Colocort foam, enema

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal foam or enema.

Hydrocortisone rectal is used to treat hemorrhoids and itching or swelling of the rectal area caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Applies to hydrocortisone: oral suspension, oral tablet

Along with its needed effects, hydrocortisone (the active ingredient contained in Colocort) 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 immediately if any of the following side effects occur while taking hydrocortisone:

• Aggression
• anxiety
• blurred vision
• decrease in the amount of urine
• dizziness
• dry mouth
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irregular heartbeats
• irritability
• mental depression
• mood changes
• nervousness
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• restlessness
• shaking
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• trouble breathing
• troubled breathing at rest
• trouble sleeping
• weight gain

• Abdominal or stomach cramping and/or burning (severe)
• abdominal or stomach pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of the skin
• decrease in height
• decreased vision
• diarrhea
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in the back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sweating
• trouble healing
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

Some side effects of hydrocortisone 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:

• Increased appetite

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp hair

Applies to hydrocortisone: compounding powder, injectable powder for injection, injectable solution, injectable suspension, oral suspension, oral tablet, rectal foam with applicator, rectal suspension

General

Corticosteroid side effects/complications are primarily dose and duration dependent; adverse effects are infrequent with physiologic or lower pharmacologic dosages. Short-term effects have included sodium retention-related weight gain and fluid accumulation, hyperglycemia/glucose intolerance, hypokalemia, and psychic disturbances. Long-term effects have included hypothalamus-pituitary-adrenal activity suppression, Cushingoid appearance, hirsutism, impotence, menstrual irregularities, peptic ulcer disease, cataracts and increased intraocular pressure/glaucoma, myopathy, osteoporosis, and vertebral compression fractures.[Ref]

Cardiovascular

Frequency not reported: Bradycardia, cardiac arrest, cardia arrhythmias, cardiac enlargement, circulatory collapse, fat embolism, hypertension, congestive heart failure, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, thrombophlebitis, vasculitis, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, necrotising angiitis[Ref]

Endocrine

Frequency not reported: Hypothalamus-pituitary-adrenal activity has been suppressed up to 12 months following long-term corticosteroid administration, Cushingoid appearance with chronic therapy, hirsutism, virilism, impotence, menstrual irregularities, hypertrichosis, moon face, latent hyperparathyroidism, hypoparathyroidism[Ref]

An antagonism occurs between the parathyroids and hypercorticism. Latent hyperparathyroidism may be unmasked by administration of corticosteroids; hypoparathyroidism may be manifest by phosphate retention occurring in renal failure caused by adrenal insufficiency.[Ref]

Gastrointestinal

Frequency not reported: Gastrointestinal upset, nausea, vomiting, peptic ulcer disease, pancreatitis, ulcerative esophagitis, abdominal distention, gastrointestinal perforation and hemorrhage, esophageal candidiasis[Ref]

Metabolic

Rare (0.01% to 0.1%): Hypernatremia
Frequency not reported: Decreased glucose tolerance, hyperglycemia, hypokalemia, fluid retention, negative nitrogen balance due to protein catabolism, increased blood urea nitrogen concentration, sodium retention, hypokalemic alkalosis, increased appetite, weight gain, hypertriglyceridemia[Ref]

Musculoskeletal

Aseptic necrosis has been reported most often to affect the femoral head. Corticosteroid myopathy has presented as weakness and wasting of the proximal limb and girdle muscles and generally has been reversible 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]

Frequency not reported: Steroid myopathy, muscle weakness, loss of muscle mass, osteoporosis, vertebral compression fractures, tendon rupture (particularly the Achilles tendon), aseptic necrosis of bone, growth suppression in pediatric patients, Charcot-like arthropathy, post-injection flare (intra-articular use), osteonecrosis[Ref]

Immunologic

Frequency not reported: Impairment in cell-mediated immunity, increased susceptibility to bacterial, viral, fungal and parasitic infections, immunosuppression, opportunistic infections from mild to fatal, reactivation of tuberculosis[Ref]

