Retacrit 40,000unt Inj, 1ml
WARNING: This drug may raise the chance of heart attack, stroke, heart failure, blood clots, and death. Talk with the doctor.People with some types of cancer have died sooner when using this drug. This drug also raised the chance of tumor growth and the tumor happening again in these people. Talk with the doctor.Your doctor will need to watch your blood cell counts and follow you closely to change the dose to match your body's needs. Talk with your doctor.If you will be having surgery, talk with your doctor. You may need to take another drug to keep you from getting blood clots while you get this drug. @ COMMON USES: It is used to treat anemia.It is used to help lower the need for blood transfusions for certain surgeries.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Erythropoiesis-stimulating agent (ESA)
Pharmacologic Class
Recombinant human erythropoietin
Pregnancy Category
Category C
FDA Approved
May 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Retacrit is a medicine that helps your body make more red blood cells. It's like a natural hormone your kidneys make, called erythropoietin. When you have certain conditions like kidney disease or are getting chemotherapy, your body might not make enough red blood cells, leading to anemia (low red blood cell count). Retacrit helps fix this, reducing the need for blood transfusions. It's given as an injection, either into a vein or under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling better. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Important Administration Instructions
Do not shake the medication.
Do not use the medication if it has been shaken.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles.
Do not use the medication if the solution has changed color.
Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposal of Used Needles and Supplies
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Follow the storage instructions provided with the medication. If you miss a dose, contact your doctor for guidance on what to do next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered via injection into the fatty tissue under the skin or into a vein by a healthcare professional.
Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling better. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Important Administration Instructions
Do not shake the medication.
Do not use the medication if it has been shaken.
Wash your hands before and after handling the medication.
Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles.
Do not use the medication if the solution has changed color.
Avoid injecting the medication into skin that is irritated, tender, bruised, red, scaly, hard, scarred, or has stretch marks.
Disposal of Used Needles and Supplies
Dispose of used needles and other sharp objects in a designated needle/sharp disposal box. Do not reuse needles or other items. When the disposal box is full, follow local regulations for proper disposal. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Follow the storage instructions provided with the medication. If you miss a dose, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Maintain adequate iron intake as advised by your doctor, as iron is crucial for red blood cell production.
- Monitor your blood pressure regularly at home, as this medication can increase blood pressure.
- Report any unusual symptoms immediately, especially signs of blood clots (e.g., chest pain, shortness of breath, leg pain/swelling, sudden weakness/numbness).
- Keep all appointments for blood tests and doctor visits to monitor your response and adjust your dose.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly variable based on indication, route, and patient response. Dosing is individualized to achieve and maintain target hemoglobin levels.
Condition-Specific Dosing:
Anemia of Chronic Kidney Disease (CKD) - IV/SC:
Initial: 50-100 units/kg 3 times per week. Adjust dose to maintain hemoglobin between 10-11 g/dL.
Chemotherapy-Induced Anemia - SC:
Initial: 150 units/kg 3 times per week OR 40,000 units once weekly. Adjust dose to maintain hemoglobin between 10-11 g/dL.
Zidovudine-Induced Anemia in HIV - SC/IV:
Initial: 100 units/kg 3 times per week. Adjust dose based on response.
Reduction of Allogeneic RBC Transfusions in Surgery - SC:
300 units/kg/day for 10 days before surgery, on the day of surgery, and for 4 days after surgery; OR 600 units/kg once weekly (21, 14, and 7 days before surgery) plus a fourth dose on the day of surgery.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Anemia of CKD: Initial 50 units/kg 3 times per week (IV/SC). Adjust dose to maintain hemoglobin between 10-12 g/dL.
Adolescent:
Anemia of CKD: Initial 50 units/kg 3 times per week (IV/SC). Adjust dose to maintain hemoglobin between 10-12 g/dL.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required, but monitor hemoglobin closely.
Moderate:
No specific dose adjustment required, but monitor hemoglobin closely.
Severe:
No specific dose adjustment required, but monitor hemoglobin closely. Dosing is standard for CKD patients.
Dialysis:
Dosing is standard for CKD patients on dialysis. Administer IV for patients on hemodialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution due to potential for altered drug metabolism.
