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Indula Tablet Misoprostol 200 mcg
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Antiulcerant Indication: Misoprostol is indicated for reducing the risk of NSAID (nonsteroidal anti-inflammatory drugs, including aspirin) induced gastric ulcers in patients at high risk of complications from gastric ulcer, eg, the elderly and patients with concomitant debilitating disease, as well as patients at high risk of developing gastric ulceration, such as patients with a history of ulcer. Misoprostol has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprostol should be taken for the duration of NSAID therapy. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.
Gynecological Indication: Labor induction (in unfavorable cervical conditions) and In the prevention & treatment of Postpartum Hemorrhage (PPH).
Drugs acting on the Uterus, Prostaglandin analogues
Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Misoprostol acid are diminished when the dose is taken with food and total availability of Misoprostol acid is reduced by use of concomitant antacid. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 mcg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.
Dosage & Administration
Anti-ulcerant dosage & administration:
- The recommended adult oral dose for reducing the risk of NSAID-induced gastric ulcers: 200 mcg Misoprostol four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol should be taken with a meal, and the last dose of the day should be at bedtime.
- Renal impairment: Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200 mcg dose is not tolerated.
Gynecological dosage & administration-
- Induction of Labor: 25 mcg vaginally 6 hourly or 50 mcg orally 4 hourly.
- Postpartum Hemorrhage (PPH) prophylaxis: 400 mcg to 600 mcg orally or rectally immediately following delivery of the child.
- Postpartum Hemorrhage (PPH) treatment: 1000 mcg rectally or, 200 mcg orally with 400 mcg sublingually.
There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary and CNS drugs and NSAIDs. Bioavailability of Misoprostol is decreased with high doses of antacid.
Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.
Gastrointestinal: GI disorders had the highest reported incidence of adverse events for patients receiving this preparation. It can cause more abdominal pain, diarrhea and other GI symptoms. The incidence of diarrhea can be minimized by administering it with food and by avoiding co administration with magnesium-containing antacids.
Gynecological: Gynecological disorders such as spotting, cramps, hypermenorrhea, menstrual disorder and dysmenorrhea have been reported. Postmenopausal vaginal bleeding may be related to Misoprostol administration.
Elderly: Overall, there were no significant differences in the safety profile in patients 65 years of age or older compared with younger patients.
Pregnancy & Lactation
Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID.
In such patients, it may be prescribed if the patient:
- Has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
- Is capable of complying with effective contraceptive measures.
- Has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
- Will begin it only on the second or third day of the next normal menstrual period.
Excretion of the active metabolite (Misoprostol acid) into milk is possible, but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.
Precautions & Warnings
Precaution should be taken in conditions where hypertension might precipitate severe complications (e.g. cerebrovascular and cardiovascular disease).
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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