Griseofulvin 125mg/5ml Oral Susp
It is used to treat fungal infections.
Drug Class
Antifungal
Pharmacologic Class
Mitotic inhibitor (fungal)
Pregnancy Category
Category C
FDA Approved
Jan 1959
DEA Schedule
Not Controlled
Overview
What is this medicine?
Griseofulvin is an antifungal medicine used to treat fungal infections of the skin, hair, and nails. It works by stopping the growth of the fungus. It's important to take it exactly as prescribed, usually for a long time, to make sure the infection is completely cleared.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Discuss with your doctor or pharmacist whether to take your medication with food or on an empty stomach.
Continue taking your medication as instructed, even if your symptoms improve.
Before using, shake the medication well.
When taking a liquid dose, measure it carefully using the device provided with the medication. If no device is included, ask your pharmacist for a measuring tool.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best disposal method or to see if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Discuss with your doctor or pharmacist whether to take your medication with food or on an empty stomach.
Continue taking your medication as instructed, even if your symptoms improve.
Before using, shake the medication well.
When taking a liquid dose, measure it carefully using the device provided with the medication. If no device is included, ask your pharmacist for a measuring tool.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry place, avoiding bathrooms.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for guidance on the best disposal method or to see if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, follow these steps:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take with a fatty meal (e.g., milk, ice cream, fatty food) to help your body absorb the medicine better.
- Complete the full course of treatment, even if your symptoms improve, to prevent the infection from returning.
- Avoid alcohol while taking this medicine, as it can cause unpleasant side effects like flushing, nausea, and vomiting.
- Protect your skin from the sun (wear protective clothing, use sunscreen) as this medicine can make you more sensitive to sunlight.
- If you are taking oral contraceptives, use an additional non-hormonal birth control method during treatment and for one month after stopping griseofulvin, as it can make birth control pills less effective.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Tinea corporis, cruris, capitis: 250 mg microsize orally twice daily or 500 mg microsize orally once daily. Tinea pedis, unguium: 500-1000 mg microsize orally once daily or in divided doses.
Dose Range:
250 - 1000 mg
Condition-Specific Dosing:
tinea_capitis:
500 mg microsize orally once daily or 250 mg microsize orally twice daily for 4-8 weeks.
tinea_corporis_cruris:
250 mg microsize orally twice daily or 500 mg microsize orally once daily for 2-4 weeks.
tinea_pedis:
500-1000 mg microsize orally once daily or in divided doses for 4-8 weeks.
tinea_unguium:
500-1000 mg microsize orally once daily or in divided doses for 4-6 months or longer.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
10-15 mg/kg/day (microsize) orally once daily or in divided doses. Max 1000 mg/day.
Adolescent:
10-15 mg/kg/day (microsize) orally once daily or in divided doses. Max 1000 mg/day. Or adult dosing if weight appropriate.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended; use with caution due to potential for accumulation of metabolites.
Dialysis:
Not dialyzable; no specific recommendations, use with caution.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
Use with caution; monitor liver function.
Severe:
Contraindicated in severe liver disease.
Pharmacology
Mechanism of Action
Griseofulvin is a fungistatic antibiotic that inhibits fungal cell division by disrupting the mitotic spindle structure. It binds to keratin precursor cells, making them resistant to fungal invasion. It is deposited in newly formed keratin structures (skin, hair, nails), protecting them from infection.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, enhanced by fatty meals. Microsize is better absorbed than ultramicrosize.
Tmax:
Approximately 4 hours (microsize).
FoodEffect:
Absorption is significantly increased when taken with a high-fat meal.
Distribution:
Vd:
Not readily available, but widely distributed to keratinized tissues.
ProteinBinding:
Approximately 80%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 9-24 hours.
Clearance:
Not readily available.
ExcretionRoute:
Primarily renal (metabolites), small amount in feces (unchanged drug).
