Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dizziness; facial flushing; headache; loss of balance; stomach pain; vomiting.
Proper storage of Netlook:
Store Netlook at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Netlook out of the reach of children and away from pets.
Overdose of Netlook in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
The oral LD of isotret (isotret (isotret (Netlook capsules) inoin capsules) inoin capsules) inoin is greater than 4000 mg/kg in rats and mice ( > 600 times the recommended clinical dose of 1.0 mg/ kg/day after normalization of the rat dose for total body surface area and > 300 times the recommended clinical dose of 1.0 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.
Isotret (isotret (isotret (Netlook capsules) inoin capsules) inoin capsules) inoin causes serious birth defects at any dosage. Female patients of childbearing potential who present with isotret (isotret (isotret (Netlook capsules) inoin capsules) inoin capsules) inoin 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 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 isotret (isotret (isotret (Netlook capsules) inoin capsules) inoin capsules) inoin 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 isotret (isotret (isotret (Netlook capsules) inoin capsules) inoin capsules) inoin overdose should not donate blood for at least 1 month.
What should I avoid while taking Netlook?
Do not take a vitamin or mineral supplement that contains vitamin A, unless your doctor tells you to.
Do not donate blood while taking Netlook (Eqv-Absorica) 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 Netlook (Eqv-Absorica).
While you are taking Netlook (Eqv-Absorica) 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.
Netlook (Eqv-Absorica) 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 Netlook (Eqv-Absorica) (Eqv-Absorica) will affect you. Netlook (Eqv-Absorica) may impair your vision, especially at night.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Netlook (Netlook) 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. Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Netlook. 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 Netlook (Netlook) 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 Netlook (Netlook) 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 Netlook (Netlook) 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 Netlook (Netlook) therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Netlook (Netlook) therapy.
Netlook (Netlook) 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 Netlook (Netlook) immediately and be referred to a neurologist for further diagnosis and care.
Serious Skin Reactions
There have been post-marketing reports of erythema multiforme and severe skin reactions [eg, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with Netlook 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 Netlook (Netlook) should be considered if warranted.
Acute pancreatitis has been reported in patients with either elevated or normal serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been reported. Netlook (Netlook) should be stopped if hypertriglyceridemia cannot be controlled at an acceptable level or if symptoms of pancreatitis occur.
Elevations of serum triglycerides in excess of 800 mg/dL have been reported in patients treated with Netlook (Netlook). Marked elevations of serum triglycerides were reported in approximately 25% of patients receiving Netlook (Netlook) 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 Netlook (Netlook) 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 Netlook (Netlook). Minimal skeletal hyperostosis and calcification of ligaments and tendons have also been observed by x-ray in prospective studies of nodular acne patients treated with a single course of therapy at recommended doses. The skeletal effects of multiple Netlook (Netlook) treatment courses for acne are unknown.
In a clinical study of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne, hyperostosis was not observed after 16 to 20 weeks of treatment with approximately 1 mg/kg/day of Netlook (Netlook) given in two divided doses. Hyperostosis may require a longer time frame to appear. The clinical course and significance remain unknown.
Premature Epiphyseal Closure
There are spontaneous reports of premature epiphyseal closure in acne patients receiving recommended doses of Netlook (Netlook). The effect of multiple courses of Netlook (Netlook) on epiphyseal closure is unknown.
Visual problems should be carefully monitored. All Netlook (Netlook) patients experiencing visual difficulties should discontinue Netlook (Netlook) treatment and have an ophthalmological examination.
Corneal opacities have occurred in patients receiving Netlook (Netlook) 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 Netlook (Netlook) have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation of the drug.
Decreased Night Vision
Decreased night vision has been reported during Netlook (Netlook) 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 should I discuss with my healthcare provider before taking Netlook?
Netlook is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.
It is dangerous to try and purchase Netlook on the Internet or from vendors outside of the United States. The sale and distribution of Netlook outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
Do not use this medication if you are allergic to Netlook or to parabens, or if you are pregnant or may become pregnant.
