What is the side effect of cytotec: Misoprostol (Oral Route) Side Effects

23.04.202128.07.2023 by alexxlab

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Cytotec Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Do not take this medication if you think that you may be pregnant. It may cause a pregnancy to end, premature birth, or birth defects. In rare cases, serious complications (such as uterine rupture) have occurred when misoprostol was used to start labor or end a pregnancy. These complications have resulted in harm to the unborn baby and mother. The risk for uterine rupture increases as your pregnancy advances and if you had prior uterine surgery (including Cesarean delivery) or if you had five or more previous pregnancies.

Avoid pregnancy while taking misoprostol and for at least one month or one completed menstrual cycle after you have stopped treatment. If you become pregnant while taking misoprostol, contact your doctor right away.

If you are pregnant, do not take this medication to reduce the risk of stomach ulcers due to aspirin or other related drugs (non-steroidal anti-inflammatory drugs-NSAIDs such as ibuprofen). Also, if you are of childbearing age, do not use this drug to reduce the risk of ulcers from NSAIDs unless you are at high risk of having an ulcer or ulcer complications.

Female patients must meet the following four requirements in order to use this drug: 1) test negative for pregnancy within two weeks before starting treatment; 2) use effective birth control to prevent pregnancy; 3) receive oral and written warnings on the dangers of using misoprostol while of childbearing age and the risks of possible birth control failure; 4) start taking misoprostol only on the second or third day of the next normal menstrual period.

This medication must not be shared with others.

Warnings:

This medication must not be shared with others.

Uses

This medication is used to prevent stomach ulcers while you take NSAIDs (such as aspirin, ibuprofen, naproxen), especially if you are at risk for developing ulcers or have a history of ulcers. Misoprostol helps to decrease your risk of serious ulcer complications such as bleeding. This medication protects your stomach lining by lowering the amount of acid that comes in contact with it.This medication is also used in combination with another drug (mifepristone) to end a pregnancy.

How to use Cytotec

This medicine comes with a patient information leaflet. Read it carefully. If you have any questions about this drug, ask your doctor, nurse, or pharmacist.

Dosage is based on your medical condition and response to therapy.

If you are taking this drug to prevent stomach ulcers, take it by mouth as directed by your doctor, usually four times a day. Take it after meals and at bedtime to minimize diarrhea.

If you are taking this medication to end a pregnancy, take it by mouth exactly as directed by your doctor.

If you are using this medication to start labor, your healthcare professional will insert it into your vagina.

Avoid taking antacids that contain magnesium while using misoprostol because they may make the diarrhea it causes worse. If you need an antacid, consult your doctor or pharmacist to help you choose a product.

For ulcer prevention, continue to take this drug for as long as you take NSAIDs. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day.

Inform your doctor if your condition lasts or gets worse.

Side Effects

Nausea or stomach cramps may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Diarrhea is common with misoprostol and usually occurs about two weeks after you start taking it, and lasts for about a week. Be sure to keep up your intake of fluids and minerals/electrolytes to prevent dehydration. Diarrhea that doesn’t stop may sometimes lead to a large loss of your body’s water and minerals. Tell your doctor right away if you develop any of these serious signs of dehydration and mineral imbalance: dizziness, decreased urination, mental/mood changes, muscle weakness, slow/irregular heartbeat.

Tell your doctor right away if you have any serious side effects, including: menstrual problems or irregularities, unusual/heavy vaginal bleeding.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking misoprostol, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal disease (such as inflammatory bowel disease).

Daily use of alcohol and tobacco may increase your risk for stomach bleeding. Limit alcohol beverages and stop smoking. Consult your doctor or pharmacist for more information.

If you are taking this medication in combination with mifepristone to end a pregnancy, rarely the pregnancy may not end. It is very important for you to be closely monitored by your doctor and to keep your scheduled appointments to follow your progress. Be sure to have clear instructions from your doctor about who to call and what to do in case of an emergency. Expect vaginal bleeding after you take the combined medicine, however tell your doctor right away if you develop any unlikely symptoms such as severe/prolonged vaginal bleeding, signs of infection (including fever, chills), or fainting.