Unchanged:
Less than 1% excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Clinical improvement may be seen within days to weeks, depending on the site of infection (e.g., skin lesions may improve faster than nail infections).
PeakEffect:
Not applicable in terms of a single peak effect for chronic fungal infections; sustained levels are required.
DurationOfAction:
Duration of therapy depends on the site and severity of infection, ranging from weeks to months.
Confidence:
High
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
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 help right away:
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
Signs of lupus, including:
+ A rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Feeling confused
Abnormal burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Feeling dizzy, tired, or weak
Diarrhea
Stomach pain
Upset stomach
Vomiting
Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 help right away:
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
Signs of lupus, including:
+ A rash on the cheeks or other body parts
+ Easy sunburn
+ Muscle or joint pain
+ Chest pain or shortness of breath
+ Swelling in the arms or legs
Signs of liver problems, such as:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Feeling confused
Abnormal burning, numbness, or tingling sensations
Redness or white patches in the mouth or throat
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause severe health problems and may be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Headache
Feeling dizzy, tired, or weak
Diarrhea
Stomach pain
Upset stomach
Vomiting
Trouble sleeping
Reporting Side Effects
This list is not exhaustive, and you may experience other 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:
- Severe headache
- Numbness or tingling in hands or feet
- Unusual tiredness or weakness
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Pale stools
- Persistent nausea or vomiting
- Severe skin rash or blistering
- Sore throat, fever, or chills (signs of infection)
- Unusual bleeding or bruising
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.
Certain health conditions, including liver disease or porphyria.
If you are pregnant or think you may be pregnant. Note that this medication should not be taken during pregnancy.
If you plan to become pregnant within one month after your last dose of this medication.
If you are breastfeeding or plan to breastfeed.
This medication can interact with other drugs and health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. Verify that it is safe to take this medication with your other medications and health conditions.
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.
Certain health conditions, including liver disease or porphyria.
If you are pregnant or think you may be pregnant. Note that this medication should not be taken during pregnancy.
If you plan to become pregnant within one month after your last dose of this medication.
If you are breastfeeding or plan to breastfeed.
This medication can interact with other drugs and health conditions. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. Verify that it is safe to take this medication with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.
Before consuming alcohol, discuss the potential risks with your doctor. Additionally, be aware that this medication can increase your sensitivity to the sun, making it easier to get sunburned. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear that provide adequate sun protection.
Do not take this medication for longer than prescribed, as this can increase the risk of a second infection. If you have a history of lupus, this drug may cause your condition to become active or worsen. Immediately report any new or worsening symptoms to your doctor.
When taking this medication, be aware that birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as a condom, while taking this drug.
This medication can potentially harm an unborn baby if taken during pregnancy. If you are pregnant or planning to become pregnant, discuss the risks with your doctor. If your partner may become pregnant, use birth control while taking this medication and for 6 months after your last dose. If your partner becomes pregnant, notify your doctor immediately.
Before consuming alcohol, discuss the potential risks with your doctor. Additionally, be aware that this medication can increase your sensitivity to the sun, making it easier to get sunburned. To minimize this risk, avoid exposure to direct sunlight, sunlamps, and tanning beds, and use protective measures such as sunscreen, clothing, and eyewear that provide adequate sun protection.
Do not take this medication for longer than prescribed, as this can increase the risk of a second infection. If you have a history of lupus, this drug may cause your condition to become active or worsen. Immediately report any new or worsening symptoms to your doctor.
When taking this medication, be aware that birth control pills and other hormone-based birth control methods may be less effective in preventing pregnancy. To minimize the risk of unintended pregnancy, use an additional form of birth control, such as a condom, while taking this drug.
