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PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO
GIVE THE DRUG TO OTHERS.
Cytotec 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,
Cytotec 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 Cytotec only on the second or third day of the next
normal menstrual period.
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Sallam dalam kasih,
Drug Description
*Cytotec® *(misoprostol) Tablets
*WARNINGS*
*CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN
CAUSE ABORTION,
PREMATURE BIRTH,
OR BIRTH DEFECTS.
*
* UTERINE RUPTURE
*
*HAS BEEN REPORTED WHEN CYTOTEC 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). CYTOTEC SHOULD NOT BE
TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY
NONSTEROIDAL 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.
Cytotec 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,
Cytotec 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 Cytotec only on the second or third day of the next
normal menstrual period.
DRUG DESCRIPTION
Cytotec oral tablets contain either 100 mcg or 200 mcg of misoprostol, a
synthetic prostaglandin E_1 analog.
Misoprostol contains approximately equal amounts of the two
diastereomers presented below with their enantiomers indicated by (±):
Cytotec (misoprostol) structural formula illustration
Misoprostol is a water-soluble, viscous liquid.
Inactive ingredients of tablets are hydrogenated castor oil,
hypromellose, microcrystalline cellulose, and sodium starch glycolate.
INDICATIONS
Cytotec (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, 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. Cytotec has not
been shown to reduce the risk of duodenal ulcers in patients taking
NSAIDs. Cytotec should be taken for the duration of NSAID therapy.
Cytotec 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.
DOSAGE AND ADMINISTRATION
The recommended adult oral dose of Cytotec 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. (See
*CLINICAL PHARMACOLOGY*: *Clinical studies*.) Cytotec should be taken
for the duration of NSAID therapy as prescribed by the physician.
Cytotec 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
Cytotec 100-mcg tablets are white, round, with SEARLE debossed on one
side and 1451 on the other side; supplied as:
*NDC Number Size*
0025-1451-60 unit-of-use bottle of 60
0025-1451-20 unit-of-use bottle of 120
0025-1451-34 carton of 100 unit dose
Cytotec 200-mcg tablets are white, hexagonal, with SEARLE debossed above
and 1461 debossed below the line on one side and a double stomach
debossed on the other side; supplied as:
*NDC Number Size*
0025-1461-60 unit-of-use bottle of 60
0025-1461-31 unit-of-use bottle of 100
0025-1461-34 carton of 100 unit dose
Store at or below 25°C (77°F), in a dry area.
Distributed by G.D. Searle, LLC
Division of Pfizer, Inc, NY, NY 10017
Revised September 2006. FDA rev date: 8/13/2003
SIDE EFFECTS
The following have been reported as adverse events in subjects receiving
Cytotec:
*Gastrointestinal*: In subjects receiving Cytotec 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 (over 5,000 patients) 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 Cytotec (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
Cytotec is prescribed. The incidence of diarrhea can be minimized by
administering after meals and at bedtime, and by avoiding
coadministration of Cytotec with magnesium-containing antacids.
*Gynecological*: Women who received Cytotec 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
Cytotec 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 Cytotec 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
Cytotec and may be causally related to the drug: nausea (3.2%),
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 Cytotec and placebo.
*Causal relationship unknown*: The following adverse events were
infrequently reported. Causal relationships between Cytotec and these
events have not been established but cannot be excluded:
*/Body as a whole/*: aches/pains, asthenia, fatigue, fever, 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 (some fatal), 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.
DRUG INTERACTIONS
See *CLINICAL PHARMACOLOGY*. Cytotec has not been shown to interfere
with the beneficial effects of aspirin on signs and symptoms of
rheumatoid arthritis. Cytotec does not exert clinically significant
effects on the absorption, blood levels, and antiplatelet effects of
therapeutic doses of aspirin. Cytotec has no clinically significant
effect on the kinetics of diclofenac or ibuprofen.
WARNINGS
See *boxed WARNINGS*.
PRECAUTIONS
Caution should be employed when administering Cytotec (misoprostol) to
patients with pre-existing cardiovascular disease.
