Alkindi Sprinkle 5mg Capsules
It is used to treat poor adrenal function.
Drug Class
Adrenal Corticosteroid
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 containing hydrocortisone, which is a type of steroid. It's used to replace a hormone that your body doesn't make enough of, especially in children with a condition called adrenal insufficiency. It helps your body function properly and prevents serious health problems.
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 medication by either pouring the entire contents directly into your child's mouth or by placing the granules onto a spoon and then into 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 the mixture is given within 5 minutes of preparation.
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 water 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 to give your child this medication as directed by their doctor or healthcare provider, even if they appear 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.
Important Administration Considerations
- Do not administer this medication through a feeding tube.
- If your child is transitioning from another form of hydrocortisone to this product, monitor them closely for signs of adrenal problems, such as extreme fatigue or weakness, stomach pain, headache, feeling unusually warm or cold, 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 place, avoiding storage in bathrooms. Keep the medication in its original container to protect it from light. After opening, discard any unused portion after 60 days.
Missed Dose Instructions
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 give your child two doses at once or administer 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 medication by either pouring the entire contents directly into your child's mouth or by placing the granules onto a spoon and then into 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 the mixture is given within 5 minutes of preparation.
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 water 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 to give your child this medication as directed by their doctor or healthcare provider, even if they appear 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.
Important Administration Considerations
- Do not administer this medication through a feeding tube.
- If your child is transitioning from another form of hydrocortisone to this product, monitor them closely for signs of adrenal problems, such as extreme fatigue or weakness, stomach pain, headache, feeling unusually warm or cold, 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 place, avoiding storage in bathrooms. Keep the medication in its original container to protect it from light. After opening, discard any unused portion after 60 days.
Missed Dose Instructions
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 give your child two doses at once or administer extra doses.
Lifestyle & Tips
- Administer exactly as prescribed, usually 2 or 3 times a day. Do not stop taking this medication suddenly without consulting your doctor, as it can lead to a serious condition called adrenal crisis.
- Alkindi Sprinkle capsules should be opened and the granules sprinkled onto a small amount of soft food (e.g., applesauce, yogurt, mashed banana) or into breast milk/formula. Do NOT sprinkle into water or other liquids. Do NOT chew the granules.
- Take with food or milk to minimize stomach upset.
- Carry a medical alert card or wear a medical alert bracelet indicating you are on hydrocortisone, especially for adrenal insufficiency.
- Discuss 'stress dosing' with your doctor for times of illness, injury, or surgery, as your dose may need to be temporarily increased.
- Avoid exposure to people with infections (especially chickenpox or measles) if possible, as your immune system may be weakened.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Not indicated for adult use. Adults typically use hydrocortisone tablets.
Pediatric Dosing
Neonatal:
Initial dose for adrenal insufficiency: 10-12 mg/m²/day, divided into 2-3 doses. Adjust based on clinical response and laboratory parameters (e.g., ACTH, cortisol).
Infant:
Initial dose for adrenal insufficiency: 10-12 mg/m²/day, divided into 2-3 doses. Adjust based on clinical response and laboratory parameters (e.g., ACTH, cortisol).
Child:
Initial dose for adrenal insufficiency: 10-12 mg/m²/day, divided into 2-3 doses. Adjust based on clinical response and laboratory parameters (e.g., ACTH, cortisol).
Adolescent:
Initial dose for adrenal insufficiency: 10-12 mg/m²/day, divided into 2-3 doses. Adjust based on clinical response and laboratory parameters (e.g., ACTH, cortisol).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
Hydrocortisone is not significantly removed by hemodialysis. No specific dose adjustment recommended.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Consider dose reduction and monitor for increased side effects due to decreased metabolism.
Severe:
Consider dose reduction and monitor for increased side effects due to decreased metabolism.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that binds to intracellular glucocorticoid receptors, 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 diverse physiological effects, including anti-inflammatory, immunosuppressive, and metabolic actions, as well as regulation of fluid and electrolyte balance.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
1-2 hours
FoodEffect:
Food can delay absorption but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 0.5-1 L/kg
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin and albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Plasma half-life: 1.5-2 hours; Biological half-life: 8-12 hours
Clearance:
Approximately 0.5 L/hr/kg
ExcretionRoute:
Renal (primarily as inactive metabolites)
Unchanged:
Less than 10%
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes for IV, hours for oral)
PeakEffect:
1-2 hours (oral)
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 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 abdominal pain, severe back pain, or severe nausea and vomiting
Signs of high blood pressure: severe headache, 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, sudden 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 abdominal 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 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 abdominal pain, severe back pain, or severe nausea and vomiting
Signs of high blood pressure: severe headache, 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, sudden 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 abdominal 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 too much medicine (Cushing's syndrome): unusual weight gain, round face (moon face), increased fat around neck/upper back (buffalo hump), thin skin, easy bruising, acne, increased hair growth, muscle weakness, mood changes (irritability, depression).
