Drug Interaction:
Antacids reduce the total availability of misoprostol acid but this dos not appear clinically
important.
Indication:
U.S.FDA DRUGS APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
186. Misoprostol 50mcg tablet 26-08-08
(Addl.stgth)
same as approved
Prevention of NSAID(including aspirin) induced ulcers in patients at high risk of complications
from a gastric ulcer.
Approved by FDA in 1988.
U.S.FDA APPROVED DRUGS DURING 2006
155. Misoprostol tablet 25mcg/100mcg/200mcg 08-12-2006 For cervical ripiening, prevention of post partum
haemorrhage & First trimester of abortion with
Mifepristone
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1.Misoprotol Anti Cancer 21-06- 2001
2.Misoprotol 50mcg tablet 26-08-2008
Addl.stgth
same as approved
3. Misoprotol tablet 08-12-2006
25mcg/100mcg/200mcg
Addl.stgh/Addl/Indcn
For cervical ripening, prevention of post patum haemorrhage and
first trimester of abortion with mifepristone
4.Misoprostol 600mcg tablet 09-01-2009
Addl.stgth
same as approved
Adverse Reaction:
GU- spotting, cramps, hypermenorrhoea, menstrual disorder, dysmennorhea.
Postmenopausal vaginal bleeding may be reduced by misoprostol administration.
GI- diarrhea, abdominal pain, nausea, flatulence, dyspepsia, vomiting, constipation.
Contra-Indications:
History of allergy to prostagladins; pregnancy.
Special precautions:
Women of child bearing potential- advise them they must not become pregnant when
misoprostol therapy is initiated, and they must use an effective contraceptive method while
taking misoprostol.
Diarrhea- usually develops in the course of therapy. The incidence can be minimised by
administering after meals or at bed time and by avoiding coadministration of misoprostol with
magnesium-containing antacids.
Dosages/ Overdosage Etc:
Approved by FDA in 1988.
Indications:
Prevention of NSAID(including aspirin) induced ulcers in patients at high risk of complications from a gastric ulcer.
Dosage:
Adults- 200mcg 4 times daily with food. if this cannot be tolerated, 100mcg can be used.
Take with meals, the last dose of the day with bedtime.
Renal impairment- dosage adjustments is not routinely needed. If necessary, dosage can be reduced, if 200mcg is not tolerated.
Patient Information:
MISOPROSTOL- PROSTAGLANDINS
1. Misoprostol can cause miscarriage, often associated with potentially dangerous bleeding.
This can result in hospitalisation, surgery, infertility, or death. Do not take misoprostol, if pregnant, and do not become pregnant while taking the medication. If pregnancy occurs during therapy, discontinue the drug and contact physician
2. Take misoprostol only according to the directions of the physician.
3. Do not give misoprostol to any one else.
5. Allergy- tell your doctor if you ever had any unusual or allergic reactions.to misoprostol or any other substances such as foods, presevative or dyes.
6. Pregnancy- Misprostol must not be used during pregnancy
7. Breast feeding- Not recommended for use during breast feeding becaue it may cause diarrhea in nursng babies
7. Children- No specific information comparing use of misoprostol in children with use with other age groups.
8. Older patients- Medicine has been tested and has not shown to cause different side effects or problems in older people than it does in younger adults.
9. Other medicines- Although certain medicines should not be used at all , in other cases two different medicines may be used together even if an interaction might occur.
Tell you doctor if you are taking any other prescription or nonprescription medicines
(OTC)
10. Other medical problems- Presence of other medical problems may affect the use of
misoprostol. Tell your doctor if you have any other medical problems especially-
Blood vessel disease- medicines similar to misoprosol have been shown to make this condtion worse
11. Dosing - dosing of misoprostol may be different for different patients. Follow your doctors orders If your dose is different do not change unless told by your doctor.
To prevent stomach ulcer in patients taking anti-inflammatory medicines including
aspirin- Tablets- Adults- 200mcg ( micromilligrams) four a day with or after meals and at bed time, or 400mcg two times a day, with last dose takem at bed time.
Children and teen agers- dose may be determined by the doctor.
12. Missed dose-If you have missed a dose of this medicine, take it as s soon as possible.
If it is almost time for the next dose,skip the dose and follow the regular schedule.
Never double doses.
13. Storage-
Do not store in bath room or near the kitchen or in damp places. Heat and moisture
may affect the medicine and cause to break down.
Do not keep outdated medicines or medicines no longer in use
Make sure that you keep outdated medicines out of reach of children.
Pharmacology/ Pharmacokinetics:
Pharmacology:
Misoprostol, a synthetic prostaglandin E, analog, has both antisecretory(inhibition of gastric acid) and in (animals) mucosal protective properties. Misoprostol can increase bicarbonate and mucous production.
Pharmacokinetics:
Misoprostol is extensively absorbed and undergoes rapid de-esterification to its free acid. After oral administration, peak concentration of misoprostol is reached in about 12+/- 3 minutes and a terminal half-life of 20 to 40 minutes.
Interaction with Food:
Maximum plasma concentrations of misoprostol acid are diminished when taken with food.
Pregnancy and lactation:
Pregnancy:
Misoprostol may cause miscarriage. If a women is or becomes pregnant, while taking the drug, discontinue the drug and appraise the patient of the potential hazards to the fetus.
Lactation:
Do not administer to nursing mothers, because of the potential excretion of misoprostol acid
which could cause significant dirrhoea to the infant