Alkem Laboratories Ltd

Valpex CR 300mg Tablet 10'S

Epilepsy/Convulsion
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    Introduction About VALPEX CR 300MG TABLET

    VALPEX CR 300MG TABLET contains Sodium Valproate which belongs to the group of medicines called Mood stabilizers. It is used to manage or control mania (feeling very excited, enthusiastic, over-active and easily irritated or distracted) caused by bipolar disorder. Bipolar disorder is when the mood fluctuates between feeling very high (mania) and very low (depression).

    VALPEX CR 300MG TABLET can be used when lithium cannot be used. VALPEX CR 300MG TABLET is also used to manage complex partial seizures (in adults and children 10 years of age and older) and simple and complex absence seizures, with or without other types of seizures.

    A seizure results from an excessive discharge of specific nerve cells and is characterized by changes in electrical activity. VALPEX CR 300MG TABLET can also be used to manage migraine headaches (episodes of moderate to severe headache, mostly unilateral, generally associated with nausea and hypersensitivity to light and sound).

    Before taking VALPEX CR 300MG TABLET, inform your doctor if you have fits, porphyria, liver, kidney, or pancreatic problems, diabetes, systemic lupus erythematosus, or any genetic diseases. Patients should be monitored for signs of suicidal ideation and behaviour and advised to seek medical advice if any such signs occur.

    Avoid consumption of alcohol while taking VALPEX CR 300MG TABLET. VALPEX CR 300MG TABLET is not recommended for use in pregnant or breastfeeding women or children (younger than 2 years) who are at a considerably increased risk of developing liver toxicity.

    The most common side effects of taking VALPEX CR 300MG TABLET are nausea, vomiting, headache, sleepiness, blurry or double vision, weight gain, hair loss, problems with walking, etc. Consult your doctor if any of the symptoms get worse.

    Uses Of VALPEX CR 300MG TABLET

    VALPEX CR 300MG TABLET is used:

    • Manage or control mania caused by bipolar disorder
    • Manage complex partial seizures (adults and children 10 years of age and older) and simple and complex absence seizures, with or without other types of seizure
    • Prevent migraine headaches

    How VALPEX CR 300MG TABLET Works

    VALPEX CR 300MG TABLET works by acting on GABA (γ aminobutyric acid) levels in the CNS, whose inhibitory activity is impaired in seizures and also in migraine headaches. It may also exert antiepileptic effects by reducing the high-frequency firing (excessive discharge) of nerve cells. VALPEX CR 300MG TABLET stabilizes mood by stabilizing the levels of chemicals in your brain that are responsible to affect your mood.

    How to use VALPEX CR 300MG TABLET

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

    Side Effects Of VALPEX CR 300MG TABLET

    Common

    • nausea, vomiting, diarrhea, increased or decreased appetite, stomach pain
    • headache, dizziness
    • sleepiness
    • weakness, shakiness
    • blurry or double vision
    • weight gain
    • hair loss
    • problems with walking or coordination

