What Factors Affect Misoprostol Dosage?

Misoprostol tablets, indications for the treatment of duodenal ulcer and gastric ulcer, including duodenal ulcer and gastric ulcer caused by arthritis patients taking non-steroidal anti-inflammatory drugs (NSAID) To ensure that they can continue to use NSAID treatment. This product can also be used to prevent ulcers caused by the use of NSAID.

Drug Name: Misoprostol tablets

Drug type: Prescription medicines, essential medicines, medicines for medical workers' injuries
Use classification: Other uterine smooth muscle stimulants

Misoprostol warnings

Pregnant women taking misoprostol can cause miscarriage, premature birth or birth defects. Uterine rupture has been reported when induced or aborted in women over 8 weeks of pregnancy. Misoprostol should not be used in pregnant women to reduce the risk of ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs).
Patients used for abortion or induction of labor must be told not to give the drug to others.
Misoprostol should not be used to reduce the risk of ulcers caused by NSAID in women who may become pregnant, unless the patient is at a high risk of gastric ulcer comorbidity caused by NSAID or at a high risk of developing gastric ulcer. These high-risk patients can use misoprostol in the following situations:
Negative serum pregnancy test within 2 weeks before treatment;
Be able to take effective contraceptive measures;
Have been warned verbally and in writing about the dangers of misoprostol to pregnancy, the risk of possible contraceptive failure, and the danger of giving the drug to other women who may become pregnant;
Misoprostol can only be started on the second or third day of the next normal menstrual cycle.

Misoprostol tablets ingredients

The main ingredients of this product are: Misoprostol, its chemical name is: (±) -methyl- (1R, 2 R, 3R) -3-hydroxyl-2 [[E)-(4 RS)-4- Hydroxy-4-methyl-1-octenyl] -5-oxocyclopentylheptanoyl ester.
The chemical structural formula is:

Molecular formula: C ₂₂ H ₃₈ O ₅
Molecular weight: 382.60

Misoprostol Tablet Properties

White / off-white, hexagonal tablet with notches on both sides and inscription 'SEARLE 1461' on one side. Each tablet contains 0.2 mg of misoprostol.

Misoprostol tablets specifications

0.2mg

Misoprostol dosage and dosage

adult:
Treatment of duodenal ulcer, gastric ulcer, and peptic ulcer caused by NSAID:
0.8mg daily, at breakfast and / or lunch, at dinner and before bedtime (take 2 or 4 times). Even if symptoms resolve quickly, treatment should begin at least 4 weeks. Ulcers in most patients heal within 4 weeks, but can be extended to 8 weeks if needed. If the ulcer recurs, a new course can be started.
Prevention of peptic ulcer caused by NSAID: 0.2 mg, 2 times, 3 times, or 4 times daily. The course of treatment and dosage depend on the condition. The dose should be individualized according to the clinical condition of the patient.
Seniors:
Can be taken at regular doses.
Patients with renal insufficiency:
Available data indicate that patients with renal insufficiency do not need to adjust the dosage.
Patients with liver dysfunction:
This product is metabolized by the fatty acid oxidation system throughout the body. Its metabolism and plasma concentration did not change significantly in patients with liver dysfunction.
Children <br /> The treatment of peptic ulcers or NSAID-induced peptic ulcers in children with misoprostol has not yet been evaluated.

Adverse reactions of misoprostol tablets

The adverse reaction terms are classified according to their incidence as follows:

* Diarrhea and abdominal pain are dose-dependent and usually occur early in treatment and are generally self-limiting. Rare cases of severe diarrhea leading to severe dehydration.
A single dose not exceeding 0.2mg taken with food, and avoiding the use of magnesium-containing antacids when taking antacids can reduce the risk of diarrhea.
When non-steroidal anti-inflammatory drugs (NSAIDs) were given at the same time, the type of adverse events associated with xigalex was similar.
Clinical Trials:
In clinical trials, more than 15,000 patients and subjects have received at least one dose of misoprostol. Adverse reactions mainly affect the digestive system.
Diarrhea and abdominal pain are dose-dependent and usually occur early in treatment and are usually self-limiting. Rare cases of severe diarrhea leading to severe dehydration.
Incidence] The characteristics of 1% adverse reactions are similar to those in the short-to-medium term (lasting 4 to 12 weeks) and long-term (up to 1 year) clinical trials.
Several studies have demonstrated the safety of long-term (more than 12 weeks) misoprostol treatment, in which patients have continued to receive misoprostol for up to 1 year. Safety includes no adverse or abnormal changes in gastric morphology as determined by a gastric biopsy.

Misoprostol taboo

Misoprostol is contraindicated in the following patients:
-Prohibited in pregnant women or women who cannot rule out pregnancy, or women who are planning to become pregnant. Misoprostol can increase uterine tension and contraction during pregnancy and may cause incomplete or complete abortion of the fetus. Use in pregnancy is associated with birth defects.
Persons who are allergic to misoprostol or any other component of this product or other prostaglandins.

