Cytotec Product

Cytotec(r) (misoprostol)

WARNINGS CYTOTEC (MISOPROSTOL)

ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. Uterine rupture has been reported when CYTOTEC was prescribed to pregnant women to induce LABOR or to induce arousal after the EIGHTH week of pregnancy (see the PRECAUTIONS section, as well as Labor and Delivery). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS. Cytotec is not recommended to decrease the possibility of NSAID-induced ulcers in women with a childbearing capacity in the event that the patient is at high risk of complications resulting from gastric ulcers resulting from the usage of the NSAID or is at a the chance of developing gastric ulcers. In these cases, Cytotec Clinic is recommended when the patient has had a positive pregnancy test in the 2 weeks prior to starting treatment. * is able to comply with contraceptive strategies that work. * has been given written and oral warnings regarding the risks of misoprostol and the possibility of contraception failure, as well as the danger for other women with childbearing possibility in the event that the medication is taken accidentally. * will start Cytotec only in the third or second day of the following normal menstrual cycle.

DESCRIPTION Cytotec tablets for oral use comprise either 100 mg or 200 mg of misoprostol, which is a artificial prostaglandin E1-like analog. Misoprostolcontains roughly equal amounts of both diastereomers listed below, with their enantiomers outlined by (+-): and

Misoprostol is water-soluble. viscous liquid. The inactive ingredients of tablets include the hydrogenated oil of castor, hydroxypropylmethylcellulose microcrystalline cellulose, as well as sodium starch glycolate. Clinical Pharmacokinetics: Misoprostol is extensively absorbed and is subjected to rapid de-esterification to form free acid which is the reason for its clinical effects and unlike the parent compound, it is detectable in plasma. Alpha side chain goes through beta oxidation while beta side chains undergoes omega oxidation that is followed by reduction of the ketones in order to create prostaglandin F derivatives. In healthy people, Cytotec (misoprostol) is quickly absorbed following the administration of oral medication with an Tmax of misoprostol acid at 12 +3 minutes and a final half-life that ranges from 20 to 40 mins. There is a high degree of variability in the levels of misoprostol acid in plasma across studies, but average values following one dose show a linear correlation to doses over a 200-400 mg. There was no accumulation of misoprostol acids was detected in studies with multiple doses and steady state plasma was reached in two days. The maximum plasma concentrations of misoprostol acid decrease by the time the dose has been taken in conjunction with food, and the total supply of misoprostol acid is decreased by the using antacids in conjunction with each other. Studies conducted in clinical studies were done using the use of antacids in conjunction this effect is not believed to be important clinically. AUC(0-4) Mean +- SD Cmax (pg/ml) (pg*hr/ml) Tmax (min) Fasting 811 +- 317 417 +- 135 14 +- 8 With Antacid 689 +- 315 349 +- 108* 20 +- 14 With High Fat Breakfast 303 +- 176* 373 +- 111 64 +- 79*

Results from fasting and comparisons with results are significantly statistically, p<0.05. Following oral injection of misoprost radiolabeled

