Alkindi Sprinkle (hydrocortisone)

Alkindi Sprinkle contains a drug called hydrocortisone. Hydrocortisone belongs to a group of medicines known as corticosteroids. Hydrocortisone is a synthetic version of the hormone cortisol. Cortisol is made naturally by the adrenal glands in the body. Alkindi Sprinkle is a prescription medicine that contains hydrocortisone also called a corticosteroid. Alkindi Sprinkle (hydrocortisone) is a synthetic (man-made) corticosteroid used to replace the body’s cortisol when the adrenal glands do not make enough (adrenal insufficiency) in children from birth to 17 years of age to treat adrenal insufficiency.

WARNING

Alkindi Sprinkle may cause serious side effects, including:

Adrenal gland problems. Not giving enough Alkindi Sprinkle or stopping Alkindi Sprinkle can cause serious and life-threating adrenal gland problems including death. Do not stop giving Alkindi Sprinkle without the advice of your healthcare provider. Tell your healthcare provider if your child has any of these symptoms:

• loss of appetite
• fatigue
• weakness
• joint pain
• nausea
• vomiting
• low blood sugar
• feeling lightheaded or dizzy
• dehydration

Your healthcare provider will change the dose depending on your child’s size. During episodes of acute infections, surgery or major trauma, your healthcare provider may recommend increased doses of Alkindi Sprinkle or use of parenteral corticosteroid formulations instead.

Taking too much Alkindi Sprinkle can increase risk of infections. Tell your healthcare provider if your child has any of these symptoms:

• fever
• cough
• flu-like symptoms
• stomach area (abdominal) pain
• diarrhea

Slowed growth in children.

Taking too much Alkindi Sprinkle and taking it for long periods of time can affect your child’s growth. Tell your healthcare provider if you are worried about your child’s growth. Your healthcare provider will change the dose depending on your child’s size.

Cushing’s syndrome.

Taking too much Alkindi Sprinkle and taking it for long periods of time can cause Cushing’s syndrome. Tell your healthcare provider if your child has any of these symptoms:

• weight gain
• slowed growth in height
• high blood sugar
• high blood pressure
• swelling
• bruising easily
• muscle weakness
• red round, face
• feeling depressed
• mood swings

Weak, brittle, or soft bones

Alkindi Sprinkle can affect your child’s bones. Your healthcare provider will change the dose depending on your child’s size and will monitor your child’s growth and bones.

Changes in behavior

Your child’s behavior may change after starting or during treatment with Alkindi Sprinkle. Tell your healthcare provider right away if your child devlops any changes in behavior including:

• strong feelings of happiness and excitement.
• overexcited and overactivity.
• loss of contact with reality, with feelings that are not real, and mental confusion.
• depression.

Vision problems.

Tell your healthcare provider if your child develops blurred vision or other vision problems during treatment with Alkindi Sprinkle. Your healthcare provider may have your child see an eye doctor.

Gastrointestinal problems

Alkindi Sprinkle can affect your child’s stomach or intestine. Tell your health care provider if your child has gastrointestinal illnesses such as stomach or intestinal ulcers, infections, gastrointestinal surgery.

The most common side effects of Alkindi Sprinkle include:

• fluid retention
• behavioral and mood changes
• alteration in glucose tolerance
• increased appetite and weight gain
• elevation in blood pressure

These are not all the possible side effects of Alkindi Sprinkle. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• See the detailed Instructions for Use that comes with your Alkindi Sprinkle for information on how to give a dose of Alkindi Sprinkle the right way.
• Give Alkindi Sprinkle exactly as prescribed by your healthcare provider.
• Do not stop giving Alkindi Sprinkle without talking to your healthcare provider.
• Do not let your child chew or crush the granules. Do not let your child swallow the capsule.
• Do not let the capsules get wet as this may make some of the granules stick to the capsule.
• Your child may sometimes pass the Alkindi Sprinkle granules in their stools (bowel movement). It does not mean that Alkindi Sprinkle is not working. Do not give your child another dose of Alkindi Sprinkle.
• Alkindi Sprinkle granules should not be given through a nasogastric tube because the granules may block the tube.
• If your child takes too much Alkindi Sprinkle, call your healthcare provider right away or go to the nearest emergency room.

Tell your healthcare provider about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines, food and drink can affect the way that Alkindi Sprinkle works and may mean that your healthcare provider needs to change your child’s dose of Alkindi Sprinkle.

Especially tell your healthcare provider if your child:

• takes medicines used to treat fungal infections such as itraconazole, posaconazole, and voriconazole.
• takes medicines used to treat bacterial infections such as rifampicin, rifabutin, erythromycin, and clarithromycin.
• takes medicines used to treat human immunodeficiency virus (HIV) infection and AIDS such as ritonavir, efavirenz, and nevirapine.
• takes seizure medicines such as phenytoin, carbamazepine, oxcarbazepine, phenobarbital, and primidone.
• takes estrogen.
• takes warfarin
• takes nonsteroidal anti-inflammatory medicines such as aspirin, ibuprofen.
• takes cyclosporine
• takes diabetes medicines
• drinks grapefruit juice.

Know the medicines your child takes. Keep a list of them to show your healthcare provider and pharmacist when your child gets a new medicine.

It is not known if Alkindi Sprinkle will harm your child’s unborn baby. Talk to your child’s healthcare provider if your child is pregnant or plans to become pregnant or is breastfeeding or plans to breastfeed. It is not known if Alkindi Sprinkle passes into the breast milk. You and your child’s healthcare provider should decide if your child will receive Alkindi Sprinkle while your child breastfeeds.