Oxetol Syrup

OXETOL SYRUP by SUN PHARMA VV

Oxetol Syrup, manufactured by Sun Pharmaceutical Industries Ltd., is an anticonvulsant medication primarily used for the management of epilepsy and seizures. It works by stabilizing excitable neuronal membranes and decreasing abnormal nerve impulses in the brain that cause seizures.

Composition

Oxetol Syrup contains Oxcarbazepine 300mg/5ml as its active ingredient.

Uses

Oxetol Syrup is prescribed for:

• Treatment and prevention of epilepsy and seizures.
• Specifically indicated for partial seizures, with or without secondarily generalized tonic-clonic seizures.
• It can be used as monotherapy (alone) or as adjunctive therapy (in combination with other anti-epileptic medications).
• Also used in children aged 2 years and above for partial-onset seizures. While primarily for epilepsy, some sources mention potential off-label use for conditions like mania, migraine, and trigeminal neuralgia, under a doctor's discretion.

Dosage and Administration

• Shake the bottle well before each use.
• Take the prescribed dose orally using a measuring cup or dosing syringe.
• Oxetol Syrup can be taken with or without food, but it is best to take it at the same time each day to maintain consistent levels in the body.
• The dosage and frequency are determined by your doctor, and it may be increased gradually.
• Do not stop taking the medication suddenly, as this can trigger seizures and worsen your condition.

Side Effects

Common Side Effects:

• Nausea, vomiting, stomach pain, diarrhea, constipation
• Dizziness, drowsiness, tiredness, fatigue
• Headache
• Unsteadiness, abnormal gait, involuntary uncoordinated actions
• Visual disturbances (blurred or double vision)
• Nystagmus (involuntary eye movement)
• Low sodium levels in the blood (hyponatremia)

Serious Side Effects (Seek immediate medical attention if experienced):

• Severe skin rash or redness (e.g., Stevens-Johnson syndrome)
• Anxiety, nervousness, depression, sudden mood changes, or suicidal thoughts
• Increased falls, trembling, coordination problems
• Symptoms of underactive thyroid
• Anaphylactic reactions, angioedema (swelling under the skin), drug rash with systemic symptoms
• Significant decrease in platelets or other blood cells
• Difficulty concentrating or memory problems

Precautions

• Allergies: Do not take if you are allergic to Oxcarbazepine, eslicarbazepine, or any other components of the suspension.
• Alcohol: Avoid alcohol consumption as it can increase dizziness and drowsiness.
• Pregnancy and Breastfeeding: Oxetol Syrup may be unsafe during pregnancy and breastfeeding. It is crucial to consult your doctor if you are pregnant, planning to conceive, or nursing, as the medication may pass into breast milk. Folic acid supplementation may be advised during pregnancy.
• Medical Conditions: Inform your doctor about any existing heart problems, kidney or liver disease (especially severe liver disease), low sodium levels, irregular heartbeat, thyroid problems, depression, history of suicidal thoughts, or blood-related disorders.
• Driving and Operating Machinery: This medicine can cause dizziness, sleepiness, and visual disturbances. Avoid driving or operating machinery until you know how it affects you.
• Drug Interactions: Inform your doctor about all other medications you are taking, including anti-psychotics, sedatives, anti-depressants, antibiotics, painkillers, other anti-convulsants, antacids, anti-anxiety drugs, anti-histamines, and birth control pills, to avoid potential interactions.
• Children: Oxetol Suspension should only be administered to children under a doctor's prescription.
• Monitoring: Regular blood tests may be necessary to monitor the medication's effectiveness, sodium levels, and for dose adjustments.
• Weight: Monitor your weight during treatment as it can cause weight gain.

Storage

Store Oxetol Syrup in a cool and dry place, below 30°C, protected from moisture, sunlight, and heat. Keep the medicine out of reach and sight of children and pets. Use the suspension within 7 weeks after opening the bottle, and dispose of any unused portion properly after this period.

OXETOL SYRUP contains oxcarbazepine as its active ingredient, an anti-epileptic medication primarily used to control seizures.

What is Oxetol Syrup used for?

Oxetol Syrup is primarily used to treat and prevent epilepsy and seizures, specifically partial seizures (also known as focal epileptic seizures), with or without secondary generalized tonic-clonic seizures. It helps manage these conditions but does not cure epilepsy.

How does Oxetol Syrup work?

Oxetol Syrup works by decreasing abnormal electrical activity in the brain. Its active ingredient, oxcarbazepine, stabilizes excitable neuronal membranes and reduces the propagation of nerve impulses that cause seizures.

What is the usual dosage for Oxetol Syrup?

