Disclaimer:
Medidex is not a provider of medical services and all information is provided for the convenience of the user. No medical decisions should be made based on the information provided on this website without first consulting a licensed healthcare provider.This website is intended for persons 18 years or older. No person under 18 should consult this website without the permission of a parent or guardian.
Claravis
Overview
What is Claravis?
Isotretinoin, USP a retinoid, is available as Claravis (isotretinoin capsules USP), in 10 mg, 20 mg, 30 mg and 40 mg hard gelatin capsules for oral administration. Chemically, isotretinoin is 13--retinoic acid and is related to both retinoic acid and retinol (vitamin A). It is a yellow to orange crystalline powder. The structural formula is:
CHO Molecular Weight: 300.44
Each capsule contains the following inactive ingredients: butylated hydroxyanisole, edetate disodium, gelatin, hydrogenated vegetable oil, polysorbate 80, soybean oil, titanium dioxide, white wax (beeswax), and vitamin E.
In addition, the 10 mg capsule contains black iron oxide and FD&C yellow no. 6. The 20 mg capsule contains black iron oxide, red iron oxide and yellow iron oxide. The 30 mg capsule contains red iron oxide and yellow iron oxide. The 40 mg capsule contains FD&C yellow no. 6.
The edible imprinting ink contains: 10 mg strength, D&C red no. 7 calcium lake, FD&C yellow no. 6 aluminum lake, propylene glycol, shellac glaze, and titanium dioxide; 20 mg strength, ammonium hydroxide, propylene glycol, shellac glaze, simethicone and titanium dioxide; 30 mg strength, D&C yellow no. 10 aluminum lake, FD&C blue no.1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, iron oxide black, propylene glycol, and shellac glaze; 40 mg strength, ammonium hydroxide, iron oxide black, propylene glycol, and shellac glaze.
Meets dissolution test 2.
What does Claravis look like?
What are the available doses of Claravis?
Sorry No records found.
What should I talk to my health care provider before I take Claravis?
Sorry No records found
How should I use Claravis?
Claravis should be administered with a meal (see PRECAUTIONS, ).
The recommended dosage range for Claravis is 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies 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. Failure to take Claravis with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Claravis has not been established. Once daily dosing is recommended.
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 Claravis, even in low doses, has not been studied, and is not recommended. It is important that Claravis be given at the recommended doses for no longer than the recommended duration. The effect of long-term use of Claravis on bone loss is unknown (see WARNINGS, Skeletal, , and ).
Contraceptive measures must be followed for any subsequent course of therapy (see ).
What interacts with Claravis?
Sorry No Records found
What are the warnings of Claravis?
Psychiatric Disorders
Claravis may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events (see , Psychiatric). Prescribers should read the brochure, . Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore,prior to initiation of Claravis therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. Signs and symptoms of depression, as described in the brochure (“Recognizing Psychiatric Disorders in Adolescents and Young Adults”), include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment. Patients should stop Claravis and the patient or a family member should promptly contact their prescriber if the patient develops depression, mood disturbance, psychosis, or aggression, without waiting until the next visit. Discontinuation of Claravis therapy may be insufficient; further evaluation may be necessary. While such monitoring may be helpful, it may not detect all patients at risk. Patients may report mental health problems or family history of psychiatric disorders. These reports should be discussed with the patient and/or the patient’s family. A referral to a mental health professional may be necessary. The physician should consider whether Claravis therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Claravis therapy.
Pseudotumor Cerebri
Claravis use has been associated with a number of cases of pseudotumor cerebri (benign intracranial hypertension), some of which involved concomitant use of tetracyclines. Concomitant treatment with tetracyclines should therefore be avoided. Early signs and symptoms of pseudotumor cerebri include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, they should be told to discontinue Claravis immediately and be referred to a neurologist for further diagnosis and care (see , Neurological).
Serious Skin Reactions
There have been postmarketing reports of erythema multiforme and severe skin reactions [e.g., Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use. These events may be serious and result in death, life-threatening events, hospitalization or disability. Patients should be monitored closely for severe skin reactions, and discontinuation of Claravis should be considered if warranted.
