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사후피임약 Plan B One Step levonorgestrel Tablet 1 5 mg for Oral

Summary: DRUG DESCRIPTION The Plan B One Step tablet contains 1 5 mg of a single active steroid ingredient levonorgestrel 18 19 Dinorpregn 4 en 20 yn 3 one 13 ethyl 17 hydroxy 17 α a totally synthetic progestogen The inactive ingredients are colloidal silicon dioxide corn starch lactose monohydrate magnesium stearate potato starch and talc Levonorgestrel has a molecular weight of 312 45 and the following structural and molecular formulas INDICATIONS Plan B® One Step is a progestin only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure To obtain optimal efficacy the tablet should be taken as soon as possible within 72 hours of intercourse Plan B One Step is available only by prescription for women younger than age 17 years and available over the counter for women 17 years and older Plan B One Step is not indicated for routine use as a contraceptive DOSAGE AND ADMINISTRATION Take Plan B One Step orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse Plan B One Step can be used at any time during the menstrual cycle If vomiting occurs within two hours of taking the tablet consideration should be given to repeating the dose HOW SUPPLIED Dosage Forms And Strengths The Plan B One Step tablet is supplied as an almost white round tablet containing 1 5 mg of levonorgestrel and is marked G00 on one side Storage And Handling The Plan B One Step levonorgestrel tablet 1 5 mg is available in a PVC aluminum foil blister package The tablet is almost white round and marked G00 on one side NDC 51285 088 88 1 tablet unit of use package Store Plan B One Step at 20°to 25°C 68°to 77°F see USP Controlled Room Temperature Mfg by Gedeon Richter Ltd Budapest Hungary for Duramed Pharmaceuticals Inc Subsidiary of Barr Pharmaceuticals Inc Pomona New York 10970 Phone 1 800 330 1271 Website www PlanBOneStep com Revised July 2009 SIDE EFFECTS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice Plan B One Step was studied in a randomized double blinded multicenter clinical trial In this study all women who had received at least one dose of study medication were included in the safety analysis 1 379 women in the Plan B One Step group and 1 377 women in the Plan B group 2 doses of 0 75 mg levonorgestrel taken 12 hours apart The mean age of women given Plan B One Step was 27 years The racial demographic of those enrolled was 54 Chinese 12 Other Asian or Black and 34 were Caucasian in each treatment group 1 6 of women in the Plan B One Step group and 1 4 in Plan B group were lost to follow up The most common adverse events >10 in the clinical trial for women receiving Plan B One Step included heavier menstrual bleeding 30 9 nausea 13 7 lower abdominal pain 13 3 fatigue 13 3 and headache 10 3 Table 1 lists those adverse events that were reported in >4 of Plan B One Step users Table 1 Adverse Events in >4 of Women by Frequency Most Common Adverse Events MedDRA Plan B One Step N = 1359 Heavier menstrual bleeding 30 9 Nausea 13 7 Lower abdominal pain 13 3 Fatigue 13 3 Headache 10 3 Dizziness 9 6 Breast tenderness 8 2 Delay of menses >7 days 4 5 Postmarketing Experience The following adverse reactions have been identified during post approval use of Plan B 2 doses of 0 75 mg levonorgestrel taken 12 hours apart Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Gastrointestinal Disorders Abdominal Pain Nausea Vomiting General Disorders and Administration Site Conditions Fatigue Nervous System Disorders Dizziness Headache Reproductive System and Breast Disorders Dysmenorrhea Irregular Menstruation Oligomenorrhea Pelvic Pain DRUG INTERACTIONS Drugs or herbal products that induce enzymes including CYP3A4 that metabolize progestins may decrease the plasma concentrations of progestins and may decrease the effectiveness of progestin only pills Some drugs or herbal products that may decrease the effectiveness of progestin only pills include barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St John wort topiramate Significant changes increase or decrease in the plasma levels of the progestin have been noted in some cases of co administration with HIV protease inhibitors or with non nucleoside reverse transcriptase inhibitors Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin only pills or the potential for enzyme alterations Drug Abuse And Dependence Levonorgestrel is not a controlled substance There is no information about dependence associated with the use of Plan B One Step WARNINGS Included as part of the PRECAUTIONS section PRECAUTIONS Ectopic Pregnancy Ectopic pregnancies account for approximately 2 of all reported pregnancies Up to 10 of pregnancies reported in clinical studies of routine use of progestin only contraceptives are ectopic A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method Healthcare providers however should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B One Step A follow up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One Step Existing Pregnancy Plan B One Step is not effective in terminating an existing pregnancy Effects on Menses Some women may experience spotting a few days after taking Plan B One Step Menstrual bleeding patterns are often irregular among women using progestin only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception If there is a delay in the onset of expected menses beyond 1 week consider the possibility of pregnancy STI HIV Plan B One Step does not protect against HIV infection AIDS or other sexually transmitted infections STIs Physical Examination and Follow up A physical examination is not required prior to prescribing Plan B One Step A follow up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One Step Fertility Following Discontinuation A rapid return of fertility is likely following treatment with Plan B One Step for emergency contraception therefore routine contraception should be continued or initiated as soon as possible following use of Plan B One Step to ensure ongoing prevention of pregnancy Patient Counseling Information Take Plan B One Step as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure If you vomit within two hours of taking the tablet immediately contact your healthcare provider to discuss whether to take another tablet Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Plan B One Step in order to be evaluated for an ectopic pregnancy After taking