Drospinetta 4 mg 28 tablets
Marcyrl Pharmaceutical Industries
Marcyrl Pharmaceutical Industries
Composition
Each active film-coated tablet contains
Drospirenone micronized 4 mg
Placebo tablet
Microcrystalline Cellulose 102
Spray Dried Lactose
Quinoline Yellow Color
Magnesium Stearate
Description
Drospinetta is an oral progestin-only contraceptive intended for use by females of reproductive potential to prevent pregnancy. It contains drospirenone, which provides contraceptive efficacy with anti-mineralocorticoid and anti-androgenic properties. It is presented as 24 active (white) tablets and 4 inert (yellow) placebo tablets to be taken in a 28-day cycle.
Indications for Use
Drospinetta is indicated for the prevention of pregnancy in women of reproductive age.
Dosage and Method of Administration
Take one white active tablet daily at the same time for 24 consecutive days, followed by one yellow inert tablet daily for 4 days.
Start on Day 1 of menstrual bleeding if not switching from another contraceptive.
If switching from another method (COC, patch, ring, injection, IUD, or implant), start Drospinetta on the corresponding day of transition.
Missed Dose
One missed white tablet: Take as soon as possible, continue remaining tablets as scheduled.
Two or more missed white tablets: Take the last missed tablet as soon as possible, use backup contraception for 7 days.
Missed yellow tablet(s): Skip and continue the pack as normal.
In case of vomiting/diarrhea within 3–4 hours of taking a tablet: take next day’s tablet early (within 12 hours).
Contraindications
Renal impairment
Adrenal insufficiency
Hepatic impairment or liver tumors
Known or suspected progestin-sensitive cancers (e.g., cervical cancer)
Undiagnosed abnormal uterine bleeding
Precautions
Hyperkalemia: Monitor potassium levels in high-risk patients.
Thromboembolic disorders: Increased risk in postpartum period or history of clotting disorders.
Bone loss: Potential for decreased estradiol levels.
Liver disease: Discontinue if liver dysfunction occurs.
Ectopic pregnancy: Be alert if abdominal pain or pregnancy symptoms develop.
Diabetes: May reduce insulin sensitivity.
Bleeding irregularities: Common in initial months; assess persistent irregular bleeding.
Depression: Monitor and discontinue if depression worsens.
Lactose intolerance: Not recommended for patients with rare galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
Side Effects
Adverse effects occurring in ≥1% of users
Acne
Headache
Nausea
Breast pain or tenderness
Weight gain
Dysmenorrhea
Metrorrhagia or vaginal hemorrhage
Decreased libido
Menstrual irregularity
Pregnancy and Breastfeeding
Not for use during pregnancy; discontinue if pregnancy occurs.
Safe for use during lactation; negligible transfer into breast milk and no effect on milk production.
Storage Conditions
Store in a dry place at a temperature not exceeding 30°C.
Packaging
Carton contains 1 strip of 24 active tablets + 4 placebo tablets and an insert leaflet.