Zitotec Tablet
Misoprostol
25mcg
Sun Pharmaceutical Industries Ltd.
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Available as:
Indications
Zitotec Tablet is used for:
NSAID-induced ulcers, Termination of pregnancy, Benign gastric and duodenal ulcers
Adult Dose
NSAID-Induced Ulcer
Adult: Benign gastric and duodenal ulceration and NSAID associated ulceration:
800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.
Prophylaxis of NSAID induced gastric and duodenal ulcer:
200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy
Induction of labor:
100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100- 200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6.
Termination of pregnancy
Day 1: 200 mg of mifepristone PO as a single dose under physician supervision
Days 2-3: 800 mcg of misoprostol buccally once as a single dose; must be administered a minimum of 24-hr and a maximum of 48-hr following mifeprostone dose on day 1
Days 7-14
Must return for follow-up visit to confirm complete termination has occurred by medical history, clinical examination, hCG testing, or ultrasonographic scan
If complete expulsion has not occurred, but the pregnancy is not ongoing, women may be treated with another dose of misoprostol 800 mcg buccally with follow-up in ~7 days
Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion
Surgical evacuation is recommended to manage ongoing pregnancies after medical abortion
Prevention of postpartum haemorrhage:
600 mcg orally immediately following delivery.
Child Dose
Renal Dose
Renal impairment: Use with caution; peak plasma concentration, half-life, and bioavailability may be increased, but it is not clear whether these increases are of clinical relevance
Administration
Should be taken with food.
Contra Indications
Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins. Women of childbearing potential. Pregnancy and lactation.
Precautions
In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol. Conditions where hypotension might precipitate severe complications e.g. cerebrovascular or CV disease. Inflammatory bowel disease. Patients prone to dehydration. Elderly. Renal impairment.
Lactation: Drug is rapidly metabolized in mother to misoprostol acid, which is biologically active and is excreted in breast milk; although no published reports of adverse effects of misoprostol in breast-feeding infants exist, caution should be exercised when misoprostol is administered to breastfeeding women
Pregnancy-Lactation
Interactions
May increase effects of oxytocin. Increased risk of misoprostol-induced diarrhoea with magnesium-containing antacids.
Adverse Effects
Side effects of Misoprostol :
>10%
Diarrhea (14-40%),Abdominal pain (13-20%)
1-10%
Headache (2%)
Frequency Not Defined
Anaphylaxis,Anemia,Cardiac dysrhythmia,Chest pain,Flatulence,Gastrointestinal hemorrhage,Hearing loss,Myocardial infarction,Nausea
Rupture of uterus,Thromboembolic disorder
Mechanism of Action
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.
Note
Zitotec 25mcg Tablet manufactured by Sun Pharmaceutical Industries Ltd.. Its generic name is Misoprostol. Zitotec is availble in Nepal.
Farmaco Nepal drug index information on Zitotec Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.