SUMMARY CMI

CELESTONE^® CHRONODOSE^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using CELESTONE CHRONODOSE?

CELESTONE CHRONODOSE contains the active ingredient betamethasone. CELESTONE CHRONODOSE is used to treat inflammatory or allergic symptoms associated with conditions such as severe allergies, skin problems, asthma or arthritis. It can also be used to prevent respiratory distress syndrome in premature infants

For more information, see Section 1. Why am I using CELESTONE CHRONODOSE? in the full CMI.

2. What should I know before I use CELESTONE CHRONODOSE?

Do not use if you have ever had an allergic reaction to betamethasone, other cortisone-like medicines, or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use CELESTONE CHRONODOSE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with CELESTONE CHRONODOSE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use CELESTONE CHRONODOSE?

• CELESTONE CHRONODOSE is usually given by a doctor or nurse.
• How it is given and the amount depends on the condition being treated.

More instructions can be found in Section 4. How do I use CELESTONE CHRONODOSE? in the full CMI.

5. What should I know while using CELESTONE CHRONODOSE?

For more information, see Section 5. What should I know while using CELESTONE CHRONODOSE? in the full CMI.

6. Are there any side effects?

Side effects are similar to those reported for other corticosteroid medicines.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

CELESTONE^® CHRONODOSE^®

Active ingredient(s): betamethasone (as acetate and sodium phosphate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using CELESTONE CHRONODOSE. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using CELESTONE CHRONODOSE.

Where to find information in this leaflet:

1. Why am I using CELESTONE CHRONODOSE?
2. What should I know before I use CELESTONE CHRONODOSE?
3. What if I am taking other medicines?
4. How do I use CELESTONE CHRONODOSE?
5. What should I know while using CELESTONE CHRONODOSE?
6. Are there any side effects?
7. Product details

1. Why am I using CELESTONE CHRONODOSE?

CELESTONE CHRONODOSE contains the active ingredient betamethasone. 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 and 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.

2. What should I know before I use CELESTONE CHRONODOSE?

Warnings

Do not use CELESTONE CHRONODOSE if:

• you are allergic to betamethasone, and other cortisone-like medicines, or any of the ingredients listed at the end of this leaflet. 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.
• Always check the ingredients to make sure you can use this medicine.
• 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.
• 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.

Check with your doctor if 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.
• take any medicines for any other condition
• you are allergic to any other medicines including other cortisone-like medicines, any other substances such as foods, dyes or preservatives.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if 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.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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 breastfeeding.

Tell your doctor if 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
• Pheochromocytoma (tumour in the adrenal gland)

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.

After CELESTONE CHRONODOSE has been given this can cause low blood sugar levels in newborns.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your 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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect CELESTONE CHRONODOSE.

4. How do I use CELESTONE CHRONODOSE?

How CELESTONE CHRONODOSE 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.

How much to use

• 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 CELESTONE CHRONODOSE is used

• 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 CELESTONE CHRONODOSE is given

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 Section 6. Are there any 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. You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using CELESTONE CHRONODOSE?

Things you should 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.
• Remind any doctor, dentist or pharmacist you visit that you are using CELESTONE CHRONODOSE.

Things you should 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.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how CELESTONE CHRONODOSE affects you.

Drinking alcohol

Check with your doctor about drinking alcohol.

If you drink alcohol while receiving CELESTONE CHRONODOSE, the risk of ulcers is increased.

Looking after your medicine

• 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.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What CELESTONE CHRONODOSE contains

Do not take this medicine if you are allergic to any of these ingredients.

What CELESTONE CHRONODOSE looks like

CELESTONE CHRONODOSE is a clear, colourless, suspension.

It is available in 1mL glass ampoules in packs of 2 and 5. (Aust R 18777).

Who distributes CELESTONE CHRONODOSE

Organon Pharma Pty Ltd
Level 5, 66 King St
Sydney NSW 2000
Australia

This leaflet was prepared in January 2025.

RCN100000544-AU

Published by MIMS April 2025

1 Name of Medicine

Betamethasone acetate and betamethasone sodium phosphate.

2 Qualitative and Quantitative Composition

Celestone Chronodose Injection is a sterile aqueous suspension containing the combination of betamethasone sodium phosphate and betamethasone acetate. Each mL of Celestone Chronodose Injection contains betamethasone 5.7 mg, as betamethasone sodium phosphate 3.9 mg (in solution) and betamethasone acetate 3 mg (in suspension) in an aqueous vehicle.

Excipients with known effect.

3 Pharmaceutical Form

Suspension for injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Celestone Chronodose is indicated in the treatment of both severe and moderate conditions, in acute and chronic self limiting diseases responsive to systemic corticosteroid therapy, especially in patients for whom treatment with oral corticosteroid medication is not feasible.

