Epival IV 500mg Ampule 5 ml

Description

About

Epival IV 500mg Ampule 5 ml belongs to a class of drugs called anticonvulsants, used to treat conditions like epilepsy and depression, extreme mood swings, or mania associated with bipolar disorder, acting as a mood stabilizer and in the prevention of migraine episodes.  Epival IV 500mg Ampule 5 ml is chemically composed of Divalproex Sodium, available as oral tablets, syrups, or suspension of varying potencies. Epival IV 500mg Ampule 5 ml may be used as an adjunct, supplementing the therapeutic effects of other anticonvulsant agents or it can be used alone to treat the condition. It can be used for the long-term management of seizures. 

Divalproex sodium contained in the Epival IV 500mg Ampule 5 ml imposes an inhibitory action on neurotransmitters which normally induces an excitatory response by blocking high voltage-activated calcium channels and voltage-gated sodium channels as well as increasing the action of GABA. It inhibits signal transmission and uncontrolled/ abnormal activities of the brain. It reduces neuronal transmission and subsequently slows down the excitability of neurons in the brain. It can take 1 to 2 weeks for Epival IV 500mg Ampule 5 ml to start showing full effects. This medicine is known to cause serious birth defects in unborn babies. Therefore, if you are pregnant and breastfeeding, avoid using it without a doctor’s advice. Also, abrupt withdrawal of Epival IV 500mg Ampule 5 ml can cause exacerbation of symptoms, for which reason you must consult a doctor first

Epival IV 500mg Ampule 5 ml is available in a more suited formulation for children as oral liquid (syrup and suspension) on prescription to be swallowed via mouth with a glass of water, usually in prescribed doses. While Epival IV 500mg Ampule 5 ml can be prescribed to children aged 10 years and adults alike, children, less than 10 years must be strictly monitored and supervised since safety is a big concern in younger children. Children, less than 2 years are not to be treated with this medicine. The dosage of Epival IV 500mg Ampule 5 ml depends on weight, age, the severity of the condition, patient’s response to the medicine, and their comorbidities as well as the type of formulation (with regards to its release mechanism) being used. Epival IV 500mg Ampule 5 ml is started in low doses which are increased with careful monitoring. The most common side effects of this medication are nausea, headache, and dizziness, mood changes.

Indications

Epival IV 500mg Ampule 5 ml is prescribed to adults and children (10and above) and it is used in the treatment of:

• Epilepsy and simple and complex seizure types such as absence/petit mal seizure
• Partial seizures 
• A bipolar disorder associated with depression/mood changes
• Mania 
• Migraine

How does Epival IV 500mg Ampule 5 ml work?

Epival IV 500mg Ampule 5 ml helps control seizures by controlling nerve impulses. Divalproex contained in the Epival IV 500mg Ampule 5 ml imposes an inhibitory action on excitatory neurotransmitters by blocking high voltage-activated calcium channels and voltage-gated sodium channels inhibiting glutamate release, a naturally occurring neurotransmitter inducing excitatory response. It also promotes the action of GABA by acting on its receptors, assisting its activity, and increasing these inhibitory transmitters in the brain. Thereby, it blocks/slows down signal transmission and uncontrolled/ abnormal activities of the brain.

How to use Epival IV 500mg Ampule 5 ml?

Epival IV 500mg Ampule 5 ml is available in the form of tablets. Swallow the tablet with a glass of water without chewing, this can be taken with or without food. In general, the treatment with Epival IV 500mg Ampule 5 ml is started at a relatively low dose that can give clinical results, which can be increased in potency and over weeks in increments as the need arises. the  Epival IV 500mg Ampule 5 ml is usually prescribed to be taken once or twice a day, the dose being dependent on weight, age, the severity of the condition, patient’s response to the medicine, and their comorbidities as well as the type of formulation (with regards to its release mechanism) and any other anticonvulsant being taken as an adjunct.

Available Potency of Epival IV 500mg Ampule 5 ml 

Epival IV 500mg Ampule 5 ml  is available in tablet form in the following potencies:

• 250 mg
• 500 mg

Controlled release/extended-release formulation: 

Controlled release formula, labeled as “CR” or “ER”- extended-release means they release chemicals in the body slowly over hours. This means once-a-day tablets can be given since medicine will stay in the body for longer durations.

Dosage

Adult Dose

Epilepsy /Seizures

Epival IV 500mg Ampule 5 ml is usually prescribed to be taken orally once a day for seizures. The type of seizures benefiting from this drug includes simple and complex partial seizures and absence seizure types. Either this medicine can be combined with other anti-seizure drugs or can be used alone depending on the seriousness of the condition under treatment.

Starting dose: 10 – 15 mg/kg/day orally once or in divided dose according to the total calculated dose.

