PANADOL- IS IT SAFE? USES,SIDE EFFECTS,DOSAGE
WHAT IS PANADOL?
Panadol tablets contain Paracetamol as the active ingredient, which is an antipyretic and analgesic agent. Anti-pyretic action will reduce your temperature and analgesic action will reduce your pain.
It is used for :
- Fever
- A headache
- Menstrual cramp
- A toothache
- Muscle Pain
It is manufactured by GlaxoSmithKline (GSK).
PANADOL- IS IT SAFE? USES,SIDE EFFECTS,DOSAGE
What is the Generic name(s)?
What is its composition?
How does it work?
What are its uses?
How effective is this medicine?
Is it addictive?
What is the dosage?
What if I miss a dose?
What to do in case of overdosage?
What to do in case of allergic reactions?
CAN I DRIVE AFTER TAKING IT?
CAN IT BE TAKEN WITH FOOD?
CAN IT BE TAKEN ON AN EMPTY STOMACH?
CAN IT BE TAKEN WITH ALCOHOL?
WHAT ARE THE SIDE EFFECTS?
DOES THIS MEDICINE HAS ANY DRUG INTERACTIONS?
PRECAUTIONS
IS IT SAFE TO USE IF I’M PREGNANT?
IS IT SAFE TO USE IF I’M BREASTFEEDING?
CAN THIS MEDICINE BE USED FOR CHILDREN AND INFANTS?
IS THIS MEDICINE AVAILABLE AS OVER THE COUNTER (OTC) PRODUCT?
FREQUENTLY ASKED QUESTIONS
Reference
WHAT IS THE GENERIC NAME (s)?
The generic content is Paracetamol[1].
WHAT IS IT’S COMPOSITION?
The active ingredient:
- PARACETAMOL
The inactive ingredients
- Maize Starch[2]
- Potassium sorbate[3]
- Purified talc
- Stearic acid[4]
- Povidone starch pregelatinised
- Hypromellose[5]
- Triacetin[6]
HOW DOES IT WORK?
- Antipyretic[7] action
By inhibiting the cyclooxygenase – 3 (COX-3) in the brain[8]. It is an iso-enzyme[9] located in our brain. - Analgesic[10] action
The analgesic action is mainly due to increasing the pain threshold perception. It is also due to de-sensitization of peripheral pain receptors and prevention of prostaglandin-mediated sensitization of nerve endings under low peroxide.
NOTE: Analgesic action of panadol/paracetamol is additive - Anti-inflammatory[11] action
They show negligible anti-inflammatory action because they are found to be poor inhibitors of Prostaglandins[12] in peripheral tissues due to the presence of peroxides at the site of inflammation.
WHAT ARE IT’S USES?
Panadol is most frequently purchased as OTC medicine for the following indications :
Physicians choose Paracetamol as the first choice of drug as an analgesic in Osteoarthritis but not indicated for severe inflammatory conditions like Rheumatoid arthritis.
HOW EFFECTIVE IT THIS MEDICINE?
Panadol shows its action within half an hour of administration and its action lasts for about 5-6 hours. The analgesic action in additive as well. Unlike other pain relievers, paracetamol does not cause any gastric irritations, erosions or bleeding. It does not have any effect on platelets, clotting factor and is not uricosuric as well.
A therapeutic dose of Paracetamol has no effect on the respiratory or cardiovascular system. Paracetamol is a substitute for aspirin when aspirin is contraindicated in patients.
IS IT ADDICTIVE?
The medicine is not at all addictive.
It is available as Over The Counter medicine which has increased its use irrationally. Unintended usage of the medicine will cause paracetamol accumulation and over-dosage can lead to toxicity as well.
Paracetamol accumulation will lead to hepatotoxicity. This situation should be avoided.
WHAT IS THE DOSAGE?
ADULT DOSAGE
- Convention Dose : 325-1000mg (650mg, every 4-6 hours)
- Maximum Dose : 4g/Day
PEDIATRIC DOSAGE
DOSAGE BASED ON HYDRATION
- Well hydrated – 15mg/kg every 4-6 hours
- Dehydrated – 10mg/kg every 4-6 hours
DOSAGE BASED ON AGE
- 2 month -One dose of 60 mg
- 3- 5 months – 60 mg/dose, every 4 or 6 hours
- 6-12 months – 120 mg/dose, every4 or 6 hours
- 12 months -36 months – 180 mg/dose, every 4 or 6 hourly
- 4-5 years – 240 mg/dose, every 4 or 6 hourly
- 6-7 years – 240-250 mg/dose, every 4 or 6 hourly
- 8-9 years – 360-375 mg/dose, every 4 or 6 hourly
- 10-11 years- 480-500 mg/dose, every 4 or 6 hourly
- 12-15 years – 480-750 mg/dose, every 4 or 6 hourly
- 16-17 years – 500-1000 mg, every 4 or 6 hourly
MAXIMUM DOSE – Do not exceed 75 mg/kg/day.
