Ethinylestradiol + Drospirenone + Levomefolate Calcium

Ethinylestradiol + Drospirenone + Levomefolate Calcium is a combined oral contraceptive pill. It is indicated for use by women to: Prevent pregnancy, Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception, Treat moderate acne for women at least 14 years old, and Raise folate levels.

Ethinylestradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components inhibit ovulation by suppressing gonadotropin release. Drospirenone has antimineralocorticoid and antiandrogenic activity. Levomefolate Calcium is a metabolite of vitamin B9.

• Contraception: Used as a combined oral contraceptive pill for prevention of pregnancy.
• PMDD: Used for treatment of symptoms of premenstrual dysphoric disorder.
• Acne: Used for treatment of moderate acne in women at least 14 years of age.
• Folate Supplementation: Used to raise folate levels in women using oral contraception (to reduce risk of neural tube defects).

Oral Contraceptive preparations

Combined Oral Contraceptive + Folate

Ethinylestradiol is a synthetic version of oestrogen and Drospirenone is a synthetic form of progesterone. The hormonal components inhibit ovulation by suppressing gonadotropin release. Drospirenone has antimineralocorticoid activity, counteracting oestrogen related sodium retention. Drospirenone exerts antiandrogenic activity. Levomefolate Calcium is a metabolite of vitamin B9.

Ethinylestradiol + Drospirenone prevents ovulation by suppressing pituitary gonadotropin secretion. Drospirenone provides antimineralocorticoid and antiandrogenic activity. Levomefolate Calcium raises folate levels.

Adult Dose:

• 1 tablet daily by mouth at the same time every day.
• 24 active orange tablets, then 4 light orange non-hormonal tablets.
• Start on the first day of menstruation (Day 1 Start) or first Sunday after onset (Sunday Start).

Take 1 tablet at the same time every day. Follow the directions on the pack for 24 orange tablets, then 4 light orange tablets. Swallow each pill whole with water if necessary.

If you miss a dose, take it as soon as remembered. If more than 24 hours late, use additional contraceptive methods.

Common Side Effects (>=2%):

• Headache/migraine (5.9%)
• Menstrual irregularities (4.1%)
• Nausea/vomiting (3.5%)
• Breast pain/tenderness (3.2%)
• Fatigue (4.2%)
• Irritability (2.8%)
• Decreased libido (2.8%)
• Weight gain (2.5%)

In PMDD trials: Menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%).

Precautions:

• Vascular risks: Stop if thrombotic event occurs; stop 4 weeks before major surgery and start 2 weeks after.
• DRSP-containing COCs may be associated with higher risk of VTE.
• Hyperkalemia: DRSP has antimineralocorticoid activity; do not use in patients predisposed to hyperkalemia.
• Liver disease: Discontinue if jaundice occurs.
• High blood pressure: Do not prescribe for women with uncontrolled hypertension.
• Lactation: When possible, advise nursing mother to use other forms of contraception until weaned.

Contraindications:

• Pregnancy
• Renal impairment
• Adrenal insufficiency
• High risk of arterial or venous thrombotic diseases
• Undiagnosed abnormal uterine bleeding
• Breast cancer or other estrogen- or progestin-sensitive cancer
• Liver tumor or liver disease
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir

Drug Interactions:

• CYP3A4 inducers (barbiturates, carbamazepine, phenytoin, rifampicin, St. John's Wort): May decrease COC effectiveness or increase breakthrough bleeding; use back-up contraception.

Food Interactions: May be taken with or without food. Caution with alcohol.

Use in Pregnancy: Do not use during pregnancy. If pregnancy occurs, discontinue.

Use in Lactation: Not recommended; can decrease milk production.

Pediatric Use: Not indicated before menarche.

Geriatric Use: Indicated for women of reproductive age.

Renal Impairment: Do not use in renal impairment.

Hepatic Impairment: Do not use in liver disease.

Overdose: Overdose may cause nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness, fatigue; withdrawal bleeding may occur in females. No specific antidote; symptomatic treatment.

Storage: Keep below 30 degree C, away from light and moisture. Keep out of reach of children.

Ethinylestradiol + Drospirenone + Levomefolate Calcium