Pancreatitis
Array
In rare instances, fatal hemorrhagic pancreatitis has been reported.
Lipids
Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Claravis. Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving Claravis in clinical trials. In addition, approximately 15% developed a decrease in high-density lipoproteins and about 7% showed an increase in cholesterol levels. In clinical trials, the effects on triglycerides, HDL, and cholesterol were reversible upon cessation of Claravis therapy. Some patients have been able to reverse triglyceride elevation by reduction in weight, restriction of dietary fat and alcohol, and reduction in dose while continuing Claravis.
Blood lipid determinations should be performed before Claravis is given and then at intervals until the lipid response to Claravis is established, which usually occurs within 4 weeks. Especially careful consideration must be given to risk/benefit for patients who may be at high risk during Claravis therapy (patients with diabetes, obesity, increased alcohol intake, lipid metabolism disorder or familial history of lipid metabolism disorder). If Claravis therapy is instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended (see PRECAUTIONS, ).
The cardiovascular consequences of hypertriglyceridemia associated with Claravis are unknown.
In rats given 8 or 32 mg/kg/day of isotretinoin (1.3 to 5.3 times the recommended clinical dose of 1 mg/kg/day after normalization for total body surface area) for 18 months or longer, the incidences of focal calcification, fibrosis and inflammation of the myocardium, calcification of coronary, pulmonary and mesenteric arteries, and metastatic calcification of the gastric mucosa were greater than in control rats of similar age. Focal endocardial and myocardial calcifications associated with calcification of the coronary arteries were observed in two dogs after approximately 6 to 7 months of treatment with isotretinoin at a dosage of 60 to 120 mg/kg/day (30 to 60 times the recommended clinical dose of 1 mg/kg/day, respectively, after normalization for total body surface area).
Hearing Impairment
Impaired hearing has been reported in patients taking Claravis; in some cases, the hearing impairment has been reported to persist after therapy has been discontinued. Mechanism(s) and causality for this event have not been established. Patients who experience tinnitus or hearing impairment should discontinue Claravis treatment and be referred for specialized care for further evaluation (see , Special Senses).
Hepatotoxicity
Clinical hepatitis considered to be possibly or probably related to Claravis therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been observed in approximately 15% of individuals treated during clinical trials, some of which normalized with dosage reduction or continued administration of the drug. If normalization does not readily occur or if hepatitis is suspected during treatment with Claravis, the drug should be discontinued and the etiology further investigated.
Inflammatory Bowel Disease
Claravis has been associated with inflammatory bowel disease (including regional ileitis) in patients without a prior history of intestinal disorders. In some instances, symptoms have been reported to persist after Claravis treatment has been stopped. Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue Claravis immediately (see , Gastrointestinal).
Skeletal
Bone Mineral Density
Hyperostosis
Premature Epiphyseal Closure
There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Claravis. The effect of multiple courses of Claravis on epiphyseal closure is unknown.
Vision Impairment
Visual problems should be carefully monitored. All Claravis patients experiencing visual difficulties should discontinue Claravis treatment and have an ophthalmological examination (see , Special Senses).
Corneal Opacities
Corneal opacities have occurred in patients receiving Claravis for acne and more frequently when higher drug dosages were used in patients with disorders of keratinization. The corneal opacities that have been observed in clinical trial patients treated with Claravis have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug (see , Special Senses).
Decreased Night Vision
Decreased night vision has been reported during Claravis therapy and in some instances the event has persisted after therapy was discontinued. Because the onset in some patients was sudden, patients should be advised of this potential problem and warned to be cautious when driving or operating any vehicle at night.
What are the precautions of Claravis?
