UNWANTED
Brand:
UNWANTED
Manufacturer:
MANKIND
Manufacturer Details
MANKIND
Compositions:
Mifepristone 200mg tablets,
|
Strength
|
Rate
|
Packing Style
|
|
200mg
|
60.00
|
21s tablets
|
List of Related Indications:
List Of Drugs:
- Mifepristone- Abortifacients - Uterine- Active Agents- (FDC- List )- (Feb 2002)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Drug Interaction:
Ketoconazole, itraconazole, erythromycin and grape friut juice, inhibit milepristone metabolism.
Rifampicin,dextromethasone, St John's wort and certain anticonvulsants (phenytoin,
phenobarbital, carbamzepine) induce mifepristone metabolism
Lab interactions:
Both plasma ACTH and plasma cortisol levels may be elevated by mifepristone
Indication:
U.S.FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
258 Mifepristone 16-12-08
+ Misoprosol (1 tab of mifepristone 200mg
and 4 tablets misoprostol 200mcg)
combipack
For the medical termination of intruterine pregnancy (MTP)
of up to 63 days gestation based on the first day of the last
menstrual period
Termination of early pregnancy, endometriosis
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Mifepristone 13-02-2002
Progesterone Antagonist For M.T.P
2.Mifepristone 16-12-2008
+ Misoprostol
(1 tablet of Misepristone 200mg and
4 tablets of Misoprostol 200mcg) combipack
For medical termination of intrauterine pregnancy (MTP) of upto
63 days gestation based on the first day of the last menstual period
Adverse Reaction:
Excessive vaginal bleeding, unusual tiredness,or weakness, uterine carmping, back pain,
diarrhea, dizziness, headache, nausea, vomiting, dyspepsia, anxiety, belching, cough,
dizziness, fever, flu-lke symptoms, headache, heartburn, increased clear or white vaginal
discharge, itching of vagina, or genital area, fatigue, pain during sexual intercourse, pain or
tenderness around eyes and cheek bones, pale skin , shortness of breath, insomnia, tightness
of chest or wheezing , unusual bleeding or bruising, sinusitis, uterine hemorrhage, vaginitis.
Contra-Indications:
Confirmed or ectopic pregnancy
Chronic adrenal failure
Concurrent long term corticosteroid therapy
History of allergy to mifepristone, misoprostol or other prostaglandin
Hemorrhage disorders or concurrent anticoagulant therapy
Inherited porphyrias
Special precautions:
Bleeding: vaginal bleeding in almost all women during the procedure. in some cases excessive
bleeding may require treatment
Confirmation of temination of pregnancy: Patients should be followed up after 14 days for the
confirmation of termination of prergnancy
Women with other disease conditions like cardiovascular , hepatic , renal , hypertensive
should be treated with caution, also women above 35 yrs and who smoke should be treated
with caution.
Dosages/ Overdosage Etc:
Indications:
Termination of pregnancy
Dosage:
For termination of pregnancy:
Oral 600mg (three 200mg tablets) as a single oral dose followed later by 400micrograms(mcg)
two 200mcg tablets of misoprostol as a single dose.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Mifepristone is synthetic 19-nonsteroidal related to norethisterone. It binds to intracellular progesterone receptor where it competitively inhibits progesterone attachment and thus antagonises the effects of endogenous propgesterone
Mifepristone by antagonising the progesterone activity induces ,labor in pregnancies.
Pharmacokinetics:
Mifepristine is rapidly absorbed after oral ingestion, the time taken to reach peak plasma concentration is approximately 1 to 2 hrs. The bioavailabilitry of mifepristone is 40% because of its presystemic metabolism. Elimination half life has been reported to be 24 and 48hrs.
