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| Product NDC Code | 71863-111 | ||||
|---|---|---|---|---|---|
| Drug Name | Alkindi sprinkle |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||
| Dosage Form | GRANULE | ||||
| RxCUI drug identifier | 2399644, 2399650, 2399652, 2399654, 2399656, 2399658, 2399659, 2399661 |
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| Application Number | NDA213876 | ||||
| Labeler Name | Eton Pharmaceuticals, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Alkindi Sprinkle
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.10 OVERDOSAGE Treatment of acute overdosage is by supportive and symptomatic therapy.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.6 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
| 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) |
Alkindi Sprinkle Drug Interactions
Information about and practical guidance on preventing clinically significant drug/drug and drug/food interactions that may occur in people taking the drug.7 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 02/2024
| 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. | |
| Concomitant use of CYP3A4 inhibitors may require a decrease in the ALKINDI SPRINKLE dose. | |
| 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. | |
| Concomitant use of CYP3A4 inducers may require an increase in the ALKINDI SPRINKLE dose. | |
| 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. | |
| Concomitant use of estrogen/estrogen containing products may require an increase in the ALKINDI SPRINKLE dose. | |
| Corticosteroids in supraphysiologic doses may increase blood glucose concentrations. | |
| Use of ALKINDI SPRINKLE in supraphysiologic doses may require a dose adjustment of antidiabetic agents. | |
| Concomitant use of warfarin and corticosteroids usually results in inhibition of response to warfarin, although there have been some conflicting reports. | |
| Monitor coagulation indices in patients receiving ALKINDI SPRINKLE and concomitant warfarin to maintain the desired anticoagulant effect. | |
| Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with concurrent use. | |
| Monitor patients receiving ALKINDI SPRINKLE and concomitant cyclosporine. | |
| 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. | |
| Monitor patients receiving ALKINDI SPRINKLE and concomitant NSAIDs. |
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Hydrocortisone is a glucocorticoid. Glucocorticoids, adrenocortical steroids, cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.. 12.2 Pharmacodynamics Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. 12.3 Pharmacokinetics Absorption Following oral administration, a dose of ALKINDI SPRINKLE 4x5 mg was approximately 87% bioavailable when compared to intravenous hydrocortisone in dexamethasone-suppressed healthy adult male volunteers. The median time to peak serum concentration (Tmax) was 0.75 hours post-dose following oral administration. In an open label, single dose study in 24 pediatric patients with adrenocortical insufficiency, ALKINDI SPRINKLE (1-4 mg based on body surface area) increased cortisol levels from baseline to median cortisol level 19.4 mcg/dL (range 12.5 – 52.4 mcg/dL) at Cmax (60 minutes post-dose). Effect of Food The coadministration of ALKINDI SPRINKLE with soft food (yogurt and fruit puree) has been studied in healthy adult male volunteers, where it was shown to be bioequivalent to administration of dry granules directly to the back of the tongue. Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein. The binding is accounted for by two protein fractions. One, corticosteroid-binding globulin is a glycoprotein; the other is albumin. Elimination Hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol which are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. The terminal half-life of hydrocortisone is about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets and ALKINDI SPRINKLE in dexamethasone-suppressed healthy adult male volunteers.
Mechanism of action
Information about the established mechanism(s) of the drugÕs action in humans at various levels (for example receptor, membrane, tissue, organ, whole body). If the mechanism of action is not known, this field contains a statement about the lack of information.12.1 Mechanism of Action Hydrocortisone is a glucocorticoid. Glucocorticoids, adrenocortical steroids, cause varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli..
Pharmacodynamics
Information about any biochemical or physiologic pharmacologic effects of the drug or active metabolites related to the drugÕs clinical effect in preventing, diagnosing, mitigating, curing, or treating disease, or those related to adverse effects or toxicity.12.2 Pharmacodynamics Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.
Pharmacokinetics
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.12.3 Pharmacokinetics Absorption Following oral administration, a dose of ALKINDI SPRINKLE 4x5 mg was approximately 87% bioavailable when compared to intravenous hydrocortisone in dexamethasone-suppressed healthy adult male volunteers. The median time to peak serum concentration (Tmax) was 0.75 hours post-dose following oral administration. In an open label, single dose study in 24 pediatric patients with adrenocortical insufficiency, ALKINDI SPRINKLE (1-4 mg based on body surface area) increased cortisol levels from baseline to median cortisol level 19.4 mcg/dL (range 12.5 – 52.4 mcg/dL) at Cmax (60 minutes post-dose). Effect of Food The coadministration of ALKINDI SPRINKLE with soft food (yogurt and fruit puree) has been studied in healthy adult male volunteers, where it was shown to be bioequivalent to administration of dry granules directly to the back of the tongue. Distribution 90% or more of circulating hydrocortisone is reversibly bound to protein. The binding is accounted for by two protein fractions. One, corticosteroid-binding globulin is a glycoprotein; the other is albumin. Elimination Hydrocortisone is metabolized in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol which are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone. The terminal half-life of hydrocortisone is about 1.5 hours following intravenous and oral dosing of hydrocortisone tablets and ALKINDI SPRINKLE in dexamethasone-suppressed healthy adult male volunteers.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.4 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 )
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.11 DESCRIPTION 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
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.2 DOSAGE AND 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)].
Dosage forms and strengths
Information about all available dosage forms and strengths for the drug product to which the labeling applies. This field may contain descriptions of product appearance.3 DOSAGE FORMS AND STRENGTHS ALKINDI SPRINKLE oral granules are white to off-white granules contained within transparent capsules and are available as follows: Strength Imprint on Capsules 0.5 mg “INF-0.5” in red ink 1 mg “INF-1.0” in blue ink 2 mg “INF-2.0” in green ink 5 mg “INF-5.0” in gray ink Oral granules: 0.5 mg, 1 mg, 2 mg, 5 mg contained in capsules. ( 3 )
| Strength | Imprint on Capsules |
|---|---|
| 0.5 mg | “INF-0.5” in red ink |
| 1 mg | “INF-1.0” in blue ink |
| 2 mg | “INF-2.0” in green ink |
| 5 mg | “INF-5.0” in gray ink |
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.1 INDICATIONS AND 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)
Spl product data elements
Usually a list of ingredients in a drug product.Alkindi Sprinkle Hydrocortisone MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE ETHYLCELLULOSE, UNSPECIFIED HYDROCORTISONE HYDROCORTISONE INF;0;5 Alkindi Sprinkle Hydrocortisone MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE ETHYLCELLULOSE, UNSPECIFIED HYDROCORTISONE HYDROCORTISONE INF;1;0 Alkindi Sprinkle Hydrocortisone MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE ETHYLCELLULOSE, UNSPECIFIED HYDROCORTISONE HYDROCORTISONE INF;2;0 Alkindi Sprinkle Hydrocortisone HYDROCORTISONE HYDROCORTISONE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE ETHYLCELLULOSE, UNSPECIFIED INF;5;0
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies in animals have been conducted with hydrocortisone to evaluate carcinogenic or mutagenic potential. Corticosteroids have been shown to impair fertility in male rats.
