Droslyn 4 (24 active+4 inert) Tablets Box

✔️ Uses of Droslyn 4

✔️ Composition of Droslyn 4

Drospirenone

✔️ Side Effects of Droslyn 4

The clinically significant side effects include:

• Hyperkalemia
• Bleeding irregularities (including amenorrhea)

Other adverse reactions include:

• Acne
• Metrorrhagia (irregular uterine bleeding)
• Headache
• Breast pain
• Weight gain
• Dysmenorrhea (painful menstruation)
• Nausea
• Vaginal hemorrhage
• Decreased libido
• Breast tenderness
• Menstrual irregularities

These reactions are based on clinical trials and may not fully reflect real-world experiences.

✔️ How does Droslyn 4 work?

Droslyn 4 mimics the action of progesterone suppresses ovulation and brings about other hormonal changes to prevent pregnancy.

✔️ Quick Suggestions:

Drospirenone should be used with caution and under the guidance of a healthcare provider. You should avoid taking drospirenone if you or your family have a history of the following conditions:

1. Breast cancer or a family history of breast cancer.
2. Liver disease or gallbladder disease.
3. Diabetes, particularly if poorly controlled.
4. Depression or any history of severe mood disorders.
5. Seizures (fits).
6. Crohn's disease or ulcerative colitis (inflammatory bowel conditions).
7. Hemolytic uremic syndrome (a blood-clotting disorder leading to kidney failure).
8. Sickle cell anemia (a genetic blood disorder).
9. Elevated levels of fat in the blood (hyperlipidemia).

Additionally, avoid taking drospirenone if:

• You are undergoing or about to undergo surgery, or if you have been bedridden or immobile for a long period.
• You have recently given birth.

Other conditions where drospirenone use should be avoided:

• Varicose veins or pain/swelling in veins under the skin.
• Systemic lupus erythematosus (a condition where the immune system attacks the body’s tissues).
• Chloasma (discoloration of the skin on the face or neck, also known as “pregnancy patches”).
• Angioedema (hereditary swelling of the lips, face, or other areas).

Drospirenone is usually taken along with ethinyl estradiol starting between Days 2 and 5 of your menstrual cycle. Follow your doctor's instructions regarding dosage and timing, as correct use is essential for effectiveness.

• Avoid direct sunlight or ultraviolet (UV) light as it may worsen skin discoloration (chloasma).
• If you experience symptoms of blood clots (e.g., pain, swelling, warmth in the leg, breathlessness, or an irregular heartbeat), seek immediate medical attention.

✔️ Indications of Droslyn 4

Droslyn is a progestin indicated for use in females as an oral contraceptive.

✔️ Pharmacology

Drospirenone is a progestin used to prevent pregnancy in females of reproductive age by suppressing ovulation. As a spironolactone analog, it also has anti-mineralocorticoid activity.

Absorption: Drospirenone is absorbed proportionally to the dose, with maximum plasma concentrations (Cmax) of around 27 ng/ml reached 2-6 hours after ingestion. Steady-state concentrations of about 41 ng/ml are achieved after 10 days of treatment. Food does not affect absorption.

Distribution: Drospirenone is 95-97% bound to serum albumin and does not bind to sex hormone-binding globulin (SHBG) or corticosteroid-binding globulin (CBG). Its apparent volume of distribution is around 4 L/kg.

Metabolism: Drospirenone is extensively metabolized, mainly due to its inactive metabolites—the acid form and 4,5-dihydro drospirenone-3-sulfate. Its oxidative metabolism is catalyzed by CYP3A4.

Excretion: The terminal half-life of Drospirenone is around 30 hours. Most of the excretion occurs via feces, with only trace amounts of unchanged drugs found in urine and feces.

✔️ Dosage & Administration of Droslyn 4

Drospirenone tablets are taken once daily, with 28 consecutive tablets in each cycle (24 white active tablets followed by 4 light pink inert tablets). They should be taken at the same time each day to maintain a 24-hour interval between doses.

Starting Droslyn: For women not currently using hormonal contraception, take the first active white tablet on the first day of menstruation. Continue taking one white active tablet daily for 24 days, followed by one light pink inert tablet for 4 days. Each new pack should start on the same day of the week as the first pack.

Switching to Drospirenone:

• From a Combined Oral Contraceptive (COC): Start on the day when the next pack of the previous COC would have begun.
• From a Transdermal Patch or Vaginal Ring: Start on the scheduled day of the next application or insertion.
• From an Injection: Start on the day the next injection would have been scheduled.
• From an Intrauterine Device (IUD) or Implant: Start on the day of removal.