When a patient is administered misoprostol radiolabeled, around 90% of radioactivity occurs in urine. Studies on the pharmacokinetics of patients suffering from various degrees of renal impairment revealed an approximate doubled of Cmax, T1/2 and AUC when compared with normal people however there was no apparent connection between the degree of impairment and the AUC. If a patient is over 64 years old of age it is evident that it is evident that the AUC for misoprostol acids is raised. There is no routine dose adjustment advised for older patients or those suffering from kidney impairment, however the dosage could need to be decreased if the normal dose is not able to be accepted. Cytotec PDF doesn't affect the hepatic mixed functional oxidase (cytochrome P-450) enzyme systems in animals. Study of interactions among misoprostol, several nonsteroidal anti-inflammatory medications did not show any effect on the kinetics of ibuprofen and diclofenac. There was an increase of 20% in the aspirin AUC was which is not believed to be clinically significant. Studies on pharmacokinetics also revealed the absence of interaction with propranolol and antipyrine when these medications were administered in combination with misoprostol. Misoprostol administered for a week did not affect the steady-state pharmacokinetics of diazepam when both drugs were administered two hours apart. The serum protein binding of misoprostol acid is less than 90% and is concentration-independent in the therapeutic range. The pharmacodynamics of misoprostol: Misoprostol is an antisecretory (inhibiting the secretion of gastric acids) in addition to (in animal models) mucosal protection properties for mucosal protection. NSAIDs block prostaglandin production, and a shortage of prostaglandins inside the gastric mucosa could result in a decrease in bicarbonate and mucus secretion, and could contribute to the harm to mucosal tissues resulted by the use of these substances. Misoprostol increases bicarbonate as well as mucus production. However, in the human body, this has been proven at doses of 200 mcg and higher that are antisecretory. Therefore, it is not possible to determine whether the capacity of misoprostol in reducing risks of developing gastric ulcers is due to its antisecretory effects as well as its mucosal protection effect or both. In vitro studies of canine parietal cells that have been tritiated with misoprostol acid as a drug ligand have led to determination and characterisation of certain prostaglandin receptors. The receptor binding is saturable, in reversibility and stereospecific. The sites exhibit a high affinity for misoprostol, its acid metabolite and for the other E type prostaglandins. However, they are it is not the case in the case of F I or F prostaglandins as well as other compounds that are not related such as histamine and Cimetidine. The affinity of receptors for misoprostol is in good agreement with an indirect measure of antisecretory action. It is possible that these receptors permit misoprostol that is taken in conjunction with food to have a positive effect topically, regardless of the lower serum concentrations achieved. Misoprostol causes a slight reduction in the pepsin concentration under normal conditions however, it does not affect histamine stimulation. It does not have a significant impact on postprandial or fasting gastrin as well as on the intrinsic factor output. The effects on gastric acid secretion: Misoprostol, over the range of 50 to 200 mcg can inhibit nocturnal and basal gastric acid secretion and acid secretion in response various stimuli, such as meals, histamine pentagastrin, as well as coffee. It is visible for within 30 minutes of oral administration and continues for at minimum 3 hours. The effects of 50 mg were comparatively weak and less long-lasting and only the 200-mcg dose had significant effects on the secretion of nocturnal hormones or on meal-stimulated and histamine secretion. Effects on the uterus: Cytotec has been shown to trigger uterine contractions, which can cause harm to the pregnancy. (See the warnings in the box.)

Other effects of pharmacology:

Cytotec does not cause an effect that is clinically significant on prolactin levels in the blood gonadotropins and TSH, growth hormone cortisol, thyroid-stimulating hormone and digestive hormones (somatostatin gastrin, vasoactive intestinal polypeptide, motilin) and creatinine or the uric acid. The ability to empty the gastric duct, the immunologic function and platelet aggregation function and the cardiovascular system aren't affected by the recommended dosages of Cytotec. Clinical studies: In a set of short-term, small (about one week) controlled studies using placebo in healthy human subjects, the doses of misoprostol were assessed for their capacity to decrease the risk of NSAID-induced damage to the mucosal lining. Research studies of 200 mg q.i.d. of misoprostol using naproxen and tolmetin, as well as studies of 200 and 100 mg q.i.d. together with ibuprofen. All of them demonstrated a decrease in the incidence of serious endoscopic injuries between 70-75% with placebo to between 10 and 30% on misoprostol. Doses of 25-200 mg q.i.d. decreased the risk of aspirin-induced mucosal injuries and bleeding. Reduced the possibility of ulcers in the gastric tract that are caused by nonsteroidal anti-inflammatory medicines (NSAIDs) two 12-week, double-blind, randomized double-blind studies in osteoarthritic patients suffering from digestive symptoms, but no ulcer when they had an endoscopy. The study NSAID The study compared the efficacy of 200 mg of Cytotec 100 mg of Cytotec as well as placebo to lower the possibility for gastric ulcer (GU) creation. Patients were roughly equally split between ibuprofen and piroxicam and naproxen, and were continued with this regimen for 12 weeks. The dose of 200 mg resulted in an impressive statistically significant reduction of gastric ulcers, in both research studies. Lower doses were less effective, resulting in an impressive result only in one study.

