Each 20 mg and 1 g vial of lyophilized powder contains methotrexate sodium equivalent to 20 mg and 1 g methotrexate respectively. Vitamin b12 is distributed into the liver, bone marrow, and other tissues, including the placenta. Leucovorin may limit methotrexate action on normal cells by competing with methotrexate for the same transport processes into the cell. Chemically methotrexate is n 4 2,4diamino6pteridinyl methylmethylaminobenzoyllglutamic acid. Methotrexate injection usp formulations which contain benzyl alcohol as preservative are contraindicated in neonates and for intrathecal, intraventricular, or highdose therapy see contraindications. The lower abdomen, thighs and upper arms are easiest for injection. Dailymed methotrexate methotrexate sodium injection. Guide for adult patients self administering methotrexate. Information on methotrexate methotrexate is a slow acting drug, which reduces disease activity. At birth, the blood concentration of vitamin b12 imneonates is 3 to 5 times that of the mother.
The preserved formulation contains benzyl alcohol and must not be used for intrathecal or high dose therapy. Methotrexate injection, usp 250 mg per 10 ml 25 mg per ml contains preservative. Other forms of methotrexate include oral tablets and solutions for injection. Home otrexup methotrexate injection, for subcutaneous use. Methotrexate is also indicated in the treatment of meningeal leukemia. Accidental ingestion safe handling practices include preparing, transporting, administering, andor disposing of material wastes. Methotrexate has caused birth defects and death in. If you have any further questions, ask your doctor or pharmacist. The clinical formulation is supplied in a sterile form for intravenous use only. Otrexup is a once weekly medication that 98% of ra patients studied agreed was easy to use. Methotrexate has caused birth defects and death in unborn babies. Methotrexate rasuvo, otrexup is a selfinjectable solution used to treat psoriasis and rheumatoid arthritis. Each tablet contains methotrexate sodium in an amount equivalent to the labeled amount of methotrexate, usp, and contains the following inactive ingredients. When a dose of 100 mgkg of body weight is given initially and followed by 50 mgkg every 6 hours, blood levels of free sulfadiazine are about 7 mg100ml.
Women must avoid becoming pregnant while using this medication. Serious infections leading to hospitalization or death including. Do not inject into skin that is tender, damaged, or has bruises or scars. For patients with inflammatory arthritis, methotrexate is supplied as 50 mg in a 2 ml vial 25 mg per 1 ml. If you have any further questions, ask your doctor or pharmacist or. Methotrexate injection side effects, medical uses, and. In the case of subcutaneous methotrexate autoinjector pens, many people have noted they are relatively painfree to use. Otrexup is a singledose autoinjector containing a prescription medicine, methotrexate. By the mid 1990s, studies indicated that methotrexate is also well absorbed when injected into the fatty layer just under the skin subcutaneous. Methotrexate injection, usp is sterile and nonpyrogenic and may be given. Cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Pregnant women who have psoriasis or rheumatoid arthritis must not use methotrexate.
Here are some important features of the vials of methotrexate. Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis pjia, after treatment with other medicines including nonsteroidal antiinflammatory nsaids have. Each 25 mgml, 2 ml vial contains methotrexate sodium equivalent to 50 mg methotrexate, 0. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. This type of injection is much easier to do than the one into the muscle and is less painful as the needle is much thinner. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides cutaneous t cell lymphoma, and lung cancer. It can be given by mouth or injection and is usually given once a week.
Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis. Otrexup contains methotrexate in a preservativefree sterile solution for a single subcutaneous injection. Also, autoinjector pens may be associated with reduced pain on injection. Otrexup is available in the following strengths and configurations. Methotrexate is a medicine that may be used to treat crohns disease, arthritis, psoriasis, and other skin conditions. Treat certain adults with severe, active rheumatoid arthritis, and children with active polyarticular juvenile idiopathic arthritis pjia, after treatment with other medicines including nonsteroidal antiinflammatory drugs nsaids. Each ml contains methotrexate sodium equivalent to 25 mg. Otrexup, rasuvo, and reditrex are only for once a week use and is not to be used daily. Aminophylline dihydrate is approximately 79% of anhydrous theophylline by weight. Highlights of prescribing information these highlights do. Sulfadiazine diffuses into the cerebrospinal fluid. Treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older see clinical studies 14.