Infant dose should not exceed 2 g/day
GERIATRIC DOSAGE
Acute pain and fever – same as adult dosing
Persistent Pain – 325-500 mg every 4 hours
Maximum 4 g/day
DOSAGE ADJUSTMENT IN RENAL IMPAIRMENT
- GFR > 50 ml/minute : No adjustment is needed
- GFR 10-50 ml/minute: Administer every 6 hours
- GFR < 10 ml : Administer every 8 hours
DOSAGE ADJUSTMENT IN HEPATIC IMPAIRMENT
Usage should be with extreme caution. A dose of less than 2g/day is well tolerated.
WHAT IF I MISS A DOSE?
If you have missed a dose to take, just take the missed dose soon as you remember it.
If the time is near to the next dose, skip the missed dose and take the regular one.
Do not take a double dose.
Try to take medicine at the same time every day.
Take care to always take the dose at right time. These tips will prevent you from missing doses:
- Keep a reminder alarm for each dose
- Arrange a Pill Box with tablets set for each dosing interval
- Keep medicine in a place where you can easily see it, but away from children
WHAT TO DO IN CASE OF OVER-DOSAGE?
Usually, in the normal dose, panadol is well tolerated. The adult maximum dose is 4 g/day and in infants, it is 2 g/day. Doses above it will be seen as over-dosage and symptoms will include skin rashes, other allergic reactions which could be either erythematous or urticaria. Serious cases will show drug fever and mucosal lesions. All reactions will be dose-dependent.
Regular overdosing will lead to acute paracetamol poisoning in patients. Under acute toxicity, the normal metabolites will be converted to toxic reactive metabolites and will lead to hepatocellular injury and lead to potentially fatal hepatic necrosis. If a dose greater than 150 mg/kg or 10 g in an adult is taken, serious toxicity can occur.
Dose greater than 250 mg/kg is fatal
NOTE: OVER-DOSAGE AND TOXICITY (HERE) ARE NOT SYNONYMOUS. REGULAR OVERDOSING WILL LEAD TO PARACETAMOL TOXICITY
In case of over-dosage follow these without panicking:
- Contact the nearest Doctor available
- Try to provide the dose and duration of medicine consumed
- If intentional overdosing with paracetamol has occurred, seek psychological help as well.
WHAT TO DO IF THERE IS AN ALLERGIC REACTION?
The occurrence of allergic reactions is very rare unless the patient is hypersensitive to Paracetamol or its derivatives.
- If you are a known hypersensitive patient, on a prior basis inform the doctor.
- If you suspect a hypersensitive reaction has occurred, stop taking the medicine.
- Inform your doctor and switch your medicine.
Allergic reactions include the following:
- Rashes
- Itching
- Dizziness
- Breathing trouble
- Swelling of tongue, face and throat
CAN I DRIVE AFTER TAKING IT?
The medicine is not known to cause any sedation because there is no agent causing sedation in this brand. So, it is pretty safe to consume medicine and drive.
It is just that you avoid any physical stress during illness, we will suggest you not to drive.
Make sure that you keep yourself hydrated.
CAN IT BE TAKEN WITH FOOD?
Physicians advise that Panadol can be taken with no regard with food and usually absorption decreases when taken with food.
Another brand named Panadol Extra should be taken cautiously with caffeine products because the medicine itself contains Caffeine.
CAN IT BE TAKEN ON AN EMPTY STOMACH?
Yes, it is safe to be taken on an empty stomach.
Unlike other NSAIDs (Non-Steroidal Anti Inflammatory Drug), paracetamol does not cause any gastric irritation or erosion. One of the main side effects of NSAIDs is gastric irritation.
CAN IT BE TAKEN WITH ALCOHOL?
Studies have shown that paracetamol can be taken with a moderate amount of alcohol.
But if you have alcoholic liver disease, it is strict that you do not drink alcohol under this medication; because both alcohol and paracetamol will potentiate your liver damage and will be fatal if not under therapeutic control. In liver failure patients taking paracetamol, if consumes alcohol in high amount, this will cause the normal paracetamol dose to be toxic.
Greater than 3 drinks/day will increase the risk of hepatic damage.
WHAT ARE THE SIDE EFFECTS?
The major side effects are:
- Skin Rashes
- Hypocalcemia
- Hyponatremia
- Pancytopenia
- Increased Bilirubin levels
DOES THIS MEDICINE HAS ANY DRUG INTERACTIONS?