Reduction of Risk of Gastric Ulcers Induced by Ibuprofen, Piroxicam, or Naproxen [No. of patients suffering from ulcer(s) (%)] Therapy Duration Therapy 4 weeks, 8 days 12 weeks. Study no. 1 Cytotec 200 mcg 1(1.4) 0 0 1(1.4)* q.i.d. (n=74) Cytotec 100 mcg 3(3.9) 1(1.3) 1(1.3) 5(6.5)* q.i.d. (n=77) Placebo (n=76) 11(14.5) 4(5.3) 4(5.3) 19(25.0) Study No. 2 Cytotec 200 mcg 1(1.5) 1(1.5) 0 2(3.1)* q.i.d. (n=65) Cytotec 100 mcg 2(3.0) 2(3.0) 1(1.5) 5(7.6) q.i.d. (n=66) Placebo (n=62) 6(9.7) 2(3.2) 3(4.8) 11(17.7) Studies No. 1 & No. 2** Cytotec 200 mcg 2(1.4) 1(0.7) 0 3(2.2)* q.i.d. (n=139) Cytotec 100 mcg 5(3.5) 3(2.1) 2(1.4) 10(7.0)* q.i.d. (n=143) Placebo (n=138) 17(12.3) 6(4.3) 7(5.1) 30(21.7) *Statistically significant in comparison to placebo, at 5%. *Combination of results of Study No. 1 and Study No. 2.

In these tests, there was no difference in the results between Cytotec or placebo in the treatment of morning or nighttime abdominal pain. The effectiveness of Cytotec in decreasing the risk of duodenal ulcers was observed however, a small number of duodenal ulcers were observed. In another study 239 patients who received aspirin ranging from 650 to 300 mg q.i.d. for rheumatoid arthritis with an endoscopic sign of duodenal or gastric inflammation were assigned to misoprostol at 200 mg q.i.d. or placebo for eight weeks while receiving aspirin. The study assessed the potential impact of Cytotec in relation to the effectiveness of aspirin in patients with rheumatoid joint pain by studying joint swelling, joint tenderness, medical assessment by the doctor, assessments of the patient, change on ARA classification, changes in handgrip strength, changes in the duration of stiffness that occurs during the morning and pain assessment by the patient during rest, movement the impact of daily activities and ESR. Cytotec was not a factor in the effectiveness of aspirin in the patients suffering from Rheumatoid Arthritis.

INDICATIONS AND USAGE Cytotec (misoprostol)

It's recommended for reducing the danger for NSAID (nonsteroidal anti-inflammatory medications, such as aspirin)-induced gastric ulcers among patients who are at risk of developing gastric ulcer-related complications such as the elderly and those with other debilitating illnesses and patients who are at a high risk of developing gastric ulcers, like those who have an ulcer history. Cytotec has not been proven to lower the risk of developing duodenal ulcers among patients who are who take NSAIDs. Cytotec is recommended throughout the duration of NSAID treatment. Cytotec has been demonstrated to lower stomach ulcers risk in controlled research lasting 3 months. Cytotec had no effect when compared with placebo, on stomach pain or discomfort that comes with NSAID usage. Contraindications See the boxed warnings. Cytotec should not be used by pregnant women to lower the chance of developing ulcers caused by non-steroidal anti-inflammatory medications (NSAIDs). Cytotec is not recommended by those who have an allergy history to prostaglandins. Warnings: See the boxed warnings. Precautions about patients with pregnancy potential using Cytotec to reduce the chance of NSAID ulcers induced by it should be advised that they must not become pregnant at the time Cytotec therapy begins and must utilize an effective method of contraception when taking Cytotec. Check out the boxed warnings. Cytotec is designed to be administered in conjunction with nonsteroidal anti-inflammatory medicines (NSAIDs) which include aspirin, in order to reduce the likelihood of developing gastric ulcers caused by NSAIDs. Cytotec is to be used only in accordance with the instructions that are provided by a physician. If the patient has concerns regarding or concerns with Cytotec or any other medication, the physician must be contacted immediately. THE PATIENT SHOULD NOT GIVE CYTOTEC TO ANYONE ELSE. Cytotec was prescribed to treat the specific patient's condition, but might not be the appropriate treatment for a different person and could pose a risk for the person who is taking it in the event that she was or is about to be pregnant. The Cytotec package that the patient receives from the pharmacist will contain an informational leaflet for the patient. The patient must read the leaflet prior to taking Cytotec and every when the prescription is renewed as the leaflet might have been updated. Be sure to keep Cytotec away from out of the hands of young children. Special note for women: Cytotec may cause abortion (sometimes incomplete) or premature labor or birth defects if it is given to women who are pregnant. Cytotec is only available in a unit-of use package that comes with a leaflet containing details for patients. Check out the Patient Information in the last paragraph of this information.

