Indications

Neurolin CR film-coated tablet is indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy
• Postherpetic neuralgia
• Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older
• Fibromyalgia
• Neuropathic pain associated with spinal cord injury

Neurolin CR controlled release tablet is indicated for:

• Neuropathic pain associated with diabetic peripheral neuropathy
• Postherpetic neuralgia

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Pharmacology

Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). It does not bind directly to GABAA, GABAB or benzodiazepine receptors. Pregabalin binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of Pregabalin has not been fully elucidated, results in animal studies suggest that binding to the alpha2-delta subunit may be involved in Pregabalin's anti-nociceptive and antiseizure effects.

Dosage

Neuropathic pain associated with diabetic peripheral neuropathy in adults (DPN): The maximum recommended dose of Pregabalin is 100 mg three times a day (300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. The maximum recommended dose of Pregabalin CR capsule is 330 mg once daily.

Postherpetic neuralgia in adults (PHN): The recommended dose of Pregabalin is 75 to 150 mg two times a day or 50 to 100 mg three times a day (150 to 300 mg/day) in patients with creatinine clearance of at least 60 ml/min. Dosing should begin at 75 mg two times a day or 50 mg three times a day (150 mg/day). The dose may be increased to 300 mg/day within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 300 mg/day and who are able to tolerate Pregabalin, may be treated with up to 300 mg two times a day or 200 mg three times a day (600 mg/day).

Begin dosing of Pregabalin CR capsule at 165 mg once daily and increase to 330 mg once daily within 1 week based on individual patient response and tolerability. Patients who do not experience sufficient pain relief following 2 to 4 weeks of treatment with 330 mg once daily and who are able to tolerate Pregabalin CR capsule, may be treated with up to 660 mg once daily. In view of the dose-dependent adverse reactions and the higher rate of treatment discontinuation due to adverse reactions, dosing above 330 mg/day should be reserved only for those patients who have on-going pain and are tolerating 330 mg daily. The maximum recommended dose of Pregabalin CR capsule is 660 mg once daily.

Management of fibromyalgia in adults: The recommended dose of Pregabalin is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day).

Neuropathic pain associated with spinal cord injury in adults: The recommended dose range of Pregabalin is 150 to 600 mg/day. The recommended starting dose is 75 mg two times a day (150 mg/day). The dose may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient pain relief after 2 to 3 weeks of treatment with 150 mg two times a day and who tolerate Pregabalin may be treated with up to 300 mg two times a day.

Conversion from Pregabalin capsules to Pregabalin CR capsule tablet: When switching from Pregabalin capsules to Pregabalin CR capsule tablet on the day of the switch, instruct patients to take their morning dose of Pregabalin capsule as prescribed and initiate Pregabalin CR capsule therapy after an evening meal.

Pregabalin tablet total daily dose (dosed 2 or 3 times daily): Pregabalin CR capsule capsule dose (dosed once a day)

• 75 mg/daily: 82.5 mg/day
• 150 mg/daily: 165 mg/day
• 225 mg/daily: 247.5 mg/day
• 300 mg/daily: 330 mg/day
• 450 mg/daily: 495 mg/day
• 600 mg/daily: 660 mg/day

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Administration

Route of administration: Pregabalin is taken in oral route. It can be taken with or without food. Pregabalin CR tablet should be administered after an evening meal. It should be swallowed whole and should not be split, crushed or chewed. If patients miss taking their dose of Pregabalin CR after an evening meal, then they should take their usual dose of Pregabalin CR prior to bedtime following a snack. If they miss taking the dose of Pregabalin CR prior to bedtime, then they should take their usual dose of Pregabalin CR following a morning meal. If they miss taking the dose of Pregabalin CR following the morning meal, then they should take their usual dose of Pregabalin CR at the usual time that evening following an evening meal. When discontinuing both Pregabalin and Pregabalin CR, it should be gradually tapered over a minimum of 1 week.

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Interaction

Drug interaction with medication: Neurolin CR is unlikely to be involved in significant pharmacokinetic drug interactions.
Drug interaction with food and others: Not applicable.

Contraindications

Pregabalin is contraindicated in patients with known hypersensitivity to Pregabalin or any of its components.

Side Effects

Most common side effects in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain and thinking abnormal (primarily difficulty with concentration/attention). Most common side effects in pediatric patients for the treatment of partial onset seizures are increased weight and increased appetite.

Pregnancy & Lactation

There are no adequate and well-controlled studies with pregabalin in pregnant women. Pregnant women should be advised of the potential risk to a fetus. Small amounts of pregabalin have been detected in the milk of lactating women. Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with pregabalin.