To make sure you can safely take Netlook, tell your doctor if you have any of these other conditions:
a personal or family history of depression or mental illness;
heart disease, high cholesterol or triglycerides;
osteoporosis or other bone disorders;
an intestinal disorder such as inflammatory bowel disease, ulcerative colitis, or Crohn's disease;
an eating disorder (anorexia nervosa); or
Netlook can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Netlook can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Netlook if you are pregnant.
For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential.
Even women who have had their tubes tied are required to use birth control while taking Netlook.
You must have a negative pregnancy test 30 days before you start taking Netlook. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Netlook, 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 Netlook and ending 30 days after you stop taking it. 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 plus spermicidal foam or gel;
a diaphragm plus spermicidal foam or gel;
a cervical cap plus spermicidal foam or gel; and
a vaginal sponge containing spermicide.
Stop using Netlook 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 Netlook, call the iPLEDGE pregnancy registry at 1-866-495-0654.
It is not known whether Netlook passes into breast milk. Do not take Netlook without first talking to your doctor if you are breast-feeding a baby.
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
Netlook (Netlook) must only be prescribed by prescribers who are registered and activated with the iPLEDGE program. Netlook (Netlook) must only be dispensed by a pharmacy registered and activated with iPLEDGE, and must only be dispensed to patients who are registered and meet all the requirements of iPLEDGE. Registered and activated pharmacies must receive Netlook (Netlook) only from wholesalers registered with iPLEDGE.
iPLEDGE program requirements for wholesalers, prescribers, and pharmacists are described below:
For the purpose of the iPLEDGE program, the term wholesaler refers to wholesaler, distributor, and/or chain pharmacy distributor. To distribute Netlook (Netlook), wholesalers must be registered with iPLEDGE, and agree to meet all iPLEDGE requirements for wholesale distribution of Netlook 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 Netlook. These include:
Registering prior to distributing Netlook and re-registering annually thereafter
Distributing only FDA approved Netlook product
Only shipping Netlook to
wholesalers registered in the iPLEDGE program with prior written consent from the manufacturer or
pharmacies licensed in the US and registered and activated in the iPLEDGE program
Notifying the Netlook manufacturer (or delegate) of any non-registered and/or nonactivated pharmacy or unregistered wholesaler that attempts to order Netlook
Complying with inspection of wholesaler records for verification of compliance with the iPLEDGE program by the Netlook manufacturer (or delegate)
Returning to the manufacturer (or delegate) any undistributed product if registration is revoked by the manufacturer or if the wholesaler chooses to not re-register annually
To prescribe Netlook, 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:
I know the risk and severity of fetal injury/birth defects from Netlook.
I know the risk factors for unplanned pregnancy and the effective measures for avoidance of unplanned pregnancy.
I have the expertise to provide the patient with detailed pregnancy prevention counseling or I will refer her to an expert for such counseling, reimbursed by the manufacturer.
I will comply with the iPLEDGE program requirements described in the booklets entitled The Guide to Best Practices for the iPLEDGE Program and The iPLEDGE Program Prescriber Contraception Counseling Guide.
Before beginning treatment of female patients of childbearing potential with Netlook and on a monthly basis, the patient will be counseled to avoid pregnancy by using two forms of contraception simultaneously and continuously one month before, during, and one month after Netlook therapy, unless the patient commits to continuous abstinence.
I will not prescribe Netlook to any female patient of childbearing potential until verifying she has a negative screening pregnancy test and monthly negative CLIA-certified (Clinical Laboratory Improvement Amendment) pregnancy tests. Patients should have a pregnancy test at the completion of the entire course of Netlook and another pregnancy test 1 month later.
I will report any pregnancy case that I become aware of while the female patient is on Netlook or 1 month after the last dose to the pregnancy registry.
To prescribe Netlook, the prescriber must access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) to:
Register each patient in the iPLEDGE program.
Confirm monthly that each patient has received counseling and education.
For female patients of childbearing potential:
Enter patient's two chosen forms of contraception each month.
Enter monthly result from CLIA-certified laboratory conducted pregnancy test.
Netlook 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.
Netlook 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 patient of childbearing potential signifies that she:
Has been counseled and has signed a Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form that contains warnings about the risk of potential birth defects if the fetus is exposed to Netlook. The patient must sign the informed consent form before starting treatment and patient counseling must also be done at that time and on a monthly basis thereafter.
