Solu-Cortef

What is Solu-Cortef used for?

Solu-Cortef is a medication that is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that Solu-Cortef may be used for. Talk with the doctor.

Description

SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.

100 mg Plain

Vials containing hydrocortisone sodium succinate equivalent to 100 mg hydrocortisone, 0.8 mg monobasic sodium phosphate anhydrous, 8.73 mg dibasic sodium phosphate dried. SOLU-CORTEF 100 mg plain does not contain diluent .

ACT-O-VIAL® System (Single-Dose Vial) in four strengths:

	100 mg ACT-O-VIAL	250 mg ACT-O-VIAL	500 mg ACT-O-VIAL	1000 mg ACT-O-VIAL
	Each 2 mL contains (when mixed):	Each 2 mL contains (when mixed):	Each 4 mL contains (when mixed):	Each 8 mL contains (when mixed):
Hydrocortisone sodium succinate	equiv. to 100 mg Hydrocortisone	equiv. to 250 mg Hydrocortisone	equiv. to 500 mg Hydrocortisone	equiv. to 1000 mg Hydrocortisone
Monobasic sodium phosphate anhydrous	0.8 mg	2 mg	4 mg	8 mg
Dibasic sodium phosphate dried	8.73 mg	21.8 mg	44 mg	87.32 mg

The diluent, as part of the packaging presentation for the ACT-O-VIAL® system, is comprised of Water for Injection only, and does not contain any preservative.

When necessary, the pH of each formula was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7 to 8.

The chemical name for hydrocortisone sodium succinate is pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy-, monosodium salt, (11β)- and its molecular weight is 484.52.

The structural formula is represented below:

Hydrocortisone sodium succinate is a white or nearly white, odorless, hygroscopic amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone, and insoluble in chloroform.

Before taking Solu-Cortef, tell your doctor:

• If you are allergic to Solu-Cortef; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: A fungal infection or malaria infection in the brain.
• If you have a herpes infection of the eye.
• If you have nerve problems in the eye.
• If you have low platelet levels.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Solu-Cortef with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Solu-Cortef?

• Tell all of your health care providers that you take Solu-Cortef. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like Solu-Cortef. Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have your eye pressure checked if you are on Solu-Cortef for a long time. Talk with your doctor.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Solu-Cortef may either raise the chance of an infection or make the vaccine not work as well.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely. Tell your doctor if you get signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Talk with your doctor before you drink alcohol.
• You may need to lower how much salt is in your diet and take extra potassium. Talk with your doctor.
• If you are 65 or older, use Solu-Cortef with care. You could have more side effects.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• If you used Solu-Cortef when you were pregnant, tell your baby’s doctor.
• Very bad health problems have happened when drugs like this one have been given into the spine (epidural). These include paralysis, loss of eyesight, stroke, and sometimes death. It is not known if drugs like this one are safe and effective when given into the spine. These drugs are not approved for this use. Talk with the doctor.

How is Solu-Cortef best taken?

Use Solu-Cortef as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle or vein.
• If you have been taking Solu-Cortef for many weeks, talk with your doctor before stopping. You may want to slowly stop Solu-Cortef.
• This medicine may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Solu-Cortef that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of Cushing’s disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped Solu-Cortef.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Bone or joint pain.
• Period (menstrual) changes.
• Chest pain or pressure.
• Change in eyesight, eye pain, or very bad eye irritation.
• Change in the way you act.
• Depression or other mood changes.
• Seizures.
• Any unexplained bruising or bleeding.
• Very bad belly pain.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• If you have or may have a condition called pheochromocytoma, talk with your doctor. Very bad and sometimes deadly effects have been seen in patients with this condition who use this type of drug.

What are some other side effects of Solu-Cortef?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Trouble sleeping.
• Restlessness.
• Sweating a lot.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Solu-Cortef?

• If you need to store Solu-Cortef at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – 100 MG SINGLE-DOSE VIAL CARTON

PRINCIPAL DISPLAY PANEL – 250 MG SINGLE-DOSE VIAL LABEL

• Single-Dose Vial
  2 mL Act-O-Vial®
  NDC 0009-0013-05
• Solu-Cortef®
  (hydrocortisone sodium
  succinate for injection, USP)
• 250 mg/vial
• For IM or IV use
  Preservative-Free
  Rx only

SRC: NLM .