- Signs of too little medicine (adrenal crisis): severe fatigue, weakness, dizziness, nausea, vomiting, abdominal pain, diarrhea, loss of appetite, weight loss, dark skin patches, low blood pressure, confusion, fainting.
- Signs of infection: fever, chills, sore throat, body aches, unusual pain or swelling.
- Gastrointestinal bleeding: black, tarry stools or severe stomach pain.
- Vision changes: blurred vision, eye pain.
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 allergy and the symptoms your child experienced.
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.
To ensure safe treatment, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Any health problems your child may have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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 allergy and the symptoms your child experienced.
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.
To ensure safe treatment, please inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Any health problems your child may have
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions
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 Tests
Your child's doctor will need to monitor their blood work regularly. Additionally, if your child is taking this medication for an extended period, they may require regular eye pressure and bone density checks.
Interactions with Other Tests and Substances
This medication may interfere with allergy skin tests, so it is crucial to inform the doctor and laboratory personnel 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 salt intake and increasing potassium consumption.
If your child has diabetes, it is essential to closely monitor their blood sugar levels.
Substance Interactions
Alcohol consumption may interact with this medication, so it is recommended that your child avoids alcohol altogether.
If your child consumes grapefruit juice or eats grapefruit regularly, consult with their doctor.
Dosage and Administration
Do not exceed the prescribed dosage, as this may 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, avoid exposing them to anyone with these conditions, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If your child has been exposed to chickenpox or measles, consult with their doctor.
Infection Risk
Steroid medications, including this one, increase the risk of infection. They can cause existing infections to worsen and may mask symptoms of infection, making them harder to detect. Infections can range from mild to severe and potentially life-threatening. The risk of infection is typically higher with higher doses of steroids.
To minimize the risk of infection, encourage your child to practice good hygiene, such as frequent handwashing, and avoid close contact with individuals 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 these conditions.
Adrenal Insufficiency
This medication may decrease the production of natural steroids in your child's body. If your child experiences a fever, infection, surgery, or injury, consult with their doctor, as they may require additional oral steroid doses to help their body cope with stress.
Carry a warning card indicating that your child 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 recently stopped taking this medication or missed a dose and is experiencing fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform their doctor.
Rare but Serious 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, inform their doctor, as this medication can cause severe and potentially life-threatening effects in individuals with this condition.
Patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Discuss this risk with your child's doctor.
Effects on Growth and Development
This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this risk with your child's doctor.
Premature Infants
If your child was born prematurely, inform their doctor, as this medication has been associated with a specific heart problem in premature infants.
Poor Adrenal Function
Stopping this medication, taking too low of a dose, or switching between dose forms can lead to severe adrenal gland problems, which can be life-threatening. If you have questions or concerns, consult with your child's doctor.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the benefits and risks to both your child and the baby. If your child used this medication during pregnancy, inform the baby'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 Tests
Your child's doctor will need to monitor their blood work regularly. Additionally, if your child is taking this medication for an extended period, they may require regular eye pressure and bone density checks.
Interactions with Other Tests and Substances
This medication may interfere with allergy skin tests, so it is crucial to inform the doctor and laboratory personnel 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 salt intake and increasing potassium consumption.
If your child has diabetes, it is essential to closely monitor their blood sugar levels.
Substance Interactions
Alcohol consumption may interact with this medication, so it is recommended that your child avoids alcohol altogether.
If your child consumes grapefruit juice or eats grapefruit regularly, consult with their doctor.
Dosage and Administration
Do not exceed the prescribed dosage, as this may 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, avoid exposing them to anyone with these conditions, as they can be severe or even life-threatening in individuals taking steroid medications like this one. If your child has been exposed to chickenpox or measles, consult with their doctor.
