Valprol-CR

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What Is Valprol-CR?

Valprol-CR is an oral controlled-release tablet from Intas Pharmaceuticals containing sodium valproate in combination with valproic acid (the same active molecule, different salt form — in solution they are equivalent). The CR (controlled-release) formulation gradually releases the active over 12–24 hours, allowing once-daily or twice-daily dosing instead of the three-or-four-times-daily schedule needed with immediate-release valproate.

Valproate is one of the oldest and most broad-spectrum anti-epileptic drugs in use. It is licensed for multiple seizure types in epilepsy, acute mania in bipolar I disorder, and migraine prophylaxis. The CR formulation is preferred for adults requiring sustained 24-hour drug levels — particularly those who experience peak-related side effects (drowsiness, tremor) on immediate-release valproate.

How Does Valprol-CR Work?

Sodium valproate has multiple complementary mechanisms that together produce its broad-spectrum anti-seizure and mood-stabilising effects:

• Voltage-gated sodium channel blockade — reduces high-frequency neuronal firing, the basis of its anti-seizure effect on partial and generalised tonic-clonic seizures.
• T-type calcium channel inhibition — particularly relevant to absence seizures, where T-type calcium currents in thalamocortical neurons drive the spike-wave pattern.
• GABAergic enhancement — raises brain GABA concentration through inhibition of GABA-degrading enzymes (GABA-T and succinic semialdehyde dehydrogenase) and increased GABA synthesis.
• NMDA receptor modulation — reduces excitatory glutamate transmission.

The combined effect is a wide therapeutic spectrum across seizure types, mood-stabilising activity in bipolar I disorder, and migraine prophylaxis through cortical-spreading-depression suppression.

Χρήσεις και ενδείξεις

• Epilepsy — generalised tonic-clonic seizures (first-line)
• Epilepsy — absence seizures (first-line, especially in childhood and juvenile-onset)
• Epilepsy — myoclonic seizures (first-line for juvenile myoclonic epilepsy)
• Epilepsy — partial (focal) seizures (with or without secondary generalisation)
• Lennox-Gastaut syndrome and other mixed seizure types
• Bipolar I disorder — acute mania (FDA-approved monotherapy)
• Bipolar I disorder — maintenance therapy (off-label, widely used)
• Migraine prophylaxis in adults (FDA-approved when migraines are frequent and disabling)
• Εκτός ενδείξεων: behavioural agitation in dementia (no longer recommended — mortality signal), aggression and impulse control, neuropathic pain

Valprol-CR is δεν first-line for: women of childbearing potential who could become pregnant (because of teratogenicity), pure absence seizures in young children if ethosuximide is available (cleaner safety), or generalised anxiety / unipolar depression. Behavioural agitation in dementia is no longer a recommended use — observational data suggest increased mortality, similar to the antipsychotic-in-dementia signal.

Valprol-CR Dosage and How to Take

Valprol-CR comes at 200 mg και 750 mg controlled-release strengths.

Standard adult dosing by indication:

• Epilepsy: Start 600 mg/day (300 mg twice daily). Increase by 200 mg every 3 days based on seizure control. Maintenance 1,000–2,000 mg/day in 1–2 divided doses. Maximum 2,500 mg/day.
• Bipolar I (acute mania): Start 750 mg/day in divided doses; increase rapidly to achieve serum level 50–125 µg/mL. Maintenance 1,000–2,500 mg/day.
• Migraine prophylaxis: Start 250 mg twice daily; increase to 500–1,000 mg/day if needed. Many patients respond at 500 mg/day.

How to Take Valprol-CR Properly

1. Take with or after food. This is the single biggest factor in GI tolerability. Empty-stomach dosing causes nausea, dyspepsia and abdominal pain in most patients.
2. Καταπιείτε ολόκληρο με νερό. Do NOT crush, split, or chew controlled-release tablets — this destroys the controlled-release mechanism and causes a dose dump that produces severe peak-related side effects (drowsiness, tremor, GI upset).
3. Twice daily for most adults, ideally morning + evening 12 hours apart. Once-daily dosing (full daily dose at bedtime) is reasonable for migraine prophylaxis at 500–1,000 mg/day.
4. Be consistent with timing. Missed doses produce noticeable trough levels. If a dose is missed and remembered within 6 hours, take it. If >6 hours, skip and resume normally — do not double-dose.
5. Monitoring schedule: baseline LFTs (AST, ALT, GGT), full blood count, and platelet count before starting. Repeat at 1 month, 3 months, 6 μήνες, then annually. Check ammonia level if patient develops drowsiness, confusion or vomiting.
6. Therapeutic drug monitoring: serum valproate trough level is useful in epilepsy (target 50–100 µg/mL) and bipolar (target 50–125 µg/mL). Not routinely needed for migraine prophylaxis.
7. Never stop abruptly. Sudden discontinuation in epilepsy can precipitate status epilepticus (medical emergency) even in patients who have been seizure-free for years. Taper over 2–6 weeks under medical supervision when discontinuing.
8. Pregnancy prevention (women of childbearing potential): use reliable contraception throughout treatment. Discuss alternative drugs if pregnancy is a possibility — valproate is one of the most teratogenic drugs in routine clinical use.

