TRETINOIN capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Tersedia dari:

American Health Packaging

INN (Nama Internasional):

TRETINOIN

Komposisi:

TRETINOIN 10 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Tretinoin capsules are indicated for the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant), characterized by the presence of the t(15;17) translocation and/or the presence of the PML/RARα gene who are refractory to, or who have relapsed from, anthracycline chemotherapy, or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are for the induction of remission only. The optimal consolidation or maintenance regimens have not been defined, but all patients should receive an accepted form of remission consolidation and/or maintenance therapy for APL after completion of induction therapy with tretinoin capsules. Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. Tretinoin capsules should not be given to patients who are sensitive to parabens, which are used as preservatives in the gelatin caps

Ringkasan produk:

Tretinoin Capsules are supplied as 10 mg capsules, two-tone (lengthwise) with reddish-brown opaque and yellow gelatin shell, imprinted with “TR” with black ink on the yellow side. Unit dose packages of 30 (3 x 10) NDC 68084-075-21 Store at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Protect from light. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

TRETINOIN- TRETINOIN CAPSULE
AMERICAN HEALTH PACKAGING
----------
TRETINOIN CAPSULES
8207521/0320
RX ONLY
WARNINGS
1. EXPERIENCED PHYSICIAN AND INSTITUTION
Patients with acute promyelocytic leukemia (APL) are at high risk in
general and
can have severe adverse reactions to tretinoin capsules. Tretinoin
capsules
should therefore be administered only to patients with APL under the
strict
supervision of a physician who is experienced in the management of
patients
with acute leukemia and in a facility with laboratory and supportive
services
sufficient to monitor drug tolerance and protect and maintain a
patient
compromised by drug toxicity, including respiratory compromise. Use of
tretinoin capsules requires that the physician concludes that the
possible benefit
to the patient outweighs the following known adverse effects of the
therapy.
2. RETINOIC ACID-APL SYNDROME
About 25% of patients with APL treated with tretinoin capsules have
experienced a syndrome called the retinoic acid-APL (RA-APL) syndrome
characterized by fever, dyspnea, acute respiratory distress, weight
gain,
radiographic pulmonary infiltrates, pleural and pericardial effusions,
edema, and
hepatic, renal, and multi-organ failure. This syndrome has
occasionally been
accompanied by impaired myocardial contractility and episodic
hypotension. It
has been observed with or without concomitant leukocytosis.
Endotracheal
intubation and mechanical ventilation have been required in some cases
due to
progressive hypoxemia, and several patients have expired with
multi-organ
failure. The syndrome generally occurs during the first month of
treatment, with
some cases reported following the first dose of tretinoin capsules.
The management of the syndrome has not been defined rigorously, but
high-
dose steroids given at the first suspicion of the RA-APL syndrome
appear to
reduce morbidity and mortality. At the first signs suggestive of the
syndrome
(unexplained fever, dyspnea and/or weight gain, abnormal chest
auscultatory
findings or radiographic abnormalities), high