Alkindi Sprinkles 0.5mg Capsules
It is used to treat poor adrenal function.
Drug Class
Adrenal Cortical Steroid; Glucocorticoid
Pharmacologic Class
Corticosteroid; Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Sep 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alkindi Sprinkles contain hydrocortisone, which is a medicine that replaces a natural hormone (cortisol) that your body needs to function properly. It's especially important for children who don't make enough of this hormone on their own. It helps with energy, blood pressure, and how the body responds to stress.
How to Use This Medicine
Proper Administration of This Medication
To ensure your child receives the correct dose, follow the instructions provided by their doctor and read all accompanying information carefully.
When administering this medication, do not allow your child to swallow the capsule whole. Instead, hold the capsule with the printed label facing upwards and gently tap it to settle the granules at the bottom. Then, carefully squeeze the bottom of the capsule and twist off the top portion.
You can administer the contents directly into your child's mouth or pour the granules onto a spoon and then place it in their mouth. It is essential that your child does not chew or crush the granules. Alternatively, you can mix the granules with a small amount of cold or room temperature soft food, such as yogurt or fruit puree, but ensure that your child consumes the mixture within 5 minutes.
After administering the medication, encourage your child to drink fluids like water, milk, breast milk, or formula. However, do not allow the capsules to come into contact with liquids, and avoid mixing the granules with any liquid.
If your child vomits or spits up after taking the medication, consult with their doctor to determine if a repeat dose is necessary. Continue to administer the medication as directed by your child's doctor or healthcare provider, even if your child appears to be feeling well.
It is not uncommon to see granules in your child's stool; this does not indicate that the medication is ineffective. Do not administer an additional dose if you observe granules in their stool.
If your child is transitioning to this product from other forms of hydrocortisone, monitor them closely for signs of adrenal problems, such as extreme fatigue, weakness, stomach pain, headache, or vomiting. Report any of these symptoms to your child's doctor immediately.
Storage and Disposal
Store this medication at room temperature in a dry location, avoiding storage in a bathroom. Keep the medication in its original container to protect it from light. After opening, discard any unused portion after 60 days.
Missed Dose
If you miss a dose, administer it as soon as you remember. However, if it is close to the time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not administer two doses at the same time or give extra doses.
To ensure your child receives the correct dose, follow the instructions provided by their doctor and read all accompanying information carefully.
When administering this medication, do not allow your child to swallow the capsule whole. Instead, hold the capsule with the printed label facing upwards and gently tap it to settle the granules at the bottom. Then, carefully squeeze the bottom of the capsule and twist off the top portion.
You can administer the contents directly into your child's mouth or pour the granules onto a spoon and then place it in their mouth. It is essential that your child does not chew or crush the granules. Alternatively, you can mix the granules with a small amount of cold or room temperature soft food, such as yogurt or fruit puree, but ensure that your child consumes the mixture within 5 minutes.
After administering the medication, encourage your child to drink fluids like water, milk, breast milk, or formula. However, do not allow the capsules to come into contact with liquids, and avoid mixing the granules with any liquid.
If your child vomits or spits up after taking the medication, consult with their doctor to determine if a repeat dose is necessary. Continue to administer the medication as directed by your child's doctor or healthcare provider, even if your child appears to be feeling well.
It is not uncommon to see granules in your child's stool; this does not indicate that the medication is ineffective. Do not administer an additional dose if you observe granules in their stool.
If your child is transitioning to this product from other forms of hydrocortisone, monitor them closely for signs of adrenal problems, such as extreme fatigue, weakness, stomach pain, headache, or vomiting. Report any of these symptoms to your child's doctor immediately.
Storage and Disposal
Store this medication at room temperature in a dry location, avoiding storage in a bathroom. Keep the medication in its original container to protect it from light. After opening, discard any unused portion after 60 days.
Missed Dose
If you miss a dose, administer it as soon as you remember. However, if it is close to the time for the next scheduled dose, skip the missed dose and resume the regular dosing schedule. Do not administer two doses at the same time or give extra doses.
Lifestyle & Tips
- Always take exactly as prescribed, do not skip doses.
