Betamethasone / Betamethasone Acetate (Celestone Soluspan)

1. Health Canada Product Monograph — Betamethasone / Betamethasone Acetate

• Given by intramuscular injection, it treats allergic, dermatologic, rheumatic, and other conditions that respond to systemic corticosteroids, including bursitis.
• Injected directly into affected soft tissue, it treats bursitis and inflammatory disorders of tendons (such as tenosynovitis) and muscle (such as fibrositis and myositis).
• Injected into or around a joint, it treats rheumatoid arthritis and osteoarthritis.
• Injected into a skin lesion, it treats various dermatologic conditions such as psoriasis, eczema, and keloids.
• Injected locally, it treats certain inflammatory and cystic disorders of the foot, such as bursitis under a corn or heel spur.

• Adequate human reproduction studies have not been done, so the possible benefits must be weighed against the risks to the mother and fetus.
• Corticosteroids cross the placenta; babies born to mothers treated with betamethasone during pregnancy should be examined for signs of adrenal insufficiency.
• A short course of betamethasone given before a late preterm delivery has been linked to an increased risk of low blood sugar in the newborn.
• This medication should not be used to manage pre-eclampsia, eclampsia, or evidence of placental damage.

• Corticosteroids pass into breast milk, so a decision should be made whether to stop breastfeeding or stop the medication, weighing the importance of treatment to the mother.

• Health Canada has not authorized a specific geriatric indication because no dedicated data are available, so use in older adults should be individualized.

• Health Canada has not authorized a specific pediatric indication because no dedicated data are available.
• Growth and development should be monitored closely in children who need prolonged corticosteroid therapy, since corticosteroids can inhibit bone growth.

• For general (systemic) effect, treatment usually starts with one intramuscular injection, repeated weekly or more often if needed; severe illness such as status asthmaticus may need a larger initial injection.
• For local effect in acute bursitis, one injection into the bursa typically relieves pain and restores movement within hours; recurrent or chronic bursitis may need repeat injections every one to two weeks.
• For joint injection in rheumatoid arthritis or osteoarthritis, the amount injected is adjusted to the size of the joint, from a very large joint like the hip down to a small joint like a finger.
• For skin lesions, a small, measured amount is injected directly into the lesion at weekly intervals, up to a defined weekly maximum.
• The suspension should be shaken well before use, and intramuscular injections should be given deep into a large muscle to avoid tissue thinning at the injection site.
• If a scheduled dose is missed, it should be given as soon as possible unless it is nearly time for the next dose, in which case the missed dose is skipped rather than doubled.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• Acute overdose is managed with supportive and symptomatic care.
• For chronic overdose in patients who still need ongoing steroid therapy for a severe underlying disease, the corticosteroid dose may only be reduced temporarily rather than stopped.
• Fluid intake should be maintained and blood sodium and potassium levels monitored, correcting any imbalance as needed.

• Increased sweating may occur.
• Facial flushing or redness may occur.
• Thinning or fragile skin may occur at or near the injection site.
• Small bruises or blood spots under the skin (petechiae and ecchymoses) may occur.
• Menstrual cycle irregularities may occur.
• Fluid retention and swelling may occur.
• Increased appetite and weight gain, with a rounded ("cushingoid") facial appearance, may develop with prolonged use.
• Mood changes, including irritability, insomnia, or euphoria, may occur.
• Headache may occur.
• Impaired wound healing may occur.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Adrenal gland suppression can develop, especially with prolonged use, and the body's ability to respond to stress such as illness, injury, or surgery may be reduced.
• High blood sugar or worsening of underlying diabetes may occur.
• Osteoporosis and an increased risk of bone fractures, including of the spine, may develop with long-term use.
• Serious infections may develop or be masked, since corticosteroids weaken the immune response.
• Peptic ulcer disease with possible bleeding or perforation may occur.
• Increased pressure in the eye, glaucoma, or cataracts may develop with prolonged use.
• Psychiatric reactions, ranging from mood swings and insomnia to severe depression or psychosis, may occur.
• Blood clots (thromboembolism) may occur.
• Muscle weakness or a steroid-related muscle disorder (myopathy) may develop.
• Serious allergic (anaphylactoid) reactions, including shock, have occurred rarely with injectable corticosteroids.
• Seek urgent medical attention for signs of infection, severe abdominal pain, vision changes, severe mood or behaviour changes, or signs of an allergic reaction such as facial swelling or difficulty breathing.

