ACITRETIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Prasco Laboratories

INN (International Name):

ACITRETIN

Composition:

ACITRETIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Acitretin Capsules are indicated for the treatment of severe psoriasis in adults. Because of significant adverse effects associated with their 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 Capsules are 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 Pos

Product summary:

Brown and white capsules, 10 mg, imprinted “A-10 mg”; bottles of 30 (NDC 66993-894-30). Brown and yellow capsules, 25 mg, imprinted “A-25 mg”; bottles of 30 (NDC 66993-896-30). Store between 15° and 25°C (59° and 77°F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

Prasco Laboratories
----------
MEDICATION GUIDE
ACITRETIN 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 discussed and
signed a Patient Agreement/Informed Consent for Female Patients form
with your prescribe

Summary of Product characteristics

ACITRETIN- ACITRETIN CAPSULE
PRASCO LABORATORIES
----------
ACITRETIN CAPSULES
CONTRAINDICATIONS AND WARNINGS: PREGNANCY
ACITRETIN CAPSULES 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 CAPSULES 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 CAPSULES 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; MALFORMA