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What is the most important information I should know about Absorica (isotretinoin)?
Isotretinoin in just a single dose can cause severe birth defects or death of a baby. Never use this medicine if you are pregnant or may become pregnant.
You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.
Isotretinoin is available only under a special program called iPLEDGE. It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States.
Before Using Absorica
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of isotretinoin in children younger than 12 years of age. Safety and efficacy have not been established.
This medicine should be used with caution in teenagers, especially those with bone problems or diseases.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of isotretinoin in the elderly. However, elderly patients may have a greater risk of problems and side effects when taking isotretinoin.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Estradiol Cypionate
- Estradiol Valerate
- Ethinyl Estradiol
- Ethynodiol Diacetate
- Medroxyprogesterone Acetate
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcoholism, severe or
- Allergy to aspirin, history of or
- Diabetes or
- Metabolism disorder, family history of or
- Severe weight problems—Use with caution. May increase risks for more serious problems.
- Anorexia (eating disorder) or
- Epiphyseal closure, premature or
- Osteomalacia (softening of the bones) or
- Osteoporosis (brittle bones), childhood or family history of or
- Other bone disorders or diseases—Use with caution. It is not known whether this medicine affects bone loss.
- Asthma or
- Depression, history of or
- Eye or vision problems or
- Hearing problems or
- Heart disease or
- Hepatitis or
- Hypertriglyceridemia (high triglycerides in the blood) or
- Intestinal disorders, history of or
- Pancreatitis (inflammation of the pancreas) or
- Pseudotumor cerebri (swelling in the brain) or
- Psychosis, history of or
- Vitamin A overdose (too much vitamin A in the body)—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Absorica Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
- Bone or joint pain
- burning, redness, itching, or other signs of eye inflammation
- difficulty with moving
- scaling, redness, burning, pain, or other signs of inflammation of the lips
- skin infection or rash
- Abdominal or stomach pain (severe)
- attempts at suicide or thoughts of suicide (usually stops after medicine is stopped)
- back pain
- bleeding or inflammation of the gums
- blurred vision or other changes in vision
- changes in behavior
- decreased vision after sunset or before sunrise (sudden or may continue after medicine is stopped)
- diarrhea (severe)
- headache (severe or continuing)
- mental depression
- nausea and vomiting
- pain or tenderness of the eyes
- pain, tenderness, or stiffness in the muscles (long-term treatment)
- rectal bleeding
- yellow eyes or skin
- Black, tarry stools
- bloody cough
- bloody or cloudy urine
- bone pain, tenderness, or aching
- burning or stinging of the skin
- chest pain
- cough or hoarseness
- dark-colored urine
- decrease in height
- difficulty breathing
- difficulty speaking
- difficulty swallowing
- discharge from the eyes
- double vision
- ear pain
- excessive tearing
- fast, irregular, pounding, or racing heartbeat or pulse
- fever with or without chills
- fractures and/or delayed healing
- high blood pressure
- hives or skin rash
- inability to move the arms, legs, or facial muscles
- inability to speak
- inflamed tissue from infection
- irregular yellow patch or lump on the skin
- joint pain, redness, stiffness, or swelling
- lack or slowing of normal growth in children
- loosening of the fingernails
- loss of appetite
- loss of bladder control
- loss or change in hearing
- muscle cramps, spasms, or weakness
- pain in the ribs, arms, or legs
- pain or burning in the throat
- pain or tenderness around the eyes and cheekbones
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pains in the chest, groin, or legs, especially calves of the legs
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- pinpoint red spots on the skin
- redness or soreness around the fingernails
- redness, soreness, or itching skin
- sensitivity of the eyes to sunlight
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
- stuffy or runny nose
- sudden loss of consciousness
- sudden loss of coordination
- sudden onset of severe acne on the chest and trunk
- sudden onset of slurred speech
- swelling of the eyelids, face, lips, hands, lower legs, or feet
- swollen, painful or tender lymph glands in the neck, armpit, or groin
- tightness in the chest
- unusual bleeding or bruising
- unusual weight gain or loss
- use of extreme physical or emotional force
- watery or bloody diarrhea
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Crusting of the skin
- difficulty in wearing contact lenses (may continue after medicine is stopped)
- dryness of the eyes (may continue after treatment is stopped)
- dryness of the mouth or nose
- dryness or itching of the skin
- headache (mild)
- increased sensitivity of the skin to sunlight
- peeling of the skin on palms of the hands or soles of the feet
- stomach upset
- thinning of the hair (may continue after treatment is stopped)
- Abnormal menstruation
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feeling
- changes in fingernails or toenails
- continuing ringing or buzzing, or other unexplained noise in the ears
- darkening of the skin
- hair abnormalities
- hair loss
- increased hair growth, especially on the face
- lightening of normal skin color
- lightening of treated areas of dark skin
- oily skin
- redness of the face
- severe sunburn
- skin rash, encrusted, scaly and oozing
- stomach burning
- trouble sleeping
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusually warm skin of the face
- voice changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Uses of Absorica
- It is used to treat pimples (acne).
- It may be given to you for other reasons. Talk with the doctor.
What are some other side effects of Absorica?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Dry mouth.
- Dry eyes.
- Dry skin.
- Dry lips.
- Nose irritation.
- Change in how contact lenses feel in the eyes.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
Absorica Dosage and Administration
Healthcare professionals who prescribe Absorica must be certified in the iPLEDGE program and must comply with the required monitoring to ensure safe use of Absorica [see Warnings and Precautions (5.2)].
The required laboratory testing must be completed prior to dosing Absorica [see Dosage and Administration (2.4)].
Pregnancy Testing, and Contraceptive measures must be followed prior to dosing Absorica [see Use in Specific Populations (8.6)].
The recommended dosage range for Absorica is 0.5 to 1 mg/kg/day given in two divided doses without regard to meals for 15 to 20 weeks (see Table 1). To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid [see Patient Counseling Information (17)].
The safety of once daily dosing with Absorica has not been established. Once daily dosing is not recommended.
Total Daily (mg)
In trials comparing 0.1, 0.5, and 1 mg/kg/day, it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects, some of which may be dose-related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated.
Duration of Use
A normal course of treatment is 15 – 20 weeks. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of Absorica, even in low doses, has not been studied, and is not recommended. It is important that Absorica be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Absorica on bone loss is unknown [see Warnings and Precautions (5.12)].
[See Use in Specific Populations (8.6)]
Perform a fasting lipid profile including triglycerides prior to use of Absorica [see Warnings and Precautions (5.8, 5.15)].
Liver Function Test
Perform liver function tests prior to use of Absorica [see Warnings and Precautions (5.10, 5.15)].
Read the Medication Guide that comes with Absorica 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 Absorica?• Absorica is used to treat a type of severe acne (nodular acne) that has not been helped by other treatments, including antibiotics. • Because Absorica can cause birth defects, Absorica is only for patients who can understand and agree to carry out all of the instructions in the iPLEDGE program. • Absorica 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. Females who are pregnant or who plan to become pregnant must not take Absorica. Females must not get pregnant:• for 1 month before starting Absorica • while taking Absorica • for 1 month after stopping Absorica
If you get pregnant while taking Absorica, 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. Absorica may cause:• depression • psychosis (seeing or hearing things that are not real) • suicide. Some patients taking Absorica 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 Absorica 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 • sleep too much or have trouble sleeping • become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence) • have a change in your appetite or body weight • have trouble concentrating • withdraw from your friends or family • feel like you have no energy • have feelings of worthlessness or guilt • start having thoughts about hurting yourself or taking your own life (suicidal thoughts) • start acting on dangerous impulses • start seeing or hearing things that are not real
After stopping Absorica, you may also need follow-up mental health care if you had any of these symptoms.
What is Absorica?
Absorica is a medicine taken by mouth to treat the most severe form of acne (nodular acne) that cannot be cleared up by any other acne treatments, including antibiotics. Absorica can cause serious side effects (see “What is the most important information I should know about Absorica?”). Absorica can only be:• prescribed by doctors that are registered in the iPLEDGE program • dispensed by a pharmacy that is registered with the iPLEDGE program • given to patients who are registered in the iPLEDGE program and agree to do everything required in the program
What is severe nodular acne?
Severe nodular acne is when many red, swollen, tender lumps form in the skin. These can be the size of pencil erasers or larger. If untreated, nodular acne can lead to permanent scars.
Who should not take Absorica?• Do not take Absorica if you are pregnant, plan to become pregnant, or become pregnant during Absorica treatment. Absorica causes severe birth defects. See “What is the most important information I should know about Absorica?”
Do not take Absorica if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Absorica.
What should I tell my doctor before taking Absorica?
Tell your doctor if you or a family member has any of the following health conditions:• mental problems • asthma • liver disease • diabetes • heart disease • bone loss (osteoporosis) or weak bones • an eating problem called anorexia nervosa (where people eat too little) • food or medicine allergies
Tell your doctor if you are pregnant or breastfeeding. Absorica must not be used by females who are pregnant or breastfeeding.