The dosage of Oxetol Syrup varies greatly depending on the patient's age, body weight, and whether it is used alone (monotherapy) or with other seizure medications (adjunctive therapy). Treatment typically begins with a low dose that is gradually increased by a doctor until the optimal therapeutic effect is achieved. For adults, initial doses often start around 300 mg twice daily, which can be increased up to 1200 mg per day or higher in certain cases. For children, the dose is based on body weight, starting typically at 8 to 10 mg per kilogram of body weight per day, divided into two doses. It is crucial to follow your doctor's specific instructions for dosing and not to change it without medical advice.

What are the possible side effects of Oxetol Syrup?

Common side effects of Oxetol Syrup can include dizziness, drowsiness, fatigue, headache, nausea, vomiting, trouble sleeping, double vision, changes in vision, loss of balance or coordination, and involuntary eye movements.

More serious side effects that require immediate medical attention include:

• Allergic reactions: Rash, itching, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing.
• Low sodium levels (hyponatremia): Symptoms may include muscle weakness, fatigue, dizziness, headache, confusion, or more seizures.
• Serious skin reactions: These can occur weeks to months after starting the medication and may include fever, flu-like symptoms, and a rash that may become red or purple, developing into blisters or peeling skin.
• Mood changes: Thoughts of suicide or self-harm, worsening mood, or feelings of depression.

Is Oxetol Syrup safe during pregnancy or breastfeeding?

Pregnancy: It is important to control epileptic seizures during pregnancy, but there may be potential risks to the baby with antiepileptic medicines like oxcarbazepine. Studies have not shown an increased risk of birth defects, but a risk cannot be completely ruled out. Some studies have shown conflicting results regarding the risk of neurodevelopmental disorders in children exposed to oxcarbazepine during pregnancy. Women who are pregnant or planning to become pregnant should discuss the benefits and risks with their doctor and consider taking folic acid supplements.

Breastfeeding: Oxcarbazepine and its active metabolite are excreted into human breast milk. While some sources suggest that levels in breast milk are low and adverse effects on breastfed infants are not expected, especially in infants older than 2 months, a risk to the infant cannot be entirely excluded. Therefore, Oxetol Syrup should generally not be used during breastfeeding according to some information, while other expert authors consider it cautiously safe. If breastfeeding, the infant should be monitored for adverse effects such as drowsiness and poor weight gain. It is essential to discuss breastfeeding while taking this medicine with your healthcare provider.

Can Oxetol Syrup be taken with other medications?

Oxetol Syrup can interact with various medications. It may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections), necessitating the use of alternative or additional birth control methods.

It can also interact with:

• Other seizure medications: Such as carbamazepine, phenytoin, phenobarbital, and valproic acid.
• CNS depressants: Including alcohol, opioids (e.g., oxycodone), benzodiazepines (e.g., alprazolam), some antidepressants (e.g., mirtazapine), antihistamines (e.g., diphenhydramine), and sleep medications (e.g., zolpidem), which can worsen side effects like dizziness and drowsiness.
• Diuretics: Medicines that reduce sodium levels in the blood, which can increase the risk of low sodium with oxcarbazepine.
• Other medications: Cyclosporine, rifampin, and St. John's wort.

Always inform your doctor or pharmacist about all prescription, over-the-counter medications, herbs, and dietary supplements you are taking.

What precautions should be taken while using Oxetol Syrup?

• Do not stop suddenly: Abruptly stopping Oxetol Syrup can lead to increased seizure frequency or status epilepticus. Your doctor will gradually decrease the dose if discontinuation is necessary.
• Blood tests: Your doctor may recommend regular blood tests to monitor sodium levels, as this medicine can cause hyponatremia (low blood sodium).
• Alcohol: Avoid or limit alcohol consumption, as it can increase drowsiness and dizziness.
• Driving and machinery: This medication can cause dizziness, drowsiness, blurred or double vision, and problems with coordination. Do not drive or operate machinery until you know how it affects you.
• Allergies: Inform your doctor if you have ever had an allergic reaction to oxcarbazepine, carbamazepine, or eslicarbazepine.
• Medical conditions: Tell your doctor if you have kidney disease, severe liver disease, heart disease, or a history of depression or suicidal thoughts.

What happens if a dose of Oxetol Syrup is missed?

If you miss a dose of Oxetol Syrup, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should Oxetol Syrup be stored?

Store Oxetol Syrup in its original closed container at room temperature, typically between 15 and 30 degrees C (59 and 86 degrees F). Keep it away from heat, moisture, and direct light, and do not freeze it. For the oral liquid, use it within 7 weeks after first opening the bottle, and discard any unused liquid after this period. Always keep the medicine out of the reach of children and pets.