Levonorgestrel and ethinyl estradiol

LoJaimiess is indicated for use by females of reproductive potential to prevent pregnancy. LoJaimiess is a combination of levonorgestrel, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )

• Take one tablet daily by mouth at the same time every day for 91 days in the order directed on the blister pack
• How to Start and Take LoJaimiess Begin LoJaimiess on the first Sunday after the onset of menstruation
• If menstruation begins on a Sunday, take the first orange tablet that day
• For each 91-day course, take in the following order: Take one orange tablet daily for 84 consecutive days
• Use a non-hormonal back-up method of contraception (such as condoms or spermicide) until an orange tablet has been taken daily for 7 consecutive days
• Then take one yellow tablet for 7 consecutive days
• A scheduled period should occur during the 7 days that the yellow tablets are taken
• Begin the next and all subsequent 91-day cycles without interruption on the same day of the week (Sunday) on which the patient began her first dose of LoJaimiess, following the same schedule: 84 days taking an orange tablet followed by 7 days taking a yellow tablet
• If the patient does not immediately start her next pill pack, instruct her to protect herself from pregnancy by using a non-hormonal back-up method of contraception until she has taken an orange tablet daily for 7 consecutive days
• Switching to LoJaimiess from another oral hormonal contraceptive or from another contraceptive method (transdermal patch, vaginal ring, injection, intrauterine contraceptive, implant) Start on the Sunday after the patient’s next period starts
• Use additional non-hormonal contraceptive (such as condoms and spermicide) until the patient has taken an orange tablet for 7 consecutive days. …

LoJaimiess (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP) tablets are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: 84 orange tablets, each containing 0.1 mg of levonorgestrel and 0.02 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. …

• Safety and efficacy of levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP have been established in women of reproductive age
• Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 18 as for users 18 years and older. Use of this product before menarche is not indicated

Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP has not been studied in postmenopausal women and is not indicated in this population.

• Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
• Counsel patients about the following information: Cigarette Smoking Cigarette smoking increases the risk of serious cardiovascular events from COC use
• Women who are over 35 years old and smoke should not use LoJaimiess [see Boxed Warning and Warnings and Precautions ]
• Venous Thromboembolism Increased risk of VTE compared to non-users of COCs is greatest after initially starting a COC or restarting (following a 4-week or greater pill-free interval) the same or a different COC [see Warnings and Precautions ] . …

• LoJaimiess is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases
• Examples include females who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ] Have current or history of deep vein thrombosis or pulmonary embolism [see Warnings and Precautions ] Have cerebrovascular disease [see Warnings and Precautions ] Have coronary artery disease [see Warnings and …

The sections below provide information on substances for which data on drug interactions with COCs are available. There is little information available about the clinical effect of most drug interactions that may affect COCs. However, based on the known pharmacokinetic effects of these drugs, clinical strategies to minimize any potential adverse effect on contraceptive effectiveness or safety are suggested. Consult the approved product labeling of all concurrently used drugs to obtain further information about interactions with COCs or the potential for metabolic enzyme or transporter system alterations. …

Vascular risks: Stop if a thrombotic or thromboembolic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years. ( 5.1 , 5.5 ) Liver disease: Discontinue if jaundice occurs. ( 5.2 ) Hypertension: If used in females with well-controlled hypertension, monitor blood pressure and stop if blood pressure rises significantly. ( 5.3 ) Gallbladder disease: May cause or worsen gallbladder disease. …

The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and stroke [see Boxed Warning and Warnings and Precautions ( 5.1 )] Vascular events [see Warnings and Precautions ( 5.1 )] Liver disease [see Warnings and Precautions ( 5.2 )] The most common adverse reactions in clinical trials for levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP were headaches, irregular and/or heavy uterine bleeding, dysmenorrhea, nausea and/or vomiting and back pain. …

8.1 Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb reduction defects) following exposure to COCs before conception or during early pregnan …

There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.