Claravis must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Claravis must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive isotretinoin only from wholesalers registered with iPLEDGE.
iPLEDGE Program requirements for wholesalers, prescribers, and pharmacists are described below:
Wholesalers
- Array
- Array
- Array
- Array
- Array
- Array
•
•
•
•
•
•
For the purpose of the iPLEDGE Program, the term wholesaler refers to wholesaler, distributor, and/or chain pharmacy distributor. To distribute Claravis, wholesalers must be registered with iPLEDGE and agree to meet all iPLEDGE requirements for wholesale distribution of isotretinoin products. Wholesalers must register with iPLEDGE by signing and returning the iPLEDGE wholesaler agreement that affirms they will comply with all iPLEDGE requirements for distribution of isotretinoin. These include:
Prescribers
The Guide to Best Practices for the iPLEDGE Program
The iPLEDGE Program Prescriber Contraception Counseling Guide
- Array
- Array
- Array
- Array
- Array
- Array
- Array
females of reproductive potential
- Array
- Array
- Array
Has
Has
Has had
Has
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- •
- Array
To prescribe isotretinoin, the prescriber must be registered and activated with the pregnancy risk management program iPLEDGE. Prescribers can register by signing and returning the completed registration form. Prescribers can only activate their registration by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:
To prescribe isotretinoin, the prescriber must access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to:
Isotretinoin must only be prescribed to female patients who are known not to be pregnant as confirmed by a negative CLIA-certified laboratory conducted pregnancy test.
Isotretinoin must only be dispensed by a pharmacy registered and activated with the pregnancy risk management program iPLEDGE and only when the registered patient meets all the requirements of the iPLEDGE Program. Meeting the requirements for a female of reproductive potential signifies that she:
If the patient has unprotected heterosexual intercourse at any time one month before, during, or one month after therapy, she must:
Effective forms of contraception include both primary and secondary forms of contraception:
Primary forms
Secondary forms
Barrier forms:
Other:
Any birth control method can fail. There have been reports of pregnancy from female patients who have used oral contraceptives, as well as transdermal patch/injectable/implantable/vaginal ring hormonal birth control products; these pregnancies occurred while these patients were taking Claravis. These reports are more frequent for female patients who use only a single method of contraception. Therefore, it is critically important that females of reproductive potential use two effective forms of contraception simultaneously. Patients must receive written warnings about the rates of possible contraception failure (included in patient education kits).
Using two forms of contraception simultaneously substantially reduces the chances that a female will become pregnant over the risk of pregnancy with either form alone. A drug interaction that decreases effectiveness of hormonal contraceptives has not been entirely ruled out for Claravis (see PRECAUTIONS, ). Although hormonal contraceptives are highly effective, prescribers are advised to consult the package insert of any medication administered concomitantly with hormonal contraceptives, since some medications may decrease the effectiveness of these birth control products.
Patients should be prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because a possible interaction has been suggested with hormonal contraceptives based on reports of breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St. John's Wort.
If a pregnancy does occur during isotretinoin treatment, isotretinoin must be discontinued immediately. The patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Any suspected fetal exposure during or one month after isotretinoin therapy must be reported immediately to the FDA via the MedWatch number 1-800-FDA-1088 and also the iPLEDGE pregnancy registry at 1-866-495-0654 or via the internet (www.ipledgeprogram.com).
All Patients
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
•
Must
•
Must
•
Must
•
Must
•
Must
•
Must
•
Must
•
Must
Isotretinoin is contraindicated in female patients who are pregnant. To receive isotretinoin all patients must meet all of the following conditions:
Females of Reproductive Potential
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
•
Must
•
Must
•
Must
•
Must
•
Must
•
Must
•
Must
•
Must
Isotretinoin is contraindicated in female patients who are pregnant. In addition to the requirements for all patients described above, females of reproductive potential must meet the following conditions:
Pharmacists
Pharmacist Guide for the iPLEDGE Program
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
The Guide to Best Practices for the iPLEDGE Program
The iPLEDGE Program Prescriber Contraception Counseling Guide
The Pharmacist Guide for the iPLEDGE Program
The iPLEDGE Program Guide to Isotretinoin for Male Patients and Female Patients Who Cannot Get Pregnant
The iPLEDGE Program Guide to Isotretinoin for Female Patients Who Can Get Pregnant
The iPLEDGE Program Birth Control Workbook
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
To dispense isotretinoin, pharmacies must be registered and activated with the pregnancy risk management program iPLEDGE.