Hepatic

Increases in serum transaminases and alkaline phosphatase have been observed with corticosteroid therapy; these laboratory changes are generally small, not associated with clinical symptoms, and are reversible upon discontinuation.[Ref]

Frequency not reported: Reversible increases in serum transaminase and alkaline phosphatase concentrations, hepatomegaly[Ref]

Hematologic

Corticosteroid therapy has been associated with a total increase in WBC; with an increase in neutrophils and a decrease in monocytes, lymphocytes, and eosinophils.[Ref]

Frequency not reported: Leukocytosis[Ref]

Dermatologic

Frequency not reported: Increased ease in bruising, ecchymosis, petechiae, delayed wound healing, acne, thin fragile skin, facial erythema, increased sweating, suppress reaction to skin testing, allergic dermatitis, burning or tingling in the perineal area after IV injection, cutaneous and subcutaneous atrophy, edema, hyperpigmentation, hypopigmentation, erythema, sterile abscess, striae, thinning scalp hair, urticaria[Ref]

Ocular

Frequency not reported: Increased intraocular pressure, glaucoma, posterior subcapsular cataracts, exophthalmos, central serous chorioretinopathy, corneal or scleral thinning, exacerbation of ophthalmic viral disease[Ref]

Psychiatric

In adults, the incidence of severe psychic reactions has been estimated to be around 5% to 6%. Psychological effects have been reported on withdrawal of corticosteroids, although the incidence is unknown.[Ref]

Frequency not reported: Psychoses, personality or behavioral changes, depression, emotional instability, euphoria, insomnia, mood swings, personality changes, psychic disorders, exacerbation of preexisting affect lability or psychotic behavior[Ref]

Hypersensitivity

Case reports of hypersensitivity reactions to corticosteroids have been relatively uncommon. Side effects have included bronchospasm, shock, urticaria, and angioedema. Cross-reactivity between aspirin and hydrocortisone (the active ingredient contained in Colocort) in patients with aspirin-sensitive respiratory disease has been suggested as the mechanism in patients with asthma, however data are controversial. Anaphylaxis has been most frequently associated with rapid injection or infusion of a high dose of corticosteroid. Reactions may be mediated by an immune or nonimmune mechanism.

Bronchospasm after intravenous hydrocortisone has been reported in some patients with aspirin-sensitive respiratory disease. A challenge study with oral aspirin followed with 100 mg hydrocortisone (IV) resulted in respiratory reactions to aspirin in 45 of 53 patients. These 45 patients then received a hydrocortisone challenge. No naso-ocular, dermal, or respiratory reactions were noted in 44 of 45 patients administered hydrocortisone. One aspirin-sensitive patient experienced bronchospasm and naso-ocular reactions to hydrocortisone and naso-ocular with minimal bronchospasm with methylprednisolone. Following aspirin desensitization and while on maintenance aspirin therapy, this patient again reacted with similar symptoms to hydrocortisone.[Ref]

Rare (0.01% to 0.1%): Hypersensitivity reaction (enema)
Frequency not reported: Anaphylaxis, anaphylactoid reaction, angioedema[Ref]

Other

Frequency not reported: Vertigo, abnormal fat deposits, malaise[Ref]

Genitourinary

Frequency not reported: Glycosuria, increased or decreased motility and number of spermatozoa

Nervous system

Frequency not reported: Convulsions, increased intracranial pressure with papilledema/pseudo-tumor cerebri (usually occurs after treatment), headache, neuritis, neuropathy, paresthesia, arachnoiditis, meningitis, paraparesis/paraplegia, sensory disturbances, epidural lipomatosis

Paresthesia, arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration. Intrathecal use is contraindicated and epidural administration is not recommended due to the occurrence of serious adverse events having been associated with these routes of administration.

Oncologic

Frequency not reported: Kaposi's sarcoma

Respiratory

Frequency not reported: Pulmonary edema, hiccups[Ref]

Some side effects of Colocort may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.