Side Effects of Valprol-CR

Common (often dose-related, may settle with slower titration):

• Nausea, vomiting, dyspepsia, abdominal pain
• Drowsiness, fatigue
• Tremor (fine, postural — often dose-dependent)
• Weight gain (10–20% of patients gain >5 kg)
• Hair thinning or hair loss (reversible on discontinuation)
• Diarrhoea or constipation
• Increased appetite

Λιγότερο συχνά αλλά σημαντικά:

• Thrombocytopenia (low platelet count) — usually mild and dose-related; check FBC every visit
• Hyperammonaemic encephalopathy — drowsiness, confusion, vomiting; can occur with normal LFTs; check ammonia level if suspected
• Polycystic ovary syndrome features in women — hyperandrogenism, menstrual irregularity, weight gain
• Increased liver enzymes (often asymptomatic)
• Pancreatitis (rare but life-threatening)
• Cognitive slowing, memory difficulties

Rare but seek medical attention immediately:

• Acute fulminant hepatic failure — particularly in children under 2 years on polypharmacy. Stop immediately if jaundice, severe vomiting or new lethargy develops.
• Οξεία παγκρεατίτιδα — severe abdominal pain, vomiting
• Hyperammonaemic encephalopathy with normal LFTs — new confusion, drowsiness, vomiting
• Severe skin reactions (Stevens-Johnson syndrome, DRESS)
• Bone marrow suppression
• Severe bleeding from thrombocytopenia or platelet dysfunction

Προειδοποιήσεις και Προφυλάξεις — ΚΡΙΣΙΜΟ

• Pregnancy: ABSOLUTE CONTRAINDICATION for migraine (FDA Category X) and STRONG WARNING for epilepsy (Category D). Sodium valproate is one of the most potent human teratogens in routine clinical use. Risk of major congenital malformations (neural tube defects, craniofacial defects, cardiac defects, limb defects, hypospadias) is approximately 10%, plus a 30–40% risk of significant neurodevelopmental impairment (lower IQ, autism spectrum disorder) in children exposed in utero. Use only if no other option is effective. Women of childbearing potential need: (1) explicit pregnancy-prevention counselling, (2) reliable contraception throughout treatment, (3) preconception folate supplementation 5 mg/day if pregnancy is planned, (4) urgent specialist review if pregnancy occurs.
• Hepatotoxicity: highest risk in children under 2 years on multiple anti-epileptics (rare in adult monotherapy). Stop immediately for jaundice, severe vomiting, lethargy, or worsening seizures.
• Pancreatitis: rare but life-threatening; idiosyncratic, can occur at any time during treatment. Seek emergency care for severe abdominal pain.
• Hyperammonaemic encephalopathy: can occur with normal LFTs — check ammonia level if patient develops drowsiness, confusion or vomiting on valproate.
• Mitochondrial disease (POLG mutations): absolute contraindication — valproate causes acute liver failure in this rare population. Genetic testing is appropriate before starting if there is family history of mitochondrial disease or unexplained liver disease.
• Urea cycle disorders: contraindication — valproate precipitates hyperammonaemic encephalopathy.
• Bleeding risk: valproate impairs platelet function and may cause thrombocytopenia. Tell the surgeon and stop 1–2 weeks before elective surgery if possible.
• Dementia patients: off-label use for behavioural agitation is no longer recommended — observational data show increased mortality.
• Never stop abruptly in epilepsy — can precipitate status epilepticus.

Contraindications — Who Should NOT Take Valprol-CR

• Pregnancy or planning pregnancy (especially for migraine prophylaxis — absolute contraindication)
• Known hypersensitivity to valproate or any tablet excipient
• Severe hepatic impairment or active liver disease
• Personal or family history of severe hepatic dysfunction caused by drugs
• Mitochondrial disease (especially POLG mutations)
• Urea cycle disorders
• Acute porphyria
• Children under 2 years (especially on polypharmacy — high hepatotoxicity risk)
• Active pancreatitis

Αλληλεπιδράσεις Φαρμάκων

Οδηγίες Αποθήκευσης

• Φυλάξτε σε θερμοκρασία δωματίου, 15–25°C. Protect from light and moisture.
• Keep tablets in the original blister pack until use.
• Do not store in the bathroom — humidity shortens shelf life.
• Keep out of reach of children — valproate is highly teratogenic and accidental ingestion by a pregnant household member is a serious risk.
• Do not use after the expiry date.
• Return unused tablets to a pharmacy for proper disposal.