Tell your doctor about all of the medicines you take including prescription and over-the-counter medicines, vitamins and herbal supplements. Absorica and certain other medicines can interact with each other, sometimes causing serious side effects. Especially tell your doctor if you take:• Vitamin A supplements. Vitamin A in high doses has many of the same side effects as Absorica. Taking both together may increase your chance of getting side effects. • Tetracycline antibiotics. Tetracycline antibiotics taken with Absorica can increase the chances of getting increased pressure in the brain. • Progestin-only birth control pills (mini-pills). They may not work while you take Absorica. Ask your doctor or pharmacist if you are not sure what type you are using. • Dilantin (phenytoin). This medicine taken with Absorica may weaken your bones. • Corticosteroid medicines. These medicines taken with Absorica may weaken your bones. • St. John's Wort. This herbal supplement may make birth control pills work less effectively.
These medicines should not be used with Absorica unless your doctor tells you it is okay.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist. Do not take any new medicine without talking with your doctor.
How should I take Absorica?• You must take Absorica exactly as prescribed. You must also follow all the instructions of the iPLEDGE program. Before prescribing Absorica, your doctor will: • explain the iPLEDGE program to you • have you sign the Patient Information/Informed Consent form (for all patients). Females who can get pregnant must also sign another consent form.
You will not be prescribed Absorica if you cannot agree to or follow all the instructions of the iPLEDGE program.• You will get no more than a 30-day supply of Absorica at a time. This is to make sure you are following the Absorica iPLEDGE program. You should talk with your doctor each month about side effects. • The amount of Absorica you take has been specially chosen for you. It is based on your body weight, and may change during treatment. • Take Absorica 2 times a day without regard to meals, unless your doctor tells you otherwise. Swallow your Absorica capsules whole with a full glass of liquid. Do not chew or suck on the capsule. Absorica can hurt the tube that connects your mouth to your stomach (esophagus) if it is not swallowed whole. • If you miss a dose, just skip that dose. Do not take two doses at the same time. • If you take too much Absorica or overdose, call your doctor or poison control center right away. • Your acne may get worse when you first start taking Absorica. This should last only a short while. Talk with your doctor if this is a problem for you. • You must return to your doctor as directed to make sure you don't have signs of serious side effects. Your doctor may do blood tests to check for serious side effects from Absorica. Females who can get pregnant will get a pregnancy test each month. • Females who can get pregnant must agree to use two separate forms of effective birth control at the same time one month before, while taking, and for one month after taking Absorica. You must access the iPLEDGE system to answer questions about the program requirements and to enter your two chosen forms of birth control. To access the iPLEDGE system, go to www.ipledgeprogram.com or call 1-866-495-0654. • You must talk about effective birth control methods with your doctor or go for a free visit to talk about birth control with another doctor or family planning expert. Your doctor can arrange this free visit, which will be paid for by the company that makes Absorica. • If you have sex at any time without using two forms of effective birth control, get pregnant, or miss your expected period, stop using Absorica and call your doctor right away.
What should I avoid while taking Absorica?• Do not get pregnant while taking Absorica and for one month after stopping Absorica. See “What is the most important information I should know about Absorica?” • Do not breastfeed while taking Absorica and for one month after stopping Absorica. We do not know if Absorica can pass through your milk and harm the baby. • Do not give blood while you take Absorica and for one month after stopping Absorica. If someone who is pregnant gets your donated blood, her baby may be exposed to Absorica and may be born with birth defects. • Do not take other medicines or herbal products with Absorica unless you talk to your doctor. See “What should I tell my doctor before taking Absorica?” • Do not drive at night until you know if Absorica has affected your vision. Absorica may decrease your ability to see in the dark. • Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, while you are using Absorica and for at least 6 months after you stop. Absorica can increase your chance of scarring from these procedures. Check with your doctor for advice about when you can have cosmetic procedures. • Avoid sunlight and ultraviolet lights as much as possible. Tanning machines use ultraviolet lights. Absorica may make your skin more sensitive to light.
Do not share Absorica with other people. It can cause birth defects and other serious health problems.
What are the possible side effects of Absorica?• Absorica can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. See “What is the most important information I should know about Absorica?” • Absorica may cause serious mental health problems. See “What is the most important information I should know about Absorica?” • serious brain problems. Absorica can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking Absorica and call your doctor right away if you get any of these signs of increased brain pressure:
|o bad headache||o blurred vision||o dizziness|
|o nausea or vomiting||o seizures (convulsions)||o stroke|
|o severe stomach, chest or bowel pain||o trouble swallowing or painful|
|o new or worsening heartburn||o diarrhea|
|o rectal bleeding||o yellowing of your skin or eyes|
|o dark urine|
|o back pain||o joint pain|
|o broken bone. Tell all healthcare providers that you take Absorica if you break a bone.|
The common, less serious side effects of Absorica are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds.
Absorica contains the color additive FD&C Yellow No. 5 (tartrazine) which may cause allergic type reactions, including asthma in some people. The overall occurrence of allergic reaction is low. This reaction is most often seen in people who also have an allergy to aspirin.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Ranbaxy Inc., the manufacturer of Absorica at 1-800-406-7984.
