Alkindi Sprinkle

Last updated on RxList: 10/12/2020
Alkindi Sprinkle Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Alkindi Sprinkle?

Alkindi Sprinkle (hydrocortisone) is a corticosteroid indicated as replacement therapy in pediatric patients with adrenocortical insufficiency.

What Are Side Effects of Alkindi Sprinkle?

Side effects of Alkindi Sprinkle include:

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

Dosage for Alkindi Sprinkle

The recommended starting replacement dosage of Alkindi Sprinkle is 8 to 10 mg/m2 daily. Higher doses may be needed based on patient's age and symptoms of the disease. Use of lower starting doses may be sufficient in patients with residual but decreased endogenous cortisol production.

Alkindi Sprinkle In Children

The safety and effectiveness of Alkindi Sprinkle have been established in pediatric patients for replacement therapy of adrenocortical insufficiency. Alkindi Sprinkle are oral granules contained within capsules that must be opened and not swallowed whole to administer the granules. Additionally, Alkindi Sprinkle granules should not be administered via nasogastric or gastric tubes as they may cause tube blockage.

What Drugs, Substances, or Supplements Interact with Alkindi Sprinkle?

Alkindi Sprinkle may interact with other medicines such as:

    • CYP3A4 inhibitors (such as anti-fungals: itraconazole, posaconazole, voriconazole; antibiotics: erythromycin and clarithromycin; antiretrovirals: ritonavir; grapefruit juice),
    • CYP3A4 inducers (such as anticonvulsants: phenytoin, carbamazepine and oxcarbazepine; antibiotics: rifampicin and rifabutin; barbiturates: phenobarbital and primidone; antiretrovirals: efavirenz and nevirapine),
  • estrogen and estrogen containing products,
  • antidiabetic agents,
  • anticoagulants,
  • cyclosporine, and
  • nonsteroidal anti-inflammatory drugs (NSAIDs)

Tell your doctor all medications and supplements you use.

Alkindi Sprinkle During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Alkindi Sprinkle; the use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. Untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. Cortisol is present in human milk. The use of hydrocortisone at a physiologic dose for adrenocortical insufficiency is not expected to adversely affect the breastfed infant or milk production. Consult your doctor before breastfeeding.

Additional Information

Our Alkindi Sprinkle (hydrocortisone) Oral Granules Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

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Alkindi Sprinkle Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • worsening of your skin condition;
  • redness, warmth, swelling, oozing, or severe irritation of any treated skin;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor; or
  • possible signs of absorbing this medicine through your skin--weight gain (especially in your face or your upper back and torso), slow wound healing, thinning or discolored skin, increased body hair, muscle weakness, nausea, diarrhea, tiredness, mood changes, menstrual changes, sexual changes.

Less serious side effects may be more likely, and you may have none at all.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Alkindi Sprinkle (Hydrocortisone Oral Granules)

SLIDESHOW

Kidney Stones: Symptoms, Causes, and Treatment See Slideshow
Alkindi Sprinkle Professional Information

SIDE EFFECTS

The following serious adverse reactions are described here and elsewhere in the label:

  • Adrenal Crisis [see WARNINGS AND PRECAUTIONS]
  • Infections [see WARNINGS AND PRECAUTIONS]
  • Growth Retardation [see WARNINGS AND PRECAUTIONS]
  • Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids [see WARNINGS AND PRECAUTIONS]
  • Decrease in Bone Mineral Density [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Ophthalmic Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

ALKINDI SPRINKLE was evaluated in an uncontrolled, open-label, single-arm clinical study in 18 pediatric patients with adrenocortical insufficiency. Adrenocortical insufficiency was due to congenital adrenal hyperplasia in 17 patients and to hypopituitarism in one patient. All patients received at least one dose of ALKINDI SPRINKLE. The age ranged from 36 days to 5.7 years at start of treatment; 8 patients were female and 10 were male; 100% were White. Adverse reactions that were reported in two or more patients (≥ 11%) are shown in Table 1.

Table 1 Adverse Reactions Occurring in ≥11% of Pediatric Patients with AdrenocorticalInsufficiency Treated with ALKINDI SPRINKLE for up to 29 Months

Adverse ReactionsN=18
(%)
Pyrexia10 (56)
Gastroenteritis9 (50)
Viral upper respiratory tract infection8 (44)
Vomiting7 (39)
Viral infection6 (33)
Conjunctivitis5 (28)
Otitis media viral3 (17)
Tonsillitis3 (17)
Body temperature increased2 (11)
Bronchitis2 (11)
Dental caries2 (11)
Diarrhea2 (11)
Genitourinary operation2 (11)
Pharyngitis2 (11)
Respiratory tract infection2 (11)
Rhinitis2 (11)

Postmarketing Experience

The following adverse reactions seen in pediatric and adult patients associated with the use of corticosteroids were identified in the literature and from postmarketing reports. Because some of these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

Allergic Reactions: Anaphylaxis, angioedema

Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis

Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria

Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon faces, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness), suppression of growth in pediatric patients

Fluid and Electrolyte Disturbances: Fluid retention, potassium loss, hypertension, hypokalemic alkalosis, sodium retention

Gastrointestinal: Abdominal distention, elevation in serum liver enzymes levels (usually reversible upon discontinuation), hepatomegaly, hiccups, malaise, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, ulcerative esophagitis

General: Increased appetite and weight gain

Metabolic: Negative nitrogen balance due to protein catabolism

Musculoskeletal: Osteonecrosis of femoral and humeral heads, Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, steroid myopathy, tendon rupture, vertebral compression fractures

Neurological: Arachnoiditis, convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually following discontinuation of treatment, insomnia, meningitis, mood swings, neuritis, neuropathy, paraparesis/paraplegia, paresthesia, personality changes, sensory disturbances, vertigo

Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, and central serous chorioretinopathy

Reproductive: Alteration in motility and number of spermatozoa

Read the entire FDA prescribing information for Alkindi Sprinkle (Hydrocortisone Oral Granules)

© Alkindi Sprinkle Patient Information is supplied by Cerner Multum, Inc. and Alkindi Sprinkle Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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