- Learn about 'stress dosing' and when to increase the dose (e.g., during illness, fever, injury, surgery). Discuss this plan with your doctor.
- Carry a medical alert card or wear a medical alert bracelet/necklace indicating adrenal insufficiency and hydrocortisone dependence.
- Always have an emergency supply of hydrocortisone and an injectable form (e.g., Solu-Cortef) for adrenal crisis, as advised by your doctor.
- Do not stop taking this medication suddenly, as it can lead to a life-threatening adrenal crisis.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not the primary indication for Alkindi Sprinkles. For adult adrenal insufficiency, typical hydrocortisone replacement is 15-25 mg/day in 2-3 divided doses using other formulations.
Condition-Specific Dosing:
adrenal_insufficiency:
Not typically used due to low dose strengths; other hydrocortisone formulations are preferred for adults.
Pediatric Dosing
Neonatal:
Initial dose for adrenal insufficiency (e.g., congenital adrenal hyperplasia, primary adrenal insufficiency) is highly individualized, typically 10-15 mg/m²/day or 0.4-0.8 mg/kg/day divided into 2-3 doses. Alkindi allows for precise titration.
Infant:
Initial dose for adrenal insufficiency (e.g., congenital adrenal hyperplasia, primary adrenal insufficiency) is highly individualized, typically 10-15 mg/m²/day or 0.4-0.8 mg/kg/day divided into 2-3 doses. Alkindi allows for precise titration.
Child:
Initial dose for adrenal insufficiency (e.g., congenital adrenal hyperplasia, primary adrenal insufficiency) is highly individualized, typically 10-15 mg/m²/day or 0.4-0.8 mg/kg/day divided into 2-3 doses. Alkindi allows for precise titration.
Adolescent:
Initial dose for adrenal insufficiency (e.g., congenital adrenal hyperplasia, primary adrenal insufficiency) is highly individualized, typically 10-15 mg/m²/day or 0.4-0.8 mg/kg/day divided into 2-3 doses. Alkindi allows for precise titration. Doses may approach adult replacement doses.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
No specific dose adjustment generally required.
Severe:
No specific dose adjustment generally required.
Dialysis:
Hydrocortisone is not significantly removed by dialysis; no dose adjustment needed.
Hepatic Impairment:
Mild:
No specific dose adjustment generally required.
Moderate:
Consider dose reduction in severe hepatic impairment due to reduced metabolism, though specific guidelines are lacking for replacement therapy.
Severe:
Consider dose reduction in severe hepatic impairment due to reduced metabolism, though specific guidelines are lacking for replacement therapy.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that binds to specific intracellular glucocorticoid receptors in target tissues. This binding leads to the formation of a steroid-receptor complex that translocates to the nucleus, where it modulates gene expression. This results in a wide range of physiological effects, including anti-inflammatory, immunosuppressive, metabolic, and electrolyte-balancing actions. In adrenal insufficiency, it replaces endogenous cortisol.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 80-90% (oral)
Tmax:
1-2 hours
FoodEffect:
Food may delay Tmax but generally does not significantly alter the extent of absorption (AUC).
Distribution:
Vd:
Approximately 0.5-1.5 L/kg
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin [CBG] and albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
Plasma half-life: 1.5-2 hours; Biological half-life: 8-12 hours
Clearance:
Primarily hepatic metabolism
ExcretionRoute:
Mainly renal (as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Hours (for full therapeutic effect)
PeakEffect:
Hours
DurationOfAction:
8-12 hours (biological effect)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of adrenal insufficiency (weak adrenal gland): severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Changes in menstrual period.
Bone or joint pain.
Chest pain or pressure.
Changes in vision, eye pain, or severe eye irritation.
Changes in behavior or mood.
Depression or other mood changes.
Hallucinations (seeing or hearing things that are not there).
Seizures.
Unexplained bruising or bleeding.
Severe stomach pain.
Black, tarry, or bloody stools.
Vomiting blood or coffee ground-like material.
Other Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Nausea and vomiting.
Difficulty sleeping.
Restlessness.
Excessive sweating.
Increased appetite.