*Information for patients*: Women of childbearing potential using
Cytotec to decrease the risk of NSAID-induced ulcers should be told that
they must not be pregnant when Cytotec therapy is initiated, and that
they must use an effective contraception method while taking Cytotec.
See *boxed WARNINGS*.
Cytotec is intended for administration along with nonsteroidal
anti-inflammatory drugs (NSAIDs), including aspirin, to decrease the
chance of developing an NSAID-induced gastric ulcer.
Cytotec should be taken only according to the directions given by a
physician.
If the patient has questions about or problems with Cytotec, the
physician should be contacted promptly.
*THE PATIENT SHOULD NOT GIVE CYTOTEC TO ANYONE ELSE*. Cytotec 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 were to become pregnant.
The Cytotec package the patient receives from the pharmacist will
include a leaflet containing patient information. The patient should
read the leaflet before taking Cytotec and each time the prescription is
renewed because the leaflet may have been revised.
Keep Cytotec out of the reach of children.
*SPECIAL NOTE FOR WOMEN: Cytotec may cause abortion (sometimes
incomplete), premature labor, or birth defects if given to pregnant women.*
Cytotec 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.
*Carcinogenesis, mutagenesis, impairment of fertility*: There was no
evidence of an effect of Cytotec 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 Cytotec on tumor occurrence or
incidence in mice receiving daily doses up to 1000 times the human dose
for 21 months. The mutagenic potential of Cytotec was tested in several
/in vitro/ assays, all of which were negative.
Misoprostol, 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 misoprostol as an abortifacient, but the drug's
teratogenic mechanism has not been demonstrated. Several reports in the
literature associate the use of misoprostol during the first trimester
of pregnancy with skull defects, cranial nerve palsies, facial
malformations, and limb defects.
Cytotec is not fetotoxic or teratogenic in rats and rabbits at doses 625
and 63 times the human dose, respectively.
*Nonteratogenic effects*: See *boxed WARNINGS*. Cytotec may endanger
pregnancy (may cause abortion) and thereby cause harm to the fetus when
administered to a pregnant woman. Cytotec may produce uterine
contractions, uterine bleeding, and expulsion of the products of
conception. Abortions caused by Cytotec 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*: Cytotec can induce or augment uterine
contractions. Vaginal administration of Cytotec, 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 Cytotec is the 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
Cytotec, 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 Cytotec on later growth, development, and functional
maturation of the child when Cytotec is used for cervical ripening or
induction of labor has not been established. Information on Cytotec's
effect on the need for forceps delivery or other intervention is unknown.
*Nursing mothers*: It is unlikely that Cytotec is excreted in human milk
since it is rapidly metabolized throughout the body. However, it is not
known if the active metabolite (misoprostol acid) is excreted in human
milk. Therefore, Cytotec should not be administered to nursing mothers
because the potential excretion of misoprostol acid could cause
significant diarrhea< in nursing infants.
*Pediatric use*: Safety and effectiveness of Cytotec in pediatric
patients have not been established.
CONTRAINDICATIONS
See *boxed WARNINGS*.
Cytotec should not be taken by pregnant women to reduce the risk of
ulcers induced by nonsteroidal anti-inflammatory drugs (NSAIDs).
*Cytotec should not be taken by anyone with a history of allergy to
prostaglandins.*
CLINICAL PHARMACOLOGY
*Pharmacokinetics*: 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. 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, Cytotec (misoprostol) is rapidly absorbed after
oral administration with a Tmax of misoprostol acid of 12 ± 3 minutes
and a terminal half-life of 20-40 minutes.
There is high variability of plasma levels of misoprostol 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
misoprostol acid was noted in multiple dose studies; plasma steady state
was achieved within two days.
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. Clinical trials were conducted
with concomitant antacid, however, so this effect does not appear to be
clinically important.
Mean ± SD Cmax(pg/ml) 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*
* Comparisons with fasting results statistically significant, p < 0.05.
