(mye soe prost' ole)
P / L : Contraindicated in pregnancy and lactation
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MISOPROSTOL ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE BIRTH DEFECTS, ABORTION, OR PREMATURE BIRTH. UTERINE RUPTURE HAS BEEN REPORTED WHEN MISOPROSTOL WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY. MISOPROSTOL SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs).
PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.
Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, Misoprostol may be prescribed if the patient
|Indication(s) & Dosage||
Misoprostol is indicated for the healing of duodenal ulcer and gastric ulcer including those induced by nonsteroidal anti-inflammatory drugs (NSAID) in arthritic patients at risk, whilst continuing their NSAID therapy. In addition, Misoprostol can be used for the prophylaxis of NSAID-induced ulcers.
Healing of duodenal ulcer, gastric ulcer and NSAID-induced peptic ulcer: 800 micrograms daily in two or four divided doses taken with breakfast and / or each main meal and at bedtime.
Treatment should be given initially for at least 4 weeks even if symptomatic relief has been achieved sooner. In most patients ulcers will be healed in 4 weeks but treatment may be continued for up to 8 weeks if required. If the ulcer relapses further treatment courses may be given.
Prophylaxis of NSAID-induced peptic ulcer: 200 micrograms twice daily, three times daily or four times daily. Treatment can be continued as required. Dosage should be individualised according to the clinical condition of each patient.
The usual dosage may be used.
Renal impairment: Available evidence indicates that no adjustment of dosage is necessary in patients with renal impairment.
Hepatic impairment: Misoprostol is metabolised by fatty acid oxidising systems present in organs throughout the body. Its metabolism and plasma levels are therefore unlikely to be affected markedly in patients with hepatic impairment.
Use of Misoprostol in children has not yet been evaluated in the treatment of peptic ulceration or NSAID-induced peptic ulcer disease.
|Administration||Should be taken with food.
|Overdosage||Symptoms: Sedation, tremor, convulsions, dyspnoea, abdominal pain, diarrhoea, hypotension, bradycardia. Management: Symptom-directed and supportive.|
Misoprostol is contraindicated:
- In women who are pregnant, or in whom pregnancy has not been excluded, or who are planning a pregnancy as misoprostol increases uterine tone and contractions in pregnancy which may cause partial or complete expulsion of the products of conception. Use in pregnancy has been associated with birth defects.
- In patients with a known hypersensitivity to misoprostol or to any other component of the product, or to other prostaglandins.
|Special Precautions||Conditions where hypotension might precipitate severe complications e.g. cerebrovascular or CV disease. Inflammatory bowel disease. Patients prone to dehydration. Elderly. Renal impairment.|
|Adverse Drug Reaction(s)||Diarrhoea, abdominal pain, dyspepsia, constipation, flatulence, nausea and vomiting; abnormal vaginal bleeding, cramps, increased uterine contractility, headache.|
|Drug Interactions||May increase effects of oxytocin. Increased risk of misoprostol-induced diarrhoea with magnesium-containing antacids.
|Use in Pregnancy/Lactation||
Misoprostol is contraindicated in women who are pregnant because it induces uterine contractions and is associated with abortion, premature birth, foetal death and birth defects. First trimester exposure to misoprostol is associated with a significantly increased risk of two birth defects: Möbius sequence (i.e. palsies of cranial nerves VI and VII) and terminal transverse limb defects. Other defects including arthrogryposis have been observed.
The risk of uterine rupture increases with advancing gestational age and with prior uterine surgery, including Caesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.
Misoprostol is rapidly metabolised in the mother to misoprostol acid, which is biologically active and is excreted in breast milk. Misoprostol should not be administered to nursing mothers because the excretion of misoprostol acid could cause undesirable effects such as diarrhoea in nursing infants.
|Storage||Oral: Store at or below 25°C (77°F).|
|Pharmacology||Misoprostol, a synthetic prostaglandin E1 analogue, exerts its antisecretory activity by directly acting on specific prostaglandin receptors found on the surface of gastric parietal cells. It exerts its protective effects on the mucosa by replacing the prostaglandins consumed during prostaglandin-inhibiting therapies e.g. NSAIDs.
