Epsolin 300mg Tablet 30’S

INTRODUCTION

EPSOLIN 300MG TABLET contains Phenytoin which belongs to the group of medicines called Anti-epileptic drugs. It is used to treat certain forms of epilepsy (fits or seizures) during or after brain surgery or severe head injury. Epilepsy is defined by the occurrence of at least two unprovoked seizures with or without fits (strong, involuntary contractions of the voluntary muscles) parted by at least 24 hours. A seizure results from an excessive discharge of specific nerve cells and it is characterized by changes in electrical activity (detected by electroencephalogram (EEG)). EPSOLIN 300MG TABLET is also used to treat trigeminal neuralgia (facial nerve pain).

During treatment with EPSOLIN 300MG TABLET, your doctor might ask you to take several blood tests, to monitor any side effects, and to check the amount of phenytoin in your blood to make dose adjustments. You should brush and floss your teeth and see a dentist regularly while taking EPSOLIN 300MG TABLET, to prevent overgrowth of gums.

Before taking EPSOLIN 300MG TABLET, inform your doctor if you have any liver or kidney problems, or porphyria (an inherited disease that affects haemoglobin biosynthesis). Avoid consumption of alcohol while taking EPSOLIN 300MG TABLET as it may affect its concentration in the blood. EPSOLIN 300MG TABLET should be used with caution in pregnant women only if advised by the doctor as it may cause harm to the unborn baby. Women of childbearing potential should use a suitable non-hormonal contraceptive method to avoid getting pregnant while taking EPSOLIN 300MG TABLET. It is not recommended for use in breastfeeding women.

Patients taking EPSOLIN 300MG TABLET may have thoughts of harming or killing themselves. If at any time you have these thoughts, immediately consult your doctor. EPSOLIN 300MG TABLET should be cautiously used in children and in elderly patients, particularly with kidney or liver problems. The most common side effects of taking EPSOLIN 300MG TABLET are irregular or involuntary eye movements, slurred speech, drowsiness, problems with movement and balance, decreased coordination and confusion. Consult your doctor if any of the side effects worsen.

USES OF EPSOLIN 300MG TABLET

Used to:

Prevent or control certain forms of epilepsy (that occur during or after brain surgeries or severe head injury)
Treats trigeminal neuralgia (facial nerve pain)
HOW EPSOLIN 300MG TABLET WORKS

EPSOLIN 300MG TABLET controls seizures (fits) by reducing the abnormal activity of the nerve cells in the brain. It also reduces the pain by blocking the transmission of pain signals across the nervous system thus reducing the symptoms of trigeminal neuralgia.

DIRECTIONS FOR USE

Take EPSOLIN 300MG TABLET as advised by your physician. Swallow EPSOLIN 300MG TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will determine the correct dose and duration for you depending on your age, body weight and disease condition. Do not stop taking EPSOLIN 300MG TABLET unless your doctor advises you to stop.

SIDE EFFECTS OF EPSOLIN 300MG TABLET
COMMON
Irregular or involuntary eye movements
Slurred speech
Drowsiness
Problems with movement and balance
Decreased coordination
Morbilliform (measles-like) rash
Confusion
RARE
Allergic reactions (such as a severe rash)
Drug reaction with eosinophilia and systemic symptoms (DRESS) (signs include fever, rash, facial swelling and enlarged lymph nodes)
Dyskinesias (impaired voluntary movement) including chorea (jerky involuntary movements of the shoulders, hips, and face), dystonia (muscular spasm and abnormal posture)
Shaking and asterixis (inability to maintain sustained posture with subsequent brief jerky involuntary movements)
Certain types of dermatitis (skin inflammation)

Stop taking EPSOLIN 300MG TABLET and contact your doctor immediately if you experience any of the following side effects:

Severe allergic reactions (swelling of the eyelids, face, lips, mouth, throat and tongue which causes breathing or swallowing difficulties and sudden wheeziness)
Signs of blood abnormalities (bruising, fever, severe sore throat, paleness, decreased red and white blood cells or platelets)
Sudden stopping of the heart known as cardiac arrest (signs include shortness of breath, being unconscious or unresponsive)
Bradycardia (signs include dizziness, tiredness, slow or skipping heartbeats and chest pain)
Suicidal thoughts or actions (like thoughts or attempts of suicide or dying, new or worsened depression, anxiety or irritability, agitation or restlessness, panic attacks, trouble sleeping, aggression, anger or violence, acting on dangerous impulses, mania (extreme increase in activity and talking) and other unusual changes in behaviour or mood)
Serious skin reactions (such as stevens-johnson syndrome, toxic epidermal necrolysis and acute generalized exanthematous pustulosis) accompanied by reddish spots or circular patches with widespread blistering and peeling of the skin, ulcers in the mouth throat, nose and genitals, red and swollen eyes, flu-like symptoms, and red scaly rash with bumps under the skin)
Hypersensitivity reactions (skin rash and fever, swollen glands) and in severe cases it causes an inflammatory disease called systemic lupus erythematosus (signs include pain and swelling of the joints)
Have confusion or mental illness (signs of high amount of medicine in the blood)
HOW TO MANAGE SIDE EFFECTS

Skin rash:

Avoid hot bathing because hot water can irritate your skin further. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. Consult your doctor if the symptom worsens.

Drowsiness:

Try a few lifestyle changes to improve your energy levels when you feel drowsy such as taking and maintaining a consistent sleep schedule. Exercise regularly (such as daily walks or running) and eat a nutritious diet with plenty of whole grains, legumes, fruits, and vegetables. Consult your doctor if the symptom worsens.

WARNING & PRECAUTIONS
PREGNANCY

EPSOLIN 300MG TABLET should be used with caution in pregnant women as it may cause harm to the unborn baby. Women of childbearing potential should use a suitable non-hormonal contraceptive method to avoid getting pregnant while taking EPSOLIN 300MG TABLET. Consult your doctor before taking this medicine and inform your doctor immediately if you become pregnant during treatment with EPSOLIN 300MG TABLET.

BREASTFEEDING

EPSOLIN 300MG TABLET is not recommended for use in breastfeeding women as it passes into breast milk. Consult your doctor before taking EPSOLIN 300MG TABLET.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you experience dizziness or drowsiness while taking EPSOLIN 300MG TABLET.

ALCOHOL

Avoid consumption of alcohol while taking EPSOLIN 300MG TABLET because it may affect the concentration of the medicine in the blood.

KIDNEY

EPSOLIN 300MG TABLET should be used with caution in patients with kidney disease. Consult your doctor before taking EPSOLIN 300MG TABLET.

LIVER

EPSOLIN 300MG TABLET should be used with caution in patients with liver disease. Consult your doctor before taking EPSOLIN 300MG TABLET.

ALLERGY

Do not take EPSOLIN 300MG TABLET if you are allergic to phenytoin or any other ingredients of this medicine, or similar medicines like hydantoins (such as fosphenytoin, ethotoin).

HEART DISEASE

EPSOLIN 300MG TABLET should be used with caution in patients with underlying cardiac disease as it may increase the risk of cardiac arrest. Consult your doctor before taking EPSOLIN 300MG TABLET

OTHERS

Before taking EPSOLIN 300MG TABLET, inform your doctor if you:

Have porphyria (an inherited disease that affects haemoglobin biosynthesis)
Had or have depression, mood problems, or suicidal thoughts or behaviour
Had or have high blood sugar (hyperglycemia)

Use in paediatrics:

[GBNKEYWORD should be used with caution in children and adolescents. Your child’s doctor may adjust the dose depending on the age and body weight of the child. Consult your child’s doctor for advice.

Use in geriatrics:

EPSOLIN 300MG TABLET should be used with caution in elderly patients and the dose may be adjusted in patients with kidney or liver disease and those taking other medicines. Consult your doctor before taking EPSOLIN 300MG TABLET.