After oral administration of radiolabeled misoprostol, about 80% of
detected radioactivity appears in urine. Pharmacokinetic studies in
patients with varying degrees of renal impairment showed an approximate
doubling of T½, Cmax, 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 misoprostol 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.
Cytotec does not affect the hepatic mixed function oxidase (cytochrome
P-450) enzyme systems in animals.
Drug interaction studies between misoprostol 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 misoprostol.
Misoprostol 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 misoprostol acid is less than 90% and is
concentration- independent in the therapeutic range.
*Pharmacodynamics*: 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.
/In vitro/ studies on canine parietal cells using tritiated misoprostol
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
misoprostol, 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
misoprostol correlates well with an indirect index of antisecretory
activity. It is likely that these specific receptors allow misoprostol
taken with food to be effective topically, despite the lower serum
concentrations attained.
Misoprostol 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*: Misoprostol, 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*: Cytotec has been shown to produce uterine
contractions that may endanger pregnancy. (See *boxed WARNINGS*.)
*Other pharmacologic effects*: Cytotec 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 Cytotec.
Clinical studies
In a series of small short-term (about 1 week) placebo-controlled
studies in healthy human volunteers, doses of misoprostol were evaluated
for their ability to reduce the risk of NSAID-induced mucosal injury.
Studies of 200 mcg q.i.d. of misoprostol 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 misoprostol. 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 Cytotec, 100 mcg of Cytotec, 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.
*Reduction of Risk of Gastric Ulcers Induced by Ibuprofen, Piroxicam, or
Naproxen
[No. of patients with ulcer(s) (%)]*
Therapy Therapy Duration
4 weeks 8 weeks 12 weeks
*Study No. 1*
Cytotec 200 mcg q.i.d.
(n=74) 1 (1.4) 0 0 1 (1.4)*
Cytotec 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 (25.0)
*Study No. 2*
Cytotec 200 mcg q.i.d.
(n=65) 1 (1.5) 1 (1.5) 0 2 (3.1)*
Cytotec 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***
Cytotec 200 mcg q.i.d.
(n=139) 2 (1.4) 1 (0.7) 0 3 (2.2)*
Cytotec 100 mcg q.i.d.
(n=143) 5 (3.5) 3 (2.1) 2 (1.4) 10 (7.0)*
Placebo
(n=138) 17 (12.3) 6 (4.3) 7 (5.1) 30 (21.7)
* Statistically significantly different from placebo at the 5% level.
** Combined data from Study No. 1 and Study No. 2.
In these trials there were no significant differences between Cytotec
and placebo in relief of day or night abdominal pain. No effect of
Cytotec 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 misoprostol 200 mcg
q.i.d. or placebo for 8 weeks while continuing to receive aspirin. The
study evaluated the possible interference of Cytotec 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. Cytotec did
not interfere with the efficacy of aspirin in these patients with
rheumatoid arthritis.
*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 Cytotec for up to
1 year.
An apparent response of the female mouse to Cytotec 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 Cytotec.
PATIENT INFORMATION
Read this leaflet before taking Cytotec® (misoprostol) and each time
your prescription is renewed, because the leaflet may be changed.
Cytotec (misoprostol) 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 Cytotec to reduce the risk of NSAID-induced ulcers if you
are pregnant. (See *boxed WARNINGS*.) Cytotec 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. Cytotec 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 Cytotec therapy, stop taking Cytotec 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 Cytotec and contact your physician immediately.
Cytotec 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 Cytotec 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 Cytotec. If
you have prolonged difficulty (more than 8 days), or if you have severe
diarrhea, cramping and/or nausea, call your doctor.
Take Cytotec only according to the directions given by your physician.
Do not give Cytotec 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
Cytotec. 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.
Consumer
IMPORTANT NOTE: This is a summary and does not contain all possible
information about this product. For complete information about this
product or your specific health needs, ask your health care
professional. Always seek the advice of your health care professional if
you have any questions about this product or your medical condition.