Gradually increase by 5 -10 mg/kg/week to get the desired clinical outcome within safe limits.

Maximum safe dose per day: 60 mg/kg/day orally.

If the daily dose is less than equal to 250 mg, it can be given as a single dose, more than 250 mg can be given orally in divided doses.

Mania

Starting dose: 750 mg/day to be given orally in divided doses, usually thrice a day.

Controlled release/extended-release formulation: 

Starting Dose: 25 mg/kg once daily given orally. 

Doses can be increased quickly to match the least effective dose able to improve the patient’s symptoms (as opposed to some other antidepressants that are titrated slowly).

Maximum safe dose per day: 60 mg/kg/day orally.

Migraine

This can be given to prevent a migraine attack as a prophylactic medicine:

Starting Dose: 250 mg orally, twice a day for 1 week.

Controlled release formula (CR or ER)

500 mg, given orally, once a day for 1 week.

Maximum safe dose per day: 1000mg/day given  orally (if indicated)

Child Dose

Epival IV 500mg Ampule 5 ml can be safely given to children aged 10 years and above. Younger children must not be treated with Epival IV 500mg Ampule 5 ml since there is not enough safety data available.

Epilepsy/seizures

Starting dose: 10 – 15 mg/kg/day orally once or in divided dose according to the total calculated dose.

Gradually increase by 5 -10 mg/kg/week to get the desired clinical outcome within safe limits.

Maximum safe dose per day: 60 mg/kg/day orally.

Changing to single-drug therapy (Monotherapy)

Once decided, the starting dose may remain the same with a gradual reduction in the dose of concomitant anticonvulsant being taken by 25% of its total dose every 2 weeks. Strict monitoring and regulation are advised while adjusting the therapy

Mania

Consult a doctor for dosage,  Epival IV 500mg Ampule 5 ml is not suitable to treat mania in children and adolescents below 18 years of age.

Elderly dose

The safety concerns of Epival IV 500mg Ampule 5 ml in the elderly population are still valid, hence caution must be taken. Your doctor should set the most appropriate dose for you based on your medical history. Doses are adjusted according to a liver impairment or other medications being taken concurrently, or other serious conditions. 

*Special Doses

Liver disease – Lower doses are advised along with monitoring of LFTs

Adjunct therapy with other anti-seizure may also require lowering the dose, your doctor will set the most appropriate dose for you

Pregnancy use and lactation

Epival IV 500mg Ampule 5 ml is FDA pregnancy risk category D (harmful to the fetus), therefore if you are pregnant, think you may be pregnant, or are planning to have a baby, please consult your doctor. Also Epival IV 500mg Ampule 5 ml is secreted into human milk, if you are breastfeeding, please consult your doctor before taking it.

Contraindications

Please inform your doctor if you have a history of any before using Epival IV 500mg Ampule 5 ml:

• Allergic reaction to Epival IV 500mg Ampule 5 ml or similar anticonvulsants
• Chronic liver disease with severe impairment of liver function
• Mitochondrial Disorders
• Disorders of urea cycle
• Concurrently with certain drugs (see drug interactions)
• Genetic conditions like Porphyria
• Pancreatitis 

Precautions‌ ‌

Please‌ ‌tell‌ ‌your‌ ‌doctor‌ ‌about‌ ‌any‌ ‌of‌ ‌the‌ ‌following‌ ‌conditions‌ ‌before using the ‌Epival IV 500mg Ampule 5 ml:‌ ‌

• A history of allergy to any or similar medicines 

• Liver and pancreas toxicity is of particular concern in younger children. Keen monitoring and caution are advised ‌Epival IV 500mg Ampule 5 ml

• In the case of liver disease before starting the treatment with ‌Epival IV 500mg Ampule 5 ml check LFTs, which must be monitored during the treatment as well. In case of severe liver inadequacy, this drug is prohibited

• Underage children less than 2 years of age are a high-risk category for suffering from serious side effects

• Women of fertile age group or those wanting to conceive/ or are pregnant must not use this medicine since it is associated with serious birth defects

• Strict long-term contraception is advised if you are using Epival IV 500mg Ampule 5 ml  to avoid pregnancy such as IUD/Coil, etc.

