TRAMADOL AN tramadol hydrochloride 100 mg/2 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tramadol hydrochloride, Quantity: 100 mg

Available from:

Juno Pharmaceuticals Pty Ltd

INN (International Name):

Tramadol hydrochloride

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium acetate trihydrate; water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

5 ampoules x 2mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

TRAMADOL AN solution for injection is indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.

Product summary:

Visual Identification: Ampoule containing a transparent, colourless or slightly yellowish solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-01-28

Patient Information leaflet

Tramadol AN cmi
1
TRAMADOL AN
INJECTION
_Tramadol hydrochloride_
CONSUMER MEDICINE INFORMATION
WARNING
LIMITATIONS OF USE
TRAMADOL AN should only be used when your doctor decides that other
treatment options are not able to effectively manage
your pain or you cannot tolerate them.
HAZARDOUS AND HARMFUL USE
TRAMADOL AN poses risks of abuse, misuse and addiction which can lead
to overdose and death. Your doctor will monitor
you regularly during treatment.
LIFE THREATENING RESPIRATORY DEPRESSION
TRAMADOL AN can cause life-threatening or fatal breathing problems
(slow, shallow, unusual or no breathing) even when
used as recommended. These problems can occur at any time during use,
but the risk is higher when first starting treatment and
after a dose increase. Your doctor will monitor you and change the
dose as appropriate.
USE OF OTHER MEDICINES WHILE USING TRAMADOL AN
Using TRAMADOL AN with other medicines that can make you feel drowsy,
such as sleeping tablets (e.g. benzodiazepines),
other pain relievers, antihistamines, antidepressants, antipsychotics,
gabapentinoids (e.g. gabapentin and pregabalin), cannabis
and alcohol, may result in severe drowsiness, decreased awareness,
breathing problems, coma and death. Your doctor will
minimise the dose and duration of use; and monitor you for signs and
symptoms of breathing difficulties and sedation. You
must not drink alcohol while using TRAMADOL AN.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TRAMADOL AN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks
and benefits.
Your doctor has weighed the risks of
you taking TRAMADOL AN against
the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS
ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET. YOU MAY NEED TO
READ IT AGAIN.
WHAT TRAMADOL
AN IS USED FOR
TRAMADOL AN is used to relieve
moderate to severe pain and belongs
to a group of medicines called
ana

Summary of Product characteristics

Australian Product Information
Tramadol AN PI v8.0
Page | 1
AUSTRALIAN PRODUCT INFORMATION
_ _
_TRAMADOL AN_
_ _
_(TRAMADOL HYDROCHLORIDE) _
_ _
WARNINGS
_LIMITATIONS OF USE _
Because of the risks associated with the use of opioids, TRAMADOL AN
should only be
used in patients for whom other treatment options, including
non-opioid analgesics, are
ineffective, not tolerated or otherwise inadequate to provide
appropriate management of
pain (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
HAZARDOUS AND HARMFUL USE
TRAMADOL AN poses risks of hazardous and harmful use which can lead to
overdose and
death. Assess the patient’s risk of hazardous and harmful use before
prescribing and
monitor the patient regularly during treatment (see SECTION 4.4.
SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
LIFE THREATENING RESPIRATORY DEPRESSION
Serious, life-threatening or fatal respiratory depression may occur
with the use of
TRAMADOL AN. Be aware of situations which increase the risk of
respiratory depression,
modify dosing in patients at risk and monitor patients closely,
especially on initiation or
following a dose increase (see SECTION 4.4 SPECIAL WARNINGS AND
PRECAUTIONS FOR USE).
CONCOMITANT USE OF BENZODIAZEPINES AND OTHER CENTRAL NERVOUS SYSTEM
(CNS)
DEPRESSANTS, INCLUDING ALCOHOL
Concomitant use of opioids with benzodiazepines, gabapentinoids,
antihistamines, tricyclic
antidepressants, antipsychotics, cannabis or other central nervous
system (CNS)
depressants, including alcohol, may result in profound sedation,
respiratory depression,
coma, and death. Limit dosages and durations to the minimum required;
and monitor
patients for signs and symptoms of respiratory depression and
sedation. Caution patients
not to drink alcohol while taking TRAMADOL AN.
1 NAME OF THE MEDICINE
Tramadol hydrochloride.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tramadol hydrochloride is an odourless, white to off-white crystalline
powder that is freely
soluble in both water and methanol and has a pKa of 9.41. The
water/n-octanol partition