Adult Dosing

Prevention of NSAID-induced gastric ulcers

• Recommended dose: 200 mcg PO qid
• Alt: 100 mcg if not tolerated

Note:

• Dose should be given with meal, and last dose at bedtime

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Reduces the risk of NSAID induced gastric ulcers in elderly patients, history of ulcer and patients with concomitant debilitating disease

• Hypersensitivity to any of the ingredients of the product
• Pregnancy
• Nursing mothers
• History of allergy to prostaglandins
• Before prior cesarean section (cervical ripening use)
• History of major uterine surgery (cervical ripening use)

• Abortion, premature birth, or birth defects have been reported in pregnant women who are receiving misoprostol
• Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or abortion beyond the eighth week of pregnancy. Avoid use of this drug in pregnant women to reduce the risk of ulcers induced by NSAIDs
• Inform patients orally and with written warnings about the abortifacient property and warn them to avoid giving the drug to others
• Avoid using this drug in women of childbearing potential unless the patient requires NSAID and are at higher risk for developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID
• Prescribe therapy in such patients only if she exhibits negative serum pregnancy test within 2 wks prior to initiation of therapy and capable of maintaining effective contraceptive measures
• Prescribe therapy only if the patient has received both oral and written warnings of the hazards of misoprostol component of this drug
• Provide patients about the information that contraception failure is associated with risk and the danger to women of childbearing potential if the drug is taken by mistake. Initiate therapy only on the second or third day of the next normal menstrual period

Renal Dose Adjustment

• Renal impairment: No dose adjustments; but may reduce if 200 mcg dose is not tolerated

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Therapy associated with abortion, premature birth, or birth defects when administered to pregnant women. Uterine rupture has occurred when misoprostol was administered in pregnant women to induce labor or abortion beyond the eighth week of pregnancy. Avoid use of this drug in pregnant women [US Black Box Warning]
• Avoid using this drug in women of childbearing potential unless the patient requires NSAID and are at higher risk for developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID [US Black Box Warning]
• Antacids containing magnesium may increase risk of diarrhea
• Symptomatic response does not preclude presence of gastric malignancy
• Therapy should be use cautiously in patients with pre-existing cardiovascular disease

Cautions: Use cautiously in:

• Cardiovascular disease
• History of ulcer disease or GI bleeding
• Inflammatory bowel disease
• Elderly
• Renal impairment

Supplemental Patient Information

• Inform patients about the abortifacient property and warn them to avoid giving the drug to others
• Instruct patient to strictly adhere to the directions given
• Advise patient not to give misoprostol to anyone else

Pregnancy Category:X

Breastfeeding: Misoprostol is a prostaglandin E1 analogue. Prostaglandin E1 and other prostaglandins appear normally in colostrum and milk. Because of the low levels of misoprostol in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants. No special precautions are required. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 01 April 2011). According to manufacturer's data, misoprostol is metabolized to misoprostol acid in the mother, which is then excreted in breast milk. There are no adverse events reported of misoprostol in breastfeeding infants of mothers. Use with caution.

• CV: Hypertension, hypotension, MI, arrhythmias
• CNS: Headache, deafness syndrome
• GI: Diarrhea, abdominal pain, nausea, flatulence, dyspepsia, vomiting, constipation
• GU: Uterine rupture, miscarriage, uterine hyperstimulation, menstrual irregularities, toxic shock syndrome
• METABOLIC: Dehydration
• RESP: Bronchospasm
• MISC: Anaphylaxis (rare), thromboembolic disorder

• Prostaglandin; acts directly on the parietal cells by binding to the prostaglandin receptor, inhibits gastric acid secretion and exerts mucosal-protective properties
• Rapidly and extensively absorbed
• Metabolism: Undergoes de-esterification to misoprostol acid in gut parietal cells; CYP450: Unknown
• Excreted in urine (80%)
• Half life: 20-40 minutes

US Trade Name(s)

• Cytotec

US Availability

misoprostol (generic)

• TABS: 100, 200 mcg

Cytotec

• TABS: 100, 200 mcg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Cytotec

UK Availability

Cytotec

• TABS: 200 mcg

Australian Trade Name(s)

• Cytotec

Australian Availability

Cytotec

• TABS: 200 mcg

[Outline]

Gastrointestinal

GI Agents; Miscellaneous

Pricing data from www.DrugStore.com in U.S.A.

• Misoprostol 200 MCG TABS [Bottle] (IVAX PHARMACEUTICALS)
  INC. mcg = $60
  mcg = $180
• Cytotec 200 MCG TABS [Bottle] (PFIZER U.S.)
  60 mcg = $125.99
  180 mcg = $356.99
• Misoprostol 100 MCG TABS [Bottle] (GREENSTONE)
  60 mcg = $41.99
  180 mcg = $103.96
• Cytotec 100 MCG TABS [Bottle] (PFIZER U.S.)
  60 mcg = $105.99
  180 mcg = $296.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Cyotec 200 MCG Oral Tablet (Apotheca, Inc)
• Cyotec 200 MCG Oral Tablet (G.D. Searle LLC)
• Cytotec 0.1 MG Oral Tablet (G.D. Searle LLC)
• Cytotec 0.1 MG Oral Tablet (Physicians Total Care, Inc.)
• Misoprostol 100 MCG Oral Tablet (Apotheca, Inc.)
• Misoprostol 100 MCG Oral Tablet (Greenstone LLC)
• Misoprostol 100 MCG Oral Tablet (IVAX Pharmaceuticals, Inc.)
• Misoprostol 200 MCG Oral Tablet (Apotheca, Inc.)
• Misoprostol 200 MCG Oral Tablet (Greenstone LLC)
• Misoprostol 200 MCG Oral Tablet (IVAX Pharmaceuticals, Inc.)