ยาคุมโปรเจสโตเจนชนิดเดี่ยว ชนิดกิน (estrogen-free oral contraceptive)
ปัจจุบันเมืองไทยเมืองไทยมียาคุมโปรเจสโตเจนชนิดเดี่ยว ชนิดกิน (estrogen-free oral contraceptive) อยู่ 3 ชนิด
🎉ยาดรอสเพอริโนน (Drosperinone) 4 มก. แบบ24+4 เม็ด ซึ่งจะมีตัวยาฮอร์โมน 24 เม็ด และเม็ดแป้ง 4 เม็ด ลืมกินยาได้นานถึง 24 ชม.
🎗️ตัวยา Desogestrel 0.075 mg จำนวน 28 เม็ด
ลืมกินยาได้ไม่เกิน 12 ชม. หากลืมเกินกว่านี้จะทำให้ประสิทธิภาพการคุมกำเนิดลดลง ต้องใช้ถุงยางอนามัยร่วมด้วย 7 วัน
🎐ตัวยา Lynestrenol 0.5 mg จำนวน 28 เม็ด
ลืมกินยาได้ไม่เกิน 3 ชม. หากลืมเกินกว่านี้จะทำให้ประสิทธิภาพการคุมกำเนิดลดลง ต้องใช้ถุงยางอนามัยร่วมด้วย 7 วัน
🌹Drosperinone-only pill: a new estrogen-free oral contraceptive
FDA Accepts Filing of New Estrogen-free Oral Contraceptive Developed by Exeltis
The pharmaceutical multinational Exeltis, with a strong position in Women's Health, has received acceptance from the US Food and Drug Administration (FDA) of the filing of Slinda® (4mg Drospirenone-only pill), the novel oral contraceptive developed by the company. The Prescription Drug User Fee Act (PDUFA) date is expected during the 27 May of 2019.
Slinda® is an investigational estrogen-free oral contraceptive, with a 24/4 dose regimen that is believed to have a favourable safety and efficacy profile.
"Developed by Exeltis, part of the global pharmaceutical group Insud Pharma, Slinda® showed to be safe, efficacious and well tolerated during extensive clinical trials. Once available in the market, it could give an improved bleeding profile and greater flexibility, maintaining contraception efficacy for up to 24 hours in the event of a delayed or missed pill dosage,"
Drospirenone is a synthetic progestin with a pharmacological profile similar to natural-produced progesterone. As an estrogen-free contraceptive option, Slinda® is expected to reduce the cardiovascular risks associated with Combined Hormonal Contraceptives (CHCs) and to offer all the unique advantages of drospirenone in terms of safety and tolerability and antimineralocorticoid and antiandrogenic activity.
The submission of Slinda® is based on an extensive development programme involving more than 3,000 patients, generating over 20,000 cycles. The study showed that Drospirenone 4 mg-only pill has a clinical efficacy historically comparable to CHCs. "No cases of thromboembolic events were reported in the entire clinical programme. The safety profile was demonstrated for all women, even higher-risk population segments, such as smokers, over-35s and obese patients,"
According to the results shown in the clinical study, Drospirenone 4mg-only pill may offer a more favourable bleeding profile than other estrogen-free contraceptives.
Slinda® is intended to give greater flexibility than other estrogen-free contraceptives, having demonstrated that in case of missing a pill, there is no impact in the efficacy during the following 24 hours, while with other estrogen-free options this is reduced to 12 hours.
Slynd® is the new progestin-only oral contraceptive approved by the FDA in May 2019. This novel progestin-only pill (POP) contains drospirenone 4 mg in each active tablet, which is a higher dose than what is found in drospirenone-containing combined oral contraceptives (COCs).
Slynd also allows a 24-hour missed pill window which improves reliability and bleeding profiles in the event of a missed dose. One study compared two arms — one with four missed doses (four 24-hour delays) and the other with no missed dose during the cycle. Even with four missed doses in the cycle, there was adequate ovarian suppression and the same follicular size was observed in both arms.
Drospirenone inhibits ovulation by suppressing luteinizing hormone (LH) secretion. Additionally, by modifying cervical mucus, it reduces sperm transport and thus prevents fertilization. Unlike other conventional synthetic progestins, drospirenone has a similar profile to endogenous progesterone.
As an analogue of 17-alpha spironolactone, drospirenone has anti-mineralocorticoid and anti-androgenic activity. Due to the anti-mineralocorticoid activity, it increases urinary sodium and serum aldosterone. Therefore, compared to other COCs causing fluid retention and edema, drospirenone has an ability to reduce blood pressure.
Drospirenone is contraindicated in women with positive or unknown antiphospholipid antibodies, ischemic heart disease, stroke, current or history of breast cancer, hepatocellular adenoma, malignant hepatoma, and severe hepatitis. Clinicians should use this medication with caution in patients who are taking other medications that can predispose them to hyperkalemia, or monitor potassium level.
The drug interaction profile is similar to drospirenone-containing COCs. Although drospirenone is metabolized independently of P450 enzymes, it is a minor substrate of CYP3A4. It is recommended to avoid use in patients taking strong 3A4 inhibitors to prevent hyperkalemia. Strong P450 and P-glycoprotein transporter inhibitors and inducers can affect the serum concentration, efficacy, and adverse effects.
In conclusion, Slynd can be used in most patients and will be an important option for patients with contraindications to estrogen — including history of high blood pressure or smoking above age 35 — PMDD, as well as patients desiring contraception without androgenic effects, such as those with acne or polycystic ovary syndrome (PCOS).
MEET SLYND: A NOVEL PROGESTIN-ONLY PILL
drospirenone (Rx)
Exeltis USA announces the approval of Slynd™
Monday, July 8, 2019
บทความอื่น
POSTED 2021.09.21
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