This information is not intended as individual medical advice and does
not substitute for the knowledge and judgment of your health care
professional. This information does not contain any assurances that this
product is safe, effective, or appropriate for you.
MISOPROSTOL - ORAL
(my-so-PROST-ohl)
COMMON BRAND NAME(S): Cytotec
WARNING: Do not take this medication if you think that you may be
pregnant. It may cause abortion, premature birth, or birth defects. In
rare cases, serious complications (e.g., uterine rupture) have occurred
when misoprostol was used to start labor or when used in combination
with another drug to cause abortion after the eighth week of pregnancy.
These complications have resulted in harm to the unborn baby and mother.
Avoid pregnancy while taking misoprostol and for at least one month or
one completed menstrual cycle after you have stopped treatment. If you
become pregnant while taking misoprostol, contact your doctor immediately.
If you are pregnant, do not take this medication to reduce the risk of
stomach ulcers due to aspirin or other related drugs (non-steroidal
anti-inflammatory drugs-NSAIDs such as ibuprofen). Also, if you are of
childbearing age, do not use this drug to reduce the risk of ulcers from
NSAIDs unless you are at high risk of having an ulcer or ulcer
complications.
Female patients must meet the following four requirements in order to
use this drug: 1) test negative for pregnancy within two weeks before
starting treatment; 2) use effective birth control to prevent pregnancy;
3) receive oral and written warnings on the dangers of using misoprostol
while of childbearing age and the risks of possible birth control
failure; 4) start taking misoprostol only on the second or third day of
the next normal menstrual period.
This medication must not be shared with others.
USES: This medication is used to prevent stomach ulcers while you take
NSAIDs (e.g., aspirin, ibuprofen, naproxen), especially if you are at
risk for developing ulcers or have a history of ulcers. Misoprostol
helps to decrease your risk of serious ulcer complications such as
bleeding. This medication protects your stomach lining by lowering the
amount of acid that comes in contact with it.
This medication is also used in combination with another drug
(mifepristone) to end a pregnancy (abortion).
OTHER USES: This section contains uses of this drug that are not listed
in the approved professional labeling for the drug but that may be
prescribed by your health care professional. Use this drug for a
condition that is listed in this section only if it has been so
prescribed by your health care professional.
This medication may also be used to assist with childbirth only at the
time of delivery (e.g., cervical ripening, induction of labor) and for
the treatment of severe bleeding after delivery. When misoprostol is
used vaginally for these purposes, it works by causing the womb muscles
to contract.
HOW TO USE: This medicine comes with a patient information leaflet. Read
it carefully. If you have any questions about this drug, ask your
doctor, nurse, or pharmacist.
Dosage is based on your medical condition and response to therapy.
If you are taking this drug to prevent stomach ulcers, take it by mouth
usually four times a day, after meals and at bedtime to minimize
diarrhea, or as directed by your doctor.
If you are taking this medication for abortion, take it by mouth exactly
as directed by your doctor.
If you are using this medication to start labor, your healthcare
professional will insert it into your vagina.
Avoid taking antacids that contain magnesium while using misoprostol
because they may make the diarrhea it causes worse. If you need an
antacid, consult your doctor or pharmacist to help you choose a product.
For ulcer prevention, continue to take this drug for as long as you take
NSAIDs. Use this medication regularly in order to get the most benefit
from it. Remember to use it at the same times each day.
Inform your doctor if your condition persists or worsens.
SIDE EFFECTS: Nausea or stomach cramps may occur. If any of these
effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or
she has judged that the benefit to you is greater than the risk of side
effects. Many people using this medication do not have serious side
effects.
Diarrhea is common with misoprostol and usually occurs about two weeks
after you start taking it, and lasts for about a week. Be sure to keep
up your intake of fluids and minerals/electrolytes to prevent
dehydration. Persistent diarrhea may sometimes lead to a large loss of
your body's water and minerals. Tell your doctor immediately if you
develop any of these serious signs of dehydration and mineral imbalance:
severe dizziness, decreased amount of urine, mental/mood changes, muscle
weakness, slow/irregular heartbeat.
