Misoprost

What are the side effects you encounter while taking this medicine?  No   Yes

Misoprost uses

• Warnings
• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Patient information
• Misoprostol tabletas informacion para el paciente
• Misoprost reviews

WARNINGS

Misoprost ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN Misoprost WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY. (See also PRECAUTIONS, and LABOR AND DELIVERY). Misoprost SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).

PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.

Misoprost 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, Misoprost 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 Misoprost, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
• will begin Misoprost only on the second or third day of the next normal menstrual period.

DESCRIPTION

Misoprost oral tablets contain either 100 mcg or 200 mcg of Misoprost, a synthetic prostaglandin E₁ analog.

Misoprost contains approximately equal amounts of the two diastereomers presented below with their enantiomers indicated by (±):

C₂₂H₃₈O₅ M. W. 382.5

Misoprost is a water-soluble, viscous liquid chemically described as (±) methyl 11α, 16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate.

Each Misoprost tablet for oral administration contains either 100 mcg or 200 mcg of Misoprost and has the following inactive ingredients: hydrogenated vegetable oil, hypromellose, microcrystalline cellulose and sodium starch glycolate.

CLINICAL PHARMACOLOGY

Pharmacokinetics

Misoprost 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. The alpha side chain undergoes beta oxidation and the beta side chain undergoes omega oxidation followed by reduction of the ketone to give prostaglandin F analogs.

In normal volunteers, Misoprost is rapidly absorbed after oral administration with a T_max of Misoprost acid of 12 ± 3 minutes and a terminal half-life of 20–40 minutes.

There is high variability of plasma levels of Misoprost acid between and within studies but mean values after single doses show a linear relationship with dose over the range of 200-400 mcg. No accumulation of Misoprost acid was noted in multiple dose studies; plasma steady state was achieved within two days.

Maximum plasma concentrations of Misoprost acid are diminished when the dose is taken with food and total availability of Misoprost acid is reduced by use of concomitant antacid. Clinical trials were conducted with concomitant antacid, however, so this effect does not appear to be clinically important.

*Comparisons with fasting results statistically significant, p<0.05
Mean ± SD	Cmax	AUC(0-4) (pg∙hr/ml)	Tmax (min)
Fasting	811 ± 317	417 ± 135	14 ± 8
With Antacid	689 ± 315	349 ± 108*	20 ± 14
With High Fat Breakfast	303 ± 176*	373 ± 111	64 ± 79*

After oral administration of radiolabeled Misoprost, about 80% of detected radioactivity appears in urine. Pharmacokinetic studies in patients with varying degrees of renal impairment showed an approximate doubling of T_1/2, C_max, and AUC compared to normals, but no clear correlation between the degree of impairment and AUC. In subjects over 64 years of age, the AUC for Misoprost acid is increased. No routine dosage adjustment is recommended in older patients or patients with renal impairment, but dosage may need to be reduced if the usual dose is not tolerated.

Drug interaction studies between Misoprost and several nonsteroidal anti-inflammatory drugs showed no effect on the kinetics of ibuprofen or diclofenac, and a 20% decrease in aspirin AUC, not thought to be clinically significant.

Pharmacokinetic studies also showed a lack of drug interaction with antipyrine and propranolol when these drugs were given with Misoprost. Misoprost given for 1 week had no effect on the steady state pharmacokinetics of diazepam when the two drugs were administered 2 hours apart.

The serum protein binding of Misoprost acid is less than 90% and is concentration-independent in the therapeutic range.

After a single oral dose of Misoprost to nursing mothers, Misoprost acid was excreted in breast milk. The maximum concentration of Misoprost acid in expressed breast milk was achieved within 1 hour after dosing and was 7.6 pg/ml (CV 37%) and 20.9 pg/ml (CV 62%) after single 200 mcg and 600 mcg Misoprost administration, respectively. The Misoprost acid concentrations in breast milk declined to < 1 pg/ml at 5 hours post-dose.

