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Claravis is a form of vitamin A that is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
Claravis is available only from a certified pharmacy under a special program called iPLEDGE.
Claravis may also be used for purposes not listed in this medication guide.
Claravis in just a single dose can cause severe birth defects or death of a baby. Never use Claravis if you are pregnant or may become pregnant.
You must have a negative pregnancy test before taking Claravis. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using this medicine and call your doctor at once if you think you might be pregnant.
Claravis can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use this medicine if you are pregnant.
For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking Claravis, before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.
You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking Claravis and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.
Primary forms of birth control include:
tubal ligation (tubes tied);
vasectomy of the male sexual partner;
an IUD (intrauterine device);
estrogen-containing birth control pills (not mini-pills); and
hormonal birth control patches, implants, injections, or vaginal ring.
Secondary forms of birth control include:
a male latex condom with or without spermicide;
a diaphragm plus a spermicide;
a cervical cap plus a spermicide; and
a vaginal sponge containing a spermicide.
Stop using Claravis and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking this medicine, call the iPLEDGE pregnancy registry at 1-866-495-0654.
Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.
You should not use Claravis if you are allergic to it.
Tell your doctor if you have ever had:
depression or mental illness;
asthma;
liver disease;
diabetes;
heart disease or high cholesterol;
osteoporosis or low bone mineral density;
an eating disorder such as anorexia;
a food or drug allergy; or
an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.
You should not breastfeed while using this medicine.
Claravis is not approved for use by anyone younger than 12 years old.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.
Always take Claravis with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.
Follow all directions about taking Claravis with or without food.
Use Claravis for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.
You may need frequent blood tests.
Never share this medicine with another person, even if they have the same symptoms you have.
Store at room temperature away from moisture, heat, and light.
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.
Do not take a vitamin or mineral supplement that contains vitamin A.
Do not donate blood while taking Claravis and for at least 30 days after you stop taking it. Donated blood that is later given to a pregnant woman could lead to birth defects in her baby if the blood contains any level of isotretinoin.
While you are taking Claravis and for at least 6 months after your last dose: Do not use wax hair removers or have dermabrasion or laser skin treatments. Scarring may result.
Claravis could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Avoid driving or hazardous activity until you know how Claravis will affect you. Claravis may impair your vision, especially at night.
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Stop using Claravis and call your doctor at once if you have:
problems with your vision or hearing;
muscle or joint pain, bone pain, back pain;
increased thirst, increased urination;
hallucinations, (see or hearing things that are not real);
symptoms of depression--unusual mood changes, crying spells, feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself;
signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);
severe stomach problems--severe stomach or chest pain, pain when swallowing, heartburn, diarrhea, rectal bleeding, bloody or tarry stools; or
increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.
Common side effects may include:
dryness of your skin, lips, eyes, or nose (you may have nosebleeds);
vision problems;
headache, back pain, joint pain, muscle problems;
skin reactions; or
cold symptoms such as stuffy nose, sneezing, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your other medicines, especially:
phenytoin;
St. John's wort;
vitamin or mineral supplements;
progestin-only birth control pills (mini-pills);
steroid medicine; or
a tetracycline antibiotic, including doxycycline or minocycline.
This list is not complete. Other drugs may affect Claravis, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Claravis (www.drugs.com/mtm/claravis.html).
Note: This document contains side effect information about isotretinoin. Some of the dosage forms listed on this page may not apply to the brand name Claravis.
Common side effects of Claravis include: cheilitis, epistaxis, hypertriglyceridemia, pruritus, xerosis cutis, decreased hdl cholesterol, increased liver enzymes, increased serum triglycerides, musculoskeletal signs and symptoms, dry nose, xeroderma, and xerostomia. Other side effects include: increased serum cholesterol. See below for a comprehensive list of adverse effects.
Applies to isotretinoin: oral capsule, oral capsule liquid filled
Oral route (Capsule, Liquid Filled)
Pregnancy Category XIsotretinoin must not be used by patients who are or may become pregnant.There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin 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 patient who is taking isotretinoin, isotretinoin 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 the risk of teratogenicity and to minimize fetal exposure, isotretinoin is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called iPLEDGE®. Under the isotretinoin REMS, prescribers, patients, pharmacies, and distributors must enroll and be registered in the program.
Along with its needed effects, isotretinoin (the active ingredient contained in Claravis) 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 while taking isotretinoin:
More common
Rare
Incidence not known
Some side effects of isotretinoin 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
Incidence not known
Applies to isotretinoin: compounding powder, oral capsule
The most commonly reported side effects include dryness of the skin and mucous membranes (e.g., cheilitis, epistaxis, conjunctivitis).
Very common (10% or more): Cheilitis/dry lips (up to 90%)
Very rare (less than 0.01%): Colitis, ileitis, gastrointestinal hemorrhage, nausea, pancreatitis/fatal pancreatitis, hemorrhagic diarrhea and inflammatory bowel disease
Frequency not reported: Esophagitis/esophageal ulceration, chapped lips, constipation, diarrhea/severe diarrhea, abdominal pain, vomiting, other nonspecific gastrointestinal symptoms, bleeding and inflammation of the gums
Very common (10% or more): Increased red blood cell sedimentation rate (up to 40%)
Common (1% to 10%): Neutropenia/severe neutropenia, anemia, thrombocytopenia/decreased platelet counts, thrombocytosis
Rare (0.01% to 0.1%): Agranulocytosis
Very rare (less than 0.01%): Lymphadenopathy
Frequency not reported: Decreased red blood cell parameters, decreased red blood cell counts/hematocrit, decreased white blood cell counts, increased platelet counts
Very common (10% or more): Increased blood triglycerides/hypertriglyceridemia (up to 30%)
Common (1% to 10%): Increased blood cholesterol/hyperlipidemia, increased blood glucose/alterations in blood sugar levels, decreased high density lipoprotein
Very rare (less than 0.01%): Diabetes mellitus, hyperuricemia
Frequency not reported: Weight loss/fluctuations in weight, decreased appetite, increased low density lipoprotein
Postmarketing reports: Increased fasting blood glucose levels
Bronchospasm occurred in patients receiving treatment, especially in those with asthma.