Plan B One Step consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period Do not use Plan B One Step as routine contraception Plan B One Step is not effective in terminating an existing pregnancy Plan B One Step does not protect against HIV infection AIDS and other sexually transmitted diseases infections For women younger than age 17 years Plan B One Step is available only by prescription Nonclinical Toxicology Carcinogenesis Mutagenesis Impairment of Fertility Carcinogenicity There is no evidence of increased risk of cancer with short term use of progestins There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 μg day to dogs for 7 years at up to 0 125 mg kg day or to rhesus monkeys for 10 years at up to 250 μg kg day In another 7 year dog study administration of levonorgestrel at 0 5 mg kg day did increase the number of mammary adenomas in treated dogs compared to controls There were no malignancies Genotoxicity Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells and in an in vivo micronucleus assay in mice Fertility There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general Use In Specific Populations Pregnancy Many studies have found no harmful effects on fetal development associated with long term use of contraceptive doses of oral progestins The few studies of infant growth and development that have been conducted with progestin only pills have not demonstrated significant adverse effects Nursing Mothers In general no adverse effects of progestin only pills have been found on breastfeeding performance or on the health growth or development of the infant However isolated post marketing cases of decreased milk production have been reported Small amounts of progestins pass into the breast milk of nursing mothers taking progestin only pills for long term contraception resulting in detectable steroid levels in infant plasma Pediatric Use Safety and efficacy of progestin only pills for long term contraception have been established in women of reproductive age Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older Use of Plan B One Step emergency contraception before menarche is not indicated Geriatric Use This product is not intended for use in postmenopausal women Race No formal studies have evaluated the effect of race However clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen another form of emergency contraception There was a non statistically significant increased rate of pregnancy among Chinese women in the Plan B One Step trial The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown Hepatic Impairment No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One Step Renal Impairment No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One Step OVERDOSE There are no data on overdosage of Plan B One Step although the common adverse event of nausea and associated vomiting may be anticipated CONTRAINDICATIONS Plan B One Step is contraindicated for use in the case of known or suspected pregnancy CLINICAL PHARMACOLOGY Mechanism of Action Emergency contraceptive pills are not effective if a woman is already pregnant Plan B One Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization by altering tubal transport of sperm and or ova In addition it may inhibit implantation by altering the endometrium It is not effective once the process of implantation has begun Pharmacokinetics Absorption Following a single dose administration of Plan B One Step in 30 women under fasting conditions maximum plasma concentrations of levonorgestrel of 19 1 ng mL were reached at 1 7 hours See Table 2 Table 2 Pharmacokinetic Parameter Values Following Single Dose Administration of Plan B One Step levonorgestrel tablet 1 5 mg to 30 Healthy Female Volunteers under Fasting Conditions Mean ± SD Cmax ng mL AUCτ ng hr mL AUCinf ng hr mL Tmax hr t½ hr Levonorgestrel 19 1 9 7 294 8 208 8 307 5 218 5 1 7 1 0 4 0 27 5 5 6 Cmax = maximum concentration AUCτ = area under the drug concentration curve from time 0 to time of last determinable concentration AUC inf = area under the drug concentration curve from time 0 to infinity Tmax = time to maximum concentration t½ = elimination half life N=29 median range Effect of Food The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of Plan B One Step has not been evaluated Distribution The apparent volume of distribution of levonorgestrel is reported to be approximately 1 8 L kg It is about 97 5 to 99 protein bound principally to sex hormone binding globulin SHBG and to a lesser extent serum albumin Metabolism Following absorption levonorgestrel is conjugated at the 17β OH position to form sulfate conjugates and to a lesser extent glucuronide conjugates in plasma Significant amounts of conjugated and unconjugated 3α 5β tetrahydrolevonorgestrel are also present in plasma along with much smaller amounts of 3α 5αtetrahydrolevonorgestrel and 16βhydroxylevonorgestrel Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates Metabolic clearance rates may differ among individuals by several fold and this may account in part for the wide variation observed in levonorgestrel concentrations among users Excretion About 45 of levonorgestrel and its metabolites are excreted in the urine and about 32 are excreted in feces mostly as glucuronide conjugates Specific Populations Pediatric This product is not intended for use in the premenarcheal population and pharmacokinetic data are not available for this population Geriatric This product is not intended for use in postmenopausal women and pharmacokinetic data are not available for this population Race No formal studies have evaluated the effect of race However clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen another form of emergency contraception There was a non statistically significant increased rate of pregnancy among Chinese women in the Plan B One Step trial The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown see Use In Specific Populations Hepatic Impairment No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One Step Renal Impairment No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One Step Drug Drug Interactions No formal drug drug interaction studies were conducted with Plan B One Step see DRUG INTERACTIONS Clinical Studies A double blind randomized multicenter multinational study evaluated and compared the efficacy and safety of three different regimens for emergency contraception Subjects were enrolled at 15 sites in 10 