Detailed information about Misoprostol

Misoprostol - Summary of Product Characteristics

Misoprostol – it is found in two drugs, Arthrotec and Cytotec . It is available on the world market under the name misoprostol.

Pharmacological form – round or hexagonal tablet of white or grayish color.

Clinical data – misoprostol can be used to terminate a pregnancy up to 9 weeks pregnant when used in combination with mifepristone.

Indications for use

A synthetic analogue of prostagladin * E1, which acts by binding to the EP3 receptor, which results in the inhibition of the secretion of gastric juice during rest and after a meal. In addition, the drug increases the secretion of bicarbonates, as well as mucus, which has a protective and soothing effect.

Prostaglandins are hormones with various effects which act locally to stimulate the nerves and regulate physiological processes. They work, among others pro-inflammatory, protects the gastric mucosa, stimulates uterine contractions and dilates blood vessels. They are formed as a result of processes related to the transformation of arachidonic acid with the participation of an enzyme called cyclooxygenase (COX). Among the several forms of this enzyme, there is cytoprotection of the gastric epithelium (protection of gastric epithelial cells), or prostanoids, e.g. in inflammatory processes. Prostaglandins formed in the gastric mucosa stimulate a number of changes which result in the reduction of hydrochloric acid secretion. They also have a protective effect by stimulating the production of mucus and bicarbonate and increase blood flow in the mucosa.

Non-steroidal anti-inflammatory drugs (NSAIDs), by reducing inflammation, inhibit cyclooxygenases, but also weaken the protective effect in the gastrointestinal tract. This increases the risk of developing diseases related to the action of hydrochloric acid. To reduce the risk of these undesirable effects, a drug analogous to the physiological prostaglandin E1, misoprostol, is administered.

Scientific characteristics of misoprostol containing medicinal products

The substance contained in misoprostol is used in the treatment and prevention of gastric and duodenal ulcers resulting from treatment with non-steroidal anti-inflammatory drugs. The drug inhibits the secretion of gastric juices. In addition to its use in gastrology, the drug is also used in gynecology. It causes uterine contractions, which result in the expulsion of pregnancy products from the woman’s reproductive organs.

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Misoprostol - an agent commonly used in medical abortion

The drug misoprostol may cause miscarriage and premature birth . It works well as a means of deliberately inducing labor, including pharmacological abortion. In this respect, it is most effective when given together with mifepristone.

Misoprostol tablets 200 mcgAbsorbed from the gastrointestinal tract, misoprostol increases the tone and contractility of the uterine muscle in pregnant women, leading to increased uterine contractions. The drug administered with mifepristone causes a miscarriage and expels the embryo from the woman’s body. Due to the low effectiveness (60 percent) and the lack of certainty of embryo expulsion, it is not recommended as a stand-alone abortifacient.

When used in combination with the drug mifepristone, it is recognized as the most effective (98 percent) and safest method of pharmacological abortion used by women worldwide.

Medical termination of pregnancy with misoprostol and mifepristone is recommended as the safest method of termination of pregnancy during the first 10 weeks of pregnancy by the World Health Organization (WHO).
In this case, the substance causing uterine contractions and expelling the embryo is misoprostol, and the progesterone antagonists inhibiting the process of embryo implantation and death is mifepristone.

Composition and form – one tablet contains 200 micrograms of misoprostol

Pharmacokinetic properties of misoprostol – after oral administration, misoprostol is absorbed from the gastrointestinal tract, reaching the maximum concentration in the blood 30 minutes after ingestion. It does not accumulate in the body.

Dosage and usage

The drug should be administered orally, with meals, not chewing, dissolving or chewing. Keep under the tongue for about 30 minutes, and then spit out the undissolved part. For pharmacological abortion, 6 tablets of misoprostol (200 mcg of misoprostol each) are needed.