Has had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial Netlook prescription. The first test (a screening test) is obtained by the prescriber when the decision is made to pursue qualification of the patient for Netlook. The second pregnancy test (a confirmation test) must be done in a CLIA-certified laboratory. The interval between the 2 tests should be at least 19 days.
For patients with regular menstrual cycles, the second pregnancy test should be done during the first 5 days of the menstrual period immediately preceding the beginning of Netlook therapy and after the patient has used 2 forms of contraception for 1 month.
For patients with amenorrhea, irregular cycles, or using a contraceptive method that precludes withdrawal bleeding, the second pregnancy test must be done immediately preceding the beginning of Netlook therapy and after the patient has used 2 forms of contraception for 1 month.
Has had a negative result from a urine or serum pregnancy test in a CLIA-certified laboratory before receiving each subsequent course of Netlook. A pregnancy test must be repeated every month, in a CLIA-certified laboratory, prior to the female patient receiving each prescription.
Has selected and has committed to use 2 forms of effective contraception simultaneously, at least 1 of which must be a primary form, unless the patient commits to continuous abstinence from heterosexual contact, or the patient has undergone a hysterectomy or bilateral oophorectomy, or has been medically confirmed to be post-menopausal. Patients must use 2 forms of effective contraception for at least 1 month prior to initiation of Netlook therapy, during Netlook therapy, and for 1 month after discontinuing Netlook therapy. Counseling about contraception and behaviors associated with an increased risk of pregnancy must be repeated on a monthly basis.
If the patient has unprotected heterosexual intercourse at any time 1 month before, during, or 1 month after therapy, she must:
Stop taking Netlook (Netlook) immediately, if on therapy
Have a pregnancy test at least 19 days after the last act of unprotected heterosexual intercourse
Start using 2 forms of effective contraception simultaneously again for 1 month before resuming Netlook (Netlook) therapy
Have a second pregnancy test after using 2 forms of effective contraception for 1 month as described above depending on whether she has regular menses or not.
Effective forms of contraception include both primary and secondary forms of contraception:
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 Netlook (Netlook). These reports are more frequent for female patients who use only a single method of contraception. Therefore, it is critically important that female patients of childbearing potential use 2 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 Netlook. 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 Netlook treatment, Netlook 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 1 month after Netlook therapy must be reported immediately 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).
Netlook is contraindicated in female patients who are pregnant. To receive Netlook all patients must meet all of the following conditions:
Must be registered with the iPLEDGE program by the prescriber
Must understand that severe birth defects can occur with the use of Netlook by female patients
Must be reliable in understanding and carrying out instructions
Must sign a Patient Information/Informed Consent (for all patients) form that contains warnings about the potential risks associated with Netlook
Must fill and pick up the prescription within 7 days of the date of specimen collection for the pregnancy test for female patients of childbearing potential
Must fill and pick up the prescription within 30 days of the office visit for male patients and female patients not of childbearing potential
Must not donate blood while on Netlook and for 1 month after treatment has ended
Must not share Netlook with anyone, even someone who has similar symptoms
Female Patients of Childbearing Potential
Netlook is contraindicated in female patients who are pregnant. In addition to the requirements for all patients described above, female patients of childbearing potential must meet the following conditions:
Must NOT be pregnant or breast-feeding
Must comply with the required pregnancy testing at a CLIA-certified laboratory
Must fill and pick up the prescription within 7 days of the date of specimen collection for the pregnancy test
Must be capable of complying with the mandatory contraceptive measures required for Netlook therapy, or commit to continuous abstinence from heterosexual intercourse, and understand behaviors associated with an increased risk of pregnancy
Must understand that it is her responsibility to avoid pregnancy one month before, during and one month after Netlook therapy
Must have signed an additional Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form, before starting Netlook, that contains warnings about the risk of potential birth defects if the fetus is exposed to Netlook
Must access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654), before starting Netlook, on a monthly basis during therapy, and 1 month after the last dose to answer questions on the program requirements and to enter the patient's two chosen forms of contraception
Must have been informed of the purpose and importance of providing information to the iPLEDGE program should she become pregnant while taking Netlook or within 1 month of the last dose
To dispense Netlook, 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:
I know the risk and severity of fetal injury/birth defects from Netlook.
