Alkindi Sprinkle 2mg Capsules
It is used to treat poor adrenal function.
Drug Class
Adrenal Cortical Steroid; Glucocorticoid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Sep 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alkindi Sprinkle is a medicine that contains hydrocortisone, which is a type of steroid. It's used to replace a natural hormone (cortisol) that your child's body isn't making enough of, a condition called adrenal insufficiency. This medicine helps your child's body function properly and manage 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 to instruct your child not to 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 expose the capsules to moisture or mix 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 administering 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 notice 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 or weakness, stomach pain, headache, feeling extremely warm or cold, or vomiting. Inform the doctor immediately if you notice any of these symptoms.
Storage and Disposal
Store this medication at room temperature in a dry location, avoiding bathrooms. 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 to instruct your child not to 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 expose the capsules to moisture or mix 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 administering 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 notice 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 or weakness, stomach pain, headache, feeling extremely warm or cold, or vomiting. Inform the doctor immediately if you notice any of these symptoms.
Storage and Disposal
Store this medication at room temperature in a dry location, avoiding bathrooms. 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
- Take the medicine exactly as prescribed, usually divided into 2 or 3 doses throughout the day. Do not skip doses.
- Learn how to administer the granules: open the capsule and sprinkle the contents onto a small amount of soft food (like applesauce, yogurt, or pudding) or directly into the mouth. Do not crush or chew the capsule.
- Always carry a medical alert card or wear a medical alert bracelet indicating adrenal insufficiency and hydrocortisone use.
- Understand 'stress dosing': During times of illness (fever, vomiting, diarrhea), injury, or surgery, the dose of hydrocortisone may need to be increased. Discuss a stress dose plan with your doctor.
- Do not stop taking this medicine suddenly without consulting your doctor, as it can lead to a serious condition called adrenal crisis.
- Regularly monitor your child's growth and report any concerns to the doctor.
- Avoid exposure to people with infections, especially chickenpox or measles, as this medicine can weaken the immune system.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use.
Pediatric Dosing
Neonatal:
Initial daily dose: 8-10 mg/m²/day (based on body surface area) or 0.4-0.6 mg/kg/day (based on weight), divided into 2-3 doses. Individualized based on clinical response and laboratory parameters. Stress dosing required during illness/stress.
Infant:
Initial daily dose: 8-10 mg/m²/day (based on body surface area) or 0.4-0.6 mg/kg/day (based on weight), divided into 2-3 doses. Individualized based on clinical response and laboratory parameters. Stress dosing required during illness/stress.
Child:
Initial daily dose: 8-10 mg/m²/day (based on body surface area) or 0.4-0.6 mg/kg/day (based on weight), divided into 2-3 doses. Individualized based on clinical response and laboratory parameters. Stress dosing required during illness/stress.
Adolescent:
Initial daily dose: 8-10 mg/m²/day (based on body surface area) or 0.4-0.6 mg/kg/day (based on weight), divided into 2-3 doses. Individualized based on clinical response and laboratory parameters. Stress dosing required during illness/stress.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor for fluid retention.
Moderate:
No specific dose adjustment recommended, but monitor for fluid retention.
Severe:
No specific dose adjustment recommended, but monitor for fluid retention.
Dialysis:
Hydrocortisone is not significantly removed by dialysis. No specific dose adjustment recommended, but monitor for fluid retention.
Hepatic Impairment:
Mild:
Caution advised; monitor for increased effects due to reduced metabolism.
Moderate:
Dose reduction may be necessary; monitor closely for signs of hypercorticism.
Severe:
Significant dose reduction likely required; monitor closely for signs of hypercorticism.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that binds to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex then binds to specific DNA sequences (glucocorticoid response elements), modulating gene transcription. This leads to widespread effects including anti-inflammatory, immunosuppressive, and metabolic actions, and replacement of endogenous cortisol in adrenal insufficiency.
Pharmacokinetics
Absorption:
Bioavailability:
Rapidly absorbed; specific percentage not explicitly stated for Alkindi Sprinkle but generally high for oral hydrocortisone.
Tmax:
0.5-1.5 hours
FoodEffect:
Food may delay Tmax but does not significantly affect AUC.
Distribution:
Vd:
0.2-0.5 L/kg
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin and albumin)
CnssPenetration:
Limited, but can cross the blood-brain barrier.
Elimination:
HalfLife:
1.5-2 hours (plasma half-life); biological half-life is longer (8-12 hours)
Clearance:
Not specifically quantified for Alkindi Sprinkle, but primarily hepatic.
ExcretionRoute:
Renal (as metabolites)
Unchanged:
<1% (renal)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes to hours for physiological effects)
PeakEffect:
Within 1-2 hours (for plasma levels)
DurationOfAction:
8-12 hours (physiological effects)
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 immediately or seek medical attention:
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 discolored sputum, 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 healing.
