Panadol Extr 500-65mg Tablets
It is used to manage pain.
Drug Class
Analgesic, Antipyretic
Pharmacologic Class
Para-aminophenol derivative (Acetaminophen), Xanthine derivative (Caffeine)
Pregnancy Category
Category B (for both acetaminophen and caffeine)
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Panadol Extra Strength is an over-the-counter medication used to relieve mild to moderate pain (like headaches, muscle aches, menstrual pain) and reduce fever. It combines acetaminophen, a pain reliever and fever reducer, with caffeine, which helps boost the pain-relieving effect of acetaminophen and can also help with alertness.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep the container tightly closed and out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. Many communities have drug take-back programs, which your pharmacist can help you locate.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, 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 once or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, taking it with food may help.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep the container tightly closed and out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal. Many communities have drug take-back programs, which your pharmacist can help you locate.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, 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 once or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Do not exceed the recommended dose. Taking too much acetaminophen can cause serious liver damage.
- Avoid consuming excessive amounts of caffeine from other sources (e.g., coffee, tea, energy drinks, other medications) while taking this product to prevent nervousness, sleeplessness, and rapid heartbeat.
- Avoid alcohol consumption while taking this medication, as it increases the risk of liver damage.
- If you are taking any other medications, check with your doctor or pharmacist to ensure they do not also contain acetaminophen to avoid accidental overdose.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2 tablets (1000mg Acetaminophen, 130mg Caffeine) every 4-6 hours as needed
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 8 tablets (4000mg Acetaminophen, 520mg Caffeine) in 24 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years without medical advice.
Adolescent:
Not recommended for adolescents under 12 years without medical advice. For 12 years and older, adult dosing may apply, but consult a healthcare professional.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution. Consider extending dosing interval.
Moderate:
Use with caution. Consider extending dosing interval (e.g., every 6-8 hours).
Severe:
Use with caution. Consider extending dosing interval (e.g., every 8 hours or longer). Consult physician.
Dialysis:
Acetaminophen is dialyzable. Caffeine is dialyzable. Supplementation may be needed post-dialysis, but consult physician.
Hepatic Impairment:
Mild:
Use with caution. Consider reduced dose or extended interval.
Moderate:
Contraindicated or use with extreme caution and significant dose reduction/interval extension. Consult physician.
Severe:
Contraindicated due to risk of hepatotoxicity from acetaminophen.
Confidence:
Medium
Pharmacology
Mechanism of Action
Acetaminophen: Exerts analgesic and antipyretic effects primarily through central inhibition of prostaglandin synthesis (likely via inhibition of cyclooxygenase, COX-3, or other central mechanisms). It has weak anti-inflammatory activity. Caffeine: Acts as a non-selective adenosine receptor antagonist (A1, A2A, A2B, A3). This antagonism leads to central nervous system stimulation, vasoconstriction, and enhancement of the analgesic effects of acetaminophen, possibly by increasing pain threshold or reducing cerebral blood flow.
Pharmacokinetics
Absorption:
Bioavailability:
Acetaminophen: 60-90%; Caffeine: >90%
Tmax:
Acetaminophen: 0.5-2 hours; Caffeine: 0.5-2 hours
FoodEffect:
Food may delay absorption of acetaminophen but does not significantly affect the extent of absorption. Caffeine absorption is not significantly affected by food.
Distribution:
Vd:
Acetaminophen: ~1 L/kg; Caffeine: ~0.6 L/kg
ProteinBinding:
Acetaminophen: 10-25%; Caffeine: 35%
CnssPenetration:
Acetaminophen: Yes; Caffeine: Yes
Elimination:
HalfLife:
Acetaminophen: 1-4 hours (prolonged in liver dysfunction); Caffeine: 3-7 hours (variable, prolonged in liver dysfunction, pregnancy, and with CYP1A2 inhibitors)
Clearance:
Rate varies by individual and liver function
ExcretionRoute:
Acetaminophen: Renal (as glucuronide and sulfate conjugates); Caffeine: Renal (as metabolites and small amount unchanged)
Unchanged:
Acetaminophen: <5%; Caffeine: ~1-2%
Pharmacodynamics
OnsetOfAction:
Acetaminophen: 30-60 minutes; Caffeine: 15-45 minutes
PeakEffect:
Acetaminophen: 1-2 hours; Caffeine: 1-2 hours
DurationOfAction:
Acetaminophen: 4-6 hours; Caffeine: 3-6 hours
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Acetaminophen has been associated with cases of acute liver failure, sometimes resulting in liver transplant or death. Most cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product. The risk of acute liver failure is higher in individuals with underlying liver disease and in those who ingest alcohol while taking acetaminophen. Patients should be advised to not exceed the maximum recommended dose and to avoid other acetaminophen-containing products.