The medicine shows few interactions but this will depend upon the dose and duration of both the drugs. Drugs interacting with Panadol are :
- Barbiturates – it increases the metabolism of paracetamol
- Carbamazepine – it increases the metabolism of paracetamol
- Dapsone – it increases the adverse effect of methemoglobinemia
- Phenytoin – it decreases the serum concentration of paracetamol
- Isoniazid – it enhances the adverse effects of paracetamol
- Lamotrigine – it decreases the concentration of lamotrigine
- Probenecid – it increases the serum concentration of paracetamol
- Vitamin K antagonist – paracetamol intake enhances the anticoagulant effects of vitamin K antagonists (Note: This does not include all the medicine which interact with it.)
PRECAUTIONS
- Do not exceed the maximum dose.
Exceeding the dose is associated with hepatic adverse effects. US Boxed warning states that paracetamol is associated with acute liver failure. This often has resulted in liver transplantation and death. - If any hypersensitivity reaction occurs after medicine intake, stop the medicine and contact the nearest physician.
- There are few disease-related concerns while taking this medicine which are:
Limit the alcohol intake
Be cautious while giving it to patients with G6PD deficiency and hepatic disease
Avoid the medicine in whom who have chronic malnutrition - When the medicine is obtained as Over The Counter (OTC) medicine, get it clarified with your pharmacist/physician both the desired dose and duration of the therapy.
- Store the tablets in a clean and dry area and out of reach from children.
IS IT SAFE TO USE IF I’M PREGNANT?
Panadol has not reported any teratogenic effect following maternal use in pregnancy. Use of Paracetamol in normal dose is safe in pregnant women and will not lead to miscarriage or still-birth. Maternal overdosage is associated with fetal death or spontaneous abortion.
Though it is safe to take, we do not recommend frequent use of this medicine during pregnancy; as it is known to be associated with early childhood asthma and wheezing.
IS IT SAFE TO USE IF I’M BREASTFEEDING?
It is excreted through breast milk. But there are no adverse events reported in nursing infants.
It is worth to be noted by a nursing mother that, for a single 650 mg dose of the medicine, it’s half-life in the breast milk is about 1.35-3.5 hours.
If the nursing mother has to take the medicine, either feed your infant after the half-life of the medicine or feed them before you take the medicine
CAN THIS MEDICINE BE USED FOR CHILDREN AND INFANTS?
It should not be given to Infants less than 2 months.
You should take care not to exceed the daily recommended dose of the medicine and do not use the medicine without an appropriate indication.
The medicine is available as OTC, which reports that there are more cases of irrational pediatric usage of the medicine. Pediatric tolerance to the adult dose is very low and is not recommended. When you self-medicate your child, do not blindly give the adult dose, rather give them the lowest dose.
If symptoms do not resolve consult physician rather than increasing the dose.
IS THIS MEDICINE AVAILABLE AS OVER THE COUNTER (OTC) PRODUCT?
Yes, the medicine is licensed by US FDA to be sold as OTC drug in retail pharmacies. Before you purchase the medicine from the pharmacy, provide the following details to the pharmacist:
- Age and weight of the patient
- Indication for which you are purchasing
- Do you take any other medicine
- Do you have any other medical condition
These will help you to get the right instruction from the pharmacist regarding the medicine dose and administration
Get the following information from pharmacists
- Dose
- Dosing interval
- Duration
The incidence of irrational and unintended usage of Panadol has increased over the last 3 decades. The Government of India has ordered the manufacturers to limit the total amount of paracetamol per tablet/capsule to 325 mg as it is available as OTC and frequently overused.
FREQUENTLY ASKED QUESTIONS
- Can I use Panadol if I’m pregnant?
Yes, you can use. Comparing to other opioid and non-opioid analgesic indicated for pain, paracetamol is the safest drug during pregnancy. It is just that you make the following assured:
Do not overdose yourself
Do not take it frequently
Make the least dose which is effective - How do I know if I am hypersensitive to the medicine?
We recommend you to do a hypersensitivity test of paracetamol with test dose in the nearest hospital if you suspect yourself allergic to it.
In fact it the much needed basic information a person should have about them self. - Can I use it for pain?
Yes, it is indicated not only for fever but also for pain. Menstrual pain, headache, toothache, muscle cramp are the main indications of the medicine - How long will it take it to act?
It takes less than half an hour for the medicine to act. Take the next dose after 4-6 hours, based on patient age and indication. You can stop taking the medicine once the symptoms are cured. - Will the medicine cause sedation?
Panadol alone will not cause sedation or sleepiness. But other combinations which contain anti-histamines will make you sleepy after medicine intake.
Reference
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