Vagiprost vaginal tablet is indicated for cervical softening and induction of labour, when there are no foetal or maternal contraindications. Vagiprost in larger doses could be used for cervical priming before surgical abortion, miscarriage and for evacuation of the uterus in cases of foetal death or anomaly.

Composition

Each vaginal tablet contains: Misoprostol (1% Dispersion) 2.5 mg (Equivalent to 25 µg Misoprostol).

Inactive: Mannitol D.C, microcrystalline Cellulose (Avicel pH 112), sodium metabisulphite, EDTAdi sodium, polyplasidone XL, sodium starch glycolate (Explotab), aerosil 200, magnesium stearate .

Pharmaceutical Form: White oblong vaginal tablet.

Dosage & Administration

• Most studies used Misoprostol tablets in a dose of 50 µg vaginally every 4 hours, but reported doses have varied from 25 µg every 2-3 hours (recommended by American college of Obstetricians and Gynecologists).
• In primigravid patients with unfavorable features (Bishop score of 4 or less), an initial dose of 50 µg may be administered vaginally. In other patients an initial dose of 25 µg should be administered vaginally.
• In both groups of patients, a second dose of 25 µg or 50 µg may be used after 6 hours following assessment of cervical status, myometrial contractility and foetal condition.
• 25 µg should be used in multigravid  patients where uterine activity is insufficient for satisfactory progress of labour (50 µg may be used where response to the initial dose has been minmal).
• Maximum dose is 100 µg in unfavorable primigravid patients or 75 µg in other patients in cases of labour induction in advanced pregnancies.
• The tablet should be inserted high into the posterior fornix.
• the patient should be instructed to remain recumbent for at least 30 minutes.

Warnings & Precautions

This product is available only to hospital and clinics with specialized obstetric units and should only be used where 24- hours’ resident medical cover is provided.

As with other oxytocic agents, vagiprost vaginal tablet should be used with caution in patients with compromised uterine and/or ruptured membranes.

In labour induction, cephalopelvic proportions should be carefully evaluated before use of prostaglandin E.

During use, uterine activity, foetal status and the progression of cervical dilatation should be carefully monitored to detect possible evidence of undesired responses, e.g. hyper tonus, sustained uterine contractions or foetal distress.

In cases where there is a known history of hypertonic uterine contractility or tetanic uterine contractions, it is recommended that uterine activity and the state f the foetus should be continuously monitored throoghout labour the possibility of uterine rupture should be considered where high tone contractions are sustained.

Caution should be exercised in administration of prostaglandin E in patients with: Asthma, epilepsy or a history of epilepsy, glaucoma or raised Intraocular pressure, compromised Cardiovascular, hepatic or renal function and hypertension.

Adverse Events

As with all prostaglandin-based medications, the most commonly reported events are vomiting, nausea and diarrhea. Other adverse events that should be especially noted are hypersensitivity to the drug, uterine rupture and cardiac arrest.

Other adverse events reported with prostaglandins in decreasing order of severity are: Pulmonary amniotic fluid embolism, abruption placentae, stillbirth, neonatal death, uterine hypercontractility or hypertonus, foetal distress, hypertension, bronchospasm/asthma, fever, backache, rash.

Adverse events that have been seen with the use of prostaglandin E for the term labour induction have included: Uterine hyper contractility with foetal bradycardia and low Apgar scores in new born.

Vagiprost- Information Leaflet

Vagiprost- Arabic Information

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