INTERACTIONS

A. Drug – Drug interactions:

Before taking EPSOLIN 300MG TABLET, inform your doctor if you are taking any of the following medicines:

Medicines used to treat heart and circulation problems (Ex. amiodarone, digoxin, furosemide, reserpine, warfarin, mexiletine, disopyramide and calcium channel blockers such as diltiazem, nicardipine, nifedipine, nimodipine, verapamil)
Medicines used to lower blood cholesterol (Ex. atorvastatin, fluvastatin and simvastatin)
Medicines used to treat epilepsy (Ex. oxcarbazepine, carbamazepine, topiramate, phenobarbital, lacosamide, lamotrigine, sodium valproate and valproic acid and succinimides such as ethosuximide, vigabatrin)
Medicines used to treat fungal infections (Ex. amphotericin B, fluconazole, itraconazole, ketoconazole, miconazole, posaconazole, voriconazole)
Medicines used to treat tuberculosis and other bacterial infections (Ex. isoniazid, chloramphenicol, sulphonamides such as sulfadiazine, rifampicin, doxycycline, clarithromycin, sulfamethoxazole trimethoprim, ciprofloxacin)
Medicines used in the treatment of HIV infection (Ex. indinavir, ritonavir, efavirenz, fosamprenavir, saquinavir)
Medicines used to treat stomach ulcers (Ex. omeprazole, sucralfate, cimetidine and antacids)
Theophylline (used to treat asthma and bronchitis)
Medicine used to treat pain (Ex. aspirin)
Medicines used to treat inflammation (Ex. prednisolone, dexamethasone)
Medicines used for sleeplessness, depression and psychiatric disorders (Ex. chlordiazepoxide, clozapine, diazepam, disulfiram, fluoxetine, methylphenidate, paroxetine, phenothiazines such as chlorpromazine, trazodone, tricyclic antidepressants such as amitriptyline, fluvoxamine, quetiapine, sertraline)
Tolbutamide (used to treat high blood sugar)
Medicines used to prevent pregnancy (Ex. estradiol, desogestrel)
Medicines used to suppress the immune system and prevent graft rejection (Ex. ciclosporin, tacrolimus)
Medicines used to treat cancer (Ex. capecitabine, carboplatin, bleomycin, cisplatin, doxorubicin, methotrexate, fluorouracil)
Medicines used to relax the muscles (Ex. rocuronium, vecuronium)
Methadone (medicine used to prevent severe pain)
Medicines used to control blood clotting (Ex. rivaroxaban, dabigatran, apixaban, edoxaban, ticagrelor)
Non-prescription medicines (Ex. folic acid (treats folate deficiency), st. john’s wort (treats depression) and vitamin D (treats osteoporosis))  

Overdosage:

If you or anyone else accidentally take too much of EPSOLIN 300MG TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of EPSOLIN 300MG TABLET include nystagmus (rapid eye movements), ataxia (clumsy movements), dysarthria (trouble speaking), shaking, hyperreflexia (overactive bodily reflexes like twitching), lethargy, slurred speech, blurred vision, nausea, vomiting, low blood pressure, low heart rate, coma and cardiac arrest.

SYNOPSIS
Drug :   Phenytoin
Pharmacological Category :   Anti-epileptic drugs
Therapeutic Indication :   Epilepsy, Trigeminal neuralgia
Dosage Forms :   Injection, Tablet, Capsule, Syrup, Suspension
MORE INFORMATION
Keep EPSOLIN 300MG TABLET out of reach of children
Store at room temperature
FAQs ABOUT EPSOLIN 300MG TABLET

How does EPSOLIN 300MG TABLET work in the body?

EPSOLIN 300MG TABLET controls seizures (fits) by reducing the abnormal activity of the nerve cells in the brain. It also reduces the pain by blocking the transmission of pain signals across the nervous system thus reducing the symptoms of trigeminal neuralgia.

Can I drink alcohol while taking EPSOLIN 300MG TABLET?

No, you are not advised to consume alcohol while taking EPSOLIN 300MG TABLET because it may affect the concentration of the medicine in the blood and may result in unwanted effects. Consult your doctor before taking EPSOLIN 300MG TABLET.

 Is EPSOLIN 300MG TABLET advised being taken during pregnancy?

EPSOLIN 300MG TABLET should be used with caution in pregnant women only if advised by your doctor, as it may cause abnormalities in the unborn foetus. Women of childbearing capability should use non-hormonal contraceptive methods to avoid getting pregnant. If you are pregnant, think you may be pregnant or planning to get pregnant, consult your doctor before taking it. Inform your doctor immediately if you become pregnant during treatment with EPSOLIN 300MG TABLET.

Can EPSOLIN 300MG TABLET be taken more than the recommended dose?

Do not take a higher dose of EPSOLIN 300MG TABLET without consulting your doctor. Taking a higher dose of EPSOLIN 300MG TABLET may not be beneficial. Instead, it can cause serious side effects. If the given dose is not effective for you, consult your doctor. Your doctor may suggest a higher dose or an alternative therapy after evaluating your disease condition.

What happens if I suddenly discontinue the use of EPSOLIN 300MG TABLET on my own?

Suddenly stop taking EPSOLIN 300MG TABLET may lead to seizures which can be life-threatening. Do not discontinue taking medicine on your own without consulting your doctor. If required, your doctor will reduce the dose slowly before completely stopping the EPSOLIN 300MG TABLET.

What if I forget to take a dose of EPSOLIN 300MG TABLET?

If you forget to take a dose of EPSOLIN 300MG TABLET, take it as soon as you remember. However, omit the missed dose if it’s almost time for the next dose. Do not take the medicine twice to make up for the missed dose.

REFERENCES

1.KD Tripathi. Anti-epileptic drugs. Essentials of Medical Pharmacology. Eighth Edition, 2019. Page – 439.

2. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Epilepsy. Pharmacotherapy Handbook. Ninth edition. Page- 518.

3. Reynolds EH, Chadwick D, Galbraith AW. One drug (phenytoin) in the treatment of epilepsy. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. May 1976. [Accessed on 3rd September 2022] https://pubmed.ncbi.nlm.nih.gov/57334/

4. Keppel Hesselink, J. M., and Schatman, M . E. (2017). Phenytoin and carbamazepine in trigeminal neuralgia: marketing-based versus evidence-based treatment. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. 2017. [Accessed on 3rd September 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5522676/

5. Gupta M, Tripp J. Phenytoin. NIH National Library of Medicine, National center for biotechnology information. July 2022. [Accessed on 3rd September 2022] https://www.ncbi.nlm.nih.gov/books/NBK551520/

6. APL Swift Services (Malta) Limited. Electronic Medicines Compendium (EMC); [Revised in August 2021] [Accessed on 3rd September 2022] https://www.medicines.org.uk/emc/files/pil.4225.pdf

7. Accord. Electronic Medicines Compendium (EMC). [Revised in June 2021] [Accessed on 3rd September 2022] https://www.medicines.org.uk/emc/files/pil.5046.pdf

8. Pfizer Manufacturing Deutschland GmbH. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 3rd September 2022] https://www.medicines.org.uk/emc/product/5359/pil

9. Pfizer Manufacturing Deutschland GmbH. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 3rd September 2022] https://www.medicines.org.uk/emc/files/pil.7556.pdf

10. Pfizer Manufacturing Deutschland GmbH. Electronic Medicines Compendium (EMC). [Revised in May 2022] [Accessed on 3rd September 2022] https://www.medicines.org.uk/emc/files/pil.7560.pdf

11. Parke-Davis, Divison of Pfizer Inc. Dilantin (Phenytoin sodium capsule). [Revised in March 2022] [Accessed on 3rd September 2022] https://labeling.pfizer.com/ShowLabeling.aspx?id=546

USEFUL DIAGNOSTIC TESTS
Complete blood count
Electroencephalogram (EEG)
Net Qty
1 N
Item Weight
40 g
Ingredient
PHENYTOIN SODIUM 300MG
Hsn Code
30049081
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