Pharmacodynamics

Misoprost 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. Misoprost 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 Misoprost to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.

In vitro studies on canine parietal cells using tritiated Misoprost acid as the ligand have led to the identification and characterization of specific prostaglandin receptors. Receptor binding is saturable, reversible, and stereospecific. The sites have a high affinity for Misoprost, for its acid metabolite, and for other E type prostaglandins, but not for F or I prostaglandins and other unrelated compounds, such as histamine or cimetidine. Receptor-site affinity for Misoprost correlates well with an indirect index of antisecretory activity. It is likely that these specific receptors allow Misoprost taken with food to be effective topically, despite the lower serum concentrations attained.

Misoprost produces a moderate decrease in pepsin concentration during basal conditions, but not during histamine stimulation. It has no significant effect on fasting or postprandial gastrin nor on intrinsic factor output.

Effects on Gastric Acid Secretion

Misoprost, over the range of 50–200 mcg, inhibits basal and nocturnal gastric acid secretion, and acid secretion in response to a variety of stimuli, including meals, histamine, pentagastrin, and coffee. Activity is apparent 30 minutes after oral administration and persists for at least 3 hours. In general, the effects of 50 mcg were modest and shorter lived, and only the 200-mcg dose had substantial effects on nocturnal secretion or on histamine and meal-stimulated secretion.

Uterine Effects

Misoprost has been shown to produce uterine contractions that may endanger pregnancy.

Other Pharmacologic Effects

Misoprost does not produce clinically significant effects on serum levels of prolactin, gonadotropins, thyroid-stimulating hormone, growth hormone, thyroxine, cortisol, gastrointestinal hormones (somatostatin, gastrin, vasoactive intestinal polypeptide, and motilin), creatinine, or uric acid. Gastric emptying, immunologic competence, platelet aggregation, pulmonary function, or the cardiovascular system are not modified by recommended doses of Misoprost.

Clinical Studies

In a series of small short-term placebo-controlled studies in healthy human volunteers, doses of Misoprost were evaluated for their ability to reduce the risk of NSAID-induced mucosal injury. Studies of 200 mcg q.i.d. of Misoprost with tolmetin and naproxen, and of 100 and 200 mcg q.i.d. with ibuprofen, all showed reduction of the rate of significant endoscopic injury from about 70–75% on placebo to 10–30% on Misoprost. Doses of 25–200 mcg q.i.d. reduced aspirin-induced mucosal injury and bleeding.

Reducing the Risk of Gastric Ulcers Caused by Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Two 12-week, randomized, double-blind trials in osteoarthritic patients who had gastrointestinal symptoms but no ulcer on endoscopy while taking an NSAID compared the ability of 200 mcg of Misoprost, 100 mcg of Misoprost, and placebo to reduce the risk of gastric ulcer (GU) formation. Patients were approximately equally divided between ibuprofen, piroxicam, and naproxen, and continued this treatment throughout the 12 weeks. The 200-mcg dose caused a marked, statistically significant reduction in gastric ulcers in both studies. The lower dose was somewhat less effective, with a significant result in only one of the studies.

*Statistically significantly different from placebo at the 5% level **Combined data from Study No. 1 and Study No. 2
	Therapy Duration
Therapy	4 weeks	8 weeks	12 weeks
Study No. 1
Misoprost 200 mcg q.i.d. (n=74)	1 (1.4)	0	0	1 (1.4)*
Misoprost 100 mcg q.i.d. (n=77)	3 (3.9)	1 (1.3)	1 (1.3)	5 (6.5)*
Placebo (n=76)	11 (14.5)	4 (5.3)	4 (5.3)	19 (25)
Study No. 2
Misoprost 200 mcg q.i.d. (n=65)	1 (1.5)	1 (1.5)	0	2 (3.1)*
Misoprost 100 mcg q.i.d. (n=66)	2 (3.0)	2 (3.0)	1 (1.5)	5 (7.6)
Placebo (n=62)	6 (9.7)	2 (3.2)	3 (4.8)	11 (17.7)
Studies No. 1 & No. 2**
Misoprost 200 mcg q.i.d. (n=139)	2 (1.4)	1 (0.7)	0	3 (2.2)*
Misoprost 100 mcg q.i.d. (n=143)	5 (3.5)	3 (2.1)	2 (1.4)	10 (7)*
Placebo (n=138)	17 (12.3)	6 (4.3)	7 (5.1)	30 (21.7)