Signs of a 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 Possible 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:
Upset stomach or vomiting.
Difficulty sleeping.
Restlessness.
Excessive sweating.
Increased appetite.
* Weight gain.
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, consult 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 immediately or seek medical attention:
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 discolored sputum, 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 healing.
Signs of a 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 Possible 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:
Upset stomach or vomiting.
Difficulty sleeping.
Restlessness.
Excessive sweating.
Increased appetite.
* Weight gain.
This is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, consult 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 too little medicine (adrenal crisis): severe tiredness, weakness, dizziness, nausea, vomiting, stomach pain, fever, confusion, low blood pressure. Seek immediate medical attention.
- Signs of too much medicine (Cushing's syndrome): unusual weight gain (especially in the face and trunk), 'moon face', 'buffalo hump', thin skin, easy bruising, muscle weakness, stretch marks, increased appetite, mood changes, difficulty sleeping.
- Signs of infection: fever, chills, sore throat, body aches, unusual pain, redness, or swelling.
- High blood sugar: increased thirst, increased urination, increased hunger.
- Fluid retention: swelling in the ankles or feet.
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 (OTC) medications
Natural products
Vitamins
* Any health problems
To ensure safe treatment, verify that it is safe to take this medication with all your child's other medications and health conditions. Never start, stop, or change the dose of any medication without consulting 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 (OTC) medications
Natural products
Vitamins
* Any health problems
To ensure safe treatment, verify that it is safe to take this medication with all your child's other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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 may interact with this medication, so it is essential to ensure your child does not consume alcohol.
If your child consumes grapefruit juice or eats grapefruit regularly, inform their doctor, as this may interact with the medication.
Dosage and Administration
Do not exceed the dosage prescribed by your child's doctor, as taking more than the recommended amount may increase the risk of severe side effects.
Vaccinations
Before your child receives any vaccinations, consult with their doctor, as some vaccines may not be suitable for children taking this medication or may increase the risk of infection.
It is also essential to note that chickenpox and measles can be severe or even life-threatening in children taking steroid medications like this one. If your child has not had these illnesses before, avoid exposing them to anyone with chickenpox or measles. If your child has been exposed to either of these illnesses, inform their doctor immediately.
Infection Risk
Steroid medications, including this one, can increase the risk of infection. They may also worsen existing infections or make it more challenging to recognize the signs of infection. Infections can range from mild to severe and, in some cases, be life-threatening. The risk of infection is typically higher with higher doses of steroids.
To minimize the risk of infection, encourage your child to wash their hands frequently and avoid close contact with people who have infections, colds, or flu. Inform your child's doctor if they exhibit any signs of infection.
Reactivation of Infections
In some cases, this medication may reactivate latent infections, such as tuberculosis or hepatitis B. Inform your child's doctor if they have a history of either of these infections.
Adrenal Insufficiency
This medication may decrease the production of natural steroids in your child's body. If your child experiences a fever, infection, undergoes surgery, or is injured, consult with their doctor, as they may require additional oral steroids to help their body cope with these stresses.
It is recommended that your child carries a warning card indicating that they may require extra steroids in certain 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 may need to be done gradually.
If your child has missed a dose or recently stopped taking this medication and experiences fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform their doctor promptly.
Rare but Serious Risks
Long-term use of this medication has been associated with an increased risk of developing Kaposi's sarcoma, a type of cancer. Discuss this risk with your child's doctor.
If your child has or may have pheochromocytoma, inform their doctor, as this medication can have severe and potentially life-threatening effects in patients with this condition.
Special Considerations
Children and teenagers taking this medication may be at risk of growth suppression. Regular growth checks may be necessary.
If your child was born prematurely, inform their doctor, as they may be at risk of developing a specific heart problem.
Poor Adrenal Function
If your child has poor adrenal function, stopping this medication, taking too low of a dose, or switching between different forms of this medication can lead to severe adrenal gland problems, which can be life-threatening. If you have any questions or concerns, consult with your child's doctor.
Pregnancy and Breastfeeding
If your child is pregnant or breastfeeding, inform their doctor, as they will need to discuss the benefits and risks of this medication. If your child used this medication during pregnancy, inform the baby's doctor.
Additional Precautions
It is essential to be aware of the potential risks and interactions associated with this medication. If you have any questions or concerns, consult with your child's doctor.
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 may interact with this medication, so it is essential to ensure your child does not consume alcohol.
If your child consumes grapefruit juice or eats grapefruit regularly, inform their doctor, as this may interact with the medication.
Dosage and Administration
Do not exceed the dosage prescribed by your child's doctor, as taking more than the recommended amount may increase the risk of severe side effects.