Representative conditions.

Rheumatic disorders.

Collagen diseases.

Allergic states.

Dermatological conditions.

Antepartum use in the prevention of respiratory distress syndrome in premature infants.

4.2 Dose and Method of Administration

Dosage must be adjusted to the specific requirements of the patient according to the severity of the condition, the response obtained and the patient's tolerance to the corticosteroid.
Recommended routes of administration are:
1. Intramuscular injection in allergic, dermatological, rheumatic and other conditions responsive to systemic corticosteroids, including bursitis.
2. Injection directly into the affected soft tissues in bursitis and associated inflammatory disorders of muscle such as fibrositis and myositis.
3. Intra-articular and periarticular injection in rheumatoid arthritis and osteoarthritis.
4. Intralesional injections in various dermatological conditions.

Systemic administration.

Local administration.

4.3 Contraindications

As with other corticosteroids, Celestone Chronodose Injection is contraindicated in systemic fungal infections and in patients hypersensitive to betamethasone sodium phosphate, betamethasone acetate, other corticosteroids or to any component of this product. Corticosteroids should not be injected into unstable joints, infected areas or intervertebral spaces. Celestone Chronodose Injection is not recommended for epidural administration.
Relative contraindications are osteoporosis, marked emotional instability, peptic ulcer, tuberculosis, acute or chronic infections, ocular herpes simplex, primary glaucoma, diverticulitis, recent intestinal anastomosis, Cushing's syndrome, renal insufficiency, hypertension, thromboembolic tendencies, diabetes mellitus and myasthenia gravis.
Corticosteroids are not indicated in the management of hyaline membrane disease after birth.

4.4 Special Warnings and Precautions for Use

Celestone Chronodose Injection should not be administered intravenously. Strict aseptic technique is mandatory. Subcutaneous injection should be avoided.
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. (See Section 4.3 Contraindications).
Rare instances of anaphylactoid/anaphylactic reactions with a possibility of shock have occurred in patients receiving parenteral corticosteroid therapy. Appropriate precautionary measures should be taken with patients who have a history of allergic reactions to corticosteroids.
Pheochromocytoma crisis, which may be fatal, has been reported after administration of systemic corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
Intramuscular injections of corticosteroids should be given deep into large muscle masses to avoid local tissue atrophy.
Soft tissue, intralesional and intra-articular administration of a corticosteroid may produce systemic as well as local effects.
Celestone Chronodose Injection contains two betamethasone esters, one of which, betamethasone sodium phosphate, disappears rapidly from the injection site. The potential for systemic effect produced by this soluble portion of Celestone Chronodose Injection should, therefore, be taken into account by the physician when using this preparation.
The lowest possible dose of corticosteroid should be used to control the condition under treatment; when dosage reduction is possible, it should be gradual.
Drug induced secondary adrenocortical insufficiency may result from too rapid corticosteroid withdrawal and may be minimised by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, if stress occurs during that period, corticotherapy should be reinstituted. If the patient is receiving corticosteroids already, the dosage may have to be increased.
Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticosteroid should be administered concurrently.
In certain conditions ordinarily considered contraindications to corticosteroid therapy, the physician must weigh anticipated clinical improvement against the possibility of undesirable corticosteroid effects.
Corticosteroids may mask the signs of infection and enhance the dissemination of an infecting organism. Hence, patients receiving corticosteroids should be watched for evidence of intercurrent infection. Should infection occur, vigorous, appropriate anti-infective therapy should be initiated. Abrupt withdrawal of corticosteroids should be avoided.
Celestone Chronodose Injection should not be administered to patients with an acute or chronic infection unless the condition is severe and unless appropriate anti-infective agents are administered concurrently. When corticosteroids are used, decreased resistance and inability to localise infection may occur.
Examination of any joint fluid present is necessary to exclude a septic process. Local injection into a previously infected joint is to be avoided. A marked increase in pain and local swelling, further restriction of joint motion, fever and malaise are suggestive of septic arthritis. If the diagnosis of sepsis is confirmed, appropriate antimicrobial therapy should be instituted.
While on corticosteroid therapy patients should not be vaccinated against smallpox. Other immunisation procedures should not be undertaken in patients receiving corticosteroids, especially high doses, because of possible hazards of neurological complications and lack of antibody response. However, immunisation procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy, e.g. for Addison's disease.
Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice. This is of particular importance in children.
Corticosteroid therapy in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for management in conjunction with an appropriate antituberculous regimen.
If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary since reactivation of the disease may occur. During prolonged corticosteroid therapy, patients should receive chemoprophylaxis. If rifampicin is used in a chemoprophylactic program, its enhancing effect on metabolic hepatic clearance of corticosteroids should be considered; adjustment in corticosteroid dosage may be required.
Prolonged corticosteroid use may produce posterior subcapsular cataracts (especially in children), glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Because rare instances of anaphylactoid reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug.
Following intra-articular steroid therapy, care should be taken by the patient to avoid overuse of the joint in which symptomatic benefit has been obtained.
Repeated injections into joints of osteoarthritis may increase joint destruction. Avoid injecting corticosteroids directly into the substance of tendons, because delayed appearance of tendon rupture has resulted.
Celestone Chronodose Injection should be administered intramuscularly with caution to patients with idiopathic thrombocytopenic purpura.
With long-term corticosteroid therapy, transfer from parenteral to oral administration should be considered after weighing the potential benefits and risk.
Dosage adjustments may be required with remission or exacerbation of the disease process, the patient's individual response to therapy and exposure of the patient to emotional or physical stress such as serious infection, surgery or injury. Monitoring may be necessary for up to one year following cessation of long-term or high dose corticosteroid therapy.
Corticosteroid effect is enhanced in patients with hypothyroidism or in those with cirrhosis.
Cautious use of corticosteroids is advised in patients with ocular herpes simplex because of possible corneal perforation.
Psychic derangements may appear with corticosteroid therapy. Existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.
Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be considered. All corticosteroids increase calcium excretion.
Corticosteroids should be used with caution in: nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess, or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.
Since complications of glucocorticosteroid treatment are dependent on dose, size and duration of treatment, a risk/ benefit decision must be made with each patient.
Corticosteroids may alter the motility and number of spermatozoa in some patients.
Results from a single, multicentre, randomised, controlled study with another corticosteroid, methylprednisolone hydrogen succinate, showed an increase of early mortality (at 2 weeks) and late mortality (at 6 months) in patients with cranial trauma who had received methylprednisolone, compared to placebo. The causes of mortality in the methylprednisolone group have not been established. Of note, this study excluded patients who were felt to have a clear indication for corticosteroids.
Visual disturbance may be reported with systemic and topical (including, intranasal, inhaled and intraocular) corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes of visual disturbances which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concurrent use of corticosteroids with potassium-depleting diuretics may enhance hypokalaemia. Concurrent use of corticosteroids with cardiac glycosides may enhance the possibility of arrhythmias or digitalis toxicity associated with hypokalaemia. Corticosteroids may enhance the potassium depletion caused by amphotericin B (amphotericin). In all patients taking any of these drug therapy combinations, serum electrolyte determinations, particularly potassium levels, should be monitored closely.