This drug must not be used during pregnancy to prevent stomach ulcers because of possible harm to an unborn baby (see also Warnings). If you are of childbearing age, use effective birth control methods while taking misoprostol and for at least one month or one completed menstrual cycle after you stop taking it. If you become pregnant or think you may be pregnant, inform your doctor right away.

This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Interactions

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, seizures, severe dizziness, slow/irregular heartbeats.

Do not share this medication with others.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Store at or below 77 degrees F (25 degrees C) in a dry place away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Cytotec 200 mcg tablet

Color: whiteShape: hexagonalImprint: SEARLE 1461 a double stomach

This medicine is a white, hexagonal, scored, tablet imprinted with “SEARLE 1461” and “a double stomach”.

Cytotec 100 mcg tablet

Color: whiteShape: roundImprint: SEARLE 1451

This medicine is a white, hexagonal, scored, tablet imprinted with “SEARLE 1461” and “a double stomach”.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Cytotec Uses, Side Effects & Warnings

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Generic name: misoprostol [ mye-so-PRAH-stole ]
Drug class: Miscellaneous GI agents

Medically reviewed by Drugs.com on Nov 30, 2022. Written by Cerner Multum.

What is Cytotec?

Cytotec is used to prevent stomach ulcers during treatment with nonsteroidal anti-inflammatory drugs (NSAID) such as aspirin, ibuprofen, naproxen, celecoxib, diclofenac, indomethacin, meloxicam, and others.

Cytotec may also be used for purposes not listed in this medication guide.

Warnings

Cytotec can cause birth defects, premature birth, uterine rupture, miscarriage, or incomplete miscarriage and dangerous uterine bleeding. Do not use this medicine if you are pregnant.

If you are able to become pregnant, you will need to have a negative pregnancy test before starting this treatment. You will also need to use effective birth control to prevent pregnancy during treatment.

Before taking this medicine

You should not use Cytotec if you are allergic to Cytotec or other prostaglandins, or if you are pregnant.

Tell your doctor if you have ever had:

May cause birth defects. Do not use if you are pregnant. You must use effective birth control while using Cytotec and for at least 1 month after your last dose. Tell your doctor if you become pregnant.

You will need to have a negative pregnancy test before starting this treatment.

Stop taking this medicine and tell your doctor right away if you become pregnant during treatment.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I take Cytotec?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not share this medicine with another person, even if they have the same symptoms you have.

Cytotec is usually taken four times a day with meals. The last dose of the day should be at bedtime. Follow your doctor’s instructions.

You may have nausea, stomach cramps, or diarrhea while taking this medicine, especially during the first few weeks after you start taking Cytotec. These symptoms usually last for about a week.

Call your doctor if you have severe nausea, stomach pain, or diarrhea lasting longer than 8 days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Cytotec?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity.

Cytotec side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Cytotec may cause serious side effects. Call your doctor at once if you have:

severe ongoing stomach discomfort or diarrhea; or
dehydration–dizziness, confusion, feeling very thirsty, less urination.

Common side effects of Cytotec may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cytotec?

Tell your doctor about all your other medicines, especially:

antacids.

This list is not complete. Other drugs may affect Cytotec, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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Related treatment guides

Duodenal Ulcer
NSAID-Induced Ulcer Prophylaxis
Stomach Ulcer

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Cytotec instructions for use: indications, contraindications, side effects – description Cytotec Tablets (5334)

💊 Composition of Cytotec

✅ Use of Cytotec

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⚠️ The state registration of this drug has been canceled

Description of the active ingredients of the preparation

Cytotec
(Cytotec)

The scientific information provided is general and cannot be used to make decisions.
decisions about the use of a particular drug.

Update date: 2020.05.01

Marketing authorization holder:

SEARLE division of Monsanto, pls
(UK)

ATX code:

A02BB01

(misoprostol)

Active substance:
misoprostol
(misoprostol)

Rec.INN

registered by WHO

Dosage form

Cytotec

Tab. 200 mcg: 20 pcs.

reg. No.: P N011767/01-2000
from 15.03.00
– Cancellation of the state. registration

Release form, packaging and composition
drug Cytotec

10 pcs. – blisters (2) – packs of cardboard.

