Mepron Oral Susp 750mg/5ml 42 X 5ml
It is used to treat or prevent infections caused by Pneumocystis jirovecii.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antiprotozoal, Antimalarial
Pharmacologic Class
Naphthoquinone derivative, Mitochondrial electron transport inhibitor
Pregnancy Category
Category C
FDA Approved
Nov 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mepron is an oral suspension used to treat or prevent a type of pneumonia called PCP (Pneumocystis pneumonia), which often affects people with weakened immune systems. It works by stopping the growth of the organism that causes the infection. It's very important to take this medicine with food, especially fatty food, to help your body absorb it properly.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Always take your medication as directed by your doctor and follow the instructions provided with your prescription.
Before using your medication, shake the container well.
Take your medication with food to help your body absorb it properly. If you have trouble taking it with food, consult your doctor for guidance.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Using Your Medication
Depending on the form of your medication, follow these instructions:
Unit-dose: Open the pouch and take the contents by mouth. You can place it directly in your mouth, in a dosing spoon, or in a cup.
Bottle: Measure your liquid dose carefully using the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, avoiding freezing.
Keep it in a dry place, away from bathrooms.
Ensure all medications are stored in a secure location, out of reach of children and pets.
Missing a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember, with food.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
To ensure you get the most benefit from your medication, follow these steps:
Always take your medication as directed by your doctor and follow the instructions provided with your prescription.
Before using your medication, shake the container well.
Take your medication with food to help your body absorb it properly. If you have trouble taking it with food, consult your doctor for guidance.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Using Your Medication
Depending on the form of your medication, follow these instructions:
Unit-dose: Open the pouch and take the contents by mouth. You can place it directly in your mouth, in a dosing spoon, or in a cup.
Bottle: Measure your liquid dose carefully using the measuring device provided with your medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature, avoiding freezing.
Keep it in a dry place, away from bathrooms.
Ensure all medications are stored in a secure location, out of reach of children and pets.
Missing a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember, with food.
If it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Always take Mepron oral suspension with food, preferably a fatty meal (e.g., milk, peanut butter, cheese, or a high-fat supplement). This significantly improves absorption and effectiveness.
- Shake the bottle well before each use.
- Use the provided measuring spoon or cup to ensure accurate dosing.
- Do not miss doses. If you miss a dose, take it as soon as you remember with food. If it's almost time for your next dose, skip the missed dose and continue your regular schedule. Do not take a double dose.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Pneumocystis Pneumonia (PCP) Treatment: 750 mg (10 mL) orally twice daily with food for 21 days. PCP Prophylaxis: 1500 mg (20 mL) orally once daily with food.
Dose Range:
750 - 1500 mg
Condition-Specific Dosing:
PCP Treatment:
750 mg BID
PCP Prophylaxis:
1500 mg QD
Pediatric Dosing
Neonatal:
Not established
Infant:
PCP Treatment (1-3 months): Not established. PCP Treatment (3 months to 12 years): 30 mg/kg/day divided BID with food for 21 days (max 750 mg BID). PCP Prophylaxis (1-3 months): Not established. PCP Prophylaxis (3 months to 12 years): 15 mg/kg once daily with food (max 1500 mg/day).
Child:
PCP Treatment (3 months to 12 years): 30 mg/kg/day divided BID with food for 21 days (max 750 mg BID). PCP Prophylaxis (3 months to 12 years): 15 mg/kg once daily with food (max 1500 mg/day).
Adolescent:
PCP Treatment (13-16 years): 750 mg (10 mL) orally twice daily with food for 21 days. PCP Prophylaxis (13-16 years): 1500 mg (20 mL) orally once daily with food.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; monitor for adverse effects. No specific dose adjustment provided.
Pharmacology
Mechanism of Action
Atovaquone is a naphthoquinone derivative that selectively inhibits the mitochondrial electron transport chain at complex III (cytochrome bc1 complex) in susceptible organisms (e.g., Pneumocystis jirovecii, Toxoplasma gondii, Plasmodium falciparum). This inhibition disrupts pyrimidine synthesis, leading to impaired DNA synthesis and replication.
Pharmacokinetics
Absorption:
Bioavailability:
Low (approximately 23% for oral suspension) but significantly increased (2-3 fold) when taken with a fatty meal.
Tmax:
1 to 8 hours (highly variable, influenced by food)
FoodEffect:
Absorption is significantly increased (2-3 fold) when taken with food, especially fatty food. This is critical for efficacy.
Distribution:
Vd:
Approximately 0.6 L/kg
ProteinBinding:
>99.9% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
62 to 77 hours (2 to 3 days)
Clearance:
Not readily quantifiable due to minimal metabolism and high protein binding.
ExcretionRoute:
Primarily fecal (>94% as unchanged drug)
Unchanged:
>94% (in feces)
Pharmacodynamics
OnsetOfAction:
Not precisely defined for clinical effect; therapeutic levels achieved within days with consistent dosing.
PeakEffect:
Not precisely defined; clinical efficacy observed over the course of treatment.