* Weight gain.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe nausea and vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of adrenal insufficiency (weak adrenal gland): severe nausea and vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Shortness of breath, significant weight gain, or swelling in the arms or legs.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth.
Changes in menstrual period.
Bone or joint pain.
Chest pain or pressure.
Changes in vision, eye pain, or severe eye irritation.
Changes in behavior or mood.
Depression or other mood changes.
Hallucinations (seeing or hearing things that are not there).
Seizures.
Unexplained bruising or bleeding.
Severe stomach pain.
Black, tarry, or bloody stools.
Vomiting blood or coffee ground-like material.
Other Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Nausea and vomiting.
Difficulty sleeping.
Restlessness.
Excessive sweating.
Increased appetite.
* Weight gain.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of adrenal crisis: severe weakness, dizziness, nausea, vomiting, abdominal pain, fever, confusion, low blood pressure, loss of consciousness. Seek immediate medical attention.
- Signs of under-dosing: persistent fatigue, weakness, poor appetite, weight loss, dark skin patches (hyperpigmentation), salt craving.
- Signs of over-dosing (Cushing's syndrome): excessive weight gain, round face ('moon face'), fatty hump between shoulders ('buffalo hump'), thin skin, easy bruising, purple stretch marks, muscle weakness, mood changes, high blood sugar, high blood pressure, slowed growth in children.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
If your child has any allergies to this medication, its components, or other substances, including foods and drugs. Please describe the allergic reaction and its symptoms.
If your child has an active infection, such as bacterial, viral, or fungal infections, including:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
If your child has nerve problems in the eye.
This list is not exhaustive, and it is crucial to discuss all your child's health conditions and medications with their doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter medications
Natural products
Vitamins
Any health problems
To ensure safe treatment, always check with your doctor before:
Starting a new medication
Stopping a medication
Changing the dosage of any medication
It is essential to inform your doctor about the following:
If your child has any allergies to this medication, its components, or other substances, including foods and drugs. Please describe the allergic reaction and its symptoms.
If your child has an active infection, such as bacterial, viral, or fungal infections, including:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ Any other type of infection
If your child has nerve problems in the eye.
This list is not exhaustive, and it is crucial to discuss all your child's health conditions and medications with their doctor. Please inform your doctor and pharmacist about:
All prescription and over-the-counter medications
Natural products
Vitamins
Any health problems
To ensure safe treatment, always check with your doctor before:
Starting a new medication
Stopping a medication
Changing the dosage of any medication
Precautions & Cautions
Important Information for Parents and Caregivers
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication.
Monitoring and Follow-Up
Your child's doctor will need to monitor their blood work regularly. Additionally, if your child is taking this medication long-term, they may need to have their eye pressure and bone density checked.
Interactions with Other Tests and Substances
This medication may affect the results of allergy skin tests. Be sure to inform the doctor and laboratory staff that your child is taking this medication.
Long-term use of this medication may increase the risk of developing cataracts, glaucoma, or osteoporosis (weak bones). Discuss this risk with your child's doctor.
To minimize potential side effects, your child's doctor may recommend reducing the amount of salt in their diet and increasing their potassium intake.
If your child has diabetes, it is crucial to closely monitor their blood sugar levels while taking this medication.
Substance Interactions
Alcohol consumption may interact with this medication, so it is essential to ensure your child does not drink alcohol.
Grapefruit juice and grapefruit can also interact with this medication. If your child consumes these regularly, discuss this with their doctor.
Dosage and Administration
Do not exceed the dosage prescribed by your child's doctor, as this can increase the risk of severe side effects.
Vaccinations
Before your child receives any vaccinations, consult with their doctor. Certain vaccines may not be effective or may increase the risk of severe infection when taken with this medication.
If your child has not had chickenpox or measles before, it is essential to avoid exposure to these illnesses, as they can be severe or even life-threatening in children taking steroid medications like this one. If your child is exposed to chickenpox or measles, contact their doctor immediately.
Infection Risk
Steroid medications, including this one, can increase the risk of infection. They can also worsen existing infections and make it more challenging to notice signs of infection. Infections can range from mild to severe and potentially life-threatening. The risk of infection is higher with higher doses of steroids.
