CLARAVIS- isotretinoin capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

ISOTRETINOIN

Koostis:

ISOTRETINOIN 20 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Claravis (isotretinoin capsules, USP) is 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, Claravis should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In addition, Claravis is indicated only for those female patients who are not pregnant, because Claravis can cause severe 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

Toote kokkuvõte:

Claravis™ (isotretinoin capsules, USP) is available as: 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

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

CLARAVIS - ISOTRETINOIN CAPSULE
Physicians Total Care, Inc.
----------
MEDICATION GUIDE
Claravis™
(isotretinoin capsules, USP)
Read the Medication Guide that comes with Claravis 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 about Claravis?
•
Claravis is used to treat a type of severe acne (nodular acne) that
has not been helped by other
treatments, including antibiotics.
•
Because Claravis can cause birth defects, Claravis is only for
patients who can understand and
agree to carry out all of the instructions in the iPLEDGE program.
•
Claravis 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. Female patients who are pregnant or who plan
to become pregnant must
not take Claravis. Female patients must not get pregnant:
•
for one month before starting Claravis
•
while taking Claravis
•
for one month after stopping Claravis.
If you get pregnant while taking Claravis, 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
2. Serious mental health problems. Claravis may cause:
•
depression
•
psychosis (seeing or hearing things that are not real)
•
suicide. Some patients taking Claravis 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 Claravis and call your doctor right away if you or a family
member notices that you have any of the
following signs and symptoms of depression or psychosis:
•
start to feel sad or have crying spells
•
lose interest in activities you once enjoyed
•

Toote omadused

CLARAVIS - ISOTRETINOIN CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
CLARAVIS™
(ISOTRETINOIN CAPSULES USP)
RX ONLY
CONTRAINDICATIONS AND WARNINGS
CLARAVIS™ MUST NOT BE USED BY FEMALE PATIENTS WHO ARE OR MAY BECOME
PREGNANT. THERE IS
AN EXTREMELY HIGH RISK THAT SEVERE BIRTH DEFECTS WILL RESULT IF
PREGNANCY OCCURS WHILE TAKING
CLARAVIS 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 FEMALE PATIENT WHO IS
TAKING CLARAVIS,
CLARAVIS MUST BE DISCONTINUED IMMEDIATELY AND SHE 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, CLARAVIS IS
APPROVED FOR MARKETING ONLY UNDER A SPECIAL RESTRICTED DISTRIBUTION
PROGRAM APPROVED BY
THE FOOD AND DRUG ADMINISTRATION. THIS PROGRAM IS CALLED IPLEDGE™.