Brand Name: Trexall
Common Dosage Forms:
Tablets: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg
Injection: 25 mg/mL base (as sodium salt)
Treatment of gestational choriocarcinoma, chorioadenoma, chorioadenoma destruens, and hydatidiform mole: 15-30 mg daily, either orally or intramuscularly, for a five-day course. Such courses are repeated for 3-5 times as required, with rest periods of 1 or more weeks interposed between courses.
Treatment of advanced stage non-Hodgkin's lymphomas: 10-25 mg/day orally for 4-8 days. Several courses are usually given with 7–10-day rest periods between each course.
Treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous T-cell lymphomas), non-metastatic osteosarcoma, and lung cancer: Methotrexate can be used alone or in combination with other anticancer agents. Treatments are variable and depend on multiple factors, including the stage of the disease and whether a combination treatment is being used.
Treatment and prophylaxis of meningeal leukemia: Doses are based on age and must be given intrathecally using preservative-free forms of the drug. Doses are given at intervals of 2-5 days. For children <1 year, give 6 mg. For children 1 year old, give 8 mg. For children 2 years old, give 10 mg. For children 3 years and older, give 12 mg.
Symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy:
Weekly Schedule: 10-25 mg per week until adequate response is achieved.
Divided Oral Dose Schedule: 2.5 mg at 12-hour intervals for three doses.
For the management of severe, acute rheumatoid arthritis in adults: 7.5 mg weekly as one dose or in three 2.5 mg doses given at 12-hour intervals. Maximum weekly dose is 20 mg.
For the management of active polyarticular-course juvenile rheumatoid arthritis in children who have had an insufficient therapeutic response to first-line therapy: Start with 10 mg/m^2 given once weekly with a maximum weekly dose of 30 mg/m^2. Doses over 20 mg/m^2 should be given either intramuscularly or subcutaneously.
Monitor: CBC, SCr, LFT, chest radiograph
Methotrexate inhibits dihydrofolic acid reductase, an enzyme which reduces dihydrofolate tetrahydrofolate. Tetrahydrofolate are important in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues are more sensitive to this effect. Its mechanism of action in the treatment of rheumatoid arthritis is unknown. Doses in the therapeutic range are well absorbed orally with peak plasma levels reached in 1-2 hours. Food delays absorption and reduces peak concentrations. Its terminal half-life is 3-10 hours for lower doses and 15 hours for higher doses. Excretion occurs via renal glomerular filtration and active tubular secretion.
NSAIDs may increase methotrexate serum levels and should not be used during high-dose therapy. Phenytoin and sulfonamides may displace protein-bound methotrexate. May increase the plasma levels of mercaptopurine. Oral antibiotics may decrease absorption of oral methotrexate. Penicillin may reduce the renal clearance of methotrexate. May decrease the clearance of theophylline.
BECAUSE OF THE POSSIBILITY OF SERIOUS TOXICITY REACTIONS (WHICH CAN BE FATAL), METHOTREXATE SHOULD ONLY BE USED IN LIFE-THREATENING NEOPLASTIC DISEASES, OR IN PATIENTS WITH PSORIASIS OR RHEUMATOID ARTHRITIS WITH SEVERE, RECALCITRANT, DISABLING DISEASES WHICH IS NOT ADEQUATELY RESPONSIVE TO OTHER FORMS OF THERAPY. Use is contraindicated in pregnant women except in neoplastic cases where the potential benefit to the patient outweighs the risk to the fetus. Pregnancy should be avoided if either partner is receiving methotrexate and for three months after discontinuing the drug for male patients and for one ovulatory cycle for female patients. Do not use in nursing mothers. Do not use in psoriasis or rheumatoid arthritis patients with alcoholism, alcoholic liver disease, other chronic liver diseases, immunodeficiency syndromes, or preexisting blood dyscrasias. Patients undergoing methotrexate therapy should be closely monitored on a monthly basis including a baseline assessment of complete blood count, hepatic enzymes, renal function tests, and a chest X-ray. For chronic use indications (psoriasis, arthritis), a liver biopsy should be performed pretreatment, at 4-8 weeks, and when cumulative dose reaches 1.5 gram. Use with caution during infections and in immunocompromised patients. Pregnancy Category X.
