Microlenyn 30 ED

Microlenyn 30 ED

ethinylestradiol + levonorgestrel

Manufacturer:

Masa Lab

Distributor:

Masa Lab
Concise Prescribing Info
Contents
Levonorgestrel 150 mcg, ethinylestradiol 30 mcg, plus 7 inactive tab
Dosage/Direction for Use
Take 1st yellow tab on day 5 of menstruation, then 1 tab daily at the same time each day. Take additional non-hormonal method of contraception (except rhythm & temp methods) during first 14 days of tablet-taking for the 1st course.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Thrombophlebitis, thromboembolic disorders (eg, valvular heart disease w/ thrombogenic complications or atrial fibrillation), history of deep vein thrombophlebitis or pulmonary embolism, cerebral vascular disease, MI, CAD, known or suspected breast carcinoma or estrogen dependent neoplasia, endometrial carcinoma, hepatic adenomas/carcinomas, undiagnosed abnormal genital bleeding, cholestatic jaundice of pregnancy/jaundice w/ prior pill use, uncontrolled HTN, headaches w/ focal neurological symptoms, diabetes w/ vascular complications. Major surgery w/ prolonged immobility. Acute liver disease. Known or suspected pregnancy.
Special Precautions
Discontinue treatment if earliest symptoms of thromboembolic & thrombotic disorders occur or are suspected; there is unexplained loss of vision, onset of proptosis or diplopia, papilledema, or retinal vascular lesions; elevated BP occurs; depression occurs or recurs to serious degree in patients w/ history of depression; there is onset or exacerbation of migraine or development of headache w/ focal neurological symptoms of new pattern that is recurrent, persistent, or severe; jaundice develops. Not for protection against HIV infection & other STD. Increased risk of serious CV side effects w/ heavy smoking (at least 15 cigarettes daily) & women >35 yr; thromboembolism, stroke, HTN, hepatic neoplasia & gallbladder disease/surgery; morbidity/mortality in the presence of HTN, hyperlipidemias, obesity & diabetes; MI persisting after discontinuation in women 40-49 yr on long-term use (at least 5 yr); pancreatitis in women w/ hypertriglyceridemia. Ischemic heart disease; subarachnoid hemorrhage; ocular lesions eg, retinal thrombosis; decreased glucose tolerance; changes in serum triglycerides & lipoprotein levels; breakthrough bleeding & spotting; fluid retention. Folate deficiency in women who becomes pregnant shortly after stopping therapy. Women w/ hereditary angioedema; acute intermittent porphyria. Re-examine women taking oral contraceptives at least once a yr. Rule out malignancy in all cases of undiagnosed persistent or recurrent abnormal vag bleeding. Monitor women w/ strong family history of breast cancer or w/ breast nodules, breast fibrocystic disease, cervical dysplasia, or abnormal mammograms. Observe prediabetic & diabetic patients receiving OCs. Consider withholding OC if dyslipidemia does not respond; backup method of contraception for the remaining cycle if GI disturbance occurs. Avoid sun or UV radiation exposure in women w/ tendency to chloasma. Women w/ history of HTN, renal disease, or HTN-related diseases during pregnancy is advised to use another method of contraception. History of jaundice during pregnancy. Pregnancy & lactation.
Adverse Reactions
Arterial thromboembolism, cerebral hemorrhage & thrombosis, coronary thrombosis, focal nodular hyperplasia of liver, gall bladder disease, hepatic adenomas or benign liver tumors, HTN, mesenteric thrombosis, MI, pulmonary embolism, ruptured cyst, thrombophlebitis & venous thrombosis w/ or w/o embolism, uterine leiomyoma; dizziness, headache, mental depression, migraine; melasma, rash; breast pain, tenderness, enlargement, secretion diminution in lactation; abdominal cramp, bloating, cholestatic jaundice, nausea & vomiting; amenorrhea during & after treatment, breakthrough bleeding, spotting, change in menstrual flow, cervical erosion & secretions, invasive cervical cancer, temporary infertility after discontinuation, vag candidiasis; changes in corneal curvature, contact lens intolerance, neuro-ocular lesions; edema, reduced carbohydrate tolerance, wt change, increased prevalence of cervical chlamydia trachomatis, hirsutism.
Drug Interactions
Concomitant use w/ anastrozole, griseofulvin, pimozide, pirfenidone. Increased level of aripiprazole, benzodiazepines, corticosteroids, CYP1A2 substrates (eg, lomitapide, pimozide, pirfenidone, ropinirole, selegiline), theophylline derivatives, tipranavir, tizanidine, tranexamic acid, voriconazole. Increased level w/ ascorbic acid, boceprevir, cobicistat, mifepristone, NSAID, voriconazole. Decreased level of anastrozole, chenodiol, hyaluronidase, lamotrigine, thyroid product, ursodiol, vit K antagonists. Decreased level w/ acitretin, aminoglutethimide, aprepitant, armodafinil, artemether, barbiturate, bexarotene, bile acid sequestrants, boceprevir, bosentan, carbamazepine, clobazam, cobicistat, colesevelam, deferasirox, elvitegravir, exenatide, felbamate, fosaprepitant, fosphenytoin, griseofulvin, lamotrigine, mifepristone, modafinil, mycophenolate, nafcillin, nevirapine, oxcarbazepine, perampanel, phenytoin, PIs, prucalopride, retinoic acid & rifamycin derivatives, rufinamide, St. John's wort, telaprevir, tipranavir, tocilizumab, topiramate.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Microlenyn 30 ED tab
Packing/Price
1 × 28's
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