- Stock: In Stock
- Brand: Renata
- Product ID: Mifepristone + Misoprostol
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AB Kit 200mg + 200mcg Tablet
Generic Name: Mifepristone 200mg + Misoprostol 200mcg
Manufacturer: Beximco Pharmaceuticals Ltd.
Drug Class: Antiprogestogen + Prostaglandin E1 Analogue
Prescription Status: Prescription Only (Rx)
Composition
| Component | Strength | Pharmacological Role |
|---|---|---|
| Mifepristone | 200 mg | Antiprogestogen — blocks progesterone receptors, sensitises uterus to prostaglandins |
| Misoprostol | 200 mcg | Prostaglandin E1 analogue — stimulates uterine contractions and cervical dilatation |
Mechanism of Action
Mifepristone competitively antagonises progesterone at uterine progesterone receptors, causing decidual breakdown and cervical softening. It also has potent antiglucocorticoid and weak antiandrogenic activity. It sensitises the myometrium to prostaglandins.
Misoprostol binds prostaglandin EP receptors in the uterus, inducing coordinated myometrial contractions and cervical dilatation, resulting in expulsion of intrauterine contents.
Indications
- Medical termination of intrauterine pregnancy up to 63 days (9 weeks) of gestation
- Cervical preparation prior to surgical termination of pregnancy
- Medical management of missed or incomplete miscarriage
- Induction of labour (under specialist supervision)
Dosage and Administration
WHO-Recommended Protocol (up to 63 days gestation):
| Step | Drug | Dose | Route |
|---|---|---|---|
| Day 1 | Mifepristone | 200 mg | Oral |
| Day 2–3 (24–48 hrs later) | Misoprostol | 800 mcg (4 × 200 mcg tablets) | Sublingual, buccal, or vaginal |
Confirm complete termination by clinical assessment or ultrasound 1–2 weeks after misoprostol administration.
Must be administered only in a licensed healthcare facility by a qualified provider. Self-administration is contraindicated.
Important Notice for Diabetic Patients
Mifepristone's Antiglucocorticoid Activity — Hyperglycaemia Risk
Mifepristone is a potent antiglucocorticoid in addition to its antiprogestogenic activity. In patients with diabetes mellitus, this can result in clinically significant blood glucose elevation. Key considerations for diabetic patients:
- Blood glucose monitoring: Closely monitor glucose from Day 1 through 48–72 hours post-treatment
- Corticosteroid therapy: Patients on systemic glucocorticoids (e.g., prednisolone) are at risk of acute adrenal insufficiency — endocrinologist review is mandatory before use
- Insulin adjustment: Dose modification may be necessary during the treatment window; consult prescribing physician
- Stress hyperglycaemia: Uterine cramping and procedural discomfort may trigger stress-induced blood glucose elevation in Type 1 and Type 2 diabetics
- GI effects of misoprostol: Vomiting and diarrhoea may impair absorption of oral hypoglycaemic agents; insulin-dependent patients should be monitored for hypoglycaemia
- Poorly controlled diabetes: Stabilise glycaemic control (target HbA1c <8%) before undergoing medical termination where clinically feasible
Contraindications
- Confirmed or suspected ectopic pregnancy (must be excluded before administration)
- Chronic adrenal failure or uncontrolled adrenal insufficiency
- Long-term systemic corticosteroid therapy
- Inherited porphyrias
- Intrauterine device (IUD) in situ — must be removed before use
- Bleeding disorders or concurrent anticoagulant therapy
- Severe hepatic or renal impairment
- Haemoglobin below 9.5 g/dL
- Known hypersensitivity to mifepristone, misoprostol, or prostaglandins
Side Effects
| Frequency | Side Effects |
|---|---|
| Very Common (>10%) | Uterine cramping, vaginal bleeding/spotting, nausea, diarrhoea, chills |
| Common (1–10%) | Vomiting, headache, dizziness, fever, incomplete abortion requiring intervention |
| Uncommon (<1%) | Heavy haemorrhage requiring transfusion, uterine infection, skin rash, anaphylaxis |
Drug Interactions
| Drug / Class | Interaction |
|---|---|
| Systemic glucocorticoids | Mifepristone antagonises glucocorticoid activity — risk of adrenal crisis; avoid or manage with specialist supervision |
| NSAIDs (ibuprofen, aspirin) | May reduce misoprostol efficacy via prostaglandin antagonism — avoid concurrent use |
| CYP3A4 inhibitors (ketoconazole, erythromycin) | Increased mifepristone plasma levels |
| CYP3A4 inducers (rifampicin, phenytoin, carbamazepine) | Reduced mifepristone efficacy |
| Anticoagulants (warfarin, heparin) | Increased haemorrhage risk |
Storage
Store below 30°C in a cool, dry place away from direct sunlight. Keep out of reach of children. Do not freeze.
Medical Disclaimer
The information provided here is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. AB Kit (Mifepristone + Misoprostol) is a prescription-only medicine that must only be used under the direct supervision of a qualified and licensed healthcare provider. Always consult your doctor, gynaecologist, or pharmacist before using this medication. DiabetesStore.com.bd does not endorse self-medication or unsupervised use of any prescription medicine. In the event of any adverse reaction or emergency, seek immediate medical attention.
