Epigran 250mg/5ml Ampule 1 ml

Description

About

{{Product}} is a solution for injection or infusion that contains “phenytoin” as an active therapeutic ingredient which is an anticonvulsive agent. It is used to treat fits (status epilepticus), to prevent and control epilepsy during and after neurosurgery or head injury, and to prevent and control epileptic episodes when oral therapy is not possible. 

{{Product}} can also be used to control certain arrhythmias which arise due to certain medicines such as digoxin. It slows the impulses in the brain that are responsible for causing seizures. 

There is a risk associated with the administration of rapid infusion rates of Epigran 250mg/5ml Ampule 1 ml. Infusion rates that exceed 50mg/min in adults and 1-3 mg/kg/min for pediatrics put the patient at risk of hypotension and arrhythmias.  Therefore, careful cardiac monitoring is necessary after IV administration. Reduction of infusion rate or discontinuation is recommended if arrhythmia appears.  

Indications

• Generalized tonic-clonic seizures
• Treatment and prevention of seizures during neurosurgery 
• Severe fits (status epilepticus)
• Short term management of seizures when oral therapy is not possible

How Does Epigran 250mg/5ml Ampule 1 ml Work?

In seizures, there is a high-frequency burst of action potential (nerve signals/excitability). {{Product}} blocks the voltage-gated sodium channels due to which the high frequency of repetitive action potential slows down. This occurs at the neuronal membranes of the motor cortex where the drug has to promote sodium efflux and reduce sodium influx to slow down the conduction velocity. This way, Epigran 250mg/5ml Ampule 1 ml stabilizes the threshold against hyperexcitability of neurons and controls epileptic episodes. 

How To Use Epigran 250mg/5ml Ampule 1 ml?  

{{Product}} is either given through intravenous injection, infusion, or intramuscularly. It must be diluted with an appropriate solvent when given IV. It will be administered as mg/dose as an injection and mg/ml solution in case of IV infusion (drip). Monitoring of the parameters like blood pressure, electrocardiogram, and respiratory function is necessary. 

IV administration should be slow. Not more than 50mg/min is recommended in adults and not more than 1-4mg/kg/min for children. Administer the dilution (1-10mg/ml) immediately after preparation and it should be completed within one hour. 

Dosage

Adult Dose

Status epilepticus

100mg IV every 6 to 8 hours followed by 10 to 20 mg/kg at the rate of 25 to 50 mg, slow IV (less than 50mg/min).

Pediatric Dose

 4 to 8 mg /kg IV in two divided doses to control tonic-clonic and complex partial seizures. 

Pregnancy And Lactation

Orofacial clefts and cardiac defects, and fetal abnormalities can occur as malformations in infants whose mothers had epileptic episodes and were treated with Epigran 250mg/5ml Ampule 1 ml. So it should be used on a pregnant woman only if no other safer alternatives are available. Vitamin K supplementation should be stopped at least one month before birth. 

{{Product}} is secreted in human milk so should be avoided in a breastfeeding mother unless there is a significant clinical need for the mother. 

Contraindications

• Hypersensitivity 
• Sinus bradycardia (low heart rate)
• Sinoartrial A-V block 
• Adams-Stokes syndrome (periodic fainting spell due to arrhythmias)
• History of acute hepatotoxicity
• Concurrent use of medicines for HIV treatment (e.g., Delavirdine)

Precautions

• Patients with heart failure and low blood pressure should be treated with continuous monitoring. 
• Dose adjustment is needed in liver and kidney disease. 
• Alcohol dependence
• Porphyria (abnormality in hemoglobin biosynthesis)
• {{Product}} should not be stopped abruptly, it can lead to withdrawal precipitated seizure.
• DiscontinueEpigran 250mg/5ml Ampule 1 ml if there are signs of rash because it can lead to Steven Johnson Syndrome which is a serious dermatologic reaction. 
• Alternative anticonvulsive therapy should be used if there are hematopoietic complications. 
• Rapid IV administration can increase the risk of hypotension and arrhythmias. Therefore, the infusion rate should be below 50mg/min in adults and 1-3mg/kg/min in pediatric patients to avoid the risk of cardiovascular toxicity. 
• Caution should be taken while treating a diabetic patient because
  Epigran 250mg/5ml Ampule 1 ml can cause a rise in blood sugar. 
• {{Product}} can cause fetal harm including birth defects and congenital development if given to a pregnant woman. 

