ACITRETIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sigmapharm Laboratories, LLC

INN (International Name):

ACITRETIN

Composition:

ACITRETIN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 con

Product summary:

Acitretin Capsules, USP 10 mg (opaque yellow and opaque white) are imprinted “Σ 80” on body and cap; Bottles of 30 (NDC 42794-080-08). Acitretin Capsules, USP 17.5 mg (opaque orange) are imprinted “Σ 81” on body and cap; Bottles of 30 (NDC 42794-081-08). Acitretin Capsules, USP 25 mg (opaque yellow) are imprinted “Σ 83” on body and cap; Bottles of 30 (NDC 42794-083-08). 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. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN. All brand names listed are the registered trade names of their respective owners and are not trademarks of Sigmapharm Laboratories, LLC.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ACITRETIN- ACITRETIN CAPSULE
Sigmapharm Laboratories, LLC
----------
MEDICATION GUIDE
ACITRETIN CAPSULES, USP
[ A-si-TRE-tin]
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/In

Summary of Product characteristics

ACITRETIN- ACITRETIN CAPSULE
SIGMAPHARM LABORATORIES, LLC
----------
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; MALFORMATI