Take misoprostol 24 hours after taking mifepristone. There are two ways of doing this. The first method is to apply the drug under the tongue, the second – into the buccal cavity (the space between the gum and the cheek).
Misoprostol in doses of 600 mcg (3 tablets of 200 mcg each) should be taken in 2 doses, at regular intervals, taking the same set of drugs every 3 hours. Spit out any undissolved tablets after 30 minutes. All misoprostol tablets should be taken in the same way, i.e. either by placing them under the tongue or in the buccal area.

We recommend that you apply the drug under your tongue because makes it impossible to detect the agent or its residues in case you need to go to the hospital.

Blood tests for mifepristone and misoprostol are not used in most countries. This means that in the event of a need for consultation after a medical abortion, the doctor will not be able to state that the woman has terminated the pregnancy.

It is important to take all the doses of your medicine, even if in the meantime bleeding starts and you have a miscarriage. Two doses of the drug will allow the uterus to cleanse completely and make medical attention less likely after an abortion.

Side effects

  • Diarrhea, the severity of the diarrhea varies from person to person
  • Headache
  • Painful intestinal cramps
  • Nausea
  • Vomiting
  • Heavy bleeding in which the woman expels clots and pregnancy products.

Bleeding usually begins 1-4 hours after using misoprostol. In rare cases, it may occur up to 72 hours after taking the drug. The bleeding is usually much greater than your normal menstrual bleeding. Maximum bleeding occurs 2-5 hours after taking the drug, and its intensity decreases within 24 hours. An overdose of the drug adversely affects the circulatory system, causing an increase in body temperature, shortness of breath, palpitations, hypotonia or bradycardia.

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Other misoprostol equivalents

Cytotec

Indications for use

Cytotec is used in the treatment and prevention of gastric and duodenal ulcers and haemorrhagic lesions and erosions caused by non-steroidal anti-inflammatory drugs. It accelerates the healing of peptic ulcers and eliminates the symptoms of the disease, and at the same time protects the gastric and duodenal mucosa by inhibiting the secretion of hydrochloric acid and gastric juices. The drug increases the secretion of bicarbonate and mucus. Cytotec can cause miscarriage and premature labor.

Cytotec tabletki 200 mcgComposition and form – one tablet of cytotec contains 200 micrograms of misoprostol.

Pharmacokinetic properties of cytotec – After oral administration, the drug is absorbed from the gastrointestinal tract, reaching the maximum concentration in the blood 30 minutes after ingestion. It does not accumulate in the body.

Dosage and method of taking

The drug should be administered orally during meals. To induce a miscarriage, you need 12 cytotec tablets (200 mcg of misoprostol each).
The drugs should be placed under the tongue and held until dissolved (at least 30 minutes). The tablets should not be swallowed. Cytotec should be taken 24 hours after taking mifepristone. 4 tablets of cytotec should be taken in 3 doses, at regular intervals, taking the same set of drugs every 3 hours. Spit out any undissolved tablets after 30 minutes. All cytotec tablets should be taken in the same way. You have to take all 3 doses of the medication, even if in the meantime bleeding starts and you have a miscarriage. Three doses of the drug will allow the uterus to completely cleanse and make medical attention less likely after an abortion.

Side effects

  • Diarrhea
  • Stomach aches
  • Nausea
  • Vomiting
  • Bloating
  • Headaches and dizziness
  • Prolonged genital bleeding

The drug does not affect psychophysical fitness and the ability to drive or operate machinery.

Arthrotec

Indications for use

Arthrotec is used to treat rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It soothes pain symptoms, redness, a feeling of heat and swelling in the joints. It is used to relieve pain, inflammation and fever. It protects the stomach. Arthrotec can cause miscarriage and premature birth.

Arthrotec tabletki 200 mcgComposition and form – one tablet of arthrotec contains 50 or 75 micrograms of diclofenac surrounded by a shell containing 200 micrograms of misoprostol. Diclofenac covers the misoprostol with a thin layer. This is clearly seen when breaking the tablet in half. Misoprostol is softer, so it will dissolve or crumble more easily than diclofenac.