I will train all pharmacists, who participate in the filling and dispensing of Netlook prescriptions, on the iPLEDGE program requirements.
I will comply and seek to ensure all pharmacists who participate in the filling and dispensing of Netlook prescriptions comply with the iPLEDGE program requirements described in the booklet entitled Pharmacist Guide for the iPLEDGE Program.
I will obtain Netlook (Netlook) product only from iPLEDGE registered wholesalers.
I will not sell, buy, borrow, loan or otherwise transfer Netlook in any manner to or from another pharmacy.
I will return to the manufacturer (or delegate) any unused product if registration is revoked by the manufacturer or if the pharmacy chooses to not reactivate annually.
I will not fill Netlook for any party other than a qualified patient.
To dispense Netlook, the pharmacist must:
be trained by the Responsible Site Pharmacist concerning the iPLEDGE program requirements.
obtain authorization from the iPLEDGE program via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654) for every Netlook prescription. Authorization signifies that the patient has met all program requirements and is qualified to receive Netlook.
write the Risk Management Authorization (RMA) number on the prescription.
Netlook (Netlook) must only be dispensed:
in no more than a 30-day supply
with an Netlook Medication Guide
after authorization from the iPLEDGE program
prior to the “do not dispense to patient after” date provided by the iPLEDGE system (within 30 days of the office visit for male patients and female patients not of childbearing potential and within 7 days of the date of specimen collection for female patients of childbearing potential)
with a new prescription for refills and another authorization from the iPLEDGE program (No automatic refills are allowed)
An Netlook Medication Guide must be given to the patient each time Netlook (Netlook) is dispensed, as required by law. This Netlook Medication Guide is an important part of the risk management program for the patients.
Netlook (Netlook) must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE program. Only FDA-approved Netlook (Netlook) products must be distributed, prescribed, dispensed, and used. Patients must fill Netlook (Netlook) 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.
The Guide to Best Practices for the iPLEDGE Program includes: Netlook teratogenic potential, information on pregnancy testing, and the method to complete a qualified Netlook prescription.
The iPLEDGE Program Prescriber Contraception Counseling Guide includes: specific information about effective contraception, the limitations of contraceptive methods, behaviors associated with an increased risk of contraceptive failure and pregnancy and the methods to evaluate pregnancy risk.
The Pharmacist Guide for the iPLEDGE Program includes: Netlook teratogenic potential and the method to obtain authorization to dispense an Netlook prescription.
The iPLEDGE program is a systematic approach to comprehensive patient education about their responsibilities and includes education for contraception compliance and reinforcement of educational messages. The iPLEDGE program includes information on the risks and benefits of Netlook which is linked to the Medication Guide dispensed by pharmacists with each Netlook prescription.
Female patients not of childbearing potential and male patients, and female patients of childbearing potential are provided with separate booklets. Each booklet contains information on Netlook therapy including precautions and warnings, a Patient Information/Informed Consent (for all patients) form, and a toll-free line which provides Netlook information in 2 languages.
The booklet for female patients not of childbearing potential and male patients, The iPLEDGE Program Guide to Netlook for Male Patients and Female Patients Who Cannot Get Pregnant, also includes information about male reproduction and a warning not to share Netlook with others or to donate blood during Netlook therapy and for 1 month following discontinuation of Netlook.
The booklet for female patients of childbearing potential, The iPLEDGE Program Guide to Netlook for Female Patients Who Can Get Pregnant, includes a referral program that offers female patients free contraception counseling, reimbursed by the manufacturer, by a reproductive specialist; and a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form concerning birth defects.
The booklet, The iPLEDGE Program Birth Control Workbook includes information on the types of contraceptive methods, the selection and use of appropriate, effective contraception, the rates of possible contraceptive failure and a toll-free contraception counseling line.
In addition, there is a patient educational DVD with the following videos — “Be Prepared, Be Protected” and “Be Aware: The Risk of Pregnancy While on Netlook”.
