Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING ALKINDI SPRINKLE oral granules are supplied as white to off-white granules in transparent capsules as follows: Strength Imprint on Capsules Amount in Bottle NDC 0.5 mg “INF-0.5” in red ink 50 capsules 71863-109-50 1 mg “INF-1.0” in blue ink 50 capsules 71863-110-50 2 mg “INF-2.0” in green ink 50 capsules 71863-111-50 5 mg “INF-5.0” in gray ink 50 capsules 71863-112-50 Store at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30 °C (59°F to 86°F). Store in the original bottle in order to protect from light. Once the bottle has been opened, use the capsules within 60 days.; PRINCIPAL DISPLAY PANEL Alkindi Sprinkle (hydrocortisone) oral granules 0.5 mg - NDC 71863-109-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 0.5 mg - NDC 71863-109-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 1 mg - NDC 71863-110-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 1 mg - NDC 71863-110-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 2 mg - NDC 71863-111-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 2 mg - NDC 71863-111-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 5 mg - NDC 71863-112-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 5 mg - NDC 71863-112-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 0.5 mg Samples - NDC 71863-117-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 1 mg Samples - NDC 71863-118-50 - 50 Tablets Container Label Carton 0.5 mg Container 0.5 mg Carton 1 mg Container 1 mg Carton 2 mg Container 2 mg Carton 5 mg Container 5 mg Alkindi Sample Container 0.5mg Alkindi Sample Container 1mg
- 16 HOW SUPPLIED/STORAGE AND HANDLING ALKINDI SPRINKLE oral granules are supplied as white to off-white granules in transparent capsules as follows: Strength Imprint on Capsules Amount in Bottle NDC 0.5 mg “INF-0.5” in red ink 50 capsules 71863-109-50 1 mg “INF-1.0” in blue ink 50 capsules 71863-110-50 2 mg “INF-2.0” in green ink 50 capsules 71863-111-50 5 mg “INF-5.0” in gray ink 50 capsules 71863-112-50 Store at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30 °C (59°F to 86°F). Store in the original bottle in order to protect from light. Once the bottle has been opened, use the capsules within 60 days.
- PRINCIPAL DISPLAY PANEL Alkindi Sprinkle (hydrocortisone) oral granules 0.5 mg - NDC 71863-109-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 0.5 mg - NDC 71863-109-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 1 mg - NDC 71863-110-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 1 mg - NDC 71863-110-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 2 mg - NDC 71863-111-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 2 mg - NDC 71863-111-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 5 mg - NDC 71863-112-50 - 50 Tablets Carton Label Alkindi Sprinkle (hydrocortisone) oral granules 5 mg - NDC 71863-112-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 0.5 mg Samples - NDC 71863-117-50 - 50 Tablets Container Label Alkindi Sprinkle (hydrocortisone) oral granules 1 mg Samples - NDC 71863-118-50 - 50 Tablets Container Label Carton 0.5 mg Container 0.5 mg Carton 1 mg Container 1 mg Carton 2 mg Container 2 mg Carton 5 mg Container 5 mg Alkindi Sample Container 0.5mg Alkindi Sample Container 1mg
Overview
ALKINDI SPRINKLE contains hydrocortisone, a corticosteroid, also known as cortisol. The chemical name of hydrocortisone is 11β,17α,21-trihydroxy-pregn-4-ene-3,20-dione and it has the chemical formula of C 21 H 30 O 5 , and molecular weight of 362 g·mol −1 . Hydrocortisone is a white or almost white powder soluble in the pH range of 1-7. Structural formula of hydrocortisone: ALKINDI SPRINKLE are oral granules contained within hard capsules. The inactive ingredients in the granules are microcrystalline cellulose, hypromellose, magnesium stearate and ethyl cellulose and the capsule shell contains hypromellose. The printing ink contains shellac, propylene glycol and concentrated ammonia solution. The printing ink also contains red iron oxide, potassium hydroxide for 0.5 mg (red), indigotine for 1 mg (blue), indigotine, yellow iron oxide, titanium dioxide for 2 mg (green) and titanium dioxide, black iron oxide, potassium hydroxide for 5 mg (gray). Structure
Indications & Usage
ALKINDI SPRINKLE is indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. ALKINDI SPRINKLE is a corticosteroid indicated as replacement therapy in pediatric patients with adrenocortical insufficiency. (1)
Dosage & Administration
' • Individualize the dose, using the lowest possible dosage. (2.1) • The recommended starting replacement dosage 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. (2.1) • Round the dose to the nearest 0.5 mg or 1 mg. More than one capsule may be needed to supply the required dose. (2.1) • Divide the total daily dose in 3 doses and administer 3 times daily. Older patients may have their daily dose divided by 2 and administered twice daily. (2.1) • When switching from other oral hydrocortisone formulations, use the same total daily hydrocortisone dosage. If symptoms of adrenal insufficiency occur, increase total daily dosage. (2.2) • ALKINDI SPRINKLE are oral granules contained within capsules. Do not swallow the capsule. Do not chew or crush the granules. (2.3) • See the Full Prescribing Information for detailed administration instructions. (2.3) 2.1 Dosage Information Individualize the dose for each patient, using the lowest possible dosage. The recommended starting replacement dosage is 8 to 10 mg/m 2 /day 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. Round the dose to the nearest 0.5 mg or 1 mg. The contents of more than one capsule may be needed to supply the required dose. Divide the total daily dose in 3 doses and administer 3 times daily. Older pediatric patients may have their daily dose divided by 2 and administered twice daily. Monitor patients for symptoms of under and/or overtreatment including signs and symptoms of adrenocortical insufficiency, linear growth and weight gain. Adjust doses accordingly. During episodes of acute febrile illness, gastroenteritis, surgery or major trauma, patients may need increased doses [see Warnings and Precautions ( 5.1 )] . 