ISOTRETINOIN capsule, liquid filled

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Isotretinoin (UNII: EH28UP18IF) (Isotretinoin - UNII:EH28UP18IF)

제공처:

Upsher-Smith Laboratories, LLC

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 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 capsules are contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)] . Isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis an

제품 요약:

Storage and Handling Store at 20° to 25°C (68° to 77°F); excursion permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light.

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

Upsher-Smith Laboratories, LLC
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: 2/2022
MEDICATION GUIDE
Isotretinoin (eye'' soe tret' i noyn) Capsules, USP
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 REMS.
•
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 i

제품 특성 요약

ISOTRETINOIN- ISOTRETINOIN CAPSULE, LIQUID FILLED
UPSHER-SMITH LABORATORIES, LLC
----------
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 LIFE-THREATENING
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 retinoids 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 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 d