Interactions With Other Medications

Drugs that increase the serum levels of Epigran 250mg/5ml Ampule 1 ml:

• Antiepileptics (e.g., oxacarbazine, topiramate)
• Azole antifungals
• Anticancer (e.g., fluorouracil)
• Sulfonamides 
• Antidepressants (e.g., fluoxetine, sertraline) 

Drugs that decrease serum levels of Epigran 250mg/5ml Ampule 1 ml:

• Antiepileptic drugs (e.g., phenobarbital, valproic acid)
• Antivirals (e.g., Ritonavir) 
• Anticancers (e.g., Cisplatin, Doxorubicin, Methotrexate) 
• Diazepam
• Folic acid 

Drugs that get affected by Epigran 250mg/5ml Ampule 1 ml are:

• Digoxin
• Cyclosporin
• Quetiapine
• Calcium channel blockers (e.g., Nifedipine, Verapamil)
• Warfarin 
• Neuromuscular blockers (e.g., Vecuronium) 

Adverse Effects

Common Adverse Effects 

Ataxia (abnormal movements)

• Slurred speech
• Nystagmus (repetitive, uncontrolled movement of the eyes)
• Confusion 
• Drowsiness
• Fatigue
• Headache
• Vertigo
• Rash
• Withdrawal seizure
• Megaloblastic anemia (folic acid deficiency)
• Hypocalcemia (low calcium levels in the blood)
• Liver toxicity 
• Purple glove syndrome (pain, edema, and discoloration at the injection site
• Arterio ventricular conduction disorder
• Purpuric rash (small spots of blood on the skin)
• Metallic or altered taste

Potential Adverse Effects 

• Angioedema (a form of skin allergies)
• Urticaria
• Low count of components of blood (platelets, RBCs, and WBCs)

Rare Adverse Effects

• Dyskinesia (involuntary movement of facial muscles)
• Ophthalmoplegia (weakness or paralysis of the eye muscle)
• Nephrotoxicity
• Stevens-Johnson syndrome (a type of severe skin disorder)
• Rickets
• Osteomalacia (softening of bones)

How To Cope with Some of The Adverse Effects

• Drowsiness – Avoid usage of caffeine, alcohol, and drugs that make you feel drowsy. Lifting heavy machinery and driving should also be avoided until you get back to normal. 
• Fatigue – A mild to moderate exercise can help suppress fatigue. Cut out on caffeine and alcoholic drinks, take good sleep, and lie in a comfortable posture. OTC pain killers can be taken if the symptoms don’t go away. 
• Vertigo –  Take a resting position in a dark and quiet room, take deep breaths followed by closing your eyes to reduce spinning sensations. Leave chaotic places and avoid being anxious. Exercise also helps cope with the symptoms of vertigo. 
• Headache –.Using a cold pack or hot compress helps in relieving headaches, caffeine helps reduce pain, and you can also take an over-the-counter analgesic medication if pain persists.
• Skin Rash – Symptoms of an allergy include coughing, wheezing, runny nose, sneezing, redness of the skin, swollen eyes, rash, blisters, and throat swelling. Take an antiallergic over-the-counter medication to suppress the symptoms. However, you should take professional advice if the symptoms persist. 

Key Facts About Epigran 250mg/5ml Ampule 1 ml

• {{Product}} belongs to a class of medicines called anticonvulsants. It controls and prevents certain types of seizures in which, seizures after neurosurgery are also included. 
• {{Product}} works by slowing down the rapid firing of neurons and their hyperexcitability which occurs in seizures. 
• {{Product}} is associated with the risk of suicidal thinking. So, the individual should be closely monitored for suicidal behavior. Also, the treatment should not be stopped abruptly to avoid this side effect. 
• Infusion rates of more than 50mg/min in adults and 1-3mg/kg/min in pediatric patients can cause hypotension and arrhythmias. Close monitoring is recommended along with infusing Epigran 250mg/5ml Ampule 1 ml to the patient below these infusion rates. 

FAQs

Q1. CAN I TAKE ALCOHOL DURING THE TREATMENT WITH {{PRODUCT}}?

Taking alcohol when you are on Epigran 250mg/5ml Ampule 1 ml can increase the blood levels of Epigran 250mg/5ml Ampule 1 ml and may render harm. Also, it enhances a side effect of Epigran 250mg/5ml Ampule 1 ml which is drowsiness. So, alcohol consumption should be limited. 

Q2. HOW DOES {{PRODUCT}} WORK?

The mechanism of {[product}}’s action is to slow down the rapid firing of the hyperexcited neurons to control the episode of seizure. 

Q3. CAN A PREGNANT OR NURSING MOTHER TAKE {{PRODUCT}}?

The use of Epigran 250mg/5ml Ampule 1 ml during pregnancy is associated with malformation and birth defects so it should be avoided in pregnancy unless there is no other alternative available. {{Product}} is also secreted in human milk so should be avoided in a breastfeeding mother unless there is a significant clinical need for the mother. 

Q4. WHAT ARE THE STORAGE CONDITIONS OF {{PRODUCT}}?

{{Product}} should be stored at room temperature, away from moisture and direct sunlight. It should not be frozen. 

Q5. CAN I DRIVE A BIKE AFTER USING {{PRODUCT}}?

You may feel drowsy or unstable after the administration of Epigran 250mg/5ml Ampule 1 ml. So, living with heavy machinery or driving vehicles should be avoided additionally after a few days of completion of the dose. 

Q6. CAN I STOP USING {{PRODUCT}} ABRUPTLY?

Abrupt cessation of the therapy shows withdrawal symptoms and return of epileptic episodes. So, the discontinuation of Epigran 250mg/5ml Ampule 1 ml should be gradual to avoid failure to achieve therapeutic goals.