Generality
Misoprostol is a synthetic analogue of prostaglandin E1 (PGE1).
It is an active ingredient used in therapy in multiple situations. More in detail, misoprostol is included in the composition of medicines used to treat or prevent damage to the gastrointestinal mucosa ( cytoprotective activity ) and - at the appropriate dosages - in the composition of medicines used in the gynecological field due to the induction of childbirth or abortion . These different uses are possible because the prostaglandin of which the misoprostol represents the synthetic analogue is able to exercise multiple activities towards the different organs and tissues of the body.
Misoprostol-containing medicines used to protect the gastrointestinal mucosa are dispensable upon presentation of a non-repeatable prescription (RNR); while the medicines based on misoprostol used in the gynecological field are exclusively for hospital use and cannot be dispensed to the public.
Examples of Specialties Medicines containing Misoprostol
- Artrotec® (in combination with diclofenac)
- Cytotec®
- Misofenac® (in combination with diclofenac)
- Misoone®
- Mysodelle®
Therapeutic indications
When is the use of misoprostol indicated?
Misoprostol is an active ingredient whose use is indicated in many situations:
- Prevention and treatment of gastrointestinal mucosal lesions caused by taking non-steroidal anti-inflammatory drugs or NSAIDs (oral administration);
- Induction of labor from the 36th week of gestation in women with unfavorable cervix in which the induction of childbirth is indicated (local administration through specific vaginal devices).
- Pharmacological abortion and therapeutic abortion (oral administration after intake of mifepristone).
Did you know that ...
Misoprostol is also included in the composition of medicinal products in combination with diclofenac, a known non-steroidal anti-inflammatory drug. These medicines are used to counteract the inflammatory processes and the combination with misoprostol is useful to prevent any damage to the gastrointestinal mucosa induced by taking diclofenac.
Warnings
Warnings and Precautions for the use of Misoprostol
First of all, it is good to point out that - as a precaution - before taking medicines based on misoprostol, it is advisable to inform the doctor of your health conditions, making it aware of the possible presence of disorders or diseases of any kind. However, below are some of the main warnings and precautions for medicines containing misoprostol used both to protect the gastric mucosa and in gynecology.
Misoprostol to protect the gastrointestinal mucosa
Before starting treatment with misoprostol to prevent or treat NSAID-induced gastrointestinal mucosal injuries, it is advisable to inform your doctor if you are in one or more of the following conditions:
- You suffer from intestinal disorders or diseases capable of inducing diarrhea. In these cases, in fact, it is necessary to take the medicine based on misoprostol with food.
- You suffer from disorders or diseases that can lead to dehydration;
- You are suffering from severe circulatory disorders (including hypertension).
Please note
Misoprostol should be used for the treatment of gastrointestinal mucosal lesions only after having ascertained - through specific tests - that the aforementioned lesions are not neoplastic in nature (ie, induced by tumors).
Misoprostol used in gynecology
Medicines based on misoprostol used to induce labor or abortion must be used only and exclusively in a hospital setting and administered to the patient only under the strict control of the doctor and the healthcare personnel specialized in this area.
If misoprostol is used to induce labor, the patient and the child must be constantly monitored before, during and after treatment with misoprostol, even after birth. Naturally, the patient must also be monitored in the case of pharmacological abortion and therapeutic abortion.
Furthermore, it should be pointed out that, before undergoing treatment with misoprostol to induce labor or abortion, it is necessary to inform the doctor if:
- You suffer from liver and / or kidney diseases;
- You are suffering from cardiovascular diseases or you are exposed to a high risk of developing cardiovascular diseases (for example, smoking, high blood pressure, etc.)
- You suffer from anemia;
- You suffer from alterations and disorders of blood clotting;
- We have previously undergone surgery of the cervix or uterus;
- A state of malnutrition is present.
However, if in doubt, contact your doctor and your gynecologist.
Please note
The use of misoprostol can cause side effects that can negatively influence the ability to drive and / or use machines. For this reason, these activities should be avoided during therapy with this active ingredient.
