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:

Amneal Pharmaceuticals of New York LLC

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. Pregnancy Category X ( 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 Possible Cardiovascular Effects , and PRECAUTIONS ). An increased risk of hepatitis has been reported to result from combined use of methotrexate and etretinate. Consequently, the combination of methotrexate with acitretin is also contraindicated (see PRECAUTIONS: Drug Interactions ). Since both acitretin and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see WARNINGS: Pseudotumor Cerebri ). Acitretin is contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids.

產品總結:

Acitretin Capsules USP, 10 mg are supplied as white to off-white body and a brown cap,  imprinted in black “IX” on the capsule cap and “667” on the capsule body. They are available as follows: Bottles of 30:                                      NDC 0115-1750-08 Acitretin Capsules USP, 17.5 mg are supplied as yellow to light yellow body and cap, imprinted in black “IX” on the capsule cap and “668” on the capsule body. They are available as follows: Bottles of 30:                                      NDC 0115-1751-08 Acitretin Capsules USP, 22.5 mg are supplied as brown body and cap, imprinted in black with “IX” on the capsule cap and “698” on the capsule body. They are available as follows: Bottles of 30:                                      NDC 0115-1752-08 Acitretin Capsules USP, 25 mg are supplied as yellow to light yellow body and a brown cap,  imprinted in black “IX” on the capsule cap and “669” on the capsule body. They are available as follows: Bottles of 30:                                      NDC 0115-1753-08 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

授权状态:

Abbreviated New Drug Application

资料单张

Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
ACITRETIN (A”SIT RE’ TIN) CAPSULES, USP
Read this Medication Guide carefully before you start taking
acitretin, and read it each time you get more
acitretin. 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.
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?
Acitretin can cause serious side effects, including:
•
Severe birth defects. If you are a female who can get pregnant, you
should use acitretin 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?”
•
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. Stop taking acitretin 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?
•
Before you receive your first prescription for acitretin, you should
have discussed and signed a
Patient Agreement/Informed Consent for Female Patients form with your
prescriber. This is to
help make sure you understand the risk o

产品特点

ACITRETIN- ACITRETIN CAPSULE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
ACITRETIN CAPSULES, USP
(10 MG, 17.5 MG, 22.5 MG AND 25 MG)
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; SYNDACTYL