All the Therapeutic System Drugs
Tocolytic Agent. Atosiban 7.5 mg/ml. Sol. FOR INJECT: 1
CONC. FOR INFUSION: 1
To start as soon as possible aft. diagn.
of preterm labour in 3 successive
stages: initial bolus dose (6.75 mg)
with 7.5 mg/ml sol. for inject., immed.
foll. by continuous high dose infus.
(300 μg/min) during 3 hrs. foll. by
lower dose (100 μg/min) for up to 45
hrs. Infus. to be performed with 7.5
mg/ml conc. sol. for infus. Tmt. not to
exceed 48 hrs. Total dose not to exceed
330 mg active substance.
To delay imminent pre-term birth in
pregn. women with reg. uterine
contracts. of at least 30 secs. durat. at
rate of ≥ 4/30 mins., cervical dilat. of 1-3
cm (multiparas: 0-3), effacement of ≥
50%; age ≥ 18 yrs., gestat. age: 24-33
completed wks; normal fetal heart rate.
C/I: Gestat. age below 24 or over 33
completed wks., prem. rupture
membranes > 30 wks gestat.,
intrauterine growth retard, abnorm.
fetal heart rate, antepartum uterine
hemorrh. req. immed. delivery,
eclampsia and severe pre-eclampsia
req. delivery, intrauterine fetal death,
suspect. intrauterine infect., placenta previa, abruptio placenta, any other cond. of mother and fetus which is
hazardous, known hypersens. to excips.
Progestogen. Progesterone 50 mg/ml. AMPS: 10 x 1 ml x 50 mg. 5-10 mg I.M.
dly. for 5-10 days until 2 days bef.
expect. menstruation.
Dysfunct. uterine bleed., selected cases as
add. tmt. infertil. such as IVF, Gift.
Antiprogestin. Mifepristone 200 mg. TABS: 3. 3 tabs (600 mg) in single oral
dose, foll. 36-48 hrs later by
misoprostol 400 μg orally.
Medical alt. to surg. terminat. intrauterine
pregn., up to 49 days of
amenorrh. (7 wks), in sequent. use with
prostaglandin analog (misoprostol).
Soft. and dilatat. cervix uteri prior to
surg. terminat. pregn. during 1st
trimester. Prep. action prostaglandin
analogs in terminat. pregn. aft. 1st
trimester.
Only approved for use in hospitals/
registered medical centers having
approval to undertake terminations of
pregnancies.
Oxytocic Agent. Oxytocin 10 IU/ml. Vial 5/10 X 1 ml
Induction or enhancement of labour:
Oxytocin may only be admin. as an intravenous continuous infusion.
10 IU of Oxytocin should be added to 1000 mL of an isotonic sodium chloride solution 0.9%. See prescription info. for dilution and rates.
If regular contractions are still absent after an infus. of 500 mL (5 IU), the attempt at labour induction should be ceased. A fresh attempt can be made on the following day. Frequency, intensity and duration of contractions, as well as the foetal heart rate, must be carefully monitored. As soon as appropriate uterine activity has been achieved, the infus. rate can be reduced. To be discontinued immediately in the event of excessive uterine activity and/or signs of placental malnutrition (foetal distress).
Caesarean section:
Immediately after extraction of the infant, 5 IU can be injected slowly I.V.
Prevention of postpartum uterine haemorrhage:
recomm. dose is 5 IU slowly I.V. after delivery of the placenta. In women given Oxytocin for induction or enhancement of labour, the infusion should be continued at an increased rate during the third stage of labour and for the next few hours thereafter.
Treatment of postpartum uterine haemorrhage:
5-10 IU I.M. or 5 IU slowly I.V., followed in severe cases by IV infus. of a solution containing 5-20 IU of oxytocin in 500 ml of a non-hydrating diluent, run at the rate necessary to control uterine atony.
Due to the antidiuretic effect of Oxytocin which suppresses urine excretion the following measures should be observed when administering this drug at high doses: An isotonic NaCl sol. (not glucose) should be used and the infused vol. of fluid must be kept low. At the same time, oral fluid intake should be restricted and the fluid balance monitored. If an electrolyte imbalance is suspected, serum electrolytes must be monitored.
Incomplete, inevitable or missed abortion:
5 IU I.M. or slowly I.V., if necessary followed by IV infus. at a rate of 20-40 mU/min or higher.
- Induction of labour for med. reasons;
- Stimulation of labour in hypnotic uterine inertia;
- During CS following the delivery of the child;
- Prevent. and tmt. of postpartum uterine atony and hemorrhage.
- In early stages of pregn. as an adjunctive ther. for the management of incomplete, inevitable or missed abortion
C/I: • Hypersens./ Hypertonic uterine contractions, mechan. obstruction to delivery, foetal distress/Any condit. in which, spontaneous labour is inadvisable and/or vaginal delivery is contraindic/ Signif. cephalopelvic disproportion/ Foetal malpresentation/ Placenta praevia and vasa praevia/ Placental abruption/
Cord presentation or prolapse/Overdistension or impaired resistance of the uterus to rupture as in multiple pregn./ Polyhydramnios/Grand multiparity/
In the presence of a uterine scar resulting from major surgery incl. CS./
Should not be used for prolonged periods in pts. with oxytocin-resistant
uterine inertia, sev. pre eclamptic toxaemia or sev. CV dis.
Must not be admin. within 6 hours after vaginal prostaglandins have been given.
Oxytocic Agent. Oxytocin 10 IU/ml. AMPS: 10 x 1 ml. See lit.
Induct. labour for medical reasons,
stimulat. labour in hypoton. uterine inertia, during cesar. sect. foll. delivery,
prevent. tmt. post. partum uterine atony
and hemorrh., early stages pregn. as
adjunct. ther. for manage. incomplete,
inevitable or missed abort.
C/I: Hypersens. See lit.
Prostaglandin. Dinoprostone 1 mg / 3 g. VAG. GEL: 3 g x 1 mg, 2 mg. Initial: 1 mg. The pt. should remain in supine pos. for at least 30 min. Aft 6 hrs: A second dose of 1 mg or 2 mg, if necessary.
Therapeutic termination of pregnancy, missed abortion.
C/I: Hypersens. Pts. with hypersens. to prostaglandins. Pts. in whom oxytocic drugs are generally contra-indicated or where prolong. contractions of the uterus are consid. inappropriate such as: Cases with a history of Caesarean sec. or major uterin. surg.; Cases where there is evidence of a potent. for obstruct. labour.
In pts. with a past history of, or existing, pelvic inflamm. dis., unless adequate prior tmt. has been instituted.
Pts. with active cardiac, pulmon., renal or hep.dis.