In these trials there were no significant differences between Misoprost and placebo in relief of day or night abdominal pain. No effect of Misoprost in reducing the risk of duodenal ulcers was demonstrated, but relatively few duodenal lesions were seen.

In another clinical trial, 239 patients receiving aspirin 650–1300 mg q.i.d. for rheumatoid arthritis who had endoscopic evidence of duodenal and/or gastric inflammation were randomized to Misoprost 200 mcg q.i.d. or placebo for 8 weeks while continuing to receive aspirin. The study evaluated the possible interference of Misoprost on the efficacy of aspirin in these patients with rheumatoid arthritis by analyzing joint tenderness, joint swelling, physician’s clinical assessment, patient’s assessment, change in ARA classification, change in handgrip strength, change in duration of morning stiffness, patient’s assessment of pain at rest, movement, interference with daily activity, and ESR. Misoprost did not interfere with the efficacy of aspirin in these patients with rheumatoid arthritis.

INDICATIONS AND USAGE

Misoprost tablets are 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, e.g., 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. Misoprost has not been shown to reduce the risk of duodenal ulcers in patients taking NSAIDs. Misoprost should be taken for the duration of NSAID therapy. Misoprost has been shown to reduce the risk of gastric ulcers in controlled studies of 3 months’ duration. It had no effect, compared to placebo, on gastrointestinal pain or discomfort associated with NSAID use.

CONTRAINDICATIONS

See boxed WARNINGS. Misoprost should not be taken by pregnant women to reduce the risk of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs).

Misoprost should not be taken by anyone with a history of allergy to prostaglandins.

WARNINGS

See boxed WARNINGS.

PRECAUTIONS

Caution should be employed when administering Misoprost to patients with pre-existing cardiovascular disease.

Information for Patients

Women of childbearing potential using Misoprost to decrease the risk of NSAID-induced ulcers should be told that they must not be pregnant when Misoprost therapy is initiated, and that they must use an effective contraception method while taking Misoprost.

See boxed WARNINGS.

Misoprost is intended for administration along with nonsteroidal anti-inflammatory drugs, including aspirin, to decrease the chance of developing an NSAID-induced gastric ulcer.

Misoprost should be taken only according to the directions given by a physician.

If the patient has questions about or problems with Misoprost, the physician should be contacted promptly.

THE PATIENT SHOULD NOT GIVE Misoprost TO ANYONE ELSE. Misoprost has been prescribed for the patient’s specific condition, may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant.

The Misoprost package the patient receives from the pharmacist will include a leaflet containing patient information. The patient should read the leaflet before taking Misoprost and each time the prescription is renewed because the leaflet may have been revised.

Keep Misoprost out of the reach of children.

SPECIAL NOTE FOR WOMEN: Misoprost may cause abortion (sometimes incomplete), premature labor, or birth defects if given to pregnant women.

Misoprost is available only as a unit-of-use package that includes a leaflet containing patient information. See PATIENT INFORMATION at the end of this labeling.

Drug Interactions

See CLINICAL PHARMACOLOGY. Misoprost has not been shown to interfere with the beneficial effects of aspirin on signs and symptoms of rheumatoid arthritis. Misoprost does not exert clinically significant effects on the absorption, blood levels, and antiplatelet effects of therapeutic doses of aspirin. Misoprost has no clinically significant effect on the kinetics of diclofenac or ibuprofen.

