Govana/Govana ED

Govana/Govana ED

gestodene + ethinylestradiol

Manufacturer:

Masa Lab

Distributor:

Masa Lab
Full Prescribing Info
Contents
Gestodene, ethinylestradiol.
Description
Each tablet contains gestodene 0.075 mg and ethinylestradiol 0.030 mg. Govana ED also contains 7 placebo tabs.
Excipients/Inactive Ingredients: Lactose monohydrate 45 mg (Govana ED only).
Action
Pharmacology: Pharmacodynamics: The synergistic anti-ovulatory effect from the combined use of Gestodene and Ethinyl estradiol directly decreases the secretion of the gonadotropin-releasing hormone (GnRH) from the hypothalamus and is considered the main action. This negative feedback mechanism disrupts ovulation by interfering with the hypothalamus pituitary-ovary axis and gonadotropin secretion from the pituitary. Specifically, the gestodene component blunts or suppresses luteinizing hormone (LH) release and the LH surge, which is necessary for ovulation, and the estrogen component blunts or suppresses the follicle-stimulating hormone (FSH), which prevents the selection and maturatuion of the dominant follicle.
Pharmacokinetics: Both Gestodene and Ethinyl estradiol are rapidly and well absorbed and widely distributed. Ethinyl estradiol is excreted by renal (22 to 58%), fecal (30 to 53%), biliary (26 to 43%).
Indications/Uses
Oral contraceptive for prevention of pregnancy.
Dosage/Direction for Use
Recommended dose: Take one tablet once daily.
Method of Administration: To begin taking oral contraceptives, the first tablets is taken on Day 1 - (first day of menstrual bleeding) of the menstrual cycle.
When initiating oral contraceptive treatment, many clinicians instruct patients to use a nonhormonal backup method for 7 days of contraceptive therapy is started within the first 5 days of the menstrual cycles.
Missed dose: Missing the first tablet of a new cycle - Taking as soon as possible; if not remembered until next day, taking 2 tablets; continuing on regular dosing schedule and using another birth control method for 7 days after the last missed dose.
Missing 1 day - taking as soon as possible; if not remembered until next day, taking 2 tablets; continuing on regular dosing schedule.
Missing 2 days in a row in the first or second week - Taking 2 tablets a day for next 2 days, then continuing on regular dosing schedule; using additional method of birth control for remainder of cycle.
Missing 2 days in a row in the third week/Missing 3 days in a row - Discarding remaining doses for current cycle: beginning a new cycle following the recommending dosing schedule and using a second method of birth control, additionally, for 7 days after the last missed dose; contacting health care professional if two menstrual periods are missed.
Missing any of the last seven tablets of twenty-eight-day cycle is not important, but beginning new cycle on time is essential.
Overdosage
Serious adverse effects generally do not occur with an acute overdosage. Irregular bleeding cycle; nausea or vomiting-occuring in less than 10% of patients.
Treatment: Specific treatment - nausea or vomiting is treated for symptomatic relief.
Supportive care - patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.
Contraindications
This medication should not be used when the following medical problems exist: breast carcinoma, neoplasia, cardiac insufficiency, cerebrovascular disease, coronary artery disease, hepatic disease, hepatic tumor, jaundice, thrombosis, uterine bleeding, pregnancy, endometrium carcinoma, hypersensitivity.
Special Precautions
Women taking oral contraceptives for 8 or more years have an increased risk of developing hepatocellular carcinoma as compared women not taking oral contraceptives.
Risk for dysplasia and carcinoma of the cervix is increased with oral contraceptive use for more than 1 year.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy category X.
Use in Lactation: Oral contraceptives are distributed into breast milk, and may diminish its quantity or quality or shorten the time of lactation, especially for those women who are only partially breast-feeding and have less physical stimulus for lactation. Use of oral contraceptives by nursing mothers in the early postpartum period is generally not recommended.
Adverse Reactions
Sign of potential side effects, especially thromboembolism, changes in the menstrual bleeding pattern or intermenstrual bleeding; headaches, migraines, hypertension, vaginal candidiasis, breast tumors, hepatocellular carcinoma, mental depression.
Drug Interactions
Concurrent use with oral contraceptives may increase concentration of anticoagulant, caffeine, benzodiazepine, cyclosporin.
Increased oral contraceptive when concurrent use with atorvastatin or theophylline.
Decreased oral contraceptive concentration when concurrent use with Barbiturates, Carbamazepine, Griseofulvin, Phenytoin, Primidone, Rifabutin, Rifampin, Ritonavir, St. John's Wort, Troglitazone.
Storage
Store below 30°C
MIMS Class
ATC Classification
G03AA10 - gestodene and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Govana: Tab (white, small, sugar-coated) 1 x 21's. Govana ED: Tab [21's (active; white, small, sugar-coated) + 7 (placebo; white, large, sugar-coated)] 1 x 28's.
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