Pharmacology
Mechanism of Action
Epoetin alfa-epbx is an erythropoiesis-stimulating agent (ESA) that stimulates erythropoiesis by the same mechanism as endogenous erythropoietin. It binds to erythropoietin receptors on the surface of erythroid progenitor cells, stimulating their proliferation and differentiation into mature red blood cells. This process leads to an increase in red blood cell mass, hemoglobin levels, and hematocrit.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 30-40% (subcutaneous), 100% (intravenous)
Tmax:
5-24 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not precisely determined, but distributes primarily to the bone marrow and other erythropoietic tissues.
ProteinBinding:
Not extensively protein bound.
CnssPenetration:
Limited
Elimination:
HalfLife:
4-13 hours (intravenous, CKD patients); 18-24 hours (subcutaneous, CKD patients); 24-36 hours (subcutaneous, healthy subjects)
Clearance:
Not precisely quantified, but involves renal and non-renal mechanisms.
ExcretionRoute:
Primarily non-renal, with a small amount excreted unchanged in urine.
Unchanged:
<10%
Pharmacodynamics
OnsetOfAction:
Within 7-14 days (initial increase in reticulocytes)
PeakEffect:
2-6 weeks (peak hemoglobin response)
DurationOfAction:
Effects persist for several days after discontinuation due to the lifespan of red blood cells.
Safety & Warnings
BLACK BOX WARNING
Increased risk of death, myocardial infarction, stroke, venous thromboembolism (VTE), thrombosis of vascular access, and tumor progression or recurrence. Use the lowest dose sufficient to avoid red blood cell transfusions. ESAs are not indicated for patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. Discontinue ESAs once chemotherapy is completed. In patients with chronic kidney disease (CKD), ESAs increase the risk of death, serious cardiovascular events, and stroke when administered to achieve hemoglobin levels >11 g/dL. In patients with cancer, ESAs shorten overall survival and/or increase the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers. In patients undergoing surgery, ESAs increase the risk of serious cardiovascular events and VTE when administered to reduce allogeneic red blood cell transfusions in patients undergoing orthopedic surgery.
Side Effects
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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 high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Excessive thirst or hunger
+ Frequent urination
+ Flushing or rapid breathing
+ Fruity-smelling breath
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps or irregular heartbeat
Rapid heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Depression
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Difficulty speaking or swallowing
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, causing severe health problems that may not be reversible and can be life-threatening. Seek immediate medical attention if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Irritation at the injection site
Fever or chills
Headache
Upset stomach or vomiting
Cough
Bone, joint, or muscle pain
Muscle spasms
Mouth irritation or mouth sores
Weight loss
Difficulty sleeping
* Signs of a common cold
This is not an exhaustive list of 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 emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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 high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of high blood sugar, such as:
+ Confusion or drowsiness
+ Excessive thirst or hunger
+ Frequent urination
+ Flushing or rapid breathing
+ Fruity-smelling breath
Signs of low potassium levels, including:
+ Muscle pain or weakness
+ Muscle cramps or irregular heartbeat
Rapid heartbeat
Shortness of breath, significant weight gain, or swelling in the arms or legs
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision
Confusion
Cool or pale arm or leg
Difficulty walking
Dizziness or fainting
Excessive sweating
Seizures
Feeling extremely tired or weak
Pale skin
Depression
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Difficulty speaking or swallowing
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may occur, causing severe health problems that may not be reversible and can be life-threatening. Seek immediate medical attention if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Irritation at the injection site
Fever or chills
Headache
Upset stomach or vomiting
Cough
Bone, joint, or muscle pain
Muscle spasms
Mouth irritation or mouth sores
Weight loss
Difficulty sleeping
* Signs of a common cold
This is not an exhaustive list of 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:
- Sudden chest pain or shortness of breath
- Pain, swelling, warmth, or redness in an arm or leg
- Sudden numbness or weakness, especially on one side of the body
- Sudden severe headache or problems with vision, speech, or balance
- Uncontrolled high blood pressure
- Seizures
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
- Unusual tiredness or paleness that suddenly worsens (could indicate pure red cell aplasia)
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 conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, and describe the symptoms you experienced.
If you have high blood pressure.
If you have active bleeding.
If you have low levels of vitamins or minerals.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia.
