Celestone

Package Leaflet: Information for the Patient

Celestone, 4 mg/ml, Solution for Injection

Betamethasone

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Celestone and what is it used for
• 2. Important information before using Celestone
• 3. How to use Celestone
• 4. Possible side effects
• 5. How to store Celestone
• 6. Contents of the pack and other information

1. What is Celestone and what is it used for

The active substance of Celestone, betamethasone, has strong anti-inflammatory, antiallergic, and antirheumatic effects. Celestone is intended for short-term use in the symptomatic treatment of various severe diseases to alleviate or eliminate the acute phase of their course:
Endocrine disorders: primary and secondary adrenal cortex insufficiency, acute adrenal cortex insufficiency, severe trauma or disease preceding surgery in patients with previously diagnosed adrenal cortex insufficiency or impaired adrenal cortex function, shock unresponsive to standard treatment due to known or suspected adrenal cortex insufficiency, post-adrenalectomy state, congenital adrenal hyperplasia, acute thyroiditis, subacute thyroiditis, thyroid crisis.
Shock: supportive treatment with concurrent use of standard treatment methods.
Cerebral edema (increased intracranial pressure): supportive treatment to reduce cerebral edema or prevent its occurrence in connection with surgery or other brain injuries, in cerebrovascular diseases (stroke).
Musculoskeletal disorders: short-term supportive treatment, exacerbations of rheumatoid arthritis, osteoarthritis (post-traumatic), synovitis, psoriatic arthritis, ankylosing spondylitis, acute gouty arthritis, acute and subacute bursitis, acute rheumatic fever, fibrositis, tendonitis, bursitis, and periarthritis.
Celestone solution for injection can also be used in the treatment of ganglions of the tendon sheath.
Skin diseases: treatment of pemphigus, herpetic pemphigus, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, mycosis fungoides, severe psoriasis, atopic dermatitis (chronic eczema), and severe seborrheic dermatitis.
Allergic conditions: control of severe allergic diseases unresponsive to standard treatment, such as seasonal or perennial allergic rhinitis, nasal polyps, bronchial asthma, contact dermatitis, atopic dermatitis, drug allergy, serum sickness, and acute non-infectious laryngeal edema.
Blood disorders: idiopathic and secondary thrombocytopenia in adults, autoimmune hemolytic anemia, transfusion reactions.
In the prevention of respiratory distress syndrome (hyaline membrane disease) in preterm infants.

2. Important information before using Celestone

When not to use Celestone:

Do not use corticosteroids in: tuberculosis, osteoporosis, emotional instability, peptic ulcer, glaucoma, recent intraocular surgery, diabetes, Cushing's syndrome, renal insufficiency, bacterial, fungal, or viral infections, treatment of hyaline membrane disease after birth.

Warnings and precautions

Before starting treatment with Celestone, discuss it with your doctor, pharmacist, or nurse, especially if you have a pheochromocytoma (adrenal gland tumor).
With the extraspinal injection of corticosteroids, severe neurological events have been reported, sometimes resulting in death. The reported specific events included spinal cord infarction, paraplegia, tetraplegia, cortical blindness, and stroke. The occurrence of these severe neurological events has been reported regardless of the use of fluoroscopy. The safety and efficacy of extraspinal administration of corticosteroids have not been established, and therefore, corticosteroids are not approved for such use.
In patients receiving corticosteroids parenterally, rare cases of anaphylactoid or anaphylactic reactions with the possibility of shock have been reported. For this reason, the doctor will take appropriate preventive measures in patients with a history of hypersensitivity to corticosteroids.
Aseptic techniques should be followed when performing injections.
Corticosteroids are not indicated for the treatment of hyaline membrane disease in preterm infants after birth.
In the preventive treatment of respiratory distress syndrome in preterm infants, corticosteroids should not be administered to pregnant women in a state of preeclampsia and during eclampsia or with placental damage.
Intramuscular injections of Celestone should be performed deeply into large muscle masses to avoid local tissue atrophy.
Caution should be exercised when administering Celestone intramuscularly to patients with idiopathic thrombocytopenic purpura (Werlhof's disease).
Local administration to soft tissues and intra-articular administration may cause both local and general effects.
After long-term parenteral treatment, oral treatment should be continued, considering the potential benefits and risks.
Corticosteroids can mask some signs of infection, and during their use, new infections may occur. The administration of corticosteroids may reduce resistance and prevent the localization of infection.
Long-term administration of corticosteroids can cause posterior subcapsular cataract (especially in children), glaucoma with possible damage to the optic nerve, and increase the susceptibility to secondary eye infections caused by fungi or viruses. Regular ophthalmological examinations should be performed, especially if treatment is long-term (lasting more than 6 weeks).
Medium and high doses of corticosteroids can cause an increase in blood pressure, sodium and water retention, and increased potassium excretion. It is recommended to significantly reduce salt intake in the diet and supplement potassium. All corticosteroids increase calcium excretion.
During corticosteroid treatment, patients should not be vaccinated against smallpox. Other live vaccinations should not be performed, especially during high-dose corticosteroid treatment, due to the risk of neurological complications and lack of antibodies. However, vaccinations may be performed in patients receiving replacement corticosteroid therapy, e.g., in Addison's disease.
Patients receiving immunosuppressive doses of corticosteroids should be informed to avoid contact with people with chickenpox or shingles. If such contact occurs, the doctor should be informed. This is especially important in children.
The administration of corticosteroids to patients with active tuberculosis should be limited to severe cases or miliary tuberculosis, in which corticosteroids are administered with antitubercular drugs.
If the administration of corticosteroids is indicated in patients with inactive tuberculosis or with a positive tuberculin test, the patient should be closely monitored, as the disease may become active. During long-term corticosteroid treatment, patients should receive antitubercular drugs prophylactically. If rifampicin is used, the increased hepatic elimination of corticosteroids should be considered; it may be necessary to adjust the corticosteroid dose.
Due to the too rapid withdrawal of corticosteroids, drug-induced secondary adrenal insufficiency may occur, which can be minimized by gradually and slowly reducing the dose. Relative adrenal insufficiency may persist for a month after the end of treatment; if a stressful situation occurs during this period, corticosteroids should be administered again.
Since the secretion of mineralocorticoids may also be impaired, the intake of table salt should be increased, and (or) a mineralocorticoid should be administered.
The effect of corticosteroids is greater in patients with hypothyroidism or liver cirrhosis.
Corticosteroids should be used with caution in patients with ocular herpes simplex due to the possible perforation of the cornea.
Corticosteroids can exacerbate existing emotional disturbances and tendencies to psychosis.
Corticosteroids should be used with caution: in non-specific ulcerative colitis, in case of risk of intestinal perforation, abscess, or other purulent infection, in cases of diverticulitis, recent intestinal anastomoses, active or latent peptic ulcers, renal or heart failure, hypertension, osteoporosis, and myasthenia, tendency to thrombosis with embolism or thrombophlebitis.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.

Children and adolescents

Infants and children treated with corticosteroids for a long time should be closely monitored for growth and development due to the risk of growth retardation and suppression of endogenous corticosteroid production.

Celestone and other medicines

Inform your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription, as well as about medicines you plan to take.
Concomitant administration of phenobarbital, rifampicin, phenytoin, or ephedrine may enhance the metabolism of corticosteroids, reducing their effect.
Signs of excess corticosteroids may occur in patients receiving corticosteroid and estrogen.
Concomitant administration of corticosteroids and potassium-excreting diuretics may enhance hypokalemia. The use of corticosteroids with digitalis glycosides may increase the risk of cardiac arrhythmias or toxic effects of digitalis glycosides due to hypokalemia. Corticosteroids may enhance potassium deficiency caused by amphotericin B. In all patients receiving these drugs concomitantly, serum electrolyte levels, especially potassium, should be closely monitored.
Concomitant administration of corticosteroids and anticoagulants may affect the anticoagulant effect, so the dosage of the anticoagulant may need to be adjusted.
Corticosteroids may reduce the salicylate levels in the blood. Acetylsalicylic acid should be used with caution with corticosteroids in patients with low prothrombin levels.
Concomitant administration of non-steroidal anti-inflammatory drugs or alcohol with corticosteroids may increase the risk of gastrointestinal ulcers or exacerbate symptoms of peptic ulcer disease.
Administration of corticosteroids to patients with diabetes may require adjustment of the dose of antidiabetic drugs, as corticosteroids can increase blood glucose levels.
Corticosteroids may reduce the effect of concomitantly administered somatropin. During somatropin administration, betamethasone doses exceeding 450 µg (0.45 mg) per square meter of body surface area should be avoided.
Certain medicines may enhance the effect of Celestone, and your doctor may want to closely monitor your condition while taking such medicines (including some HIV medicines: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Animal studies have shown that high doses of corticosteroids administered during pregnancy may cause fetal developmental abnormalities. There are no studies on developmental abnormalities in humans during corticosteroid treatment in pregnancy. Corticosteroids should be administered to pregnant women and women of childbearing age only when the benefits of treatment outweigh the potential risk to the mother and fetus.
There are no data confirming the safety of preventive corticosteroid use after 32 weeks of pregnancy. The doctor should therefore consider the benefits versus the potential risk to the mother and fetus before administering corticosteroids during this period of pregnancy.
In the preventive treatment of respiratory distress syndrome in preterm infants, corticosteroids should not be administered to pregnant women in a state of preeclampsia and during eclampsia or with signs of placental damage.
Newborns born to mothers treated with high doses of corticosteroids during pregnancy should be closely monitored due to the risk of adrenal insufficiency and thoroughly examined due to the risk of congenital cataract, although it is very small.
Women receiving corticosteroids during pregnancy should be monitored during delivery and after delivery, as adrenal insufficiency may occur due to stress related to delivery.
In newborns whose mothers received Celestone at the end of pregnancy, hypoglycemia may occur after birth.
Breastfeeding
Corticosteroids pass through the placental barrier and into human milk.
Since there is a risk of adverse reactions in breastfed infants whose mothers are taking Celestone, a decision should be made to either discontinue breastfeeding or discontinue the use of Celestone, considering the benefits of treatment for the mother.
Fertility
In some patients, corticosteroids may affect sperm motility and count.

