The package insert of the medicine Reutrexato

the package insert of the medicine Reutrexato.

what For?

rheumatoid Arthritis: methotrexate is indicated in cases of adult patients with rheumatoid arthritis, active, classical or definite (the criterion of the American College of Rheumatology – ACR) with therapeutic response is insufficient, or who do not tolerate first-line therapy, including full dose of nonsteroidal anti-inflammatory drugs (NSAID), and, typically, the use of at least one or more nonsteroidal anti-rheumatic that modify the disease. Aspirin, anti-inflammatory agents, non-steroidal and/or steroidal low dose can be maintained, although the possibility of increased toxicity with the use of concomitant NSAID, including salicylates, has not been fully explored (see Drug). Steroids may be reduced gradually in patients who respond to methotrexate. The combined use of methotrexate with gold, penicillamine, hydroxychloroquine, disodium salt, or agents, cytotoxic has not been studied and may increase the incidence of adverse effects. Rest and physical therapy when indicated should be continued.

Contraindications

When should I not use?

Pregnancy: methotrexate can cause fetal death or congenital anomalies.

REUTREXATO is contraindicated in dyscrasia blood, hypoplasia of the bone marrow, leukopenia, thrombocytopenia, anemia, significant liver disease including fibrosis, cirrhosis, hepatitis, active or recent infectious disease active and during the procedure of immunization, hypersensitivity to methotrexate in women who are breastfeeding, and in patients with laboratory evidence of syndrome(s) of immunodeficiency.

Dosage

How to use?

rheumatoid Arthritis: the patient should be fully informed about the risks involved and should be under constant medical supervision. The assessments of hematologic, liver, renal and pulmonary function should be made by history, physical examination and laboratory before beginning, periodically during, and before reinstitute therapy with methotrexate. Appropriate measures should be taken to prevent conception during therapy with methotrexate.

Both the physician and pharmacist should emphasize to the patient that the recommended dose is administered weekly in rheumatoid arthritis and that the daily use mistaken the recommended dose can lead to toxicity is fatal.

All schemes must be individually set for each patient. A dose initial test can be administered before the scheme regular dosing schedule to detect any greater sensitivity to adverse effects. Count complete blood with platelets should be evaluated 7 to 10 days after the beginning of treatment.

rheumatoid Arthritis: the recommended regimen starting dose:
1) a single oral dose of 7.5 mg once per week.

2) Dosage oral divided doses of 2.5 mg, every 12 hours, for three doses, administered as a cycle, one time per week.

The therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

The scores of each scheme should be increased to 15 mg/week after 6 weeks in patients who do not respond to treatment. If necessary, the dose can be adjusted gradually to achieve an excellent answer, but should not exceed, typically, a weekly dose of 20 mg.

once clinical response is achieved, each dosing schedule should be reduced to the lowest effective dose possible and with the greatest range possible. Although rare, some patients can be maintained in doses of 2.5 mg/week.

The duration of optimal therapy is unknown. The limited data available from long-term studies indicate that the clinical improvement the home is maintained for at least 2 years with maintenance therapy. When methotrexate is discontinued, the arthritis usually worsens within 3 to 6 weeks.

Warnings and Precautions

what should I know before using?

Precautions
Methotrexate has the potential for serious toxicity, usually at doses related. The physician should be familiar with the various features of the drug and its clinical use is established. Patients in therapy with methotrexate should be subject to appropriate supervision, so the signs and symptoms of possible toxic effects or adverse reactions must be detected and evaluated immediately. Pre-treatment, periodic tests and studies blood are essential for the use of REUTREXATO. The suppression of hematopoietic can occur abruptly, even with the safe dose apparent. Any profound decrease in the count of blood cells indicate immediate interruption of the drug, and adopted appropriate therapy.

In all circumstances in which the use of REUTREXATO is considered for therapy, the physician must evaluate the need and usefulness of the drug against the risks of toxic effects or adverse reactions. Most adverse reactions are reversible if detected early. In the event of such reactions, the dose should be reduced or the treatment to be stopped, and measures must be adopted appropriate correction, according to the opinion of the clinic of the doctor. If therapy with methotrexate is restarted, should be initiated with caution, considering the need for treatment, and with special attention to possible recurrence of toxicity.

The toxicity profile of methotrexate has been studied in the elderly. Due to the potential to decrease liver and renal function in this population, these patients should be monitored closely for early signs of toxicity.

When methotrexate is discontinued, the arthritis usually worsens within 3 to 6 weeks.

Both the physician and pharmacist should emphasize to the patient that the recommended dose is administered weekly in rheumatoid arthritis and that the daily use mistaken the recommended dose can lead to toxicity is fatal.

methotrexate is excreted primarily by the kidneys. The use of the drug in the presence of renal dysfunction can result in the accumulation of quantities of toxic or even occur a kidney injury additional. The table kidney of these patients should be determined before and during therapy with methotrexate and should be taken exercise proper caution when revealed loss of renal function. The dose of methotrexate should be reduced or therapy withheld until the renal function be improved or restored.