The Responsible Site Pharmacist must register the pharmacy by signing and returning the completed registration form. After registration, the Responsible Site Pharmacist can only activate the pharmacy registration by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:
To dispense isotretinoin, the pharmacist must:
Claravis must only be dispensed:
A Claravis Medication Guide must be given to the patient each time Claravis is dispensed, as required by law. This Claravis Medication Guide is an important part of the risk management program for the patients.
Claravis must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE Program. Only FDA-approved isotretinoin products must be distributed, prescribed, dispensed, and used. Patients must fill isotretinoin prescriptions only at US licensed pharmacies.
A description of the iPLEDGE Program educational materials available with iPLEDGE is provided below. The main goal of these educational materials is to explain the iPLEDGE Program requirements and to reinforce the educational messages.
General
Although an effect of Claravis on bone loss is not established, physicians should use caution when prescribing Claravis to patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. This would include patients diagnosed with anorexia nervosa and those who are on chronic drug therapy that causes drug-induced osteoporosis/osteomalacia and/or affects vitamin D metabolism, such as systemic corticosteroids and any anticonvulsant.
Patients may be at increased risk when participating in sports with repetitive impact where the risks of spondylolisthesis with and without pars fractures and hip growth plate injuries in early and late adolescence are known. There are spontaneous reports of fractures and/or delayed healing in patients while on therapy with Claravis or following cessation of therapy with Claravis while involved in these activities. While causality to Claravis has not been established, an effect must not be ruled out.
Information for Patients
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
- Array
•
•
•
•
Signs and symptoms of depression include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment
•
•
•
•
•
•
•
•
•
•
•
•
See and Boxed .
Hypersensitivity
Anaphylactic reactions and other allergic reactions have been reported. Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura (bruises and red patches) of the extremities and extracutaneous involvement (including renal) have been reported. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical management.
Drug Interactions
Claravis use is associated with depression in some patients
in vitro
Laboratory Tests
Pregnancy Test
Carcinogenesis, Mutagenesis and Impairment of Fertility
Pregnancy
Category X
See Boxed .
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Claravis.
Pediatric Use
The use of isotretinoin in pediatric patients less than 12 years of age has not been studied. The use of isotretinoin for the treatment of severe recalcitrant nodular acne in pediatric patients ages 12 to 17 years should be given careful consideration, especially for those patients where a known metabolic or structural bone disease exists (see PRECAUTIONS, ). Use of isotretinoin in this age group for severe recalcitrant nodular acne is supported by evidence from a clinical study comparing 103 pediatric patients (13 to 17 years) to 197 adult patients (≥18 years). Results from this study demonstrated that isotretinoin, at a dose of 1 mg/kg/day given in two divided doses, was equally effective in treating severe recalcitrant nodular acne in both pediatric and adult patients.
In studies with isotretinoin, adverse reactions reported in pediatric patients were similar to those described in adults except for the increased incidence of back pain and arthralgia (both of which were sometimes severe) and myalgia in pediatric patients (see ).
In an open-label clinical trial (N = 217) of a single course of therapy with Claravis for severe recalcitrant nodular acne, bone density measurements at several skeletal sites were not significantly decreased (lumbar spine change > -4% and total hip change > -5%) or were increased in the majority of patients. One patient had a decrease in lumbar spine bone mineral density > 4% based on unadjusted data. Sixteen (7.9%) patients had decreases in lumbar spine bone mineral density > 4%, and all the other patients (92%) did not have significant decreases or had increases (adjusted for body mass index). Nine patients (4.5%) had a decrease in total hip bone mineral density > 5% based on unadjusted data. Twenty-one (10.6%) patients had decreases in total hip bone mineral density > 5%, and all the other patients (89%) did not have significant decreases or had increases (adjusted for body mass index). Follow-up studies performed in eight of the patients with decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in five patients at the lumbar spine, while the other three patients had lumbar spine bone density measurements below baseline values. Total hip bone mineral densities remained below baseline (range -1.6% to -7.6%) in five of eight patients (62.5%).
In a separate open-label extension study of ten patients, ages 13 to 18 years, who started a second course of isotretinoin 4 months after the first course, two patients showed a decrease in mean lumbar spine bone mineral density up to 3.25% (see WARNINGS, Skeletal, ).
