Microgynon 30 ED

Microgynon 30 ED

levonorgestrel + ethinylestradiol

Manufacturer:

Bayer HealthCare Pharma

Distributor:

DKSH
Full Prescribing Info
Contents
Levonorgestrel, ethinylestradiol.
Description
Each memo-pack contains 21 tablets each containing levonorgestrel 150 mcg and ethinylestradiol 30 mcg plus 7 inactive tablets.
Action
Normally, when Microgynon 30 ED is taken according to instructions, the eggs are prevented from maturing to the point at which they can be fertilized. In addition, the cervical mucus remains thick which makes it difficult for the man's sperms to ascend. Furthermore, the uterine membrane is not prepared for the nidation of a fertilized egg. Microgynon 30 ED thus offers multiple protection against pregnancy.
Pharmacokinetics: Levonorgestrel: Levonorgestrel is absorbed quickly and completely. Maximum active substance levels were reached in serum just 1 hr after ingestion of Microgynon 30 ED. The metabolic clearance rate from plasma is approximately 1.5 mL/min/kg. Levonorgestrel is eliminated not in unchanged form, but in the form of metabolites via the kidney and bile. Biotransformation takes place via the familiar pathways of steroid metabolism. There are no known pharmacologically active products of metabolism. Levonorgestrel is bound to serum albumin and SHBG. Only around 1.5% of the respective total concentration is present in unbound form. The absolute bioavailability of levonorgestrel amounts to almost 100%. Approximately 0.1% of the maternal dose can be passed on to a baby with the breast milk.
Ethinylestradiol: Orally administered ethinylestradiol is absorbed quickly and completely. Ingestion of Microgynon 30 ED leads to maximum plasma levels after 1-2 hrs. A metabolic clearance rate from plasma of approximately 5 mL/min/kg has been determined for ethinylestradiol. Ethinylestradiol is bound nonspecifically to serum albumin to the extent of 98%. Ethinylestradiol is metabolized even during its absorption phase and during its 1st liver transit, leading to reduced and individually varying oral bioavailability. Because of the half-life of the terminal elimination phase from plasma, a steady state characterised by a 30-40% higher plasma substance level becomes established after approximately 5-6 daily administrations. The absolute bioavailability of ethinylestradiol is subject to considerable interindividual variations. After oral ingestion, it amounts to around 40-60% of the dose. In women with fully established lactation, around 0.02% of the maternal dose can be passed on to the baby with the breast milk.
Indications/Uses
Progestogen-estrogen combination for oral contraception.
Dosage/Direction for Use
The 1st tablet is taken starting on the 1st day of the cycle (ie, the 1st day of the menstrual bleeding). Thereafter, 1 tab is taken everyday until the pack is used up. On the very next day, a new pack is started. During this continuous tablet-taking, menstruation-like bleeding occurs about every 28 days.
Only in the 1st cycle of use must an additional, nonhormonal method of contraception (with the exception of the rhythm or temperature methods) be employed during the first 14 days of tablet-taking.
Contraindications
Pregnancy; severe disturbances of liver function; a history of idiopathic jaundice and severe pruritus of pregnancy; Dubin-Johnson syndrome; Rotor syndrome; a history of or existing hepatic tumours; a history of or existing thromboembolic processes in arteries or veins and states which predispose to such diseases (eg, disturbances of the clotting system with a tendency towards thrombosis, certain heart diseases); sickle-cell anaemia; existing or treated carcinoma of the breast or endometrium; severe diabetes with vascular changes; disturbances of lipometabolism; a history of herpes of pregnancy; otosclerosis with deterioration during pregnancy.
Warnings
Reasons for Immediate Discontinuation of Medication: The occurrence for the first time of migrainous headaches or the more frequent occurrence of unusually severe headaches; sudden perceptual disorders (eg, disturbances of vision or hearing); first symptoms of thrombophlebitis or thromboembolism; a feeling of pain and tightness in the chest; pending operations (6 weeks beforehand) and immobilization (following accidents). In all these cases, there may be an increased risk of thrombosis. Further reasons for discontinuation are: Onset of jaundice; onset of hepatitis; generalized pruritus; increase in epileptic seizures; significant rise in blood pressure; pregnancy.
Special Precautions
Before starting treatment, a thorough general medical (including blood pressure measurement, urine test for sugar and, if necessary, special liver tests) and gynaecological examination (including the breasts and a cytological smear of the cervix) should be carried out to detect any diseases requiring treatment or any risks.
The family case history should be carefully noted. Disturbances of the clotting system must be ruled out if any members of the family have suffered from thromboembolic diseases (eg, deep vein thrombosis, stroke, myocardial infarction) already at a young age. Pregnancy must be excluded.
Control examinations are recommended at about 6-monthly intervals during the use of the preparation.
Women suffering from diabetes, hypertension, varicose veins, otosclerosis, multiple sclerosis, epilepsy, porphyria, tetany, chorea minor and women with a history of phlebitis or with a tendency to diabetes should be closely supervised.
According to the present state of knowledge, an association between the use of hormonal contraceptives and an increased risk of venous and arterial thromboembolic diseases cannot be ruled out.
The relative risk of arterial thromboses (eg, stroke, myocardial infarction) appears to increase further when heavy smoking, increasing age and the use of combined oral contraceptives coincide.
In rare cases, benign and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal steroids. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential-diagnostic considerations.
Use in lactation: When the preparation is used during lactation, it must be considered that milk production may be reduced during the initial period of use. Furthermore, minute amounts of the active substances are eliminated with the milk. In general, however, contraception is indicated only in long periods of lactation, since cycles do not usually occur during short periods.
Use In Pregnancy & Lactation
Use in pregnancy: This drug is contraindicated in pregnant women.
Use in lactation: When the preparation is used during lactation, it must be considered that milk production may be reduced during the initial period of use. Furthermore, minute amounts of the active substances are eliminated with the milk. In general, however, contraception is indicated only in long periods of lactation, since cycles do not usually occur during short periods.
Side Effects
Headaches; gastric upsets; nausea; a feeling of tension in the breasts; intermenstrual bleeding; influence on body weight and libido; depressive moods; chloasma.
Individual cases of poor tolerance of contact lenses have been reported.
Drug Interactions
The regular intake of other medicaments (eg, barbiturates, hydantoins, phenylbutazone, rifampicin, ampicillin) may interfere with the action of the preparation.
The requirement for oral antidiabetics or insulin can change.
MIMS Class
ATC Classification
G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Tab 1 x 28's.
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