To minimize the risk of infection, encourage your child to wash their hands frequently and avoid contact with people who have infections, colds, or flu. If your child shows any signs of infection, contact their doctor promptly.
Some infections, such as tuberculosis and hepatitis B, can reactivate in patients taking medications like this one. If your child has a history of these infections, inform their doctor.
Adrenal Insufficiency
This medication may lower the natural steroid levels in your child's body. If your child experiences stress due to fever, infection, surgery, or injury, consult with their doctor, as they may need additional oral steroids.
It is recommended to carry a warning card indicating that your child may require extra steroids during stressful situations. If your child has been taking this medication for an extended period, consult with their doctor before stopping or reducing the dosage, as this can lead to severe side effects.
Other Potential Risks
Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk with your child's doctor.
If your child has or may have pheochromocytoma, a rare condition, inform their doctor, as this medication can have severe and potentially life-threatening effects in these patients.
Patients with cancer may be at higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Discuss this risk with your child's doctor.
This medication may affect growth in children and teenagers. Regular growth checks may be necessary.
If your child was born premature, inform their doctor, as this medication can increase the risk of a specific heart problem in these children.
Special Considerations
For children with poor adrenal function, stopping or reducing the dosage of this medication, or switching between different forms of this medication, can lead to severe and potentially life-threatening adrenal gland problems.
If your child is pregnant or breastfeeding, discuss the benefits and risks of this medication with their doctor. If your child used this medication during pregnancy, inform the baby's doctor.
In the event that your child misses a dose or recently stopped taking this medication and experiences symptoms such as fatigue, weakness, shakiness, fast heartbeat, confusion, sweating, or dizziness, contact their doctor promptly.
It is essential to inform all of your child's healthcare providers, including doctors, nurses, pharmacists, and dentists, that your child is taking this medication.
Monitoring and Follow-Up
Your child's doctor will need to monitor their blood work regularly. Additionally, if your child is taking this medication long-term, they may need to have their eye pressure and bone density checked.
Interactions with Other Tests and Substances
This medication may affect the results of allergy skin tests. Be sure to inform the doctor and laboratory staff that your child is taking this medication.
Long-term use of this medication may increase the risk of developing cataracts, glaucoma, or osteoporosis (weak bones). Discuss this risk with your child's doctor.
To minimize potential side effects, your child's doctor may recommend reducing the amount of salt in their diet and increasing their potassium intake.
If your child has diabetes, it is crucial to closely monitor their blood sugar levels while taking this medication.
Substance Interactions
Alcohol consumption may interact with this medication, so it is essential to ensure your child does not drink alcohol.
Grapefruit juice and grapefruit can also interact with this medication. If your child consumes these regularly, discuss this with their doctor.
Dosage and Administration
Do not exceed the dosage prescribed by your child's doctor, as this can increase the risk of severe side effects.
Vaccinations
Before your child receives any vaccinations, consult with their doctor. Certain vaccines may not be effective or may increase the risk of severe infection when taken with this medication.
If your child has not had chickenpox or measles before, it is essential to avoid exposure to these illnesses, as they can be severe or even life-threatening in children taking steroid medications like this one. If your child is exposed to chickenpox or measles, contact their doctor immediately.
Infection Risk
Steroid medications, including this one, can increase the risk of infection. They can also worsen existing infections and make it more challenging to notice signs of infection. Infections can range from mild to severe and potentially life-threatening. The risk of infection is higher with higher doses of steroids.
To minimize the risk of infection, encourage your child to wash their hands frequently and avoid contact with people who have infections, colds, or flu. If your child shows any signs of infection, contact their doctor promptly.
Some infections, such as tuberculosis and hepatitis B, can reactivate in patients taking medications like this one. If your child has a history of these infections, inform their doctor.
Adrenal Insufficiency
This medication may lower the natural steroid levels in your child's body. If your child experiences stress due to fever, infection, surgery, or injury, consult with their doctor, as they may need additional oral steroids.
It is recommended to carry a warning card indicating that your child may require extra steroids during stressful situations. If your child has been taking this medication for an extended period, consult with their doctor before stopping or reducing the dosage, as this can lead to severe side effects.