Animal Toxicology

A reversible increase in the number of normal surface gastric epithelial cells occurred in the dog, rat, and mouse. No such increase has been observed in humans administered Misoprost for up to 1 year.

An apparent response of the female mouse to Misoprost in long-term studies at 100 to 1000 times the human dose was hyperostosis, mainly of the medulla of sternebrae. Hyperostosis did not occur in long-term studies in the dog and rat and has not been seen in humans treated with Misoprost.

Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of an effect of Misoprost on tumor occurrence or incidence in rats receiving daily doses up to 150 times the human dose for 24 months. Similarly, there was no effect of Misoprost on tumor occurrence or incidence in mice receiving daily doses up to 1000 times the human dose for 21 months. The mutagenic potential of Misoprost was tested in several in vitro assays, all of which were negative.

Misoprost, when administered to breeding male and female rats at doses 6.25 times to 625 times the maximum recommended human therapeutic dose, produced dose-related pre- and post-implantation losses and a significant decrease in the number of live pups born at the highest dose. These findings suggest the possibility of a general adverse effect on fertility in males and females.

Pregnancy

Pregnancy Category X

Teratogenic effects

See boxed WARNINGS. Congenital anomalies sometimes associated with fetal death have been reported subsequent to the unsuccessful use of Misoprost as an abortifacient, but the drug’s teratogenic mechanism has not been demonstrated. Several reports in the literature associate the use of Misoprost during the first trimester of pregnancy with skull defects, cranial nerve palsies, facial malformations, and limb defects.

Misoprost is not fetotoxic or teratogenic in rats and rabbits at doses 625 and 63 times the human dose, respectively.

Nonteratogenic effects

See boxed WARNINGS. Misoprost may endanger pregnancy and thereby cause harm to the fetus when administered to a pregnant woman. Misoprost may produce uterine contractions, uterine bleeding, and expulsion of the products of conception. Abortions caused by Misoprost may be incomplete. If a woman is or becomes pregnant while taking this drug to reduce the risk of NSAID induced ulcers, the drug should be discontinued and the patient apprised of the potential hazard to the fetus.

Labor and Delivery

Misoprost can induce or augment uterine contractions. Vaginal administration of Misoprost, outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony. A major adverse effect of the obstetrical use of Misoprost is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported.

There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher doses of Misoprost, including the manufactured 100 mcg tablet. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.

The effect of Misoprost on the later growth, development, and functional maturation of the child when Misoprost is used for cervical ripening or induction of labor have not been established.

Information on misoprostol’s effect on the need for forceps delivery or other intervention is unknown.

Nursing Mothers

Misoprost is rapidly metabolized in the mother to Misoprost acid, which is biologically active and is excreted in breast milk. There are no published reports of adverse effects of Misoprost in breast-feeding infants of mothers taking Misoprost. Caution should be exercised when Misoprost is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of Misoprost in pediatric patients have not been established.

ADVERSE REACTIONS

The following have been reported as adverse events in subjects receiving Misoprost:

Gastrointestinal

In subjects receiving Misoprost 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14–40% and in all studies averaged 13%. Abdominal pain occurred in 13–20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo.

Diarrhea was dose related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of Misoprost (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if Misoprost is prescribed. The incidence of diarrhea can be minimized by administering after meals and at bedtime, and by avoiding coadministration of Misoprost with magnesium-containing antacids.

Gynecological

Women who received Misoprost during clinical trials reported the following gynecological disorders: spotting (0.7%), cramps (0.6%), hypermenorrhea (0.5%), menstrual disorder (0.3%) and dysmenorrhea (0.1%). Postmenopausal vaginal bleeding may be related to Misoprost administration. If it occurs, diagnostic workup should be undertaken to rule out gynecological pathology. (see boxed WARNINGS).

Elderly

There were no significant differences in the safety profile of Misoprost in approximately 500 ulcer patients who were 65 years of age or older compared with younger patients.