Methotrexate tablets, usp contain an amount of methotrexate sodium equivalent. It is important to take methotrexate on the same day each week. Actemra subcutaneous formulation is not intended for. Shingrix is a vaccine indicated for prevention of herpes zoster shingles in adults aged 50 years and older. Cimzia is provided in a package that contains everything required to reconstitute and inject the drug see how suppliedstorage and handling 16. Risk of serious infections see full prescribing information for complete boxed warning. The vial can be used for more than one dose because it contains a preservative called benzyl alcohol to keep it clean sterile between uses. Methotrexate injection, usp isotonic liquid, contains preservative is available in 25 mgml, 2 ml 50 mg vials. Vials of vinblastine sulfate for injection usp contain 10 mg. Methotrexate mtx has been a valuable treatment for rheumatoid arthritis ra for more than 30 years, and it remains the anchor drug for ra therapy. Make sure the needle does not come into contact with anything on the way to the skin 4. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. The best areas are shown in the image light blue areas. Methotrexate sodium for injection, lyophilized, preservative free, for single use only, is available in 20 mg and 1 gram vials.
Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. It prevents the growth of the white blood cells that cause inflammation. If all or part of antares is sold or merged into another entity, the information we have about you may be transferred to a third party as part of that transaction. Each 10 mgml, 2 ml vial contains methotrexate sodium equivalent to 20 mg methotrexate, and the following inactive ingredients. Information for the user methotrexate 25 mgml injection read all of this leaflet carefully before you start using this medicine. It may take up to 3 months, during which time the dose may need to be adjusted, to have its full effect. Treatment of candidemia, acute disseminated candidiasis. The product catalog provides you with a full listing of tevas brand and generic product lines. Psoriasis patients previously treated with puva and to a lesser extent, methotrexate or other immunosuppressive agents, uvb, coal tar, or radiation therapy, are at an increased risk of developing.
Methotrexate sodium for injection products are sterile and nonpyrogenic and may be given by the intramuscular, intravenous, intraarterial or intrathecal route. Methotrexate methotrexate pfizer medical information. Leucovorin rescues bone marrow and gastrointestinal cells from methotrexate but has no apparent effect on preexisting methotrexate nephrotoxicity. Rasuvo methotrexate injection is a singledose autoinjector containing a prescription medicine, methotrexate. Methotrexate injection usp without preservative may be given by the intramuscular, intravenous as a bolus, intraarterial, intrathecal or intraventricular via ommaya reservoir into the cns routes. Methotrexate tablets, usp for oral administration are available in a packaging system designated as the rheumatrex methotrexate tablets, usp dose pack for therapy with a weekly dosing schedule of 5 mg, 7.
Aminophylline injection, usp is a sterile, nonpyrogenic solution of aminophylline in water for injection. Once the needle is in place, release your pinch on the. Otrexup, rasuvo, and reditrex are folate analog metabolic inhibitors indicated for. The inactive ingredient is sodium chloride 140 mgvial for the 350 mg vial. Learn about side effects, warnings, dosage, and more. Methotrexate injection fda prescribing information, side. Leucovorin calcium for injection leucovorin calcium for injection is indicated for intravenous or intramuscular administration and is supplied as a sterile lyophilized powder. You should not repeat injections into the same spot. If your child has juvenile idiopathic arthritis jia, he or she may already be using injectable mtx. Although mtx is generally safe, intolerability may be an important cause of treatment discontinuation and often includes gastrointestinal gi adverse events aes 46. Each vial contains either mitomycin 5 mg and mannitol 10 mg, or mitomycin 20 mg and mannitol 40 mg, or mitomycin 40 mg and mannitol 80 mg. Information for the user methotrexate 25 mgml solution for injection methotrexate read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Exposure to premixed, injectable methotrexate can occur by. Trexall methotrexate tablets usp, for oral administration, is available in 5 mg, 7. It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Methotrexate formerly amethopterin is an antimetabolite used in the treatment of certain neoplastic diseases, severe psoriasis, and adult rheumatoid arthritis. Trexall fda prescribing information, side effects and uses. Methotrexate formulations with preservatives must not be used for highdose treatment or injected into the spine intrathecal. Highlights of prescribing information these highlights do not include all the information needed to use humira safely and effectively. Neoral soft gelatin capsules cyclosporine capsules, usp. Methotrexate injection usp formulations which contain benzyl alcohol as preservative are contraindicated in neonates and for intrathecal. Methotrexate injection, usp, isotonic liquid, preservative free, for single use only, is available in 10 mgml, 2 ml 20 mg vials and 25 mgml, 20 ml 500 mg, 40 ml 1 g and 100 ml 2. Mitomycin for injection is a sterile dry mixture of mitomycin and mannitol, which, when reconstituted with sterile water for injection, provides a solution for intravenous administration.
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