Marvelouse Plus-FE Tablet

Marvelouse Plus-FE Tablet is used for: Oral contraception

Oral Oral contraception Adult: Dosing instruction may vary according to the brand. For 21-day pack: Start dose on 1st day of menstrual cycle. 1 tablet daily for 21 days followed by 7 pill-free days. Start a new pack on the 8th day after the last tablet is taken. For 28-day pack: Start dose on 1st day of menstrual cycle. 1 tablet daily without interruption. Dose should be taken at the same time everyday.

Instructions When initially starting, use additional contraceptive method during first consecutive 7 days of administration Start on 1st day of menstrual cycle or on Sunday immediately following onset of menses Missed periods If 1 menstrual period is missed and all doses have been taken on schedule (ie, no missed tablets), continue with next dosing cycle (pack) If 2 consecutive menstrual periods are missed, a pregnancy test is required before beginning the next dosing cycle (pack)

Documented hypersensitivity Active or history of breast cancer Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease Estrogen-dependent neoplasia Liver disease, liver tumors Undiagnosed abnormal vaginal bleeding Uncontrolled hypertension (ie, persistent BP values >160 mm Hg systolic or >100 mg Hg diastolic) Diabetes mellitus with vascular involvement, jaundice with prior oral contraceptive use Inherited or acquired hypercoagulopathies Smoke, if age >35 years Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations

Cigarette smoking increases risk of serious cardiovascular adverse effects from combination hormonal contraceptive use This risk increases with age (>35 yr) and with heavy smoking (15 or more cigarettes/day) Advise women who use hormonal oral contraceptives not to smoke Cautions Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy) Carefully observe women with history of depression and discontinue therapy if depression recurs to a serious degree Women with a history of hypertension or hypertension-related diseases or renal disease should be encouraged to use another method of contraception Discontinue if the following develop jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema Discontinue 4 week before major surgery or prolonged immobilization Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted) Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use Risk of venous thromboembolism (VTE) is highest in first year of use and when a combination oral contraceptive is started or restarted after a break in use of four weeks or more CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section to decrease risk for venous thromboembolism before initiating combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives (MMWR July 7, 2011) Discontinue hormonal therapy prior to starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with combination drug regimen Chloasma may occur with use, especially in females with history of chloasma gravidarum; advise females with history of chloasma to avoid exposure to sun or ultraviolet radiation while on therapy Breast cancer Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between ever (current or past) use of COCs and risk of breast cancer Some studies report a small increase in risk of breast cancer among current or recent users(<6 months since last use) and current users with longer duration of COC use A woman's risk depends on conditions where naturally high hormone levels persist for long periods of time including early-onset menstruation before age 12, late-onset menopause, after age 55, first child after age 30, nulliparity

Pregnancy Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy; studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy Administration of oral contraceptives to induce withdrawal bleeding should not be used as a test for pregnancy; oral contraceptives should not be used during pregnancy to treat threatened or habitual abortion It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing oral contraceptive use; if the patient has not adhered to prescribed schedule, possibility of pregnancy should be considered at time of first missed period; oral contraceptive use should be discontinued if pregnancy is confirmed Lactation Small amounts of oral contraceptive steroids identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given in postpartum period may interfere with lactation by decreasing quantity and quality of breast milk If possible, the nursing mother should be advised not to use oral contraceptives but to use other forms of contraception until she has completely weaned her child

Serum levels may be increased when used with paracetamol, ascorbic acid, atorvastatin. Serum levels may be reduced by aprepitant, griseofulvin, modafinil, troglitazone, rifampicin, topiramate, nevirapine, amprenavir, lopinavir, nelfinavir and ritonavir. May affect the efficacy of coumarin derivatives. Concurrent use with aminoglutethimide, carbamazepine, felbamate, phenobarbital, phenytoin or topiramate may lead to decrease in contraceptive effectiveness. May reduce the clearance of alprazolam, chlordiazepoxide and diazepam. May increase the clearance of lorazepam, oxazepam, temazepam, clofibric acid, morphine, salicylic acid. May inhibit the metabolism of theophylline, ciclosporin and prednisolone. May decrease the serum levels of lamotrigine. May increase serum levels of selegiline and TCAs e.g. amitriptyline, imipramine. Contraindicated (3) fezolinetant ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC) tranexamic acid oral Serious (36) amobarbital anastrozole apalutamide armodafinil atazanavir belzutifan bosentan brigatinib butabarbital calaspargase pegol carbamazepine conivaptan dexamethasone efavirenz elagolix elvitegravir enasidenib encorafenib enoxaparin enzalutamide eslicarbazepine acetate exemestane fedratinib fexinidazole fosamprenavir griseofulvin heparin idelalisib isavuconazonium sulfate ivosidenib leniolisib lesinurad (DSC) letrozole lonafarnib lopinavir sunvozertinib

Side effects of Desogestrel + Ethinyl estradiol : Frequency Not Defined Arterial/venous thromboembolism Edema Hypertension MI Cerebral hemorrhage Headache Migraine Chloasma Melasma Breast swelling/tenderness Menstrual cramps Emotional lability Abdominal pains Appetite changes Nausea Weight changes Application site rxn (if transdermal preparation) Gallbladder disease Hepatic adenomas Optic neuritis Vaginal candidiasis

Desogestrel is a progestogen that is structurally related to levonorgestrel while ethinylestradiol is a synthetic oestrogen. Used together, they inhibit ovulation by a negative feedback mechanism on the hypothalamus, which alters the normal FSH and LH secretion pattern by the anterior pituitary. It inhibits the follicular phase FSH and midcycle surge of gonadotropins. It also causes changes in the cervical mucus, making it unsuitable for sperm penetration. It may also alter tubal transport of the ova through the fallopian tubes. Progestational agents may also alter sperm fertility.

Marvelouse Plus-FE 0.15 mg, 0.03 mg & 75 mg Tablet manufactured by Techno Drugs Ltd.. Its generic name is Desogestrel + Ethinyl estradiol. Marvelouse Plus-FE is availble in Bangladesh. Farmaco BD drug index information on Marvelouse Plus-FE Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.