Droslyn Tablet
Drospirenone
4 mg
Incepta Pharmaceuticals Ltd.
| Pack size | 28's pack |
|---|---|
| Unite Price | 400.00 BDT |
Indications
Droslyn Tablet is used for:
Contraception
Adult Dose
Contraception
1 tablet once daily for 28 consecutive days; 1 white active tablet/day during the first 24 days and 1 green inert tablet/day during the 4 following days.
Hepatic impairment: Contraindicated
Child Dose
Renal Dose
Renal impairment: Contraindicated
Administration
Should take every day at about the same time of the day so that the interval between 2 tablets is always 24 hr
Contra Indications
Renal impairment
Adrenal insufficiency
Presence or history of cervical cancer or progestin-sensitive cancers
Liver tumors, benign or malignant, or hepatic impairment
Undiagnosed abnormal uterine bleeding
Precautions
Use leads to decreased estradiol serum levels; unknown if clinically relevant loss of bone mineral density may occur
Some studies suggest COC containing progestin and estradiol associated with increased risk of cervical cancer or intraepithelial neoplasia; however, controversy continues about the extent to which such findings may be due to differences in sexual behavior and other factors
Discontinue if jaundice or acute or chronic disturbances of liver function develop; do not resume until LFTs return to normal and causation identified; drospirenone contraindicated with hepatic impairment or benign or malignant liver tumors
Consider possibility of ectopic pregnancy in women who become pregnant or report lower abdominal pain
Progestins may decrease insulin sensitivity; patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring
Bleeding irregularities (eg, breakthrough or intracyclic bleeding or spotting) may occur, especially during the first 3 months; may resolve over time or by changing to different contraceptive; if persists, evaluate for causes (eg, pregnancy, malignancy)
Carefully observe females for history of depression and discontinue drospirenone if depression recurs to a serious degree
Thromboembolism risk with combined oral contraceptives containing drospirenone and ethinyl estradiol higher than those containing some other progestins plus ethinyl estradiol
Drospirenone has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to spironolactone 25 mg
Pregnancy-Lactation
Pregnancy
Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral progestins during early pregnancy
Discontinue if pregnancy occurs, as there is no reason to use hormonal contraceptives during pregnancy
Human data
Epidemiologic studies and meta-analyses have not found increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following maternal use of oral progestins before conception or during early pregnancy
Lactation
Negligible amounts of drospirenone are excreted in the breast milk
At therapeutic doses, no effects on breastfed newborns/infants are anticipated
Human data
After daily administration of 4 mg, the average drospirenone concentration in breast milk over 24-hour period is 5.6 ng/mL
Based on this concentration, the estimated average infant daily dosages for an exclusively breastfed infant is 840 ng/kg/day (relative infant dose is 1.5%)
Interactions
Effects of other drug on hormonal contraception
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease systemic concentrations of hormonal contraceptives and potentially diminish the effectiveness or increase breakthrough bleeding
Instruct women to use a nonhormonal backup contraceptive for 28 days after discontinuing the enzyme inducer
Strong CYP3A4 inhibitors may result in a moderate increase of drospirenone systemic exposure
Effects of drospirenone on other drugs
Potential for increased serum potassium concentration if drospirenone coadministered with other drugs that increase potassium levels
Side Effects
Side effects of Drospirenone :
>10%
Unscheduled bleeding, cycle 1 (64.4%)
Unscheduled bleeding, cycle 13 (40.3%)
1-10%
Acne (3.8%)
Metrorrhagia (2.8%)
Headache (2.7%)
Breast pain (2.2%)
Weight increased (1.9%)
Dysmenorrhea (1.9%)
Nausea (1.8%)
Vaginal hemorrhage (1.7%)
Libido decreased (1.3%)
Breast tenderness (1.2%)
Menstruation irregular (1.2%)
Mode of Action
Spironolactone analogue with antimineralocorticoid and antiandrogenic activity; suppresses luteinizing hormone and ovulation by binding to the progesterone receptor; also alters cervical mucus, causing unfavorable sperm penetration; changes to the endometrial lining may decrease implantation.
Note
Droslyn 4 mg Tablet generic name is Drospirenone. Droslyn 4 mg Tablet is manufactured by Incepta Pharmaceuticals Ltd.Droslyn is availble in all over Bangladesh.
Mes BD drug index information on Droslyn Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.