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Antalgin 60mg 20 caps, Indomethacin

Antalgin 60mg 20 caps, Indomethacin
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Antalgin 60mg 20 caps, Indomethacin



Antalgin is indicated for active stages: Osteoarthritis (hands, fingers, coxarthrosis, gonarthrosis, and spine), rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis and gout.

In various processes accompanied by acute inflammation and pain: Dental, bursitis, tendinitis, synovitis, tenosynovitis, capsulitis, shoulder pain, back pain and lumbosciatic, premenstrual syndrome, dysmenorrhea.

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

Pharmacokinetics HUMAN Antalgin * 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 post-administration. The presence of a negligible food delays absorption, without altering its bioavailability.

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 achieved in two hours. The half life of indomethacin distribution is 2 to 8 hours. The plasma concentrations required to achieve the therapeutic effect are 1 mcg / ml.

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

It is extensively metabolized in the liver (microsomal enzymes) 3 resulting in inactive metabolites.

Is eliminated by the kidneys by 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. It removes milk and ½ of elimination is on average 4.5 hours.

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

The endometrium that emerges when menstruating, also triggers the formation of arachidonic acid and prostaglandin F2 alpha causes smooth muscle contraction and uterine vessels and sensitizes the receptors, thus making this the pain.

If this substance is released into the circulation in large amounts, the overall effects are associated with dysmenorrhea such as diarrhea, nausea, flushing and fainting.

Hypersensitivity to indomethacin. History of asthma, urticaria, or allergic rhinitis acetylsalicylic acid or other NSAIDs. Pregnancy and lactation. Children under 12 years. Association triamterene or indomethacin with diflunisal. Perioperative coronary by-pass.

It should not be administered to patients with active peptic ulcer or a history of recurrent gastrointestinal ulceration.

Use with other NSAIDs may mask symptoms and signs of peptic ulcer. It should not be administered to patients with active peptic ulcer or a history of recurrent gastrointestinal ulceration.

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

With increasing age seems to increase the chance of side effects. Antalgin should be used with great care in the elderly.

There are no safe conditions for the use of Antalgin * children under 12 years. Children treated with Antalgin * should be carefully monitored and they should do a periodic liver function tests at appropriate intervals. There have been cases of fatal hepatotoxicity.

It should warn 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, or parkinsonism, since in some cases may aggravate these conditions. Caution in patients on therapy with lithium to manage Antalgin * (see Interactions and other gender).

As Antalgin * is eliminated primarily by the kidneys, it should carefully monitor patients with significant impairment of renal function and use them as a lower daily dosage, to avoid excessive accumulation of the drug.

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

ADVERSE REACTIONS: They are related to the dose used, the higher, the more likely they occur, varying in degree and intensity. The side effects that occur most often are:

Gastrointestinal: The most commonly observed are: nausea, anorexia, vomiting, epigastric discomfort, abdominal pain, constipation or diarrhea.

During treatment with indomethacin were observed single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach, duodenum, small intestine or large intestine.

There have been reports of gastrointestinal bleeding without significant ulceration and perforation of preexisting sigmoid lesions (diverticulum, carcinoma, etc.).

CNS: headache may occur, sometimes accompanied by dizziness or lightheadedness, usually at the beginning of treatment, although the intensity of these effects rarely necessary to stop treatment if the headache persists despite reduced dosage should discontinuation of indomethacin.

Very rarely (less than 1%) can aggravate epilepsy or parkinsonism states.

Allergic: Pruritus, erythema nodosum, Quincke, possible asthma attack especially in patients who are 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 being a COX-1 inhibitor does not alter the endogenous production of thromboxane A2 and therefore is not expected to present high inhibodores prothrombotic risk as selective COX-2.

Ocular: In some patients receiving prolonged corneal deposits were observed and a case of ocular retinopathy although similar changes in rheumatoid arthritis patients who had not received indomethacin.

If such changes occur, you should stop taking Antalgin *. Blurred vision may be an early symptom and requires a thorough eye exam. As these changes may be asymptomatic, it is convenient to make periodic eye examinations 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.

Infections: As other anti / non-steroidal analgesics, indomethacin may mask usual signs and symptoms of infection.

The physician should keep in mind the possibility to not unduly delay proper treatment of an infection. Indomethacin should be used with caution in patients with controlled infections.

Like other NSAIDs, Antalgin * can inhibit platelet aggregation. This effect is of shorter duration than that seen with aspirin and usually stops within a period of 24 hours after discontinuation of administration. The normalization of platelet aggregation is associated with dose: 10 to 12.5 hours to 37.5 mg and 18.75 to 32.75 hours with 150 mg.

It has been observed in the prolongation of bleeding time (although within normal limits) in healthy subjects. As this effect may be greater in patients with impaired blood clotting (enf. Von Willebrand disease, hemophilia, thrombocytopenia) Antalgin * should be used with caution in these patients.

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

In patients with reduced renal blood flow, in which renal prostaglandins have an important role to maintain renal perfusion, administration of a nonsteroidal antiinflammatory analgesic agent may precipitate overt renal decompensation.

Patients at greatest risk of this disorder are: diabetes, renal dysfunction carriers 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.

There have been increases 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).


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 healthy subjects. However, you should carefully monitor any changes in prothrombin time.

Aminoglycoside antibiotics: Increased plasma concentrations.

Receptor blockers, beta-adrenergic inhibitors and angiotensin converting enzyme: cases have been reported reduced antihypertensive effect of these drugs to coadministrarlos NSAID.

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

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

Indomethacin reduces the basal activity of the renin as well as increasing the activity induced by the administration of furosemide or salt or loss of plasma volume. They should consider these facts in evaluating the plasma renin activity.

Both MALIVAL * AP, as potassium-sparing diuretics may lead to increases in serum potassium.

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

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

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

Probenecid: Probenecid may increase plasma concentrations of indomethacin, and may require lower daily dosage Antalgin *.

CHANGES IN RESULTS OF LABORATORY TESTS: As with other anti-inflammatory analgesics, Antalgin *, bordering increases can cause one or more liver function tests.

It has been reported in less than 1% of patients, significant increases (to three times the upper limit of normal) of glutamic-pyruvic transaminase (ALT) or glutamic-oxaloacetic transaminase (AST) of serum.

If a patient presents with symptoms and / or signs suggesting liver dysfunction or had abnormal values ​​in a test of liver function during treatment with Antalgin * should investigate whether liver is producing more intense reaction.<

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