Neotrexate (Generic Methotrexate Tablets)

Neotrexate Tablets (Generic Methotrexate Tablets)
© The Swiss Pharmacy

Neotrexate Tablets (Generic Methotrexate Tablets) have been used
to produce regression in a wide range of neoplastic conditions
including acute leukaemias, non-Hodgkin's lymphoma, soft-tissue
and osteogenic sarcomas, and solid tumours particularly breast,
lung, head and neck, bladder, cervical, ovarian, and testicular
carcinoma.
The treatment of neoplastic disease. Methotrexate has also been
used in the treatment of severe cases of uncontrolled psoriasis,
unresponsive to conventional therapy.
It is also used in the treatment of adults with severe, active, classical
or definite rheumatoid arthritis who are unresponsive or intolerant
to conventional therapy.

Neotrexate Tablets are
manufactured by GlaxoSmithKline
Pharmaceuticals Limited, India in
the strength of 2.5 mg.

Chemical Structure

The active ingredient contained in Neotrexate
tablets is Methotrexate.
Each Neotrexate tablet contains 2.5 mg of
Methotrexate.

Uses of Neotrexate 2.5 mg Tablets:
Neotrexate (Generic Methotrexate Tablets) is a type of medicine called an
immunosuppressant. This means it lowers the body’s immune system. The
immune system is important in fighting infections, but sometimes immune
system cells attack the body’s own tissues and trigger long term inflammation.
Methotrexate reduces inflammation caused by your condition by dampening
down the activity of these cells in the immune system.
Methotrexate is used to treat a number of inflammatory conditions including
rheumatoid arthritis, psoriasis, eczema, inflammatory bowel diseases and
inflammatory diseases of the eye. It is not a painkiller, but as a result of
reducing the inflammation caused by your condition, you may notice a
reduction in pain.
At higher doses, it is used to treat some kinds of cancer.

Recommended Adult Dosage
The dose of Neotrexate (Generic Methotrexate Tablets) for various
indications is given below:
Choriocarcinoma And Similar Trophoblastic Diseases: Methotrexate is
administered orally in doses of 15 to 30 mg daily for a five-day course.
Such courses are usually repeated for 3 to 5 times as required, with rest
periods of one or more weeks interposed between courses, until any
manifesting toxic symptoms subside.
Leukemia: Acute lymphoblastic leukemia in pediatric patients and young
adolescents is the most responsive to present day chemotherapy.
Corticosteroid therapy, in combination with other antileukemic drugs or in
cyclic combinations with Methotrexate included, has appeared to produce
rapid and effective remissions.

When used for induction, Methotrexate in doses of 3.3 mg/m in combination with
60 mg/m of Prednisone, given daily, produced remissions in 50% of patients
treated, usually within a period of 4 to 6 weeks. Methotrexate in combination
with other agents appears to be the drug of choice for securing maintenance of
drug-induced remissions.
Lymphomas: In Burkitt’s tumor, Stages I-II, methotrexate has produced prolonged
remissions in some cases. Recommended dosage is 10 to 25 mg/day orally for 4 to
8 days. In Stage III, Methotrexate is commonly given concomitantly with other
anti-tumor agents. Treatment in all stages usually consists of several courses of
the drug interposed with 7 to 10 day rest periods. Lymphosarcomas in Stage III
may respond to combined drug therapy with methotrexate given in doses of 0.625
to 2.5 mg/kg daily.

Mycosis Fungoides (Cutaneous T Cell Lymphoma): Therapy with Methotrexate as a
single agent appears to produce clinical responses in up to 50% of patients
treated. Dosage in early stages is usually 5 to 50 mg once weekly. Dose reduction
or cessation is guided by patient response and hematologic monitoring.
Methotrexate has also been administered twice weekly in doses ranging from 15
to 37.5 mg in patients who have responded poorly to weekly therapy.
Adult Rheumatoid Arthritis: Recommended Starting Dosage Schedules
1. Single oral doses of 7.5 mg once weekly.
2. Divided oral dosages of 2.5 mg at 12 hour intervals for 3 doses given as a
course once weekly.
Polyarticular-Course Juvenile Rheumatoid Arthritis: The recommended starting
dose is 10 mg/m given once weekly.

For either adult RA or polyarticular-course JRA dosages may be adjusted
gradually to achieve an optimal response.
Psoriasis: Recommended Starting Dose Schedules
1. Weekly single oral dose schedule: 10 to 25 mg per week until adequate
response is achieved.
2. Divided oral dose schedule: 2.5 mg at 12-hour intervals for three
doses.
Dosages in each schedule may be gradually adjusted to achieve optimal
clinical response; 30 mg/week should not ordinarily be exceeded.

