Cytomis100 mcg
Tablet
Misoprostol
Incepta Pharmaceuticals Ltd.
Product Code : 4311
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Medicine overview
Indications of Cytomis 100 mcg
Cytomis 100 mcg is indicated for-
Prophylaxis of gastric and duodenal ulceration in NSAID users at high risk of complications from gastric ulcer e.g. the elderly, patients with concomitant debilitating disease and patients with a history of ulcer.
Healing of established NSAID- induced gastric and duodenal damage. ... Read moreCytomis 100 mcg is indicated for-
Prophylaxis of gastric and duodenal ulceration in NSAID users at high risk of complications from gastric ulcer e.g. the elderly, patients with concomitant debilitating disease and patients with a history of ulcer.
Healing of established NSAID- induced gastric and duodenal damage.
Healing of gastric and duodenal ulcers in the absence of NSAID therapy.
Induction of labor.
Prevention and treatment of postpartum hemorrhage.
Theropeutic Class
Drugs acting on the Uterus, Prostaglandin analogues
Pharmacology
Cytomis 100 mcg is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Cytomis 100 mcg acid are diminished when the dose is taken with food and total availability of Cytomis 100 mcg acid is reduced by use of concomitant antacid. Cytomis 100 mcg has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Cytomis 100 mcg can increase bicarbonate and mucus production, but in man this has been shown at doses 200 mcg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Cytomis 100 mcg to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.
Dosage & Administration of Cytomis 100 mcg
Anti-ulcerant dosage & administration:
The recommended adult oral dose for reducing the risk of NSAID-induced gastric ulcers: 200 mcg Cytomis 100 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. Cytomis 100 mcg should be taken for the duration of NSAID therapy as prescribed by the physician. Cytomis 100 mcg should be taken with a meal, and the last dose of the day should be at bedtime.
Renal impairment: Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200 mcg dose is not tolerated.
Gynecological dosage & administration-
Induction of Labor: 25 mcg vaginally 6 hourly or 50 mcg orally 4 hourly.
Postpartum Hemorrhage (PPH) prophylaxis: 400 mcg to 600 mcg orally or rectally immediately following delivery of the child.
Postpartum Hemorrhage (PPH) treatment: 1000 mcg rectally or, 200 mcg orally with 400 mcg sublingually.
Dosage of Cytomis 100 mcg
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. Cytomis 100 mcg 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 Cytomis 100 mcg 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 Cytomis 100 mcg 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 Cytomis 100 mcg. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral Cytomis 100 mcg 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.
Interaction of Cytomis 100 mcg
There is no evidence of clinically significant interaction between Cytomis 100 mcg and cardiac, pulmonary, CNS drugs and NSAID's. The bioavailability of Cytomis 100 mcg is decreased with high doses of antacid.
Contraindications
Cytomis 100 mcg is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.
Side Effects of Cytomis 100 mcg
Generally, Cytomis 100 mcg is well tolerated. The most frequent adverse effects associated with Cytomis 100 mcg 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
Because of the abortifacient property of the Cytomis 100 mcg component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID.In such patients, it may be prescribed if the patient:
Has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
Is capable of complying with effective contraceptive measures.
Has received both oral and written warnings of the hazards of Cytomis 100 mcg, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
Will begin it only on the second or third day of the next normal menstrual period.
Excretion of the active metabolite (Cytomis 100 mcg acid) into milk is possible, but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.
Precautions & Warnings
In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Cytomis 100 mcg 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 Cytomis 100 mcg therapy is initiated and they must use an effective contraception method while taking Cytomis 100 mcg.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.
Overdose Effects of Cytomis 100 mcg
The toxic dose of Cytomis 100 mcg 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.
Storage Conditions
Store in a cool and dry place, protected from light and moisture. Keep out of the reach of the children.
Drug Classes
Drugs acting on the Uterus, Prostaglandin analogues
Mode Of Action
Cytomis 100 mcg is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Cytomis 100 mcg acid are diminished when the dose is taken with food and total availability of Cytomis 100 mcg acid is reduced by use of concomitant antacid. Cytomis 100 mcg has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Cytomis 100 mcg can increase bicarbonate and mucus production, but in man this has been shown at doses 200 meg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Cytomis 100 mcg to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.
Pregnancy
Because of the abortifacient property of the Cytomis 100 mcg component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient:
has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
is capable of complying with effective contraceptive measures.
has received both oral and written warnings of the hazards of Cytomis 100 mcg, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
will begin it only on the second or third day of the next normal menstrual period.
Excretion of the active metabolite (Cytomis 100 mcg acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.
Pediatric Uses
Use in children: Safety and effectiveness of Cytomis 100 mcg in children below the age of 18 years have not been established.
Disclaimer
The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.