Solu-Cortef Act-O-Vial (PF) 1,000 mg/8 mL solution for injection

Generic name:
Hydrocortisone sodium succinate - injection

Pronunciation
(HYE-droe-KOR-ti-sone SOE-dee-um SUX-i-nate)

Brand name(s)
A-Hydrocort , Solu-Cortef

This medication is used to treat various conditions such as arthritis, severe allergies, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, and skin diseases. It weakens your immune system's response to various diseases to reduce symptoms such as swelling and allergic-type reactions. Hydrocortisone may also be used with other medications to replace certain hormones if you have decreased adrenal gland function or Addison's disease. Hydrocortisone belongs to a class of drugs known as corticosteroids.

Hydrocortisone injection is used when a similar drug cannot be taken by mouth or when a very fast treatment is needed for patients with severe medical conditions. Talk to your doctor about the risks and benefits of hydrocortisone, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Hydrocortisone may also be used for COVID-19, but is only effective in hospitalized patients who need supplemental oxygen or a mechanical ventilator to breathe.

This medication is given by slow injection into a vein or directly into a muscle, as directed by your doctor. The dosage is based on your medical condition and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Do not stop using this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.

Tell your doctor if you do not get better or if you get worse.

Stomach upset, headache, dizziness, trouble sleeping, appetite changes, menstrual period changes, acne, or pain/redness/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This medication may make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Tell your doctor right away if you have any serious side effects, such as:

• weakness
• puffy face
• muscle pain/cramps
• unusual weight gain
• slow wound healing
• thinning skin
• bone/joint pain
• mental/mood changes (such as depression, mood swings, agitation)
• easy bruising/bleeding
• vision problems
• swelling ankles/feet/hands
• fast/slow/irregular heartbeat
• unusual hair/skin growth
• red/purple spots on the skin

Get medical help right away if you have any very serious side effects, such as:

• symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds)
• seizures

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, such as:

• 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using hydrocortisone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• bleeding problems
• blood clots
• bone loss (osteoporosis)
• diabetes
• certain eye diseases (such as cataracts, glaucoma, herpes infection of the eye)
• heart problems (such as heart failure, recent heart attack)
• high blood pressure
• current/past infections (such as those caused by fungus, herpes, tuberculosis, threadworm)
• kidney disease
• liver disease (such as hepatitis B)
• mental/mood conditions (such as psychosis, anxiety, depression)
• stomach/intestinal problems (such as diverticulitis, ulcer, ulcerative colitis)
• seizures
• thyroid problems
• mineral imbalance (such as low levels of potassium or calcium in the blood)
• a certain adrenal gland tumor (pheochromocytoma)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages.

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

This medication may mask signs of infection. It can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using hydrocortisone before having any immunizations, vaccinations, or skin tests. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

During pregnancy, this medication should be used only when clearly needed. It may rarely harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who use this medication for a long time may have hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (such as prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aldesleukin
• desmopressin
• mifepristone
• other drugs that can cause bleeding/bruising (such as antiplatelet drugs like clopidogrel, NSAIDs like ibuprofen/naproxen, "blood thinners" like warfarin/dabigatran)

Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.

This medication may interfere with certain lab tests (such as skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you use this medication for a long time, lab and/or medical tests (such as blood counts, blood sugar/mineral levels, blood pressure, bone density tests, height/weight measurements, eye exams, X-rays) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

This medication may cause bone problems (osteoporosis) when used for a long time. Lifestyle changes that may help reduce the risk of bone problems include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Talk with your doctor about lifestyle changes that might benefit you.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store the vials at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. After the medication is mixed in solution in the vial, the drug may be kept at room temperature for up to 72 hours if protected from light. Consult your pharmacist for details. Discard any unused liquid.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.