If you experience vomiting, diarrhea, stomatitis or decrease of levels of blood, which can result in dehydration, treatment with methotrexate should be discontinued until recovery.

methotrexate should be used with extreme caution in the presence of infection, peptic ulcer, ulcerative colitis, debility, in children and the elderly, and in the presence of third space is significant (for example, pleural effusion).

The treatment with REUTREXATO should be stopped if there is a significant drop in blood count. Patients with granulocytopenia, important and fever should be evaluated immediately and usually require parenteral therapy of broad-spectrum antibiotic. In the depression of bone marrow severe, it may be necessary transfusion of blood or platelets.

pulmonary Symptoms (especially dry cough) or pneumonitis, non-specific, occurring during the therapy with methotrexate, may be indicative of injury that is potentially dangerous and require interruption of treatment and careful investigation. Although clinically variable, the typical patient with pulmonary disease induced by methotrexate has fever, cough, dyspnea, hypoxemia and infiltration interstitial to X-rays of the chest, and should exclude the infectious process. This injury can occur in any of the doses.

Since it is reported that methotrexate may have an action immunosuppressive, this factor must be taken into consideration in the evaluation of the use of REUTREXATO when the immune response of the patient may be important or essential. Therefore, the immunization may be ineffective and immunization with virus vaccines is contra-indicated.

laboratory Tests: patients undergoing therapy with methotrexate should be monitored closely so that toxic effects are detected quickly. The evaluation before the start of therapy should include complete blood count, platelet count, liver enzymes, assessment of renal function and chest X-ray. In the therapy of rheumatoid arthritis, monitoring of these parameters is recommended, with tests hematological at least once per month and assessment of renal function and liver function every 1 or 3 months. During the initial dose or change of dose, or during periods of increased risk of levels blood levels of methotrexate (ex. dehydration), monitoring is more frequent is also indicated.

the Relationship between change in liver function tests and fibrosis or cirrhosis of the liver has not been established. Abnormalities transient testing assessment of liver function have been observed frequently after administration of methotrexate, and there is no need, usually, to modify the therapy.

Persistent abnormalities in these tests before the new dose and/or decrease of serum albumin may be indicators of serious liver toxicity and require evaluation. Liver function tests, including albumin serum, should be performed periodically prior to establishing dosing but are often normal in the face of developing fibrosis or cirrhosis. These injuries can only be detected by biopsy.

it has Not been established when to perform liver biopsy in patients with rheumatoid arthritis, both in terms of cumulative dose, and in terms of the duration of therapy. There is an experience described in 217 rheumatoid arthritis patients with liver biopsy before and during treatment (after a cumulative dose of at least 1500 mg) and with 714 patients with biopsy only during treatment. Were diagnosed in 64 (7%) cases of fibrosis and 1 (0.1%) in the case of cirrhosis. Of the 64 cases of fibrosis, 60 were light. The staining with reticulina is more sensitive in the initial phase of fibrosis and its use may increase these numbers. It is unknown the use of more extended that will increase these risks.

lung function Testing may be useful if there is suspicion of pulmonary disease induced by methotrexate, especially if the necessary conditions are available. Warnings Methotrexate should only be used by physicians who have knowledge and experience in therapy antimetabólica.

Due to the possibility of serious toxic reactions, the patient should be informed by the doctor about the risks involved and should be under constant medical supervision. There have been reported deaths with the use of methotrexate in the treatment of rheumatoid arthritis. In the treatment of rheumatoid arthritis, the use of methotrexate should be restricted to patients with severe disease, recalcitrant, or disabling, which do not respond adequately to other forms of therapy and only when the diagnosis is established and after appropriate consultation.

periodic Monitoring of toxicity, including tests of liver and kidney function, blood count complete with differential and platelet count, is a mandatory part of therapy with methotrexate. Liver biopsies periodic may be indicated in some situations. Patients with increased risk of impairment in the elimination of methotrexate (ex. renal dysfunction, pleural effusions or ascites) should be monitored more frequently (see Precautions).

The methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use. Elevations in acute liver enzymes are noted frequently; are usually transient and asymptomatic, and also do not seem to be scheduled for the liver disease subsequent. Liver biopsy, after continuous use, you can display histological alterations, and have been reported to fibrosis and cirrhosis; often these latter injuries are not preceded by symptoms or tests abnormal liver function.

The use of concomitant medications with potential hepatotóxico should be avoided.

therapy with methotrexate should not be initiated in patients who ingest alcohol to excess.

methotrexate is toxic to the hematopoietic system and may produce depression of the bone marrow, anemia, leukopenia, thrombocytopenia, and bleeding.

Suppression severe unexpected of the marrow (sometimes fatal) toxicity and gastrointestinal have been reported with concomitant administration of methotrexate (usually in high dose) along with some anti-inflammatory drugs non-steroidal (NSAID).