Interactions with drugs: Read Clinical Pharmacology. Cytotec is not proven to affect the positive effects of aspirin in reducing signs and symptoms of rheumatoidarthritis. Cytotec doesn't have any clinically significant effect on concentration of the blood infusion and antiplatelet properties of the therapeutic doses of aspirin. Cytotec does not have a clinically significant influence on the kinetics diclofenac and ibuprofen. The toxicology of animals: A significant increase in the amount of normal gastric epithelial surface cells was observed in dogs as well as the mouse, rat and rat. The same increase was not observed in humans who have been given Cytotec for as long as one year. The apparent reaction of female mice to Cytotec during long-term studies with doses ranging from 100 to 1000 times the human dose was hyperostosis predominantly of the medulla the sternebrae. Hyperostosis didn't occur during long-term studies with rats and dogs and hasn't been observed in patients being treated by Cytotec. Carcinogenesis, mutagenesis, and impairment of fertility There was no evidence of an impact of Cytotec on the development of tumors or incidence in rats that received daily doses of up to 150 times that of human doses during 24 weeks. In the same way, there was no impact of Cytotec on the development of tumors or the incidence of tumors in mice receiving daily doses of up to 1000 times humans dose over 21 months. The mutagenic potency of Cytotec was examined in a number of in vitro experiments and all were positive. Misoprostol was given to breeding males and female rats in doses ranging from 6.25 times up to 625 times that of the recommended dose for human therapeutics resulted in dose-related post- and pre-implantation loss and a significant reduction by the quantity of pups that were born at the most powerful dose. The results suggest an adverse impact on fertility both in the male and female. Pregnancy Categories X for Pregnancy. Teratogenic effects: Check the boxes of WARNINGS. Congenital anomalies which can lead to deaths of the fetus have been reported in the aftermath of the failure of misoprostol to induce abortion however the mechanism of teratogenicity has not been proven. There are several reports in the literature that refer to the use of misoprostol in the first trimester of pregnancy with skull anomalies as well as cranial nerve abnormalities, facial malformations and abnormalities in the limbs. Cytotec is not fetotoxic nor toxic to rabbits or rats in doses of 625 and 63 times the human dose respectively. Nonteratogenic effects: Refer to the boxed warnings. Cytotec can cause harm to the pregnancy (may cause an abortion) and thus result in harm to the fetus if administered to pregnant women. Cytotec could cause Uterine contractions, uterine bleeding, as well as the expulsion from the origin of conception. The abortions caused by Cytotec could be insufficient. If a woman becomes or is pregnant during treatment with this medication to lower the chance of NSAID ulcers, the medication should be stopped and the patient informed of the possible danger to the pregnant fetus.

