When we mention Misoprostol or Cytotec we are basically talking about the same thing.
Misoprostol is synthetic analogue of natural prostaglandin E1 (PGE1), used to prevent gastric ulcers, for the treatment of miscarriages, to induce labor, as an abortifacient and to control postpartum hemorrhage.
Misoprostol was invented and commercialized by GD Searle & Company (now Pfizer) under the trade name Cytotec. Therefore Cytotec is just the trade name given to Misoprostol.
How does Cytotec work?
Cytotec pills contain the active ingredient Misoprostol, which is a type of medication known as prostaglandin analog. It is used in the treatment and prevention of stomach and intestine (peptic) ulcers.
Cytotec works by imitating the action of the natural prostaglandins.
Prostaglandins are a group of natural body chemicals found in several parts of the body.
Misoprostol acts on the stomach receptors just as the natural prostaglandins that help to protect the gastric mucosa. By binding to these receptors, it stimulates the stomach to produce a protective mucus.
It covers the stomach and the intestine lining, and also reduces the acid production in the stomach. Misoprostol can, therefore, be used to help curing ulcers in these areas.
The analgesics called nonsteroidal anti-inflammatory drugs (NSAIDs), such as Diclofenac and Naproxen, can reduce the production of protective prostaglandins in the bowel.
This means that this analgesics have the potential to damage the intestinal epithelium, causing ulcers, bleeding and, sometimes, even holes in the intestine. Misoprostol can be used to help people who are currently taking NSAIDs to manage long-term conditions, such as arthritis, preventing this type of damages in the intestinal lining.
Use with caution in:
- People with heart diseases.
- Pregnant women (because it results in abortion).
- People with high blood pressure (hypertension).
- People with cerebrovascular diseases, for instance, individuals who have had a stroke or mini-stroke;
- People who suffer from frequent diarrhea, due, for instance to conditions such as Crohn’s disease, ulcerative colitis or irritable bowel syndrome.
How does Cytotec affect another medication?
Antiacids containing magnesium should be avoided while taking this Cytotec, because they can increase the incidence of diarrhea, which is one of the most common side effects of Misoprostol.
Side effects of Cytotec / Misoprostol
Below we can find some side effects in people who took Cytotec:
In subjects who were taking Cytotec – 400mcg or 800mcg per day, during clinical trials, the most frequent gastrointestinal side effects were diarrhea and abdominal pain. The occurrence of diarrhea with 800 mcg in controlled studies in patients on NSAIDs ranged from 14% to 40%, and, in overall studies (over 5 000 patients), the calculated averaged was 13%. Abdominal pain occurred in 13% – 20% of patients in NSAID trials and approximately 7% in all studies. Nevertheless, there were no consistent differences from placebo.
Diarrhea was related to the dose and was developed during the early stage of the treatment (after 13 days). It often limited itself (typically settling after 8 days), even though sometimes it was necessary to interrupt Cytotec (in 2% of patients). Rare occurrences of heavy diarrhea that led to a severe dehydration have been reported. Patients with underlying conditions such as inflammatory bowel disease or those with signs of dehydration should be carefully monitored when Cytotec is prescribed. Diarrhea can be minimized ´through drug administration after meals and before bedtime, avoiding as well combined administration of Cytotec with antacids containing magnesium.
Women that have taken Cytotec during clinical trials reported the following gynecological disorders: spots (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Vaginal bleeding after menopause may be related to Cytotec administration. If this occurs, diagnostic investigation should be undertaken to rule out any gynecological pathology.
There were no significant differences in the safety profile of Cytotec in 500 patients aged 65 and more with ulcers when compared to younger patients.
Additional adverse events that were reported are categorized as described bellow:
Incidence greater than 1%
In clinical trials, the following adverse reactions were reported by more than 1% of subjects that were receiving Cytotec and may be causally related to the medication: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidence of these events with Cytotec and with placebo.
Unknown causal links
The following adverse effects have been rarely reported. Causal links between Cytotec and these effects have not been established, but they can’t also be excluded:
In the body: aches, asthenia, fatigue, fever, chills, weight changes;
Skin: rash, dermatitis, alopecia, pallor, breast pain;
Sensorial systems: taste alteration, abnormal vision, conjunctivitis, deafness, tinnitus, earache;
Respiratory: upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis;
Cardiovascular: chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction (some fatal), thromboembolic events (eg, pulmonary embolism, arterial thrombosis and stroke);
Gastrointestinal: GI bleeding, GI inflammation / infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, increased amylase;
Hypersensitivity: anaphylactic reaction;
Metabolic: glycosuria, gout, increased nitrogen, increased alkaline phosphatase;
Genito-urinary: polyuria, dysuria, hematuria, urinary tract infection.
Nervous system: anxiety, change of appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, increasing sweating, neuropathy, neurosis, confusion;
Musculoskeletal: arthralgia, myalgia, muscle cramps, stiffness, back pain.
Blood / Coagulation: anemia, abnormal differential, thrombocytopenia, purpura, increased sedimentation rate.
The toxic dose of Cytotec in humans hasn’t been determined. Cumulative total daily doses of 1600 mcg have been tolerated, showing only symptoms of gastrointestinal discomfort. In animals, the acute toxic effects are: diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and central nervous system depression. Clinical signs that may indicate an overdose are: sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. The symptoms should be treated with supportive care.
It is not known if Misoprostol acid is dialyzable. However, since Misoprostol is metabolized as a fatty acid, dialysis highly is unlikely to be a suitable treatment for overdose.
Cytotec – 200 mcg
The pills are hexagonal and white. On one side they are marked with the word SEARLE above and with 1461 below the threshold. On the other side it displays the image of a double stomach.
Cytotec – 100 mcg
The pills are rounded and white. The word SEARLE appears in one of its sides, and marked with 1451 on the other side.