The most frequent adverse effects are ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequent adverse effects are malaise, fatigue, chills and fever, dizziness, sun sensitivity, and decreased resistance to infection. Potentially serious effects include rash, nephrotoxicity, hepatotoxicity, cough, and anemia.
Preferably taken on an empty stomach.
It is important to keep well-hydrated while taking this medication.
Avoid alcohol and salicylates while taking this medication.
Avoid prolonged exposure to natural or artificial sunlight.
It is important to follow appropriate contraceptive measures during therapy and for 3 months (males) and one ovulatory cycle (females) after completing therapy.
If a dose is missed, and you are on a weekly dosing schedule, take the dose as soon as possible and restart your weekly schedule from that date.
If a dose is missed and you are on a daily schedule, contact your physician.
It is important to have periodic blood work completed during therapy.
Contact your physician if any of the frequent adverse effects (listed above) are persistent or troublesome.
Contact your physician if you experience any of the following: diarrhea, vomiting, abdominal pain, black stools, jaundice, unexplained muscle pain, any type of infection, sore throat, cough, dyspnea, hypoxemia, or any type of unknown skin reaction.
1. There is strong evidence that
omega-3 fatty acids have a
beneficial effect in bipolar
2. Omega-3 fatty acid
supplementation is associated with
reduced mania and depression in
juvenile bipolar disorder .
3. Clinical studies have reported
that oral fish oil supplementation
has beneficial effects in
rheumatoid arthritis and among
some asthmatics .
4. Fish oil improves tubular
dysfunction, lipid profiles and
oxidative stress in patients with
IgA nephropathy .
5. Dietary supplementation with
flaxseed oil lowers blood pressure
in dyslipidaemic patients.
6. Omega 3 fatty acids improve
the cardiovascular risk profile of
subjects with metabolic syndrome,
including markers of inflammation
7. Omega-3 in modest doses
reduces cardiac deaths, and in high
doses reduces nonfatal
8. Dietary supplementation with
omega-3 fatty acids reduces the
incidence of sudden cardiac death
in patients with myocardial
9. Omega-3 fatty acid reduce the
total mortality and sudden death in
patients with left ventricular systolic
10. Raising blood levels of
omega-3 fatty acid levels may be 8
times effective than distributing
automated external defibrillators
(AEDs), and 2 times more effective
than implanting implanting
cardioverter defibrillators (ICDs) in
preventing sudden death.
11. Omega-3 fatty acid
supplementation reduces total
mortality and sudden death in
patients who have already had a
12. Consuming small quantities of
fish is associated with a reduction
in coronary heart disease.
13. Omega-3 fatty acids and
vitamin D supplementation results
in a substantial reduction in
coronary calcium scores and
slowed plaque growth .
14. Omega-3 fatty acids prevent
atrial fibrillation after coronary
artery bypass surgery.
15. Omega-3 fatty acid
supplementation has a therapeutic
effect in children with ADHD.
16. A combination of omega-3 and
omega-6 fatty acids as well as
magnesium and zinc consumption
provide a beneficial effect
on attentional, behavioural, and
emotional problems of children and
17. Fish oil supplementation has a
significant therapeutic effect on
children with autism.
18. Omega-3 fatty acids appear to
be an effective treatment for
children with autism.
19. The consumption of omega-3
fatty acid supplements decreases
homocysteine levels in diabetic
20. Omega-3 fatty acids improve
macro- and microvascular function
in subjects with type 2 diabetes
21. In patients with stable
coronary artery disease, an
independent and inverse
association exists between n-3
fatty acid levels and inflammatory
22. Omega-3 fatty acids improve
endothelial function in peripheral
23. Fish oil has a beneficial effect
on blood viscosity in peripheral
24. Fish oil supplementation
improves walking distance in
peripheral arterial disease.
