Cytomis 200 mcg

Description

Indications
Cytomis is prescribed for the following conditions:

• Prevention of gastric and duodenal ulcers in individuals at high risk due to prolonged NSAID use, such as elderly patients, those with chronic illnesses, or those with a history of ulcers.
• Treatment of existing NSAID-induced gastric and duodenal ulcers.
• Healing of gastric and duodenal ulcers not related to NSAID use.
• Induction of labor.
• Prevention and management of postpartum hemorrhage.

Use this medication only as directed by a registered physician.

Pharmacology
Misoprostol is rapidly absorbed and undergoes de-esterification to its active form, Misoprostol acid, which is responsible for its therapeutic effects. When taken with food, peak plasma levels of Misoprostol acid are lower, and its overall availability decreases if taken alongside antacids.

Misoprostol has both antisecretory effects (reducing gastric acid production) and mucosal protective properties in animal studies. NSAIDs inhibit prostaglandin synthesis, leading to reduced bicarbonate and mucus secretion, which may contribute to ulcer formation. Misoprostol helps counteract this by increasing bicarbonate and mucus production at doses of 200 mcg or higher. However, it is unclear whether its ability to prevent gastric ulcers is due to its acid-reducing properties, mucosal protection, or both.

Dosage & Administration

• For gastric and duodenal ulcers (including NSAID-induced ulcers): 800 mcg daily, divided into 2-4 doses, taken with meals and at bedtime. Treatment should continue for at least four weeks and may extend up to eight weeks if necessary.
• For the prevention of NSAID-induced ulcers: 200 mcg taken 2-4 times daily along with NSAID therapy. If not well tolerated, a reduced dose of 100 mcg may be used. Treatment should continue for the duration of NSAID therapy as advised by the physician.
• For labor induction: 25 mcg is placed in the posterior vaginal fornix. If needed, the dose may be repeated every six hours until a total of 200 mcg is reached. Alternatively, 100 mcg may be taken orally, with repeated doses of 100-200 mcg every four hours until labor progresses (as indicated by a Bishop score of 7 or more). The maximum number of doses is six. Continuous monitoring of maternal and fetal health is required. Oxytocin may be administered at least four hours after the last dose of Misoprostol.
• For postpartum hemorrhage prevention: 600 mcg taken orally immediately after delivery.
• For postpartum hemorrhage treatment: 600 mcg taken orally or 1000 mcg administered rectally.

Use this medication only as directed by a registered physician.

Drug Interactions
No significant interactions have been observed between Cytomis and cardiac, pulmonary, or central nervous system medications, as well as NSAIDs. However, taking high doses of antacids may reduce the bioavailability of Cytomis.

Contraindications
Misoprostol should not be used in individuals allergic to prostaglandins. It is also strictly contraindicated during pregnancy.

Side Effects
Cytomis is generally well tolerated. Common side effects include gastrointestinal discomfort such as diarrhea, abdominal pain, indigestion, flatulence, nausea, and vomiting. Other reported side effects include dizziness, rashes, and skin reactions. The likelihood of diarrhea may be reduced by taking the medication with meals and at bedtime while avoiding magnesium-containing or laxative antacids.

Pregnancy & Lactation
Misoprostol has abortifacient properties and should not be used during pregnancy. Women of childbearing potential should only take it if NSAID therapy is essential and they are at high risk of gastric or duodenal ulcers. In such cases, the following precautions must be taken:

• A negative pregnancy test within two weeks before starting treatment.
• Commitment to using effective contraception.
• Understanding the risks associated with Misoprostol, including potential contraceptive failure and harm to a developing pregnancy.
• Beginning therapy only on the second or third day of their next menstrual cycle.

The presence of Misoprostol acid in breast milk has not been thoroughly studied, and its use is not recommended for breastfeeding mothers due to the potential risk to infants.

Precautions & Warnings

• For NSAID-induced ulcer prevention and treatment: Misoprostol should not be used in pregnant women and must only be prescribed to women of childbearing potential if they require NSAID therapy. These patients must be advised to use effective contraception.
• For labor induction: The pregnancy must be at least 38 weeks by reliable dating or show evidence of fetal lung maturity (L/S ratio >2.0 or positive phosphatidylglycerol test). Labor induction is contraindicated in cases of fetal distress, placental abruption, placenta previa, or unexplained vaginal bleeding. The fetus must be in a vertex presentation.

Use in Special Populations
The safety and effectiveness of Cytomis in children under 18 years of age have not been established.

Overdose Effects
The toxic dose of Cytomis in humans is not well defined. Symptoms of overdose may include sedation, tremors, seizures, difficulty breathing, abdominal pain, diarrhea, and fever. Supportive treatment should be provided in case of overdose.

Therapeutic Class
Drugs affecting the uterus, Prostaglandin analogs.

Storage Conditions
Store in a cool, dry place, away from light and moisture. Keep out of reach of children.