Tell your doctor immediately if any of these unlikely but serious side
effects occur: menstrual problems or irregularities, unusual/heavy
vaginal bleeding.
A very serious allergic reaction to this drug is unlikely, but seek
immediate medical attention if it occurs. Symptoms of a serious allergic
reaction may include: rash, itching, swelling, severe dizziness, trouble
breathing.
This is not a complete list of possible side effects. If you notice
other effects not listed above, contact your doctor or pharmacist.
Contact your doctor for medical advice about side effects. The following
numbers do not provide medical advice, but in the US you may report side
effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In
Canada, you may call Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking misoprostol, tell your doctor or pharmacist
if you are allergic to it; or if you have any other allergies.
Before using this medication, tell your doctor or pharmacist your
medical history, especially of: stomach/intestinal disease (e.g.,
inflammatory bowel disease), risk factors for uterine rupture when this
drug is used vaginally (e.g., prior Cesarean delivery, uterine surgery,
five or more previous pregnancies).
Daily use of alcohol and tobacco may increase your risk for stomach
bleeding. Limit alcohol beverages and stop smoking. Consult your doctor
or pharmacist for more information.
If you are taking this medication in combination with mifepristone to
end a pregnancy, an incomplete abortion may rarely occur. It is very
important for you to be closely monitored by your doctor and to keep
your scheduled appointments to follow your progress. Be sure to have
clear instructions from your doctor about who to call and what to do in
case of an emergency. Expect vaginal bleeding after you take the
combined medicine, however tell your doctor immediately if you develop
any unlikely symptoms such as severe/prolonged vaginal bleeding, signs
of infection (e.g., fever, chills), or fainting.
This drug must not be used during pregnancy to prevent stomach ulcers
because of possible harm to an unborn baby (see also Warnings). If you
are of childbearing age, use effective birth control methods while
taking misoprostol and for at least one month or one completed menstrual
cycle after you stop taking it. If you become pregnant or think you may
be pregnant, inform your doctor immediately.
It is not known if this medication passes into breast milk.
Breast-feeding while using this medication is not recommended because it
may have undesirable effects on a nursing infant. Consult your doctor
before breast-feeding.
DRUG INTERACTIONS: See also the How to Use section.
Your healthcare professionals (e.g., doctor or pharmacist) may already
be aware of any possible drug interactions and may be monitoring you for
it. Do not start, stop or change the dosage of any medicine before
checking with them first.
Before using this medication, tell your doctor or pharmacist of all
prescription and nonprescription/herbal products you may use.
Keep a list of all your medications with you, and share the list with
your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control
center or emergency room immediately. US residents can call the US
national poison hotline at 1-800-222-1222. Canadian residents should
call their local poison control center directly. Symptoms of overdose
may include: severe drowsiness, seizures, severe dizziness,
slow/irregular heartbeats.
NOTES: Do not share this medication with others.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it
is near the time of the next dose, skip the missed dose and resume your
usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at or below 77 degrees F (25 degrees C) in a dry place
away from light and moisture. Do not store in the bathroom. Keep all
medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain
unless instructed to do so. Properly discard this product when it is
expired or no longer needed. Consult your pharmacist or local waste
disposal company for more details about how to safely discard your product.
Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.
giotona@yahoo.com wrote:
> salam sejahtra,
> Mhn maaf sebelumnya.. Saya ingin bertanya apakah ada pengaruhnya obat peluntur dengan perkembangan janin? Adik saya 7bln yg lalu sewaktu mengetahui pacarnya telat dtg bln dia mncoba meminumkan cytotec... Tapi tdk berhasil keluar. Setelah putus asa akhirnya mereka memutuskan utk menikah, mhn saya di bantu sbg pertimbangan selanjutnya. Thank you
>
>
> ------------------------------------
>
>
--
"Absolutely Drug less Health Care solution Organization"
[Non-text portions of this message have been removed]
------------------------------------
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