Anticoagulants, oral.

Antidiabetics.

Estrogens, including oral contraceptives.

Hepatic enzyme inducers.

Interactions with strong CYP3A4 inhibitors.

Nonsteroidal anti-inflammatory agents (NSAIDs).

Somatotropin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions to Celestone Chronodose injection relate both to dose and to duration of therapy. These reactions can usually be reversed or minimised by a reduction in dosage; this is generally preferable to withdrawal of drug treatment.
Adverse reactions have been the same as those reported to other corticosteroids: fluid and electrolyte, musculoskeletal, gastrointestinal, dermatological, neurological, endocrine, ophthalmic, metabolic and psychiatric disturbances.

Cardiovascular.

Fluid and electrolyte disturbances.

Musculoskeletal.

Gastrointestinal.

Dermatologic.

Neurologic.

Endocrine.

Ophthalmic.

Metabolic.

Psychiatric.

Other.

Reporting suspected adverse effects.

4.9 Overdose

A single overdose of a corticosteroid would not be expected to produce acute symptoms. Hypercorticoid effects are not anticipated unless there has been repeated administration of high doses.

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Celestone Chronodose is an injectable preparation containing both soluble and slightly soluble esters of betamethasone that provides anti-inflammatory, antirheumatic and antiallergic effects in the treatment of corticosteroid responsive disorders.

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Prompt therapeutic activity in conditions responsive to corticosteroids is initiated by betamethasone sodium phosphate, a soluble ester that is absorbed quickly into tissues after injection.
Sustained activity is provided by betamethasone acetate, which is only slightly soluble and affords a repository for slow absorption.
The combined rapid and depot actions of these forms of betamethasone facilitate rapid control as well as steady maintenance of corticosteroid effects.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzalkonium chloride, disodium edetate, dibasic sodium phosphate, monobasic sodium phosphate, water for injections.

Inactive ingredients.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

The expiry date can be found on the packaging. In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG).

6.4 Special Precautions for Storage

Protect ampoules from light.
Store below 25°C.

6.5 Nature and Contents of Container

Injection, suspension in flint glass (Type I) ampoule with rubber stopper. Ampoules, 1 mL: 5s, 2s.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Betamethasone acetate.

CAS number.

Chemical structure.

Betamethasone sodium phosphate.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes