Kit-63

Generic

Mifepristone + Misoprostol

 

Indications

This kit is for early Menstrual Regulation (MR) and pregnancy termination up to 9 weeks (63 days) of pregnancy.

 

Pharmacology

Mifepristone: Mifepristone could be a manufactured steroid with anti-progestational movement comes about from competitive interaction with progesterone at progesterone-receptor destinations. Based on ponders with different verbal measurements in a few creature species, the compound represses the movement of endogenous or exogenous progesterone and the Menstrual Direction (MR) comes about. Amid pregnancy, the compound sensitizes the myometrium to the contraction-inducing movement of prostaglandins.

Misoprostol is a prostaglandin E1 analogue that is synthesized. It works by engaging with specific receptors on myometrial cells to produce contraction. This interaction causes a change in calcium concentration, which causes muscular contraction to begin. Misoprostol softens the cervix and contracts the uterus, causing the uterine contents to be expelled. It works by interacting with prostaglandin receptors.

 

Dosage & Administration

This can only be prescribed by qualified medical professionals who are able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The qualified medical professionals must also be able to provide surgical Intervention/MVA (Manual Vaccum Aspiration) in cases of incomplete abortion or severe bleeding or have made plans to provide such care through others and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Day 1 (First visit): Mifepristone administration: One tablet of Mifepristone (200 mg) is taken in a single oral dose under the supervision of a qualified medical professional in a clinic, medical office or hospital.

Day 2 (Second visit): Misoprostol administration: 24-48 hours after ingesting the Mifepristone tablet, the patient takes four 200 microgram tablets (800 micrograms) of Misoprostol buccally or sublingually. Misoprostol tablets can be administered by the patient herself (place two tablets on each side of cheeck & gum or under the tongue). She should wait for 30 minutes. During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of Misoprostol.

Day 10 to 14 (Third visit): Post-treatment examination: Patients must return to the clinic, medical office or hospital within 10 to 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred.

Patients who have an ongoing pregnancy at this visit have a risk of fetal malformation resulting from the treatment. Surgical termination/MVA is recommended to manage Menstrual Regulation (MR)/termination of pregnancy failures.

 

Interaction

Mifepristone: In spite of the fact that particular sedate or nourishment intuitive with Mifepristone have not been considered, on the premise of this drug's digestion system by CYP 3A4, it is conceivable that Ketoconazole, Itraconazole, Erythromycin and grapefruit juice may hinder its digestion system (expanding serum levels of mifepristone).

Misoprostol: Misoprostol has not been appeared to meddled with the advantageous impacts of headache medicine on signs and indications of rheumatoid joint pain. Misoprostol does not apply clinically critical impacts on the absorption,blood levels and antiplatelet impacts of restorative measurements of aspirin.

 

Contraindications

Organization of Mifepristone is contraindicated in patients with any one of the taking after conditions: History of sensitivity or known extreme touchiness to Mifepristone, Misoprostol or other prostaglandin, affirmed or suspected ectopic pregnancy or undiscovered adnexal mass (the treatment method will not be successful to end an ectopic pregnancy), IUD in put, inveterate adrenal disappointment, haemorrhagic disarranges or concurrent anticoagulant treatment, acquired porphyria, On the off chance that a understanding does not have satisfactory get to to therapeutic offices prepared to supply crisis treatment of inadequate prepare, blood transfusions and crisis revival during the period from the primary visit until released by the regulating physician.

 

Side Effects

Mifepristone: This medication is used to cause vaginal bleeding and uterine cramping, both of which are important for menstrual regulation (MR). Nausea, vomiting, and diarrhoea were the most commonly reported side effects. Pelvic pain, fainting, headaches, dizziness, and asthenia were all reported on a very rare basis.

Shivering, hyperthermia, dizziness, pain due to uterine contractions, severe vaginal bleeding, shock, pelvic pain, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), shivering, hyperthermia, dizziness, shivering, hyperthermia, dizziness, shivering, hyperthermia, dizziness, shivering, hyperthermia,

 

Pregnancy & Lactation

Pregnancy- Mifepristone: is shown for Menstrual Control (MR) (through 63 days pregnancy) and has no other affirmed sign for utilize amid pregnancy. Patients who have an progressing pregnancy at the final visit have a hazard of fetal distortion coming about from the treatment. Surgical end is suggested to oversee Menstrual Direction (MR) treatment failures.

Mifepristone and Lactation: It is unknown whether Mifepristone is excreted in human milk. Breast milk, on the other hand, excretes many hormones with a similar chemical structure. Because the effects of Mifepristone on newborns are uncertain, breast-feeding mothers should speak with their doctor about whether or not they should discard their breast milk for a few days after taking the medicine.

Misoprostol: Although it is unknown whether Misoprostol or Misoprostol is excreted in human milk, Misoprostol should not be given to nursing mothers since misoprostol acid excretion may induce diarrhoea in nursing infants.

 

Precautions & Warnings

The understanding ought to not provide combination of Mifepristone & Misoprostol to anybody else. The combination of Mifepristone & Misoprostol has been endorsed for the patient's particular condition, it may not be the right treatment for another individual, and may be perilous to the other individual in the event that she is or were to ended up pregnant. Any Intra Uterine Gadget [IUD] ought to be expelled some time recently treatment with Mifepristone starts. Menstrual Direction (MR) by surgery is prescribed in cases when combination of Mifepristone & Misoprostol comes up short to cause Menstrual Direction (MR). Patients who have an continuous pregnancy at final visit have a chance of fetal distortion coming about from the treatment. Surgical termination/MVA is suggested to oversee Menstrual Direction (MR)/ end of pregnancy disappointments.

 

Therapeutic Class

Drugs acting on the Uterus, Prostaglandin analogues

 

Storage Conditions

Store in a cold, dry, and light-protected location.

 

Pharmaceutical Name

General Pharmaceuticals Ltd.