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.
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
Only approved for use in hospitals/
registered medical centers having
approval to undertake terminations of
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 10 mg/ml. AMPS: 1 x 0.5 ml (alcohol. sol.). Extraamniot.
use for ther. term. pregn. (100
μg/ml). Adapt. to pt. response. Prepare
sol. cont. 100 μg/ml using diluent
provided. Subseq. instils. vary 1
ml-2ml (usually 2 ml) accord. uterine
response. 2 hrs to elapse betw. instils.
(Never less than 1 hr). Max. cont.
admin: Not more than 2 days.
Ther. abort. 1st/2nd trimester; evac.
uterus missed abort; alt. to complete
ther. terminat. when intra-amniot. saline
injects. failed. Extra-amniot. route more
effect. and better tolerat. than I.V. route.
C/I: Hypersens., not to use extra-amniot.
route in cervicitis/vag. infects. Pts
already receiv. I.V. oxytocic drugs.
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
For labour induct. in term and near term
pregn. women who have favor. induct.
features and who have a singleton
pregn. with vertex present.
C/I: Hypersens. to prostaglandins or
other constituents of the gel.
For pts. in whom oxytocic drugs are
general. contra-indicated or where
prolong. contract. of the uterus are
consid. inappropr. such as:
Cases with a hist. of Caesarean sect. or
major uter. Surg.; Cases where there is
cephalopelvic disproport.; Cases in
which fetal malpresentat. is present;
Cases where there is clinical suspic. or
definite evidence of pre-existing fetal
distress; Cases in which there is a history
of difficult labour and/or traumat. deliv.;
Grand multiparae with over five prev. term pregnan.; Pts. with ruptured
In pts. with a past hist. of, or exist.,
pelvic inflamm. dis., unless adequate
prior tmt. has been instituted.
In pts. where there is clinic. suspic. or
definite evid. of placenta praevia or
unexplain. vaginal bleed. during this
Pts. with active cardiac, pulmonary,
renal or hepatic dis