning of treatment and rarely require cessation of therapy.

Allergic: Pruritus, erythema nodosum, angioedema, asthma attack possibility especially in patients allergic to aspirin or other NSAIDs.

Cardiovascular: Patients have fluid retention and peripheral edema. Therefore, as with other NSAIDs should be used with caution in patients with cardiac dysfunction, hypertension or other conditions that favor retention.

Indomethacin be a COX-1 inhibitor does not alter the endogenous production of thromboxane A2, so there is expected to present the prothrombotic risk of COX-2 selective inhibitors.

Eye: In some patients receiving prolonged corneal deposits have been observed and one case of retinopathy, although there have been similar ocular changes in rheumatoid arthritis patients who had not received indomethacin.

Given these changes, stop taking Stratasin *. Blurred vision may be an early symptom and requires a thorough eye exam.

As these changes may be asymptomatic, there should be regular eye exams to patients under prolonged treatment.

Hematologic: The incidence of adverse events in this area is very sporadic and are leukopenia, petechiae, purpura, thrombocytopenia, hemolytic anemia.

Like other NSAIDs, Stratasin * can inhibit platelet aggregation. This effect is of shorter duration than that observed with aspirin and stops about 24 hours post-administration suspension. Normalization of platelet aggregation is associated with dose: 10 mg 37.5 12.5 hours and 18.75 to 32.75 hours with 150 mg.

Platelet inhibition occurs mainly in patients with coagulation defects (Von Willebrand disease, hemophilia, thrombocytopenia) blood, Indomethacin should be used with caution in these patients.

Renal: As with other nonsteroidal anti-inflammatory analgesics, there is a risk sporadic prolonged treatment should an acute interstitial nephritis with hematuria, proteinuria, and occasionally nephrotic syndrome.

In patients with decreased renal blood flow where renal prostaglandins have a role in maintaining renal perfusion, administration of a nonsteroidal anti-inflammatory analgesic agent may precipitate overt renal decompensation.

Patients at greatest risk of this condition include: diabetic, carrying a renal dysfunction and / or liver disease, advanced age, congestive heart failure, sepsis or treatment associated with nephrotoxic drugs. When stopping treatment with indomethacin usually recovers the state before indomethacin treatment.

Increases were observed in serum potassium and even hyperkalemia, even in some patients with normal renal function. In these cases, this effect has been attributed to a hyporeninemic hypoaldosteronism state (see Interactions and other gender).

DRUG INTERACTIONS AND OTHER GENDER:

Aspirin: The combination increases the frequency of GI adverse events without improving the therapeutic effect.

Anticoagulants: Indomethacin does not modify the hypoprothrombinemia produced by anticoagulants in patients and in healthy subjects. Yet monitor possible changes in prothrombin time.

Antimicrobial aminoglycosides: Increased plasma concentrations.

Blocking beta-adrenergic receptors and inhibitors of angiotensin converting enzyme: There have been reports of decreased antihypertensive effect of these drugs to coadministrarlos with NSAIDs.

Diflunisal: Concurrent use of indomethacin has been associated with fatal gastrointestinal hemorrhage, 30-35% while increasing renal concentration of indomethacin and its conjugate.

Diuretics: NSAIDs may reduce the diuretic, natriuretic and antihypertensive effects of loop diuretics, potassium-sparing or thiazide.

Indomethacin reduces basal activity of plasma renin and increased the activity induced by furosemide administration, or salt or loss of plasma volume.

It should consider these facts in evaluating the plasma renin activity.

Both Stratasin * as potassium-sparing diuretics may lead to increases in serum potassium.

Lithium: Indomethacin causes significant increase in the plasma concentration of lithium and decreased renal clearance of lithium, which leads to lithium intoxication.

Is advisable to determine the plasma concentration of lithium initiation of concomitant therapy.

Methotrexate: Indomethacin decreases tubular secretion and enhances the toxicity of methotrexate.

Probenecid When indomethacin is administered to patients receiving probenecid. Probenecid may increase plasma concentrations of indomethacin and may require a lower daily dose of indomethacin

CHANGES IN RESULTS OF LABORATORY TESTS have been reported in less than 1% of patients significant increases (three times the upper limit of normal) of glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) serum.

If abnormalities of liver function tests persist or if signs and symptoms of hepatic or systemic manifestations (eg, eosinophilia, rash, etc.). Stopping treatment with indomethacin.

PRECAUTIONS IN RELATION TO EFFECTS Carcinogenesis, Mutagenesis, Impairment of Fertility: Indomethacin no such effects in long-term studies, conducted on animals and there are no reports of them in humans.

DOSAGE AND ADMINISTRATION: Oral.

Indomethacin administration is recommended during or immediately after food or an antacid.

With Indomethacin do not need high initial dose "attack".

In chronic rheumatic, you get maximum benefit and reduce adverse reactions initiating therapy with low doses and gradually they need to be increased. In general, it is recommended not to exceed the maximum of 200 mg daily.

By giving the symptoms, reduce the dosage to the minimum necessary to control them, or has given, discontinue the drug.

Usually starting dose is 50-75 mg daily in divided doses. In rheumatic processes with persistent night pain and / or morning stiffness, can be useful to give a dose of 100 mg at bedtime to provide relief.

Generally in rheumatic and in acute gouty arthritis, soft tissue injury (bursitis, tendinitis), etc., the recommended dosage is 150 to 200 mg daily in divided doses up to yield all symptoms and signs.

Juvenile rheumatoid arthritis: If this is essential for use in children Stratasin * administered at a dosage of 2 mg / kg / day or 150 mg / day (whichever is less), distributed in two or three doses per day and increasing it as necessary, at one week intervals, up to 4 mg / kg / day or 200 mg / day (whichever is less).

In dysmenorrhea or premenstrual syndrome is recommended the administration of 75 mg / day in divided dose.

Women frequently suffer from these disorders and has regular cycles, you can start therapy two days before symptoms present.

Decreasing the dose of indomethacin in patients with significantly impaired renal function and 25% in the elderly. No dose adjustment is required in the dialysis patient.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION have been administered doses above 175 mg to 1,500 mg children and adults which have been tolerated with minor symptoms. The symptoms are uncharacteristic.

May be present nausea, vomiting, gastritis, gastrointestinal ulceration with perforation and bleeding.

If overdose is recent, we recommend the administration of activated charcoal (especially if it is less than an hour), gastric lavage and maintain vital signs, symptomatic measures.

In patients with GI symptoms may be given high doses of antacids, H2 receptor inhibitors. We recommend keeping close watch for signs of ulceration and / or gastric bleeding.

PRESENTATION: Box of 30 and 40 capsules of 25 mg.

RECOMMENDED STORAGE: Store at room temperature not more than 30 ° C and dry.
Drug Name: Indomethacin
Comparable patent medicine: Indocid
Active substance: Indomethacin
Presentation: Capsules
Concentration: 25 mg
Laboratory and Research Representations medical
Box with 30 pills
Made In: Mexico