Vaccinations
Before your child receives any vaccinations, consult with their doctor, as some vaccines may not be suitable for children taking this medication or may increase the risk of infection.
It is also essential to note that chickenpox and measles can be severe or even life-threatening in children taking steroid medications like this one. If your child has not had these illnesses before, avoid exposing them to anyone with chickenpox or measles. If your child has been exposed to either of these illnesses, inform their doctor immediately.
Infection Risk
Steroid medications, including this one, can increase the risk of infection. They may also worsen existing infections or make it more challenging to recognize the signs of infection. Infections can range from mild to severe and, in some cases, be life-threatening. The risk of infection is typically higher with higher doses of steroids.
To minimize the risk of infection, encourage your child to wash their hands frequently and avoid close contact with people who have infections, colds, or flu. Inform your child's doctor if they exhibit any signs of infection.
Reactivation of Infections
In some cases, this medication may reactivate latent infections, such as tuberculosis or hepatitis B. Inform your child's doctor if they have a history of either of these infections.
Adrenal Insufficiency
This medication may decrease the production of natural steroids in your child's body. If your child experiences a fever, infection, undergoes surgery, or is injured, consult with their doctor, as they may require additional oral steroids to help their body cope with these stresses.
It is recommended that your child carries a warning card indicating that they may require extra steroids in certain 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 may need to be done gradually.
If your child has missed a dose or recently stopped taking this medication and experiences fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform their doctor promptly.
Rare but Serious Risks
Long-term use of this medication has been associated with an increased risk of developing Kaposi's sarcoma, a type of cancer. Discuss this risk with your child's doctor.
If your child has or may have pheochromocytoma, inform their doctor, as this medication can have severe and potentially life-threatening effects in patients with this condition.
Special Considerations
Children and teenagers taking this medication may be at risk of growth suppression. Regular growth checks may be necessary.
If your child was born prematurely, inform their doctor, as they may be at risk of developing a specific heart problem.
Poor Adrenal Function
If your child has poor adrenal function, stopping this medication, taking too low of a dose, or switching between different forms of this medication can lead to severe adrenal gland problems, which can be life-threatening. If you have any questions or concerns, consult with your child's doctor.
Pregnancy and Breastfeeding
If your child is pregnant or breastfeeding, inform their doctor, as they will need to discuss the benefits and risks of this medication. If your child used this medication during pregnancy, inform the baby's doctor.
Additional Precautions
It is essential to be aware of the potential risks and interactions associated with this medication. If you have any questions or concerns, consult with your child's doctor.
Overdose Information
Overdose Symptoms:
- Symptoms of Cushing's syndrome (long-term overdose): weight gain, moon face, buffalo hump, thin skin, easy bruising, muscle weakness, striae, high blood pressure, high blood sugar.
- Acute overdose is rare but may cause nausea, vomiting, and gastrointestinal bleeding. Long-term overdose leads to adrenal suppression and Cushingoid features.
What to Do:
In case of suspected overdose, contact a poison control center immediately or seek emergency medical attention. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Live attenuated vaccines (in immunosuppressed patients)
Major Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine): May decrease hydrocortisone levels, requiring dose increase.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): May increase hydrocortisone levels, requiring dose reduction.
- Non-steroidal anti-inflammatory drugs (NSAIDs): Increased risk of gastrointestinal ulceration and bleeding.
- Anticoagulants (e.g., warfarin): May alter anticoagulant effect (increase or decrease).
Moderate Interactions
- Diuretics (thiazide, loop): Enhanced potassium depletion, increased risk of hypokalemia.
- Antidiabetic agents (insulin, oral hypoglycemics): May increase blood glucose, requiring dose adjustment of antidiabetic agents.
- Cardiac glycosides (e.g., digoxin): Increased risk of toxicity with hypokalemia.
- Cholestyramine, colestipol: May decrease hydrocortisone absorption.
- Oral contraceptives/estrogens: May increase hydrocortisone levels due to increased corticosteroid-binding globulin.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Serum Electrolytes (Sodium, Potassium)
Rationale: To establish baseline and monitor for mineralocorticoid effects (e.g., hypokalemia, hypernatremia).
Timing: Prior to initiation of therapy.
Blood Glucose
Rationale: To establish baseline and monitor for glucocorticoid-induced hyperglycemia.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: To establish baseline and monitor for hypertension.
Timing: Prior to initiation of therapy.
Growth (Height and Weight)
Rationale: Crucial for pediatric patients to monitor for growth suppression.
Timing: Prior to initiation of therapy.
Bone Mineral Density (BMD)
Rationale: For patients on long-term therapy to assess risk of osteoporosis.
Timing: Baseline, especially for long-term use.