countries the racial ethnic characteristics of the study population overall were 54 Chinese 34 Caucasian and 12 Black or Asian other than Chinese 2 381 healthy women with a mean age of 27 years who needed emergency contraception within 72 hours of unprotected intercourse were involved and randomly allocated into one of the two levonorgestrel groups A single dose of 1 5 mg of levonorgestrel Plan B One Step was administered to women allocated into group 1 Two doses of 0 75 mg levonorgestrel 12 hours apart Plan B were administered to women in group 2 In the Plan B One Step group 16 pregnancies occurred in 1 198 women and in the Plan B group 20 pregnancies occurred in 1 183 women The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman menstrual cycle Among women receiving Plan B One Step 84 of expected pregnancies were prevented and among those women taking Plan B 79 of expected pregnancies were prevented The expected pregnancy rate of 8 with no contraceptive use was reduced to approximately 1 with Plan B One Step Emergency contraceptives are not as effective as routine contraception since their failure rate while low based on a single use would accumulate over time with repeated use see INDICATIONS AND USAGE In the clinical study bleeding disturbances were the most common adverse event reported after taking the levonorgestrel containing regimens More than half of the women had menses within two days of the expected time however 31 of women experienced change in their bleeding pattern during the study period 4 5 of women had menses more than 7 days after the expected time PATIENT INFORMATION Plan B One Step levonorgestrel Tablet 1 5 mg for Oral Use What is Plan B® One Step Plan B® One Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex It is a backup method of preventing pregnancy and is not to be used routinely Plan B® One Step can reduce your chance of pregnancy after unprotected sex if your regular birth control was used incorrectly or fails or if you have had sex without birth control For example if you were using a condom and it broke or slipped if you did not use your regular birth control as you should have or if you did not use any birth control Plan B® One Step may work for you What Plan B® One Step is not Plan B® One Step will not work if you are already pregnant and will not affect an existing pregnancy Plan B® One Step should not be used as regular birth control It is important to have another reliable source of birth control that is right for you Plan B® One Step will not protect you from HIV infection the virus that causes AIDS and other sexually transmitted diseases When is the appropriate time to use Plan B® One Step You can use Plan B® One Step after you have had unprotected sex in the last 72 hours 3 days and you do not want to become pregnant Plan B® One Step can be used as a backup or emergency method to regular birth control if for example Your regular birth control method was used incorrectly or failed your partner condom broke or slipped You made a mistake with your regular method You did not use any birth control method When is it not appropriate to use Plan B® One Step Plan B® One Step should not be used as a regular birth control method It does not work as well as most other forms of birth control when they are used consistently and correctly Plan B® One Step is a backup or emergency method of contraception Plan B® One Step should not be used if you are already pregnant because it will not work Plan B® One Step should not be used if you are allergic to levonorgestrel or any other ingredients in Plan B® One Step Plan B® One Step does not protect against HIV the virus that causes AIDS or other sexually transmitted diseases STDs The best ways to protect yourself against getting HIV or other STDs are to use a latex condom correctly with every sexual act or not to have sex at all How does Plan B® One Step work Plan B® One Step is one pill with levonorgestrel a hormone that has been used in many birth control pills for over 35 years Plan B® One Step contains a higher dose of levonorgestrel than birth control pills but works in a similar way to prevent pregnancy It works mainly by stopping the release of an egg from the ovary It is possible that Plan B® One Step may also work by preventing fertilization of an egg the uniting of sperm with the egg or by preventing attachment implantation to the uterus womb How can I get the best results from Plan B® One Step You have only a few days to try to prevent pregnancy after unprotected sex The sooner you take Plan B® One Step the better it works Plan B® One Step should be taken as soon as possible within 72 hours 3 days after unprotected sex How effective is Plan B® One Step The sooner you take Plan B® One Step the better it will work Take Plan B® One Step as soon as possible after unprotected sex If it is taken as soon as possible within 72 hours 3 days after unprotected sex it will significantly decrease the chance that you will get pregnant Seven out of every 8 women who would have gotten pregnant will not become pregnant How will I know if Plan B® One Step worked Most women will have their next menstrual period at the expected time or within a week of the expected time If your menstrual period is delayed beyond 1 week you may be pregnant You should get a pregnancy test and follow up with your healthcare professional What if I am already pregnant and use Plan B® One Step There is no medical evidence that Plan B® One Step would harm a developing baby If you take Plan B® One Step accidentally after you are already pregnant or it does not work and you become pregnant it is not likely to cause any harm to you or your pregnancy The pregnancy will continue Plan B® One Step will not work if you are already pregnant What should I do if my menstrual period is delayed beyond 1 week and I have severe lower stomach abdominal pain If you have severe lower stomach abdominal pain about 3 to 5 weeks after taking Plan B® One Step you may have a pregnancy outside the uterus which is called a tubal pregnancy A tubal pregnancy requires immediate medical treatment so you should see a healthcare professional right away Can I use Plan B® One Step for regular birth control No Plan B® One Step should not be used for regular birth control It is an emergency or backup method to be used if your regular birth control fails or is used incorrectly or if you have sex without birth control You should protect