Geriatric Use
Clinical studies of isotretinoin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Although reported clinical experience has not identified differences in responses between elderly and younger patients, effects of aging might be expected to increase some risks associated with isotretinoin therapy (see and ).
What are the side effects of Claravis?
Clinical Trials and Postmarketing Surveillance
The adverse reactions listed below reflect the experience from investigational studies of Claravis, and the postmarketing experience. The relationship of some of these events to Claravis therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving Claravis are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g., of the lips, nasal passage, and eyes).
Dose Relationship
Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see and ADVERSE REACTIONS).
Body as a Whole
Allergic reactions, including vasculitis, systemic hypersensitivity (see PRECAUTIONS, ), edema, fatigue, lymphadenopathy, weight loss.
Cardiovascular
Palpitation, tachycardia, vascular thrombotic disease, stroke.
Endocrine/Metabolic
Hypertriglyceridemia (see WARNINGS, ), alterations in blood sugar levels (see PRECAUTIONS, ).
Gastrointestinal
Inflammatory bowel disease (see WARNINGS, ), hepatitis (see WARNINGS, ), pancreatitis (see WARNINGS, ), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms.
Hematologic
Allergic reactions (see PRECAUTIONS, ), anemia, thrombocytopenia, neutropenia, rare reports of agranulocytosis (see PRECAUTIONS, ). See PRECAUTIONS, for other hematological parameters.
Musculoskeletal
Skeletal hyperostosis, calcification of tendons and ligaments, premature epiphyseal closure, decreases in bone mineral density (see WARNINGS, ), musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia (see PRECAUTIONS, ), transient pain in the chest (see PRECAUTIONS, ), arthritis, tendonitis, other types of bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis (see PRECAUTIONS, ).
Neurological
Pseudotumor cerebri (see WARNINGS, ), dizziness, drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke, syncope, weakness.
Psychiatric
Suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression, violent behaviors (see WARNINGS, ), emotional instability.Of the patients reporting depression, some reported that the depression subsided with discontinuation of therapy and recurred with reinstitution of therapy.
Reproductive System
Abnormal menses.
Respiratory
Bronchospasms (with or without a history of asthma), respiratory infection, voice alteration.
Skin and Appendages
Acne fulminans, alopecia (which in some cases persists), bruising, cheilitis (dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas, erythema multiforme, flushing, fragility of skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections (including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles, photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial erythema, seborrhea, and eczema), Stevens-Johnson syndrome, sunburn susceptibility increased, sweating, toxic epidermal necrolysis, urticaria, vasculitis (including Wegener's granulomatosis; see PRECAUTIONS, ), abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see PRECAUTIONS, ).
Special Senses
Hearing
Vision: corneal opacities (see WARNINGS, ), decreased night vision which may persist (see WARNINGS, ), cataracts, color vision disorder, conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual disturbances.
Urinary System: glomerulonephritis (see PRECAUTIONS, ), nonspecific urogenital findings (see PRECAUTIONS, for other urological parameters).
Laboratory
Elevation of plasma triglycerides (see WARNINGS, ), decrease in serum high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment.
Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH (see WARNINGS, ).
Elevation of fasting blood sugar, elevations of CPK (see PRECAUTIONS, ), hyperuricemia.
Decreases in red blood cell parameters, decreases in white blood cell counts (including severe neutropenia and rare reports of agranulocytosis; see PRECAUTIONS, ), elevated sedimentation rates, elevated platelet counts, thrombocytopenia.
White cells in the urine, proteinuria, microscopic or gross hematuria.
What should I look out for while using Claravis?
What might happen if I take too much Claravis?
The oral LD of isotretinoin is greater than 4000 mg/kg in rats and mice (>600 times the recommended clinical dose of 1 mg/kg/day after normalization of the rat dose for total body surface area and >300 times the recommended clinical dose of 1 mg/kg/day after normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in rabbits (653 times the recommended clinical dose of 1 mg/kg/day after normalization for total body surface area). 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.
Claravis causes serious birth defects at any dosage (see Boxed ). Females of reproductive potential who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus, as described in the Boxed . Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling as described in . 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 one month after the overdose. All patients with isotretinoin overdose should not donate blood for at least one month.
