Vagiprost
Overview
Vagiprost
Ovules, 25 mcg
COMPOSITION
Each ovule contains the active substance misoprostol 25 mcg.
Excipient: semi-synthetic solid glycerides.
WHAT IT IS USED FOR
A gynaecological medicine (a synthetic analogue of prostaglandin E1) used for cervical ripening and induction of labour:
in pregnancy at or near term, for maternal or fetal indications;
in pregnant women with prolonged pregnancy;
in antenatal fetal death.
It is used only in a hospital setting, under the supervision of medical staff.
HOW IT WORKS
Misoprostol prepares the cervix (helping it to open) and stimulates uterine contractions, inducing labour. After vaginal administration, the increase in uterine tone begins after about 20 minutes.
HOW TO USE
Administered vaginally, exclusively by medical staff, in hospital. One ovule every 4–6 hours for 24 hours; if needed, administration may be repeated after 24 hours. Before administration, the match between the dimensions of the pelvis and the fetus is assessed, and during treatment the uterine activity, cervix and condition of the fetus are closely monitored.
Safety and efficacy in pregnant adolescents under 18 years have not been established.
WHEN IT SHOULD NOT BE USED
hypersensitivity to misoprostol or to any of the excipients;
multiple pregnancy; a history of multiparity;
previous caesarean section or other uterine surgery;
a history of difficult or traumatic deliveries or fetal distress;
chronic fetal hypoxia, fetal heart rhythm disturbances, cephalopelvic disproportion, abnormal fetal position or abnormal development of the fetal skull;
placenta praevia, vaginal bleeding of unidentified origin;
genital tract infections; a history of pelvioperitonitis;
rupture of the amniotic sac;
severe heart, kidney, liver or lung disease;
obstetric situations in which surgical intervention is preferable.
Important to know
The medicine is used exclusively in hospital, as it may over-stimulate the uterus and increase the risk of uterine rupture; for this reason, uterine activity and the condition of the fetus are closely monitored. Use with particular caution in pregnant women with glaucoma or raised intraocular pressure, bronchial asthma, hypertension, cardiovascular disease, epilepsy, or liver or kidney impairment.
Non-steroidal anti-inflammatory medicines (including acetylsalicylic acid) may theoretically reduce the effect, and magnesium-containing antacids may worsen diarrhoea. This material is for information; treatment decisions are made by the doctor. Always read the package leaflet.
Possible side effects
In the mother – common: nausea, vomiting, diarrhoea, back pain, a sensation of warmth in the vagina; uncommon: headache, hot flushes, pain; very rare: hypersensitivity reactions, respiratory disturbances, excessive uterine contractions (hypertonus) or uterine rupture.
In the fetus/newborn – rare: fetal distress and changes in heart rate due to uterine hyperstimulation, acidosis, a low condition of the newborn.
Medical staff monitor for any adverse reactions during administration.
STORAGE
Store below 25 °C. Do not freeze. Keep out of the reach of children. Shelf life: 36 months.
QUESTIONS AND CONTACTS
For questions about the medicine, please consult your doctor or pharmacist. Manufacturer: FARMAPRIM SRL, 5 Crinilor str., Porumbeni village, Criuleni district, Republic of Moldova, MD-4829. Pharmacovigilance: safety@farmaprim.md.
Brief information prepared on the basis of the approved Summary of Product Characteristics. It does not replace consultation with a doctor or pharmacist and does not contain all information about the medicine. Always read the package leaflet.