yourself against STDs and pregnancy every time you have sex If you have unprotected sex again after taking Plan B® One Step it will not help protect you from getting pregnant How often can I use Plan B® One Step Plan B® One Step is meant for emergency protection only and is not designed to be used frequently If you find that you need to use emergency contraception often talk to your healthcare professional and learn about methods of birth control and STD prevention that are right for you Will I experience any side effects from Plan B® One Step When used as directed Plan B® One Step is safe for women Some women will have mild temporary side effects such as menstrual changes nausea lower stomach abdominal pain tiredness headache dizziness breast pain and vomiting These are similar to the side effects that some women have when taking regular birth control pills Some women taking Plan B® One Step will have menstrual changes such as spotting or bleeding before their next period Some women may have a heavier or lighter next period or a period that is early or late If your period is more than a week late you should get a pregnancy test What warnings should I know about when using Plan B® One Step Plan B® One Step does not protect against the AIDS virus HIV or other sexually transmitted diseases STDs Do not use If you are already pregnant because it will not work If you are allergic to levonogestrel or any of the ingredients in Plan B® One Step For regular birth control When using this product you may have Menstrual changes Nausea Lower stomach abdominal pain Tiredness Headache Dizziness Breast pain Vomiting Keep out of reach of children In case of overdose get medical help or contact a Poison Control Center right away at 1 800 222 1222 What are the directions for using Plan B® One Step Women 17 years of age and older Take Plan B® One Step as soon as possible within 72 hours 3 days after unprotected sex If you vomit within 2 hours of taking the medication call a healthcare professional to find out if you should repeat the dose Prescription only for women younger than age 17 If you are younger than age 17 see a healthcare professional What should I do if I have questions about Plan B® One Step If you have questions or need more information about this product call our toll free number 1 800 330 1271 visit our website at www PlanBOneStep com or ask a healthcare professional Other information Tablet is enclosed in a blister seal Do not use if the blister seal is broken Store at room temperature 20 25 °C 68 77 °F You may report side effects to FDA at 1 800 FDA 1088 Active ingredient levonorgestrel 1 5 mg Inactive ingredients colloidal silicon dioxide potato starch magnesium stearate talc corn starch lactose monohydrate Protect yourself in more ways than one If you are sexually active but you are not ready for a pregnancy it is important to use regular pregnancy protection There are many types of birth control Whichever type you choose it is important to use your regular birth control method as directed This ensures that you have effective protection against pregnancy every time you have sex But things do not always go as planned For example if you were using a condom and it broke or slipped or if you did not use your regular birth control as you should have or if you did not use any birth control Plan B® One Step may work for you Plan B® One Step is an emergency contraceptive that helps prevent pregnancy after unprotected sex or when your birth control fails or is not used correctly Remember Plan B® One Step is only for emergency pregnancy prevention There are many other products that work for regular birth control that are available by prescription or over the counter There is also another form of protection to think about when you have sex protection against sexually transmitted diseases STDs Some common STDs are HIV AIDS chlamydia genital herpes gonorrhea hepatitis human papilloma virus HPV genital warts syphilis and trichomonas Some of these STDs can be very serious and can lead to infertility inability to have a baby problems during pregnancy chronic illness and even death All sexually active women are at risk of catching STDs because they may not know that their partner has an STD the partner himself may not know If your partner uses a latex condom correctly each and every time you have sex with him this will help reduce but not eliminate the chance that you will catch an STD No other birth control methods will effectively protect you from STDs The female condom may give you some STD protection but it is not as effective as a male latex condom For more information on STDs call the Centers for Disease Control and Prevention CDC AIDS STD Hotline The CDC phone numbers are 1 800 342 AIDS 2437 for English 1 800 344 7432 for Spanish or 1 800 243 7889 for hearing impaired TDD Be sure to protect yourself against pregnancy and STDs by using some form of birth control plus a latex condom Of course not having sex is the most effective way to prevent pregnancy and stay free of STDs Plan B® One Step is used to prevent pregnancy after unprotected sex Plan B® One Step should not be used for regular birth control if you are already pregnant because it will not work or if you are allergic to levonorgestrel or any of the ingredients in Plan B® One Step The sooner you take Plan B® One Step the better it will work Plan B® One Step does not protect against the AIDS virus HIV or other sexually transmitted diseases STDs Common side effects associated with the use of Plan B® One Step include menstrual changes nausea lower stomach abdominal pain tiredness headache dizziness breast pain and vomiting 약이름을 톰과 제리 그런식으로 쉽게 짓지 않느냐고 반문하던이가 있었다 새약이 만들어지면 약이름이 만들어 지는 경로가 따로 있긴 하다 개인적으로 약이름이 참 잘좋다고생각되는약중의 하나 더 간편하게 피임을 해결될 수 있는 약이긴 하지만 여성용 사후피임약 사전에 다른 방법으로 먼저 원치 않는 임신을 해결 하여야 할 것이며 언제나 복용할 시엔 의사와 상의 주의를 요함 나라마다 규정이 다르긴 하나 이전에 나온 Plan B levonorgestrel Tablets 0 75 mg 18세 이상 처방없이 살 수 있다 12시간에 걸쳐서 두 번 복용해야 함 Available without a prescription for consumers 18 and older Rx only for women age 17 and younger image blog Aries21usa 02 04 2010 Scrap Rx List com DRUG DESCRIPTION The Plan B One Step tablet contains 1 5 mg of a single active steroid ingredient levonorgestrel 18 19 Dinorpregn 4 en 20 yn 3 one 13 ethyl 17 hydroxy 17 α a totally synthetic progestogen The inactive ingredients are colloidal silicon dioxide corn starch lactose monohydrate magnesium stearate potato starch and talc