Other Potential Risks
Long-term use of this medication has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this risk with your child's doctor.
If your child has or may have pheochromocytoma, a rare condition, inform their doctor, as this medication can have severe and potentially life-threatening effects in these patients.
Patients with cancer may be at higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Discuss this risk with your child's doctor.
This medication may affect growth in children and teenagers. Regular growth checks may be necessary.
If your child was born premature, inform their doctor, as this medication can increase the risk of a specific heart problem in these children.
Special Considerations
For children with poor adrenal function, stopping or reducing the dosage of this medication, or switching between different forms of this medication, can lead to severe and potentially life-threatening adrenal gland problems.
If your child is pregnant or breastfeeding, discuss the benefits and risks of this medication with their doctor. If your child used this medication during pregnancy, inform the baby's doctor.
In the event that your child misses a dose or recently stopped taking this medication and experiences symptoms such as fatigue, weakness, shakiness, fast heartbeat, confusion, sweating, or dizziness, contact their doctor promptly.
Overdose Information
Overdose Symptoms:
- Acute overdose is rare but may present as exaggerated side effects: fluid retention, hypertension, hyperglycemia, hypokalemia, muscle weakness, mood changes.
- Chronic overdose leads to Cushing's syndrome (see warning symptoms above).
What to Do:
In case of suspected overdose, contact a poison control center immediately (call 1-800-222-1222 in the US) or seek emergency medical attention. Management is supportive and symptomatic. Chronic overdose requires gradual dose reduction under medical supervision.
Drug Interactions
Contraindicated Interactions
- Live or live-attenuated vaccines (when hydrocortisone is used in immunosuppressive doses, not typically for replacement therapy)
- Systemic fungal infections (unless used to control drug reactions)
Major Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates, carbamazepine, primidone): May decrease hydrocortisone levels, requiring dose increase.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, cobicistat, clarithromycin): May increase hydrocortisone levels, requiring dose reduction.
- NSAIDs (Nonsteroidal Anti-inflammatory Drugs): Increased risk of gastrointestinal ulceration and bleeding.
- Anticoagulants (e.g., warfarin): May alter anticoagulant effect (increase or decrease INR), requiring close monitoring.
- Diuretics (thiazide or loop): Increased risk of hypokalemia.
Moderate Interactions
- Digoxin: Increased risk of digitalis toxicity due to hypokalemia.
- Antidiabetic agents (insulin, oral hypoglycemics): Hydrocortisone can increase blood glucose, requiring adjustment of antidiabetic therapy.
- Cholestyramine, colestipol: May decrease absorption of hydrocortisone.
- Oral contraceptives/estrogens: May increase hydrocortisone levels due to increased CBG.
Minor Interactions
- Not specifically categorized as minor for hydrocortisone, but general caution with drugs affecting electrolyte balance or gastric pH.
Monitoring
Baseline Monitoring
Electrolytes (Sodium, Potassium)
Rationale: To establish baseline and monitor for mineralocorticoid effects or deficiency.
Timing: Prior to initiation
Blood Pressure
Rationale: To establish baseline and monitor for hypertension or hypotension.
Timing: Prior to initiation
Blood Glucose
Rationale: To establish baseline and monitor for hyperglycemia.
Timing: Prior to initiation
Growth parameters (height, weight, BMI)
Rationale: Crucial for pediatric patients to monitor for adequate replacement and avoid overtreatment/growth suppression.
Timing: Prior to initiation
Bone Mineral Density (DEXA scan)
Rationale: Consider for long-term therapy to monitor for osteoporosis risk.
Timing: Prior to initiation (if long-term therapy anticipated)
Routine Monitoring
Growth parameters (height, weight, BMI)
Frequency: Every 3-6 months (pediatric)
Target: Normal growth velocity for age
Action Threshold: Growth deceleration or excessive weight gain may indicate dose adjustment needed.
Blood Pressure
Frequency: Every 3-6 months or at clinic visits
Target: Age-appropriate normal range
Action Threshold: Persistent hypertension or hypotension.
Blood Glucose
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Fasting glucose <100 mg/dL
Action Threshold: Persistent hyperglycemia.
