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Accutane Drug Description
ACCUTANE®
(isotretinoin) Capsules
CAUSES BIRTH DEFECTS








DO NOT GET PREGNANT

CONTRAINDICATIONS AND WARNINGS
Accutane 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 Accutane 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 Accutane 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
Accutane, Accutane 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 Accutane's teratogenicity and to minimize fetal exposure, Accutane
is approved for marketing only under a special restricted distribution program
approved by the Food and Drug Administration. This program is called iPLEDGE™.
Accutane must only be prescribed by prescribers who are registered and activated
with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered
and activated with iPLEDGE, and must only be dispensed to patients who are registered
and meet all the requirements of iPLEDGE (see PRECAUTIONS).
Table 1 : Monthly Required iPLEDGE Interactions



 
Female Patients of Childbearing Potential
Male Patients, And Female Patients Not of
Childbearing Potential


PRESCRIBER


   Confirms patient counseling
X
X


   Enters the 2 contraception methods chosen by the patient
X
 


   Enters pregnancy test results
X
 


PATIENT


   Answers educational questions before every prescription
X
 


   Enters 2 forms of contraception
X
 


PHARMACIST


   Contacts system to get an authorization
X
X



DRUG DESCRIPTION



What are the possible side effects of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
sudden numbness or...
Read All Potential Side Effects for Accutane »




Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg
soft gelatin capsules for oral administration. Each capsule contains beeswax,
butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes,
hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin
and parabens (methyl and propyl), with the following dye systems: 10 mg — iron
oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue
No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No.
10, and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both
retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline
powder with a molecular weight of 300.44. The structural formula is:







Last reviewed on RxList: 2/22/2010




Accutane Drug Description
ACCUTANE®
(isotretinoin) Capsules
CAUSES BIRTH DEFECTS








DO NOT GET PREGNANT

CONTRAINDICATIONS AND WARNINGS
Accutane 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 Accutane 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 Accutane 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
Accutane, Accutane 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 Accutane's teratogenicity and to minimize fetal exposure, Accutane
is approved for marketing only under a special restricted distribution program
approved by the Food and Drug Administration. This program is called iPLEDGE™.
Accutane must only be prescribed by prescribers who are registered and activated
with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered
and activated with iPLEDGE, and must only be dispensed to patients who are registered
and meet all the requirements of iPLEDGE (see PRECAUTIONS).
Table 1 : Monthly Required iPLEDGE Interactions



 
Female Patients of Childbearing Potential
Male Patients, And Female Patients Not of
Childbearing Potential


PRESCRIBER


   Confirms patient counseling
X
X


   Enters the 2 contraception methods chosen by the patient
X
 


   Enters pregnancy test results
X
 


PATIENT


   Answers educational questions before every prescription
X
 


   Enters 2 forms of contraception
X
 


PHARMACIST


   Contacts system to get an authorization
X
X



DRUG DESCRIPTION



What are the possible side effects of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
sudden numbness or...
Read All Potential Side Effects for Accutane »




Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg
soft gelatin capsules for oral administration. Each capsule contains beeswax,
butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes,
hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin
and parabens (methyl and propyl), with the following dye systems: 10 mg — iron
oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue
No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No.
10, and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both
retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline
powder with a molecular weight of 300.44. The structural formula is:







Last reviewed on RxList: 2/22/2010




Accutane Drug Description
ACCUTANE®
(isotretinoin) Capsules
CAUSES BIRTH DEFECTS








DO NOT GET PREGNANT

CONTRAINDICATIONS AND WARNINGS
Accutane 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 Accutane 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 Accutane 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
Accutane, Accutane 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 Accutane's teratogenicity and to minimize fetal exposure, Accutane
is approved for marketing only under a special restricted distribution program
approved by the Food and Drug Administration. This program is called iPLEDGE™.
Accutane must only be prescribed by prescribers who are registered and activated
with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered
and activated with iPLEDGE, and must only be dispensed to patients who are registered
and meet all the requirements of iPLEDGE (see PRECAUTIONS).
Table 1 : Monthly Required iPLEDGE Interactions



 
Female Patients of Childbearing Potential
Male Patients, And Female Patients Not of
Childbearing Potential


PRESCRIBER


   Confirms patient counseling
X
X


   Enters the 2 contraception methods chosen by the patient
X
 


   Enters pregnancy test results
X
 


PATIENT


   Answers educational questions before every prescription
X
 


   Enters 2 forms of contraception
X
 


PHARMACIST


   Contacts system to get an authorization
X
X



DRUG DESCRIPTION



What are the possible side effects of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
sudden numbness or...
Read All Potential Side Effects for Accutane »




Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg
soft gelatin capsules for oral administration. Each capsule contains beeswax,
butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes,
hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin
and parabens (methyl and propyl), with the following dye systems: 10 mg — iron
oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue
No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No.
10, and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both
retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline
powder with a molecular weight of 300.44. The structural formula is:







Last reviewed on RxList: 2/22/2010




Accutane Drug Description
ACCUTANE®
(isotretinoin) Capsules
CAUSES BIRTH DEFECTS








DO NOT GET PREGNANT

CONTRAINDICATIONS AND WARNINGS
Accutane 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 Accutane 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 Accutane 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
Accutane, Accutane 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 Accutane's teratogenicity and to minimize fetal exposure, Accutane
is approved for marketing only under a special restricted distribution program
approved by the Food and Drug Administration. This program is called iPLEDGE™.
Accutane must only be prescribed by prescribers who are registered and activated
with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered
and activated with iPLEDGE, and must only be dispensed to patients who are registered
and meet all the requirements of iPLEDGE (see PRECAUTIONS).
Table 1 : Monthly Required iPLEDGE Interactions



 
Female Patients of Childbearing Potential
Male Patients, And Female Patients Not of
Childbearing Potential


PRESCRIBER


   Confirms patient counseling
X
X


   Enters the 2 contraception methods chosen by the patient
X
 


   Enters pregnancy test results
X
 


PATIENT


   Answers educational questions before every prescription
X
 


   Enters 2 forms of contraception
X
 


PHARMACIST


   Contacts system to get an authorization
X
X



DRUG DESCRIPTION



What are the possible side effects of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
sudden numbness or...
Read All Potential Side Effects for Accutane »




Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg
soft gelatin capsules for oral administration. Each capsule contains beeswax,
butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes,
hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin
and parabens (methyl and propyl), with the following dye systems: 10 mg — iron
oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue
No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No.
10, and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both
retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline
powder with a molecular weight of 300.44. The structural formula is:







Last reviewed on RxList: 2/22/2010




Accutane Drug Description
ACCUTANE®
(isotretinoin) Capsules
CAUSES BIRTH DEFECTS








DO NOT GET PREGNANT

CONTRAINDICATIONS AND WARNINGS
Accutane 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 Accutane 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 Accutane 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
Accutane, Accutane 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 Accutane's teratogenicity and to minimize fetal exposure, Accutane
is approved for marketing only under a special restricted distribution program
approved by the Food and Drug Administration. This program is called iPLEDGE™.
Accutane must only be prescribed by prescribers who are registered and activated
with the iPLEDGE program. Accutane must only be dispensed by a pharmacy registered
and activated with iPLEDGE, and must only be dispensed to patients who are registered
and meet all the requirements of iPLEDGE (see PRECAUTIONS).
Table 1 : Monthly Required iPLEDGE Interactions



 
Female Patients of Childbearing Potential
Male Patients, And Female Patients Not of
Childbearing Potential


PRESCRIBER


   Confirms patient counseling
X
X


   Enters the 2 contraception methods chosen by the patient
X
 


   Enters pregnancy test results
X
 


PATIENT


   Answers educational questions before every prescription
X
 


   Enters 2 forms of contraception
X
 


PHARMACIST


   Contacts system to get an authorization
X
X



DRUG DESCRIPTION



What are the possible side effects of isotretinoin (Accutane, Amnesteem, Claravis, Sotret)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:

depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
sudden numbness or...
Read All Potential Side Effects for Accutane »




Isotretinoin, a retinoid, is available as Accutane in 10-mg, 20-mg and 40-mg
soft gelatin capsules for oral administration. Each capsule contains beeswax,
butylated hydroxyanisole, edetate disodium, hydrogenated soybean oil flakes,
hydrogenated vegetable oil, and soybean oil. Gelatin capsules contain glycerin
and parabens (methyl and propyl), with the following dye systems: 10 mg — iron
oxide (red) and titanium dioxide; 20 mg — FD&C Red No. 3, FD&C Blue
No. 1, and titanium dioxide; 40 mg — FD&C Yellow No. 6, D&C Yellow No.
10, and titanium dioxide.
Chemically, isotretinoin is 13-cis-retinoic acid and is related to both
retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline
powder with a molecular weight of 300.44. The structural formula is:







Last reviewed on RxList: 2/22/2010





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Accurate, FDA approved Accutane information for healthcare professionals and patients - brought to you by Drugs.com. Accutane Official FDA information, side effects and uses.


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