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Claravis (Generic Isotretinoin)

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Every patient:

Those who are pregnant or may become pregnant should not use isotretinoin. Isotretinoin carries a significant risk of resulting in pregnancy loss, premature birth, neonatal death, or birth abnormalities in the unborn child (physical problems that are present at birth).

To ensure that pregnant women do not take isotretinoin and that women do not become pregnant while using isotretinoin, a programme called iPLEDGE has been established. Only individuals who are enrolled with iPLEDGE, have a prescription from a doctor who is registered with iPLEDGE, and fill the prescription at a pharmacy that is registered with iPLEDGE are eligible to receive isotretinoin, including men and women who are unable to become pregnant. Do not purchase isotretinoin online.

Before you can take the prescription, you must sign an informed consent form confirming that you have read and understand the information on the dangers of using isotretinoin. Throughout your treatment, you will need to visit your doctor once a month to discuss your condition and any adverse effects you may be having. Your doctor may write you a prescription at each appointment for a maximum of 30 days’ worth of medication, with no more refills. If you are a woman who has a chance of getting pregnant, you must also take a pregnancy test every month at an authorised lab and have your prescription filled and picked up no later than seven days after the results. You must get this prescription filled and picked up if you are a male or a woman who cannot get pregnant within 30 days of your medical visit. If you arrive to pick up your medication after the allotted time limit has elapsed, your pharmacist is unable to dispense it.

If there is anything concerning isotretinoin or the iPLEDGE programme that you do not understand, or if you have any doubts about your ability to maintain appointments or take your medication as prescribed each month, let your doctor know right away.

After you begin your therapy, your doctor will provide you with an identifying number and card. This number is required to fill prescriptions and to use the iPLEDGE website and phone line for information. Store the card in a secure location where it won’t be misplaced. If you do misplace your card, you can call or use the website to request a new one.

While taking isotretinoin and for one month after finishing your treatment, avoid giving blood.

Don’t give isotretinoin to anyone else, not even if they have the same symptoms you do.

The patient information sheet (Medication Guide) from the manufacturer will be sent to you by your doctor or pharmacist when you start isotretinoin treatment and at each time you get a prescription refill. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available online at the websites of the manufacturer, the Food and Drug Administration (FDA), and the iPLEDGE programme (

The dangers of taking isotretinoin should be discussed with your doctor.

Patients who are female:

During your isotretinoin therapy, you must adhere to certain conditions in order to be able to become pregnant. Even if you have not yet begun menstruation (had monthly periods) or have had a tubal ligation (also known as having your tubes tied; a procedure to prevent pregnancy), you must still complete these conditions. Only if you have gone without a period for a continuous 12 months, your doctor certifies that you have passed menopause (a change of life), or you have undergone surgery to remove your uterus and/or both ovaries, may you be exempt from satisfying these requirements. If none of these apply to you, you must fulfil the conditions listed below.

For the month before you start taking isotretinoin, for the duration of your treatment, and for the month after your treatment, you must utilise two reliable types of birth control. Your doctor will notify you in writing about birth control and will specify which methods are suitable. In order to discuss the birth control that is best for you, you can also schedule a free consultation with a doctor or family planning specialist. Unless you can guarantee that you won’t have any sexual contact with a male for a month prior to your treatment, a month during your treatment, and a month following your treatment, you must use one of these two methods of birth control at all times.

Pregnancy must be avoided for 1 month prior to, throughout, and for 1 month following isotretinoin treatment if you decide to take it. You must be aware that birth control methods might all fail. Consequently, it is crucial to use two types of birth control at all times in order to lower the risk of unintended pregnancy. If you don’t comprehend anything that was spoken to you about birth control or if you don’t believe that you will be able to utilise two forms of birth control constantly, let your doctor know right away.

Tell your doctor what kind of birth control pill you’ll be taking if you intend to use one while taking isotretinoin. Micro-dosed progestin oral contraceptives (sometimes known as “minipills”) are rendered ineffective by isotretinoin (Ovrette, Micronor, Nor-QD). While taking isotretinoin, avoid using this method of birth control.

Inform your doctor of all the drugs, vitamins, and herbal supplements you are taking if you intend to use hormonal contraceptives, such as birth control tablets, patches, implants, injections, rings, or intrauterine devices. Hormonal contraceptives are affected negatively by a number of drugs. If you use a hormonal contraceptive of any kind, avoid taking St. John’s wort.

Before starting isotretinoin, two pregnancy tests must come back negative. Your doctor will advise you on the timing and location of these tests. Also, you must undergo a pregnancy test in a lab every month while receiving treatment, as well as 30 days following your final dose.

Every month, you must confirm the two methods of birth control you are using and respond to two questions regarding the iPLEDGE programme by calling or visiting the iPLEDGE website. If you have done this, if you have seen your doctor to discuss how you are feeling and how you are taking your birth control, and if you have had a negative pregnancy test within the last seven days, you will only be eligible to continue receiving isotretinoin.

If you suspect pregnancy, skip a period, or engage in sexual activity without using two types of birth control, stop taking isotretinoin immediately and contact your doctor. Your doctor will notify the iPLEDGE programme, the isotretinoin manufacturer, and the Food and Drug Administration if you become pregnant while undergoing therapy or within 30 days of finishing it (FDA). You will also speak with a doctor who focuses on issues related to pregnancy who can guide you in choosing what is best for both you and your unborn child. Doctors will utilise information about your and your unborn child’s health to better understand how isotretinoin affects developing children.

Men’s health patients:

When you take the recommended doses of this medication, a very little quantity of isotretinoin will likely be found in your semen. If your partner is or gets pregnant, it is unknown if this trace level of isotretinoin may harm the developing foetus. If your partner becomes pregnant while you’re taking isotretinoin, plans to become pregnant, or already is pregnant, let your doctor know right once.

Why is this medication prescribed?

A specific type of severe acne called recalcitrant nodular acne, which has not responded to previous therapies like antibiotics, is treated with isotretinoin. Isotretinoin belongs to the group of drugs known as retinoids. It functions by reducing the amount of some natural compounds that might exacerbate acne.

How should this medicine be used?

The oral medication isotretinoin is available as a capsule. Isotretinoin is typically given twice daily with meals for a period of 4 to 5 months. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the isotretinoin directions exactly. Never take it in larger or less amounts or more frequently than directed by your doctor.

With a full glass of drink, swallow the capsules whole. The capsules should not be crushed, chewed, or sucked.

Your doctor will likely start you on an average dose of isotretinoin and adjust it as needed based on your response to the drug and any negative side effects. If you have any questions about how much isotretinoin to take, consult your doctor or pharmacist before proceeding.

You might not experience isotretinoin’s full benefits for a few weeks or longer. At the start of your isotretinoin treatment, your acne may develop worse. This is typical and doesn’t indicate that the medication isn’t doing its job. Even after you quit using isotretinoin for your acne, it can still get better.

Other uses for this medicine

Several forms of cancer and other skin diseases have been treated with isotretinoin. Discuss the potential dangers of using this medicine for your illness with your doctor.

Other prescriptions for this drug are possible. For more information, consult your physician or pharmacist.

What special precautions should I follow?

Before taking isotretinoin,

  • If you have any allergies, including to isotretinoin, vitamin A, other drugs, or any of the substances in isotretinoin capsules, notify your doctor right once. For a list of the inactive ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any prescription and over-the-counter drugs, vitamins, herbal remedies, and dietary supplements you are now taking or intend to use. Be sure to mention medications for seizures such as phenytoin (Dilantin); medications for mental illness; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone; tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Monodox, Vibramycin, others), minocycline (Minocin, Vectrin), oxytetracycline (Terramycin), and tetracycline (Sumycin, Tetrex, others); and vitamin A supplements. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Inform your doctor if you or anyone in your family has ever considered or attempted suicide, has depression, mental illness, diabetes, asthma, osteoporosis (a condition where the bones are brittle and break easily), osteomalacia (weak bones caused by a lack of vitamin D or difficulty absorbing this vitamin), or other conditions that cause weak bones, high blood triglyceride levels, or a disorder of lipid metabolism. Moreover, let your doctor know if you are obese and if you currently or have previously consumed substantial amounts of alcohol.
  • You shouldn’t breastfeed while using isotretinoin and for one month after stopping it.
  • Plan to use protective clothing, sunglasses, and sunscreen as well as to minimise excessive or prolonged sun exposure. Your skin may become more sensitive to sunlight if you use isotretinoin.
  • You should be aware that taking isotretinoin may alter your mood, behaviour, or mental health. Some isotretinoin users had depression or psychosis (loss of reality awareness), turned violent, had suicidal thoughts, attempted suicide, or were actually successful in doing so. If you or a member of your family notices any of the following symptoms, you should seek medical attention right away: anxiety, sadness, crying spells, loss of interest in previously enjoyed activities, poor performance at work or school, sleeping more than usual, trouble falling asleep or staying asleep, irritability, anger, aggression, changes in appetite or weight, difficulty concentrating, withdrawal from friends or family, lack of energy, feelings of worthlessness or guilt (seeing or hearing things that do not exist). Make sure your family members are aware of which symptoms require immediate attention so they can phone the doctor on your behalf if you are unable to do so on your own.
  • You should be aware that using contacts during and after your treatment with isotretinoin may make your eyes feel dry and unpleasant.
  • Isotretinoin may impair your capacity for night vision, so you should be aware of this. Any moment during your therapy, this issue could materialise out of nowhere, and it might persist even after your treatment has ended. Driving or operating machinery at night requires extreme caution.
  • Plan to refrain from waxing, laser skin treatments, and dermabrasion (surgical skin smoothing) while you are on isotretinoin and for six months after your treatment. The possibility of developing scars from these therapies is increased by isotretinoin. Find out from your doctor when you can receive these therapies without risk.
  • Before engaging in strenuous physical activity, such as sports, consult your doctor. Isotretinoin may weaken or thicken bones unnaturally, which may raise the risk of certain bone injuries in those who engage in specific forms of physical activity. Tell all of your healthcare professionals that you are taking isotretinoin if you break a bone while receiving treatment.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Ignore the missed dose and carry on with my normal dosing routine. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

