ISOTRETINOIN capsule, liquid filled

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Amneal Pharmaceuticals NY LLC

INN (Tên quốc tế):

ISOTRETINOIN

Thành phần:

ISOTRETINOIN 10 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by definition,2 means “many” as opposed to “few or several” nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics . In addition, isotretinoin capsulesare indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS, Skeletal, Bone Mineral Density, Hyperostosis, Premature Epiphyseal Closure ). Pregnancy: Category X. See Boxed CONTRAINDICATIONS AND WARNINGS . Allergic Reactions Isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see PRECAUTIONS, Hypersensitivity ).

Tóm tắt sản phẩm:

Isotretinoin capsules, USP are available as: 10 mg: Oval, gray, soft gelatin capsules, printed with “A66”. Cartons of 30 capsules containing 3 prescription blister packs of 10 capsules: NDC 69238-1174-3 20 mg: Oval, brown, soft gelatin capsules, printed with “A67”. Cartons of 30 capsules containing 3 prescription blister packs of 10 capsules: NDC 69238-1175-3 30 mg: Oval, dark orange, soft gelatin capsules, printed with “A01”. Cartons of 30 capsules containing 3 prescription blister packs of 10 capsules: NDC 69238-1017-3 40 mg: Oval, orange, soft gelatin capsules, printed with “A68”. Cartons of 30 capsules containing 3 prescription blister packs of 10 capsules: NDC 69238-1176-3 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.   KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

ISOTRETINOIN- ISOTRETINOIN CAPSULE, LIQUID FILLED
Amneal Pharmaceuticals NY LLC
----------
MEDICATION GUIDE
Isotretinoin (EYE so 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 doctor about your medical condition or your treatment.
What is the most important information I should know aboutisotretinoin
capsules?
•
Isotretinoin capsules are used to treat a type of severe acne (nodular
acne) that has not been helped
by other treatments, including antibiotics.
•
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.
•
Isotretinoin capsules may cause serious mental health problems.
1.
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
•
while taking isotretinoin capsules
•
for 1 month after stopping isotretinoin capsules.
If you get pregnant while takingisotretinoin capsules, stop taking it
right away and call your
doctor. Doctors and patients should report all cases of pregnancy to:
•
FDA MedWatch at 1-800-FDA-1088, and
•
The iPLEDGE Pregnancy Registry at 1-866-495-0654
1.
Serious mental health problems. Isotretinoin capsules may cause:
•
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. And
some people have ended their own lives.
Stop isotretinoin capsulesand call your doctor right away if you or a
family member notic

Đặc tính sản phẩm

ISOTRETINOIN- ISOTRETINOIN CAPSULE, LIQUID FILLED
AMNEAL PHARMACEUTICALS NY LLC
----------
ISOTRETINOIN CAPSULES, USP
10 MG, 20 MG, 30 MG, 40 MG
RX ONLY
CAUSES BIRTH DEFECTS
DO NOT GET PREGNANT
CONTRAINDICATIONS AND WARNINGS
ISOTRETINOIN MUST NOT BE USED BY PATIENTS WHO ARE OR MAY BECOME
PREGNANT. THERE IS AN EXTREMELY HIGH RISK THAT LIFE-THREATENING BIRTH
DEFECTS WILL RESULT IF PREGNANCY OCCURS WHILE TAKING ISOTRETINOIN 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.
BIRTH DEFECTS WHICH HAVE BEEN DOCUMENTED FOLLOWING ISOTRETINOIN
EXPOSURE INCLUDE ABNORMALITIES OF THE FACE, EYES, EARS, SKULL, CENTRAL
NERVOUS SYSTEM, CARDIOVASCULAR SYSTEM, AND THYMUS AND PARATHYROID
GLANDS. CASES OF IQ SCORES LESS THAN 85 WITH OR WITHOUT OTHER
ABNORMALITIES HAVE BEEN REPORTED. THERE IS AN INCREASED RISK OF
SPONTANEOUS ABORTION, AND PREMATURE BIRTHS HAVE BEEN REPORTED.
DOCUMENTED EXTERNAL ABNORMALITIES INCLUDE: SKULL ABNORMALITY; EAR
ABNORMALITIES (INCLUDING ANOTIA, MICROPINNA, SMALL OR ABSENT EXTERNAL
AUDITORY CANALS); EYE ABNORMALITIES (INCLUDING MICROPHTHALMIA); FACIAL
DYSMORPHIA; CLEFT PALATE. DOCUMENTED INTERNAL ABNORMALITIES INCLUDE:
CNS ABNORMALITIES (INCLUDING CEREBRAL ABNORMALITIES, CEREBELLAR
MALFORMATION, HYDROCEPHALUS, MICROCEPHALY, CRANIAL NERVE DEFICIT);
CARDIOVASCULAR ABNORMALITIES; THYMUS GLAND ABNORMALITY; PARATHYROID
HORMONE DEFICIENCY. IN SOME CASES DEATH HAS OCCURRED WITH CERTAIN OF
THE ABNORMALITIES PREVIOUSLY NOTED.
IF PREGNANCY DOES OCCUR DURING TREATMENT OF A PATIENT WHO IS TAKING
ISOTRETINOIN, ISOTRETINOIN MUST BE DISCONTINUED IMMEDIATELY AND THE
PATIENT SHOULD BE REFERRED TO AN OBSTETRICIAN-GYNECOLOGIST EXPERIENCED
IN REPRODUCTIVE TOXICITY FOR FURTHER EVALUATION AND COUNSELING.
SPECIAL PRESCRIBING REQUIREMENTS
BECAUSE OF ISOTRETINOIN'S TERATOGENICITY AND TO MINIMIZE FETAL
EXPOSURE,
ISOTRETINOIN IS APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED
DISTRIB