DurationOfAction:
Related to half-life; sustained therapeutic levels with daily/BID dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Depression
Fever
White patches in the mouth
Cough
Liver problems, which can be rare but potentially deadly. Be aware of signs such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Diarrhea
Upset stomach or vomiting
Muscle pain
Trouble sleeping
Excessive sweating
Runny or stuffy nose
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Depression
Fever
White patches in the mouth
Cough
Liver problems, which can be rare but potentially deadly. Be aware of signs such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although 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 unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Headache
Diarrhea
Upset stomach or vomiting
Muscle pain
Trouble sleeping
Excessive sweating
Runny or stuffy nose
Flu-like symptoms
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- Severe rash or allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat)
- Worsening of respiratory symptoms (e.g., increased shortness of breath, cough)
- Signs of liver problems (e.g., yellowing of skin or eyes, dark urine, persistent nausea/vomiting, severe stomach pain)
- Unusual bleeding or bruising (if taking warfarin)
- Persistent or severe nausea, vomiting, or diarrhea (may indicate poor absorption or side effect)
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking rifabutin or rifampin, as these medications may interact with this drug.
This list is not exhaustive, and it is crucial to disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you are currently taking rifabutin or rifampin, as these medications may interact with this drug.
This list is not exhaustive, and it is crucial to disclose all your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are currently breast-feeding, you must discuss this with your doctor. This conversation will help you understand the potential benefits and risks of taking this drug, both for you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Limited information on acute overdose. Symptoms may include exaggeration of known side effects such as nausea, vomiting, diarrhea, rash, or headache.
What to Do:
In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention immediately. Treatment is generally supportive, as atovaquone is highly protein-bound and not significantly dialyzable.
Drug Interactions
Major Interactions
- Rifampin (significant decrease in atovaquone concentrations)
- Rifabutin (significant decrease in atovaquone concentrations)
- Tetracycline (decreased atovaquone concentrations)
- Metoclopramide (decreased atovaquone concentrations)
Moderate Interactions
- Warfarin (may increase INR; monitor coagulation)
- Indinavir (decreased indinavir concentrations)
Confidence Interactions
Monitoring
Baseline Monitoring
Baseline clinical status and symptoms
Rationale: To assess the severity of infection and establish a baseline for monitoring treatment response.
Timing: Prior to initiation of therapy
Liver function tests (LFTs)
Rationale: Although not extensively metabolized, caution is advised in severe hepatic impairment. Baseline LFTs can help identify pre-existing conditions.
Timing: Prior to initiation of therapy, especially in patients with suspected hepatic impairment
Routine Monitoring
Clinical response (resolution of symptoms)
Frequency: Daily/regularly during treatment
Target: Improvement in respiratory symptoms, fever, and overall well-being
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or alternative diagnosis.
INR (if on warfarin)
Frequency: Regularly as per standard warfarin monitoring guidelines, especially at initiation and dose changes of atovaquone.
Target: Therapeutic range for warfarin (e.g., 2.0-3.0)
Action Threshold: INR outside target range; adjust warfarin dose as needed.
Symptom Monitoring
- Rash
- Nausea
- Diarrhea
- Vomiting
- Abdominal pain
- Headache
- Fever
- Cough
- Shortness of breath (worsening or new)
- Yellowing of skin or eyes (jaundice)
- Unusual bleeding or bruising (if on warfarin)
Special Patient Groups
Pregnancy
Category C. Atovaquone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at high doses; human data are limited.
Second Trimester:
Limited human data; use only if clearly needed.
Third Trimester:
Limited human data; use only if clearly needed.
Lactation
Atovaquone is excreted into human breast milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderately Safe) - Potential for adverse effects in the infant, but benefits to mother may outweigh risks. Monitor infant for rash, diarrhea, or other adverse effects.
Pediatric Use
Dosing is established for children 3 months of age and older for PCP treatment and prophylaxis. Safety and efficacy in infants younger than 3 months have not been established.
Geriatric Use
No specific dose adjustment is required based on age. However, elderly patients may have reduced renal or hepatic function, and should be monitored for adverse effects.
Clinical Information
Clinical Pearls
- **Crucial for Absorption:** Always administer Mepron oral suspension with food, especially a fatty meal, to maximize absorption and ensure therapeutic drug levels. Poor absorption can lead to treatment failure.
- **Shake Well:** The oral suspension must be shaken vigorously before each dose to ensure uniform distribution of the active ingredient.
- **Taste Masking:** The suspension has a banana-peppermint flavor, which may help with palatability for some patients.
- **Alternative for Sulfa Allergy:** Atovaquone is a valuable alternative for PCP treatment and prophylaxis in patients who are intolerant or allergic to trimethoprim-sulfamethoxazole (TMP-SMX).
Alternative Therapies
- For PCP Treatment: Trimethoprim-sulfamethoxazole (TMP-SMX), Pentamidine, Clindamycin + Primaquine, Dapsone + Trimethoprim.
- For PCP Prophylaxis: Trimethoprim-sulfamethoxazole (TMP-SMX), Dapsone, Pentamidine (aerosolized).
- For Toxoplasmosis: Pyrimethamine + Sulfadiazine + Leucovorin.
Cost & Coverage
Average Cost:
High (e.g., $1000-$2000+) per 210 mL bottle (750mg/5mL)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.