Very common (10% or more): Epistaxis (Up to 30%)
Common (1% to 10%): Hoarseness, nasal dryness, nasopharyngitis
Very rare (less than 0.01%): Bronchospasm, dry throat
Frequency not reported: Respiratory infection/upper respiratory tract infection, voice alteration
In some cases, acne flares occurred during the initial stages of treatment and persisted for several weeks
Common (1% to 10%): Dermatitis, dry skin, localized exfoliation, pruritus, rash erythematous, skin fragility/risk of frictional trauma
Rare (0.01% to 0.1%): Allergic skin reaction, alopecia/persistent or resistant alopecia
Very rare (less than 0.01%): Mucocutaneous/gram positive bacterial infection, allergic vasculitis, acne fulminans, acne aggravated/acne flare, facial erythema, exanthema, hair disorders/persistent hair thinning, hirsutism, nail dystrophy, paronychia, photosensitivity/photoallergic reaction, pyogenic granuloma, skin hyperpigmentation, sweating/increased sweating, increased formation of granulation tissue
Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eruptive xanthoma, hypopigmentation, increased sunburn susceptibility, urticaria, eczema, contact dermatitis, sunburn, peeling of the palms and soles
Postmarketing reports: Bruising, seborrhea
Papilledema occurred as a sign of benign intracranial hypertension.
Common (1% to 10%): Blepharitis, conjunctivitis, dry eye, eye irritation
Very rare (less than 0.01%): Blurred vision, cataract/lenticular cataracts, color blindness/color vision deficiencies, contact lens intolerance, corneal opacity/reversible corneal opacities, decreased night vision/persistently decreased night vision, keratitis, papilledema, photophobia, visual disturbances, optic neuritis, hordeolum
Frequency not reported: Eyelid inflammation, decreased visual acuity, eye pruritus, asthenopia, ocular hyperemia, increased lacrimation
Common (1% to 10%): Arthralgia/severe arthralgia, back pain/severe back pain, myalgia/severe myalgia with or without elevated creatine phosphokinase (CPK) levels
Very rare (less than 0.01%): Arthritis, premature epiphyses fusion, exostosis, skeletal hyperostosis/hyperostosis, reduced bone density/decreased bone mineral density, tendonitis, rhabdomyolysis, increased blood CPK, rhabdomyolysis, other types of bone abnormalities, calcinosis/calcification of ligaments and tendons
Frequency not reported: Neck pain, musculoskeletal pain/discomfort/stiffness, extremity pain
Back pain occurred more frequently in children and adolescent patients.
Rhabdomyolysis, sometimes leading to hospitalization or death, has occurred, especially in patients undertaking vigorous physical activity.
Common (1% to 10%): Proteinuria, microscopic or gross hematuria
Frequency not reported: Abnormal menses, nonspecific urogenital findings, white cells in the urine
Common (1% to 10%): Headache
Very rare (less than 0.01%): Benign intracranial hypertension, convulsions, drowsiness, dizziness
Frequency not reported: Stroke, pseudotumor cerebri/increased intracranial pressure, lethargy, paresthesia, seizures, syncope
Common (1% to 10%): Transient and reversible increased transaminase levels
Very rare (less than 0.01%): Hepatitis
Frequency not reported: Increased alkaline phosphatase/lactate dehydrogenase/blood bilirubin
Depression symptoms have been reported to disappear after discontinuation of the drug and reappear when treatment is resumed.
Rare (0.01% to 0.1%): Depression, aggravated depression, aggression/aggressive tendencies, anxiety, mood alterations
Very rare (less than 0.01%): Abnormal behavior, psychosis/psychotic disorder, suicidal ideation/attempt, suicide
Frequency not reported: Nervousness, insomnia, violent behavior, emotional instability, irritability, panic attack, anger, euphoria, behavioral disorders
Postmarketing reports: Auditory hallucinations
Rare (0.01% to 0.1%): Anaphylactic reaction, hypersensitivity/systemic hypersensitivity
Frequency not reported: Allergic reactions
Very rare (less than 0.01%): Impaired hearing/impaired hearing at certain frequencies, malaise
Frequency not reported: Fatigue, pain, tinnitus, weakness, disseminated herpes simplex, delayed wound healing, exuberant granulation tissue with crusting, local or systemic infections due to gram positive bacteria (Staphylococcus aureus)
Postmarketing reports: Infection
Very rare (less than 0.01%): Vasculitis, Wegener's granulomatosis
Frequency not reported: Edema, palpitations, tachycardia, vascular thrombotic disease, transient chest pain, flushing
Very rare (less than 0.01%): Glomerulonephritis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Claravis (www.drugs.com/mtm/claravis.html).
March 28, 2020
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