Pharmacological Interactions
Interactions between Misoprostol and Other Drugs
When misoprostol is used in therapy for its cytoprotective action against the gastrointestinal mucosa, it must not be administered in association with antacids containing magnesium .
When misoprostol is used in the gynecological field to induce labor or abortion, on the other hand, it must not be administered in combination with oxytocic drugs and / or other drugs used to promote the onset of labor .
However, before starting misoprostol therapy - for any type of therapeutic indication - it is necessary to tell the doctor if you are taking, or have recently taken, any drugs or products of any kind, including medicines without medical prescription (SOP), over-the-counter drugs (OTC), herbal and phytotherapeutic products and homeopathic products.
Side effects
Side effects caused by misoprostol intake
Like any other active ingredient, misoprostol can also induce side effects, although not all patients manifest them or make them equally. In fact, each person reacts subjectively to the administration of the drug manifesting side effects that are different in type and intensity, or not manifesting them at all.
However, below are the main side effects that could occur during treatment with misoprostol. For more detailed information, however, it is advisable to consult your doctor or gynecologist as appropriate, and carefully read the package insert for the medicinal product to be taken.
Misoprostol to protect the gastrointestinal mucosa
When administered orally to protect the gastrointestinal mucosa from NSAID-induced lesions, misoprostol could give rise to the following side effects:
- Allergic reactions, even serious, in sensitive individuals;
- Dizziness and headache;
- Abdominal pains;
- Nausea and / or vomiting;
- Diarrhea or constipation;
- Skin rash;
- In women, uterine cramps, vaginal bleeding, intermenstrual bleeding, menorrhagia or dysmenorrhea;
- Fever and chills.
Misoprostol in the gynecological field
When misoprostol is taken orally to induce abortion after mifepristone administration, the following side effects may develop:
- Allergic reactions, even serious, in sensitive individuals;
- Nausea and / or vomiting;
- Diarrhea;
- Abdominal pain and gastrointestinal cramps;
- Severe vaginal bleeding;
- Temperature;
- Infections of the uterus;
- Headache, dizziness and feeling sick.
When, on the other hand, misoprostol is administered through the insertion of special vaginal devices to induce labor, the following side effects could occur:
- Allergic reactions, even serious, in sensitive individuals;
- Changes in the heart rate of the unborn child;
- Abnormal uterine contractions;
- Abnormal labor;
- Meconium in the amniotic fluid;
- Neonatal respiratory depression and transient tachypnea of the newborn;
- Fetal acidosis;
- Uterine hypertonus;
- Postpartum hemorrhage;
- Ischemic hypoxic encephalopathy;
- Nausea and / or vomiting;
- Anteparto hemorrhage;
- Placental premature detachment;
- Laceration of the uterus;
- Hypertension.
Overdose
Overdose misoprostol can lead to symptoms such as:
- Temperature;
- Diarrhea;
- Lethargy;
- Sedation;
- Convulsions;
- Tremors;
- Abdominal pains;
- Chest pain;
- Dyspnoea;
- Uterine contractions (even in non-pregnant women);
- Palpitations;
- Hypotension and / or bradycardia sometimes fatal.
Given the seriousness of the symptomatology, in the case of an overdose of misoprostol - ascertained or presumed - it is necessary to go to the nearest emergency room or contact the health personnel if you are already in the hospital.
Unfortunately, there are no antidotes against overdosage with misoprostol, the treatment is symptomatic and supportive.
Action mechanism
How does Misoprostol work?
As a synthetic analogue of prostaglandin E1, misoprostol is capable of exerting different effects in different organs and tissues:
- At the gastrointestinal level misoprostol exerts a cytoprotective action through the following mechanisms of action:
- Stimulation of normal physiological protection mechanisms (bicarbonate secretion, mucus production, etc.);
- Inhibition of gastric acid secretion and pepsin secretion .
- In pregnant women, at the level of the uterus, misoprostol leads to the maturation of the cervix and induces the contraction of the uterine smooth muscle favoring, depending on the case, the beginning of labor or abortion.
