Midiana® (Drospirenone/Ethinyl Estradiol) 3 mg/0.03 mg, 21 film-coated tablets

What is Midiana® (Drospirenone/Ethinyl Estradiol)?

Midiana® is a combined oral contraceptive that contains two active ingredients: drospirenone and ethinyl estradiol. This medication helps prevent pregnancy by inhibiting ovulation and altering the endometrium. Drospirenone also possesses antiandrogenic and mild antimineralocorticoid properties, making it similar to natural progesterone.

What are the active ingredients in Midiana®?

Midiana® contains:

• Ethinyl Estradiol: 30 mcg
• Drospirenone: 3 mg

Other ingredients include lactose monohydrate, corn starch, pregelatinized corn starch, povidone K25, and magnesium stearate. The tablet coating consists of polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, and soy lecithin.

How does Midiana® work?

Midiana® achieves its contraceptive effect through several mechanisms:

• Inhibition of Ovulation: Prevents the release of an egg from the ovaries.
• Alteration of Endometrium: Changes the lining of the uterus, making it less suitable for implantation.
• Thickening of Cervical Mucus: Makes it more difficult for sperm to enter the uterus.

What are the benefits of Midiana®?

In addition to preventing pregnancy, Midiana® may reduce the risk of endometrial and ovarian cancer. Drospirenone, one of the active ingredients, helps reduce acne symptoms and prevents fluid retention, which is beneficial for women prone to swelling.

What are the pharmacokinetic properties of Midiana®?

Drospirenone:

• Absorption: Quickly and almost completely absorbed, reaching maximum serum concentration (37 ng/mL) 1-2 hours after ingestion.
• Distribution: Binds to serum albumin, shows a two-phase decline in serum concentration.
• Biotransformation: Undergoes significant metabolism, primarily through non-cytochrome P450 pathways.
• Elimination: Excreted through kidneys and intestines, with a half-life of about 40 hours.

Ethinyl Estradiol:

• Absorption: Rapidly and completely absorbed, reaching maximum concentration (100 pg/mL) 1-2 hours after ingestion.
• Distribution: Binds to plasma proteins, induces the synthesis of SHBG and transcortin.
• Biotransformation: Fully metabolized, with a clearance rate of 5 mL/min/kg.
• Elimination: Metabolites excreted via kidneys and intestines, with a half-life of about 1 day.

What are the indications for using Midiana®?

Midiana® is primarily indicated for the prevention of pregnancy.

Can Midiana® be used during pregnancy and breastfeeding?

Midiana® is contraindicated during pregnancy and breastfeeding. If pregnancy occurs while using the medication, it should be discontinued immediately. Combined oral contraceptives can reduce the quantity and alter the composition of breast milk, hence they are recommended only after breastfeeding has completely stopped.

What are the contraindications for Midiana®?

Midiana® should not be used in the presence of:

• Hypersensitivity to any of its components
• Current or past venous thrombosis
• Current or past arterial thrombosis (e.g., myocardial infarction)
• Uncontrolled hypertension
• Severe hepatic or renal insufficiency
• Hormone-dependent malignancies
• Pregnancy or suspected pregnancy
• Lactation

How should Midiana® be taken?

Take one tablet daily at the same time each day for 21 consecutive days, followed by a 7-day break during which menstrual-like bleeding occurs. Begin the next pack on the 8th day, regardless of whether the bleeding has stopped.

What should be done if a dose is missed?

If less than 12 hours late, take the missed tablet as soon as possible and continue with the next tablet at the usual time. If more than 12 hours late, the contraceptive effect may be reduced; use additional contraception methods for the next 7 days.

What are the side effects of Midiana®?

Possible side effects include irregular bleeding, nausea, abdominal pain, headache, mood changes, acne, and weight gain. Rarely, it may cause thrombosis or thromboembolism.

How should Midiana® be stored?

Store Midiana® in a place protected from light at a temperature not exceeding 25°C (77°F). The shelf life is 2 years.