TRANDATE INJECTION 100 mg20 ml

Država: Singapur

Jezik: engleski

Izvor: HSA (Health Sciences Authority)

Aktivni sastojci:

LABETALOL HCl

Dostupno od:

DCH AURIGA SINGAPORE

ATC koda:

C07AG01

Doziranje:

100 mg/20 ml

Farmaceutski oblik:

INJECTION

Sastav:

LABETALOL HCl 100 mg/20 ml

Administracija rute:

INTRAVENOUS

Tip recepta:

Prescription Only

Proizveden od:

UBI Pharma Inc

Status autorizacije:

ACTIVE

Datum autorizacije:

1988-07-14

Uputa o lijeku

 
CONFIDENTIAL 

1 
Proposed Package Insert 
  severe hypertension, including severe hypertension
of pregnancy, when rapid control of blood pressure is essential 

TRANDATE™  
LABETALOL 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
5 mg/ml labetalol hydrochloride solution for injection in a 20
ml or a 5 ml ampoule. 
PHARMACEUTICAL FORM 
Solution for injection.  
CLINICAL PARTICULARS 
INDICATIONS 
_TRANDATE injection is indicated for: _
  anaesthesia when a hypotensive technique is indicated 
  hypertensive episodes following
acute myocardial infarction. 
DOSAGE AND ADMINISTRATION 
_TRANDATE_ injection is intended for i.v. use in hospitalised
patients. Patients should always receive the drug whilst in 
the supine or left lateral position. Raising the patient into
the upright position within 3 h of i.v. _TRANDATE_ 
administration should be avoided
since excessive postural hypotension
may occur. It is desirable to monitor the blood 
pressure and heart rate after injection and during infusion.  In
most patients, there is a small decrease in the heart rate; 
severe bradycardia is unusual but may be controlled
by injecting atropine 1 to 2 mg intravenously.
 Respiratory function 
should be observed particularly in patients with any known
impairment. 
_TRANDATE_ injection has been administered to patients with
uncontrolled hypertension already receiving other 
hypotensive agents, including beta-blocking drugs,
without adverse effects. 
•  ADULTS 
_TRANDATE INJECTION: _
FOR SEVERE HYPERTENSION_  _
_BOLUS INJECTION _
If it is essential to reduce the blood
pressure quickly a dose of 50 mg should be given by i.v.
injection (over a period of at 
least 1 min) and, if necessary, repeated at  5 min
intervals until a satisfactory response occurs.
 The total dose should not 
exceed 200 mg.  The maximum effect usually occurs 

Svojstava lijeka

1
TRANDATE
TM
LABETALOL
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg/ml labetalol hydrochloride solution for injection in a 20 ml or a
5 ml ampoule.
PHARMACEUTICAL FORM
Solution for injection.
CLINICAL PARTICULARS
INDICATIONS
_TRANDATE injection is indicated for: _
_ _

severe hypertension, including severe hypertension of pregnancy, when
rapid control of
blood pressure is essential

May be used to achieve control hypotension during anaesthesia
DOSAGE AND ADMINISTRATION
_TRANDATE _injection is intended for i.v. use in hospitalised
patients. Patients should always
receive the drug whilst in the supine or left lateral position.
Raising the patient into the
upright position within 3 h of i.v. _TRANDATE _administration should
be avoided since
excessive postural hypotension may occur. It is desirable to monitor
the blood pressure and
heart rate after injection and during infusion. In most patients,
there is a small decrease in
the heart rate; severe bradycardia is unusual but may be controlled by
injecting atropine 1
to 2 mg intravenously. Respiratory function should be observed
particularly in patients with
any known impairment.
_TRANDATE _injection has been administered to patients with
uncontrolled hypertension
already receiving other hypotensive agents, including beta-blocking
drugs, without adverse
effects.
POPULATIONS
• ADULTS
INTERACTION
DOSE
SEVERE HYPERTENSION
Bolus injection
If
it
is
essential
to
reduce
the
blood
pressure quickly a dose of 50 mg should
be given by i.v. injection (over a period of
at least 1 min) and, if necessary, repeated
at
5
min
intervals
until
a
satisfactory
2
response occurs. The total dose should
not exceed 200 mg.
The maximum effect usually occurs within
5 min and the duration of action is usually
about 6 h but may be as long as 18 h.
Intravenous infusion
A 1 mg/ml solution of TRANDATE should
be used, i.e. the contents of two 20 ml
ampoules or eight 5 ml ampoules (200 mg)
diluted to 200 ml with Sodium Chloride and
Dextrose
Injection
BP
or
5%
Dextrose
Intravenous Infusion BP.