Nonclinical toxicology
Information about toxicology in non-human subjects.13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies in animals have been conducted with hydrocortisone to evaluate carcinogenic or mutagenic potential. Corticosteroids have been shown to impair fertility in male rats.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Recent Major Changes Warnings and Precautions (5.2, 5.9, 5.10) 02/2024
Alkindi Sprinkle: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.17 PATIENT COUNSELING INFORMATION Advise the caregiver or patient to read the FDA-approved patient labeling (Medication Guide). Adrenal Crisis Inform the patient or caregiver that undertreatment or sudden discontinuation of ALKINDI SPRINKLE may lead to symptoms of adrenocortical insufficiency, adrenal crisis, and death. Advise the caregiver that the potential dosing inaccuracy of manipulated oral hydrocortisone preparations (e.g., split or crushed tablets or compounded suspension) may result in differences. When switching treatment from conventional oral hydrocortisone to ALKINDI SPRINKLE, advise the patient or caregiver that this could lead to unintended clinical consequences and recommend close monitoring of patients after the switch. Inform the patient or caregiver to contact their healthcare provider if they have prolonged vomiting, are severely ill or are unable to take oral medications. [see Warnings and Precautions ( 5.1 )] Immunosuppression and Increased Risk of Infections Advise patients and/or caregivers that greater than replacement dosage of corticosteroids can suppress the immune system and increase the risk of infections. Instruct patients and/or caregivers to contact their healthcare provider if they develop any infections [see Warnings and Precautions ( 5.2 )] Administration Information Advise the patient or caregiver that ALKINDI SPRINKLE is a granule formulation contained in a capsule. Do not swallow the capsule. Do not chew or crush the granules. Open the capsule and give the granules directly into the patient’s mouth. Alternatively, sprinkle the granules onto soft food and give immediately as the taste masking cover can dissolve in as little as 5 minutes. Avoid wetting the capsule as this may cause some granules to stick to the capsule. Immediately following administration, take a sip of fluids to ensure all granules have been swallowed. [see Dosage and Administration ( 2.3 )]. Growth Retardation Discuss with the caregiver that long-term use of corticosteroids in excessive doses may cause growth retardation in pediatric patients. [see Warnings and Precautions ( 5.3 )] Cushing’s Syndrome Inform patients and caregivers that prolonged use of corticosteroids in supraphysiologic doses may cause Cushing’s syndrome and that symptoms and signs include weight gain, decreased height velocity, hyperglycemia, hypertension, edema, easy bruising, muscle weakness, red round face, depression or mood swings. [see Warnings and Precautions ( 5.4 )] Decrease in Bone Mineral Density Inform the patient or caregiver that corticosteroids decrease bone formation and increase bone resorption that may lead to osteoporosis. [see Warnings and Precautions ( 5.5 )] Psychiatric Adverse Reactions Advise the patient or caregiver that corticosteroid use may be associated with severe psychiatric adverse reactions such as euphoria, mania, psychosis with hallucinations or depression. Instruct caregivers and/or patients to seek medical advice if psychiatric symptoms develop. [see Warnings and Precautions ( 5.6 )] Ophthalmic Adverse Reactions Inform patients or caregivers that ophthalmic effects such as cataract, glaucoma or central serous chorioretinopathy have been reported with prolonged use of high-dose corticosteroids. Instruct patients or caregivers to report any blurred vision or visual disturbances to their healthcare provider. [see Warnings and Precautions ( 5.7 )] Gastrointestinal Adverse Reactions Discuss with patients or caregivers that use of corticosteroids may increase risk of gastrointestinal perforation in certain gastrointestinal disorders [see Warnings and Precautions ( 5.8 )]. Excretion of Granules ALKINDI SPRINKLE granules may sometimes be seen in stools since the center of the granule is not absorbed in the gut after the active substance has been released. Inform patients or caregivers that this does not mean the product is ineffective and they should not take another dose. ALKINDI SPRINKLE is manufactured for Eton Pharmaceuticals, Inc. by Glatt Pharmaceutical Services GmbH & Co. KG Werner-Glatt-Strasse 1, Binzen, Baden-Wuerttemberg, 79589, Germany. ALKINDI SPRINKLE ® is a registered trademark of Diurnal Limited. ALKINDI is covered by the following US patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. ALKINDI SPRINKLE is distributed in the USA by Eton Pharmaceuticals, Inc. under license from Diurnal Limited.