Driving and using machines

Although visual disturbances are rare, patients who drive vehicles or operate machinery should be informed about this fact.

Celestone contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e., the medicine is considered "sodium-free".
The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared Celestone medicinal product for intravenous administration.
To obtain accurate information about the sodium content in the diluent used to dilute the medicinal product, healthcare professionals should consult the Summary of Product Characteristics of the diluent used.

3. How to use Celestone

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

The dose of Celestone is determined individually depending on the type of disease, its severity, and the response to the medicine.

In adults, the initial dose of Celestone solution for injection is up to 8 mg of betamethasone per day. If after an adequate period of administration of the initial dose, a satisfactory response to treatment does not occur, the administration of Celestone solution for injection should be discontinued, and other appropriate treatment should be used.
In children, the initial daily dose of betamethasone is from 0.02 to 0.125 mg/kg body weight.
Dosing in infants and children, as well as in adults, depends on the type of disease and its severity.
In emergency situations, intravenous administration of Celestone is recommended. Celestone solution for injection can be administered as an intravenous infusion after dilution with 0.9% sodium chloride solution or 5% glucose solution. Celestone should be added to the infusion just before its connection. The unused solution should be immediately placed in the refrigerator and used within 24 hours.
After improvement, the maintenance dose should be established by gradually reducing the initial dose to the smallest effective dose.

Dosing in the following diseases

Shock:supportive treatment with Celestone solution for injection can be administered in a dose equivalent to 3 mg of betamethasone. If shock persists, the dose can be repeated every

• 4 - 6 hours. The administration of high doses of corticosteroids should be discontinued immediately after stabilization of the patient's condition.

Cerebral edema: improvement may occur within a few hours after administration of Celestone solution for injection in a dose equivalent to 2 - 4 mg of betamethasone. Patients in a coma may receive doses of 2 to 4 mg four times a day.
Musculoskeletal disorders:recommended doses depend on the size of the joint and the site of administration:
Large joints (knee, hip, shoulder) 2 – 4 mg
Small joints (joints of the foot, hand, chest) 0.8 – 2 mg
Bursa 2 – 3 mg
Tendon sheath 0.4 – 1 mg
Soft tissues 2 – 6 mg
Ganglion 1 – 2 mg
In the prevention of respiratory distress syndrome (hyaline membrane disease) in preterm infants:if labor is imminent before 32 weeks of gestation or if spontaneous preterm labor is inevitable during this period of gestation, Celestone solution for injection (in a dose equivalent to 4 – 6 mg of betamethasone) should be administered intramuscularly every

• 12 hours for 24 - 48 hours (two to four doses). It is recommended to administer Celestone solution for injection 48 to 72 hours before the expected delivery.

Transfusion reactions:to prevent transfusion reactions, 1 ml or 2 ml of Celestone solution for injection (4 to 8 mg of betamethasone) should be administered intravenously immediately before blood transfusion. Celestone should not be mixed with the transfused blood. When repeating blood transfusions, the same dose can be administered before each transfusion, not exceeding four doses per day.
In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Celestone can cause side effects, although not everybody gets them.
The side effects that occur after using Celestone solution for injection are the same as those of other corticosteroids and depend on both the dose and the duration of treatment. They usually disappear or decrease after reducing the dose without the need to discontinue treatment.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Celestone

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C. Do not freeze.
Store in the original package to protect from light.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Celestone contains

• The active substance of Celestone is betamethasone in the form of betamethasone sodium phosphate.
• One ampoule (1 ml solution) contains 4 mg of betamethasone in the form of betamethasone sodium phosphate.
• The other ingredients are: disodium edetate, disodium phosphate dihydrate, phosphoric acid (to adjust pH), water for injections.

What Celestone looks like and contents of the pack

Celestone is a solution for injection.
A clear, colorless to slightly yellowish solution, free from visible particles.
Available packs:
1 ampoule or 50 ampoules of colorless glass, 1 ml in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Organon Polska Sp. z o.o.
Marszałkowska Street 126/134
00-008 Warsaw
Tel.: +48 22 105 50 01
[email protected]
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Date of last revision of the leaflet: 11/2022