• Any pre-existing heart condition must also be discussed with your doctor

• Elderly patients (65 years and above) should exercise caution since Epival IV 500mg Ampule 5 ml has scanty data available regarding safety, also it can cause dizziness and fainting spells, dose adjustment may be done by the doctor

• Epival IV 500mg Ampule 5 ml must not be given to the patients with a history of recent head trauma

• The drug must not be stopped abruptly even if your symptoms have improved since it can produce worsening symptoms. Always ask a doctor before stopping

• Tolerance is also common with ‌Epival IV 500mg Ampule 5 ml where one may not feel clinical benefits the same as before. Do not add on to your dose without consulting a doctor first

• Epival IV 500mg Ampule 5 ml may alter the results of certain blood/urine tests like thyroid function, and ketone bodies in urine. Always tell your doctor n laboratory personnel about your current medicines

• Alteration in blood cell count like platelets (thrombocytopenia) can occur when Epival IV 500mg Ampule 5 ml reaches a certain level in the blood. Report to your doctor if you notice abnormal bleeding patterns or bruises 

• Epival IV 500mg Ampule 5 ml causes slowing down of brain function, alcohol consumption must be avoided with it

Interaction with other medications

Certain medications could interact with Epival IV 500mg Ampule 5 ml and may increase or decrease its absorption, in which case, your doctor might alter your dosage. A few of these interacting drugs are given below:

• Acetylsalicylic acid

• Amitriptyline/Non-nortriptyline

• Antivirals like ritonavir, lopinavir 

• Benzodiazepines  

• Carbapenem antibiotics

• Cholestyramine 

• Cimetidine 

• Clonazepam 

• Ethosuximide 

• Lamotrigine 

• Haloperidol 

• Propofol 

• Phenobarbital 

• Phenytoin

• Some oral contraceptives (not enough proof available)

• Rifampin 

• SSRI antidepressants 

• Warfarin 

Adverse effects

Like most medicines, Epival IV 500mg Ampule 5 ml has some side effects which include:

Common Side effects

• Nausea 

• Headache 

• Skin rash 

• Drowsiness 

• Dizziness

• Weight gain 

Rare side effects

• Anaphylactic reaction 

• Blurred vision

• Swollen gums 

• Dry mouth 

• Oral ulcers

• Uncontrolled muscle movements/ seizures 

• Itching/redness of eyes 

• Increased ammonium levels in the blood

• Increased hair fall

• Palpitations 

• Somnolence 

• Shaky hands/tremors  

• Altered blood cell count

• Menstrual cycle irregularities 

• Acute pancreatitis 

• Liver/Pancreas toxicity 

• Abnormal bleeding

• Unexplained bruises 

• Erectile dysfunction

• Loss of libido 

LIST OF HOW TO DEAL WITH ADVERSE EFFECTS

Dry Mouth – Can be helped by sipping water throughout the day, chewing sugarless gum, using alcohol-free mouthwash, allowing ice to melt in the mouth, or using a saliva substitute.

Fatigue – Patients experiencing this adverse effect are advised to take deep breaths, intake tea or coffee, get a good night’s rest, and not overburden themselves for a few days.

Feeling drowsy – If the medication makes you feel drowsy or sleepy, stop what you’re doing and sit or lie down until you feel better, and do not rise too fast or immediately from a sitting or lying down position to a standing posture. Do not drive or use tools or machinery in case of any of these effects.

Headaches – In which case make sure you rest and drink plenty of fluids. Avoid the use of alcohol. Take a prescribed painkiller. Consult your doctor if the headaches last longer than a week or are severe

Feeling or being sick (nausea or vomiting) or diarrhea – Avoid eating rich or spicy food. It might help to take medication after food. If you’re sick, try drinking small, frequent sips of water. 

Feeling dizzy (lightheaded) or weak –If the medication makes you feel dizzy or weak, stop what you’re doing and sit or lie down until you feel better, and do not rise too fast or immediately from sitting or lying down position to a standing posture. Do not drive or use tools or machinery in case of any of these effects.

Muscular Aches and Pains- A hot or cold compress can be placed at the area of discomfort to bring relief; an over-the-counter pain reliever such as paracetamol or ibuprofen can be ingested to bring ease as well. Avoid high-intensity exercise while suffering from muscular pain.

Flatulence- Can be eased by consuming smaller, more frequent meals that don’t trigger your flatulence. Getting a minimum of 30 minutes of daily exercise has shown great results in combating flatulence. 

Heartburn – can be dealt with by chewing on mint-flavored gum that’ll help neutralize the acid in the body. Standing up straighter, adding ginger to the daily diet, elevating the patient’s upper body, and having licorice supplements has shown to provide relief.

Skin Rash- can be eased by applying soothing and healing lotions or creams such as calamine lotion/cream. Apply a cold compress to the rash helps reduce itchiness and redness caused by the rash. An antihistamine (prescribed by a doctor) is also recommended as an effective way to combat any skin rash.

Dehydration- Patients are recommended to always care around a water bottle with them wherever they go and periodically keep sipping to prevent thirst and extremely dry mouth. Ice pops in hot weather and energy drinks (verified by the doctor) help combat dehydration.

Fever – patients are asked to ingest over the counter painkillers (such as Paracetamol), partake in plenty of fluids, and rest for a couple of days till the symptoms pass

FAQs

#1. WHAT EXACTLY DOES Epival IV 500mg Ampule 5 ml DO?