Use and Posology
How to take Misoprostol
Misoprostol to protect the gastrointestinal mucosa
The misoprostol medicines used in the prevention and treatment of NSAID-induced gastrointestinal mucosa lesions are formulated as tablets for oral use . These tablets should be swallowed whole, using a little water, preferably with meals.
In the prevention of gastrointestinal mucosal lesions, the usual recommended dose is 200 mcg (micrograms) of active ingredient, to be taken 2-4 times a day.
In the treatment of these lesions, on the other hand, the dosage can be increased up to 800 mcg per day, to be taken in 2-4 divided doses.
However, the dosage of misoprostol will be established by the doctor on an individual basis for each patient.
Misoprostol in the gynecological field
When used to induce pharmacological or therapeutic abortion, misoprostol is administered orally (in the form of tablets to be swallowed whole) from 36 to 48 hours after the administration of mifepristone (abortion pill). The usual dose used in these cases is 400 mcg of misoprostol. Clearly, administration should only be performed by specialized medical personnel.
The medicines containing misoprostol used to induce labor, on the other hand, are found in the form of vaginal devices that must be inserted near the cervix (cervix) by specialized medical personnel . Such devices usually contain 200 mcg of misoprostol which are gradually released within 24 hours (indicatively, 7 mcg per hour). Immediately after their insertion, the patient must remain in a lying position for at least 30 minutes and must be constantly monitored until labor begins or contractions do not become regular. However, the vaginal device containing misoprostol could be removed earlier in the event of:
- Irregular twitches too strong, prolonged or too frequent;
- Changes in the cervix;
- Child suffering.
In any case, the device must be removed after 24 hours from the insertion.
Pregnancy and breastfeeding
Can Misoprostol be taken during pregnancy and during breastfeeding?
Misoprostol medicines used for the treatment or prevention of NSAID-induced gastrointestinal mucosal lesions should not be used during pregnancy as they could induce abortion or cause premature labor. Since the active ingredient is excreted in breast milk, its use is also contraindicated during breastfeeding.
As for the medicinal products based on misoprostol used to induce labor or abortion, their use must take place only in certain situations - when it is necessary to induce labor and when voluntary interruption of pregnancy is permitted and possible - and only under strict medical supervision.
For more information, we recommend reading the dedicated articles: Medications for the Induction of Childbirth - Pharmacological Abortion - Therapeutic Abortion.
Contraindications
When Misoprostol should not be used
The use of misoprostol - regardless of the reason for which it is necessary to use the medicines containing it - should not be used in case of known hypersensitivity to misoprostol itself and / or to one or more of the excipients contained in the medicinal product that is necessary use.
Misoprostol to protect the gastrointestinal mucosa
In addition, misoprostol medicines used to protect the gastrointestinal mucosa should not be used during pregnancy and during breastfeeding.
Misoprostol to induce labor
The use of medicines based on misoprostol to induce childbirth, on the other hand, is also contraindicated under the following conditions:
- If labor has already begun;
- If the child is suffering;
- If you have already been given oxytocic drugs or other drugs to induce labor;
- If the patient has abnormalities of the uterus (uterus in the shape of a heart or uterus bicorne) or has undergone previous surgery on the cervix or uterus (cesarean section included);
- If the patient has placenta previa;
- In case of abnormal presentation of the fetus;
- In the presence of signs or symptoms that could indicate the presence of chorioamnionitis;
- If you have been pregnant for less than 36 weeks.
Misoprostol to induce abortion
Finally, the use of misoprostol medicines to induce abortion is contraindicated also in the following cases:
- If the state of pregnancy has not been confirmed by biological tests and ultrasound;
- If more than 7 weeks (49 days) have passed since the first day of the last menstrual cycle;
- If your doctor suspects an ectopic pregnancy.
- If the patient cannot take mifepristone (abortion pill).
Please note
For more in-depth information regarding indications, warnings and precautions, interactions, side effects, use during pregnancy and during lactation and contraindications of the various medicines based on misoprostol, it is advisable to consult your doctor again and read the package insert for the medicinal product to be used.