Instructions for use
Information about safe handling and use of the drug product.Instructions for Use ALKINDI SPRINKLE®(ælˈkɪndi spr-en-kle) (hydrocortisone) oral granules Read this Instructions for Use before you start using ALKINDI SPRINKLE, and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your child’s medical condition or treatment. Important information you need to know before giving ALKINDI SPRINKLE ALKINDI SPRINKLE comes in a capsule that must be opened before use. Do not let your child swallow the capsule. Small children may choke. Do not let your child chew or crush the granules in the capsule. Do not let the capsules get wet as this may make some of the granules stick to the capsule. Your healthcare provider will decide the right dose of ALKINDI SPRINKLE for your child. Follow your healthcare provider’s instructions for the dose of ALKINDI SPRINKLE to give your child. Ask your healthcare provider or pharmacist if you are not sure how to prepare or give the prescribed dose of ALKINDI SPRINKLE to your child. Call your healthcare provider if granules come back up into your child’s mouth (regurgitation) or your child has vomiting after swallowing ALKINDI SPRINKLE. Your child may not have received the full dose of ALKINDI SPRINKLE and another dose of ALKINDI SPRINKLE may be needed. 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. Supplies needed to give ALKINDI SPRINKLE: ALKINDI SPRINKLE capsule(s) for prescribed dose 1 spoon soft food such as yogurt or pureed fruit or sip of fluids such as water, milk, breastmilk or formula Preparing and giving ALKINDI SPRINKLE: Step 1: Check the expiration date on the ALKINDI SPRINKLE bottle. Do not use ALKINDI SPRINKLE after the expiration date on the bottle has passed. Step 2: Remove the prescribed dose of ALKINDI SPRINKLE capsules from the bottle. Step 3: Hold and Tap Hold the capsule with the writing at the top. Tap the capsule to make sure the granules fall to the bottom. Step 4: Squeeze Gently squeeze the bottom of the capsule to loosen the top of the capsule from the bottom. Step 5: Twist Carefully twist off the top of the capsule. Step 6: Giving ALKINDI SPRINKLE ALKINDI SPRINKLE can be given (a) with food onto a spoon, (b) without food onto a spoon, or (c) directly into the child’s mouth. Do not add the granules to a fluid before giving ALKINDI SPRINKLE because it can result in less than the full dose given and it may leave a bitter taste in the mouth. (a) With food onto a spoon Pour all granules from each capsule directly onto a spoonful of cold or room temperature soft food (such as yogurt or fruit puree) and give right away. (b) Without food onto a spoon Pour all granules directly onto a spoon and place them in the child’s mouth. (c) Directly onto the child’s tongue. Pour all granules that make up the prescribed dose directly onto the child’s tongue. Tap the capsule to make sure all granules are removed. The ALKINDI SPRINKLE granules should be given and swallowed within 5 minutes to avoid a bitter taste. Step 7: Give Fluids After giving ALKINDI SPRINKLE, give a sip of fluids such as water, milk, breastmilk or formula right away to make sure all granules are swallowed. Throwing Away (disposal of) ALKINDI SPRINKLE: Ask your pharmacist how to throw away medicines you no longer use. How should I store ALKINDI SPRINKLE? Store ALKINDI SPRINKLE at room temperature between 68°F to 77°F (20°C to 25°C). Store in the original bottle to protect from light. After the bottle has been opened, use the ALKINDI SPRINKLE capsules within 60 days. Keep ALKINDI SPRINKLE and all medicines out of the reach of children. ALKINDI SPRINKLE is manufactured for Eton Pharmaceuticals, Inc. by Glatt Pharmaceutical Services GmbH & Co. KG Werner-Glatt-Strasse 1, Binzen, Baden-Wuerttemberg, 79589, Germany ALKINDI SPRINKLE® is a registered trademark of Diurnal Limited. ALKINDI is covered by the following US patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. For more information, go to www.alkindisprinkle.com or call 1-833-343-2500. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Revised: 12/2022 IMAGE-1 IMAGE-2 IMAGE-3 IMAGE-4 IMAGE-5 IMAGE-6
| (a) With food onto a spoon | (b) Without food onto a spoon |
Spl medguide
Information about the patient medication guide that accompanies the drug product. Certain drugs must be dispensed with an accompanying medication guide. This field may contain information about when to consult the medication guide and the contents of the medication guide.Medication Guide ALKINDI SPRINKLE® (ælˈkɪndi spr-en-kle) (hydrocortisone) oral granules Read this Medication Guide before you start giving ALKINDI SPRINKLE to your child, and each time your child gets a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your child’s medical condition or treatment. What is the most important information I should know about ALKINDI SPRINKLE? ALKINDI SPRINKLE may cause serious side effects, including: Adrenal gland problems. Not giving enough ALKINDI SPRINKLE, stopping ALKINDI SPRINKLE, or switching to ALKINDI SPRINKLE after taking another hydrocortisone medicine (the same class of medicines as ALKINDI SPRINKLE) by mouth, can cause serious and life-threatening adrenal gland problems including death. Do not stop giving ALKINDI SPRINKLE without talking to your healthcare provider. Tell your healthcare provider if