Precautions & Warnings

Angioedema (e.g., swelling of the throat, head and neck) can occur and may be associated with life threatening respiratory compromise requiring emergency treatment. Neurolin CR should be discontinued immediately in these cases. Neurolin CR should also be discontinued immediately if hypersensitivity reactions (e.g., hives, dyspnea and wheezing) occur. Antiepileptic drugs, including Neurolin CR, increase the risk of suicidal thoughts or behavior. Respiratory depression may occur with Neurolin CR when used with concomitant CNS depressants or in the setting of underlying respiratory impairment. Patients need to be monitored and dosage adjusted as appropriate. Neurolin CR may cause dizziness and somnolence and impair patients ability to drive or operate machinery. Increased seizure frequency or other adverse reactions may occur if Neurolin CR is rapidly discontinued. Neurolin CR should be withdrawn gradually over a minimum of 1 week. Neurolin CR may cause peripheral edema. Caution should be exercised when coadministering Neurolin CR and thiazolidinedione antidiabetic agents.

Use in Special Populations

Use in children and adolescents: Safety and effectiveness in pediatric patients have not been established for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, neuropathic pain associated with spinal cord injury and fibromyalgia. In case of adjunctive therapy for partial onset seizures, safety and effectiveness in pediatric patients below the age of 1 month have not been established. The safety and effectiveness of Neurolin CR extended-release tablet in pediatric patients have not been established.

Overdose Effects

In case of overdose with Neurolin CR, sign and symptoms are reduced consciousness, depression/anxiety, confusional state, agitation and restlessness. Seizures and heart block have also been reported. There is no specific antidote. If indicated, elimination of unabsorbed drug may be attempted by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.

Therapeutic Class

Adjunct anti-epileptic drugs, Primary anti-epileptic drugs

Storage Conditions

Keep in a cool & dry place (below 30°C), protected from light & moisture. Keep out of the reach of children.

Chemical Structure

Common Questions about Neurolin CR 165 mg Tablet

What is Neurolin CR 165 mg CR Tablet?

Neurolin CR 165 mg CR Tablet is an anticonvulsant and is considered to be the first-line of treatment for neurotic pain, shingles, seizures and fibromyalgia.

How long do I need to use Neurolin CR 165 mg CR Tablet before I see improvement in my condition?

Neurolin CR 165 mg CR Tablet is to be taken till the time you see an improvement in your health conditions.

At what frequency do I need to use Neurolin CR 165 mg CR Tablet?

Neurolin CR 165 mg CR Tablet should be taken in the dosage as prescribed by the doctor.

Should I use Neurolin CR 165 mg CR Tablet empty stomach, before food or after food?

Neurolin CR 165 mg CR Tablet should be taken after food in a prescribed dosage.

What are the instructions for the storage and disposal of Neurolin CR 165 mg CR Tablet?

Neurolin CR 165 mg CR Tablet should be kept in a cool dry place and in its original packaging. Make sure this medication remains unreachable to children and pets.

Does Neurolin CR 165 mg CR Tablet work in the same way for each disease?

No, Neurolin CR 165 mg CR Tablet works in different ways for different diseases.

How long do I need to take Neurolin CR 165 mg CR Tablet?

The duration of Neurolin CR 165 mg CR Tablet depends on the condition for which you are consuming this medicine. It is advised to consult the doctor before consuming Neurolin CR 165 mg CR Tablet.

Is it necessary to continue taking Neurolin CR 165 mg CR Tablet even if I feel fine?

Yes, you should not stop taking Neurolin CR 165 mg CR Tablet even if you feel fine. Consult your doctor before stopping Neurolin CR 165 mg CR Tablet.

Can I take Diazepam and Neurolin CR 165 mg CR Tablet together?

Yes, Neurolin CR 165 mg CR Tablet and Diazepam can be used together.

Can the use of Neurolin CR 165 mg CR Tablet cause weight gain?

Yes, Neurolin CR 165 mg CR Tablet may cause weight gain because it increases your hunger. Consult a dietician if you have any further concerns to keep your weight stable.

Quick Tips

• Neurolin CR 165 mg CR Tablet should be taken as per the dose and duration prescribed by your doctor.
• Neurolin CR 165 mg CR Tablet may cause sleepiness. Do not drive or do anything requiring concentration until you know how it affects you.
• Neurolin CR 165 mg CR Tablet may cause blurring or loss of vision. Inform your doctor immediately if you notice any vision changes.
• Inform your doctor if you develop any unusual changes in mood or behavior, new or worsening depression, or suicidal thoughts or behavior.
• Do not stop taking Neurolin CR 165 mg CR Tablet suddenly without talking to your doctor as it may worsen your underlying condition.

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