In pregnant women with non-malignant diseases, methotrexate is contraindicated. Advise females of reproductive potential to use effective contraception during therapy and for 6 months after the final dose.
Advise males of reproductive potential to use effective contraception during and for at least 3 months after the final methotrexate dose [see Contraindications 4 , Use in Specific Populations 8.
Immunization with live virus vaccines is not recommended. There have been reports of disseminated vaccinia infections after smallpox immunization in patients receiving methotrexate therapy. Most adverse reactions are reversible if detected early. When such reactions do occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken.
If Otrexup therapy is reinstituted, it should be carried out with caution, with adequate consideration of further need for the drug and increased alertness as to possible recurrence of toxicity.
The clinical pharmacology of methotrexate has not been well studied in older individuals. Due to diminished hepatic and renal function as well as decreased folate stores in this population, relatively low doses should be considered, and these patients should be closely monitored for early signs of toxicity [see Use in Specific Populations].
Gastrointestinal Diarrhea and ulcerative stomatitis require interruption of therapy: If vomiting , diarrhea, or stomatitis occur, which may result in dehydration, Otrexup should be discontinued until recovery occurs. Otrexup should be used with extreme caution in the presence of peptic ulcer disease or ulcerative colitis. In patients with preexisting hematopoietic impairment, Otrexup should be used with caution, if at all. Otrexup should be stopped immediately if there is a significant drop in blood counts.
Patients with profound granulocytopenia and fever should be evaluated immediately and usually require parenteral broad-spectrum antibiotic therapy. Hepatic Otrexup has the potential for acute elevated transaminases and chronic fibrosis and cirrhosis hepatotoxicity.
Chronic toxicity is potentially fatal; it generally has occurred after prolonged use generally two years or more and after a total dose of at least 1. In studies in psoriatic patients, hepatotoxicity appeared to be a function of total cumulative dose and appeared to be enhanced by alcoholism , obesity , diabetes and advanced age.
An accurate incidence rate has not been determined; the rate of progression and reversibility of lesions is not known. Special caution is indicated in the presence of preexisting liver damage or impaired hepatic function. In psoriasis, liver function tests, including serum albumin , should be performed periodically prior to dosing but are often normal in the face of developing fibrosis or cirrhosis.
These lesions may be detectable only by biopsy. The usual recommendation is to obtain a liver biopsy at 1 pretherapy or shortly after initiation of therapy 2 to 4 months , 2 a total cumulative dose of 1. Moderate fibrosis or any cirrhosis normally leads to discontinuation of the drug; mild fibrosis normally suggests a repeat biopsy in 6 months.
Milder histologic findings such as fatty change and low grade portal inflammation, are relatively common pretherapy. Although these mild changes are usually not a reason to avoid or discontinue Otrexup therapy, the drug should be used with caution. In rheumatoid arthritis, age at first use of methotrexate and duration of therapy have been reported as risk factors for hepatotoxicity; other risk factors, similar to those observed in psoriasis, may be present in rheumatoid arthritis but have not been confirmed to date.
Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in this population. There is a combined reported experience in rheumatoid arthritis patients with liver biopsies both before and during treatment after a cumulative dose of at least 1. Of the 64 cases of fibrosis, 60 were deemed mild. The reticulin stain is more sensitive for early fibrosis and its use may increase these figures.
It is unknown whether even longer use will increase these risks. Liver function tests should be performed at baseline at 4 to 8 week intervals in patients receiving Otrexup for rheumatoid arthritis. Pretreatment liver biopsy should be performed for patients with a history of excessive alcohol consumption, persistently abnormal baseline liver function test values or chronic hepatitis B or C infection. During therapy, liver biopsy should be performed if there are persistent liver function test abnormalities or there is a decrease in serum albumin below the normal range in the setting of well controlled rheumatoid arthritis.
If the results of a liver biopsy show mild changes Roenigk, grades I, II, IIIa , Otrexup may be continued and the patient monitored as per recommendations listed above. Otrexup should be discontinued in any patient who displays persistently abnormal liver function tests and refuses liver biopsy or in any patient whose liver biopsy shows moderate to severe changes Roenigk grade IIIb or IV. Infection Or Immunologic States Otrexup should be used with extreme caution in the presence of active infection, and is contraindicated in patients with overt or laboratory evidence of immunodeficiency syndromes.
Immunization may be ineffective when given during Otrexup therapy. Immunization with live virus vaccines is generally not recommended. There have been reports of disseminated vaccinia infections after smallpox immunizations in patients receiving methotrexate therapy. Hypogammaglobulinemia has been reported rarely. Potentially fatal opportunistic infections, especially Pneumocystis jiroveci pneumonia, may occur with Otrexup therapy.
When a patient presents with pulmonary symptoms, the possibility of Pneumocystis jiroveci pneumonia should be considered. Neurologic There have been reports of leukoencephalopathy following intravenous administration of methotrexate to patients who have had craniospinal irradiation. Chronic leukoencephalopathy has also been reported in patients who received repeated doses of high-dose methotrexate with leucovorin rescue even without cranial irradiation.
Discontinuation of methotrexate does not always result in complete recovery. A transient acute neurologic syndrome has been observed in patients treated with high dose regimens. Manifestations of this stroke -like encephalopathy may include confusion , hemiparesis , transient blindness, seizures and coma. The exact cause is unknown. After the intrathecal use of methotrexate, the central nervous system toxicity which may occur can be classified as follows: This condition can be progressive and even fatal.