    Rare

    • skin problems like rashes

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

    • toxic epidermal necrolysis or Stevens-Johnson Syndrome (blistering, peeling or bleeding of your lips, eyes, mouth, nose, genitals, hands or feet with or without rash, fever, chills or aching muscles)
    • erythema multiforme (skin rash especially on palms or feet, or lesions with a pink or red ring and a pale centre which may be itchy, scaly or filled with fluid)
    • angioedema or an anaphylactic reaction (allergy-triggered swelling with painful itchy welts around the eyes, lips, throat and sometimes hands and feet, trouble swallowing or breathing)
    • Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) causing skin rash, fever, lymph node enlargement and possible impairment of other organs
    • liver problems (a sudden illness causing nausea, vomiting, extreme tiredness, drowsiness, weakness, stomach pain, yellow skin or whites of the eyes, loss of appetite, swelling of the legs and feet, recurrence of fits, dark urine, swollen face)
    • pancreatic problems (severe stomach pain that might spread in your back, nausea or vomiting that does not go away)
    • decreased platelet count (spontaneous bruising or bleeding due to blood clotting problems, or getting more infections than usual)
    • severe decrease of white blood cells or bone marrow failure (fever and breathing difficulty)
    • low red blood cell count or abnormally increased red blood cell size
    • pancytopenia (bone marrow disorders that affect red blood cells, white blood cells and platelets)
    • jerky muscle movements
    • increased blood ammonia levels (problems with balance and co-ordination, feeling lethargic or less alert, associated with vomiting, changes in mental status)
    • underactive thyroid gland (tiredness or weight gain)
    • inflammation of the envelope of the lungs (breathing difficulty and pain)
    • rapid, uncontrollable eye movements
    • worsening of fits
    • muscle pain and weakness
    • systemic lupus erythematosus (SLE) causing joint pain, fever, fatigue or rash
    • kidney problems (renal failure, tubulointerstitial nephritis and Fanconi syndrome) which may cause reduced urinary output or blood in the urine
    • Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion causing confusion
    • suicidal thoughts or actions (thoughts about dying, attempts to commit suicide, new or worse depression, anxiety or irritability, agitation, restlessness, panic attacks, trouble sleeping (insomnia), aggression, anger, violence, acting on dangerous impulses, extreme excitability, other unusual changes in behavior or mood)
    • very low body temperature
    • drowsiness or sleepiness (elderly)

    How To Manage Side Effects

    Diarrhea

    Drink lots of fluids, like water or fruit juice, to keep yourself hydrated. Check with your doctor before taking any medicine for diarrhoea. If the diarrhoea does not get better, contact your doctor.

    Dizziness Or Drowsiness

    Lie down until the dizziness is resolved, then get up slowly. Do not hurry and move slowly and carefully. Get adequate rest. Drink plenty of water and other fluids. Avoid coffee, cigarettes, alcohol, and drugs. If dizziness does not get better, consult your doctor.

    Headache

    Drink plenty of water and get adequate rest. Try to be relaxed and stress-free. Check with your doctor before taking any medicine for a headache. If your headache does not get better, consult your doctor.

    Loss Of Appetite

    Eat when you are hungry. Eat smaller meals more often than usual. Snack only when you're hungry. Eat a nutritious snack rich in calories and protein, such as dried fruit and nuts. If your appetite does not improve, contact your doctor.

    Nausea And Vomiting

    Take VALPEX CR 300MG TABLET with, or just after, meals. Stick to simple meals. Avoid eating oily or spicy foods. If you still feel nauseous, contact your doctor. Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like eating; you don't have to eat or avoid any specific foods. Do not take any medicine for vomiting without your doctor's consultation. If vomiting does not get better, contact your doctor.

    Stomach Pain

    Try to rest and relax. Eat and drink slowly, or try to eat smaller meals more frequently. Keep a heating pad on your stomach. If your stomach still aches, contact your doctor.

    Visual Disturbances

    Avoid driving or going outside on your own if you have blurred eyesight. Close your eyes for some time until your eyesight gets clear. Contact your doctor if your vision remains blurred for a long period.

    Warning & Precautions

    Pregnancy

    Contraindicated

    VALPEX CR 300MG TABLET is not recommended for use in pregnant women, especially if you are taking it to manage migraine headaches. Females of child-bearing capability must use effective contraception. Consult your doctor before taking it.

    Breastfeeding

    Use with Caution

    VALPEX CR 300MG TABLET should be used with caution in breastfeeding women as a little amount may pass through the breast milk. Consult your doctor before taking it.

    Driving and Using Machines

    Use with Caution

    Do not drive or operate any machines if you feel sleepy, confused or dizzy after taking VALPEX CR 300MG TABLET.

    Alcohol

    Contraindicated

    Alcohol consumption is not recommended while taking VALPEX CR 300MG TABLET as it may cause sleepiness or dizziness or make these worse.

    Kidney

    Use with Caution

    VALPEX CR 300MG TABLET should be taken with caution in patients with kidney problems. Consult your doctor before taking it.