your child has any of these symptoms: loss of appetite joint pain low blood sugar fatigue nausea feeling lightheaded or dizzy weakness vomiting problems with body salt (electrolyte) levels Your healthcare provider will change the dose of ALKINDI SPRINKLE depending on your child’s size. Tell your healthcare provider if your child cannot swallow medicines by mouth. During episodes of acute infections, surgery, major trauma or if your child cannot take medicines by mouth, your healthcare provider may recommend increased doses of ALKINDI SPRINKLE or use of corticosteroid medicines given directly into the bloodstream instead. The amount of hydrocortisone in a dose of ALKINDI SPRINKLE may not be the same as in previous hydrocortisone medicines that your child takes by mouth if these oral hydrocortisone medicines have been changed (for example, crushed or compounded). When switching to ALKINDI SPRINKLE, your healthcare provider may need to prescribe a starting dose of ALKINDI SPRINKLE that is different from previous hydrocortisone medicines that your child may have been taking by mouth. Watch your child closely after being switched to ALKINDI SPRINKLE and contact your healthcare provider if your child has any symptoms of adrenal gland problems. Your healthcare provider may need to change the dose of ALKINDI SPRINKLE. See “What are the possible side effects of ALKINDI SPRINKLE?” for more information about side effects. What is ALKINDI SPRINKLE? ALKINDI SPRINKLE is a prescription medicine that contains a medicine 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 (hydrocortisone) is a man-made (synthetic) 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. Who should not take or be given ALKINDI SPRINKLE? Do not give your child ALKINDI SPRINKLE if they: are allergic to hydrocortisone or any of the ingredients in ALKINDI SPRINKLE. See the end of this Medication Guide for a complete list of ingredients in ALKINDI SPRINKLE. have any reaction like swelling or shortness of breath after being given ALKINDI SPRINKLE. Get medical help right away and tell your healthcare provider as soon as possible as these can be signs of an allergic reaction. What should I tell my healthcare provider before giving ALKINDI SPRINKLE? Before you give your child ALKINDI SPRINKLE, tell your healthcare provider about all of your child’s medical conditions, including if they: are feeling unwell, or their body is under stress because of surgery or trauma. Your healthcare provider may need to increase the dose of ALKINDI SPRINKLE for a short period of time. have a fever or infection. have nausea, vomiting, or diarrhea. are due for vaccinations. Taking ALKINDI SPRINKLE should not stop your child from being vaccinated. Tell your healthcare provider when your child is due for vaccinations. are scheduled for surgery. cannot swallow medicines by mouth or are fed through a nasogastric or gastric tube. are pregnant or plan to become pregnant. 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. are breastfeeding or plan 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. 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, andclarithromycin. 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. How should I give ALKINDI SPRINKLE? 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. See “ What is the most important information I should know about ALKINDI SPRINKLE? ” 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. Call your healthcare provider if granules come back up into your child’s mouth (regurgitation) or your child has vomiting after swallowing ALKINDI SPRINKLE. Your child may not have received the full dose of ALKINDI SPRINKLE and another dose of ALKINDI SPRINKLE may be needed. 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. What are the possible side effects of ALKINDI SPRINKLE? ALKINDI SPRINKLE may cause serious side effects, including: See “What is the most important information I should know about ALKINDI SPRINKLE?” Weakened immune system and increased risk of Infections. Taking too much ALKINDI SPRINKLE can weaken your body's immune system and increase your change of getting infections. Tell your healthcare provider if your child has any infection or has any of these symptoms: fever stomach area (abdominal) pain cough diarrhea flu-like symptoms 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 high blood sugar swelling muscle weakness feeling depressed slowed growth in height high blood pressure bruising easily red, round face 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 develops any changes inbehavior 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 healthcare provider if your child has gastrointestinal illnesses such as stomach or intestinal ulcers, infections, or gastrointestinal surgery. Vaccinations. Administration of live vaccine may be acceptable while taking ALKINDI SPRINKLE. The most common side effects of ALKINDI SPRINKLE include: fluid retention change in blood sugar (glucose) tolerance increase in blood pressure behavioral and mood changes increased appetite and weight gain 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. How should I store ALKINDI SPRINKLE? Store ALKINDI SPRINKLE at room temperature between 68°F to 77°F (20°C to 25°C). Store in the original bottle to protect from light. After the bottle has been opened, use the ALKINDI SPRINKLE capsules within 60 days. Keep ALKINDI SPRINKLE and all medicines out of the reach of children. General information about the safe and effective use of ALKINDI SPRINKLE. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ALKINDI SPRINKLE for a condition for which it was not prescribed. Do not give ALKINDI SPRINKLE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ALKINDI SPRINKLE that is written for health professionals. What are the ingredients in ALKINDI SPRINKLE? Active ingredient: hydrocortisone Inactive ingredients: granules: microcrystalline cellulose, hypromellose, magnesium stearate, ethyl cellulose. capsule: hypromellose printing ink: shellac, propylene glycol, concentrated ammonia solution. ALKINDI SPRINKLE is manufactured for Eton Pharmaceuticals, Inc. by Glatt Pharmaceutical Services GmbH & Co. KG Werner-Glatt-Strasse 1, Binzen, Baden- Wuerttemberg, 79589, Germany ALKINDI SPRINKLE® is a registered trademark of Diurnal Limited. ALKINDI is covered by the following US patents: 9,649,280; 9,675,559; 9,717,740; and other patents in other countries internationally. For more information, go to www.alkindisprinkle.com or call 1-833-343-2500 . This Medication Guide has been approved by the U.S. Food and Drug Administration Revised 06/2024
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.8.4 Pediatric Use The safety and effectiveness of ALKINDI SPRINKLE have been established in pediatric patients for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. Use of ALKINDI SPRINKLE in pediatric patients is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency. No new adverse reactions were identified [see Adverse Reactions (6) and Clinical Pharmacology (12.3)]. 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 [see Dosage and Administration (2.2)].
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)8.1 Pregnancy Risk Summary Untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. The use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. Available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. However, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders,such as underlying maternal disease and use of concomitant medications. In addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore, limits fetal exposure. Animal Data Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring.
Use in specific populations
Information about use of the drug by patients in specific populations, including pregnant women and nursing mothers, pediatric patients, and geriatric patients.8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Untreated adrenocortical insufficiency in pregnancy can result in a high rate of complications, including maternal mortality. The use of physiologic doses of hydrocortisone is not expected to cause major birth defects, miscarriage and adverse maternal and fetal outcomes. Available data from observational studies with hydrocortisone use in pregnancy have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Available data from observational studies with hydrocortisone use in pregnant women have not identified a clear drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Evidence from published epidemiologic studies suggest that there may be a small increased risk of cleft lip with or without cleft palate associated with first trimester systemic corticosteroid use in pregnant patients. However, the data are limited and report inconsistent findings, and studies have important methodological limitations, including non-randomized design, retrospective data collection, lack of dose-response data and the inability to control for confounders,such as underlying maternal disease and use of concomitant medications. In addition, unlike other corticosteroids, hydrocortisone is enzymatically deactivated by the placenta and therefore, limits fetal exposure. Animal Data Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats and rabbits without adrenocortical insufficiency have yielded an increased incidence of cleft palate in the offspring. 8.2 Lactation Risk Summary 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. There are no data on the presence of hydrocortisone in breast milk, the effect on the breastfed infant or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALKINDI SPRINKLE and any potential adverse effects on the breastfed infant from ALKINDI SPRINKLE or from the underlying maternal condition. 8.4 Pediatric Use The safety and effectiveness of ALKINDI SPRINKLE have been established in pediatric patients for replacement therapy of adrenocortical insufficiency and the information on this use is discussed throughout the labeling. Use of ALKINDI SPRINKLE in pediatric patients is supported by use in pediatric patients for adrenocortical insufficiency with another hydrocortisone product, along with supportive pharmacokinetic and safety data in 24 pediatric patients with adrenocortical insufficiency. No new adverse reactions were identified [see Adverse Reactions (6) and Clinical Pharmacology (12.3)]. 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 [see Dosage and Administration (2.2)].
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.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.
| 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 |
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API