Side Effects
Urgent 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
A fast heartbeat
Difficulty urinating or a change in urine output
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ 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. 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 do not go away, contact your doctor or seek medical help:
Feeling nervous and excitable
* 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
A fast heartbeat
Difficulty urinating or a change in urine output
A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ 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. 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 do not go away, contact your doctor or seek medical help:
Feeling nervous and excitable
* 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:
- Signs of liver damage: yellowing of skin or eyes (jaundice), dark urine, clay-colored stools, severe stomach pain, nausea, vomiting, unusual tiredness.
- Signs of allergic reaction: rash, hives, itching, swelling of the face/lips/tongue/throat, severe dizziness, trouble breathing.
- Symptoms of caffeine overdose: severe nervousness, restlessness, insomnia, tremors, rapid or irregular heartbeat, severe stomach upset.
- If pain or fever worsens or lasts more than 7 days (for pain) or 3 days (for fever), stop use and consult a doctor.
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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.
To guarantee your safety, carefully review all your medications and health issues with your doctor and pharmacist. Never start, stop, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Do not exceed the recommended treatment duration, and only take this medication for the length of time specified by your doctor.
To minimize the risk of liver problems, avoid taking other products that contain acetaminophen. Carefully examine the labels of all medications and supplements to ensure you are not inadvertently taking multiple sources of acetaminophen. Liver damage has been associated with acetaminophen use, particularly when exceeding 4,000 mg per day or when taking multiple products containing acetaminophen. In severe cases, this has led to liver transplants or death. If you have any questions or concerns, consult your doctor.
Follow the dosage instructions precisely, and do not take more than the recommended amount of acetaminophen per day. If you are unsure about the maximum daily dose, consult your doctor or pharmacist. While some individuals may be advised to take up to 4,000 mg per day, others, such as those with liver problems or children, may require lower doses. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you are not experiencing any symptoms.
To avoid potential interactions, limit your consumption of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat. Additionally, consult your doctor before consuming alcohol while taking this medication.
Be aware that this medication may affect the results of certain laboratory tests. Ensure that your doctor and laboratory personnel are informed that you are taking this medication. Do not administer this medication to children under 12 years old without first consulting your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
To minimize the risk of liver problems, avoid taking other products that contain acetaminophen. Carefully examine the labels of all medications and supplements to ensure you are not inadvertently taking multiple sources of acetaminophen. Liver damage has been associated with acetaminophen use, particularly when exceeding 4,000 mg per day or when taking multiple products containing acetaminophen. In severe cases, this has led to liver transplants or death. If you have any questions or concerns, consult your doctor.
Follow the dosage instructions precisely, and do not take more than the recommended amount of acetaminophen per day. If you are unsure about the maximum daily dose, consult your doctor or pharmacist. While some individuals may be advised to take up to 4,000 mg per day, others, such as those with liver problems or children, may require lower doses. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you are not experiencing any symptoms.
To avoid potential interactions, limit your consumption of caffeine (found in tea, coffee, cola, and other products) and chocolate, as combining these with this medication may cause nervousness, shakiness, and a rapid heartbeat. Additionally, consult your doctor before consuming alcohol while taking this medication.
Be aware that this medication may affect the results of certain laboratory tests. Ensure that your doctor and laboratory personnel are informed that you are taking this medication. Do not administer this medication to children under 12 years old without first consulting your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the potential benefits and risks of this medication with your doctor to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Acetaminophen overdose: Nausea, vomiting, stomach pain, loss of appetite, sweating, extreme tiredness, dark urine, yellowing of the skin or eyes (jaundice). These symptoms may not appear until 24-48 hours after ingestion.
- Caffeine overdose: Severe nervousness, restlessness, insomnia, tremors, rapid heartbeat, stomach upset, seizures (in severe cases).