25. The omega-3 fatty acid
docosapentaenoic acid (DPA)
reduces the risk of peripheral
arterial diseaseassociated with
26. An 8-month treatment with
omega-3 fatty acids (EPA and DHA)
has a positive effects, such as
decreasing inflammation, in
patients with cystic fibrosis.
27. Omega-3 fatty acids may have
a protective effect against mucus
over-production caused by
pulmonary bacterial colonization in
28. Omega-3 fatty acid
erythrocyte sedimentation rate, and
interleukin-8 concentrations in
cystic fibrosis patients.
29. DHA increases resistance to
Pseudomonas aeruginosa infection.
30. EPA supplementation has
therapeutic value in the treatment
of chronic hepatitis C patients.
31. EPA and DHA have therapeutic
value in the treatment of systemic
32. Omega-3 fish oil reduces the
severity of symptoms in patients
with systemic lupus
33. Fish and long-chain omega-3
fatty acid intake reduce the risk of
coronary heart disease and total
mortality in diabetic women.
34. Higher plasma concentrations
of EPA and DPA are associated with
a lower risk of nonfatal myocardial
infarction among women.
35. Omega-3 fatty acid
consumption is inversely associated
with incidence of hypertension.
36. Fish oil, but not flaxseed oil,
decreases inflammation and
prevents pressure overload-
induced cardiac dysfunction.
37. The consumption of fish
reduces the risk of ischemic stroke
in elderly individuals.
38. A moderate intake of EPA and
DHA may postpone cognitive
decline in elderly men.
39. Omega-3 fatty acids may have
a therapeutic effect on postpartum
40. Omega-3 fatty acids may have
therapeutic value in the treatment
of dry eye syndrome.
41. Omega-3 fatty acid
therapeutic value in the treatment
of children with attention-deficit/
hyperactivity disorder (ADHD)
42. Fish consumption reduces the
risk of ischemic stroke in men.
43. Omega-3 Fatty acids
supplementation prevents and
reverses insulin resistance.
44. Omega-3 fatty acids prevent
the formation of urinary calcium
oxalate stone formation.
45. Omega-3 fatty acids are
beneficial for children with
46. Omega 3 fatty acid
supplementation may contribute to
the prevention of early preterm
birth in both low-risk and high-risk
47. Fish consumption is associated
with a 63% reduction in prostate
48. Omega 3 fatty acids decrease
the severity of autoimmune
49. Eicosapentaenoic acid (EPA)
may have a therapeutic role in
50. Omega-3 fatty acids resulted
in an improvement in weight
bearing in dogs with osteoarthritis.
51. Primary open-angle glaucoma
patients have reduced blood levels
of DHA and EPA.
52. Omega-3 fatty acids
alleviate insulin resistance and
fatty liver in obese mice.
53. Intake of eicosapentaenoic and
docosahexaenoic acids from fish
may be associated with a reduced
prevalence of allergic rhinitis.
54. Cod liver oil (omega-3 Fatty
Acids) reduces the need for NSAIDs
in patients with rheumatoid
55. Omega-3 Fatty Acids has
significant therapeutic benefits
and drug sparing activity in the
treatment of rheumatoid arthritis.
56. Diets containing EPA and DHA
have an inhibitory effect on breast
cancer growth and metastasis.
57. Dietary Omega-3 fatty acids
may protect smokers against
chronic obstructive pulmonary
disease (COPD) .
58. Omega-3 fatty acids were
shown to be more effective than
placebo for depression in both
adults and children in small
controlled studies and in an open
study of bipolar depression.
59. The omega-3 fatty acid EPA is
as effective as fluoxetine (Prozac)
in treating major depressive
60. A diet low in trans-unsaturated
fat and rich in omega-3 fatty acids
and olive oil may reduce the risk of
age-related macular degeneration.
61. Higher intake of omega 3 fatty
acids may reduce the risk of