How should I store and handle Claravis?
Claravis (isotretinoin capsules USP) is available as:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Claravis (isotretinoin capsules USP) is available as:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Claravis (isotretinoin capsules USP) is available as:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Claravis (isotretinoin capsules USP) is available as:Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Protect from light.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clinical improvement in nodular acne patients occurs in association with a reduction in sebum secretion. The decrease in sebum secretion is temporary and is related to the dose and duration of treatment with Claravis, and reflects a reduction in sebaceous gland size and an inhibition of sebaceous gland differentiation.
Non-Clinical Toxicology
NSAIDs may diminish the antihypertensive effect of ACE-inhibitors, ARBs, or beta-blockers (including propranolol).
Monitor patients taking NSAIDs concomitantly with ACE-inhibitors, ARBs, or beta-blockers for changes in blood pressure.
In addition, in patients who are elderly, volume-depleted (including those on diuretic therapy), or have compromised renal function, co-administration of NSAIDs with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. Monitor these patients closely for signs of worsening renal function.
Concomitant administration of some antacids (magnesium oxide or aluminum hydroxide) and sucralfate can delay the absorption of naproxen.
When naproxen as naproxen tablets is administered with aspirin, its protein binding is reduced, although the clearance of free naproxen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of naproxen and aspirin is not generally recommended because of the potential of increased adverse effects.
As with other NSAIDs, concomitant administration of cholestyramine can delay the absorption of naproxen.
Clinical studies, as well as postmarketing observations, have shown that naproxen tablets can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see ), as well as to assure diuretic efficacy.
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Naproxen and other nonsteroidal anti-inflammatory drugs have been reported to reduce the tubular secretion of methotrexate in an animal model. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. No significant interactions have been observed in clinical studies with naproxen and coumarin-type anticoagulants. However, caution is advised since interactions have been seen with other nonsteroidal agents of this class. The free fraction of warfarin may increase substantially in some subjects and naproxen interferes with platelet function.
There is an increased risk of gastrointestinal bleeding when selective serotonin reuptake inhibitors (SSRIs) are combined with NSAIDs. Caution should be used when NSAIDs are administered concomitantly with SSRIs.
Other Information Concerning Drug Interactions
Naproxen is highly bound to plasma albumin; it thus has a theoretical potential for interaction with other albumin-bound drugs such as coumarin-type anticoagulants, sulphonylureas, hydantoins, other NSAIDs, and aspirin. Patients simultaneously receiving naproxen and a hydantoin, sulphonamide or sulphonylurea should be observed for adjustment of dose if required.
Probenecid given concurrently increases naproxen anion plasma levels and extends its plasma half-life significantly.
Drug/Laboratory Test Interactions
Naproxen may decrease platelet aggregation and prolong bleeding time. This effect should be kept in mind when bleeding times are determined.
The administration of naproxen may result in increased urinary values for 17-ketogenic steroids because of an interaction between the drug and/or its metabolites with m-di-nitrobenzene used in this assay. Although 17-hydroxy-corticosteroid measurements (Porter-Silber test) do not appear to be artifactually altered, it is suggested that therapy with naproxen be temporarily discontinued 72 hours before adrenal function tests are performed if the Porter-Silber test is to be used.
Naproxen may interfere with some urinary assays of 5-hydroxy indoleacetic acid (5HIAA).
Carcinogenesis
A 2-year study was performed in rats to evaluate the carcinogenic potential of naproxen at rat doses of 8, 16, and 24 mg/kg/day (50, 100, and 150 mg/m). The maximum dose used was 0.28 times the systemic exposure to humans at the recommended dose. No evidence of tumorigenicity was found.
Claravis must only be prescribed by prescribers who are registered and activated with the iPLEDGE Program. Claravis must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive isotretinoin only from wholesalers registered with iPLEDGE.
iPLEDGE Program requirements for wholesalers, prescribers, and pharmacists are described below:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Review
Read user comments about the side effects, benefits, and effectiveness of losartan oral.
Overall User Ratings
514Total User Reviews
User Reviews
Learn about
User Reviews
Professional
Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
Tips
Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).