There may be negative effects from isotretinoin. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Red, chapped, and painful lips
  • Dry lips, nose, eyes, or skin
  • Nosebleeds
  • Variations in skin tone
  • Skin on the palms of the hands and soles of the feet that is peeling off
  • Alterations to the nails
  • Slowed-down wound or painful healing
  • Swollen or bleeding gums
  • Hair thinning or unwelcome hair growth
  • Sweating
  • Flushing
  • Voice variations
  • Tiredness
  • Cold signs

Some adverse effects may be severe. You should stop taking isotretinoin and call your doctor or seek emergency medical attention right away if you have any of the following symptoms or any of those noted in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections:

  • Headache
  • Fuzzy vision
  • Dizziness
  • Nausea
  • Vomiting
  • Seizures
  • Slow or challenging speech
  • Weakness or numbness in one bodily region or side.
  • Abdominal pain
  • Chest ache
  • Swallowing issues or swallowing discomfort
  • New or escalating heartburn
  • Diarrhoea
  • Abdominal bleeding
  • Eyes or skin that have a yellow tint
  • Urine with a dark colour
  • Back, joint, muscular, or bone pain
  • Muscular tremor
  • Having trouble hearing
  • Hearing ringing
  • Vision issues
  • Eyes that are constantly dry or hurt
  • Uncommon thirst
  • Excessive urination
  • Difficulty breathing
  • Fainting
  • Hammering or rapid heartbeat
  • Teary, red, itchy, or swollen eyes
  • Fever
  • Rash
  • Skin that is peeling or blistering, particularly on the arms, legs, or face
  • Mouth, throat, nose, or eye sores
  • Bruises or red areas on the legs
  • Eye, face, tongue, throat, arms, hands, feet, ankles, or lower legs swelling
  • Swallowing issues or swallowing discomfort

Teenagers using isotretinoin risk having their bones stop growing too young. The hazards of giving your child this medication should be discussed with your child’s doctor.

Further negative effects of isotretinoin are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it away from excessive heat and moisture at room temperature (not in the bathroom).

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose signs could include the following:

  • Vomiting
  • Flushing
  • Severe lip chapping
  • Abdominal pain
  • Headache
  • Dizziness
  • Inability to coordinate

Anyone who has taken an excessive amount of isotretinoin should be aware of the possibility of birth abnormalities and should refrain from giving blood for a month following the overdose. Pregnant women should discuss the dangers of continuing their pregnancy after an overdose with their doctors. During one month following the overdose, women who are capable of getting pregnant should use two types of birth control. Men should wear condoms or refrain from sexual activity with their partners for a month following an overdose since isotretinoin may be present in the semen.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor how you are responding to isotretinoin, your doctor will request a number of lab tests.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Absorica®
  • Accutane®
  • Amnesteem®
  • Claravis®
  • Myorisan®
  • Sotret®
  • Zenatane®
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