    Liver

    Contraindicated

    VALPEX CR 300MG TABLET is not recommended in patients with liver problems or a family history of liver problems caused by taking medicine. Consult your doctor before taking it.

    Allergy

    Contraindicated

    Do not take VALPEX CR 300MG TABLET if you are allergic to Valproic acid, divalproex sodium, sodium valproate, aspirin or any of the other ingredients of this medicine.

    Use In Pediatrics

    Contraindicated

    VALPEX CR 300MG TABLET is not recommended for use in children (younger than two years) who are at a considerably increased risk of developing liver toxicity. Consult your doctor before taking it.

    Use In Geriatrics

    Use with Caution

    VALPEX CR 300MG TABLET should be used with caution in elderly patients as they may experience drowsiness or sleepiness. Consult your doctor before taking it.

    Others

    VALPEX CR 300MG TABLET is not recommended for use if you:

    • have porphyria (a rare illness affecting metabolism)
    • have urea cycle disorder (too much ammonia builds up in the body)
    • have a genetic problem caused by a mitochondrial disorder (Ex. Alpers-Huttenlocher syndrome)

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

    • are switching from another medicine that contains valproate
    • have fits, a brain disease or condition affecting your brain
    • have problems with your pancreas
    • have high blood sugar or are being tested for diabetes
    • are carnitine palmitoyl transferase type II deficient
    • have systemic lupus erythematosus (a rare immune system disease which affects the skin, bones, joints and internal organs)
    • have or had depression, mood disorders, or suicidal thoughts or behavior
    • have any other medical conditions

    Interactions

    A. Drug-Drug interactions:

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

    • medicines used for pain, inflammation and fever (Ex. aspirin, metamizole)
    • medicines used to manage fits (Ex. phenobarbital, primidone, acetazolamide, lamotrigine, phenytoin, carbamazepine, rufinamide, topiramate, felbamate)
    • medicines used to calm emotional and mental health disorders (Ex. quetiapine, diazepam, olanzapine)
    • moclobemide (used in depression and anxiety)
    • selegiline (used to manage Parkinson’s disease)
    • warfarin (used for blood thinning)
    • medicines used to manage HIV (Ex. zidovudine, lopinavir, ritonavir)
    • medicines used to manage bacterial infections (Ex. panipenem, imipenem, meropenem, rifampicin, erythromycin, linezolid)
    • medicines used to manage or manage malaria (Ex. mefloquine, chloroquine)
    • temozolomide (used to manage cancer)
    • cimetidine (used to manage stomach ulcers)
    • cholestyramine (used to control blood fat levels)
    • nimodipine (used for bleeding in the brain)
    • propofol (used for anaesthesia)
    • medicines containing oestrogen

    Overdosage:

    If you or anyone else accidentally take too much of VALPEX CR 300MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of GBNKEYWORD] overdose are nausea, vomiting, headache, blurred eyesight, dizziness, poor reflexes, confusion, memory loss, tiredness, weak or ‘floppy’ muscles, fits, loss of consciousness, behavioural changes, fast breathing, shortness of breath or chest pain.

    Synopsis

    Drug :   Valproic acid
    Pharmacological Category :   Aliphatic carboxylic acid
    Therapeutic Indication :   Mania, Seizures, Migraine headaches
    Dosage Forms :   Tablet, Oral solution

    More Information

    • Keep VALPEX CR 300MG TABLET out of reach of children
    • Store VALPEX CR 300MG TABLET between 15-30°C

    FAQs About VALPEX CR 300MG TABLET

    Q: Can VALPEX CR 300MG TABLET be taken during pregnancy?

    A: VALPEX CR 300MG TABLET is not recommended for use by pregnant women, especially if you are taking it to manage migraine headaches. Females of childbearing capability must use effective contraception. Do not stop taking your contraception until your doctor advises you further.

    If you are pregnant, think you may be pregnant or are planning to get pregnant, consult your doctor before taking VALPEX CR 300MG TABLET. Inform your doctor immediately if you become pregnant during management with VALPEX CR 300MG TABLET.

    Q: Can VALPEX CR 300MG TABLET make me feel suicidal?