Pharmacokinetic properties of arthrotec – After oral administration, it is completely absorbed from the gastrointestinal tract, reaching the maximum concentration in the blood after 1-2 hours. after administration. It does not accumulate in the body.

Dosage and method of taking

Arthrotec is taken orally with a meal. It should not be chewed, dissolved, or chewed. The drug is available in two versions – arthrotec 50 and arthrotec 75 . These numbers indicate the amount of diclofenac contained in one tablet. In each of them the amount of misoprostol is the same. For a pharmacological abortion, 12 tablets of arthrotec are needed (each tablet contains 200 mcg of misoprostol). Arthrotec should be taken 24 hours after taking mifepristone. The drug should be applied under the tongue and taken in 3 doses, at regular intervals, taking the same set of drugs every 3 hours. Spit out any undissolved tablets after 30 minutes (any diclofenide in them can destroy the liver and kidneys). All arthrotec tablets should be taken in the same way.
Take all 3 doses of your medication, even if in the meantime bleeding starts and you have a miscarriage. Three doses of the drug will allow the uterus to completely cleanse and make medical attention less likely after an abortion.

Side effects

  • Gastrointestinal disorders
  • Gastritis and / or duodenitis
  • Esophagitis
  • Reflect
  • Nausea
  • Abdominal pain and diarrhea, generally temporary (can be prevented by taking the medicine with meals and avoiding neutralizing medications containing magnesium)
  • Constipation
  • Headache and dizziness
  • Edema and sodium retention
  • Allergic skin reactions (itching, rash, photosensitivity)
  • Bronchospasm (aspirin-induced asthma)
  • Proteinuria
  • Oliguria
  • Kidney problems
  • Intrauterine haemorrhage
  • Painful genital bleeding
  • Uterine contractions
  • Vaginitis
  • Bleeding from the genital organs

The drug, by causing side effects of such a disease, e.g. dizziness, visual disturbances, may affect the psychophysical efficiency, thus posing a danger related to driving and operating machinery.

Other information about misoprostol

Misoprostol – taking with food

The drug should not be administered on an empty stomach. During the procedure, you should eat and drink normally. Some women experience nausea after taking misoprostol, so it would be good if your meals were easy to digest.

Contraindications to the use or independent use of misoprostol

  • Hypersensitivity to the action of prostaglandin.

Breast-feeding

Active substances in medicines containing misoprostol pass into the milk of a nursing woman, causing diarrhea in the infant. For this reason, before the planned pharmacological abortion using misoprostol , arthrotec or cytotec , a woman should feed the baby and possibly provide the food needed for later feeding. During the first 4 hours after taking misoprostol milk is not used as a food . For this reason, they should be poured out after they have been extracted.

Painkillers that can be used after taking misoprostol

ibuprofen is the most effective painkiller for severe spasms of the lower abdomen after taking misoprostol-containing drugs. In case of pain, you can also use non-steroidal anti-inflammatory drugs, such as diclofenac or paracetamol. A bottle of warm water against your belly may also be a relief. Due to the fact that arthrotec is a combination of misoprostol with a pain reliever called diclofenac, taking its first dose, after dissolving the outer layer (containing misoprostol), you can swallow the remainder of one of the 4 tablets, which will act as a pain reliever.

Where to buy misoprostol?

In most countries around the world, misoprostol (misoprostol) is available from local pharmacies over the counter. In Poland, the drug is registered under the trade names Cytotec (available on prescription) and Arthrotec (usually available without a prescription). When you buy these drugs in a pharmacy, you can talk about ailments for which these drugs are commonly used to treat. Due to the fact that in order to perform a pharmacological abortion, mifepristone is also needed in addition to misoprostol. It is best to purchase a full abortion kit from an online pharmacy run by a reliable, legally operating organization.

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