Medication info

Pregabalin Capsule 75 mg (Pregabalin)

Prescription medicationHard capsule경구Approval withdrawn
Ingredient · strength
Pregabalin›75mg / 1 capsule
Manufacturer / importer
(주)유앤생명과학
Appearance
A hard capsule with a brownish upper part and white lower part containing a white powder
Packaging
30 capsules/bottle, 60 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 202003820 · 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This product's status changed to Approval withdrawn on 2025.02.27.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, improvement of fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication should be taken orally as pregabalin, divided into two doses per day regardless of food. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day; can be increased to 300 mg per day within 3 to 7 days, and if necessary, can be increased to a maximum of 600 mg per day at intervals of 7 days. - Central neuropathic pain: Starting dose of 150 mg per day.
Child dose
Safety and efficacy data for pediatric patients under 12 years of age and adolescent patients aged 12-17 is insufficient, and therefore, administration is not recommended.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

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

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

This medication is used to treat pain caused by peripheral and central neuropathies in adults. It also helps to manage partial seizures in adult patients with epilepsy as an adjunct therapy. Finally, it is effective in alleviating pain associated with fibromyalgia. These efficacies are utilized to improve nerve-related pain and seizures.

How to take

Adult dose

This medication should be taken orally as pregabalin, divided into two doses per day regardless of food. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day; can be increased to 300 mg per day within 3 to 7 days, and if necessary, can be increased to a maximum of 600 mg per day at intervals of 7 days. - Central neuropathic pain: Starting dose of 150 mg per day.

Child dose

Safety and efficacy data for pediatric patients under 12 years of age and adolescent patients aged 12-17 is insufficient, and therefore, administration is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so mood changes or unusual behaviors should be carefully monitored during treatment. Do not take this medication if you have an allergy to any of its components or specific genetic disorders such as lactose intolerance. Diabetic patients may need to adjust the dosage of blood sugar control medication due to weight gain, and treatment should be discontinued immediately if symptoms of angioedema appear. Elderly patients should be especially cautious at the beginning of treatment due to the risk of dizziness or drowsiness, which could lead to falls or injuries. Consult with a healthcare professional if symptoms such as blurred vision or changes in vision occur. When discontinuing the medication, withdrawal symptoms such as insomnia, headache, nausea, and anxiety may occur, so abrupt cessation should be avoided. Patients with a history of substance abuse require special caution when taking this medication due to the risks of drug abuse. Patients with decreased kidney function may require dose adjustments, and those with heart disease should consult their healthcare provider before taking this medication. Concurrent use of this drug with opioid analgesics may increase the risk of central nervous system depression, so caution is advised. During early pregnancy, there may be risks to the fetus, so pregnant women should avoid taking it, and women of childbearing age should use effective contraception. Women who are breastfeeding should consult their healthcare provider about whether to discontinue breastfeeding or the medication, as this drug may be transmitted through breast milk. Dizziness and drowsiness may occur while taking this medication, so caution is needed when driving or operating dangerous machinery. In case of overdose, symptoms such as confusion, drowsiness, depression may appear, and treatment such as blood dialysis may be necessary. Store out of reach of children, and do not transfer to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, angioedema, anaphylaxis-like symptoms, Stevens-Johnson syndrome, mucocutaneous epidermal necrolysis, toxic epidermal necrolysis, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, pulmonary edema, severe respiratory depression, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough + fever, jaundice of skin or eyes

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
Show 23 more
  • sexual dysesthesia
  • restlessness
  • anxiety
  • mood fluctuations
  • emotional flatness
  • emotional elevation
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • lack of impulse control
  • apathy
  • ataxia
  • motor coordination abnormalities
  • balance disorders
  • amnesia
  • attention deficits
  • memory impairment
  • tremors
  • speech disorders
  • sensory disturbances
  • sensory deficits

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 15 and 30 degrees Celsius to preserve the medication's effectiveness.

Appearance and packaging

Appearance

A hard capsule with a brownish upper part and white lower part containing a 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.