Pregno Tablet
Mifepristone
200mg
OHM Pharmaceuticals Lab Pvt. Ltd.
| Pack size | 1's |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 625.00 NPR |
Indications
Pregno Tablet is used for:
Termination of pregnancy, Labour induction, Cervical softening and dilatation, Postcoital contraception.
Adult Dose
Pregnancy Termination
Mifepristone: Indicated for the medical termination of intrauterine pregnancy through 70 days gestation in combination with misoprostol
Day 1: 200 mg of mifepristone PO as a single dose under physician supervision
Days 2-3: 800 mcg of MISOPROSTOL buccally once as a single dose; must be administered a minimum of 24-hr and a maximum of 48-hr following mifeprostone dose on day 1
Days 7-14
Must return for follow-up visit to confirm complete termination has occurred by medical history, clinical examination, hCG testing, or ultrasonographic scan
If complete expulsion has not occurred, but the pregnancy is not ongoing, women may be treated with another dose of misoprostol 800 mcg buccally with follow-up in ~7 days
Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion
Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion
Child Dose
Renal Dose
Administration
May be taken with or without food.
200 mg PO once given by a healthcare provider in a clinic, medical office, or hospital followed 24-48 hr later by misoprostol buccal administration
Buccal administration (misoprostol)
Because most women will expel the pregnancy within 2-24 hr of taking misoprostol, discuss with the patient an appropriate location for her to be when she takes the misoprostol, taking into account that expulsion could begin within 2 hr of administration
Administer misoprostol 800 mcg buccally within 24-48 hr after taking Mifeprex
The effectiveness of the regimen may be lower if misoprostol is administered <24 hr or >48 hr after mifepristone administration
Tell the patient to place two 200 mcg misoprostol tablets in each cheek pouch (the area between the cheek and gums) for 30 minutes and then swallow any remnants with water or another liquid
During the period immediately following the administration of misoprostol, the patient may need medication for cramps or GI symptoms
Contra Indications
Confirmed or suspected ectopic pregnancy, chronic adrenal failure, concurrent long-term corticosteroid therapy, history of allergy to mifepristone, misoprostol or other prostaglandin, haemorrhagic disorders or concurrent anticoagulant therapy, porphyria, hepatic or renal impairment; pregnancy and lactation; IUD in place; undiagnosed adnexal mass.
Precautions
Patient w/ haemostatic disorders or anaemia; malnutrition. Patients taking strong CYP3A4 inhibitors (when used in the treatment of Cushing's syndrome). Hepatic and renal impairment. Lactation. Monitoring Parameters Termination of pregnancy: Monitor Hb, haematocrit and RBC count in cases of heavy bleeding; CBC in patients who show signs of infection. Conduct clinical exam and/or ultrasound to confirm complete termination of pregnancy. Cushing's syndrome: Monitor thyroid function, serum glucose, psychiatric symptoms, signs/symptoms of adrenal insufficiency; cushingoid appearance.
Lactation
Distributed in human milk; because of the potential for serious adverse reactions in nursing infants from mifepristone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Pregnancy-Lactation
Interactions
Increased serum levels w/ CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, erythromycin). Decreased serum levels w/ CYP3A4 inducers (e.g. dexamethasone, rifampicin, phenytoin).
Potentially Fatal: Increased risk of adverse effects w/ simvastatin, lovastatin and CYP3A4 substrates w/ narrow therapeutic range (e.g. ciclosporin, pimozide, ergotamine). Antagonises the effect of glucocorticoids. Increased risk of vag bleeding w/ anticoagulants.
Adverse Effects
Side effects of Mifepristone :
>10%
Abdominal pain, cramping (96%),Uterine cramping (83%),Nausea (43-61%),Headache (2-31%),Vomiting (1-26%),Diarrhea (12-20%),Dizziness (1-12%)
1-10% (Mifeprex)
Fatigue (10%),Back pain (9%),Decreased hemoglobin >2 g/dL (6%),Uterine hemorrhage (5%),Viral infection (4%).Dyspepsia (3%),Insomnia (3%),Rigors (3%),Vaginitis (3%),Anemia (2%),Anxiety (2%),Fainting (2%),Leg pain (2%),Leukorrhea (2%),Pelvic pain (2%),Sinusitis (2%),Weakness (2%)
Mechanism of Action
Mifepristone is a progesterone antagonist with antiglucocorticoid activity. It binds to the intracellular progesterone receptor where it competitively inhibits progesterone attachment. It is also a partial progesterone agonist.
Note
Pregno 200mg Tablet manufactured by OHM Pharmaceuticals Lab Pvt. Ltd.. Its generic name is Mifepristone. Pregno is availble in Nepal.
Farmaco Nepal drug index information on Pregno Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.