ACITRETIN capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

ACITRETIN (UNII: LCH760E9T7) (ACITRETIN - UNII:LCH760E9T7)

可用日期:

Teva Pharmaceuticals USA, Inc.

INN（国际名称）:

ACITRETIN

组成:

ACITRETIN 10 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, Acitretin Capsules should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, Acitretin Capsules should be reserved for non-pregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments (see boxed CONTRAINDICATIONS AND WARNINGS  — Acitretin Capsules can cause severe birth defects). Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy results similar to the initial course of therapy. (See boxed CONTRAINDICATIONS AND WARNINGS.) Acitretin is contraindicated in patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values (see boxed WARNINGS ,Hepatotoxicity ; WARNINGS ,Lipids and Possibl

產品總結:

Acitretin Capsules USP are available as follows: 10 mg: Two-piece hard gelatin capsule with light green opaque cap and white opaque body filled with yellow powder, imprinted in black ink with TEVA on the cap and 1135 on the body, available in bottles of 30 capsules (NDC 0093-1135-56). 17.5 mg: Two-piece hard gelatin capsule with yellow opaque cap and yellow opaque body filled with yellow powder, imprinted in black ink with TEVA on the cap and 1138 on the body, available in bottles of 30 capsules (NDC 0093-1138-56). 25 mg: Two-piece hard gelatin capsule with light green opaque cap and yellow opaque body filled with yellow powder, imprinted in black ink with TEVA on the cap and 1136 on the body, available in bottles of 30 capsules (NDC 0093-1136-56). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required). PROTECT FROM LIGHT. AVOID EXPOSURE TO HIGH TEMPERATURES AND HUMIDITY AFTER THE BOTTLE IS OPENED. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

授权状态:

Abbreviated New Drug Application

资料单张

Teva Pharmaceuticals USA, Inc.
----------
Dispense with Medication
Guide available at:
www.tevausa.com/medguides
MEDICATION GUIDE
Acitretin (a" si tre
′ tin) Capsules
Read this Medication Guide
carefully before you start
taking acitretin capsules and
read it each time you get more
acitretin capsules. There may
be new information.
The first information in this
Medication Guide is about
birth defects and how to avoid
pregnancy. After this section
there is important safety
information about possible
effects for any patient taking
acitretin capsules. All patients
should read this entire
Medication Guide carefully.
This information does not
take the place of talking with
your prescriber about your
medical condition or
treatment.
What is the most important
information I should know
about acitretin capsules?
Acitretin capsules can cause
serious side effects, including:
•
Severe birth defects. If
you are a female who
can get pregnant, you
should use acitretin
capsules only if you
are not pregnant now,
can avoid becoming
pregnant for at least 3
years, and other
medicines do not work
for your severe
psoriasis or you
cannot use other
psoriasis medicines.
Information about
effects on unborn
babies and about how
to avoid pregnancy is
found in the next
section: “What are the
important warnings
and instructions for
females taking
acitretin capsules?”
•
Liver problems,
including abnormal
liver function tests and
inflammation of your
liver (hepatitis). Your
prescriber should do
blood tests to check
how your liver is
working before you
start taking and during
treatment with
acitretin capsules.
Stop taking acitretin
capsules and call your
prescriber right away
if you have any of the
following signs or
symptoms of a serious
liver problem:
•
yellowing of
your skin or
the whites of
your eyes
•
nausea and
vomiting
•
loss of appetite
•
dark urine
What are the important
warnings and instructions for
females taking acitretin
capsules?
•
Before you receive
your first prescription
for acitretin capsules,
you should have

产品特点

ACITRETIN- ACITRETIN CAPSULE
TEVA PHARMACEUTICALS USA, INC.
----------
ACITRETIN CAPSULES, USP
RX ONLY
CONTRAINDICATIONS AND WARNINGS: PREGNANCY
ACITRETIN MUST NOT BE USED BY FEMALES WHO ARE PREGNANT, OR WHO INTEND
TO BECOME PREGNANT DURING THERAPY OR AT ANY TIME FOR AT LEAST 3 YEARS
FOLLOWING DISCONTINUATION OF THERAPY. ACITRETIN ALSO MUST NOT BE USED
BY
FEMALES WHO MAY NOT USE RELIABLE CONTRACEPTION WHILE UNDERGOING
TREATMENT AND FOR AT LEAST 3 YEARS FOLLOWING DISCONTINUATION OF
TREATMENT. ACITRETIN IS A METABOLITE OF ETRETINATE (TEGISON), AND
MAJOR
HUMAN FETAL ABNORMALITIES HAVE BEEN REPORTED WITH THE ADMINISTRATION
OF
ACITRETIN AND ETRETINATE. POTENTIALLY, ANY FETUS EXPOSED CAN BE
AFFECTED.
CLINICAL EVIDENCE HAS SHOWN THAT CONCURRENT INGESTION OF ACITRETIN AND
ETHANOL HAS BEEN ASSOCIATED WITH THE FORMATION OF ETRETINATE, WHICH
HAS
A SIGNIFICANTLY LONGER ELIMINATION HALF-LIFE THAN ACITRETIN. BECAUSE
THE
LONGER ELIMINATION HALF-LIFE OF ETRETINATE WOULD INCREASE THE DURATION
OF
TERATOGENIC POTENTIAL FOR FEMALE PATIENTS, ETHANOL MUST NOT BE
INGESTED
BY FEMALE PATIENTS OF CHILDBEARING POTENTIAL EITHER DURING TREATMENT
WITH
ACITRETIN OR FOR 2 MONTHS AFTER CESSATION OF THERAPY. THIS ALLOWS FOR
ELIMINATION OF ACITRETIN, THUS REMOVING THE SUBSTRATE FOR
TRANSESTERIFICATION TO ETRETINATE. THE MECHANISM OF THE METABOLIC
PROCESS FOR CONVERSION OF ACITRETIN TO ETRETINATE HAS NOT BEEN FULLY
DEFINED. IT IS NOT KNOWN WHETHER SUBSTANCES OTHER THAN ETHANOL ARE
ASSOCIATED WITH TRANSESTERIFICATION.
ACITRETIN HAS BEEN SHOWN TO BE EMBRYOTOXIC AND/OR TERATOGENIC IN
RABBITS, MICE, AND RATS AT ORAL DOSES OF 0.6, 3, AND 15 MG PER KG,
RESPECTIVELY. THESE DOSES ARE APPROXIMATELY 0.2, 0.3, AND 3 TIMES THE
MAXIMUM RECOMMENDED THERAPEUTIC DOSE, RESPECTIVELY, BASED ON A MG-
PER-M COMPARISON.
MAJOR HUMAN FETAL ABNORMALITIES ASSOCIATED WITH ACITRETIN AND/OR
ETRETINATE ADMINISTRATION HAVE BEEN REPORTED INCLUDING
MENINGOMYELOCELE; MENINGOENCEPHALOCELE; MULTIPLE SYNOSTOSES; FACIAL
DYSMORPHIA; SYNDACTYLY; ABSENCE OF TERMINAL PHALANGES; MALFORMATIO