Precautions for misoprostol tablets

[u] Warning: [/ u]
Fertile women should not receive misoprostol until pregnancy is ruled out, and they should be fully informed about the importance of effective contraception during treatment. If pregnancy is suspected, stop using this product.
We recommend that such patients use this product only in the following situations:
-Take effective contraceptive measures.
-The risk of pregnancy is known (see [Contraindications]).
[u] Note: [/ u]
Gastrointestinal bleeding, ulcers, and perforations may occur in patients receiving NSAID. Even in the absence of gastrointestinal symptoms, doctors and patients need to be alert to the occurrence of ulcers, and under appropriate conditions, endoscopy and biopsy should be performed before using this product to ensure that the upper digestive tract is not malignant Lesions. These tests, and any other tests deemed necessary by the clinician, should be repeated at appropriate intervals for follow-up.
Symptoms are relieved after treatment with misoprostol and the possibility of malignant gastric disease cannot be ruled out.
For patients with diarrhea-prone factors such as inflammatory bowel disease, to reduce the risk of diarrhea, misoprostol should be taken with food, and magnesium-containing antacids should be avoided.
For patients at risk of dehydration; close monitoring should be performed.
The results of clinical studies show that this product does not cause hypotension at doses that can effectively promote the healing of gastric and duodenal ulcers. However, this product should be used with caution when the patient is in a situation where hypotension may cause serious complications, such as cerebrovascular disease, coronary artery disease, or severe peripheral vascular disease (including hypertension).
In healthy volunteers and diabetic patients, this product has not been found to have an adverse effect on sugar metabolism.
[u] Impact on the ability to drive vehicles and manipulate machines [/ u]
Misoprostol can cause dizziness. The patient should handle the machine carefully or drive the vehicle.

Misoprostol tablets for pregnant and lactating women

Pregnancy < br Misoprostol is contraindicated in pregnant women, as this product can cause uterine contractions and is associated with abortion, premature birth, fetal death and birth defects. Exposure to misoprostol in early pregnancy results in a significantly increased risk of two birth defects; Mobius syndrome, 6th, 7th cranial nerve palsy, and lateral limb lateral defects. Other observed defects include joint contractures.
Lactation period < br In the mother, misoprostol is rapidly metabolized to bioactive misoprostol, which can be secreted by milk. Women who are breastfeeding should not use misoprostol because the misoprostol secreted by milk can cause adverse reactions such as diarrhea in breastfed infants.

Misoprostol tablets for children

The use of misoprostol in children has not been evaluated.

Misoprostol tablets for elderly

The safety profile of misoprostol in patients aged 65 years or older was not significantly different compared to younger patients.

Misoprostol tablets drug interactions

Rarely, NSAIDs with misoprostol lead to elevated aminotransferase levels and peripheral edema.
This product is mainly metabolized by fatty acid oxidation system and has no adverse effects on liver P450 enzyme system. No clinically significant pharmacokinetic interactions were found when combined with antipyrine or diazepam. When misoprostol was given multiple times, a certain increase in propranolol concentration was observed (AUC increased by about 20% on average and Cmax increased by about 30% on average). Large-scale clinical studies have not found drug-drug interactions caused by this product. Studies of the interaction of misoprostol with several NSAIDs have shown that misoprostol has no clinically significant pharmacokinetics for ibuprofen, diclofenac, piroxicam, aspirin, naproxen, or indomethacin influences.
The simultaneous use of magnesium-containing antacids should be avoided during misoprostol treatment, as this may exacerbate the diarrhea caused by misoprostol.

Misoprostol overdose

[u] Signs and symptoms of drug overdose [/ u]
The poisoning dose of misoprostol in humans is unknown. Clinical signs that may indicate overdose include sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia.
[u] Treatment of drug overdose [/ u]
Because misoprostol is metabolized like fatty acids, dialysis is not a suitable method for treating drug overdose. When overdose occurs, standard supportive care should be used as needed.
In clinical studies, patients could tolerate a daily dose of 1.2 mg for 3 months without significant adverse effects.

Misoprostol tablets pharmacology and toxicology

This product is an analogue of natural prostaglandin E1, which can promote the healing of peptic ulcer or relieve symptoms. This product protects the stomach and duodenal mucosa by inhibiting the secretion of basic, irritating and nocturnal gastric acids, reducing the amount of gastric acid secretion, reducing the proteolytic enzyme activity of gastric juice, and increasing the secretion of bicarbonate and mucus .
In animal experiments (dogs, rats, mice) with single and multiple doses several times the clinically recommended therapeutic dose, the results of toxicological studies are consistent with the known pharmacological effects of prostaglandin E. The main symptoms are diarrhea, vomiting, dilated pupils, tremor, and high fever. It has also been found to cause gastric mucosal hyperplasia in dogs, rats, and mice. Rats and dogs discontinued after one year of administration and the proliferation was reversible. A gastric histological biopsy was performed on patients 1 year after taking the drug, and no adverse tissue changes were found. No important findings were found in the reproductive, teratogenic, and perinatal toxicology studies of rats and rabbits. When the dose exceeds 100 times the human dose, it is found that the implantation rate is reduced and the development of the pups is delayed. It can be concluded that misoprostol has no significant effect on reproduction, no teratogenicity and embryo toxicity, and does not affect the development of rat pups before and after perinatal period.
Misoprostol was negative in a group of studies that evaluated the potential for mutagenesis by six in vitro analyses and one in vivo test. Carcinogenicity studies in rats and mice have shown no carcinogenic risk.

Pharmacokinetics of misoprostol tablets

This product is quickly absorbed after oral administration, and the blood concentration of its active metabolite (misoprostol) reaches a peak after 30 minutes. The plasma clearance half-life of misoprostol is 20-40 minutes. Repeated administration, 0.4 mg each time, twice daily, no accumulation of active metabolites in plasma was found.

Misoprostol Tablets Storage

Store in a dry place below 30 ° C.

Misoprostol tablets packaging

Cold-formed foam board, 28 pieces / box, 30 pieces / box, 120 pieces / box.

Misoprostol tablet expiration date

36 months.

Misoprostol tablets perform the standard

Import drug registration standard JX19990198. ^[1]