Additionally, if you are using a multi-dose container, tell your doctor:
If you are pregnant or may become pregnant, as this medication is not recommended during pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 2 weeks after the last dose.
If the patient is a premature baby or newborn, as this form of the medication is not suitable for them.
This is not an exhaustive list of potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have, to ensure it is safe to take this medication with your other treatments.
Do not start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, and describe the symptoms you experienced.
If you have high blood pressure.
If you have active bleeding.
If you have low levels of vitamins or minerals.
If you have a condition called Pure Red Cell Aplasia (PRCA), a type of anemia.
Additionally, if you are using a multi-dose container, tell your doctor:
If you are pregnant or may become pregnant, as this medication is not recommended during pregnancy.
If you are breastfeeding, as you should not breastfeed while taking this medication and for 2 weeks after the last dose.
If the patient is a premature baby or newborn, as this form of the medication is not suitable for them.
This is not an exhaustive list of potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about:
All medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Any health problems you have, to ensure it is safe to take this medication with your other treatments.
Do not start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring Your Health
Regular blood pressure checks are necessary while taking this medication, as it can cause high blood pressure. Follow your doctor's instructions for scheduling these checks. Additionally, you will need to have blood work done as directed by your doctor to monitor your health. If you have any questions or concerns, discuss them with your doctor.
Special Considerations
If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products contain phenylalanine.
Safe Use of Your Medication
Do not exceed the dosage prescribed by your doctor, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more of this medication than directed, contact your doctor immediately.
Potential Risks
This medication can increase red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to serious health issues, including stroke, heart attack, and blood clots. If you have any questions or concerns, discuss them with your doctor.
Multi-Dose Container Precautions
This medication contains benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur in these children, especially when combined with other medications containing benzyl alcohol. If you have questions, consult with your doctor.
Single-Dose Container Precautions
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Monitoring Your Health
Regular blood pressure checks are necessary while taking this medication, as it can cause high blood pressure. Follow your doctor's instructions for scheduling these checks. Additionally, you will need to have blood work done as directed by your doctor to monitor your health. If you have any questions or concerns, discuss them with your doctor.
Special Considerations
If you have phenylketonuria (PKU), consult with your doctor before taking this medication, as some products contain phenylalanine.
Safe Use of Your Medication
Do not exceed the dosage prescribed by your doctor, as taking more than the recommended amount can increase the risk of severe side effects. If you accidentally take more of this medication than directed, contact your doctor immediately.
Potential Risks
This medication can increase red blood cell production in the blood. Be aware that misuse or abuse of this type of medication can lead to serious health issues, including stroke, heart attack, and blood clots. If you have any questions or concerns, discuss them with your doctor.
Multi-Dose Container Precautions
This medication contains benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as serious side effects can occur in these children, especially when combined with other medications containing benzyl alcohol. If you have questions, consult with your doctor.
Single-Dose Container Precautions
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Polycythemia (excessively high red blood cell count), which can lead to increased blood viscosity and serious cardiovascular events (e.g., stroke, myocardial infarction, VTE)
- Severe hypertension
What to Do:
There is no specific antidote. Management involves phlebotomy to reduce hemoglobin and hematocrit levels, and supportive care for symptoms. Call 911 or your local emergency number immediately. For general information, call a poison control center at 1-800-222-1222.
Drug Interactions
Major Interactions
- Thalidomide, Lenalidomide, Pomalidomide (increased risk of VTE when used with ESAs in multiple myeloma patients)
Moderate Interactions
- Iron supplements (may be needed to support erythropoiesis, but not a direct interaction)
- Other myelosuppressive agents (may affect bone marrow response to ESA)
Monitoring
Baseline Monitoring
Hemoglobin (Hb) and Hematocrit (Hct)
Rationale: To establish baseline anemia severity and guide initial dosing.
Timing: Before initiation of therapy
Iron status (serum ferritin, transferrin saturation [TSAT])
Rationale: Adequate iron stores are essential for optimal response to ESA therapy. Iron deficiency can lead to ESA hyporesponsiveness.
Timing: Before and during therapy
Blood Pressure (BP)
Rationale: ESAs can cause or exacerbate hypertension.
