Hydrocortisone (Oral)

Hydrocortisone helps reduce inflammation in different parts of the body. It is used to treat various conditions, including inflammation (swelling), severe allergies, adrenal issues, arthritis, asthma, blood or bone marrow disorders, eye or vision issues, lupus, skin conditions, and ulcerative colitis. Hydrocortisone is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help ease swelling, redness, itching, and allergic reactions.

This medicine is available only with your doctor's prescription.

If you will be taking this medicine for a long time, it is very important that your doctor checks you regularly for any side effects that may be caused by this medicine. Blood or urine tests may be needed to check for side effects.

Not taking enough or stopping Alkindi® Sprinkle, or switching from other hydrocortisone medicine may cause serious adrenal gland problems (e.g., adrenal crisis). Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, joint pain, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems (e.g., Cushing's syndrome). Talk to your doctor right away if you have blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

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 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 a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

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. These may be symptoms of eye or vision problems (e.g., cataracts, glaucoma, central serous chorioretinopathy). 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 people 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 sleeping, or personality changes while taking this medicine.

This medicine might cause thinning of the bones (osteoporosis) 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.

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.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against its potential benefits. Here are some important points to consider:

Allergies

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

Pediatric

Research so far has not shown any specific problems in children that would limit the use of hydrocortisone oral granules. Its safety and effectiveness have been confirmed.

There is no information available on how age affects the use of hydrocortisone tablets in children. Its safety and effectiveness have not been confirmed.

Geriatric

There is no information available on how age affects the use of hydrocortisone in older patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might occur. In these cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medicine or may adjust your other medications.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both 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 necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the same time as eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Make sure to tell your doctor about any other medical issues, especially:

• 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
• Hypothyroidism (underactive thyroid) or
• Infection (e.g., bacterial, virus, or fungus) or
• Liver disease (including cirrhosis) or
• Mood changes, including depression or
• Myasthenia gravis (severe muscle weakness) or
• Osteoporosis (weak bones) or
• Peptic ulcer, active or history of or
• Personality changes 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.

• Fever or
• Infection (e.g., gastroenteritis) or
• Stress or
• Surgery or
• Trauma—Use with caution. May increase risk for serious side effects.

• Fungal infections—Should not be used in patients with 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 immediately if any of the following side effects occur:

More common

• Aggression
• anxiety
• blurred vision
• burning, dry, or itching eyes
• decrease in the amount of urine
• discharge, excessive tearing
• dizziness
• dry mouth
• ear congestion
• fast, slow, pounding, or irregular heartbeat or pulse
• fever
• headache
• irregular heartbeats
• irritability
• mental depression
• mood changes
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• redness, pain, swelling of eye, eyelid, or inner lining of the eyelid
• restlessness
• runny or stuffy nose
• shaking
• sneezing
• sore throat
• swelling of the fingers, hands, feet, or lower legs
• trouble breathing
• trouble sleeping
• trouble thinking, speaking, or walking
• unusual tiredness or weakness
• weight gain

Incidence not known

• 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, tenderness, wasting, or weakness
• nausea
• pain in the back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• stomach pain or cramps
• sweating
• trouble healing
• unexplained weight loss
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

Some side effects may happen 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

• Hives
• increased appetite
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, or lips

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

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.

In the U.S.

• Alkindi Sprinkle
• Cortef

Available Dosage Forms:

• Tablet
• Granule

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

This medicine comes with a Medication Guide. Read and follow these instructions carefully.

The oral granules are contained within capsules. Do not swallow the capsule. Do not chew or crush the granules. Do not let the capsules get wet because some of the granules may stick to the capsule. Do not give the granules through a nasogastric or gastric tube because it may block the tube.

If you are switching from other oral hydrocortisone medicine to Alkindi® Sprinkle, your doctor may give you a starting dose of this medicine that is different from the previous oral hydrocortisone medicine that you have been taking.

Part of the oral granules may pass into your child's stool (bowel movement). This is normal and nothing to worry about.

To use the granules:

• Your doctor will tell you how to prepare or give the dose to your child. Ask your doctor or pharmacist if you have questions.
• Take one capsule from the bottle.
• Hold the capsule with the writing at the top. Tap the capsule to make sure the granules fall to the bottom.
• Squeeze the bottom of the capsule gently to loosen the top of the capsule from the bottom.
• Twist the top of the capsule carefully.
• You may give the medicine with or without food onto a spoon or directly into the child's mouth. If you are taking this medicine with food, pour the granules onto a spoonful of cold or room temperature soft food (eg, yogurt, fruit puree).
• Do not add the granules to a fluid because it may decrease the full dose and it may leave a bitter taste.
• The medicine should be given and swallowed within 5 minutes to avoid bitter taste.
• Give a sip of fluids like water, milk, breast-milk, or formula right away to make sure all granules are swallowed.
• Call your doctor right away if the granules come back up into your child's mouth (regurgitation) or your child has vomiting after swallowing the granules. Your child may not receive the full dose of this medicine and another dose may be needed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):Dose depends on medical condition: Adults—At first, 20 to 240 milligrams (mg) per day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor.
• For oral dosage form (granules):For adrenal problems:Children—Dose is based on body surface area and must be determined by your doctor. Your doctor may adjust the dose depending on the age and symptoms. Dose is usually 0.5 to 1 milligram (mg) divided in 3 doses and given 3 times a day. Some patients may have their dose divided in 2 doses and given 2 times a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Use the oral granules within 60 days after opening the bottle.

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