Although an effect of Netlook (Netlook) on bone loss is not established, physicians should use caution when prescribing Netlook (Netlook) 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 Netlook (Netlook) or following cessation of therapy with Netlook (Netlook) while involved in these activities. While causality to Netlook (Netlook) has not been established, an effect must not be ruled out.
Information for Patients
Patients must be instructed to read the Medication Guide supplied as required by law when Netlook (Netlook) is dispensed. The complete text of the Medication Guide is reprinted at the end of this document. For additional information, patients must also be instructed to read the iPLEDGE program patient educational materials. All patients must sign the Patient Information/Informed Consent (for all patients) form.
Female patients of childbearing potential must be instructed that they must not be pregnant when Netlook (Netlook) therapy is initiated, and that they should use 2 forms of effective contraception simultaneously for 1 month before starting Netlook (Netlook), while taking Netlook (Netlook), and for 1 month after Netlook (Netlook) has been stopped, unless they commit to continuous abstinence from heterosexual intercourse. They should also sign a second Patient Information/Informed Consent About Birth Defects (for female patients who can get pregnant) form prior to beginning Netlook (Netlook) therapy. They should be given an opportunity to view the patient DVD provided by the manufacturer to the prescriber. The DVD includes information about contraception, the most common reasons that contraception fails, and the importance of using 2 forms of effective contraception when taking teratogenic drugs and comprehensive information about types of potential birth defects which could occur if a female patient who is pregnant takes Netlook (Netlook) at any time during pregnancy. Female patients should be seen by their prescribers monthly and have a urine or serum pregnancy test, in a CLIA-certified laboratory, performed each month during treatment to confirm negative pregnancy status before another Netlook prescription is written.
Netlook (Netlook) is found in the semen of male patients taking Netlook (Netlook), but the amount delivered to a female partner would be about 1 million times lower than an oral dose of 40 mg. While the no-effect limit for Netlook induced embryopathy is unknown, 20 years of postmarketing reports include 4 with isolated defects compatible with features of retinoid exposed fetuses; however 2 of these reports were incomplete, and 2 had other possible explanations for the defects observed.
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 Netlook (Netlook) treatment, patients and family members should be asked about any history of psychiatric disorder, and at each visit during treatment 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 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 Netlook (Netlook) 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 Netlook (Netlook) treatment 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 Netlook (Netlook) therapy is appropriate in this setting; for some patients the risks may outweigh the benefits of Netlook (Netlook) therapy.
Patients must be informed that some patients, while taking Netlook (Netlook) or soon after stopping Netlook (Netlook), have become depressed or developed other serious mental problems. Symptoms of depression include sad, “anxious” or empty mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating. Some patients taking Netlook (Netlook) 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. There were reports that some of these people did not appear depressed. There have been reports of patients on Netlook (Netlook) becoming aggressive or violent. No one knows if Netlook (Netlook) caused these behaviors or if they would have happened even if the person did not take Netlook (Netlook). Some people have had other signs of depression while taking Netlook (Netlook).
Patients must be informed that they must not share Netlook (Netlook) with anyone else because of the risk of birth defects and other serious adverse events.
Patients must be informed not to donate blood during therapy and for 1 month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to Netlook (Netlook).
Patients should be reminded to take Netlook with a meal. To decrease the risk of esophageal irritation, patients should swallow the capsules with a full glass of liquid.
Patients should be informed that transient exacerbation (flare) of acne has been seen, generally during the initial period of therapy.
Wax epilation and skin resurfacing procedures (such as dermabrasion, laser) should be avoided during Netlook (Netlook) therapy and for at least 6 months thereafter due to the possibility of scarring.
Patients should be advised to avoid prolonged exposure to UV rays or sunlight.
Patients should be informed that they may experience decreased tolerance to contact lenses during and after therapy.
Patients should be informed that approximately 16% of patients treated with Netlook (Netlook) in a clinical trial developed musculoskeletal symptoms (including arthralgia) during treatment. In general, these symptoms were mild to moderate, but occasionally required discontinuation of the drug. Transient pain in the chest has been reported less frequently. In the clinical trial, these symptoms generally cleared rapidly after discontinuation of Netlook (Netlook), but in some cases persisted. There have been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity.
