Alkindi Sprinkle 1mg Capsules

Hydrocortisone is a corticosteroid that binds to specific glucocorticoid receptors in the cytoplasm of target cells. This binding leads to the translocation of the receptor-steroid complex into the nucleus, where it modulates gene expression. It exerts its effects by regulating protein synthesis, leading to diverse physiological actions including anti-inflammatory, immunosuppressive, and metabolic effects. In adrenal insufficiency, it replaces endogenous cortisol, which is essential for maintaining metabolic homeostasis, cardiovascular function, and stress response.

Urgent 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 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 Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Nausea or 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, 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.

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 infections (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or any other type of infection.
* If your child has nerve problems affecting the eye.

This list is not exhaustive, and it is crucial to discuss all your child's medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. To ensure safe treatment, you must verify that it is safe to take this medication with all your child's other medications and health issues. Never start, stop, or adjust the dose of any medication without consulting your doctor.

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 Testing

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 undergo eye pressure and bone density tests.

Interactions with Other Tests and Substances

This medication may interfere with allergy skin tests, so it is crucial to inform the doctor and lab workers that your child is taking this medication. Furthermore, long-term use may increase the risk of developing cataracts, glaucoma, or osteoporosis (weak bones). Discuss these potential risks with your child's doctor.

Dietary Considerations

Your child may need to follow a low-salt diet and take potassium supplements. Consult with your child's doctor to determine the best course of action.

Blood Sugar Monitoring

If your child has diabetes, it is essential to closely monitor their blood sugar levels while taking this medication.

Substance Interactions

Alcohol consumption may interact with this medication, so it is recommended that your child avoids alcohol altogether. Additionally, if your child consumes grapefruit juice or eats grapefruit regularly, inform 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 infection when taken with this medication. It is also essential to note that chickenpox and measles can be severe or even life-threatening in individuals 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, inform their doctor immediately.

Infection Risk

Steroid medications, including this one, increase the risk of infection. They can exacerbate existing infections and make symptoms harder to detect. Infections can range from mild to severe and potentially life-threatening. To minimize the risk, 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 infections.

Adrenal Insufficiency

This medication may decrease the body's natural production of steroids. If your child experiences stress, such as a fever, infection, surgery, or injury, consult with their doctor, as they may require additional oral steroids. Carry a warning card indicating that your child may need extra steroids in emergency situations. If your child has been taking this medication for an extended period, consult with their doctor before stopping or reducing the dosage. If your child experiences fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness after missing a dose or stopping the medication, inform their doctor immediately.

Rare but Serious Risks

Long-term use of this medication may increase the risk of developing Kaposi's sarcoma, a type of cancer. Discuss this potential risk with your child's doctor.

Pheochromocytoma

If your child has or may have pheochromocytoma, inform their doctor, as this medication can have severe and potentially life-threatening effects in individuals with this condition.

Tumor Lysis Syndrome

Patients with cancer may be at increased risk of developing tumor lysis syndrome, a potentially life-threatening condition. Discuss this risk with your child's doctor.

Growth and Development

This medication may affect growth in children and adolescents. Regular growth checks may be necessary. Consult with your child's doctor to determine the best course of action.

Premature Infants

If your child was born premature, inform their doctor, as this medication may increase the risk of a specific heart problem in these individuals.

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, inform their doctor to discuss the potential benefits and risks to both your child and the baby. If your child used this medication during pregnancy, inform the baby's doctor.

• Systemic fungal infections (unless used as replacement therapy for adrenal insufficiency)
• Live or live attenuated vaccines (when used in immunosuppressive doses, not typically for replacement therapy)

• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase hydrocortisone levels, leading to increased risk of adverse effects. Dose adjustment of hydrocortisone may be needed.
• CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital, carbamazepine): May decrease hydrocortisone levels, leading to reduced efficacy. Dose adjustment of hydrocortisone may be needed.
• NSAIDs (e.g., ibuprofen, naproxen): Increased risk of gastrointestinal ulceration and bleeding.
• Diuretics (e.g., thiazides, loop diuretics): Increased risk of hypokalemia.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effects (either increase or decrease INR). Close monitoring of INR is required.
• Antidiabetics (e.g., insulin, oral hypoglycemics): Hydrocortisone may increase blood glucose levels, requiring adjustment of antidiabetic therapy.