What to Do:
In case of overdose, get medical help or contact a Poison Control Center right away. Call 1-800-222-1222. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Drug Interactions
Contraindicated Interactions
- Alcohol (chronic heavy use due to increased risk of hepatotoxicity with acetaminophen)
- Other acetaminophen-containing products (risk of overdose)
Major Interactions
- Warfarin (Acetaminophen can increase INR, especially with chronic use or higher doses)
- Isoniazid, Phenytoin, Carbamazepine, Rifampin (may increase risk of acetaminophen hepatotoxicity)
- CYP1A2 inhibitors (e.g., Cimetidine, Fluoroquinolones like Ciprofloxacin, Enoxacin, Fluvoxamine - can increase caffeine levels and risk of toxicity)
- Other CNS stimulants (additive effects, increased risk of adverse cardiovascular events)
Moderate Interactions
- Oral contraceptives (may decrease caffeine clearance)
- Disulfiram (may inhibit caffeine metabolism)
- Mexiletine (may inhibit caffeine metabolism)
- Theophylline (additive effects, increased risk of toxicity)
- Barbiturates (may decrease acetaminophen efficacy)
Minor Interactions
- Nicotine (smoking can increase caffeine clearance)
- Certain herbal supplements (e.g., St. John's Wort, Ephedra - potential additive stimulant effects)
Monitoring
Baseline Monitoring
Not routinely required for OTC use.
Rationale: This is an OTC medication for acute symptom relief.
Timing: N/A
Routine Monitoring
Symptoms of liver damage (e.g., yellowing skin/eyes, dark urine, severe abdominal pain)
Frequency: As needed, if symptoms arise
Target: N/A
Action Threshold: Seek immediate medical attention if symptoms occur.
Pain/fever relief
Frequency: Monitor effectiveness with each dose
Target: N/A
Action Threshold: If symptoms persist or worsen after 7 days (pain) or 3 days (fever), consult a doctor.
Symptom Monitoring
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Symptoms of liver damage (yellowing of skin or eyes, dark urine, clay-colored stools, severe stomach pain, nausea, vomiting, unusual tiredness)
- Symptoms of caffeine overdose (nervousness, restlessness, insomnia, tremors, rapid heartbeat, stomach upset)
- Gastrointestinal upset (nausea, stomach pain)
Special Patient Groups
Pregnancy
Acetaminophen is generally considered safe for use during pregnancy at recommended doses. Caffeine should be used in moderation; high doses are generally discouraged. Consult a healthcare provider before use.
Trimester-Specific Risks:
First Trimester:
Acetaminophen: Low risk. Caffeine: Moderate intake generally considered safe, but high intake may be associated with increased risk of miscarriage or low birth weight.
Second Trimester:
Acetaminophen: Low risk. Caffeine: Moderate intake generally considered safe.
Third Trimester:
Acetaminophen: Low risk. Caffeine: Moderate intake generally considered safe. High intake near term may cause neonatal withdrawal symptoms.
Lactation
Acetaminophen is considered compatible with breastfeeding (L1). Caffeine is generally considered safe in moderation (L2), but large doses can cause irritability or sleep disturbances in the infant. Monitor infant for adverse effects.
Infant Risk:
Acetaminophen: Low risk. Caffeine: Low risk with moderate maternal intake; higher risk of irritability/insomnia with high maternal intake.
Pediatric Use
Not recommended for children under 12 years of age without specific medical advice due to the combination product and caffeine content. Acetaminophen dosing for children is weight-based, and caffeine is generally not recommended for young children.
Geriatric Use
Use with caution in elderly patients due to potential for age-related decline in liver and kidney function, increased sensitivity to caffeine's CNS effects, and polypharmacy. Start with lower doses and monitor closely.
Clinical Information
Clinical Pearls
- This combination product is particularly effective for tension headaches and migraines due to the synergistic effect of acetaminophen and caffeine.
- Advise patients to check labels of all other medications (prescription and OTC) to avoid accidental acetaminophen overdose.
- Educate patients on the signs of liver damage and the importance of seeking immediate medical attention if they occur.
- Remind patients that caffeine can cause sleeplessness if taken too close to bedtime.
- The analgesic effect of acetaminophen is enhanced by caffeine, allowing for potentially lower effective doses of acetaminophen or improved efficacy for certain pain types.
Alternative Therapies
- Single-ingredient Acetaminophen (e.g., Tylenol)
- NSAIDs (e.g., Ibuprofen, Naproxen)
- Aspirin
- Other pain relievers depending on the type and severity of pain
Cost & Coverage
Average Cost:
Varies, typically $5-$15 per 20-50 tablets
Generic Available:
Yes
Insurance Coverage:
Not typically covered by prescription insurance as it is an OTC product. May be eligible for FSA/HSA.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.