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Alkindi Sprinkle

hydrocortisone

Hydrocortisone is a man-made version of a natural substance (cortisol) made by the adrenal gland. This drug is used to treat low cortisol levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency). Hydrocortisone belongs to a class of drugs known as corticosteroids. Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.

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30 Sprinkle capsules, 0.5 mg

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About Alkindi Sprinkle

Overview

Hydrocortisone is a man-made version of a natural substance (cortisol) made by the adrenal gland. This drug is used to treat low cortisol levels caused by diseases of the adrenal gland (such as Addison's disease, adrenocortical insufficiency). Hydrocortisone belongs to a class of drugs known as corticosteroids. Corticosteroids are needed in many ways for the body to function well. They are important for salt and water balance and keeping blood pressure normal.

How to use

Read the Medication Guide and Instructions for Use provided by your pharmacist before you start taking hydrocortisone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually 2 or 3 times a day. Take it with food or milk to prevent stomach upset. This medication comes as granules inside a capsule. Do not swallow the capsules whole. Make sure not to get the capsules wet. To use this medication, open the capsule first. You may take this medication by pouring it directly on your tongue, or by pouring it on a spoon and placing the medication in your mouth, or by sprinkling the granules onto a spoonful of cold or room-temperature soft food (such as yogurt or applesauce) before taking the medication. Do not mix the granules in liquid. Do not chew or crush the granules. If taking with soft food, make sure to swallow the mixture within 5 minutes after preparing. Drink some fluids (such as water, milk) after taking the granules to make sure all the medication is swallowed.

This medication should not be given through a feeding tube.

The dosage is based on your medical condition, body size, and response to treatment.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used hydrocortisone for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

Tell your doctor if your condition does not get better or if it gets worse.

Side effects

Nausea, vomiting, headache, trouble sleeping, increased sweating, or acne may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

The granules may appear in your stool. This effect is harmless because your body has already absorbed the medication.

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: signs of infection (such as sore throat that doesn't go away, fever), weakness, swelling ankles/feet, unusual weight gain, vision problems (such as blurred vision), easy bruising/bleeding, puffy face, mental/mood changes (such as depression, mood swings, agitation), muscle pain/cramps, thinning skin, slow wound healing, bone pain, menstrual period changes, irregular heartbeat, seizures, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds).

This medication may rarely 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.

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 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.

Warnings & Precautions

Before taking 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: eye disease (such as cataracts, glaucoma), heart problems (such as heart failure, recent heart attack), high blood pressure, liver disease, kidney disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, herpes, fungal infection), bleeding problems, blood clots, mental/mood disorders (such as psychosis, anxiety, depression), mineral imbalance (such as low level of potassium/calcium in the blood), seizures.

This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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 worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have any immunizations/vaccinations without the consent of your doctor.

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.

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

During pregnancy, hydrocortisone should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended period of 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.

It is unknown if this drug passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Storage

Store in original bottle at room temperature away from light and moisture. Do not store in the bathroom. Once the bottle is opened, discard any capsules after 60 days. Keep all medications away from children and pets.

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.

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 are: aldesleukin, 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 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 lab tests (such as skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

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 their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Missed Doses:

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Notes:

Do not share this medication with others.

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

This medication may cause bone problems (osteoporosis) if taken for an extended time. Lifestyle changes that help promote healthy bones include increasing weight-bearing exercise, stopping smoking, limiting alcohol, and eating well-balanced meals that contain adequate calcium and vitamin D. You may also need to take calcium and vitamin D supplements.

Selected from the Licensed Solutions data included with permission and copyrighted by FDB, inc., 2014. This copyrighted material has been downloaded and Licensed data provider and is not for distribution in professional healthcare settings. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment. 

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