Misotab (misoprostol brand, Asia/Africa)

Introduction

Misotab tablet is a medication containing as its main active ingredient. It is designed for the prevention and treatment of gastric and duodenal ulcers, especially in patients at high risk due to NSAID use, advanced age, or underlying health conditions. It also plays a crucial role in the healing of existing ulcers, whether NSAID-related or not. Beyond gastrointestinal care, Misotab is widely used in obstetric practice for the induction of labor and for the prevention and management of postpartum hemorrhage, making it a versatile and essential treatment option.

Dosage & Administration

Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required. Prophylaxis of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Induction of labor: Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician. Prevention of postpartum hemorrhage: 600 mcg orally immediately following delivery. Treatment of postpartum hemorrhage: 600 mcg orally or 1000 mcg per rectally.

Side Effects

Generally, Misotab is well tolerated. The most frequent adverse effects associated with Misotab therapy involve the GI tract such as diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

Precautions & Warnings

In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misotab is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misotab therapy is initiated and they must use an effective contraception method while taking Misotab. In case of induction of labor: The pregnancy should have completed 38 weeks gestation by reliable dating, or lung maturity as evidenced by a L/S >2.0 or a positive phosphotidyl glycerol test, or completed 36 weeks gestation with a maternal or fetal medical indication for induction of labor. Induction of labor is contraindicated in acute fetal distress, abruptio placenta, placenta previa or unexplained vaginal bleeding. The fetus should be in vertex presentation.

Use in Special Populations

Use in children: Safety and effectiveness of Misotab in children below the age of 18 years have not been established.

Overdose Effects

The toxic dose of Misotab in human has not been determined. Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.

Therapeutic Class

Drugs acting on the Uterus, Prostaglandin analogues

Storage Conditions

Store in a cool and dry place, protected from light and moisture. Keep out of the reach of the children.