2.2 Switching to ALKINDI SPRINKLE from Other Oral Hydrocortisone Formulations When switching patients from other oral hydrocortisone formulations to ALKINDI SPRINKLE, use the same total daily hydrocortisone dosage. Closely monitor patients after switching to ALKINDI SPRINKLE for symptoms of adrenocortical insufficiency. If symptoms of adrenal insufficiency occur after switching, increase the total daily dosage of ALKINDI SPRINKLE [see Warnings and Precautions (5.1)]. 2.3 Administration Instructions ALKINDI SPRINKLE are oral granules contained within capsules. Do not swallow the capsules. Do not chew or crush the granules. Do not use ALKINDI SPRINKLE granules in nasogastric or gastric tubes as they may cause tube blockage. Open the capsule and administer the granules as follows: Hold the capsule so that the printed strength is at the top and tap to ensure all the granules are in the lower half of the capsule. Squeeze the bottom of the capsule gently and twist off the top of the capsule. The granules may be administered by pouring the granules directly onto the patient’s tongue, pouring the granules onto a spoon and placing in the patient’s mouth, or sprinkling onto a spoonful of cold or room temperature soft food (such as yogurt or fruit puree). The granules should be given and swallowed within 5 minutes to avoid a bitter taste as the outer taste masking cover can dissolve. Tap the capsule to ensure all the granules are removed. Avoid wetting the capsule on the tongue or soft food as this may result in granules remaining in the capsule. Immediately follow administration with ingestion of fluids such as water, milk, breast milk or formula to ensure all granules are swallowed. Do not add the granules to liquid as this can result in reductions in the dose administered and may result in a bitter taste. Instruct patients and/or caregivers to contact their healthcare provider if the full dose is not administered (e.g., regurgitating, vomiting of granules). A repeat dose may be required to avoid adrenal insufficiency [see Warnings and Precautions (5.1)].
Warnings & Precautions
Adrenal Crisis: Undertreatment, sudden discontinuation of therapy, or switching from another oral hydrocortisone formulation may lead to adrenocortical insufficiency, adrenal crisis and death. Adrenal crisis may also be induced by stress events such as infections or surgery. Increase the dose during periods of stress. Switch patients who are vomiting, severely ill or unable to take oral medications to parenteral corticosteroid formulations. (5.1) Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement : Use of a greater than replacement dosage can suppress the immune system and increase the risks of new infections or exacerbation of latent infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections. Monitor patients for signs and symptoms of infections. (5.2) Growth Retardation: Long-term use in excessive doses may cause growth retardation. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response and monitor the patient’s growth. (5.3) Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids: Prolonged use with supraphysiologic doses may cause Cushing’s syndrome. Monitor patients for signs and symptoms of Cushing’s syndrome every 6 months, pediatric patients under one year of age may require more frequent monitoring. (5.4) Decrease in Bone Mineral Density: Corticosteroids decrease bone formation and increase bone resorption which may lead to inhibition of bone growth and development of osteoporosis. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response. (5.5) Psychiatric Adverse Reactions: Use may be associated with severe psychiatric adverse reactions such as euphoria, mania, psychosis with hallucinations and delirium or depression. Symptoms typically emerge within a few days or weeks of starting the treatment. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. (5.6) Ophthalmic Adverse Reactions: Cataracts, glaucoma and central serous chorioretinopathy have been reported with prolonged use of high doses. Monitor patients for blurred vision or other visual disturbances and if they occur, refer them to an ophthalmologist. (5.7) Gastrointestinal Adverse Reactions: Increased risk in patients with certain gastrointestinal disorders. Signs and symptoms may be masked. (5.8) 5.1 Adrenal Crisis Undertreatment with ALKINDI SPRINKLE or sudden discontinuation of therapy with ALKINDI SPRINKLE may lead to adrenocortical insufficiency, adrenal crisis, and death. Adrenal crisis may also be induced by stress events such as infections or surgery when patients require higher doses of corticosteroids. Symptoms of adrenocortical insufficiency include poor feeding, fatigue, low muscle tone, joint pain, nausea, vomiting, hypoglycemia, low blood pressure and electrolyte disturbances. Increase the