Electrolytes (Sodium, Potassium)
Frequency: Periodically (e.g., annually or as clinically indicated)
Target: Normal range
Action Threshold: Hypokalemia or hyponatremia.
Clinical signs of adrenal insufficiency or excess
Frequency: At every clinic visit
Target: Absence of symptoms
Action Threshold: Symptoms of under-dosing (fatigue, weakness, nausea, vomiting, hypotension) or over-dosing (Cushingoid features, weight gain, striae).
Symptom Monitoring
- Signs of adrenal crisis (severe fatigue, weakness, dizziness, nausea, vomiting, abdominal pain, fever, confusion, hypotension, loss of consciousness)
- Signs of under-dosing (persistent fatigue, weakness, poor appetite, weight loss, hyperpigmentation, salt craving)
- Signs of over-dosing/Cushing's syndrome (excessive weight gain, moon face, buffalo hump, thin skin, easy bruising, striae, muscle weakness, mood changes, hyperglycemia, hypertension, growth suppression in children)
Special Patient Groups
Pregnancy
Hydrocortisone is Category C. For women with adrenal insufficiency, continued hydrocortisone replacement therapy is essential during pregnancy. The benefits of maintaining physiological cortisol levels outweigh potential risks to the fetus. Doses may need to be adjusted, especially in the third trimester.
Trimester-Specific Risks:
First Trimester:
No clear evidence of increased risk of congenital malformations with physiological replacement doses.
Second Trimester:
Generally considered safe for continued replacement therapy.
Third Trimester:
Dose may need to be increased due to increased CBG and metabolic demands. Monitor for signs of adrenal insufficiency.
Lactation
Hydrocortisone is considered compatible with breastfeeding (L3). It is naturally present in breast milk. At physiological replacement doses, the amount transferred to breast milk is small and unlikely to cause adverse effects in the infant.
Infant Risk:
Low risk. Monitor infant for any signs of adrenal suppression (e.g., poor weight gain, lethargy) if mother is on high doses, though this is unlikely with replacement therapy.
Pediatric Use
Alkindi Sprinkles are specifically designed and indicated for pediatric patients (from birth to <18 years of age) with adrenal insufficiency. Close monitoring of growth, development, and signs of under- or over-treatment is crucial. Dosing is individualized based on body surface area or weight.
Geriatric Use
No specific dose adjustments are generally required for elderly patients with adrenal insufficiency. However, geriatric patients may have increased susceptibility to adverse effects of corticosteroids (e.g., osteoporosis, diabetes, hypertension), so careful monitoring of comorbidities is important.
Clinical Information
Clinical Pearls
- Alkindi Sprinkles offer precise dosing for pediatric patients, which is critical for managing adrenal insufficiency and minimizing the risk of under- or over-treatment.
- Educate patients/caregivers thoroughly on 'stress dosing' protocols for illness, injury, or surgery to prevent adrenal crisis.
- Emphasize the importance of strict adherence and never abruptly stopping the medication.
- Patients should carry emergency identification (medical alert card/bracelet) indicating their condition and medication.
- Ensure patients/caregivers have access to and know how to administer emergency injectable hydrocortisone.
Alternative Therapies
- Other oral hydrocortisone formulations (e.g., tablets, liquid suspensions) for adrenal insufficiency.
- Prednisone, Dexamethasone (other glucocorticoids, but typically not preferred for physiological replacement due to longer half-life and different potency profiles).
- Fludrocortisone (mineralocorticoid replacement, often co-administered with hydrocortisone in primary adrenal insufficiency).
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per 30 capsules (0.5mg, 1mg, 2mg, 5mg strengths)
Insurance Coverage:
Specialty Tier (requires prior authorization, may have high co-pay)
General Drug Facts
If your child's symptoms or health issues persist or worsen, it is essential to contact their doctor promptly. To ensure safe and effective treatment, never share your child's medication with others, and do not administer someone else's medication to your child. Some medications may include an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about this medication, we encourage you to discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider. This medication is accompanied by a Medication Guide, which provides important information about its use. Please read this guide carefully and review it again whenever the medication is refilled. If you have any questions or concerns, do not hesitate to reach out to your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.