Levonorgestrel has a molecular weight of 312 45 and the following structural and molecular formulas INDICATIONS Plan B® One Step is a progestin only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure To obtain optimal efficacy the tablet should be taken as soon as possible within 72 hours of intercourse Plan B One Step is available only by prescription for women younger than age 17 years and available over the counter for women 17 years and older Plan B One Step is not indicated for routine use as a contraceptive DOSAGE AND ADMINISTRATION Take Plan B One Step orally as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure Efficacy is better if the tablet is taken as soon as possible after unprotected intercourse Plan B One Step can be used at any time during the menstrual cycle If vomiting occurs within two hours of taking the tablet consideration should be given to repeating the dose HOW SUPPLIED Dosage Forms And Strengths The Plan B One Step tablet is supplied as an almost white round tablet containing 1 5 mg of levonorgestrel and is marked G00 on one side Storage And Handling The Plan B One Step levonorgestrel tablet 1 5 mg is available in a PVC aluminum foil blister package The tablet is almost white round and marked G00 on one side NDC 51285 088 88 1 tablet unit of use package Store Plan B One Step at 20°to 25°C 68°to 77°F see USP Controlled Room Temperature Mfg by Gedeon Richter Ltd Budapest Hungary for Duramed Pharmaceuticals Inc Subsidiary of Barr Pharmaceuticals Inc Pomona New York 10970 Phone 1 800 330 1271 Website www PlanBOneStep com Revised July 2009 SIDE EFFECTS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice Plan B One Step was studied in a randomized double blinded multicenter clinical trial In this study all women who had received at least one dose of study medication were included in the safety analysis 1 379 women in the Plan B One Step group and 1 377 women in the Plan B group 2 doses of 0 75 mg levonorgestrel taken 12 hours apart The mean age of women given Plan B One Step was 27 years The racial demographic of those enrolled was 54 Chinese 12 Other Asian or Black and 34 were Caucasian in each treatment group 1 6 of women in the Plan B One Step group and 1 4 in Plan B group were lost to follow up The most common adverse events >10 in the clinical trial for women receiving Plan B One Step included heavier menstrual bleeding 30 9 nausea 13 7 lower abdominal pain 13 3 fatigue 13 3 and headache 10 3 Table 1 lists those adverse events that were reported in >4 of Plan B One Step users Table 1 Adverse Events in >4 of Women by Frequency Most Common Adverse Events MedDRA Plan B One Step N = 1359 Heavier menstrual bleeding 30 9 Nausea 13 7 Lower abdominal pain 13 3 Fatigue 13 3 Headache 10 3 Dizziness 9 6 Breast tenderness 8 2 Delay of menses >7 days 4 5 Postmarketing Experience The following adverse reactions have been identified during post approval use of Plan B 2 doses of 0 75 mg levonorgestrel taken 12 hours apart Because these reactions are reported voluntarily from a population of uncertain size it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure Gastrointestinal Disorders Abdominal Pain Nausea Vomiting General Disorders and Administration Site Conditions Fatigue Nervous System Disorders Dizziness Headache Reproductive System and Breast Disorders Dysmenorrhea Irregular Menstruation Oligomenorrhea Pelvic Pain DRUG INTERACTIONS Drugs or herbal products that induce enzymes including CYP3A4 that metabolize progestins may decrease the plasma concentrations of progestins and may decrease the effectiveness of progestin only pills Some drugs or herbal products that may decrease the effectiveness of progestin only pills include barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St John wort topiramate Significant changes increase or decrease in the plasma levels of the progestin have been noted in some cases of co administration with HIV protease inhibitors or with non nucleoside reverse transcriptase inhibitors Consult the labeling of all concurrently used drugs to obtain further information about interactions with progestin only pills or the potential for enzyme alterations Drug Abuse And Dependence Levonorgestrel is not a controlled substance There is no information about dependence associated with the use of Plan B One Step WARNINGS Included as part of the PRECAUTIONS section PRECAUTIONS Ectopic Pregnancy Ectopic pregnancies account for approximately 2 of all reported pregnancies Up to 10 of pregnancies reported in clinical studies of routine use of progestin only contraceptives are ectopic A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method Healthcare providers however should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Plan B One Step A follow up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One Step Existing Pregnancy Plan B One Step is not effective in terminating an existing pregnancy Effects on Menses Some women may experience spotting a few days after taking Plan B One Step Menstrual bleeding patterns are often irregular among women using progestin only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception If there is a delay in the onset of expected menses beyond 1 week consider the possibility of pregnancy STI HIV Plan B One Step does not protect against HIV infection AIDS or other sexually transmitted infections STIs Physical Examination and Follow up A physical examination is not required prior to prescribing Plan B One Step A follow up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Plan B One Step Fertility Following Discontinuation A rapid return of fertility is likely following treatment with Plan B One Step for emergency contraception therefore routine contraception should be continued or initiated as soon as possible following use of Plan B One Step to ensure ongoing prevention of pregnancy Patient Counseling Information Take Plan B One Step as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure If you vomit within two hours of taking the tablet immediately contact your healthcare provider to discuss whether to take another tablet Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking Plan B One Step in order to be evaluated for an ectopic pregnancy After taking Plan B One Step consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period Do not use Plan B One Step as routine contraception Plan B One Step is not effective in terminating an existing