dosage of ALKINDI SPRINKLE during periods of stress (infections, surgery). Switch patients who are vomiting, severely ill or unable to take oral medications to parenteral corticosteroid formulations without delay. Once the patient recovers, gradually reduce the steroid dosage used during the acute event. When switching patients to ALKINDI SPRINKLE from another oral hydrocortisone formulation, consider the potential for dosing inaccuracy if the other oral hydrocortisone formulation has been manipulated (e.g., split or crushed tablets, compounded formulations). Manipulation of oral hydrocortisone formulations may result in a relative difference in hydrocortisone exposure when using the same dosage to initiate ALKINDI SPRINKLE treatment. Closely monitor patients after switching to ALKINDI SPRINKLE to ensure ALKINDI SPRINKLE is providing the same level of hydrocortisone exposure as the previously used oral hydrocortisone formulation. If symptoms of adrenal insufficiency occur, increase the total daily dosage of ALKINDI SPRINKLE. 5.2 Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement Use of the recommended dosage of ALKINDI SPRINKLE [see Dosage and Administration (2.1, 2.2)] as a replacement therapy in pediatric patients with adrenocortical insufficiency is not expected to cause immunosuppression or increase the risk of infection. The use of a greater than replacement dosage can suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. The use of ALKINDI SPRINKLE at greater than replacement dosage can: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection Infections associated with the use of corticosteroids at a greater than replacement dosage range from mild to severe or fatal, and the rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider ALKINDI SPRINKLE dosage reduction as needed. 5.3 Growth Retardation Long-term use of corticosteroids in excessive doses may cause growth retardation in pediatric patients. Historical cohorts of adults treated from childhood for congenital adrenal hyperplasia have been found to have growth retardation. Effects on linear growth are less likely when using corticosteroids as replacement therapy. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response and monitor the patient’s growth. 5.4 Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids Prolonged use of corticosteroids in supraphysiologic doses may cause Cushing’s syndrome. Symptoms and signs of Cushing’s syndrome include weight gain, decreased height velocity, hyperglycemia, hypertension, edema, easy bruising, muscle weakness, red round face, depression or mood swings. Monitor patients for signs and symptoms of Cushing’s syndrome every 6 months; pediatric patients under one year of age may require more frequent monitoring, e.g., every 3 to 4 months. 5.5 Decrease in Bone Mineral Density Corticosteroids decrease bone formation and increase bone resorption which may lead to development of osteoporosis. Historical cohorts of adults treated from childhood for congenital adrenal hyperplasia have been found to have reduced bone mineral density and increased fracture rates. Use the minimum dosage of ALKINDI SPRINKLE to achieve desired clinical response. 5.6 Psychiatric Adverse Reactions Corticosteroid use may be associated with severe psychiatric adverse reactions. Euphoria, mania, psychosis with hallucinations and delirium or depression have been seen in patients at replacement doses of hydrocortisone [see Adverse Reactions ( 6 )] . Symptoms typically emerge within a few days or weeks of starting the treatment. Risks may be higher with high doses, although dose levels do not allow prediction of the onset, type, severity or duration of reactions. Most reactions resolve after either dose reduction or withdrawal, although specific treatment may be necessary. Monitor patients for behavioral and mood disturbances during treatment with ALKINDI SPRINKLE. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. 5.7 Ophthalmic Adverse Reactions Ophthalmic effects, such as cataract, glaucoma or central serous chorioretinopathy have been reported with prolonged use of corticosteroids in high doses. Monitor patients for blurred vision or other visual disturbances. If patients develop ophthalmic adverse reactions, refer them to an ophthalmologist for further evaluation. 5.8 Gastrointestinal Adverse Reactions There is an increased risk of gastrointestinal perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation may be masked in patients receiving corticosteroids. Corticosteroids should be used with caution if there is a probability of impending perforation, abscess, or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; and active or latent peptic ulcer. Concurrent administration of corticosteroids with non-steroidal anti-inflammatory drugs (NSAIDS) may increase the risk of gastrointestinal adverse reactions. Monitor patients receiving corticosteroids and concomitant NSAIDS for gastrointestinal adverse reactions [see Drug Interactions ( 7 )] . 5.9 Risk of Kaposi’s Sarcoma with Use of a Dosage Greater Than Replacement Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions at a dosage greater than replacement (supraphysiologic dosage). If patients take a supraphysiologic chronic dosage of ALKINDI SPRINKLE, they are at increased risk of developing Kaposi’s sarcoma. 5.10 Vaccination Administration of live vaccines may be acceptable in ALKINDI SPRINKLE-treated pediatric patients with adrenocortical insufficiency who receive replacement corticosteroids.