Absorption: Rapidly absorbed from the GI tract (oral). Peak plasma concentration in 15-30 mins.
Metabolism: Rapidly metabolised to misoprostol acid (active form).
Excretion: Mainly via urine. Elimination half-life: 20-40 minutes.
|ATC Classification||G02AD06 - misoprostol; Belongs to the class of prostaglandins. Used as an oxytocic.
A02BB01 - misoprostol; Belongs to the class of prostaglandins. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|CYTOMIS 100||Incepta Pharmaceuticals Limited||Misoprostol BP 100mcg Tablet||Tablet||30's: MRP 240.00|
|CYTOMIS 200||Incepta Pharmaceuticals Limited||Misoprostol 200 mcg Tablet||Tablet||30's: MRP 450.00|
|G-MISOPROSTOL||Gonoshasthaya Pharmaceuticals Ltd||Misoprostol INN 200mcg||Tablet||200mcg x30's: 301.20 MRP|
|ISOVENT 200||Square Pharmaceuticals Ltd.||Misoprostol 200 mcg||Tablet||3x10's: 453.00 MRP|
|ISOVENT 600||Square Pharmaceuticals Ltd.||Misoprostol 600 mcg||Tablet||10x1's: 401.30 MRP|
|MISOCLEAR||The Acme Laboratories Ltd.||Misoprostol INN 200mcg||Tablet||200mcg x30's: 450.00 MRP|
|MISOPA 100||Beximco Pharmaceuticals Ltd||Misoprostal BP 100mcg||Tablet||30's: 240.00 MRP|
|MISOPA 200||Beximco Pharmaceuticals Ltd||Misoprostal BP 200mcg||Tablet||30's: 450.00 MRP|
|MISOPA 600||Beximco Pharmaceuticals Ltd||Misoprostal BP 600mcg||Tablet||10's: 400.00 MRP|
Do not take misoprostol to prevent ulcers if you are pregnant or plan to become pregnant. Misoprostol may cause miscarriages, premature labor, or birth defects.
If you are a woman of childbearing age, you may take misoprostol to prevent ulcers only if you have had a negative pregnancy test in the past 2 weeks and if you use a reliable method of birth control while taking misoprostol. You must begin taking misoprostol on the second or third day of your menstrual period. If you become pregnant while taking misoprostol, stop taking it and call your doctor immediately.
Before taking misoprostol, ask your pharmacist or doctor for a copy of the manufacturer's information for the patient and read it carefully. Talk to your doctor about the risks of taking misoprostol.
Do not let anyone else take your medication, especially a woman who is or may become pregnant.
Why this medication is prescribed?
Misoprostol is used to prevent ulcers in people who take certain arthritis or pain medicines, including aspirin, that can cause ulcers. It protects the stomach lining and decreases stomach acid secretion.
How to use this medicine?
Misoprostol may come as a tablet to take by mouth. It is usually taken 4 times a day, after meals and at bedtime with food. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take misoprostol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Misoprostol must be taken regularly to be effective. Women should not take their first dose until the second or third day of their menstrual period (to be sure that they are not pregnant). Do not stop taking misoprostol without talking to your doctor.
Other uses of this medicine
Misoprostol is also used sometimes to treat ulcers and to induce labor. Misoprostol is used in combination with mifepristone to end an early pregnancy. Talk to your doctor about the possible risks of using this drug for your condition.
This medication may be prescribed for other uses; ask your doctor for more information.
What special precautions should I follow?
Before taking misoprostol,
- tell your doctor if you are allergic to misoprostol or any other drugs.
- tell your doctor what prescription and nonprescription medications you are taking, especially antacids, aspirin, arthritis medications, and vitamins.
- tell your doctor if you are breast-feeding.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Misoprostol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
If you experience any of the following symptoms, call your doctor immediately:
bloody or black, tarry stools
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
Ref: U.S. Natl. Library of Medicine
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