"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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Solu Cortef Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Solu-Cortef (hydrocortisone sodium succinate) is used to treat various conditions such as severe allergic reactions, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases. Hydrocortisone is a corticosteroid hormone (glucocorticoid). Some strengths of this medication are available in generic form. Common side effects include stomach upset, headache, dizziness, menstrual period changes, trouble sleeping, increased appetite, weight gain, or pain/redness/swelling at the injection site.
The initial dose of Solu-Cortef is 100 mg to 500 mg, depending on the specific disease being treated. This dose may be repeated at intervals of 2, 4 or 6 hours depending on patient response and condition. Solu-Cortef may interact with aspirin and salicylates, birth control, blood thinners, bupropion, drugs for diabetes, drugs that cause potassium loss, estrogens, mifepristone, natalizumab, non-steroidal anti-inflammatory drugs (NSAIDs), antibiotics, azole antifungals, rifamycins, anti-seizure medications, or herbal products. Tell your doctor all medications you are taking. Solu-Cortef should be used only when prescribed during pregnancy. Infants born to mothers using this medication may have low levels of corticosteroid hormone. Tell your doctor if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. This medication passes into breast milk. Although there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.
Our Solu-Cortef (hydrocortisone sodium succinate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Solu Cortef Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: bone/joint pain, easy bruising/bleeding, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, increased thirst/urination, fast/slow/pounding/irregular heartbeat, shortness of breath, swelling of the ankles/feet, tendon pain, persistent weight gain, puffy face, unusual hair growth, thinning skin, slow wound healing, signs of infection (e.g., persistent fever/cough/sore throat, painful urination, eye pain/discharge), muscle weakness/pain, mental/mood changes (e.g., mood swings, depression, agitation), vision changes, seizures, unusual skin growths.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Solu Cortef (Hydrocortisone Sodium Succinate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Solu Cortef FDA Prescribing Information: Side Effects
The following adverse reactions have been reported with SOLU-CORTEF or other corticosteriods:
Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic: Acne, allergic dermatitis, burning or tingling (especially in the perineal area, after intravenous injection), cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.
Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.
Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.
Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.
Metabolic: Negative nitrogen balance due to protein catabolism.
Musculoskeletal: Aseptic necrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures.
Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration (see WARNINGS, Neurologic).
Ophthalmic: Exophthalmoses, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections.
Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, injection site infections following non-sterile administration (see WARNINGS), malaise, moon face, weight gain.
Read the entire FDA prescribing information for Solu Cortef (Hydrocortisone Sodium Succinate) »
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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