Pediatric patients and their caregivers should be informed that approximately 29% (104/358) of pediatric patients treated with Netlook (Netlook) developed back pain. Back pain was severe in 13.5% (14/104) of the cases and occurred at a higher frequency in female patients than male patients. Arthralgias were experienced in 22% (79/358) of pediatric patients. Arthralgias were severe in 7.6% (6/79) of patients. Appropriate evaluation of the musculoskeletal system should be done in patients who present with these symptoms during or after a course of Netlook (Netlook). Consideration should be given to discontinuation of Netlook (Netlook) if any significant abnormality is found.
Neutropenia and rare cases of agranulocytosis have been reported. Netlook (Netlook) should be discontinued if clinically significant decreases in white cell counts occur.
Patients should be advised that severe skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported in post-marketing data. Netlook (Netlook) should be discontinued if clinically significant skin reactions occur.
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.
Carcinogenesis, Mutagenesis and Impairment of Fertility
In male and female Fischer 344 rats given oral Netlook at dosages of 8 or 32 mg/kg/day (1.3 to 5.3 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area) for greater than 18 months, there was a dose-related increased incidence of pheochromocytoma relative to controls. The incidence of adrenal medullary hyperplasia was also increased at the higher dosage in both sexes. The relatively high level of spontaneous pheochromocytomas occurring in the male Fischer 344 rat makes it an equivocal model for study of this tumor; therefore, the relevance of this tumor to the human population is uncertain.
The Ames test was conducted with Netlook in two laboratories. The results of the tests in one laboratory were negative while in the second laboratory a weakly positive response (less than 1.6 x background) was noted in S. typhimurium TA100 when the assay was conducted with metabolic activation. No dose-response effect was seen and all other strains were negative. Additionally, other tests designed to assess genotoxicity (Chinese hamster cell assay, mouse micronucleus test, S. cerevisiae D assay, in vitro clastogenesis assay with human-derived lymphocytes, and unscheduled DNA synthesis assay) were all negative.
In rats, no adverse effects on gonadal function, fertility, conception rate, gestation or parturition were observed at oral dosages of Netlook of 2, 8, or 32 mg/kg/day (0.3, 1.3, or 5.3 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area).
In dogs, testicular atrophy was noted after treatment with oral Netlook for approximately 30 weeks at dosages of 20 or 60 mg/kg/day (10 or 30 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area). In general, there was microscopic evidence for appreciable depression of spermatogenesis but some sperm were observed in all testes examined and in no instance were completely atrophic tubules seen. In studies of 66 men, 30 of whom were patients with nodular acne under treatment with oral Netlook, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of 50 men (ages 17 to 32 years) receiving Netlook (Netlook) therapy for nodular acne, no significant effects were seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
Category X. See Boxed CONTRAINDICATIONS AND WARNINGS.
It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive Netlook (Netlook).
The use of Netlook (Netlook) in pediatric patients less than 12 years of age has not been studied. The use of Netlook (Netlook) 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. Use of Netlook (Netlook) 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 Netlook (Netlook), 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 Netlook (Netlook), 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.
In an open-label clinical trial (N=217) of a single course of therapy with Netlook (Netlook) 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 8 of the patients with decreased bone mineral density for up to 11 months thereafter demonstrated increasing bone density in 5 patients at the lumbar spine, while the other 3 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 5 of 8 patients (62.5%).
In a separate open-label extension study of 10 patients, ages 13 to 18 years, who started a second course of Netlook (Netlook) 4 months after the first course, two patients showed a decrease in mean lumbar spine bone mineral density up to 3.25%.
Clinical studies of Netlook 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 Netlook therapy.
5. Katz RA, Jorgensen H, Nigra TP. Elevation of serum triglyceride levels from oral Netlook in disorders of keratinization. Arch Dermatol 116:1369-1372, 1980.
6. Ellis CN, Madison KC, Pennes DR, Martel W, Voorhees JJ. Netlook therapy is associated with early skeletal radiographic changes. J Am Acad Dermatol 10:1024-1029, 1984.
What happens if I miss a dose of Netlook?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
DailyMed. "ISOTRETINOIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).