Contraindications
➔
Neotrexate tablets are contraindicated in patients with a known hypersensitivity
to Methotrexate or any component of the tablet.
➔
Methotrexate can cause fetal death or teratogenic effects when administered to a
pregnant woman. Methotrexate is contraindicated in pregnant women with
psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic
diseases only when the potential benefit outweighs the risk to the fetus. Women of
childbearing potential should not be started on methotrexate until pregnancy is
excluded and should be fully counseled on the serious risk to the fetus should they
become pregnant while undergoing treatment.
➔
Pregnancy should be avoided if either partner is receiving Methotrexate; during
and for a minimum of three months after therapy for male patients, and during
and for at least one ovulatory cycle after therapy for female patients.

Contraindications
➔
Because of the potential for serious adverse reactions from Methotrexate
in breast fed infants, it is contraindicated in nursing mothers.
➔
Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic
liver disease or other chronic liver disease should not receive Methotrexate.
➔
Patients with psoriasis or rheumatoid arthritis who have overt or
laboratory evidence of immunodeficiency syndromes should not receive
Methotrexate.
➔
Patients with psoriasis or rheumatoid arthritis who have preexisting blood
dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia
or significant anemia, should not receive Methotrexate.

Storage Instructions
Neotrexate Tablets (Generic Methotrexate
Tablets) have to be stored at controlled room
temperature i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15° to 30°C
(59° to 86°F).
Keep this as well as all other medicines away
from children and pets.

Warnings
Embryo-Fetal Toxicity: Based on published reports and its mechanism of action,
Methotrexate Tablets can cause fetal harm, including fetal death, when
administered to a pregnant woman. Methotrexate Tablets is contraindicated for
use in pregnant women receiving Methotrexate Tablets for the treatment of non-
malignant diseases. Advise pregnant women with neoplastic diseases of the
potential risk to a fetus.
Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, can
occur with methotrexate.If anaphylaxis or other serious hypersensitivity reaction
occurs, immediately and permanently discontinue Methotrexate Tablets.
Myelosuppression: Methotrexate suppresses hematopoiesis and can cause severe
and life-threatening pancytopenia, anemia, leukopenia, neutropenia, and
thrombocytopenia. Obtain blood counts at baseline, periodically during treatment,
and as clinically indicated.

Warnings
Gastrointestinal Toxicity: Diarrhea, vomiting, nausea, and stomatitis
occurred in up to 10% of patients receiving methotrexate for treatment of
non-neoplastic diseases. Hemorrhagic enteritis and fatal intestinal
perforation have been reported. Patients with peptic ulcer disease or
ulcerative colitis are at a greater risk of developing severe gastrointestinal
adverse reactions.
Hepatotoxicity: Methotrexate can cause severe and potentially irreversible
hepatotoxicity, including fibrosis, cirrhosis, and fatal liver failure. The
safety of Methotrexate Tablets in patients with hepatic disease is unknown.
Pulmonary Toxicity: Pulmonary toxicity, including acute or chronic
interstitial pneumonitis and irreversible or fatal cases, can occur with
Methotrexate.

Warnings
Dermatologic Reactions: Severe, including fatal dermatologic reactions,
such as toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative
dermatitis, skin necrosis, and erythema multiforme, can occur with
Methotrexate.
Renal Toxicity: Methotrexate can cause renal toxicity, including
irreversible acute renal failure. Monitor renal function at baseline,
periodically during treatment and as clinically indicated. Withhold or
discontinue Methotrexate Tablets for severe renal toxicity taking into
account the importance of Methotrexate Tablet treatment in the context of
the severity of the disease being treated, the severity of the adverse drug
reaction, and availability of alternative therapy.

Warnings
Risk of Serious Adverse Reactions with Medication Error: Deaths occurred
in patients as a result of medication errors. Most commonly, these errors
occurred in patients who were taking methotrexate daily when a weekly
dosing regimen was prescribed.
For patients prescribed a once weekly dosing regimen, instruct patients
and caregivers to take the recommended dosage as directed, because
medication errors have led to death.
Folic Acid Supplementation: Products containing folic acid or its
derivatives may decrease the clinical effectiveness of Methotrexate.
Therefore, instruct patients not to take products containing folic acid or
folinic acid unless directed to do so by their healthcare provider.