Timing: Before initiation and regularly during therapy
Complete Blood Count (CBC) with differential and platelet count
Rationale: To assess overall hematologic status and rule out other causes of anemia.
Timing: Before initiation
Routine Monitoring
Hemoglobin (Hb)
Frequency: Weekly or bi-weekly until stable, then monthly
Target: 10-11 g/dL (CKD, chemotherapy-induced anemia); avoid exceeding 11 g/dL
Action Threshold: If Hb rises rapidly (>1 g/dL in 2 weeks) or exceeds target range, reduce dose or interrupt therapy.
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly or bi-weekly)
Target: Individualized, aim for controlled BP
Action Threshold: If BP significantly increases or becomes difficult to control, consider dose reduction or discontinuation, and intensify antihypertensive therapy.
Iron status (TSAT, ferritin)
Frequency: Monthly or every 3 months, or as clinically indicated
Target: TSAT ≥20%, Ferritin ≥100 ng/mL (CKD patients)
Action Threshold: If iron stores are low, initiate or increase iron supplementation.
Signs and symptoms of thromboembolic events
Frequency: Ongoing clinical assessment
Target: Absence of symptoms
Action Threshold: Prompt evaluation and management if symptoms occur (e.g., chest pain, shortness of breath, leg swelling, sudden weakness/numbness).
Symptom Monitoring
- Headache
- Hypertension (new onset or worsening)
- Seizures
- Symptoms of blood clots (e.g., chest pain, shortness of breath, pain/swelling in leg, sudden weakness/numbness on one side of body, vision changes)
- Symptoms of allergic reaction (e.g., rash, hives, itching, swelling, dizziness, trouble breathing)
- Symptoms of pure red cell aplasia (PRCA) (e.g., sudden worsening of anemia, fatigue, pallor)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on fetal development at doses higher than clinical doses.
Trimester-Specific Risks:
First Trimester:
Potential for adverse developmental effects observed in animal studies at high doses.
Second Trimester:
Potential for adverse developmental effects observed in animal studies at high doses.
Third Trimester:
Potential for adverse developmental effects observed in animal studies at high doses.
Lactation
It is unknown whether epoetin alfa-epbx is excreted in human milk. Caution should be exercised when Retacrit is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Retacrit and any potential adverse effects on the breastfed child from Retacrit or from the underlying maternal condition.
Infant Risk:
Risk level unknown; potential for adverse effects on breastfed infant cannot be ruled out.
Pediatric Use
Approved for anemia of chronic kidney disease in pediatric patients aged 1 month to 16 years. Dosing is weight-based. Safety and efficacy in neonates (<1 month) and infants (<1 year) for other indications are not established. Close monitoring of hemoglobin and blood pressure is crucial.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment is generally not required based on age alone, but careful monitoring for adverse events, particularly cardiovascular events, is important.
Clinical Information
Clinical Pearls
- Always ensure adequate iron stores (TSAT ≥20%, ferritin ≥100 ng/mL) before and during ESA therapy, as iron deficiency is the most common cause of ESA hyporesponsiveness.
- Do not exceed a hemoglobin target of 11 g/dL in CKD or chemotherapy-induced anemia patients due to increased risks of serious adverse cardiovascular events and mortality.
- Monitor hemoglobin levels frequently (e.g., weekly or bi-weekly) when initiating or adjusting dose, and less frequently (e.g., monthly) once stable.
- Educate patients on the signs and symptoms of thromboembolic events and the importance of immediate reporting.
- Retacrit is a biosimilar to Epogen/Procrit. Ensure proper prescribing and dispensing based on local regulations and formularies.
- Patients may experience flu-like symptoms (e.g., fever, chills, myalgia) especially at the beginning of therapy; these are usually transient.
Alternative Therapies
- Darbepoetin alfa (Aranesp)
- Methoxy polyethylene glycol-epoetin beta (Mircera)
- Blood transfusions (for acute, severe anemia or when ESAs are contraindicated/ineffective)
- Iron supplementation (oral or IV, often used adjunctively with ESAs)
- Other agents for specific anemia causes (e.g., vitamin B12, folate for deficiency anemias)
Cost & Coverage
Average Cost:
Varies significantly by dose and formulation. Typically high. per vial/syringe
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization, often subject to step therapy)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.