This medication can potentially harm an unborn baby if taken during pregnancy. If you are pregnant or planning to become pregnant, discuss the risks with your doctor. If your partner may become pregnant, use birth control while taking this medication and for 6 months after your last dose. If your partner becomes pregnant, notify your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Headache
- Confusion
What to Do:
In case of overdose, seek immediate medical attention or call a poison control center. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- Warfarin (decreased anticoagulant effect)
- Oral contraceptives (decreased contraceptive efficacy)
Moderate Interactions
- Barbiturates (decreased griseofulvin absorption)
- Cyclosporine (decreased cyclosporine levels)
- Alcohol (disulfiram-like reaction, increased CNS depression)
Monitoring
Baseline Monitoring
Liver Function Tests (LFTs)
Rationale: To assess baseline hepatic function, as griseofulvin is metabolized by the liver and can cause hepatotoxicity.
Timing: Prior to initiation of therapy.
Complete Blood Count (CBC)
Rationale: To assess baseline hematologic status, as rare cases of leukopenia or neutropenia have been reported.
Timing: Prior to initiation of therapy.
Routine Monitoring
Liver Function Tests (LFTs)
Frequency: Periodically, especially during prolonged therapy (e.g., monthly for the first few months, then every 2-3 months).
Target: Within normal limits.
Action Threshold: Discontinue if significant elevation (e.g., >3x ULN) or clinical signs of liver injury occur.
Complete Blood Count (CBC)
Frequency: Periodically, especially during prolonged therapy (e.g., every 1-2 months).
Target: Within normal limits.
Action Threshold: Discontinue if significant leukopenia or neutropenia develops.
Renal Function (BUN, Creatinine)
Frequency: Periodically, especially in patients with pre-existing renal impairment.
Target: Within normal limits.
Action Threshold: Not a primary concern, but monitor for changes.
Symptom Monitoring
- Signs of liver injury (e.g., persistent nausea, vomiting, abdominal pain, dark urine, jaundice, fatigue)
- Signs of hematologic abnormalities (e.g., fever, sore throat, unusual bleeding or bruising)
- Skin rash or severe photosensitivity reaction
- Neurological symptoms (e.g., headache, dizziness, confusion, paresthesias)
- Gastrointestinal upset (e.g., nausea, vomiting, diarrhea)
Special Patient Groups
Pregnancy
Griseofulvin is generally not recommended during pregnancy due to potential teratogenic effects observed in animal studies. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Highest risk for teratogenicity; avoid if possible.
Second Trimester:
Risk decreases but still generally avoided.
Third Trimester:
Risk decreases but still generally avoided.
Lactation
Griseofulvin is excreted into breast milk. Due to potential for adverse effects in the infant, caution is advised. Weigh the benefits of breastfeeding against the potential risks to the infant.
Infant Risk:
Low to moderate risk; monitor infant for gastrointestinal upset or rash.
Pediatric Use
Dosing is weight-based. Safety and efficacy in children younger than 2 years have not been established. Long-term use in children should be carefully considered due to potential effects on growth plates (though rare).
Geriatric Use
No specific dose adjustment is generally needed based on age alone. However, elderly patients may have reduced renal or hepatic function, requiring careful monitoring of LFTs and renal function.
Clinical Information
Clinical Pearls
- Griseofulvin is fungistatic, meaning it inhibits fungal growth rather than directly killing it. This often necessitates long treatment durations.
- Absorption is significantly improved by taking the medication with a high-fat meal. This is a critical patient education point.
- Treatment duration is highly dependent on the site of infection: skin infections (2-4 weeks), hair/scalp (4-8 weeks), fingernails (4-6 months), toenails (6-12 months or longer).
- Patients should be advised about potential photosensitivity and to use sun protection.
- Due to enzyme induction, advise women of childbearing potential using oral contraceptives to use alternative or additional birth control methods.
- Regular monitoring of liver function tests is important, especially with prolonged therapy.
Alternative Therapies
- Terbinafine (oral)
- Itraconazole (oral)
- Fluconazole (oral)
- Ketoconazole (oral, less common for dermatophytes due to toxicity)
- Topical antifungals (for localized, superficial infections where systemic therapy is not warranted)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 120ml oral suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 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 for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.