For men and women in the fertile age, steps should be taken appropriate measures to avoid conception during therapy with methotrexate. Methotrexate has been reported to cause fetal death and/or congenital anomalies. After the suspension of therapy with methotrexate, the risk of genetic abnormalities can still persist. Thus, both men and women should be advised to avoid sex that can lead to conception for a period not defined (at least 8 weeks) after treatment to ensure the restoration of normal production of germ cells.

Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise, enterites bleeding and death due to perforation of the intestine may occur.

The therapy with methotrexate in patients with renal function deficient should be undertaken with extreme caution and in reduced doses because the renal dysfunction may prolong the elimination of methotrexate.

The interruption of the therapy with methotrexate should be considered as a consequence of toxicity in the following situations: pulmonary Symptoms (especially dry cough), evidence of persistent liver function impaired, suppression of the hematopoietic system, stomatitis ulcerative, fibrosis of the liver significant, renal function impaired, acute watery diarrhoea, pregnancy.

Drug Interactions

The methotrexate binds partly to albumin in serum and the toxicity can be increased as a result of the displacement determined by certain drugs, such as salicylates, fenilbutazona, phenytoin, and sulfonamides.

The renal tubular transport is also diminished by probenecid, salicylates, and organic acids that are weak such as nonsteroidal anti-inflammatory drugs.

oral Antibiotics, such as tetracyclines, chloramphenicol and antibiotics of broad spectrum non-absorbable, may decrease intestinal absorption of methotrexate or interfere with the movement enteroepática by inhibition of the intestinal flora and suppressing metabolism of the drug by bacteria. Trimethoprim/sulfamethoxazole has been reported to increase the depression of the bone marrow in some patients receiving methotrexate. Therefore, care should be taken when nonsteroidal anti-inflammatory drugs, salicylates, and drugs mentioned above are administered concomitantly with methotrexate.

In patients with rheumatoid arthritis, controlled clinical trials have included the use of doses constant of nonsteroidal anti-inflammatory drugs no observed problems. Therefore, it is recommended that the dose of methotrexate is carefully controlled during treatment with nonsteroidal anti-inflammatory drugs.

Preparations vitamin containing folic acid or its derivatives may decrease response to methotrexate systemically administered.

Adverse Reactions Changes in Laboratory Tests
Adverse reactions the most common reported in studies in patients with rheumatoid arthritis involving the gastrointestinal system. Symptoms include nausea, stomatitis, gastrointestinal discomfort, diarrhea, vomiting, and anorexia. Changes in laboratory findings include elevation of liver enzymes and, occasionally, decreased white cell count. In general, the incidence and severity of side effects are considered as being related to the dose of methotrexate.

The incidence of adverse reactions in double-blind studies in patients with rheumatoid arthritis treated with oral dose low methotrexate (7.5 to 15 mg/week), are listed below. All patients were receiving nonsteroidal anti-inflammatory drugs concomitantly, and some also were taking low doses of corticosteroids.

Incidence greater than 10%: significant elevation of liver enzymes, and nausea.

Incidence of 3% to 10%: stomatitis, gastrointestinal discomfort, dermatitis, diarrhea, headache and vomiting. Incidence 1% to 3%: alopecia, anorexia, dizziness, and infection.

Incidence less than 1%: chest pain, epistaxis, itching, tinitus, ulcer, vaginal, leukopenia (< 3.000/mm3), decreased platelets (< 100,000 cells/mm3).

Other reactions, usually reported in higher dose, in anticancer chemotherapy are the following:
Skin: urticaria, photosensitivity, depigmentation, bruising, telangiectasia, acne, furunculosis. Lesions of psoriasis may be aggravated by exposure concomitant to the ultraviolet radiation.

Blood: anemia, hypogammaglobulinemia, hemorrhage in various sites, septicemia.

the food System:: pharyngitis, haematemesis, melaena, ulceration, gastrointestinal, and bleeding, enteritis, hepatic toxicity resulting in atrophy, acute liver necrosis, alteration of fat, fibrosis of the periportal, or cirrhosis of the liver.

urogenital System: renal failure, azotemia, cystitis, hematuria; oogênese or spermatogenesis deficient, oligoespermia transient, menstrual dysfunction, miscarriage and defects of the fetus, nephropathy severe.

System lung: deaths from interstitial pneumonitis have been reported, and interstitial lung disease, chronic obstructive has occurred occasionally.

the central nervous System: drowsiness, blurred vision. Aphasia, hemiparesis, paresis and convulsions have also occurred following administration of methotrexate. After low doses, rare patients have reported cognitive dysfunction, subtle, transient, mood change or feeling cranial not usual.

Other rare reactions have been related or attributed to the use of methotrexate, such as metabolic changes, diabetes, osteoporosis, loss of libido/impotence, and sudden death. Dermatitis radiation and sunburn can back by the use of methotrexate. Some cases of reaction type anaphylactic were reported.

Introduction

Reutrexato
Pharmaceutical form and presentations
Tablets of 2.5 mg. box with 24 tablets.

Laboratory

Apsen Farmacêutica S. A.

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