DR. Renu Labor and Birth: Cytotec may cause or enhance contractions in the uterus. In vaginal use, Cytotec in excess of its approved use is used to ripen the cervical area for the purpose of inducing labor as well as for the treatment of serious postpartum hemorrhage that occurs in the presence of the uterine atony. A major adverse effect of the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, a retained placenta, extreme bleeding from the genital region as well as bradycardia in fetal and uterine areas as well as maternal and fetal deaths have been documented. There is a higher risk of uterine hypertachysystole meconium leakage, meconium staining on amniotic fluid, as well as Cesarean birth due to uterine hyperstimulation through the increasing doses of Cytotec and the 100 mg tablet that is manufactured. The risk of rupture in the uterus is increased with increasing gestational age and prior uterine surgery such as Cesarean delivery. Grand multiparity is also thought to be an important risk factor for rupture of the uterus. The impact on the effect of Cytotec on the subsequent growth and development as well as the maturity of the baby's functional development when Cytotec is employed for cervical ripening or to induce labor is not known. The effects of Cytotec on the necessity for forceps delivery or any other interventions is not known. Nursing mothers: It's likely for Cytotec is excreted from human milk because it is metabolized quickly in the human body. It isn't certain whether Cytotec's active component (misoprostol acid) is excreted by human milk. This is why Cytotec should not be given to mothers who are nursing because the potential for excretion of misoprostol acid can cause severe diarrhoea in infants who are nursing. Use in pediatrics: Safety and efficacy of Cytotec in children has not been proven. AVERSE REACTIONS The following reactions have been identified as negative reactions in patients receiving Cytotec Gastrointestinal: those taking Cytotec 500 or 800 mg every day in clinical trials the most common digestive adverse reactions included abdominal pain and diarrhea. The frequency of diarrhea was 800 mg in controlled trials with patients receiving NSAIDs ranged between 14-40%, and in all studies (over five thousand participants) averaged 13 percent. Abdominal pain was experienced by 13-20% of the patients participating in NSAID trials, and around 7 % in all studies however there was no discernible variation from placebo. Diarrhea was a result of dose and was usually seen at the beginning of treatment (after the 13th day) generally, it was self-limiting (often disappearing within 8 days) However, sometimes it required removal of Cytotec (2 percent of patients). A few cases of extreme diarrhea that resulted in severe dehydration were reported. Patients with an underlying illness such as inflammatory bowel diseases or those who dehydration, should it occur, is potentially dangerous and should be closely monitored in the event that Cytotec has been prescribed. The likelihood of suffering from diarrhea can be reduced by administering it after meals and before bed, and by not combining Cytotec along with magnesium-containing antacids. Gynecological: Women who took Cytotec in clinical trials experienced these gynecological problems including the spotting (0.7 percent) and cramps (0.6 percent) hypermenorrhea (0.5 percent) menstrual disorder (0.3 percent) along with dysmenorrhea (0.1 0.1%). Vaginal bleeding after menopausal may be a result of Cytotec administration. If this happens, a an investigation of the cause is required to rule out any gynecological cause. (See the boxed warnings.)

Older: There were no significant variations in the safety characteristics of Cytotec for approximately 500 ulcer patients older than 65 years old. older than younger patients. The adverse events described are classified according to the following criteria: Incidence higher than 1percent in clinical trials: these adverse reactions were identified by more than 1 percent of subjects taking Cytotec and could be directly connected to the medication including nausea (3.2 percent) flatulence (2.9%), flatulence (2.9 %)) headache (2.4%), headache (2.4 %)) dyspepsia (2.0 percent) and vomiting (1.3%)) and constipation (1.1 percent). There were however no significant differences in the instances of these reactions for Cytotec as well as placebo. Unknown causal relationship The following adverse events were not reported as often. The causal relationships among Cytotec and these incidents are not known, however they are not impossible to exclude the body in its entirety Asthenia/aches fatigue, fever, weight fluctuations, rigors. Skin: rash, dermatitis, alopecia, pallor, breast pain. Special senses: abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache. Respiratory tract: Upper respiratory tract infections, bronchitis dyspnea, bronchospasm epistaxis. Cardiovascular chest pains, swelling hypertension, diaphoresis, hypotension arrhythmia, phlebitis the increase in cardiac enzymes as well as syncope. Gastrointestinal: GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase. Anaphylaxis and hypersensitivity glycosuria, gout, an increase in nitrogen, alkaline-phosphatase levels increased. Genitourinary: dysuria and polyuria and hematuria. It is a urinary tract infection. Nervous system/Psychiatric anxiety, changes in appetite, depression dizziness, drowsiness impermanence, thirst loss of libido the sweating increases, neuropathy brain fog, and confusion. Musculoskeletal: arthralgia, myalgia, muscle cramps, stiffness, back pain. Blood/Coagulation: Anemia, abnormality in differentials, thrombocytopenia purpura ESR increased. Overdosage The toxic dose of Cytotec in humans is still unknown. The cumulative daily doses of 1600 mg are well-tolerated, with no signs of stomach pain being described. Animals, most acute toxic effects include diarrhea, gastrointestinal lesions focal cardiac necrosis, liver necrosis renal tubular necrosis testsicular atrophy and respiratory issues and depressing the central nervous system. Signs that be indicative of an overdose include seizures, tremors, convulsions and dyspnea abdominal discomfort as well as fever, diarrhea and palpitations, hypotension or bradycardia. The symptoms should be treated with treatment that is supportive. It isn't known whether misoprostol is dialyzable. But, since misoprostol can be processed as an fat acid, it's unlikely that dialysis is an the best treatment for excessive dosing.