Contraindications
ALKINDI SPRINKLE is contraindicated in patients with hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE. Anaphylactic reactions have occurred in patients receiving corticosteroids [see Adverse Reactions ( 6.2 )] . Hypersensitivity to hydrocortisone or to any of the ingredients in ALKINDI SPRINKLE. ( 4 )
Adverse Reactions
The following serious adverse reactions are described here and elsewhere in the label: Adrenal Crisis [see Warnings and Precautions ( 5.1 )] Immunosuppression and Increased Risk of Infection with Use of a Dosage Greater Than Replacement [see Warnings and Precautions ( 5.2 )] Growth Retardation [see Warnings and Precautions ( 5.3 )] Cushing’s Syndrome Due to Use of Excessive Doses of Corticosteroids [see Warnings and Precautions ( 5.4 )] Decrease in Bone Mineral Density [see Warnings and Precautions ( 5.5 )] Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )] Ophthalmic Adverse Reactions [see Warnings and Precautions ( 5.7 )] Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.8 )] Risk of Kaposi's Sarcoma with Use of Dosage Greater Than Replacement [see Warnings and Precautions (5.9)] Vaccinations [see Warnings and Precautions (5.10)] 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. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 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 Adrenocortical Insufficiency 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) 6.2 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
Drug Interactions
Table 2 Drug Interactions with ALKINDI SPRINKLE CYP3A4 Inhibitors Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inhibitors of CYP3A4 may lead to increases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions associated with the use of excessive doses. Intervention: Concomitant use of CYP3A4 inhibitors may require a decrease in the ALKINDI SPRINKLE dose. Examples: Anti-fungals: itraconazole, posaconazole, voriconazole Antibiotics: erythromycin and clarithromycin Antiretrovirals: ritonavir Grapefruit juice CYP3A4 Inducers Clinical Impact: Hydrocortisone is metabolized by cytochrome P450 3A4 (CYP3A4). Concomitant administration of inducers of CYP3A4 may lead to decreases in serum concentrations of ALKINDI SPRINKLE and increase the risk of adverse reactions, including adrenal crisis. Intervention: Concomitant use of CYP3A4 inducers may require an increase in the ALKINDI SPRINKLE dose. Examples: Anticonvulsants: phenytoin, carbamazepine and oxcarbazepine Antibiotics: rifampicin and rifabutin Barbiturates: phenobarbital and primidone Antiretrovirals: efavirenz and nevirapine Estrogen and Estrogen Containing Products Clinical Impact: Oral estrogen and estrogen-containing oral contraceptives may interact with hydrocortisone by increasing serum cortisol-binding globulin (CBG) concentration. Concomitant use may reduce the efficacy of ALKINDI SPRINKLE by binding and delaying or preventing absorption. Intervention: Concomitant use of estrogen/estrogen containing products may require an increase in the ALKINDI SPRINKLE dose. Antidiabetic Agents Clinical Impact: Corticosteroids in supraphysiologic doses may increase blood glucose concentrations. Intervention: Use of ALKINDI SPRINKLE in supraphysiologic doses may require a dose adjustment of antidiabetic agents. Anticoagulant Agents Clinical Impact: Concomitant use of warfarin and corticosteroids usually results in inhibition of response to warfarin, although there have been some conflicting reports. Intervention: Monitor coagulation indices in patients receiving ALKINDI SPRINKLE and concomitant warfarin to maintain the desired anticoagulant effect. Cyclosporine Clinical Impact: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with concurrent use. Intervention: Monitor patients receiving ALKINDI SPRINKLE and concomitant cyclosporine. Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Clinical Impact: Concomitant use of NSAIDs and corticosteroids increases the risk of gastrointestinal adverse reactions. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Intervention: Monitor patients receiving ALKINDI SPRINKLE and concomitant NSAIDs. CYP3A4 Inhibitors : concomitant administration may require a decrease in the ALKINDI SPRINKLE dose. ( 7 ) CYP3A4 Inducers : concomitant administration may require an increase in the ALKINDI SPRINKLE dose. ( 7 ) Estrogen and Estrogen Containing Products : concomitant administration may require an increase in the ALKINDI SPRINKLE dose. ( 7 ) Antidiabetic agents: excessive doses may increase blood glucose concentrations. Dose adjustment of antidiabetic agents may be required. ( 7 ) NSAIDs: concomitant administration increases risk of gastrointestinal adverse reactions. ( 7 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling (Medication Guide). Revised 12/2024
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