Additional adverse events which were reported are categorized as follows:

Incidence Greater Than 1%

In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving Misoprost and may be causally related to the drug: nausea, flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidences of these events for Misoprost and placebo.

Causal Relationship Unknown

The following adverse events were infrequently reported. Causal relationships between Misoprost and these events have not been established but cannot be excluded:

Body as a whole

Aches/pains, asthenia, fatigue, fever, chills, rigors, weight changes

Skin

Rash, dermatitis, alopecia, pallor, breast pain

Special senses

Abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache

Respiratory

Upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis

Cardiovascular

Chest pain, edema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope, myocardial infarction, thromboembolic events (e.g., pulmonary embolism, arterial thrombosis, and CVA).

Gastrointestinal

GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase

Hypersensitivity

Anaphylaxis

Metabolic

Glycosuria, gout, increased nitrogen, increased alkaline phosphatase

Genitourinary

Polyuria, dysuria, hematuria, urinary tract infection

Nervous System/Psychiatric

Anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion

Musculoskeletal

Arthralgia, myalgia, muscle cramps, stiffness, back pain

Blood/Coagulation

Anemia, abnormal differential, thrombocytopenia, purpura, ESR increased

OVERDOSAGE

The toxic dose of Misoprost in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported.

In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive therapy.

It is not known if Misoprost acid is dialyzable. However, because Misoprost is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.

DOSAGE AND ADMINISTRATION

The recommended adult oral dose of Misoprost for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used.. Misoprost should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprost 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. (See CLINICAL PHARMACOLOGY).

HOW SUPPLIED

Misoprost Tablets, 100 mcg are available as white, round, unscored, flat beveled-edged tablets, debossed with “4430” on one side and

and “100” on the reverse side, containing 100 mcg Misoprost, packaged in unit-of-use bottles of 60 and 120 tablets.

Misoprost Tablets, 200 mcg are available as white, round, scored, flat beveled-edged tablets, debossed with “4431” on one side and

and “200” on the reverse side, containing 200 mcg Misoprost, packaged in unit-of-use bottles of 60 and 100 tablets.

PHARMACIST: Dispense in this unit-of-use, child-resistant container as defined in the USP.

Provide Patient Information Leaflet with each dispensing.

Store at 20° to 25°C (68° to 77°F) in a dry area.

NOTE: The Spanish text follows the English text.

El texto español sigue al texto inglés.

Pharmacist - Detach here and give lower portion to patient.

PATIENT INFORMATION

Read this leaflet before taking Misoprost and each time your prescription is renewed, because the leaflet may be changed.

Misoprost is being prescribed by your doctor to decrease the chance of getting stomach ulcers related to the arthritis/pain medication that you take.

Do not take Misoprost to reduce the risk of NSAID induced ulcers if you are pregnant (See boxed WARNINGS). Misoprost can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Misoprost has been reported to cause the uterus to rupture (tear) when given after the eighth week of pregnancy. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.

If you become pregnant during Misoprost therapy, stop taking Misoprost and contact your physician immediately. Remember that even if you are on a means of birth control it is still possible to become pregnant. Should this occur, stop taking Misoprost and contact your physician immediately.

Misoprost may cause diarrhea, abdominal cramping, and/or nausea in some people. In most cases these problems develop during the first few weeks of therapy and stop after about a week. You can minimize possible diarrhea by making sure you take Misoprost with food.

Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take Misoprost. If you have prolonged difficulty (more than 8 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor.

Take Misoprost only according to the directions given by your physician.

Do not give Misoprost to anyone else. It has been prescribed for your specific condition, may not be the correct treatment for another person, and would be dangerous if the other person were pregnant.

This information sheet does not cover all possible side effects of Misoprost. This patient information leaflet does not address the side effects of your arthritis/pain medication. See your doctor if you have questions.

Keep out of reach of children.

