Medication info

Pregabalin Capsule 25 mg (Pregabalin)

Prescription medicationApproval withdrawn
Ingredient · strength
Pregabalin›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
A hard capsule with a pale yellow upper part and white lower part containing a white powder that is white or light yellow.
Packaging
30 capsules per bottle
Approval status
Approval withdrawn

MFDS item code 201901230 · Approved 2019.02.26

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of peripheral and central neuropathic pain and fibromyalgia, adjunctive therapy for partial seizures in epilepsy.
Who uses it
Adults · Children
Adult dosage
This medication is administered orally without regard to meals, divided into two doses daily. 1. Neuropathic pain - Peripheral neuropathic pain: The starting dose is 150 mg per day, which may be increased to 300 mg per day after 3 to 7 days. Further increases up to a maximum of 600 mg per day may be made at 7-day intervals. - Central neuropathic pain: Starting dose is 150 mg per day.
Children's dosage
Due to insufficient safety and efficacy data, use in children under 12 years old and adolescents aged 12 to 17 is not recommended.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Improvement of peripheral and central neuropathic pain and fibromyalgia, adjunctive therapy for partial seizures in epilepsy.

  • Peripheral neuropathic pain
  • central neuropathic pain
  • epilepsy
  • partial seizures
  • fibromyalgia.
View approved original text

This medication is used to treat peripheral and central neuropathic pain in adults. It is also utilized as an adjunct for partial seizures, with or without secondary generalization, in epilepsy patients. Additionally, it is effective in treating fibromyalgia. It aids in alleviating major neurological pain, seizures, and musculoskeletal symptoms, thereby improving the quality of life for patients.

Dosage and Administration

Adult dosage

This medication is administered orally without regard to meals, divided into two doses daily. 1. Neuropathic pain - Peripheral neuropathic pain: The starting dose is 150 mg per day, which may be increased to 300 mg per day after 3 to 7 days. Further increases up to a maximum of 600 mg per day may be made at 7-day intervals. - Central neuropathic pain: Starting dose is 150 mg per day.

Children's dosage

Due to insufficient safety and efficacy data, use in children under 12 years old and adolescents aged 12 to 17 is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behavior, thus mood or behavior changes should be closely monitored during use. Patients with hypersensitivity to this medication or with genetically determined lactose intolerance should not take it. Diabetic patients should be aware that weight gain may affect blood sugar control. Immediate discontinuation of the medication is necessary if serious allergic reactions such as angioedema occur. Elderly patients should be cautious due to risks of dizziness or drowsiness, which may lead to injuries, and may experience vision changes such as blurred vision. Discontinuing this medication suddenly can result in withdrawal symptoms such as insomnia, headaches, or anxiety, and should be tapered off gradually under medical guidance. Due to the potential for drug abuse or dependence, patients must inform healthcare providers of their mental health status and history of drug use. Patients with impaired renal function may require dosage adjustments. Patients with heart disease should take this medication with caution. Due to its central nervous system depressant effects, there may be increased risk of respiratory depression when used with opioids or other depressants. During early pregnancy, there is a risk of fetal malformations; therefore, women who are pregnant or planning to become pregnant must consult their healthcare provider and use effective contraception. Breastfeeding women should discuss with their doctor whether to discontinue breastfeeding or the medication since it may be passed into breast milk. Risky activities such as driving or operating machinery should be avoided until the dizziness or drowsiness from the medication has resolved. In the event of severe skin reactions, the medication should be immediately discontinued, and healthcare providers should be notified. In case of overdose, immediate hospital care is required, and blood dialysis may be performed if needed. This medication should be stored out of reach of children, and should not be transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema, facial swelling, swelling around the mouth and upper airway), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy.

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • spatial disorientation
  • increased sensitivity
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • sexual dysfunction
  • restlessness
  • anxiety
  • mood swings
  • emotional lability
  • difficulties in finding the right words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulse control issues
  • apathy
  • ataxia
  • coordination disorders
  • balance issues
  • amnesia
  • attention deficits
  • memory impairment
  • tremors
  • speech disturbances
  • sensory disturbances
  • sensory loss.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a sealed container to prevent air and moisture ingress, preferably in a cool place between 15 and 30 degrees Celsius. Storing it this way will help maintain its effectiveness over time.

Appearance and packaging

Appearance

A hard capsule with a pale yellow upper part and white lower part containing a white powder that is white or light yellow.

Package unit

30 capsules per bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.