ISOTRETINOIN capsule, liquid filled

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Upsher-Smith Laboratories, LLC

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 capsules are 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

Bidhaa muhtasari:

Soft gelatin capsules, 10 mg (pale yellow), imprinted in black ink with "V10". Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 0832-8301-30). Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 0832-8301-01). Soft gelatin capsules, 20 mg (white to slight pink), imprinted in black ink with "V20". Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 0832-8302-30). Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 0832-8302-01). Soft gelatin capsules, 30 mg (pink), imprinted in black ink with "V30". Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 0832-8303-30). Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 0832-8303-01). Soft gelatin capsules, 40 mg (orange), imprinted in black ink with "V40". Boxes of 30 containing 3 Prescription Packs of 10 capsules (NDC 0832-8304-30). Boxes of 100 containing 10 Prescription Packs of 10 capsules (NDC 0832-8304-01). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

ISOTRETINOIN- ISOTRETINOIN CAPSULE, LIQUID FILLED
Upsher-Smith Laboratories, LLC
----------
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 doctor about your medical condition or your treatment.
What is the most important information I should know about
isotretinoin 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 taking isotretinoin 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
2.
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 capsules and call your doctor right away if you or a
family

Tabia za bidhaa

ISOTRETINOIN- ISOTRETINOIN CAPSULE, LIQUID FILLED
UPSHER-SMITH LABORATORIES, 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 CAPSULES 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
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.
BIRTH DEFECTS WHICH HAVE BEEN DOCUMENTED FOLLOWING ISOTRETINOIN
CAPSULES 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 CAPSULES, ISOTRETINOIN CAPSULES 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 TERATOGENICITY AND TO MINIMIZE FETAL EXPOSURE,
ISOTRETINOIN CAPSULES APPROVED FO