Consult the Patient Information and Instructions for Use for further guidance on correct usage.

✔️ Interaction

Substances Decreasing the Effectiveness of Hormonal Contraceptives (HCs): Certain drugs and herbal products, particularly those inducing the enzyme cytochrome P450 3A4 (CYP3A4), can reduce the effectiveness of hormonal contraceptives (HCs) by lowering their systemic concentrations. This may lead to breakthrough bleeding or unintended pregnancy. Examples of such substances include:

• Efavirenz, Phenytoin, Barbiturates, Carbamazepine, Bosentan, Felbamate, Griseofulvin, Oxcarbazepine, Rifampicin, Rifabutin, Rufinamide, Aprepitant, St. John's Wort.

Substances Increasing the Systemic Concentrations of HCs: Co-administration of strong CYP3A4 inhibitors, such as ketoconazole, has been shown to moderately increase the systemic exposure of Drospirenone. However, interaction with drugs like omeprazole, simvastatin, and midazolam is unlikely to have significant effects on the metabolism of Drospirenone.

Potential for Increased Serum Potassium Concentration: Drospirenone has the potential to raise serum potassium levels, especially when used with other potassium-elevating drugs such as:

• ACE inhibitors, angiotensin-II receptor antagonists, Potassium-sparing diuretics, Potassium supplements, Heparin, Aldosterone antagonists, and NSAIDs.

✔️ Drospirenone should not be used in the following conditions:

• Renal impairment
• Adrenal insufficiency
• History or presence of progestin-sensitive cancers
• Liver tumors (benign or malignant) or hepatic impairment
• Undiagnosed abnormal uterine bleeding

✔️ Pregnancy & Lactation

• Based on epidemiological studies and meta-analyses, there is minimal to no increased risk of birth defects in children born to women who inadvertently use oral progestin during early pregnancy. However, if pregnancy occurs, Drospirenone should be discontinued, as hormonal contraceptives are not needed during pregnancy.
• Negligible amounts of Drospirenone are excreted into breast milk, and no adverse effects are expected on breastfed newborns or infants at therapeutic doses. No negative impact on milk production or infant growth and development has been observed with the use of progestin-only pills (POPs)

✔️ Precautions & Warnings

• Hyperkalemia: Drospirenone has anti-mineralocorticoid activity, which could lead to hyperkalemia, especially in high-risk patients. This risk is similar to that seen with a 25 mg dose of spironolactone. Drospirenone is contraindicated in patients with conditions predisposing to hyperkalemia, such as renal or hepatic impairment and adrenal insufficiency. For patients taking long-term medications that may elevate serum potassium, potassium levels should be checked before starting treatment and during the first cycle.
• Thromboembolic Disorders: While progestin-only preparations have not been shown to increase the risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism (VTE), caution is advised in patients with a history of thromboembolic events. Drospirenone should be discontinued in the event of arterial or venous thromboembolic events or during prolonged immobilization due to surgery or illness.
• Bone Loss: Drospirenone treatment may reduce estradiol levels, and while it is unclear if this leads to clinically significant bone mineral density loss, it should be monitored.
• Liver Disease: Drospirenone should be discontinued if liver dysfunction, jaundice, or other liver abnormalities develop. It is contraindicated in patients with liver tumors or hepatic impairment.
• Ectopic Pregnancy: Physicians should be vigilant for ectopic pregnancy in women using Drospirenone who present with lower abdominal pain or become pregnant.
• Hyperglycemia in Diabetics: Drospirenone may reduce insulin sensitivity in diabetic patients, increasing the risk of hyperglycemia. Regular monitoring and adjustments to diabetes management may be necessary.
• Bleeding Irregularities & Amenorrhea: Women using Drospirenone may experience breakthrough bleeding, spotting, or amenorrhea, especially within the first three months of use. If bleeding irregularities persist or occur after regular cycles, further evaluation for pregnancy or other underlying conditions is recommended.
• Depression: Patients with a history of depression should be monitored closely, and Drospirenone should be discontinued if depression recurs to a significant degree.

✔️ Overdose Effects

Overdosage of Drospirenone has not been linked to any serious adverse effects. Potential symptoms include nausea, vomiting, and vaginal bleeding. No specific antidote exists, and treatment should focus on symptomatic relief. As Drospirenone has anti-mineralocorticoid properties, serum potassium, and sodium levels should be monitored, along with signs of metabolic acidosis in cases of overdose.

✔️ Storage:

• Keep the medicine out of reach of children
• Store Droslyn 4 at room temperature