pregnancy Plan B One Step does not protect against HIV infection AIDS and other sexually transmitted diseases infections For women younger than age 17 years Plan B One Step is available only by prescription Nonclinical Toxicology Carcinogenesis Mutagenesis Impairment of Fertility Carcinogenicity There is no evidence of increased risk of cancer with short term use of progestins There was no increase in tumorgenicity following administration of levonorgestrel to rats for 2 years at approximately 5 μg day to dogs for 7 years at up to 0 125 mg kg day or to rhesus monkeys for 10 years at up to 250 μg kg day In another 7 year dog study administration of levonorgestrel at 0 5 mg kg day did increase the number of mammary adenomas in treated dogs compared to controls There were no malignancies Genotoxicity Levonorgestrel was not found to be mutagenic or genotoxic in the Ames Assay in vitro mammalian culture assays utilizing mouse lymphoma cells and Chinese hamster ovary cells and in an in vivo micronucleus assay in mice Fertility There are no irreversible effects on fertility following cessation of exposures to levonorgestrel or progestins in general Use In Specific Populations Pregnancy Many studies have found no harmful effects on fetal development associated with long term use of contraceptive doses of oral progestins The few studies of infant growth and development that have been conducted with progestin only pills have not demonstrated significant adverse effects Nursing Mothers In general no adverse effects of progestin only pills have been found on breastfeeding performance or on the health growth or development of the infant However isolated post marketing cases of decreased milk production have been reported Small amounts of progestins pass into the breast milk of nursing mothers taking progestin only pills for long term contraception resulting in detectable steroid levels in infant plasma Pediatric Use Safety and efficacy of progestin only pills for long term contraception have been established in women of reproductive age Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older Use of Plan B One Step emergency contraception before menarche is not indicated Geriatric Use This product is not intended for use in postmenopausal women Race No formal studies have evaluated the effect of race However clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen another form of emergency contraception There was a non statistically significant increased rate of pregnancy among Chinese women in the Plan B One Step trial The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown Hepatic Impairment No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One Step Renal Impairment No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One Step OVERDOSE There are no data on overdosage of Plan B One Step although the common adverse event of nausea and associated vomiting may be anticipated CONTRAINDICATIONS Plan B One Step is contraindicated for use in the case of known or suspected pregnancy CLINICAL PHARMACOLOGY Mechanism of Action Emergency contraceptive pills are not effective if a woman is already pregnant Plan B One Step is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization by altering tubal transport of sperm and or ova In addition it may inhibit implantation by altering the endometrium It is not effective once the process of implantation has begun Pharmacokinetics Absorption Following a single dose administration of Plan B One Step in 30 women under fasting conditions maximum plasma concentrations of levonorgestrel of 19 1 ng mL were reached at 1 7 hours See Table 2 Table 2 Pharmacokinetic Parameter Values Following Single Dose Administration of Plan B One Step levonorgestrel tablet 1 5 mg to 30 Healthy Female Volunteers under Fasting Conditions Mean ± SD Cmax ng mL AUCτ ng hr mL AUCinf ng hr mL Tmax hr t½ hr Levonorgestrel 19 1 9 7 294 8 208 8 307 5 218 5 1 7 1 0 4 0 27 5 5 6 Cmax = maximum concentration AUCτ = area under the drug concentration curve from time 0 to time of last determinable concentration AUC inf = area under the drug concentration curve from time 0 to infinity Tmax = time to maximum concentration t½ = elimination half life N=29 median range Effect of Food The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of Plan B One Step has not been evaluated Distribution The apparent volume of distribution of levonorgestrel is reported to be approximately 1 8 L kg It is about 97 5 to 99 protein bound principally to sex hormone binding globulin SHBG and to a lesser extent serum albumin Metabolism Following absorption levonorgestrel is conjugated at the 17β OH position to form sulfate conjugates and to a lesser extent glucuronide conjugates in plasma Significant amounts of conjugated and unconjugated 3α 5β tetrahydrolevonorgestrel are also present in plasma along with much smaller amounts of 3α 5αtetrahydrolevonorgestrel and 16βhydroxylevonorgestrel Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates Metabolic clearance rates may differ among individuals by several fold and this may account in part for the wide variation observed in levonorgestrel concentrations among users Excretion About 45 of levonorgestrel and its metabolites are excreted in the urine and about 32 are excreted in feces mostly as glucuronide conjugates Specific Populations Pediatric This product is not intended for use in the premenarcheal population and pharmacokinetic data are not available for this population Geriatric This product is not intended for use in postmenopausal women and pharmacokinetic data are not available for this population Race No formal studies have evaluated the effect of race However clinical trials demonstrated a higher pregnancy rate in Chinese women with both Plan B and the Yuzpe regimen another form of emergency contraception There was a non statistically significant increased rate of pregnancy among Chinese women in the Plan B One Step trial The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown see Use In Specific Populations Hepatic Impairment No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of Plan B One Step Renal Impairment No formal studies were conducted to evaluate the effect of renal disease on the disposition of Plan B One Step Drug Drug Interactions No formal drug drug interaction studies were conducted with Plan B One Step see DRUG INTERACTIONS Clinical Studies A double blind randomized multicenter