METHOREX 2.5 Tablets 2.5 mg

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Methotrexate Disodium

Available from:

Cadila Healthcare Limited, INDIA

ATC code:

Antimetabolites

INN (International Name):

Methotrexate Disodium

Dosage:

2.5 mg

Pharmaceutical form:

Tablets

Manufactured by:

CADILA HEALTHCARE LIMITED, INDIA

Product summary:

Physical description: Yellow, round, uncoated tablets, with debossing ''L2'' on one side and scoring on the other side. The tablet should be free from all physical defects; Local technical representative: Abacus Pharma Africa Limited (8473)

Authorization status:

Registered/Compliant

Authorization date:

2021-03-29

Summary of Product characteristics

Summary Product Characteristics (SPC)
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SUMMARY OF PRODUCT CHARACTERISTIC (SPC)
1.
NAME OF THE MEDICINAL PRODUCT
1.
NAME OF THE MEDICINAL PRODUCT
METHOREX 2.5 Methotrexate Tablets USP 2.5mg
2.
STRENGTH
2.5mg per Tablet
1.3 PHARMACEUTICAL FORM
Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
METHOREX 2.5
METHOTREXATE TABLETS USP 2.5MG
Each uncoated tablet contains:
Methotrexate sodium
equivalent to Methotrexate 2.5 mg the
product contains Lactose.
For full list excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablets.
Yellow, round, uncoated tablets, with debossing “L2” on one side
and scoring on other
side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS NEOPLASTIC
DISEASES
Summary Product Characteristics (SPC)
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2
Methotrexate tablets, USP are indicated in the treatment of
gestational
choriocarcinoma, chorioadenoma destruens and hydatidiform mole.
Methotrexate tablets, USP are used in maintenance therapy in
combination with other
chemotherapeutic agents. Methotrexate tablets, USP are 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, particularly squamous cell and small cell types.
Methotrexate tablets, USP
are also used in combination with other chemotherapeutic agents in the
treatment of
advanced stage non-Hodgkin’s lymphomas.
PSORIASIS
Methotrexate is indicated in the symptomatic control of severe,
recalcitrant, disabling
psoriasis that is not adequately responsive to other forms of therapy,
but only when the
diagnosis has been established, as by biopsy and/or after dermatologic
consultation. It
is important to ensure that a psoriasis “flare” is not due to an
undiagnosed concomitant
disease affecting immune responses.
RHEUMATOID ARTHRITIS INCLUDING POLYARTICULAR-COURSE JUVENILE
RHEUMATOID
ARTHRITIS
Methotrexate is indicated in the management of selected adults with
severe, active,
rheumatoid arthritis (ACR criteria),