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Celestone Soluspan Side Effects

Generic Name: betamethasone

Note: This document contains side effect information about betamethasone. Some of the dosage forms listed on this page may not apply to the brand name Celestone Soluspan.

For the Consumer

Applies to betamethasone: injection suspension

Along with its needed effects, betamethasone (the active ingredient contained in Celestone Soluspan) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking betamethasone:

Incidence Not Known

  • Blindness
  • bloating
  • bloody or black, tarry stools
  • blue lips and fingernails
  • blurred vision
  • bone pain
  • bowel or bladder dysfunction
  • bulging soft spot on the head of an infant
  • change in ability to see colors, especially blue or yellow
  • changes in skin color, pain, tenderness, or swelling of the foot or leg
  • chest pain or discomfort
  • chills
  • constipation
  • cough
  • coughing that sometimes produces a pink frothy sputum
  • darkened urine
  • decrease in height
  • decrease in the amount of urine
  • decreased urine
  • decreased vision
  • difficult, fast, noisy breathing
  • difficulty swallowing
  • dilated neck veins
  • discouragement
  • dry mouth
  • extreme tiredness or weakness
  • eye pain
  • eyeballs bulge out of the eye sockets
  • fast, pounding, or irregular heartbeat or pulse
  • feeling sad or empty
  • fever
  • general feeling of discomfort or illness
  • headache
  • hives, skin rash
  • impaired wound healing
  • increased sweating
  • increased thirst
  • indigestion
  • irregular breathing
  • irritability
  • lack of appetite
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • mood changes
  • muscle cramp, pain, tenderness, wasting, or weakness
  • nausea
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain in the back, ribs, arms, or legs
  • pain in the chest, groin, or legs, especially the calves
  • painful, swollen joints
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness, soreness, or itching skin
  • right upper abdominal pain and fullness
  • seizures
  • severe, sudden headache
  • slow heartbeat
  • slurred speech
  • sores, welts, or blisters
  • stomach distention
  • stomach pain or burning
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • swelling of the face, fingers, feet, or lower legs
  • tearing
  • tightness in the chest
  • trouble concentrating
  • trouble sleeping
  • troubled breathing at rest
  • unusual tiredness or weakness
  • vision changes
  • vomiting
  • weight gain
  • yellow eyes or skin

Some side effects of betamethasone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence Not Known

  • Abnormal fat deposits
  • darkening or lightening of normal skin color
  • dry, scaly skin
  • increased appetite
  • increased sweating
  • lightening of treated areas of dark skin
  • moon face
  • thinning hair
  • weight gain

For Healthcare Professionals

Applies to betamethasone: compounding powder, injectable solution, injectable suspension, oral syrup, oral tablet

General

Corticosteroid complications are primarily dose and duration of therapy dependent. Adverse effects have occurred less frequently at physiologic or lower pharmacologic dosages.

Adverse effects associated with duration of corticosteroid therapy include those occurring during short-term therapy (up to three weeks) or those occurring during long-term therapy (greater than three weeks).

Short-term effects have included sodium retention-related weight gain and fluid accumulation, hyperglycemia and glucose intolerance, hypokalemia, gastrointestinal upset and ulceration, reversible depression of the hypothalamic-pituitary-adrenal axis, and mood changes including mild euphoria and insomnia, nervousness, restlessness, mania, catatonia, depression, delusions, hallucinations, and violent behavior.

Long-term effects have included hypothalamic-pituitary-adrenal activity suppression, Cushingoid appearance, hirsutism or virilism, impotence, menstrual irregularities, peptic ulcer disease, cataracts and increased intraocular pressure/glaucoma, myopathy, osteoporosis, and vertebral compression fractures.[Ref]

Cardiovascular

Cardiovascular side effects have included hypertension and congestive heart failure due to long-term fluid retention as well as direct vascular effects.[Ref]

Endocrine

Endocrine side effects have included decreased glucose tolerance and hyperglycemia resulting in diabetes-like symptoms. Hypothalamic-pituitary-adrenal activity has been suppressed up to 12 months following long-term corticosteroid administration. Cushingoid appearance commonly has occurred with chronic therapy. Hirsutism or virilism, impotence, and menstrual irregularities may occur.[Ref]

Corticosteroid therapy may induce glucose intolerance by reducing the utilization of glucose in tissues and increasing hepatic glucose output. Diabetes mellitus requiring diet modifications and hypoglycemic agents has developed in some patients.

Adrenal suppression can persist for up to twelve months after long-term corticosteroid therapy. Giving corticosteroids once a day or once every other day may reduce adrenal suppression. After corticosteroid therapy has been tapered, supplemental corticosteroid therapy during times of physical stress may be required.[Ref]

Gastrointestinal

Gastrointestinal side effects have included gastrointestinal upset, nausea, vomiting, and peptic ulcer disease. Pancreatitis, ulcerative esophagitis, gastrointestinal perforation, and hemorrhage also have been reported.[Ref]

Gastrointestinal effects have most commonly included nausea, vomiting, dyspepsia, and anorexia. Peptic ulcer disease has been associated with long-term corticosteroid therapy, but is relatively uncommon. Routine prophylactic therapy was not warranted in all individuals. Aluminum/magnesium-containing antacids generally have been used to manage GI complaints without significant drug interactions.[Ref]

Metabolic

Metabolic side effects have included hypernatremia (rare), hypokalemia, fluid retention, negative nitrogen balance and increased blood urea nitrogen concentration. Glucocorticoids have been reported to decrease the secretion of thyrotropin (TSH).[Ref]

Musculoskeletal

Musculoskeletal side effects have included myopathy, osteoporosis, vertebral compression fractures, tendon rupture (particularly the Achilles tendon), and aseptic necrosis of bone. Aseptic necrosis has been reported most often to affect the femoral head.[Ref]

Corticosteroid myopathy has presented as weakness and wasting of the proximal limb and girdle muscles and generally has resolved following cessation of therapy.

