SoluCORTEF (Injection)

Hydrocortisone is used to treat certain medical conditions, including inflammation (swelling), severe allergic reactions, kidney diseases, adrenal problems, arthritis, asthma, blood or bone marrow issues, eye or vision problems, lupus, skin conditions, and ulcerative colitis.

Hydrocortisone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help reduce swelling, redness, itching, and allergic reactions.

This medicine should only be given by or under the supervision of a doctor.

It is very important that your doctor closely monitors you or your child while you are taking this medicine to ensure it is working properly. Blood and urine tests may be necessary to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Using too much of this medicine or using it for a long time may increase your risk of adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

This medicine may make you more likely to get infections than usual. Avoid contact with people who are sick or have infections, and wash your hands often. If you are exposed to chickenpox or measles, tell your doctor right away. If you develop fever, chills, sore throat, or any other signs of an infection, call your doctor immediately.

If you are using this medicine for a long time, inform your doctor about any additional stress or anxiety you may be experiencing, including other health issues and emotional stress. Your dose of this medicine might need to be adjusted temporarily during times of extra stress.

This medicine may increase your risk of broken bones (fractures) or slow growth in children if used long-term. Inform your doctor if you experience any bone pain or if you are at increased risk for osteoporosis. If your child is using this medicine, let the doctor know if you believe your child is not growing properly.

Contact your doctor right away if you experience blurred vision, difficulty reading, eye pain, or any other changes in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor).

While being treated with hydrocortisone, do not receive any immunizations (vaccines) without your doctor's approval. Hydrocortisone may weaken your immune system, making the vaccine less effective or increasing the risk of getting the infection the vaccine is meant to prevent. Additionally, avoid close contact with anyone in your household who receives live virus vaccines, as they could potentially pass the virus to you. Examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Keep your distance from them and do not stay in the same room for long. If you have questions about this, consult your doctor.

This medicine may cause mood or behavior changes in some patients. Inform your doctor right away if you experience depression, mood swings, an unusual sense of well-being, trouble sleeping, or personality changes while using this medicine.

Check with your doctor immediately if you feel muscle pain, tenderness, and increased muscle weakness while on this medicine.

Ensure that any doctor or dentist treating you is aware that you are using this medicine. It may affect the results of certain skin tests.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children older than 1 month that would limit the use of hydrocortisone injection. However, safety and effectiveness have not been established for children 1 month of age and younger.

Geriatric

Studies performed to date have not found any specific problems in elderly patients that would limit the usefulness of hydrocortisone injection. However, older patients may have age-related liver, kidney, or heart issues, which might require careful dosing for those receiving this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted for their importance, but this list may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Abametapir
• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Aspirin
• Atazanavir
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Choline Salicylate
• Ciprofloxacin
• Clonixin
• Cobicistat
• Conivaptan
• Darunavir
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Enoxacin
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fosnetupitant
• Gatifloxacin
• Gemifloxacin
• Ibuprofen
• Indomethacin
• Itraconazole
• Ketoprofen
• Ketorolac
• Lenacapavir
• Levofloxacin
• Lomefloxacin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Norfloxacin
• Ofloxacin
• Omaveloxolone
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Alcuronium
• Atracurium
• Auranofin
• Colestipol
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Rifapentine
• Saiboku-To

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtimes, as interactions may happen. Using alcohol or tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Bleeding problem (e.g., idiopathic thrombocytopenic purpura) or
• Fungal infections—Should not be given to patients with these conditions.

• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Eye infection (e.g., herpes infection of the eyes) or
• Glaucoma or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Hypothyroidism (underactive thyroid) or
• Infection (e.g., bacteria, virus) or
• Infestation (e.g., worm, larva) or
• Kidney disease or
• Liver disease (including cirrhosis) or
• Mental health problems, history of or
• Mood changes, including depression or
• Myasthenia gravis (severe muscle weakness) or
• Osteoporosis (weak bones) or
• Peptic ulcer, active or history of or
• Pheochromocytoma (adrenal tumor) or
• Stomach or intestinal problems (e.g., diverticulitis, ulcerative colitis) or
• Tuberculosis, inactive or
• Weak immune system (e.g., Kaposi sarcoma)—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Acne
• back pain
• bloody or black tarry stools
• bone pain, tenderness, or aching
• chest pain or discomfort
• chills
• cough
• darkening or lightening of skin color
• discouragement
• eye pain and blurred vision
• facial hair growth in females
• fast, pounding, or irregular heartbeat or pulse
• fast, slow, or irregular breathing
• feeling sad or empty
• fever
• fractures
• full or round face, neck, or trunk
• general feeling of illness
• headache
• heartburn, indigestion
• increased appetite
• increased fat deposits on the face, neck, and trunk
• increased hair growth on the face, forehead, back, arms, and legs
• increased sweating, thirst, urination
• irritability
• itching
• lightheadedness, dizziness, or fainting
• loss of appetite
• loss of interest or pleasure
• loss of sexual desire or ability
• menstrual irregularities
• muscle wasting and weakness
• seizures
• severe and continuing nausea
• skin rash
• slow wound healing
• sore throat
• stomach pain and cramping
• swelling of eyes or eyelids
• thinning of the scalp hair
• tightness in chest
• tiredness
• trouble concentrating
• trouble breathing
• unusual tiredness or weakness
• unusual weight loss
• vomit that looks like coffee grounds

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• A-Hydrocort
• SoluCORTEF

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in a vein or as a shot into a muscle.

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