• Use with caution in patients with congestive heart failure or high blood pressure, since sodium and fluid retention can worsen these conditions.
• Use with caution in patients with active or latent peptic ulcer disease, diverticulitis, or ulcerative colitis.
• Use with caution in patients with diabetes, since blood sugar levels may rise.
• Use with caution in patients with osteoporosis or those at increased risk of it, such as postmenopausal women.
• Use with caution in patients with myasthenia gravis, since muscle weakness can worsen.
• Use with caution in patients with a current or past psychiatric condition.
• Use with caution in patients with liver disease (such as cirrhosis) or an underactive or overactive thyroid, since these change how the drug is processed.
• Avoid injecting directly into an already-infected joint, unstable joint, tendon, or the space between spinal bones.
• Use with caution in patients who have been exposed to chickenpox or measles and have not previously had these infections, since corticosteroids can make these illnesses more severe.
• Live vaccines should generally be avoided during corticosteroid treatment because of a reduced immune response and a theoretical risk from the vaccine itself.

• Contraindicated in patients with known hypersensitivity to this medication or any ingredient in the formulation.
• Contraindicated in patients with herpes simplex infection of the eye.
• Contraindicated in patients with a systemic fungal infection.
• Contraindicated in patients who have recently received a vaccinia (smallpox) vaccination.
• Contraindicated in patients with cerebral malaria.
• Contraindicated for intramuscular use in patients with idiopathic thrombocytopenic purpura.
• Contraindicated for injection into a locally infected area.

• Hepatic enzyme-inducing drugs such as phenytoin, carbamazepine, rifampin, or barbiturates can speed up the clearance of the corticosteroid and reduce its effect.
• Estrogens, including oral contraceptives, can increase corticosteroid effects, so patients on both should be monitored for excess steroid effect.
• Potassium-depleting diuretics or amphotericin B can worsen potassium loss when combined with a corticosteroid.
• Combining with digoxin and a potassium-depleting drug increases the risk of arrhythmias or digoxin toxicity related to low potassium.
• Oral anticoagulants such as warfarin may have their blood-thinning effect increased or decreased, requiring closer monitoring.
• Nonsteroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid, increase the risk of stomach ulcers and bleeding when combined with a corticosteroid.
• Antidiabetic medication doses may need adjustment, since corticosteroids can raise blood sugar.
• Corticosteroids can blunt the response to growth hormone (somatotropin) therapy.
• Aminoglutethimide can cause loss of corticosteroid-induced adrenal suppression.
• Macrolide antibiotics can reduce corticosteroid clearance, increasing its effect.
• Anticholinesterase drugs used for myasthenia gravis can cause severe weakness when combined with a corticosteroid.
• Isoniazid blood levels may be reduced by concurrent corticosteroid use.
• Cholestyramine can increase corticosteroid clearance, reducing its effect.
• Cyclosporine and corticosteroids can each increase the other's activity when used together, and convulsions have been reported with this combination.
• Strong CYP3A4 inhibitors, such as itraconazole, clarithromycin, or ritonavir, can raise corticosteroid levels and increase the risk of steroid side effects.
• Vaccines, especially live vaccines, may be less effective during corticosteroid therapy, and routine vaccination should be deferred if possible until treatment ends.
• Alcohol consumed together with a corticosteroid can raise the risk or severity of stomach ulcers.

• Not applicable. Betamethasone / Betamethasone Acetate is given by injection, not taken orally, so food does not affect its absorption or use.

• The timing of injections is determined by the treating clinician based on the condition being treated and the response to previous doses, rather than by time of day or meals.

• Store at 25°C, with excursions between 2°C and 30°C permitted; protect from light.

• Betamethasone / Betamethasone Acetate is a corticosteroid given by injection to reduce inflammation and allergic symptoms in the joints, muscles, skin, and other tissues.
• Tell every healthcare provider you see that you have received corticosteroid injections, since this can affect how your body responds to stress, infection, or surgery.
• Report any signs of infection, severe pain, vision changes, or mood changes to your doctor promptly, since these can indicate a serious reaction.