Clinical and pharmacological group:

Synthetic analogue of prostaglandin E ₁ . Antiulcer drug

Pharmaco-therapeutic group:

Antiulcer agent-PGE1

Pharmacological action

Synthetic analogue of prostaglandin E ₁ . It has a cytoprotective effect associated with an increase in the formation of mucus in the stomach and an increase in the secretion of bicarbonate by the gastric mucosa. Having a direct effect on the parietal cells of the stomach, misoprostol suppresses basal, nocturnal and stimulated (food, histamine, pentagastrin) secretion. Decreases basal (but not histamine-stimulated) pepsin production.

Induces myometrial smooth muscle contraction and dilates the cervix. Increases the frequency and strength of contractions of the myometrium, providing a weak stimulating effect on the smooth muscles of the gastrointestinal tract.

The action begins after 30 minutes and lasts at least 3-6 hours. At a dose of 50 micrograms, the effect is moderate and short, 200 micrograms – pronounced.

Pharmacokinetics

When administered orally, it is rapidly and completely absorbed (food delays absorption). Plasma protein binding is 85%. In the walls of the gastrointestinal tract and liver, it is metabolized to the pharmacologically active misoprostolic acid. C_max reached after 12 min. C _ss – after 2 days. Does not accumulate with repeated administration. T _1/2 – 20-40 min. Excreted by the kidneys (80%) and bile (15%). In case of impaired renal function, an increase in C _max by almost 2 times and an increase in T _1/2 is possible.

Indications of the active substances of the drug
Cytotec

Prevention of gastric ulcer development associated with the use of NSAIDs in patients with an increased risk of ulcer formation, treatment of exacerbation of duodenal ulcer, gastric ulcer.

In combination with mifepristone: early termination of pregnancy (up to 42 days of amenorrhea).

Open list of ICD-10 codes

K25	Gastric ulcer
K26	Duodenal ulcer
K27	Peptic ulcer
O04	Medical abortion
Y45	Analgesics, antipyretics and anti-inflammatory drugs

Dosage regimen

The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

Taken orally. A single dose – 200-400 mcg, with hypersensitivity and renal failure – 100 mcg. The frequency of administration and duration of use depend on the indications and the effectiveness of treatment.

Side effects

From the digestive system: abdominal pain, flatulence, nausea, vomiting, diarrhea, constipation.

From the reproductive system: pain in the lower abdomen associated with contractions of the myometrium, dysmenorrhea, polymenorrhea, menorrhagia, metrorrhagia.

Allergic reactions: skin rash, itching, angioedema.

Other: change in body weight, asthenia, increased fatigue; extremely rarely – convulsions (in women in the pre- or postmenopausal period).

Contraindications for use

Severe liver dysfunction, inflammatory bowel disease, pregnancy, lactation, severe renal failure, enteritis, children and adolescents under 18 years of age, hypersensitivity to misoprostol.

Use during pregnancy and lactation

Use during pregnancy and lactation (breastfeeding) is contraindicated.

Be aware that misoprostol increases uterine tone and may cause miscarriage when used as a gastroprotective agent.

If use in women of childbearing potential is necessary, a serum pregnancy test should be performed and remain negative for 2 weeks prior to initiation of misoprostol therapy. Treatment can be started only on the 2-3rd day of normal menstruation. During the entire course of treatment, reliable methods of contraception should be used.

Use in hepatic impairment

Contraindicated in severe hepatic impairment.

Use in impaired renal function

Contraindicated in severe renal impairment.

Use in children

Contraindicated in children and adolescents under 18 years of age.

Special instructions

Use with caution in patients with arterial hypotension, ischemic heart disease, cerebrovascular accident, coronary cardiosclerosis, epilepsy, enterocolitis, diarrhea, hypersensitivity to prostaglandins or their analogues.

Use for termination of pregnancy is carried out only in combination with mifepristone and only in specialized medical institutions with appropriately trained medical personnel and with the ability to provide emergency surgical gynecological and blood transfusion care.

Acetylsalicylic acid and other NSAIDs should not be given for 1 week after taking misoprostol.

Drug interactions

Concomitant use with antacids reduces the concentration of misoprostol in blood plasma.