Routine Monitoring
Clinical signs of adrenal insufficiency or Cushing's syndrome
Frequency: Regularly (e.g., at each clinic visit)
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires dose adjustment or further investigation.
Growth velocity (Height and Weight)
Frequency: Every 3-6 months (pediatric patients)
Target: Normal growth curve for age
Action Threshold: Growth deceleration or failure to thrive may indicate over- or under-dosing.
Blood Pressure
Frequency: Regularly (e.g., at each clinic visit)
Target: Age-appropriate normal range
Action Threshold: Sustained hypertension.
Serum Electrolytes (Sodium, Potassium)
Frequency: Periodically (e.g., every 6-12 months, or as clinically indicated)
Target: Within normal limits
Action Threshold: Significant deviations (e.g., hypokalemia, hypernatremia).
Blood Glucose
Frequency: Periodically (e.g., every 6-12 months, or as clinically indicated)
Target: Within normal limits
Action Threshold: Persistent hyperglycemia.
Bone Mineral Density (BMD)
Frequency: Every 1-2 years for long-term therapy
Target: Stable or improving BMD
Action Threshold: Significant bone loss.
Symptom Monitoring
- Signs of adrenal crisis (severe fatigue, weakness, dizziness, nausea, vomiting, abdominal pain, fever, confusion, low blood pressure)
- Signs of Cushing's syndrome (weight gain, moon face, buffalo hump, thin skin, easy bruising, muscle weakness, striae)
- Signs of infection (fever, chills, sore throat, unusual pain)
- Mood changes (irritability, depression, euphoria)
- Sleep disturbances
- Fluid retention (swelling in ankles/feet)
- Gastrointestinal upset (stomach pain, heartburn)
Special Patient Groups
Pregnancy
Hydrocortisone crosses the placenta. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. For women with adrenal insufficiency, continued hydrocortisone replacement is essential during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts with high doses or prolonged use, though data are conflicting. For replacement therapy, risk is generally considered low.
Second Trimester:
Generally considered safer than first trimester for systemic corticosteroids, but continued monitoring is essential.
Third Trimester:
May be associated with fetal growth restriction or adrenal suppression in the neonate if used in high doses or for prolonged periods. Neonates should be monitored for signs of hypoadrenalism.
Lactation
Hydrocortisone is excreted in human milk. The amount is generally considered low, especially with replacement doses. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Alkindi and any potential adverse effects on the breastfed infant.
Infant Risk:
Low risk with typical replacement doses. Monitor breastfed infants for signs of adrenal suppression (e.g., poor weight gain, irritability) or other adverse effects, though unlikely.
Pediatric Use
Alkindi Sprinkle is specifically indicated for the treatment of adrenal insufficiency in pediatric patients less than 18 years of age. Close monitoring of growth, development, and signs of over- or under-dosing is critical. Stress dosing education for parents/caregivers is paramount.
Geriatric Use
Alkindi Sprinkle is not indicated for geriatric patients. General considerations for corticosteroid use in the elderly (e.g., increased risk of osteoporosis, diabetes, hypertension, cataracts) would apply if hydrocortisone were used in this population.
Clinical Information
Clinical Pearls
- Alkindi Sprinkle is the first and only FDA-approved hydrocortisone oral granule formulation specifically designed for pediatric adrenal insufficiency, allowing for precise, low-dose administration.
- Emphasize the importance of strict adherence to the dosing schedule and the critical need for stress dosing during illness, injury, or surgery.
- Educate parents/caregivers on the signs and symptoms of both adrenal crisis (under-dosing) and Cushing's syndrome (over-dosing) to ensure timely intervention.
- Advise patients/caregivers to always carry an emergency hydrocortisone injection kit and a medical alert identification.
- Regular monitoring of growth velocity in pediatric patients is essential to ensure appropriate dosing and prevent growth suppression.
Alternative Therapies
- Other oral hydrocortisone formulations (e.g., tablets, compounded solutions) for adrenal insufficiency (though not specifically approved for pediatric AI in the same way as Alkindi).
- Other glucocorticoids (e.g., prednisone, dexamethasone) are generally not used for chronic replacement therapy in adrenal insufficiency due to their longer half-lives and different mineralocorticoid profiles, but may be used in specific situations or for other indications.
Cost & Coverage
Average Cost:
Highly variable, typically several thousand dollars per 100 capsules (e.g., 2mg)
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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 use, 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. If you have any questions or concerns about this medication, it is crucial to discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is vital to read this guide carefully and review it again each time the medication is refilled. If you have any questions or concerns about the medication, do not hesitate to reach out to your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.
This medication is accompanied by a Medication Guide, which is a comprehensive patient fact sheet. It is vital to read this guide carefully and review it again each time the medication is refilled. If you have any questions or concerns about the medication, do not hesitate to reach out to your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.