Warnings
Serious Infections: Patients treated with methotrexate are at increased risk for
developing life-threatening or fatal bacterial, fungal, or viral infections,
including opportunistic infections such as Pneumocystis jiroveci pneumonia,
invasive fungal infections, hepatitis B reactivation, tuberculosis primary infection
or reactivation, and disseminated Herpes zoster and cytomegalovirus infections
Neurotoxicity: Methotrexate can cause severe acute and chronic neurotoxicity,
which can be progressive, irreversible, and fatal. The risk of
leukoencephalopathy is increased in patients who received prior cranial
radiation.
Secondary Malignancies: Secondary malignancies can occur with Methotrexate.
The risk of cutaneous malignancies is further increased when cyclosporine is
administered to patients with psoriasis who received prior Methotrexate.

Warnings
Tumor Lysis Syndrome: Methotrexate can induce tumor lysis syndrome in
patients with rapidly growing tumors. Institute appropriate prophylactic
measures in patients at risk for tumor lysis syndrome prior to initiation of
Methotrexate tablets.
Immunization and Risks Associated with Live Vaccines: Disseminated
infections following administration of live vaccines have been reported.
Immunization with live vaccines is not recommended during treatment.
Follow current vaccination practice guidelines for administration of
immunizations in patients receiving Methotrexate Tablets.

Warnings
Infertility: Based on published reports, methotrexate can cause impairment
of fertility, oligospermia, and menstrual dysfunction. It is not known if the
infertility may be reversible. Discuss the risk of infertility with females and
males of reproductive potential.
Increased Risk of Adverse Reactions Due to Third-Space Accumulation:
Methotrexate accumulates in third-spaces (e.g., pleural effusions or
ascites), which results in prolonged elimination and increases the risk of
adverse reactions. Evacuate significant third-space accumulations prior to
Methotrexate tablets administration.

Possible Side Effects
Common Methotrexate (Neotrexate tablets) side effects observed during clinical
trials were ulcerative stomatitis, leukopenia, nausea, and abdominal distress.
Other clinically relevant adverse reactions were infection, malaise, fatigue, chills,
fever, and dizziness.
The most common side effects of Methotrexate that exceeded the rate of placebo
in 12- to 18-week double-blind studies in patients (n=128) with rheumatoid
arthritis are listed below:
Incidence 10% or higher: Elevated liver tests 15%, nausea/vomiting 10%
Incidence 3% to less than 10%: Stomatitis, thrombocytopenia (platelet count less
than 100,000/mm3)
Incidence 1% to less than 3%: Rash/pruritus/dermatitis, diarrhea, alopecia,
leukopenia (white blood cell count less than 3000/mm3), pancytopenia, dizziness

Neotrexate Overdosage
Symptoms of Methotrexate overdosage include adverse reactions
reported at pharmacologic doses, particularly hematologic and
gastrointestinal reactions (e.g., leukopenia, thrombocytopenia,
anemia, pancytopenia, myelosuppression, mucositis, stomatitis,
oral ulceration, nausea, vomiting, gastrointestinal ulceration, or
gastrointestinal bleeding).
In some cases, no symptoms were reported; however, sepsis or
septic shock, renal failure, and aplastic anemia were also
reported.

Treatment of Neotrexate Overdosage
Leucovorin and Levoleucovorin are indicated for diminishing the Methotrexate
adverse reactions of Methotrexate overdosage. Administer Leucovorin or
Levoleucovorin as soon as possible after methotrexate overdosage). Monitor
serum creatinine and methotrexate levels to guide Leucovorin or Levoleucovorin
therapy.
Glucarpidase is indicated for the treatment of toxic plasma Methotrexate
concentrations (greater than 1 micromole per liter) in patients with delayed
Methotrexate clearance due to impaired renal function.
Administer concomitant hydration and urinary alkalinization. Neither
hemodialysis nor peritoneal dialysis has been shown to improve Methotrexate
elimination; however, Methotrexate has been effectively cleared with acute,
intermittent hemodialysis using a high-flux dialyzer.

Neotrexate Tablets During Pregnancy
Methotrexate (Neotrexate tablets) has been classified by the US FDA as
Pregnancy Category X.
Based on published reports and its mechanism of action, Methotrexate can
cause embryo-fetal toxicity and fetal death when administered to a
pregnant woman.
Therefore, it is not recommended for women of childbearing potential
unless there is clear medical evidence that the benefits can be expected to
outweigh the considered risks. Pregnant women with psoriasis or
rheumatoid arthritis should not receive Methotrexate.
There are no animal data that meet current standards for nonclinical
developmental toxicity studies. Advise pregnant women with neoplastic
diseases of the potential risk to a fetus.

Neotrexate Tablets are manufactured by
GlaxoSmithKline Pharmaceuticals Limited, India.
For More details Click Here

Neotrexate (Generic Methotrexate Tablets)

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