It is an anticonvulsant used to treat complex and partial seizures, symptoms of mania in bipolar disorder inhibiting signal transmission in the brain producing excitation and as a result uncontrolled movement

#2. HOW LONG DOES IT TAKE FOR Epival IV 500mg Ampule 5 ml TO START WORKING?

Normally it takes 2 weeks or more for Epival IV 500mg Ampule 5 ml to show its full effects.

#3. HOW LONG WILL I HAVE TO TAKE Epival IV 500mg Ampule 5 ml FOR?

Time duration depends on why you’re taking Epival IV 500mg Ampule 5 ml. Consult your physician for this, Epival IV 500mg Ampule 5 ml can be taken for longer periods from 1 to 3 weeks or more for epilepsy. 

#4. CAN I STOP TAKING Epival IV 500mg Ampule 5 ml?

Do not just stop taking the medicine, make sure to complete your treatment course even if you feel better. Stopping it suddenly may cause exacerbation of symptoms, having said that it is not addicting.

#5. IS Epival IV 500mg Ampule 5 ml HIGHLY ADDICTIVE?

No, it is not considered to be addictive and does not cause dependence but stopping the medicine abruptly can cause undesirable adverse symptoms.

#6. CAN I DRINK ALCOHOL WITH Epival IV 500mg Ampule 5 ml?

Consuming alcohol when taking Epival IV 500mg Ampule 5 ml may cause excessive drowsiness and could increase the risk of liver damage, hence should be avoided. 

#7. WHAT IF I TAKE TOO MUCH OF Epival IV 500mg Ampule 5 ml?

If you have taken too much of the prescribed Epival IV 500mg Ampule 5 ml you may experience symptoms of toxicity which will vary depending on the dose ingested, for example, fast pounding, irregular heartbeat, upset stomach, blurred vision, fainting, dizziness, seizures, or life-threatening severe symptoms. Contact your doctor or emergency immediately if you have any of these symptoms. 

#8. WHAT IF I FORGET TO TAKE Epival IV 500mg Ampule 5 ml?

Epival IV 500mg Ampule 5 ml is taken once or twice a day so you can take the missed dose as soon as you remember unless it’s about time until your next dose, in which case you should skip the missed dose. If it helps to remind you, set an alarm or use a pill organizer or a mobile application so you do not miss any dose. Make sure to complete your course of treatment even if you feel better and think you do not need to take it anymore.

#9. CAN I TAKE Epival IV 500mg Ampule 5 ml DURING PREGNANCY OR BREASTFEEDING?

Epival IV 500mg Ampule 5 ml has a safety concern for unborn babies and is known to cause serious defects in these babies. If you are pregnant, think you may be pregnant, or are planning to conceive a baby, please consult your doctor before using Epival IV 500mg Ampule 5 ml. If you are breastfeeding, please consult your doctor before taking Epival IV 500mg Ampule 5 ml. Foolproof contraception is advised when you are using Epival IV 500mg Ampule 5 ml to avoid pregnancy.

#10. CAN I DRIVE OR RIDE A BIKE AFTER TAKING Epival IV 500mg Ampule 5 ml?

Usually  Epival IV 500mg Ampule 5 ml  is known to cause drowsiness and dizziness so make sure you know how your body reacts while using ‘product’. Do not drive or use any sharp or heavy machinery until you feel normal again.

#11. HOW SHOULD Epival IV 500mg Ampule 5 ml BE STORED?

Store it at room temperature below 30 °C, away from excess heat, direct sunlight, and moisture. Make sure it is not consumed by pets, children, and other people. Dispose of the unused medicine. 

#12. CAN Epival IV 500mg Ampule 5 ml AFFECT MY SEXUAL ACTIVITY?

Sexual dysfunction may occur with Epival IV 500mg Ampule 5 ml in some patients. It may cause a decrease in libido or cause erection problems in some patients. You must discuss this with your consultant before starting. 

#13. CAN Epival IV 500mg Ampule 5 ml AFFECT MY ORAL CONTRACEPTION?

No, oral contraceptives are not known to interact with Epival IV 500mg Ampule 5 ml.

#14. WILL  Epival IV 500mg Ampule 5 ml AFFECT MY FERTILITY?

Epival IV 500mg Ampule 5 ml has been reported to decrease fertility in some patients, however, this is reversible and returns to normal once your therapy ends. Problems like irregularities in menses, erectile dysfunction, and loss of libido all have an impact.

#15. WILL I HAVE TO TAKE OTHER EPILEPSY MEDICINES WITH Epival IV 500mg Ampule 5 ml? 

Epival IV 500mg Ampule 5 ml may or may not be used in combination with other anticonvulsants depending on your condition and response. Dose adjustment is done accordingly if more than one type of anticonvulsant is being taken together.