Corticosteroids inhibit intestinal absorption and increase urinary excretion of calcium leading to bone resorption and bone loss. Postmenopausal females are at risk of loss of bone density. Sixteen percent of elderly patients treated with corticosteroids for 5 years may experience vertebral compression fractures.[Ref]

Immunologic

Immunologic side effects have included impairment in cell-mediated immunity and increased susceptibility to bacterial, viral, fungal and parasitic infections. Immune response to skin tests has been suppressed. Rare cases of anaphylaxis have been reported in patients receiving parenteral corticosteroids.[Ref]

Ocular

Ocular side effects have included increased intraocular pressure, glaucoma, and posterior subcapsular cataracts.[Ref]

One study reviewing the use of intranasal steroids in 286,078 patients found no increased risk of cataracts.[Ref]

Dermatologic

Dermatologic side effects have included an increased ease in bruising, ecchymosis, petechiae striae, delayed wound healing, and acne.[Ref]

Psychiatric

Psychiatric side effects have included psychoses, personality or behavioral changes, and pseudotumor cerebri.[Ref]

Hematologic

Hematologic side effects have included thrombocytopenia, lymphopenia, and platelet alterations resulting in thrombolic events.[Ref]

Other

Pseudorheumatism or glucocorticoid-withdrawal syndrome not related to adrenal insufficiency has occurred on withdrawal of corticosteroids. Patients experienced anorexia, nausea, vomiting, lethargy, headache, fever, arthralgias, myalgias, and postural hypotension. Symptoms resolved when corticosteroid therapy was reinstated.[Ref]

References

1. Thomas TP "The complications of systemic corticosteroid therapy in the elderly." Gerontology 30 (1984): 60-5

2. Seale JP, Compton MR "Side-effects of corticosteroid agents." Med J Aust 144 (1986): 139-42

3. "Product Information. Celestone (betamethasone)." Schering Corporation, Kenilworth, NJ.

4. Klepikov PV, Kutyrina IM, Tareyeva IE "Steroid-induced hypertension in patients with nephrotic syndrome." Nephron 48 (1988): 286-90

5. Swartz SL, Dluhy RG "Corticosteroids: clinical pharmacology and therapeutic use." Drugs 16 (1978): 238-55

6. Cunliffe WJ, Burton JL, Holti G, Wright V "Hazards of steroid therapy in hepatic failure." Br J Dermatol 93 (1975): 183-5

7. Downie WW, Dixon JS, Lowe JR, Rhind VM, Leatham PA, Pickup ME "Adrenocortical suppression by synthetic corticosteroid drugs: a comparative study of prednisolone and betamethasone." Br J Clin Pharmacol 6 (1978): 397-9

8. Lamberts SE, Bruining HA, De Jong FH "Corticosteroid therapy in severe illness." N Engl J Med 337 (1997): 1285-92

9. Zaynoun ST, Salti IS "The effect of intracutaneous glucocorticoids on plasma cortisol levels." Br J Dermatol 88 (1973): 151-6

10. Tsuruoka S, Sugimoto K, Fujimura A "Drug-induced Cushing syndrome in a patient with ulcerative colitis after betamethasone enema: Evaluation of plasma drug concentration." Ther Drug Monit 20 (1998): 387-9

11. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94

12. Mizuta H, Kubota K, Shiraishi M, Kai K, Nakamura E, Takagi K "Steroid-related bilateral osteonecrosis of the patella." Arthroscopy 9 (1993): 114-6

13. Ledford D, Apter A, Brenner AM, Rubin K, Prestwood K, Frieri M, Lukert B "Osteoporosis in the corticosteroid-treated patient with asthma." J Allergy Clin Immunol 102 (1998): 353-62

14. Need AG, Philcox JC, Hartley TF, Nordin BE "Calcium metabolism and osteoporosis in cortiscosteroid-treated postmenopausal women." Aust N Z J Med 16 (1986): 341-6

15. Kitazawa Y "Increased intraocular pressure induced by corticosteroids." Am J Ophthalmol 82 (1976): 492-5

16. Debnath SC, Abomelha MS, Jawdat M, et al "Ocular side effects of systemic steroid therapy in renal transplant patients." Ann Ophthalmol 19 (1987): 435-7

17. Derby L, Maier WC "Risk of cataract among users of intranasal corticosteroids." J Allerg Clin Immunol 105 (2000): 912-6

18. McDonnell PJ, Kerr Muir MG "Glaucoma associated with systemic corticosteroid therapy." Lancet 08/17/85 (1985): 386-7

19. Leigh IM, Sanderson KV "Cutaneous changes produced by prolonged systemic steroid therapy." Br J Dermatol 101 Suppl (1979): 71-3

20. Klein JF "Adverse psychiatric effects of systemic glucocorticoid therapy." Am Fam Physician 46 (1992): 1469-74

21. Hoff DA, Mammel MC "Suspected betamethasone-induced leukemoid reaction in a premature infant." Pharmacotherapy 17 (1997): 1031-4

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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