TEMODAL

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

TEMOZOLOMIDE

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

TEMOZOLOMIDE

Dosis:

100 MG

Bentuk farmasi:

KAPSUL

Unit dalam paket:

DUS, 5 SACHET @ 1 KAPSUL

Diproduksi oleh:

ORION CORPORATION - Finland

Tanggal Otorisasi:

2021-08-18

Karakteristik produk

TEMODAL

Capsules
Temozolomide
COMPOSITION
Each TEMODAL

capsule contains 20 mg or 100 mg temozolomide.
DESCRIPTION
Temozolomide is an imidazotetrazine alkylating agent with antitumor
activity. It
undergoes rapid chemical conversion in the systemic circulation at
physiologic pH to
the active compound, MTIC (monomethyl triazeno imidazole carboxamide).
The
cytotoxicity of MTIC is thought to be due primarily to alkylation at
the O
6
position of
guanine with additional alkylation also occuring at the N
7
position. Cytotoxic lesions
that develop subsequently are thought to involve aberrant repair of
the methyl adduct.
From Preclinical safety data Temozolomide known as embryotoxic,
teratogenic and
genotoxic alkylating agent.
Preclinical safety data
Single-cycle (5-day dosing, 23 days non-treatment), three- and
six-cycle toxicity
studies were conducted in rats and dogs. The primary targets of
toxicity included the
bone marrow, lymphoreticular system, testes, the gastrointestinal
tract and, at higher
doses, which were lethal to 60 % to 100 % of rats and dogs tested,
degeneration of
the retina occurred. Most of the toxicity showed evidence of
reversibility, except for
adverse events on the male reproductive system and retinal
degeneration. However,
because the doses implicated in retinal degeneration were in the
lethal dose range,
and no comparable effect has been observed in clinical studies, this
finding was not
considered to have clinical relevance.
Temozolomide
is
an
embryotoxic,
teratogenic
and
genotoxic
alkylating
agent.
Temozolomide is more toxic to the rat and dog than to humans, and the
clinical dose
approximates the minimum lethal dose in rats and dogs. Dose-related
reductions in
leucocytes and platelets appear to be sensitive indicators of
toxicity. A variety of
neoplasms, including mammary carcinomas, keratocanthoma of the skin
and basal cell
adenoma were observed in the six-cycle rat study while no tumors or
pre-neoplastic
changes were evident in dog studies. Rats appears to be particularly
sensitive to