SoluCORTEF

In the U.S.

• A-Hydrocort
• SoluCORTEF

Available Dosage Forms:

• Solution
• Suspension
• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone injection in children older than 1 month of age. However, safety and efficacy have not been established in children 1 month of age and younger.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocortisone injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in the dose for patients receiving this medicine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide 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 required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Bemiparin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Choline Salicylate
• Clonixin
• Cobicistat
• Conivaptan
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Netupitant
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

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

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Eye infection (eg, 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 (eg, bacteria, virus) or
• Infestation (eg, 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 (eg, diverticulitis, ulcerative colitis) or
• Tuberculosis, inactive or
• Weak immune system (eg, Kaposi sarcoma)—Use with caution. May make these conditions worse.

• Fungal infections—Should not be given in patients with these conditions.

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to SoluCORTEF. Please read with care.

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.

Along with its needed effects, a medicine 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:

• 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 in breathing
• unusual tiredness or weakness
• unusual weight loss
• vomit that looks like coffee grounds

Other side effects not listed may also occur 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.