TRETINOIN capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Catalent U.K. Packaging Limited

INN (Jina la Kimataifa):

TRETINOIN

Tungo:

TRETINOIN 10 mg

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

APPROVED DRUG PRODUCT MANUFACTURED UNDER CONTRACT

Tabia za bidhaa

TRETINOIN- TRETINOIN CAPSULE
CATALENT U.K. PACKAGING LIMITED
----------
TRETINOIN CAPSULES
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-dose
stero