Sustalux SR 200 is a Natural Micronised Progesterone 200mg Sustained-Release (SR) oral tablet. It is a prescription medicine (Rx) formulated as a bioidentical progestogen for women requiring progesterone supplementation.

It is indicated for luteal phase support in ART (IVF/IUI) cycles, prevention of miscarriage in threatened or recurrent pregnancy loss, management of corpus luteum insufficiency, and progesterone deficiency states.

Natural Micronised Progesterone (NMP) is bioidentical progesterone - chemically identical to the progesterone produced by a woman's corpus luteum after ovulation. "Micronised" means the hormone particles are ground to a very fine size, dramatically improving oral absorption.

Unlike synthetic progestogens (progestins), NMP does not carry the androgenic, glucocorticoid, or anti-estrogenic side effects associated with older synthetic forms, making it better tolerated in pregnancy and fertility treatments.

Sustained Release (SR) technology is built into the tablet matrix to slowly release the drug over an extended period - typically 12-24 hours - rather than releasing all at once. This provides steadier plasma progesterone levels throughout the day.

Compared to standard-release progesterone tablets, the SR formulation reduces peak-and-trough fluctuations, meaning fewer side effects such as dizziness and drowsiness, and more consistent hormonal support for the endometrium and early pregnancy.

Progesterone is essential in early pregnancy: it maintains the uterine lining (endometrium), prevents uterine contractions, supports embryo implantation, and suppresses the maternal immune response to the developing embryo.

Supplementing with Sustalux SR 200 ensures adequate progesterone levels when the corpus luteum (the ovarian structure responsible for natural progesterone production) is insufficient - a common cause of early pregnancy loss.

Luteal phase deficiency (LPD) occurs when the corpus luteum produces insufficient progesterone after ovulation, leading to an inadequate uterine lining for implantation and an increased risk of early miscarriage.

Sustalux SR 200 supplementation during the luteal phase of the menstrual cycle or in early pregnancy provides the necessary progesterone support to correct this deficiency and improve implantation and early pregnancy outcomes.

In assisted reproductive technology (ART) cycles such as IVF and IUI, the natural luteal phase is often disrupted by stimulation protocols and egg retrieval. This makes progesterone supplementation mandatory to prepare and maintain the endometrium for embryo implantation.

Sustalux SR 200 is used as luteal phase support starting from the day of egg retrieval or embryo transfer, and is continued into early pregnancy as directed by the fertility specialist.

Sustalux SR 200 is a prescription medication for adult women. It is typically prescribed for:

• Women undergoing IVF, IUI, or other ART procedures requiring luteal phase support
• Women with a history of recurrent miscarriage or threatened abortion
• Women with corpus luteum insufficiency or progesterone deficiency
• Women with irregular cycles requiring progestogen support
• Post-menopausal women as part of hormone replacement therapy (under specialist advice)

Take as directed by your gynaecologist or fertility specialist. The tablet must be swallowed whole - do not crush, split, or chew, as this destroys the sustained-release mechanism.

Typically taken at bedtime with or after food. Taking at night takes advantage of natural drowsiness as a side effect, improving tolerability. Do not alter the dose or stop the medication without consulting your doctor, especially during pregnancy.

Natural Micronised Progesterone has an established safety profile in pregnancy and is considered the preferred form of progesterone supplementation in early pregnancy by many obstetric guidelines.

However, Sustalux SR 200 is a prescription medication and must only be used under medical supervision. Your obstetrician will determine the appropriate dose, duration, and tapering schedule based on your clinical condition and trimester.

Natural Micronised Progesterone is generally well tolerated. Common side effects may include drowsiness or dizziness (especially if taken in the morning), breast tenderness, mild nausea, or bloating.

Rare or serious effects may include allergic reactions, significant dizziness or falls, or mood changes. Report any unusual or persistent symptoms to your doctor promptly. Do not drive or operate machinery if drowsiness occurs.

Consult your doctor carefully if you have:

• Known or suspected hormone-sensitive cancers (breast, ovarian, endometrial)
• Undiagnosed vaginal bleeding
• Severe liver disease
• History of thromboembolic disorders (blood clots)
• Known allergy to progesterone or any excipient in the formulation
• Porphyria

Natural Micronised Progesterone may interact with certain anticonvulsants, rifampicin, antifungals, or other hormone therapies. It may alter the efficacy of some diabetes medications and anticoagulants.

Always inform your doctor and pharmacist about all prescription medicines, over-the-counter drugs, and supplements you are currently taking before starting Sustalux SR 200.

Progesterone levels rise within hours of the first dose. The sustained-release formulation maintains steady blood levels over 12-24 hours. Clinical effects on the endometrium (lining thickening, implantation support) develop over several days of consistent use.

Duration of therapy is determined by your doctor and depends on the indication - ranging from a few weeks of luteal phase support to continuation into the second or third trimester in some high-risk pregnancies.

Store in a cool, dry and dark place below 25°C. Protect from direct sunlight, heat, and moisture. Keep out of reach of children. Do not use if the blister is damaged, punctured, or beyond the expiry date printed on the carton.

• Sustalux SR 200 - Natural Micronised Progesterone 200mg SR Film-Coated Tablets
• Pack: 10 × 1 × 10 Tablets per carton (100 tablets)
• Rx - Prescription Only Medicine
• Manufactured by Santheras Pharmaceuticals Pvt. Ltd.
• Mfg. Lic. No.: 1874-OSP & 1894-B