Home' Australian Pharmacist : Australian Pharmacist July 2015 Contents Australian Pharmacist July 2015 I © Pharmaceutical Society of Australia Ltd.
CONTINUING PROFESSIONAL DEVELOPMENT
Compounded products are to be
labelled according to regulatory
requirements18 and should include the
approved pharmacopoeial name (where
applicable) and the name and strength
of any preservatives used. All active
ingredients and their amounts/
proportions should be included if a
pharmacopoeial formulation is not used.
Ancillary labels should specify storage
conditions, provide an expiry date
(28 days) and indicate specific usage
conditions. Label 1, 16, 21, 23 and J
should be used.
This medicine may cause
drowsiness and may
increase the effects of alcohol.
If affected, do not drive a motor
vehicle or operate machinery.
This medicine may cause dizziness
especially when you stand up quickly.
Ask your doctor or
pharmacist for advice.
special handling and
disposal required —
ask your pharmacist.
This product has been
compounded by the pharmacist.
beFore eaCh use
The pharmacist is responsible for
ensuring the quality of compounded
products and should verify that
products are prepared according to
documented procedures and meet
product specifications before release
to the patient. Reviews of processes
and procedures should be conducted
regularly in order to identify areas for
improvement and the resulting actions
should be documented.
In the preparation of compounded
products, the pharmacist is guided
by the professional standards,
the prescriber and the needs of the
carer and patient. Patient counselling
and education may be adapted from
CMIs available for commercial products.6
Essential information should include:
Patient advice and counselling
• Adverse effects and special
precautions would be as for the
capsules, and are outlined in the
Australian Medicines Handbook.
• Thalidomide is teratogenic and
is contraindicated in pregnancy
1,15 Even a single dose
can cause severe birth defects.
Ensure effective contraception
(using two methods) during, and
for four weeks after stopping,
treatment. Male patients with
partners of child-bearing potential
must also use adequate contraceptive
methods (thalidomide is excreted
• Ensure the product is safely stored
to avoid inadvertent ingestion by
women of child-bearing potential.
• Since sleepiness and dizziness often
occur, patients should not drive or
operate machinery until they know
how the medicine will affect them.
• Thalidomide may cause orthostatic
hypotension, therefore patients
should get up gradually from sitting/
lying to minimise this effect or sit/lie
down if they become dizzy.
• Patients should seek immediate
medical attention if they develop
any numbness, tingling or pain in
their hands or feet; shortness of
breath; chest pain; swelling of their
arms or legs; or a severe rash.
(Peripheral neuropathy is a potentially
severe and irreversible adverse effect,
and thalidomide increases the risk of
venous and arterial thromboembolic
events in multiple myeloma and
other malignancies. The risk of
venous thromboembolism is even
greater when it is combined with
other antineoplastics, including
Directions for use
• SHAKE WELL before use to ensure an
• Use the measuring device supplied to
accurately measure the required dose.
• Thalidomide should be taken at least
1 hour after food and preferably at
night to avoid feeling sleepy during
• The preparation should be stored
protected from light in a cool place
(below 25 °C) and kept away from
children and pets.
SOLUTIONS THROUGH COMPOUNDING
Thalidomide (20 mg/mL) Oral Suspension
Vehicle for Oral Solution NF* and
Vehicle for Oral Suspension NF (1:1)
to 100 mL
Perform in a protective environment and use equipment and clothing for
1. Weigh the active ingredient or empty the contents of the required number of
capsules (e.g. twenty 100 mg capsules) into a glass mortar of sufficient size.
2. Add a small amount of the vehicle to wet the powder and mix to a
3. Continue adding most of the vehicle using the method of doubling
(geometric dilution) and mix thoroughly to form a smooth mixture.
4. Transfer to a tared, child-resistant, amber prescription bottle.
5. Rinse the mortar with the remaining vehicle and make up to the final volume.
6. Shake well and label.
* For a sugar-free preparation, use Vehicle for Oral Solution, Sugar Free NF.
Figure 3. Formula and method of preparation
Links Archive Australian Pharmacist June 2015 Australian Pharmacist August 2015 Navigation Previous Page Next Page