DOSAGE and ADMINISTRATION The suggested adult dose of Cytotec to reduce the risk of gastric ulcers is milligrams four times a day in conjunction with food. If this dosage is not accepted 100 mg is acceptable. (See Clinical Pharmacology: Clinical research.) Cytotec is recommended during the course of NSAID treatment as directed by the doctor. Cytotec is best taken after an entrée and the final dosing of the day must be taken at nighttime. Renal impairment Modification of the dosing schedule for patients with renal impairment is not usually required however dosage may be decreased if the 200 mg dose is not a good fit for the patient. (See Clinical Pharmacology.) What is the method of supply? Cytotec 100 mg tablets are round, white and have SEARLE embossed on one end and 1451 on another side. The tablets are available as Number of Drug Classification Size (NDC) 0025-1451-60 Unit-of-Use bottle containing 60, 0025-1451-20 unit of use bottle of 120 0025-1451 34 cartons of 100 units Cytotec 200 mg tablets are white hexagonal in shape, with SEARLE embossed above and 1461 debossed beneath the line on the one side and the double stomach embossed on the opposite side. available as NDC number Size 0025-1461-60 unit-of use bottle of 60 0025-1461-31 bottle for unit-of-use of 100 0025-1461-34 carton 100 units. Store below 25 degrees Celsius (77degF) and in an area of dryness. Patient information only for Rx patients. this leaflet prior to taking Cytotec(r) (misoprostol) or each time your prescription needs to be renewed, the leaflet could be altered. Cytotec (misoprostol) can be prescribed by your physician to reduce the risk of developing stomach ulcers due to the pain medication or arthritis you are taking. Don't use Cytotec to decrease the chance of NSAID ulcers that are caused by NSAIDs if are pregnant. ( Check the boxed warnings). Cytotec may cause an abortion (sometimes insufficient, which can cause dangerous bleeding and needing hospitalization and/or surgery) and premature birth as well as birth deformities. It is also essential to stay clear of pregnancy during the time you are taking this medication. It is recommended to avoid pregnancy for at least a month or until the end of one menstrual cycle once stopping taking it. Cytotec has been found to cause the rupture of the uterus (tear) in the event of use at the end of 8 weeks into pregnancy. The rupture (tearing) in the uterus may result in bleeding severe or hysterectomy and/or fatal fetal or maternal death. If you fall pregnant during Cytotec therapy discontinue using Cytotec and consult your doctor immediately. Keep in mind that even if are using a method of birth control, it is still possible to fall pregnant. If this occurs then take a break from Cytotec and speak to your doctor immediately.

CYTOTEC IMAGE

Cytotec could cause diarrhea and abdominal cramps or nausea in certain individuals. Most often, these issues begin during the first couple of weeks of treatment and subside after a few days. The best way to prevent diarrhea is by taking Cytotec along with food. Because the side effects of Cytotec are typically moderate to mild and typically disappear within a couple of days, patients are able to continue taking Cytotec. If you experience prolonged discomfort (more than eight days) or suffer from severe cramping, diarrhea or nausea, consult your physician. Use Cytotec strictly according to the instructions given by your doctor. Don't provide Cytotec to anyone other than yourself. It is prescribed to treat your particular health condition, but might not be the best treatment for another individual and may be harmful when the other person was pregnant. This information sheet is not able to provide all the possible side effects associated with Cytotec. The information sheet for patients doesn't address the adverse effects associated with the arthritis/pain medication. Consult your physician if you have any concerns. Make sure that the product is out of your reach from children. G.D. Searle & Co. Postal Box 5110 USA For medical queries, write to the abortion clinic Toronto USA Searle and Co. Healthcare Information Services DR.RENU