Each Miso-Fem Ortho 12 tablet contains 200 mcg of misoprostol, a synthetic prostaglandin E1 (PGE1) analogue.
Each uncoated tablet contains: Misoprostol 200 mcg.
Excipients/Inactive Ingredients: qs.
Pharmacology: Pharmacodynamics: Misoprostol belongs to a group of hormones called prostaglandins which can cause uterine contractions and opening (ripening) of the cervix and is widely used in obstetrics and gynecology. Misoprostol also has antisecretory (inhibiting gastric acid secretions) and has mucosal protective properties. Misoprostol protects the gastro duodenal mucus by inhibiting basal, stimulated, and nocturnal acid secretion and by reducing the proteolytic activity of gastric fluid and increasing bicarbonal and mucous secretion.
Pharmacokinetics: Misoprostol is readily absorbed and undergoes de-esterification to its free acid if bound to plasma protein and its metabolites include prostaglandins-F analogues. The compound is lipophilic methyl ester prodrug and is readily metabolized to the free acid which is biologically active. When administered orally peak plasma concentration is attained within 30 minutes and rapidly declines by 120 minutes. 80% of the drug is excreted through the renal route and 15% through the fecal route.
Miso-Fem Ortho 12 is indicated for: Prevention of post-partum hemorrhage; Treatment of post-partum hemorrhage; Treatment of incomplete abortion and miscarriages; Treatment of duodenal ulcer, gastric ulcer and NSAID induced peptic ulcer; Prophylaxes of NSAID induced peptic ulcers.
Prevention of post-partum hemorrhage: 600 mcg orally administrated immediately after the delivery of the baby and confirmation that all the features have been delivered (in case of multiple births).
Treatment of post-partum hemorrhage: 800 mcg sublingually or 1000 mcg administrated rectally significantly reduces the need for additional interventions.
Treatment of incomplete abortion and missed miscarriage in the first trimester: 800 mcg administered vaginally or sublingually and repeated after 24 hours. (Healthcare provider is advised to offer all women receiving medical management of miscarriage pain relief, antibiotics and antiemetics as needed).
Treatment of duodenal ulcer, gastric ulcer and NSAID induced peptic ulcer: 800 mcg orally taken in two or four divided doses after breakfast and/or main meal and at bedtime. In most patients, ulcer will be healed in four weeks but treatment may be continued for up to eight weeks if required. If the ulcer relapses further, treatment courses may be given.
Miso-Fem Ortho 12 is contraindicated in: Hypersensitivity to prostaglandins, Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass, Treatment or prevention of ulcers in pregnant women or women of child bearing potential, Chronic adrenal failure, Hemorrhagic disorders or concurrent anticoagulant therapy.
The patient may require immediate medical attention if excessive bleeding or other adverse reaction occurs. Also the patients should be given instructions on what to do if cramps and gastrointestinal disturbances occur after administration of misoprostol.
There may be increased risk of uterine tachy systole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and caesarian delivery due to uterine hyperstimulation with the use of higher doses of misoprostol.
It may cause diarrhea and should not be co-administrated with other drugs that cause diarrhea (such as magnesium containing antacids).
In twin or multiple pregnancies, misoprostol should not be used to treat or prevent post-partum hemorrhage until after the delivery of all newborns.
Use in Children: Use of Miso-Fem Ortho 12 in children has not yet been evaluated.
Pregnancy: In twin or multiple pregnancies, Miso-Fem Ortho 12 should not be used to treat or prevent post-partum hemorrhage until after the delivery of all newborn.
Breastfeeding: Misoprostol levels in breast milk are immeasurable after five hours of a single oral dose of 600 mcg. Therefore when administrated for postpartum hemorrhage, misoprostol has no breastfeeding contraindications. However, misoprostol should not be continually administered to nursing mothers to treat peptic ulcers because the continuous excretion of misoprostol in milk can cause diarrhea in nursing infants.
Patient may experience pain due to uterine contraction.
Gastrointestinal side effects like diarrhea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting, constipation, etc.
Shivering and dizziness.
A02BB01 - misoprostol ; Belongs to the class of prostaglandins. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
G02AD06 - misoprostol ; Belongs to the class of prostaglandins. Used as an oxytocic.
Tab 200 mcg (uncoated, white to off-white, round, bevel edged, flat faced, debossed on one side and plain on other side) x 3 x 4's.