CYTOMIS KIT Tablet

Cytomis Kit Tablet (Mifepristone 200mg + Misoprostol 200mcg)

Manufacturer: Incepta Pharmaceuticals Ltd.
Generic Name: Mifepristone 200mg + Misoprostol 200mcg
Therapeutic Class: Drugs acting on the Uterus / Prostaglandin Analogues
Pack: 1 tablet Mifepristone 200mg + 4 tablets Misoprostol 200mcg per kit
Price: ৳300.00 per kit

Indications

Cytomis Kit is indicated for early menstrual regulation and medical termination of intrauterine pregnancy up to 9 weeks (63 days) of gestation, as confirmed by ultrasound. It must be prescribed and administered only by qualified medical professionals in an appropriate healthcare setting.

Composition

Each Cytomis Kit contains:

• Strip 1: 1 tablet — Mifepristone 200mg
• Strip 2: 4 tablets — Misoprostol 200mcg each (total 800mcg)

Mechanism of Action

Mifepristone is a synthetic antiprogestogen that competitively blocks progesterone receptors at decidual and myometrial levels, sensitises the uterus to prostaglandins, softens and dilates the cervix, and promotes myometrial contractions leading to expulsion of the conceptus.

Misoprostol is a synthetic prostaglandin E1 analogue that binds to prostaglandin receptors in the myometrium, causing uterine contractions and cervical ripening. The sequential combination of mifepristone followed by misoprostol achieves a high rate of complete medical abortion.

Dosage and Administration — Three-Visit Protocol

Day 1 (Visit 1): Mifepristone 200mg — taken orally under direct medical supervision at the clinic or hospital.

Day 2–3 (Visit 2, 24–48 hours after mifepristone): Misoprostol 800mcg (4 × 200mcg tablets) — administered buccally (held in the cheek pouches for 30 minutes then swallowed) or sublingually under medical supervision. Most women experience cramping and bleeding within 1–4 hours of misoprostol administration.

Day 10–14 (Visit 3 — Follow-up): Clinical assessment to confirm complete expulsion by physical examination and/or ultrasound. If the procedure is incomplete, surgical intervention may be required.

Note: This regimen must only be initiated, supervised, and completed by a registered physician experienced in reproductive healthcare.

Contraindications

• Confirmed or suspected ectopic pregnancy
• Intrauterine device (IUD) in place (must be removed before use)
• Chronic adrenal failure or long-term corticosteroid therapy
• Inherited porphyria
• Coagulation disorders or anticoagulant therapy
• Hypersensitivity to mifepristone, misoprostol, or any prostaglandin
• Gestation beyond 63 days (9 weeks) confirmed by ultrasound
• Haemorrhagic disorders

Warnings and Precautions

• Use only in settings where emergency surgical intervention (surgical evacuation) is immediately accessible.
• Patients must be advised to seek immediate medical attention if they experience heavy bleeding (soaking more than 2 maxi pads per hour for 2 consecutive hours), severe abdominal pain, fever exceeding 38°C lasting more than 24 hours, or foul-smelling vaginal discharge.
• Incomplete abortion requires prompt surgical intervention to prevent haemorrhage and infection.
• Rh-negative women should receive Rh immunoglobulin at the time of misoprostol administration, as per standard clinical practice.
• Not for use in women who cannot comply with the three-visit protocol.

Side Effects

Very common (≥1/10): Uterine cramping and pain, vaginal bleeding (expected therapeutic effect), nausea, vomiting, diarrhoea.

Common (≥1/100 to <1/10): Headache, dizziness, chills, fever (low-grade), fatigue.

Uncommon: Heavy bleeding requiring transfusion or surgical intervention, infection/sepsis (rare but serious — presents with fever, tachycardia, and pelvic pain).

Misoprostol-specific: Shivering, hot flushes, and mild transient hypo- or hypertension may occur.

Drug Interactions

• NSAIDs (e.g., ibuprofen, diclofenac): May theoretically reduce prostaglandin effect; avoid concurrent use unless directed by a physician.
• Corticosteroids: Mifepristone may antagonise the effect of systemic corticosteroids; avoid in patients on long-term corticosteroid therapy.
• Anticoagulants: Increased risk of haemorrhage; contraindicated.
• CYP3A4 inhibitors/inducers: Mifepristone is metabolised by CYP3A4; strong inhibitors (e.g., ketoconazole) or inducers (e.g., rifampicin, carbamazepine) may alter plasma levels.

Use in Pregnancy and Lactation

Pregnancy: This kit is intended for termination of pregnancy; it is not indicated for use in ongoing wanted pregnancies. If the pregnancy continues after treatment (failed medical abortion), there is a risk of foetal abnormalities, and surgical termination should be discussed.

Lactation: Misoprostol is excreted in breast milk in small quantities. Women who are breastfeeding should be advised to discard breast milk for 24 hours after misoprostol administration. Mifepristone is detectable in breast milk; interruption of breastfeeding for at least 3 days after mifepristone administration is recommended.

Special Populations

Adolescents: Not indicated for use in females below the legal age of consent without appropriate guardianship and legal compliance.

Hepatic/Renal Impairment: Use with caution; no dose adjustment established. Consult a physician.

Storage

Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the pack.

Pricing

Cytomis Kit (Mifepristone 200mg + Misoprostol 200mcg × 4): ৳300.00 per kit

Disclaimer: This product information is for reference purposes only and does not substitute professional medical advice, diagnosis, or treatment. Always consult a registered physician or qualified healthcare professional before taking any medication.