A-Hydrocort

Name: A-Hydrocort

Precautions While Using A-Hydrocort

It is very important that your doctor check the progress of you or your child closely while you are receiving this medicine to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor right away if you have more than one of these symptoms while you are 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 cause you to get more infections than usual. Avoid 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 start to have fever, chills, sore throat, or any other signs of an infection, call your doctor right away.

If you are using this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

This medicine may increase your risk of having broken bones (fractures) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have an increased risk for osteoporosis. If your child is using this medicine, tell the doctor if you think your child is not growing properly.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

While you are being treated with hydrocortisone, do not have any immunizations (vaccines) without your doctor's approval. Hydrocortisone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

This medicine may cause changes in mood or behavior for some patients. Tell your doctor right away if you have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while taking this medicine.

Check with your doctor right away if you feel muscle pain, tenderness, and an increase in muscle weakness while taking this medicine.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain skin tests.

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

How is A-Hydrocort Supplied

A-Hydrocort sterile powder is available in the following package:

NDC

Container

Concentration

0409-4856-15

Single-Dose Vial

100 mg

STORAGE CONDITIONS

Store unreconstituted product at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Store solution at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light.

Use solution only if it is clear. Unused solution should be discarded after 3 days.

Lyophilized in container.

Revised: April, 2008

Printed in USA

EN-1768

Hospira, Inc., Lake Forest, IL 60045 USA

Rl-2526

A-Hydrocort 
hydrocortisone sodium succinate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0409-4856
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE SODIUM SUCCINATE (HYDROCORTISONE) HYDROCORTISONE SODIUM SUCCINATE 100 mg  in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS 0.8 mg  in 2 mL
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 8.73 mg  in 2 mL
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:0409-4856-05 10 VIAL, SINGLE-DOSE (10 VIAL) in 1 CARTON
1 2 mL in 1 VIAL, SINGLE-DOSE
2 NDC:0409-4856-15 25 VIAL, SINGLE-DOSE (25 VIAL) in 1 TRAY
2 2 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040666 05/12/2011
Labeler - Hospira, Inc. (141588017)
Revised: 05/2011   Hospira, Inc.

Side effects

Stomach upset, headache, dizziness, menstrual period changes, trouble sleeping, increased appetite, weight gain, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.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.

Drug interactions

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 (including 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 include: aldesleukin, birth control pills/patch/ring, drugs for diabetes, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen), estrogens, mifepristone, drugs affecting liver enzymes that remove hydrocortisone from your body (e.g., aprepitant, azole antifungals such as ketoconazole, rifamycins such as rifampin, certain anti-seizure medications such as phenytoin and phenobarbital), herbal products (e.g., licorice).If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This medication may interfere with certain laboratory tests (including skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Notes

Do not share this medication with others.Laboratory and/or medical tests (e.g., blood counts, blood glucose/mineral levels, blood pressure, bone density tests, height/weight measurements, eye examinations, X-rays) should be performed periodically to monitor your progress or check for side effects during long-term treatment. Consult your doctor for more details.Lifestyle changes that help reduce the risk of bone loss (osteoporosis) during long-term treatment include doing weight-bearing exercise, getting adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Talk with your doctor about lifestyle changes that might benefit you.If you use this medication for prolonged periods, you should wear or carry identification stating that you are using it.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom.After mixing and dilution, 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.

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How should this medicine be used?

Hydrocortisone injection comes as powder to be mixed with liquid to be injected intramuscularly (into a muscle) or intravenously (into a vein). Your dosing schedule will depend on your condition and on how you respond to treatment.

You may receive hydrocortisone injection in a hospital or medical facility, or you may be given the medication to use at home. If you will be using hydrocortisone injection at home, your healthcare provider will show you how to inject the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems using hydrocortisone injection.

Your doctor may change your dose of hydrocortisone injection during your treatment to be sure that you are always using the lowest dose that works for you. Your doctor may also need to change your dose if you experience unusual stress on your body such as surgery, illness, or infection. Tell your doctor if your symptoms improve or get worse or if you get sick or have any changes in your health during your treatment.

Manufacturer

  • Abbott Hospital Products

  • Hospira, Inc.

For the Consumer

Applies to hydrocortisone: oral suspension, oral tablet

Along with its needed effects, hydrocortisone (the active ingredient contained in A-Hydrocort) 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 immediately if any of the following side effects occur while taking hydrocortisone:

More common
  • Aggression
  • anxiety
  • blurred vision
  • decrease in the amount of urine
  • dizziness
  • dry mouth
  • fast, slow, pounding, or irregular heartbeat or pulse
  • headache
  • irregular heartbeats
  • irritability
  • mental depression
  • mood changes
  • nervousness
  • noisy, rattling breathing
  • numbness or tingling in the arms or legs
  • pounding in the ears
  • restlessness
  • shaking
  • swelling of the fingers, hands, feet, or lower legs
  • trouble thinking, speaking, or walking
  • trouble breathing
  • troubled breathing at rest
  • trouble sleeping
  • weight gain
Incidence not known
  • Abdominal or stomach cramping and/or burning (severe)
  • abdominal or stomach pain
  • backache
  • bloody, black, or tarry stools
  • cough or hoarseness
  • darkening of the skin
  • decrease in height
  • decreased vision
  • diarrhea
  • eye pain
  • eye tearing
  • facial hair growth in females
  • fainting
  • fever or chills
  • flushed, dry skin
  • fractures
  • fruit-like breath odor
  • full or round face, neck, or trunk
  • heartburn or indigestion (severe and continuous)
  • increased hunger
  • increased thirst
  • increased urination
  • loss of appetite
  • loss of sexual desire or ability
  • lower back or side pain
  • menstrual irregularities
  • muscle pain or tenderness
  • muscle wasting or weakness
  • nausea
  • pain in the back, ribs, arms, or legs
  • painful or difficult urination
  • skin rash
  • sweating
  • trouble healing
  • unexplained weight loss
  • unusual tiredness or weakness
  • vision changes
  • vomiting
  • vomiting of material that looks like coffee grounds

Some side effects of hydrocortisone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Increased appetite
Incidence not known
  • Abnormal fat deposits on the face, neck, and trunk
  • acne
  • dry scalp
  • lightening of normal skin color
  • red face
  • reddish purple lines on the arms, face, legs, trunk, or groin
  • swelling of the stomach area
  • thinning of the scalp hair

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