Medication info

Pregabalin 150 mg Capsule

Prescription medicationHard capsule경구Approval withdrawn
Ingredient · strength
Pregabalin›150mg / 1 capsule
Manufacturer / importer
(주)유앤생명과학
Appearance
A white hard capsule filled with white powder
Packaging
30 capsules/bottle, 60 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 202003821 · Approved 2020.05.26

This product's status changed to Approval withdrawn on 2025.02.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of peripheral and central neuropathic pain, adjunctive treatment for partial seizures in epilepsy, improvement of fibromyalgia
Who takes it
Adults · Children
Adult dose
This drug is administered orally in divided doses twice a day without regard to meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day, may be increased to 300 mg per day within 3 to 7 days, and may be raised to a maximum of 600 mg with 7-day intervals if necessary. - Central neuropathic pain: Starting dose of 150 mg per day, may be increased to 300 mg per day after one week.
Child dose
The safety and efficacy data are insufficient for children under 12 years of age and adolescents aged 12-17, so administration is not recommended.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

Treatment of peripheral and central neuropathic pain, adjunctive treatment for partial seizures in epilepsy, improvement of fibromyalgia

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

This medicine is used in adults for the treatment of peripheral and central neuropathic pain. It is also utilized as an adjunctive treatment for patients with epilepsy who experience partial seizures, especially those accompanied by secondary generalized symptoms or not. Additionally, it is effective in alleviating symptoms of fibromyalgia. Therefore, this medication is used to manage neuropathic pain and epileptic seizures and to improve symptoms of fibromyalgia.

How to take

Adult dose

This drug is administered orally in divided doses twice a day without regard to meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day, may be increased to 300 mg per day within 3 to 7 days, and may be raised to a maximum of 600 mg with 7-day intervals if necessary. - Central neuropathic pain: Starting dose of 150 mg per day, may be increased to 300 mg per day after one week.

Child dose

The safety and efficacy data are insufficient for children under 12 years of age and adolescents aged 12-17, so administration is not recommended.

Precautions

This drug may increase the risk of suicidal thoughts or actions, and if there are any changes in mood or behavior during treatment, medical personnel should be informed immediately. This drug should not be used in patients with hypersensitivity to the ingredients or certain hereditary lactose intolerance. Diabetic patients should be cautious of weight gain and changes in blood sugar, and may need dose adjustments of antidiabetic medications. If symptoms of angioedema occur, the medication should be discontinued immediately. Elderly patients should be particularly cautious at the beginning of treatment due to the risk of injury from dizziness or drowsiness. Temporary visual obscurity or changes in vision may occur; consult medical personnel if any abnormal symptoms arise. Withdrawal symptoms such as insomnia, headaches, and anxiety may occur upon discontinuation, so medication adjustments should be discussed with healthcare providers. Patients with a history of drug abuse should be cautious due to the possibility of misuse of this drug. Patients with impaired renal function may require dose adjustments, and heart failure patients should use it cautiously. Co-administration with opioid analgesics may enhance central nervous system depression, so caution is advised. During early pregnancy, there is a risk of fetal malformation, so it should not be administered to pregnant women except in special cases, and women of childbearing potential should use effective contraception. Breastfeeding women should consider discontinuation of breastfeeding or the medication due to the possibility of the drug passing into breast milk. It is advisable to avoid hazardous activities like driving or operating machinery until dizziness or drowsiness resolves after taking this medication. Severe skin reactions may occur, so if there are any symptoms of skin abnormalities, the medication should be stopped immediately and medical personnel consulted. Overdose may result in drowsiness, confusion, depression, and may require treatment such as hemodialysis. This drug should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme drowsiness, sudden severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disorientation
  • irritability
  • depression
  • elation
  • decreased libido
  • insomnia
  • depersonalization
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  • hyperesthesia
  • restlessness
  • anxiety
  • mood swings
  • emotional blunting
  • emotional elevation
  • difficulty finding the right words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • movement coordination problems
  • balance disorders
  • amnesia
  • attention deficits
  • memory impairment
  • trembling
  • speech disturbances
  • sensory abnormalities
  • hypoesthesia

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly closed container. It is important to maintain a storage temperature between 15 and 30 degrees Celsius. Proper storage helps maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

A white hard capsule filled with white powder

Package unit

30 capsules/bottle, 60 capsules/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.