ACITRETIN capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Amneal Pharmaceuticals of New York LLC

INN (Internationale Bezeichnung):

ACITRETIN

Zusammensetzung:

ACITRETIN 10 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Acitretin capsules, USP are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with its use, acitretin capsules, USP should be prescribed only by those knowledgeable in the systemic use of retinoids. In females of reproductive potential, acitretin capsules, USP 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, USP 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: Hepato

Produktbesonderheiten:

White to off-white body and a brown cap, 10 mg, imprinted in black “WPI” on the capsule cap and “2263” on the capsule body; bottles of 30 (NDC 0115-1667-08). Yellow to light yellow body and cap, 17.5 mg, imprinted in black “WPI” on the capsule cap and “2264” on the capsule body; bottles of 30 (NDC 0115-1668-08). Brown body and cap, 22.5 mg, imprinted in black with “WPI” on the capsule cap and “2265” on the capsule body; bottles of 30 (NDC 0115-1698-08).   Yellow to light yellow body and a brown cap, 25 mg, imprinted in black “WPI” on the capsule cap and “2266” on the capsule body; bottles of 30 (NDC 0115-1669-08). 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.

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

ACITRETIN- ACITRETIN CAPSULE
Amneal Pharmaceuticals of New York LLC
----------
MEDICATION GUIDE
ACITRETIN (A-SI-TRE-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 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:
1. 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?”
2. 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

Fachinformation

ACITRETIN- ACITRETIN CAPSULE
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
ACITRETIN
CAPSULES, USP
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