    A: Thoughts of harming or killing oneself are seen in a small number of patients being managed with VALPEX CR 300MG TABLET. Patients taking VALPEX CR 300MG TABLET should be monitored for signs of suicidal ideation and behaviours, especially sudden changes in mood, behaviours, thoughts, or feelings, and advised to seek medical advice if any such signs occur.

    Q: Can VALPEX CR 300MG TABLET cause weight gain?

    A: Yes. Taking VALPEX CR 300MG TABLET may make you put on weight. Discuss with your doctor for advice before taking VALPEX CR 300MG TABLET.

    Q: Can I take other medicines with VALPEX CR 300MG TABLET?

    A: Before taking VALPEX CR 300MG TABLET, inform your doctor if you are taking, have taken, or might take any other medicine, including prescription, over-the-counter or herbal medicine, as these might cause serious side effects by interacting with each other.

    Q: Can VALPEX CR 300MG TABLET cause erectile dysfunction?

    A: According to some studies, men on VALPEX CR 300MG TABLET therapy show irregularities in androgens blood levels, sperm motility, and erectile dysfunction. Consult your physician if you have trouble getting an erection or related symptoms during VALPEX CR 300MG TABLET management.

    Q: Can VALPEX CR 300MG TABLET cause autism?

    A: Autism and related disorders are more often diagnosed in children exposed to VALPEX CR 300MG TABLET during pregnancy. Consult your doctor for further doubts.

    Q: Can VALPEX CR 300MG TABLET be given to children?

    A: VALPEX CR 300MG TABLET is not recommended for use in children (younger than two years) who are at a considerably increased risk of developing liver toxicity. Your doctor will decide on the correct dose of VALPEX CR 300MG TABLET or select a suitable alternative management for your child.

    Q: What if I forget to take a dose of VALPEX CR 300MG TABLET?

    A: If you forget to take a dose of VALPEX CR 300MG TABLET, take it as soon as you remember. However, omit the missed dose if it's almost time for the next one. Do not take VALPEX CR 300MG TABLET twice to make up for the missed dose.

    Q: Can VALPEX CR 300MG TABLET be stopped?

    A: Continue taking VALPEX CR 300MG TABLET until your doctor tells you to stop unless you experience any unwanted effects, a worsening of your condition, or any new symptoms. Contact your doctor in such cases.

    If you stop taking VALPEX CR 300MG TABLET without your doctor’s advice, your condition may get worse. When your doctor finds it okay to discontinue VALPEX CR 300MG TABLET management, your dose will be lowered gradually.

    References

    1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Epilepsy. Pharmacotherapy Handbook. Ninth edition. Page-518, 530.

    2. Rahman M, Nguyen H. Valproic Acid. NIH National Library of Medicine, National center for biotechnology information. StatPearls [Internet]. July 2022. [Accessed on 9th August 2022] https://www.ncbi.nlm.nih.gov/books/NBK559112/

    3. Cutrer FM, Limmroth V, Moskowitz MA. Possible mechanisms of valproate in migraine prophylaxis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. April 1997. [Accessed on 9th August 2022] https://pubmed.ncbi.nlm.nih.gov/9137844/#:~:text=Valproate%20increases%20brain%20GABA%20levels,and%20directly%20attenuates%20nociceptive%20neurotransmission.

    4. Sanofi-aventis SA. Electronic Medicines Compendium (EMC). [Revised in January 2022] [Accessed on 9th August 2022] https://www.medicines.org.uk/emc/files/pil.6102.pdf

    5. AbbVie Ltd. Valproic Avid. [Revised in October 2021] [Accessed on 9th August 2022] https://www.rxabbvie.com/pdf/depakote.pdf

    Useful Diagnostic Tests

    • Electroencephalogram (EEG)
    • MRI

    Author Details

    Written By Dr. Dhivakaran R - BDS
    Reviewed For Accuracy By Dr. Sankara Babu Gorle - MBBS, MD (Pharmacology)
    Last updated on 05 Apr 2023 | 05:47 PM(IST)
    Lab updated