ACITRETIN capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Mylan Pharmaceuticals Inc.

INN (Nama Antarabangsa):

ACITRETIN

Komposisi:

ACITRETIN 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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-m2 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; malformations of hip, ankle, and forearm; low-set ears; high palate; decreased cranial volume; cardiovascular malformation; and alterations of the skull and cervical vertebrae. Acitretin capsules should be prescribed only by those who have special competence in the diagnosis and treatment of severe psoriasis, are experienced in the use of systemic retinoids, and understand the risk of teratogenicity. Because of the teratogenicity of acitretin, a program called the MyMAC program, My M ylan A citretin C ommitment, has been developed to educate women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occurring with the use of this drug and for 3 years after its discontinuation. The MyMAC program requirements are described below and program materials are available at www.acitretincommitment.com or may be requested by calling 1-877-446-3679 (1-877-4-INFO-RX) (see also PRECAUTIONS section). Important Information for Women of Childbearing Potential: Acitretin capsules should be considered only for women with severe psoriasis unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments. Females of reproductive potential must not be given a prescription for acitretin capsules until pregnancy is excluded. Acitretin capsules are contraindicated in females of reproductive potential unless the patient meets ALL of the following conditions: There have been 25 cases of reported conception when the male partner was taking acitretin. The pregnancy outcome is known in 13 of these 25 cases. Of these, 9 reports were retrospective and 4 were prospective (meaning the pregnancy was reported prior to knowledge of the outcome).3 Timing of Paternal Acitretin Treatment Relative to Conception Delivery of Healthy Neonate Spontaneous Abortion Induced Abortion Total At time of conception 5a 5 1 11 Discontinued ~ 4 weeks prior 1b 1 Discontinued ~ 6 to 8 months prior 1 1 a Four of 5 cases were prospective. b With malformation pattern not typical of retinoid embryopathy (bilateral cystic hygromas of neck,    hypoplasia of lungs bilateral, pulmonary atresia, VSD with overriding truncus arteriosus). For All Patients: AN ACITRETIN CAPSULES MEDICATION GUIDE MUST BE GIVEN TO THE PATIENT EACH TIME ACITRETIN CAPSULES ARE DISPENSED, AS REQUIRED BY LAW. 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 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 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 capsules is also contraindicated (see PRECAUTIONS: Drug Interactions). Since both acitretin capsules and tetracyclines can cause increased intracranial pressure, their combined use is contraindicated (see WARNINGS: Pseudotumor Cerebri). Acitretin capsules are contraindicated in cases of hypersensitivity (e.g., angioedema, urticaria) to the preparation (acitretin or excipients) or to other retinoids .

Ringkasan produk:

Acitretin Capsules, USP are available containing 10 mg or 25 mg of acitretin, USP. The 10 mg capsules are hard shell gelatin capsules with a swedish orange opaque cap and swedish orange opaque body filled with yellow granular powder. The capsules are axially printed with MYLAN over AC I 02 in black ink on the cap and body. They are available as follows: NDC 0378-7020-93 bottles of 30 capsules The 25 mg capsules are hard shell gelatin capsules with a brown opaque cap and yellow opaque body filled with yellow granular powder. The capsules are axially printed with MYLAN over AC I 13 in white ink on the cap and body. They are available as follows: NDC 0378-7023-93 bottles of 30 capsules 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. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Status kebenaran:

Abbreviated New Drug Application

Risalah maklumat

Mylan Pharmaceuticals Inc.
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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:
o
yellowing of your skin or the whites of your eyes
o
nausea and vomiting
o
loss of appetite
o
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 for

Ciri produk

ACITRETIN- ACITRETIN CAPSULE
MYLAN PHARMACEUTICALS INC.
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ACITRETIN CAPSULES, USP 10 MG AND 25 MG
RX ONLY
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;
ABSE