NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
CELESTONE CHRONODOSE
INJECTION
Betamethasone sodium phosphate/betamethasone acetate
Consumer Medicine Information
What is in this leaflet?
This leaflet answers some common questions about Celestone Chronodose.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 using Celestone Chronodose against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine or in a safe place.
You may want to read it again.
What Celestone Chronodose is used for
Celestone Chronodose contains betamethasone as the active ingredient. Betamethasone is a glucocorticoid and belongs to a group of medicines called corticosteroids.
Celestone Chronodose is used to treat symptoms associated with inflammatory processes and/or allergic reactions, which may include:
swelling
redness
itching.
It may be used as part of the treatment for a number of different diseases such as severe allergies, skin problems, asthma or arthritis.
Although Celestone Chronodose may relieve the symptoms of these diseases, it will not cure them.
Celestone Chronodose can also be used to prevent respiratory distress syndrome in premature infants.
Your doctor may have prescribed Celestone Chronodose for another reason.
Ask your doctor if you have any questions about why Celestone Chronodose has been prescribed for you.
Before you start Celestone Chronodose
When you must not receive it:
Celestone Chronodose should not be used if:
1.you have an allergy to:
Celestone Chronodose, or betamethasone
any of the ingredients listed at the end of this leaflet
any other cortisone-like medicines.
Some of the symptoms of an allergic reaction may include:
shortness of breath, wheezing, difficulty breathing or a tight feeling in your chest
swelling of the face, lips, tongue or other parts of the body
rash, itching, hives or flushed, red skin.
2.you have a fungal infection within your body or any other serious or long-term infections
Cortisone-like medicines such as Celestone Chronodose may decrease your resistance and make infections spread.
3.you have recently been vaccinated against smallpox.
Cortisone-like medicines such as Celestone Chronodose must not be injected into unstable joints, infected areas, intervertebral spaces or by the epidural route.
Celestone Chronodose must not be used if the packaging is torn or shows signs of tampering.
Celestone Chronodose must not be used after the expiry date (EXP) has passed.
If you are not sure whether you should start Celestone Chronodose, talk to your doctor.
Before you start to receive it
Tell your doctor if:
you are allergic to:
any other medicines including other cortisone-like medicines
any other substances such as foods, dyes or preservatives.
you are pregnant or intend to become pregnant
If it is necessary for you to start Celestone Chronodose, your doctor will discuss the benefits and risks of using it during pregnancy.
you are breast-feeding or plan to breast-feed
The active ingredients in Celestone Chronodose pass into breast milk and may affect your baby. If there is a need to use Celestone Chronodose, your doctor will discuss the benefits and risks of using it while breast-feeding.
you need any type of vaccination
Cortisone-like medicines such as Celestone Chronodose may lower your body’s immune response and result in nervous system complications if used with a vaccine.
you have any of the following:
osteoporosis
emotional or mental health problems
stomach or intestinal problems, including ulcers
tuberculosis
Herpes infection of the eye
any other infections, including recent measles or chicken pox
kidney or liver problems
high blood pressure or heart problems
diabetes
myasthenia gravis
glaucoma
Cushing’s syndrome
thyroid problems
seizures
bruising or bleeding problems.
Children
Cortisone-like medicines such as Celestone Chronodose can cause infections such as chicken pox or measles to be more serious in children. These medicines can also slow or stop growth in children or growing teenagers if used for a long time.
Taking other medicines
Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Celestone Chronodose may interfere with each other. These include:
aspirin, salicylates, anti-inflammatory medicines
barbiturate sedatives
phenytoin, a medicine used to treat epilepsy
certain antibiotics such as rifampicin, clarithromycin and amphotericin b (amphotericin)
some cough and cold medicines
tablets or injections used to treat diabetes
hormone-type medicines including hormone replacement therapy and oral contraceptives
certain diuretics, also called fluid or water tablets
certain medicines used to treat heart failure
medicines used to stop blood clots
growth hormone
vaccines
certain antifungals such as ketoconazole and itraconazole
some medicines used to treat HIV infection such as ritonavir and cobicistat-containing products
You may need to take different amounts of your medicines or you may need to take different medicines.
How Celestone Chronodose is used
How it is given
Celestone Chronodose is usually given by a doctor or nurse. How it is given and the amount depends on the condition being treated.
Into a muscle (e.g. allergic, skin and rheumatic conditions, bursitis)
1 mL, repeated weekly or more often if necessary
2 mL if the illness is severe
Into soft tissue (e.g. bursitis, fibrositis)
1 mL at intervals of 1 to 2 weeks
Into joints (e.g., rheumatoid arthritis, osteoarthritis, pain relief)
0.25 to 2 mL
Into the skin (eg skin lesions, psoriasis)
not more than 1 mL at weekly intervals
How long it is given
Your doctor will decide how long you need to have this medicine. If you have been receiving it for some time, the dose will be reduced gradually before stopping.
