Pregaben 25

Indications for Use

Pregaben is prescribed for the following conditions:

• Neuropathic pain related to diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia (PHN)
• As an adjunctive treatment for partial-onset seizures in individuals aged 1 month and older
• Fibromyalgia
• Neuropathic pain associated with spinal cord injuries

Pregaben CR Tablets are specifically indicated for:

• Neuropathic pain due to diabetic peripheral neuropathy (DPN)
• Postherpetic neuralgia (PHN)

Pharmacology Overview

Pregabalin, a derivative of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), does not bind directly to GABAA, GABAB, or benzodiazepine receptors. Instead, it has a strong affinity for the alpha2-delta site, an auxiliary component of voltage-gated calcium channels found in central nervous system tissues. Although the precise mechanism of action remains to be fully clarified, studies suggest that its binding to the alpha2-delta subunit may play a role in the drug’s pain-relieving and anti-seizure properties.

Dosage Recommendations

For Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (DPN):

• Adults: The maximum recommended dose is 300 mg per day, divided into three doses of 100 mg each. Start with 150 mg daily (50 mg three times a day), and adjust based on tolerance and efficacy.
• Pregaben CR capsules: Initiate treatment at 165 mg once daily, increasing to 330 mg once daily within a week, depending on patient response. The upper limit for Pregaben CR is 330 mg daily.

For Postherpetic Neuralgia (PHN):

• Adults: Start with 150 mg daily (75 mg twice a day or 50 mg three times a day), potentially increasing to 300 mg per day within one week based on efficacy and tolerance.
• For Pregaben CR, begin with 165 mg once daily and increase to 330 mg within a week. If pain relief is insufficient after 2 to 4 weeks on 330 mg, consider increasing to 660 mg once daily, reserving this for patients who tolerate the current dose.

For Fibromyalgia:

• The recommended dosage ranges from 300 to 450 mg daily, starting at 150 mg daily (75 mg twice a day) and increasing based on patient response.

For Neuropathic Pain from Spinal Cord Injury:

• Adults may start at 150 mg daily, with the potential to increase to 600 mg based on response and tolerance.

Switching from Pregabalin Capsules to Pregabalin CR:

• On the day of the switch, take the usual morning dose of Pregabalin capsules and start Pregabalin CR after the evening meal.

Administration Guidelines

Pregabalin is administered orally and can be taken with or without food. Pregaben CR should be taken after the evening meal and swallowed whole without splitting, crushing, or chewing. If a dose is missed, follow specific guidelines for rescheduling based on the timing of meals. Discontinuation should occur gradually over at least one week.

Drug Interactions

Pregaben is not expected to cause significant pharmacokinetic interactions with other medications. No relevant food interactions have been noted.

Contraindications

Pregabalin is contraindicated in individuals with known hypersensitivity to the drug or its components.

Common Side Effects

The most frequently reported side effects include dizziness, drowsiness, dry mouth, swelling, blurred vision, weight gain, and cognitive difficulties. In pediatric patients, increased weight and appetite are commonly observed when treating partial-onset seizures.

Pregnancy and Lactation

Pregabalin has not been adequately studied in pregnant women; thus, potential risks to the fetus should be discussed. Trace amounts may appear in breast milk, and breastfeeding is not recommended during treatment due to possible risks.

Precautions and Warnings

Pregabalin may cause serious allergic reactions such as angioedema. If any severe reactions occur, treatment should be stopped immediately. The drug can increase the risk of suicidal thoughts or behaviors. Caution is advised when using Pregabalin alongside CNS depressants, as respiratory depression may occur. Gradual discontinuation is essential to avoid increased seizure frequency or adverse effects.

Use in Special Populations

The safety and effectiveness of Pregaben in pediatric populations for certain conditions have not been established, particularly for those under one month of age.

Overdose Effects

In the event of an overdose, symptoms may include reduced consciousness, anxiety, confusion, agitation, seizures, and heart block. Supportive care and monitoring of vital signs are recommended, as there is no specific antidote.

Therapeutic Class

Pregabalin falls under adjunct anti-epileptic drugs and primary anti-epileptic drugs.

Storage Conditions

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