• Cardiac glycosides (e.g., digoxin): Increased risk of digitalis toxicity if hypokalemia occurs due to hydrocortisone.
• Cyclosporine: Increased plasma concentrations of both hydrocortisone and cyclosporine may occur.
• Anticholinesterases (e.g., neostigmine, pyridostigmine): May cause severe weakness in patients with myasthenia gravis.
• Oral contraceptives/Estrogens: May increase hydrocortisone levels due to reduced metabolism.

• Not typically listed as clinically significant for replacement therapy.

• Signs of under-replacement/adrenal crisis: severe fatigue, weakness, dizziness, nausea, vomiting, abdominal pain, fever, hypotension, hypoglycemia, confusion, loss of consciousness.
• Signs of over-replacement/Cushing's syndrome: weight gain (especially central obesity), moon face, buffalo hump, thin skin, easy bruising, striae, muscle weakness, hyperglycemia, hypertension, mood changes, growth suppression (in children).

Hydrocortisone is a Category C drug. For women with adrenal insufficiency, hydrocortisone replacement therapy is essential during pregnancy to prevent maternal adrenal crisis and ensure fetal well-being. Doses may need to be increased during pregnancy, especially in the third trimester and during labor/delivery. The benefits of treatment generally outweigh the potential risks.

Hydrocortisone is excreted into breast milk in small amounts. At typical replacement doses, the amount transferred to the infant is generally considered too low to cause adverse effects. It is generally considered compatible with breastfeeding. Monitor the infant for any signs of adrenal suppression (e.g., poor weight gain, delayed development) or other adverse effects, though these are unlikely.

Alkindi Sprinkle is specifically indicated for pediatric patients with adrenal insufficiency. Close monitoring of growth (height, weight, BMI) is crucial to ensure adequate replacement without causing growth suppression due to over-replacement. Dosing is individualized based on body surface area or weight and adjusted based on clinical response and laboratory parameters. Stress dosing education for caregivers is paramount.

No specific dose adjustments are typically required for hydrocortisone replacement therapy in geriatric patients. However, geriatric patients may be more susceptible to the adverse effects of corticosteroids, such as osteoporosis, hypertension, and diabetes. Monitor for comorbidities and potential drug interactions.

• Alkindi Sprinkle is a specialized formulation designed for precise dosing in pediatric patients, allowing for titration in small increments.
• The granules can be sprinkled on a small amount of soft food (e.g., yogurt, applesauce) or directly into the mouth. Do NOT mix with liquids or hot food.
• Emphasize the critical importance of 'stress dosing' during illness, injury, or surgery. Patients/caregivers must be educated on when and how to increase the dose to prevent adrenal crisis.
• Patients should always carry emergency hydrocortisone (oral and/or injectable) and wear a medical alert identification.
• Regular follow-up with an endocrinologist is essential to monitor growth, clinical symptoms, and adjust dosing as needed.
• Long-term use, even at replacement doses, warrants monitoring for potential side effects like bone density changes, especially if doses are at the higher end of the replacement range.

• Other oral hydrocortisone formulations (e.g., tablets, compounded liquid)
• Fludrocortisone (for mineralocorticoid replacement, often co-administered with hydrocortisone in primary adrenal insufficiency)
• Prednisone or Dexamethasone (other glucocorticoids, but generally not preferred for physiological replacement due to longer half-lives and different potency profiles)

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 give them someone else's medication. Some medications may have additional patient information leaflets, 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 detailed 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 child's doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek medical attention. Be prepared to provide information about the medication, including the amount taken and the time it happened, to ensure prompt and effective treatment.