If too much is given (overdose)
A single overdose of Celestone Chronodose is unlikely to cause serious side effects.
Repeated use of high doses may result in more severe side effects, as listed under Side Effects below.
Contact the Poisons Information Centre on 131126 if you think you or someone else may have been given too much Celestone Chronodose.
While you are using Celestone Chronodose
Things you must do
If you become pregnant while being treated with Celestone Chronodose, tell your doctor immediately.
If you are having emotional or physical stress such as serious infection, surgery or injury, tell your doctor.
This may affect the dose of Celestone Chronodose you need.
Check with your doctor about drinking alcohol.
If you drink alcohol while receiving Celestone Chronodose, the risk of ulcers is increased.
Tell all doctors, dentists and pharmacists who are treating you that you are being treated with Celestone Chronodose.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are being treated with Celestone Chronodose.
Things you must not do
While you are being treated with Celestone Chronodose, and even after you stop it, do not have any vaccinations without your doctor’s approval.
Things to be careful of
If Celestone Chronodose is injected into one of your joints, you should be careful not to put too much stress or strain on that joint for a while, even if it begins to feel better. Make sure your doctor has told you how much you are allowed to move this joint while it is healing.
If redness or swelling occurs at the place of injection, and continues or gets worse, check with your doctor.
Always check with your doctor as soon as possible if you notice any signs of a possible infection, such as sore throat, fever, sneezing or coughing.
Celestone Chronodose may lower your resistance and make any infection you do get harder to treat.
If you are having any laboratory tests, tell your doctor.
Celestone Chronodose may give false results in skin tests.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Celestone Chronodose.
All medicines have side effects.Sometimes they are serious, most of the time they are not.You may need medical treatment if you get some of the side effects.
When this medicine is used for short periods of time, side effects are usually rare.
Ask your doctor or pharmacist any questions you may have.
Older patients are more likely to develop high blood pressure or bone disease from cortisone-like medicines. Women are especially at risk of developing bone disease.
Tell your doctor immediately if any of the following occur:
swelling of the face, lips or tongue that may cause difficulty in swallowing or breathing
asthma, wheezing, shortness of breath
sudden or severe itching, skin rash, hives
fainting, seizures or fits
vomiting blood or material that looks like coffee grounds
bleeding from the back passage (rectum), black sticky bowel motions (stools) or bloody diarrhoea
severe pain in the food pipe (oesophagus) or stomach
irregular heart rhythm.
These are serious reactions. You may need urgent medical attention.
Tell your doctor if you notice any of the following:
unusual weight gain, puffiness, swelling of the ankles or legs
muscle weakness with chronic fatigue, muscle loss, pain or cramps
tendon pain
joint pain
slow wound healing, thinning and breakdown of skin, bruising or reddish or purplish spots under the skin, red face, increased sweating
headache or dizziness
menstrual irregularities
swelling of the face (moon face), acne
thirst or passing large amounts of urine
feeling ‘high’,mood swings, depression and strange thoughts, personality changes, difficulty sleeping
visual disturbances or blurred vision
changes to your vision or pain in the eyes.
Very rarely, cortisone-like medicines given by injection may cause blindness if given around the head and neck. Skin darkening or loss of pigment, skin breakdown, abscess or redness, and joint damage caused by the injection, may also rarely occur.
Other side effects not listed above may also occur in some patients.If you notice any other side effects, check with your doctor.
After using Celestone Chronodose
Storage
Celestone Chronodose is usually stored in the doctor’s surgery or clinic, or at the pharmacy.
It should be protected from light and kept at temperatures below 25°C.
Product description
What it looks like
Celestone Chronodose is a clear, colourless, suspension. It is available in 1mL glass ampoules in packs of 2 and 5.
Ingredients
Active ingredient:
betamethasone sodium phosphate
betamethasone acetate
Inactive ingredients:
Benzalkonium chloride
Disodium edetate
Dibasic sodium phosphate
Monobasic sodium phosphate
Nitrogen
Water for Injections.
Sponsor
In Australia:
Organon Pharma Pty Ltd
Building A, 26 Talavera Road, Macquarie Park, NSW 2113 Australia
In New Zealand:
Organon New Zealand Limited
P O Box 99 851
Newmarket
Auckland 1149
New Zealand
Australian Registration Number
AUST R 18777
Date of Preparation
December 2020
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