Infection Risk
Steroid medications, including this one, increase the risk of infection. They can cause existing infections to worsen and may mask symptoms of infection, making them harder to detect. Infections can range from mild to severe and potentially life-threatening. The risk of infection is typically higher with higher doses of steroids.
To minimize the risk of infection, encourage your child to practice good hygiene, such as frequent handwashing, and avoid close contact with individuals 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 these conditions.
Adrenal Insufficiency
This medication may decrease the production of natural steroids in your child's body. If your child experiences a fever, infection, surgery, or injury, consult with their doctor, as they may require additional oral steroid doses to help their body cope with stress.
Carry a warning card indicating that your child 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 recently stopped taking this medication or missed a dose and is experiencing fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness, inform their doctor.
Rare but Serious 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, inform their doctor, as this medication can cause severe and potentially life-threatening effects in individuals with this condition.
Patients with cancer may be at a higher risk of developing tumor lysis syndrome (TLS), a potentially life-threatening condition. Discuss this risk with your child's doctor.
Effects on Growth and Development
This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Discuss this risk with your child's doctor.
Premature Infants
If your child was born prematurely, inform their doctor, as this medication has been associated with a specific heart problem in premature infants.
Poor Adrenal Function
Stopping this medication, taking too low of a dose, or switching between dose forms can lead to severe adrenal gland problems, which can be life-threatening. If you have questions or concerns, consult with your child's doctor.
Pregnancy and Breastfeeding
If your child is pregnant, becomes pregnant, or is breastfeeding, consult with their doctor to discuss the benefits and risks to both your child and the baby. If your child used this medication during pregnancy, inform the baby's doctor.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely to cause life-threatening symptoms.
- Chronic overdose can lead to signs of Cushing's syndrome (see warning symptoms above), fluid retention, hypertension, hyperglycemia, hypokalemia, and increased susceptibility to infection.
What to Do:
In case of suspected overdose, seek immediate medical attention. Call your local poison control center (e.g., 1-800-222-1222 in the US) or emergency services. Management is supportive and symptomatic.
Drug Interactions
Major Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine): May decrease hydrocortisone levels, requiring dose increase.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, cobicistat): May increase hydrocortisone levels, requiring dose reduction.
- Live or live attenuated vaccines: Risk of severe or fatal infection in immunosuppressed patients.
Moderate Interactions
- Potassium-depleting diuretics (e.g., thiazides, loop diuretics): Increased risk of hypokalemia.
- NSAIDs: Increased risk of gastrointestinal ulceration and bleeding.
- Anticoagulants (e.g., warfarin): May alter anticoagulant effects (either increase or decrease). Monitor INR.
- Antidiabetic agents (e.g., insulin, oral hypoglycemics): Hydrocortisone may increase blood glucose, requiring dose adjustment of antidiabetic agents.
- Cholestyramine, colestipol: May decrease absorption of hydrocortisone.
- Cyclosporine: Increased risk of seizures and other CNS effects with concomitant use.
- Digitalis glycosides: Increased risk of arrhythmias due to hypokalemia.
Minor Interactions
- Oral contraceptives: May increase hydrocortisone levels.
- Grapefruit juice: May increase hydrocortisone levels (CYP3A4 inhibition).
Monitoring
Baseline Monitoring
Height and Weight
Rationale: To establish baseline growth parameters and calculate BSA for dosing.
Timing: Prior to initiation and regularly thereafter.
Blood Pressure
Rationale: Corticosteroids can cause hypertension.
Timing: Prior to initiation.
Electrolytes (Sodium, Potassium)
Rationale: To assess baseline electrolyte balance; corticosteroids can cause fluid retention and hypokalemia.
Timing: Prior to initiation.
Blood Glucose
Rationale: Corticosteroids can cause hyperglycemia.
Timing: Prior to initiation.
Routine Monitoring
Height and Weight
Frequency: Every 3-6 months (or more frequently in young children)
Target: Normal growth velocity for age
Action Threshold: Growth deceleration or excessive weight gain.
Blood Pressure
Frequency: At each clinic visit
Target: Age-appropriate normal range
Action Threshold: Sustained hypertension.
Electrolytes (Sodium, Potassium)
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Normal range
Action Threshold: Hypokalemia, hypernatremia.
Blood Glucose
Frequency: Periodically (e.g., every 6-12 months or as clinically indicated)
Target: Normal range
Action Threshold: Hyperglycemia.