Simultaneous use with magnesium-containing antacids may increase diarrhea.

When used simultaneously with acenocoumarol, a case of a decrease in the anticoagulant effect of acenocoumarol has been described.

When used simultaneously with diclofenac, indomethacin, the side effects of diclofenac and indomethacin increase.

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If you want to place a link to the description of this drug – use this code

Cytotec . Description of the drug in the reference book Vidal.

Cytotec :: Instructions :: Price :: Description of the drug Additive components: MCC, aerosil, sodium CMC, hypromellose, castor oil.

The active substance of Cytotec tablets is a synthesized analogue of prostaglandin E1 produced by the body. This molecule enhances the protective properties of the gastrointestinal mucosa by stimulating the production of mucus by the glandular cells of the stomach, enhancing the natural secretion of bicarbonate molecules.

It increases the resistance of the gastrointestinal mucosa, preventing aggressive components from food, alcoholic beverages, therapeutic drugs from harming the cells that form the gastrointestinal mucosa. Cytotec has the following effects:

– causes acid neutralization by enhancing the synthesis of bicarbonates;

– protects the walls of the stomach from aggressive molecules by increasing the production of mucus, improving its qualitative composition;

– improves blood supply to the gastrointestinal mucosa with stimulation of regenerative processes.

The misoprostol molecule reduces the production of pepsi molecules. The therapeutic effect starts 30 minutes after the use of the dosage form, lasts about 180 minutes. Misoprostol provokes contraction of the myometrium, increases the intensity of contractions.

Cytotec is prescribed for:

the need to use NSAIDs;
peptic ulcer of any localization;
duodenal ulcer with or without bleeding;
gastric ulcer with or without bleeding.

Cytotec tablet is taken by mouth. It is indicated to use the dosage form directly with food, after meals and before going to bed. For the treatment of ulcerative lesions of the gastrointestinal tract, gastritis with mucosal erosions, the daily dose is 0.8 mg divided into 2-4 doses.

In order to prevent the development of ulcerative lesions of the gastrointestinal tract, 0.4-0.8 mg / day is prescribed with a dose divided into 2-4 doses. If necessary, therapy with drugs of the NSAID group is indicated to take Cytotec during the entire treatment. During the period of exacerbation of duodenal ulcer, the drug should be taken for 1 month. A month later, endoscopy is done. If incomplete scarring is detected, the course is extended for another month.

The use of Cytotec tablets may be accompanied by:

constipation;
dysmenorrhea;
diarrhea;
skin rashes;
pain in the lower abdomen;
asthenia;
gagging;
headaches;
hypermenorrhea;
bloody vaginal discharge;
bouts of nausea;
change in body weight;
convulsions;
flatulence;
epigastric pains.

Cytotec is not prescribed for:

severe liver pathologies;
arterial hypotension;
acute renal failure;
disorders of cerebral circulation;
intestinal pathologies associated with inflammation;
pregnancy;
pregnancy planning;
indications in premenopausal patients;
indications in nursing;
hypersensitivity to misoprostol;
indications in patients under 17 years of age.

Caution is required when prescribing Cytotec tablets for:

organic pathologies of cerebral vessels;
acute peripheral circulatory disorders;
epilepsy.

Cytotec tablets may cause self-abortion. The use of misoprostol-containing agents during pregnancy and suspected pregnancy is contraindicated.

Drug, drug group	Possible interaction result with misoprostol
Antacids	Significant reduction in the bioavailability of misoprostol
Magnesium-containing antacids, aluminum-containing antacids	Occurrence or aggravation of diarrhea

The use of the drug in dosages that exceed therapeutic may be accompanied by the following symptoms:

tremor;

epigastric pain;

tachycardia;

febrile condition;

hypotension;

by slowing down the reaction rate;

diarrhea;

drowsiness;

convulsive syndrome.

It is indicated to carry out the therapy corresponding to the appeared symptomatology.

Cytotec is available in tablet form. Packing: 50 tablets/package.

Storage temperature of Cytotec tablets is up to 30 degrees Celsius. The shelf life of the drug is 3 years.

Misoprostol, Mirolut, Misoprostol-HPMC, Cytotec.