multinational study evaluated and compared the efficacy and safety of three different regimens for emergency contraception Subjects were enrolled at 15 sites in 10 countries the racial ethnic characteristics of the study population overall were 54 Chinese 34 Caucasian and 12 Black or Asian other than Chinese 2 381 healthy women with a mean age of 27 years who needed emergency contraception within 72 hours of unprotected intercourse were involved and randomly allocated into one of the two levonorgestrel groups A single dose of 1 5 mg of levonorgestrel Plan B One Step was administered to women allocated into group 1 Two doses of 0 75 mg levonorgestrel 12 hours apart Plan B were administered to women in group 2 In the Plan B One Step group 16 pregnancies occurred in 1 198 women and in the Plan B group 20 pregnancies occurred in 1 183 women The number of pregnancies expected in each group was calculated based on the timing of intercourse with regard to each woman menstrual cycle Among women receiving Plan B One Step 84 of expected pregnancies were prevented and among those women taking Plan B 79 of expected pregnancies were prevented The expected pregnancy rate of 8 with no contraceptive use was reduced to approximately 1 with Plan B One Step Emergency contraceptives are not as effective as routine contraception since their failure rate while low based on a single use would accumulate over time with repeated use see INDICATIONS AND USAGE In the clinical study bleeding disturbances were the most common adverse event reported after taking the levonorgestrel containing regimens More than half of the women had menses within two days of the expected time however 31 of women experienced change in their bleeding pattern during the study period 4 5 of women had menses more than 7 days after the expected time PATIENT INFORMATION Plan B One Step levonorgestrel Tablet 1 5 mg for Oral Use What is Plan B® One Step Plan B® One Step is emergency contraception that helps prevent pregnancy after birth control failure or unprotected sex It is a backup method of preventing pregnancy and is not to be used routinely Plan B® One Step can reduce your chance of pregnancy after unprotected sex if your regular birth control was used incorrectly or fails or if you have had sex without birth control For example if you were using a condom and it broke or slipped if you did not use your regular birth control as you should have or if you did not use any birth control Plan B® One Step may work for you What Plan B® One Step is not Plan B® One Step will not work if you are already pregnant and will not affect an existing pregnancy Plan B® One Step should not be used as regular birth control It is important to have another reliable source of birth control that is right for you Plan B® One Step will not protect you from HIV infection the virus that causes AIDS and other sexually transmitted diseases When is the appropriate time to use Plan B® One Step You can use Plan B® One Step after you have had unprotected sex in the last 72 hours 3 days and you do not want to become pregnant Plan B® One Step can be used as a backup or emergency method to regular birth control if for example Your regular birth control method was used incorrectly or failed your partner condom broke or slipped You made a mistake with your regular method You did not use any birth control method When is it not appropriate to use Plan B® One Step Plan B® One Step should not be used as a regular birth control method It does not work as well as most other forms of birth control when they are used consistently and correctly Plan B® One Step is a backup or emergency method of contraception Plan B® One Step should not be used if you are already pregnant because it will not work Plan B® One Step should not be used if you are allergic to levonorgestrel or any other ingredients in Plan B® One Step Plan B® One Step does not protect against HIV the virus that causes AIDS or other sexually transmitted diseases STDs The best ways to protect yourself against getting HIV or other STDs are to use a latex condom correctly with every sexual act or not to have sex at all How does Plan B® One Step work Plan B® One Step is one pill with levonorgestrel a hormone that has been used in many birth control pills for over 35 years Plan B® One Step contains a higher dose of levonorgestrel than birth control pills but works in a similar way to prevent pregnancy It works mainly by stopping the release of an egg from the ovary It is possible that Plan B® One Step may also work by preventing fertilization of an egg the uniting of sperm with the egg or by preventing attachment implantation to the uterus womb How can I get the best results from Plan B® One Step You have only a few days to try to prevent pregnancy after unprotected sex The sooner you take Plan B® One Step the better it works Plan B® One Step should be taken as soon as possible within 72 hours 3 days after unprotected sex How effective is Plan B® One Step The sooner you take Plan B® One Step the better it will work Take Plan B® One Step as soon as possible after unprotected sex If it is taken as soon as possible within 72 hours 3 days after unprotected sex it will significantly decrease the chance that you will get pregnant Seven out of every 8 women who would have gotten pregnant will not become pregnant How will I know if Plan B® One Step worked Most women will have their next menstrual period at the expected time or within a week of the expected time If your menstrual period is delayed beyond 1 week you may be pregnant You should get a pregnancy test and follow up with your healthcare professional What if I am already pregnant and use Plan B® One Step There is no medical evidence that Plan B® One Step would harm a developing baby If you take Plan B® One Step accidentally after you are already pregnant or it does not work and you become pregnant it is not likely to cause any harm to you or your pregnancy The pregnancy will continue Plan B® One Step will not work if you are already pregnant What should I do if my menstrual period is delayed beyond 1 week and I have severe lower stomach abdominal pain If you have severe lower stomach abdominal pain about 3 to 5 weeks after taking Plan B® One Step you may have a pregnancy outside the uterus which is called a tubal pregnancy A tubal pregnancy requires immediate medical treatment so you should see a healthcare professional right away Can