Bone Mineral Density (BMD)
Frequency: Baseline and then every 1-2 years for long-term therapy
Target: Age-appropriate Z-score
Action Threshold: Osteopenia/osteoporosis.
Adrenal Function (ACTH, Cortisol)
Frequency: As clinically indicated to assess adequacy of replacement therapy
Target: Target levels vary based on specific adrenal insufficiency type and clinical goals
Action Threshold: Evidence of under- or over-replacement.
Symptom Monitoring
- Signs of adrenal insufficiency (fatigue, weakness, nausea, vomiting, abdominal pain, weight loss, hypotension, hyperpigmentation)
- Signs of corticosteroid excess (Cushingoid features: moon face, buffalo hump, striae, acne, hirsutism, easy bruising, muscle weakness, mood changes)
- Signs of infection (fever, chills, sore throat, unusual pain)
- Gastrointestinal symptoms (abdominal pain, black/tarry stools)
- Vision changes (blurred vision, eye pain)
- Mood or behavioral changes (irritability, anxiety, depression, insomnia)
Special Patient Groups
Pregnancy
Hydrocortisone crosses the placenta. While animal studies show adverse effects, human data are limited. 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 for maternal and fetal well-being.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of oral clefts, though data are inconsistent and overall risk is low.
Second Trimester:
Potential for fetal growth restriction, though typically associated with higher doses or prolonged use.
Third Trimester:
Potential for fetal adrenal suppression, requiring monitoring of the neonate for signs of hypoadrenalism.
Lactation
Hydrocortisone is excreted into breast milk in small amounts. Low doses are generally considered compatible with breastfeeding. Monitor the infant for signs of adrenal suppression (e.g., poor weight gain, delayed development) or other adverse effects.
Infant Risk:
L2 (Safer) - Low risk of adverse effects in breastfed infants, especially with typical replacement doses.
Pediatric Use
Alkindi Sprinkle is specifically indicated for pediatric patients with adrenal insufficiency. Close monitoring of growth (height and weight), blood pressure, and bone mineral density is crucial. Dosing is individualized based on body surface area and clinical response. Children are more susceptible to the systemic effects of corticosteroids, including growth suppression and adrenal suppression.
Geriatric Use
No specific dose adjustments are generally required based solely on age. However, elderly patients may be more susceptible to the adverse effects of corticosteroids, including osteoporosis, hypertension, diabetes, and fluid retention. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Alkindi Sprinkle is designed for precise dosing in pediatric patients, allowing for smaller, more accurate increments than traditional tablets.
- Always administer the granules with a small amount of soft food or breast milk/formula; never mix with water or other liquids, and do not chew.
- Emphasize the importance of 'stress dosing' during illness, injury, or surgery to prevent adrenal crisis.
- Educate caregivers on the signs and symptoms of both under- and over-replacement to ensure timely intervention.
- Regular monitoring of growth parameters is critical in pediatric patients receiving long-term hydrocortisone therapy.
Alternative Therapies
- Hydrocortisone tablets (e.g., Cortef, Hydrocortone)
- Other glucocorticoids (e.g., prednisone, dexamethasone) for specific indications, though hydrocortisone is preferred for physiological replacement in adrenal insufficiency due to its shorter half-life and mineralocorticoid activity.
- Fludrocortisone (for mineralocorticoid replacement, often used concomitantly with hydrocortisone in primary adrenal insufficiency).
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per 30 capsules
Insurance Coverage:
Tier 3 or 4 (Specialty Drug)
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 give them someone else's medication. 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 recommended that you discuss them with your child's doctor, nurse, pharmacist, or other healthcare provider.
This medication is accompanied by a Medication Guide, which is a detailed patient fact sheet. It is crucial to read this guide carefully and review it again whenever the medication is refilled. If you have any questions or concerns about the medication, do not hesitate to reach out to your child's doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention or contact your local poison control center. When seeking help, be prepared to provide information about the medication, including the amount taken and the time it happened, to ensure prompt and effective treatment.
This medication is accompanied by a Medication Guide, which is a detailed patient fact sheet. It is crucial to read this guide carefully and review it again whenever the medication is refilled. If you have any questions or concerns about the medication, do not hesitate to reach out to your child's doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, it is vital to seek immediate medical attention or contact your local poison control center. When seeking help, be prepared to provide information about the medication, including the amount taken and the time it happened, to ensure prompt and effective treatment.