Misoprost TABLETAS INFORMACION PARA EL PACIENTE

Lea esta hoja informativa antes de tomar Misoprost y cada vez que renueve su receta porque puede haber cambios.

Su médico le ha recetado Misoprost para disminuir la posibilidad de adquirir úlceras estomacales relacionadas con la medicina que usted toma para la artritis/dolor.

Para evitar el riesgo de úlceras inducidas por AINE, no tome Misoprost durante el período de embarazo (consulte los cuadros de ADVERTENCIAS). Misoprost puede provocar abortos (algunas veces incompletos, dando lugar a hemorragias peligrosas que pueden requerir hospitalización y cirugía), partos prematuros o malformaciones del feto. Es importante evitar quedarse embarazada durante el tratamiento con este medicamento y durante un mínimo de un mes o un ciclo menstrual después de dejar de tomarlo.

Misoprost ha sido asociado a desgarros uterinos al tomarlo después de la octava semana de embarazo. El desgarro del útero puede producir graves hemorragias, histerectomía y/o muerte de la madre o del feto.

Si usted queda embarazada durante el tratamiento con Misoprost, deje de tomarlo y avise inmediatamente al médico. Recuerde que si usted emplea algún medio anticonceptivo, existe la posibilidad de que quede embarazada. Si esto ocurriera, deje de tomar Misoprost y avise inmediatamente al médico.

En algunas personas, Misoprost puede causar diarrea, calambres abdominales y/o náuseas. En la mayoría de los casos, estos problemas se presentan durante las primeras semanas del tratamiento y desaparecen después de una semana. Usted puede disminuir al mínimo la posibilidad de diarrea si toma Misoprost con los alimentos.

Como estos efectos secundarios generalmente son de leves a moderados y usualmente desaparecen en unos días, muchos pacientes pueden continuar tomando Misoprost. Si usted sigue teniendo dificultad prolongada (más de 8 días), o si tiene diarrea grave, calambres y/o náuseas, llame al médico.

Tome Misoprost siguiendo las instrucciones de su médico sólamente.

No dé Misoprost a nadie más. Ha sido recetado para su padecimiento específico y puede no ser el tratamiento adecuado para otra persona. También pudiera ser peligroso si la otra persona quedara embarazada.

Esta hoja informativa no cubre todos los posibles efectos secundarios de Misoprost. Esta hoja informativa para el paciente no se refiere a todos los efectos secundarios de su medicina para la artritis/dolor. Si tiene alguna pregunta, llame a su médico.

Manténgase fuera del alcance de los niños.

Rev. A 10/2009

Manufactured In Ireland By:

IVAX PHARMACEUTICALS IRELAND

Waterford, Ireland

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Misoprost 200mcg Tablet

Misoprost structure Company logo Company logo

Misoprost pharmaceutical active ingredients containing related brand and generic drugs:

• Misoprostol

Misoprost available forms, composition, doses:

• Tablets; Oral; Misoprostol 0.025 mg
• Tablets; Oral; Misoprostol 0.1 mg
• Tablets; Oral; Misoprostol 0.2 mg

Misoprost destination | category:

• Human:
• Antacids, antireflux agents and antiulcerants
• Drugs acting on the uterus
• Prostaglandins

Misoprost Anatomical Therapeutic Chemical codes:

• A02BB01 - Misoprostol
• G02AD06 - Misoprostol

Misoprost pharmaceutical companies:

• Cipla

References

1. Dailymed."MISOPROSTOL TABLET [BRYANT RANCH PREPACK]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."MISOPROSTOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "misoprostol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Misoprost?

Depending on the reaction of the Misoprost after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Misoprost not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Misoprost addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Misoprost, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Misoprost consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

Visitor reviews

There are no reviews yet. Be the first to write one!

Your name:  Email:  Spam protection:  < Type 14 here

The information was verified by Dr. Rachana Salvi, MD Pharmacology