ISOTRETINOIN capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

ISOTRETINOIN (UNII: EH28UP18IF) (ISOTRETINOIN - UNII:EH28UP18IF)

Prieinama:

Actavis Pharma, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2)] . Isotretinoin is contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . Isotretinoin is contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other all

Produkto santrauka:

Isotretinoin capsules, USP are supplied as follows: Storage and Handling of Isotretinoin Capsules, USP Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

INOIN- ISOTRETINOIN CAPSULE
Actavis Pharma, Inc.
----------
MEDICATION GUIDE
Isotretinoin (eye" soe tret' i noyn) Capsules
Read the Medication Guide that comes with isotretinoin capsules before
you start taking it and each time you get a prescription. There may be
new
information. This information does not take the place of talking with
your healthcare provider about your medical condition or your
treatment.
What is the most important information I should know about
isotretinoin capsules?
•
Isotretinoin capsules can harm your unborn baby, including birth
defects (deformed babies), loss of a baby before birth (miscarriage),
death of the
baby, and early (premature) births. Patients who are pregnant or who
plan to become pregnant must not take isotretinoin capsules.
Patients must not get pregnant:
•
for 1 month before starting isotretinoin capsules
•
during treatment with isotretinoin capsules
•
for 1 month after stopping isotretinoin capsules
If you get pregnant during treatment with isotretinoin capsules, stop
taking it right away and call your healthcare provider. Healthcare
providers
and patients should report all cases of pregnancy during treatment or
1 month after stopping treatment to:
•
FDA MedWatch at 1-800-FDA-1088, and
•
the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or
www.ipledgeprogram.com
Because isotretinoin capsules can cause birth defects, isotretinoin
capsules are only for patients who can understand and agree to carry
out all of
the instructions in the iPLEDGE Program.
•
Serious mental health problems, including:
•
depression
•
psychosis (seeing or hearing things that are not real)
•
suicide. Some patients taking isotretinoin capsules have had thoughts
about hurting themselves or putting an end to their own lives
(suicidal
thoughts). Some people tried to end their own lives. Some people have
ended their own lives.
Stop taking isotretinoin capsules and call your healthcare provider
right away if you or a family member notices that you have any of the
following signs
and sym

Prekės savybės

ISOTRETINOIN- ISOTRETINOIN CAPSULE
ACTAVIS PHARMA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ISOTRETINOIN CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ISOTRETINOIN CAPSULES.
ISOTRETINOIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: EMBRYO-FETAL TOXICITY - CONTRAINDICATED IN PREGNANCY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ISOTRETINOIN CAPSULES CAN CAUSE LIFE-THREATENING BIRTH DEFECTS AND IS
CONTRAINDICATED
IN PREGNANCY. THERE IS AN EXTREMELY HIGH RISK THAT SEVERE BIRTH
DEFECTS WILL RESULT IF
PREGNANCY OCCURS WHILE TAKING ISOTRETINOIN CAPSULES IN ANY AMOUNT,
EVEN FOR SHORT
PERIODS OF TIME. POTENTIALLY ANY FETUS EXPOSED DURING PREGNANCY CAN BE
AFFECTED.
THERE ARE NO ACCURATE MEANS OF DETERMINING WHETHER AN EXPOSED FETUS
HAS BEEN
AFFECTED. (4, 5.1, 8.1)
_ _ISOTRETINOIN CAPSULES ARE AVAILABLE ONLY THROUGH A RESTRICTED
PROGRAM CALLED THE
IPLEDGE REMS. (5.2)
INDICATIONS AND USAGE
Isotretinoin capsules are a retinoid indicated for the treatment of
severe recalcitrant nodular acne in non-
pregnant patients 12 years of age and older with multiple inflammatory
nodules with a diameter of 5 mm
or greater. Because of significant adverse reactions associated with
its use, isotretinoin capsules are
reserved for patients with severe nodular acne who are unresponsive to
conventional therapy, including
systemic antibiotics. (1)
Limitations of Use:
If a second course of isotretinoin capsules therapy is needed, it is
not recommended before a two-month
waiting period because the patient’s acne may continue to improve
following a 15 to 20-week course of
therapy. (1)
DOSAGE AND ADMINISTRATION
Recommended dosage for ISOTRETINOIN CAPSULES IS 0.5 TO 1 MG/KG/DAY
given in two divided doses
without regard to meals for 15 to 20 weeks (2.1)
Adult patients with very severe disease (scarring, trunk involvement)
may increase dosage to 2
mg/kg/day of isotretinoin capsules in divided doses. (2.1)
Once daily