I use Plan B® One Step for regular birth control No Plan B® One Step should not be used for regular birth control It is an emergency or backup method to be used if your regular birth control fails or is used incorrectly or if you have sex without birth control You should protect yourself against STDs and pregnancy every time you have sex If you have unprotected sex again after taking Plan B® One Step it will not help protect you from getting pregnant How often can I use Plan B® One Step Plan B® One Step is meant for emergency protection only and is not designed to be used frequently If you find that you need to use emergency contraception often talk to your healthcare professional and learn about methods of birth control and STD prevention that are right for you Will I experience any side effects from Plan B® One Step When used as directed Plan B® One Step is safe for women Some women will have mild temporary side effects such as menstrual changes nausea lower stomach abdominal pain tiredness headache dizziness breast pain and vomiting These are similar to the side effects that some women have when taking regular birth control pills Some women taking Plan B® One Step will have menstrual changes such as spotting or bleeding before their next period Some women may have a heavier or lighter next period or a period that is early or late If your period is more than a week late you should get a pregnancy test What warnings should I know about when using Plan B® One Step Plan B® One Step does not protect against the AIDS virus HIV or other sexually transmitted diseases STDs Do not use If you are already pregnant because it will not work If you are allergic to levonogestrel or any of the ingredients in Plan B® One Step For regular birth control When using this product you may have Menstrual changes Nausea Lower stomach abdominal pain Tiredness Headache Dizziness Breast pain Vomiting Keep out of reach of children In case of overdose get medical help or contact a Poison Control Center right away at 1 800 222 1222 What are the directions for using Plan B® One Step Women 17 years of age and older Take Plan B® One Step as soon as possible within 72 hours 3 days after unprotected sex If you vomit within 2 hours of taking the medication call a healthcare professional to find out if you should repeat the dose Prescription only for women younger than age 17 If you are younger than age 17 see a healthcare professional What should I do if I have questions about Plan B® One Step If you have questions or need more information about this product call our toll free number 1 800 330 1271 visit our website at www PlanBOneStep com or ask a healthcare professional Other information Tablet is enclosed in a blister seal Do not use if the blister seal is broken Store at room temperature 20 25 °C 68 77 °F You may report side effects to FDA at 1 800 FDA 1088 Active ingredient levonorgestrel 1 5 mg Inactive ingredients colloidal silicon dioxide potato starch magnesium stearate talc corn starch lactose monohydrate Protect yourself in more ways than one If you are sexually active but you are not ready for a pregnancy it is important to use regular pregnancy protection There are many types of birth control Whichever type you choose it is important to use your regular birth control method as directed This ensures that you have effective protection against pregnancy every time you have sex But things do not always go as planned For example if you were using a condom and it broke or slipped or if you did not use your regular birth control as you should have or if you did not use any birth control Plan B® One Step may work for you Plan B® One Step is an emergency contraceptive that helps prevent pregnancy after unprotected sex or when your birth control fails or is not used correctly Remember Plan B® One Step is only for emergency pregnancy prevention There are many other products that work for regular birth control that are available by prescription or over the counter There is also another form of protection to think about when you have sex protection against sexually transmitted diseases STDs Some common STDs are HIV AIDS chlamydia genital herpes gonorrhea hepatitis human papilloma virus HPV genital warts syphilis and trichomonas Some of these STDs can be very serious and can lead to infertility inability to have a baby problems during pregnancy chronic illness and even death All sexually active women are at risk of catching STDs because they may not know that their partner has an STD the partner himself may not know If your partner uses a latex condom correctly each and every time you have sex with him this will help reduce but not eliminate the chance that you will catch an STD No other birth control methods will effectively protect you from STDs The female condom may give you some STD protection but it is not as effective as a male latex condom For more information on STDs call the Centers for Disease Control and Prevention CDC AIDS STD Hotline The CDC phone numbers are 1 800 342 AIDS 2437 for English 1 800 344 7432 for Spanish or 1 800 243 7889 for hearing impaired TDD Be sure to protect yourself against pregnancy and STDs by using some form of birth control plus a latex condom Of course not having sex is the most effective way to prevent pregnancy and stay free of STDs Plan B® One Step is used to prevent pregnancy after unprotected sex Plan B® One Step should not be used for regular birth control if you are already pregnant because it will not work or if you are allergic to levonorgestrel or any of the ingredients in Plan B® One Step The sooner you take Plan B® One Step the better it will work Plan B® One Step does not protect against the AIDS virus HIV or other sexually transmitted diseases STDs Common side effects associated with the use of Plan B® One Step include menstrual changes nausea lower stomach abdominal pain tiredness headache dizziness breast pain and vomiting 약이름을 톰과 제리 그런식으로 쉽게 짓지 않느냐고 반문하던이가 있었다 새약이 만들어지면 약이름이 만들어 지는 경로가 따로 있긴 하다 개인적으로 약이름이 참 잘좋다고생각되는약중의 하나 더 간편하게 피임을 해결될 수 있는 약이긴 하지만 여성용 사후피임약 사전에 다른 방법으로 먼저 원치 않는 임신을 해결 하여야 할 것이며 언제나 복용할 시엔 의사와 상의 주의를 요함 나라마다 규정이 다르긴 하나 이전에 나온 Plan B levonorgestrel Tablets 0 75 mg 18세 이상 처방없이 살 수 있다 12시간에 걸쳐서 두 번 복용해야 함 Available without a prescription for consumers 18 and older Rx only for women age 17 and younger image blog Aries21usa 02 04 2010 Scrap Rx List com

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