products-page-bottom-left-box

Miso-Fem

DKT (Deep K.Tyagi Foundation Nigeria)
Grace House, 2 Iwaya Road, Onike-Yaba, Lagos
Email: info@dktnigeria.org
Tel: 08129917858
Website: http://dktnigeria.org

Brand Name

Miso-Fem

Manufacturer

Jagsonpal Pharmaceuticals Ltd, India

Therapeutic Class

Oxytocics and antioxytocics

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: B4-3625): Misoprostol 200 mcg

Pack Size: (1) A single blister with 4 tablets of Miso-Fem (Misoprostol 200 mcg) 

MISO FEM

Pharmacology

Miso-Fem tablets contain 200 mcg of Misoprostol. It is a white to off-white, round, bevel edged, flat faced, uncoated tablets debussed with “J” debussed above and “08” debussed below the score lone on one side and plain on the other side.

PHARMACODYNAMICS

(1) Misoprostol belongs to the group of hormones called prostaglandins

(2) It has antisecretory and mucosal protective properties

PHARMACOKINETICS

(1) It is readily absorbed

(2) It undergoes rapid de-esterification to its free radicals

(3) Peak plasma concentration is attained within 30minutes if administered orally

(4) Peak plasma concentration is rapidly declines by 120minutes if administered orally

(5) 80% of the drug is excreted through the renal route and 15% through the fecal route

Indications

(1) Prevention of postpartum Hemorrhage

(2) Treatment of postpartum hemorrhage

(3) Treatment of incomplete abortion and missed miscarriage in the first trimester

(4) Treatment of duodenal ulcer, gastric ulcer and NSAID induced peptic ulcer

(5) Prophylaxis of NSAID induced peptic ulcer.

(6) Cervical ripening

(7) Induction of labour (living or dead fetus)

Contra-indications

(1) Hypersensitivity to prostaglandins

(2) Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass

(3) Treatment of ulcers in pregnancy or women of child bearing age

(4) Chronic adrenal failure

(5) Hemorrhagic disorders or concurrent anticoagulant therapy

(6) Inherited porphyria

(7) If an IUD is in place

Precautions/Warnings

(1) In twins and multiple pregnancies: Treatment should not be done until all fetuses have been delivered

(2) Breastfeeding: Misoprostol levels in breast milk are immeasurable after 5 hours of a single oral dose of 600 mcg

(3) Use in children has not yet been evaluated

(4) Get immediate medical attention in case of excessive bleeding or other adverse reactions

(5) Increased risk of uterine rupture

(6) Should not be co-administered with antacids

Interactions

(1) No interference with the beneficial effect of aspirin on signs and symptoms of rheumatoid arthritis

(2) Increases the possibility of diarrhea if taken concurrently with antacids

Adverse Effects

(1) Patients may experience pain due to uterine contraction

(2) G.I side effects like diarrhea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting, constipation, etc

(3) Shivering and dizziness

(4) Severe genital bleeding

(5) Shock

(6) Uterine rupture

(7) Pelvic pain

Dosage & Administration

(1) Prevention of postpartum hemorrhage: 600 mcg orally immediately after all fetuses have been delivered

(2) Treatment of postpartum hemorrhage: 800 mcg sublingually or 1000 mcg rectally

(3) Treatment of incomplete abortion in the first trimester of pregnancy: 800 mcg vaginally or sublingually and repeated after 24 hours

(4) Treatment of duodenal ulcer: 800 mcg orally daily in two or four divided doses with breakfast and/ or each main meal and at bedtime

(5) Prophylaxis of NSAID induced peptic ulcer: 200 mcg orally two to four times daily

(6) Cervical ripening: 400 mcg vaginally or orally 3 hours before transcervical procedure

(7) Induction of labour:

(A) For living foetus: 25 mcg intravaginally stat, repeat every 3 - 6 hours upto 6 doses maximum

(B) For intrauterine foetal death (IUFD):

(i) 13 - 17 weeks: 200 mcg vaginally every 6 to 12 hours for a total of 4 doses

(ii) 18 - 26 weeks: 100 mcg vaginally every 6 to 12 hours for a total of 4 doses

(iii) Beyond 26 weeks:

 for unripe cervix (Bishop score <6), 25 - 50 micg vaginally upto 6 doses

 for ripe cervix (Bishop score >6) 25 - 50 mcg stat, subsequent doses should be doubled to 50 - 100 mcg if the contractions are not effective. Maximum daily dose is 600 mcg. Repeat after 24 hours if expulsion has not occurred

Storage/Handling Recommendations

Store at or below 30 degree Celsius in a dry place

Review Date

2017-04-19 10:27:04