Indula 200

Generic

Misoprostol.

 

Indications

• Misoprostol is used to prevent stomach and duodenal ulcers in NSAID users who are at high risk of gastric ulcer complications, such as the elderly, patients with disabling disease, and patients with a history of ulcer.
• Healing of NSAID-induced gastric and duodenal damage that has already occurred.
• In the absence of NSAID medication, gastric and duodenal ulcers heal.
• The process of inducing labor.
• Postpartum hemorrhage prevention and treatment

 

Pharmacology

Misoprostol is broadly retained, and experiences quick de-esterification to its free corrosive, which is mindful for its clinical action and, not at all like the parent compound, is perceptible in plasma. Most extreme plasma concentrations of Misoprostol corrosive are reduced when the measurements is taken with nourishment and add up to accessibility of Misoprostol corrosive is diminished by utilize of concomitant stomach settling agent. Misoprostol has both antisecretory (restraining gastric corrosive emission) and (in creatures) mucosal defensive properties. NSAIDs hinder prostaglandin blend, and a lack of prostaglandins inside the gastric mucosa may lead to reducing bicarbonate and bodily fluid discharge and may contribute to the mucosal harm caused by these specialists.Misoprostol can increment bicarbonate and bodily fluid generation, but in man this has been appeared at dosages 200 meg and over that are too antisecretory. It is subsequently not conceivable to tell whether the capacity of Misoprostol to decrease the hazard of gastric ulcer is the result of its antisecretory impact, its mucosal defensive impact, or both.

 

Dosage & Administration

Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 meg 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 meg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 meg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.

Induction of labor: Place 25 meg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 meg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 meg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 meg 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 meg orally immediately following delivery.

Treatment of postpartum hemorrhage: 600 meg orally or 1000 meg per rectally.

 

Interaction

There is no evidence that Misoprostol interacts with cardiac, pulmonary, CNS, or NSAID medications in a clinically meaningful way. With high doses of antacid, Misoprostol bioavailability is reduced.

 

Contraindications

Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.

 

Side Effect

Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol 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.

 

Pregnancy & Lactation

It is not recommended for pregnant women due to the abortifacient characteristic of the Misoprostol component. It should not be used in women of reproductive age unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or complications from gastric or duodenal ulcers. It may be prescribed in such cases if the patient has had a negative serum pregnancy test during the previous two weeks.

is capable of following through on effective contraception.
has been given both spoken and written warnings about the dangers of Misoprostol, including the possibility of contraceptive failure and the risk to other women of childbearing potential if the drug is taken by accident.
It won't start until the second or third day of the following normal menstrual period.
The active metabolite (Misoprostol acid) can be excreted in milk, however this has not been examined. It is not recommended for use by nursing women due to the risk of major adverse reactions in nursing infants.

 

Precautions & Warnings

In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol 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 Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol.

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.

 

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.

 

Pharmaceutical Name

Renata Limited