Medication info
Pregabalin Orally Disintegrating Tablets 50 mg (Pregabalin)

Pregabalin Orally Disintegrating Tablets 50 mg (Pregabalin)

Prescription medicationOrally disintegrating Tablet
Ingredient · strength
Pregabalin›50mg / 1 tablet
Manufacturer / importer
(주)휴온스
Appearance
Yellow round orally disintegrating tablet
Packaging
30 tablets/PTP [10 tablets/PTP x 3], 100 tablets/PTP [10 tablets/PTP x 10]
Approval status
Active

MFDS item code 202600537 · Approved 2026.02.24

Summary

Main use
Treatment of peripheral and central neuropathic pain, adjunctive effect in partial seizure of epilepsy, improvement of fibromyalgia
Who uses it
Adults · Children
Adult dosage
This medication is taken orally in divided doses twice a day, without regard to meals, and is placed on the tongue to disintegrate and swallow without water. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Starting dose of 150 mg per day, possible increase to 300 mg per day after 3 to 7 days, and if necessary, further increase to a maximum of 600 mg every 7 days. - Central Neuropathic Pain
Children's dosage
There is insufficient safety and efficacy data for pediatric patients under 12 years of age and adolescents aged 12-17, therefore, administration is not recommended.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Treatment of peripheral and central neuropathic pain, adjunctive effect in partial seizure of epilepsy, improvement of fibromyalgia

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

This medication is used to alleviate peripheral and central neuropathic pain in adults. Additionally, it serves as an adjunctive treatment for partial seizures in patients with epilepsy, applicable in both cases with or without systemic symptoms. Furthermore, it is effective in relieving pain caused by fibromyalgia. It is used for improving various neuropathic pain and symptoms.

Dosage and Administration

Adult dosage

This medication is taken orally in divided doses twice a day, without regard to meals, and is placed on the tongue to disintegrate and swallow without water. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Starting dose of 150 mg per day, possible increase to 300 mg per day after 3 to 7 days, and if necessary, further increase to a maximum of 600 mg every 7 days. - Central Neuropathic Pain

Children's dosage

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

Precautions

This medication may increase the risk of suicidal thoughts or behavior, so careful monitoring for mood changes or abnormal behavior is necessary during treatment. Patients with hypersensitivity to this medication should not take it. Diabetic patients may experience weight gain from this medication, necessitating dosage adjustment of blood glucose control medications. In the event of severe allergic reactions such as angioedema, discontinue use immediately and consult a healthcare professional. Elderly patients are cautioned against the risk of falls or injuries due to dizziness or drowsiness that may occur with this medication. Visual disturbances or changes in eyesight may occur, and symptoms may improve upon discontinuation of the medication. Discontinuation of this medication may lead to withdrawal symptoms such as insomnia, headaches, and anxiety, so it should be gradually reduced according to a doctor's instructions. Patients with a history of substance abuse should take this medication cautiously due to the potential for misuse or abuse. Patients with reduced kidney function may require dosage adjustments, and the improvement of kidney function should be monitored in consultation with healthcare professionals. Patients with heart disease should be cautious as this medication may increase the risk of congestive heart failure. Co-administration with opioid analgesics may enhance the central nervous system depressant effects, leading to respiratory depression risk. Patients with weakened respiratory function or the elderly may face a higher risk of severe respiratory depression, requiring possible dosage adjustments. In the early stages of pregnancy, there is a risk of fetal malformations, so pregnant women should not take this medication, and women of childbearing age should use effective contraception. This medication can cause dizziness and drowsiness; therefore, driving or operating hazardous machinery should be avoided until symptoms are confirmed. Severe skin reactions may rarely occur; if a rash or blistering appears, discontinue use immediately and consult a physician. This medication has low pharmacokinetic interactions with other drugs, but when combined with central nervous system depressants, side effects may increase, so caution is advised. During breastfeeding, as this medication can pass into breast milk and affect infants, it may be prudent to either discontinue nursing or stop taking the medication. Elderly patients may experience delayed excretion of this medication due to reduced kidney function, necessitating dosage adjustments. In cases of overdose, symptoms such as drowsiness, confusion, depression, and seizures may occur, requiring immediate treatment in a medical facility. This medication should be stored out of reach of children, and transferring it to another container could lead to accidents.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • facial swelling
  • cold sweat
  • shock
  • anaphylaxis-like symptoms
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • severe dermatological reaction
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  • difficulty breathing
  • respiratory depression
  • severe respiratory depression
  • pulmonary edema
  • jaundice
  • liver dysfunction
  • sudden and severe headache
  • serious neurological symptoms
  • loss of consciousness
  • mental disorders
  • paralysis (facial paralysis)
  • severe edema or

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • impaired sense of direction
  • irritability
  • depression
  • euphoric feelings
  • decreased libido
  • insomnia
  • depersonalization
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  • sexual dysesthesia
  • restlessness
  • anxiety
  • mood fluctuations
  • emotional downturn
  • emotional elevation
  • difficulty finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • numbness
  • ataxia
  • coordination issues
  • balance disorders
  • amnesia
  • attention deficits
  • memory impairment
  • tremors
  • speech disturbances
  • sensory disturbances
  • decreased sensation

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. It is best to maintain the storage temperature between 1°C and 30°C to preserve the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Yellow round orally disintegrating tablet

Package unit

30 tablets/PTP [10 tablets/PTP x 3], 100 tablets/PTP [10 tablets/PTP x 10]

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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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.