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Συχνές Ερωτήσεις

What conditions is Valprol-CR used for?

Valprol-CR (sodium valproate + valproic acid) is licensed for: multiple seizure types in epilepsy (generalised tonic-clonic, absence, myoclonic, partial), acute mania in bipolar I disorder, και migraine prophylaxis in adults. It is one of the broadest-spectrum anti-epileptic drugs available. Off-label uses include neuropathic pain and behavioural agitation in some psychiatric conditions, but it is no longer recommended for behavioural agitation in dementia (mortality signal in observational data).

Why is Valprol-CR so dangerous in pregnancy?

Sodium valproate is one of the most teratogenic drugs in routine clinical use. In-utero exposure carries approximately 10% risk of major congenital malformations (neural tube defects, cardiac defects, craniofacial defects, hypospadias, limb defects) plus a 30–40% risk of significant neurodevelopmental impairment (lower IQ, autism spectrum disorder). For migraine prophylaxis the FDA classifies it as Pregnancy Category X (absolute contraindication); for epilepsy Category D (use only if benefit outweighs the substantial fetal risk and no other option is available). Women of childbearing potential need explicit counselling, reliable contraception, and 5 mg/day folate before any planned pregnancy.

Why must I never stop Valprol-CR abruptly?

In epilepsy, sudden discontinuation can precipitate status epilepticus — a medical emergency where seizures do not stop spontaneously, with significant mortality if untreated. This can happen even in patients who have been seizure-free for years. Always taper over 2–6 weeks under medical supervision when discontinuing. The same caution applies to bipolar maintenance therapy — abrupt discontinuation can precipitate a manic relapse.

What blood tests do I need on Valprol-CR?

Before starting: liver function tests (AST, ALT, GGT), full blood count including platelet count, baseline weight, fasting glucose. Κατά τη διάρκεια της θεραπείας: repeat LFTs and FBC at 1 month, 3 months, 6 months, then annually. If unwell: check ammonia level if any new drowsiness, confusion or vomiting (hyperammonaemic encephalopathy can occur with normal LFTs). For epilepsy, periodic serum valproate trough level (target 50–100 µg/mL).

Why can I not crush or split Valprol-CR tablets?

The CR (controlled-release) coating is what produces the sustained 12–24 hour drug release. Crushing or splitting destroys the coating and causes a “dose dump” — the entire dose is absorbed within 2–3 hours, producing very high peak levels with severe drowsiness, tremor, GI upset and sometimes hyperammonaemic encephalopathy. If a smaller dose is needed, use immediate-release valproate or step down to the 200 mg CR strength rather than splitting a 750 mg CR tablet.

Will Valprol-CR cause weight gain or hair loss?

Both are common. Αύξηση βάρους affects 10–20% of patients (usually 5–10 kg over the first 6–12 months) and is driven by increased appetite plus metabolic effects. Mitigate with consistent diet and exercise. Hair thinning or hair loss affects up to 10% of patients, usually starts in the first 3–6 months, and is reversible on dose reduction or discontinuation. Zinc and selenium supplementation is sometimes used (limited evidence).

Can Valprol-CR be used with lamotrigine?

Yes but with extreme caution. Valproate doubles lamotrigine levels by inhibiting its metabolism, sharply increasing the risk of severe rash and Stevens-Johnson syndrome — the most serious lamotrigine side effect. The combination is sometimes used (it has good cognitive and seizure-control properties) but lamotrigine must be started at half the usual dose with a much slower up-titration (12-week protocol). Specialist supervision is essential.

Why do certain antibiotics (carbapenems) interact so dangerously with Valprol-CR?

Carbapenem antibiotics (meropenem, ertapenem, imipenem) dramatically reduce valproate levels — sometimes by >90% within 1–3 days — through a poorly understood mechanism that may involve enterohepatic recirculation. The result is sudden loss of seizure control even in patients on stable therapeutic levels for years. Avoid this combination. If a patient on valproate needs a carbapenem (e.g. for hospital-acquired infection), switch the antibiotic to an alternative, OR switch the anti-epileptic before the carbapenem is started.

Is Valprol-CR appropriate for behavioural agitation in dementia?

No longer recommended. Off-label use of valproate for behavioural agitation in Alzheimer's and other dementias was common until observational studies suggested an increased mortality signal, similar to the signal that led to black-box warnings on antipsychotic use in dementia. Current guidelines favour non-pharmacological approaches first, then short-term low-dose risperidone or quetiapine if needed, with valproate reserved for very specific cases under specialist supervision.

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