Micropil

Micropil

Manufacturer:

Dyna Drug

Distributor:

Dyna Drug
Full Prescribing Info
Contents
Norethisterone, ethinyl estradiol.
Description
Each tablet contains norethisterone 400 mcg and ethinyl estradiol 35 mcg.
Action
Micropil is an oral contraceptive containing progestogen (norethisterone) capable of fully inhibiting ovulation. It is combined with estrogen (ethinyl estradiol), capable of controlling menstrual irregularity and has an additive effect on progestogen in suppressing ovulation and fertility.
Pharmacology: Micropil produces a contraceptive effect primarily by suppressing the hypothalamic-pituitary system resulting in the prevention of ovulation. The estrogen component, ethinyl estradiol, acts by suppressing the secretion of follicle-stimulating hormone (FSH), resulting in the prevention of follicular development and the rise of plasma estradiol which is thought to be the stimulus for releasing luteinizing hormone (LH). The progestogen component, norethisterone, primarily acts by inhibiting the preovulatory rise of LH. Long-term administration of combined pills results in inhibition of both FSH and LH secretions. It has been found that combination type of oral contraceptives may also produce a direct effect on ovarian steroidogenesis or the response of the ovary to gonadotropins. Although the primary mechanism of action is inhibition of ovulation, alterations in the genital tract including changes in the cervical mucus (which increase the difficulty of sperm penetration) and development of poor endometrial lining (which reduces the likelihood of implantation) may also contribute to contraceptive effectiveness.
Pharmacokinetics: Studies have shown that both norethisterone and ethinyl estradiol are rapidly absorbed from the gastrointestinal tract. Following oral administration, metabolites of both compounds appear in the urine as conjugated glucuronides and sulfates.
Toxicology: The use of contraceptives may be associated with increased risk of several serious conditions including thromboembolism, stroke, myocardial infarction, hepatic adenoma, gallbladder disease and hypertension.
Indications/Uses
Oral contraception. Dysfunctional uterine bleeding, dysmenorrhea, endometriosis and ovarian dysgenesis cycles.
Dosage/Direction for Use
1 tablet daily beginning on day 5 of the next menstrual period (counting the 1st day of menses as day 1) for 21 days, followed by 7 tablet-free days.
Continue taking the tablet every evening after supper until the packet of 21 tablets is finished. Rest for 1 week and then start with another packet whether or not period has occurred.
Continue Micropil dosage regimen for as long as contraception is desired.
If usual menstrual cycle is <24 days, begin taking Micropil on day 1 for the 1st packet only. For subsequent cycles, begin on day 5.
Note: Take pill in numerical order and regularly at the same time every evening (after supper or at bedtime).
Patient taking pills for the 1st time should use an additional method of contraception until the first 7 pills have been taken. This only applies on the 1st month or cycle.
Menstrual period should be expected during the week when patient is not taking Micropil or is taking the red film-coated tablet in Micropil Plus. Patient should not be alarmed if the amount is less than usual.
Missed Tablet: If a tablet is forgotten, it should be taken as soon as remembered and then the subsequent dose in the evening. If patient forgot taking pills for 2 consecutive days, spotting or flow may occur. Patient should then take 3 tablets and use additional contraceptive precaution for the rest of the cycle.
Contraindications
Absolute Contraindications: Patients with liver diseases eg, Dubin-Johnson and Rotor syndromes, benign cholestatic jaundice of pregnancy and those who show any residual liver dysfunction due to previous liver disease.
Cancer of the breast and genitalia or a history thereof.
Thrombophlebitis and/or thromboembolic phenomena or a history thereof.
Relative Contraindications: Physician should use caution in prescribing oral contraceptives to patients with the following conditions: Myomata uteri, cerebrovascular accidents, epilepsy, migraine, cardiovascular and renal disease, diabetes mellitus, ophthalmological problems, other diseases aggravated by pregnancy and during lactation.
If adequate medical follow-up is available and the patient appears in good condition, then pills may be contemplated. If factors mentioned previously cannot be addressed, then it would be judicious to avoid the use of contraceptive pills and to prescribe an alternative method.
Special Precautions
Oral contraceptives should be used with caution in patients with cardiovascular disease or renal impairment and conditions influenced by fluid retention.
Missed Period: If bleeding fails to occur, start with another packet on the 8th day after the last pill in the preceding course.
If menstrual cycle did not occur for 2 consecutive months, consult a physician to rule out pregnancy or any abnormality.
Bleeding Between Periods: If menses occurred while the pack is not yet finished, continue taking the pills. Take 2 tablets every evening until bleeding stops. For the remaining days when patient will lack pills, the pills from another packet or a second method of birth control (eg, condom, foam) should be used and another packet started on the 8th day after the last day of the cycle. In case of spotting which seldom lasts more than a few days, patient should continue taking 1 tablet every evening.
Continuous Use: Long-term studies have shown that contraceptive pills are quite safe even when taken for a number of years. However, a physician should still be consulted for further information eg, increased risks of having certain diseases with familial history.
Carcinogenicity: Among the millions of women taking pills, there have been no report of an increased incidence of any form of cancer. In a survey conducted by Rice-Wray on 2,040 women over 22,948 cycle, there was no evidence of genital cancer in any of them. Nevertheless, it is wise to have an annual medical check-up by a physician.
Use in pregnancy: If pregnancy is desired after some months or years, simply stop taking the pills. Micropil has excellent reversibility and does not affect fertility. Fertility is resumed 1-2 months after Micropil is stopped.
Use In Pregnancy & Lactation
Use in pregnancy: If pregnancy is desired after some months or years, simply stop taking the pills. Micropil has excellent reversibility and does not affect fertility. Fertility is resumed 1-2 months after Micropil is stopped.
Side Effects
Breast ache, nausea and weight gain.
Tendency to gain weight is less pronounced because the water-retaining and appetite-stimulating effects of Micropil are very minimal.
Headache is a common complaint of women taking oral contraceptives. It is associated with any particular type of pill. However, with Micropil headache is very seldom or rare. If this occurs, consult a physician to rule out any organic cause.
Dizziness is usually avoided by taking the pills at bedtime. It also disappears when the first 1 or 2 packets of pills have been taken.
Drug Interactions
Oral contraceptive metabolism and clearance may be enhanced by enzyme-inducing drugs eg, carbamazepine, griseofulvin, phenobarbitone, phenytoin and rifampicin.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
G03AA05 - norethisterone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Tab 1 x 21's, 12 packets.
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