Alkindi Sprinkle
- Generic Name: hydrocortisone oral granules
- Brand Name: Alkindi Sprinkle
Alkindi Sprinkle (Hydrocortisone Oral Granules) side effects drug center
Alkindi Sprinkle Side Effects Center
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.
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)
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 Reactions | N=18 (%) |
| Pyrexia | 10 (56) |
| Gastroenteritis | 9 (50) |
| Viral upper respiratory tract infection | 8 (44) |
| Vomiting | 7 (39) |
| Viral infection | 6 (33) |
| Conjunctivitis | 5 (28) |
| Otitis media viral | 3 (17) |
| Tonsillitis | 3 (17) |
| Body temperature increased | 2 (11) |
| Bronchitis | 2 (11) |
| Dental caries | 2 (11) |
| Diarrhea | 2 (11) |
| Genitourinary operation | 2 (11) |
| Pharyngitis | 2 (11) |
| Respiratory tract infection | 2 (11) |
| Rhinitis | 2 (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.