Pulmonary Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion , which may occur acutely at any time during therapy and has been reported at low doses. Male fertility Methotrexate may be genotoxic. This means that the medicine may cause genetic mutation. Methotrexate can affect sperm production with the potential to cause birth defects. Therefore, you must avoid fathering a child whilst taking methotrexate and for at least 6 months after treatment is stopped.
Since treatment with methotrexate may lead to infertility, it might be advisable for male patients to look into the possibility of sperm preservation before starting treatment. Tiredness and dizziness can occur during treatment. If affected, you should not drive or operate machinery. Important information about some of the ingredients of Methotrexate This medicinal product contains less than 1 mmol sodium 23 mg per pre-filled syringe, i.
Always use Methotrexate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.
Methotrexate is administered once a week only. Together with your doctor you should decide on a suitable fixed weekday each week on which you receive your injection. Incorrect intake of Methotrexate can lead to severe, including potentially lethal, side effects.
Dosage in patients with rheumatoid arthritis The recommended starting dose for methotrexate is 7. In case of inadequate action and if tolerated well, Methotrexate doses may be gradually increased by 2. The mean weekly dose is mg. Generally, a weekly dose of 25 mg Methotrexate should not be exceeded.
Upon achieving the desired therapeutic results, the dose should be reduced gradually to the lowest possible effective maintenance dose. However, regular check-ups should be done more often. Use in children below 3 years of age is not recommended due to the insufficient experience in this age group. There was however an increase in skin sensitivity. It reduces the reabsorption of electrolytes from the renal tubules. Serotonin shown as small spheres, D is produced in vesicles A within the nerve cell presynaptic neuron, terminal end shown, G.
If you happen to be interested feel free to shoot me an email. I regularly fry shiitakes and then add some soy R 7 also may be substituted or unsubstituted alkyl e. A more common cause of goiter in America is an increase in thyroid stimulating hormone TSH in response to a defect in normal hormone synthesis within the thyroid gland.
Because of the risk of severe or even fatal toxic reactions, the patient should be fully informed of the risks involved including early signs and symptoms of toxicity and the recommended safety measures.
They are to be informed about the necessity to immediately consult the physician if symptoms of intoxication occur as well as about the subsequent necessary monitoring of symptoms of intoxication including regular laboratory tests. Methotrexate has been reported to cause impairment of fertility, oligospermia, menstrual dysfunction, and amenorrhoea in humans, during and for a short period after cessation of therapy.
In addition, methotrexate causes embryotoxicity, abortion and foetal defects in humans. Therefore, the possible risks of effects on reproduction should be discussed with patients of childbearing potential see section 4.
Men treated with methotrexate are recommended not to father a child during treatment and at least 6 months thereafter. Since treatment with methotrexate can lead to severe and possibly irreversible disorders in spermatogenesis, men should seek advice about the possibility of sperm preservation before starting therapy.
Skin and mucosal contacts with methotrexate are to be avoided. In the case of contamination, the parts concerned should be rinsed with plenty of water. Recommended examinations and safety measures: Before beginning methotrexate therapy or re-instituting methotrexate therapy after a rest period: Complete blood count with differential blood count and platelets, liver enzymes, bilirubin, serum albumin, chest x-ray and renal function tests.
If clinically indicated, tuberculosis and hepatitis should be excluded. During therapy in the first two weeks weekly, then every two weeks for the next month; afterwards, depending on leukocyte count and stability of the patient at least once a month during the first six months and every three months thereafter: An increased monitoring frequency should be considered also when the dose is increased.
Particularly elderly patients should be examined for early signs of toxicity in short intervals. Examination of the mouth and throat for mucosal changes. Complete blood count with differential blood count and platelets.
Haemopoietic suppression caused by methotrexate may occur abruptly and with apparently safe dosages. Any profound drop in white cell or platelet counts indicate immediate withdrawal of the medicinal product and appropriate supportive therapy. Patients must be instructed to report all signs and symptoms suggestive of infection. Patients simultaneously taking haematotoxic medicinal products e.
During longer-term therapy with methotrexate bone marrow biopsies are to be performed. Particular attention should be given to the appearance of liver toxicity. Treatment should not be instituted or should be discontinued if any abnormality of liver function tests, or liver biopsy, is present or develops during therapy. Such abnormalities should return to normal within two weeks after which treatment may be recommenced at the discretion of the physician.
There is no evidence to support use of a liver biopsy to monitor hepatic toxicity in rheumatological indications. For psoriasis patients the need of a liver biopsy prior to and during therapy is controversial. Further research is needed to establish whether serial liver chemistry tests or propeptide of type III collagen can detect hepatotoxicity sufficiently. The evaluation should be performed case by case and differentiate between patients with no risk factors and patients with risk factors such as excessive prior alcohol consumption, persistent elevation of liver enzymes, history of liver disease, family history of inheritable liver disease, diabetes mellitus, obesity, and history of significant exposure to hepatotoxic drugs or chemicals, and prolonged methotrexate treatment or cumulative doses of 1.
Monitoring of liver enzymes in serum: In the case of a constant increase in liver enzymes, a reduction of the dose or discontinuation of therapy should be taken into consideration. Due to its potentially toxic effect on the liver, additional hepatotoxic medicinal products should not be taken during treatment with methotrexate unless clearly necessary, and the consumption of alcohol should be avoided or minimised see section 4.
Closer monitoring of liver enzymes should be exercised in patients taking other hepatotoxic medicinal products concomitantly e.
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