How should I store Absorica?• Store Absorica at room temperature, 68° to 77° F (20° to 25° C). Protect from light. • Keep Absorica and all medicines out of the reach of children.
General Information about Absorica
Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use Absorica for a condition for which it was not prescribed. Do not give Absorica to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about Absorica. If you would like more information, talk with your doctor.
You can ask your doctor or pharmacist for information about Absorica that is written for health care professionals. You can also call iPLEDGE program at 1-866-495-0654 or visit www.ipledgeprogram.com.
What are the ingredients in Absorica?
Active ingredient: Isotretinoin, USP
Inactive ingredients: Propyl gallate, sorbitan monooleate, soybean oil and stearoyl polyoxylglycerides. Gelatin capsules contain the following dye systems: 10 mg – iron oxide (yellow) and titanium dioxide; 20 mg – iron oxide (red) and titanium dioxide; 25 mg – FD&C Blue #1, FD&C Yellow #5 (tartrazine)*, FD&C Yellow #6 and titanium dioxide; 30 mg – iron oxide (black, red and yellow) and titanium dioxide; 35 mg – FD&C Blue #2, iron oxide (black, red and yellow) and titanium dioxide; and 40 mg – iron oxide (black, red and yellow) and titanium dioxide.
Dilantin is a registered trademark of Warner-Lambert Company LLC.
Ranbaxy Laboratories Inc.
Ranbaxy Laboratories Inc.
Jacksonville, FL 32257 USA
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: July 2015
Dosage Forms And Strengths
ABSORICA is available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg capsules.
- 10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240” on cap and “10” on the body
- 20 mg: Red, opaque, capsule imprinted with black ink “G 241” on cap and “20” on the body
- 25 mg: Green, opaque, capsule imprinted with white ink “G 342” on cap and “25” on the body
- 30 mg: Brown, opaque, capsule imprinted with white ink “G 242” on cap and “30” on the body
- 35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343” on cap and “35” on the body
- 40 mg: Brown and red, capsule imprinted with white ink “G 325” on cap and “40” on the body
ABSORICA (isotretinoin) Capsules are supplied as follows:
10 mg: Dark yellow, opaque, capsule imprinted with black ink “G 240” on cap and “10” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-115-31
20 mg: Red, opaque, capsule imprinted with black ink “G 241” on cap and “20” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-116-31
25 mg: Green, opaque, capsule imprinted with white ink “G 342” on cap and “25” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-133-31
30 mg: Brown, opaque, capsule imprinted with white ink “G 242” on cap and “30” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-117-31
35 mg: Dark blue, opaque, capsule imprinted with white ink “G 343” on cap and “35” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-134-31
40 mg: Brown and red, capsule imprinted with white ink “G 325” on cap and “40” on the body Box of 30 capsules (3 x 10 Prescription Packs): NDC 10631-118-31
Storage And Handling
Store at 20° C -25° C (68° F -77° F), excursion permitted between 15° C 30° C (59° F -86° F) [see USP controlled room temperature]. Protect from light.
Manufactured for: Ranbaxy Laboratories Inc., Jacksonville, FL 32257 USA GK-244. Revised: September 2015.
In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects.
ABSORICA causes serious birth defects at any dosage (see BOXED CONTRAINDICATIONS AND WARNINGS). Females of reproductive potential who present with ABSORICA overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus, as described in the BOXED CONTRAINDICATIONS AND WARNINGS. Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling as described in WARNINGS AND PRECAUTIONS. Educational materials for such patients can be obtained by calling the manufacturer. Because an overdose would be expected to result in higher levels of isotretinoin in semen than found during a normal treatment course, male patients should use a condom, or avoid reproductive sexual activity with a female patient who is or might become pregnant, for 1 month after the overdose. All patients with ABSORICA overdose should not donate blood for at least 1 month.
- Store at room temperature
- Protect from light.
- Keep Absorica and all medicines out of the reach of children.
Isotretinoin Pregnancy Warnings
Use is contraindicated. AU TGA pregnancy category: X US FDA pregnancy category: X Comments: -Female patients of reproductive potential should be tested for pregnancy before receiving a prescription for this drug. -Any suspected fetal exposure during or 1 month after isotretinoin therapy must be reported at once to the FDA via the MedWatch number 1-800-FDA-1088 and also to the iPLEDGE pregnancy registry at 1-866-495-0654 or via the Internet (www.ipledgeprogram.com), and patients should be referred to a healthcare provider specialized or experienced in teratology. -Effective contraception (at least 2 reliable forms) is required during therapy and for 1 month after the last dose; local protocol should be consulted regarding contraception timing.
Severe birth defects have occurred after exposure to this drug in any dose and over any duration, even for short periods of time. There are no accurate means to determine whether an exposed fetus is affected. AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.