Medication info
Lyrica 25 mg (Pregabalin)

Lyrica 25 mg (Pregabalin)

Prescription medicationTablet경구
Ingredient · strength
Pregabalin›25mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
Light pink oval tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202108022 · Approved 2021.12.20 · Insurance code 660703730

Summary

Main use
Improvement of peripheral and central neuropathic pain and epilepsy (partial seizures), fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication should be taken orally, divided into two doses per day, without regard to meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day, can be increased to 300 mg within 3 to 7 days, and if necessary, can be titrated up to a maximum of 600 mg at intervals of 7 days. - Central neuropathic pain: Starting dose of 150 mg per day, may be increased to 300 mg after one week, further titration to 600 mg after another week if no tolerability is shown at the target daily dose. 2. Epilepsy - Starting dose of 150 mg per day for adults, can be increased to 300 mg after one week based on individual response and tolerability. If needed, may be further titrated to a maximum of 600 mg at intervals of 7 days. 3. Fibromyalgia - The recommended dose for fibromyalgia is 300 mg-450 mg per day. The starting dose is 75 mg twice daily (150 mg per day), and may be increased to 300 mg per day (150 mg twice daily) within a week based on efficacy and tolerability. If patients do not experience sufficient benefits at 300 mg per day, the dose may be increased to 450 mg per day (225 mg twice daily) within a week. Although clinical trials have been conducted at a daily dose of 600 mg, there is no evidence of additional benefits or sufficient tolerability at this dosage. Considering dose-dependent adverse reactions, administration of doses exceeding 450 mg per day is not recommended. 4. Discontinuation of Treatment - Current clinical experience suggests that if discontinuing this medication, it should be done gradually over a period of at least one week. 5. Patients with Renal Impairment - This medication is primarily excreted unchanged by the kidneys after systemic circulation. The clearance rate of this medication is directly affected by creatinine clearance, so dose reductions in patients with impaired renal function should be individualized based on creatinine clearance. Creatinine clearance can be determined using the following formula: Creatinine clearance (mL/min)* = [140 - age (years)] x weight (kg) 72 x serum creatinine level (mg/dL) * For women, multiply the result by 0.85. This medication is effectively removed from the plasma by hemodialysis (about 50% within 4 hours). In patients undergoing hemodialysis, the daily dosage of pregabalin should be adjusted based on renal function. In addition to the daily dosage corresponding to renal function, supplemental doses should be administered immediately after every 4 hours of hemodialysis. [Table 1] Dosing of Pregabalin based on Renal Function Creatinine clearance (CLcr), (mL/min) Total daily dose of Pregabalin (mg/day) Dosing Method Starting Dose (mg/day) Maximum Dose (mg/day) ≥60 150 600 BID or TID ≥30-<60 75 300 BID or TID ≥15-<30 25-50 150 QD or BID <15 25 75 QD Additional dose after Hemodialysis 25 100 Single Dose TID = total daily dose divided into three doses BID = total daily dose divided into two doses QD = administered once daily a: Total daily dose (mg/day) should be administered as specified in the dosing method. b: Additional doses refer to single doses administered as needed. 6. Patients with Liver Impairment - No dose adjustment is necessary in patients with liver impairment. 7. Pediatric and Adolescent Patients - Due to insufficient safety and efficacy data in children under the age of 12 and adolescents aged 12-17, administration is not recommended. 8. Elderly Patients (aged 65 years and older) - Dose reduction may be necessary in elderly patients with impaired renal function.
Child dose
There is insufficient safety and efficacy data for children under 12 years and adolescents aged 12-17, therefore administration is not recommended.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Improvement of peripheral and central neuropathic pain and epilepsy (partial seizures), fibromyalgia

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

This medication is used to treat peripheral and central neuropathic pain in adults. It is also used as an adjunctive treatment for partial seizures, with or without secondary generalized symptoms, in patients with epilepsy. Additionally, it is applied to alleviate the symptoms of fibromyalgia. In summary, this medication controls various nerve-related pain and epilepsy seizures and is effectively used in the treatment of fibromyalgia.

How to take

Adult dose

This medication should be taken orally, divided into two doses per day, without regard to meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day, can be increased to 300 mg within 3 to 7 days, and if necessary, can be titrated up to a maximum of 600 mg at intervals of 7 days. - Central neuropathic pain: Starting dose of 150 mg per day, may be increased to 300 mg after one week, further titration to 600 mg after another week if no tolerability is shown at the target daily dose. 2. Epilepsy - Starting dose of 150 mg per day for adults, can be increased to 300 mg after one week based on individual response and tolerability. If needed, may be further titrated to a maximum of 600 mg at intervals of 7 days. 3. Fibromyalgia - The recommended dose for fibromyalgia is 300 mg-450 mg per day. The starting dose is 75 mg twice daily (150 mg per day), and may be increased to 300 mg per day (150 mg twice daily) within a week based on efficacy and tolerability. If patients do not experience sufficient benefits at 300 mg per day, the dose may be increased to 450 mg per day (225 mg twice daily) within a week. Although clinical trials have been conducted at a daily dose of 600 mg, there is no evidence of additional benefits or sufficient tolerability at this dosage. Considering dose-dependent adverse reactions, administration of doses exceeding 450 mg per day is not recommended. 4. Discontinuation of Treatment - Current clinical experience suggests that if discontinuing this medication, it should be done gradually over a period of at least one week. 5. Patients with Renal Impairment - This medication is primarily excreted unchanged by the kidneys after systemic circulation. The clearance rate of this medication is directly affected by creatinine clearance, so dose reductions in patients with impaired renal function should be individualized based on creatinine clearance. Creatinine clearance can be determined using the following formula: Creatinine clearance (mL/min)* = [140 - age (years)] x weight (kg) 72 x serum creatinine level (mg/dL) * For women, multiply the result by 0.85. This medication is effectively removed from the plasma by hemodialysis (about 50% within 4 hours). In patients undergoing hemodialysis, the daily dosage of pregabalin should be adjusted based on renal function. In addition to the daily dosage corresponding to renal function, supplemental doses should be administered immediately after every 4 hours of hemodialysis. [Table 1] Dosing of Pregabalin based on Renal Function Creatinine clearance (CLcr), (mL/min) Total daily dose of Pregabalin (mg/day) Dosing Method Starting Dose (mg/day) Maximum Dose (mg/day) ≥60 150 600 BID or TID ≥30-<60 75 300 BID or TID ≥15-<30 25-50 150 QD or BID <15 25 75 QD Additional dose after Hemodialysis 25 100 Single Dose TID = total daily dose divided into three doses BID = total daily dose divided into two doses QD = administered once daily a: Total daily dose (mg/day) should be administered as specified in the dosing method. b: Additional doses refer to single doses administered as needed. 6. Patients with Liver Impairment - No dose adjustment is necessary in patients with liver impairment. 7. Pediatric and Adolescent Patients - Due to insufficient safety and efficacy data in children under the age of 12 and adolescents aged 12-17, administration is not recommended. 8. Elderly Patients (aged 65 years and older) - Dose reduction may be necessary in elderly patients with impaired renal function.

Child dose

There is insufficient safety and efficacy data for children under 12 years 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 symptoms such as depression, mood changes, or unusual behavior is necessary while taking it. Patients with an allergy to pregabalin or any components of this medication should not take it. Diabetic patients should be cautious, as dosage adjustments of blood glucose control medications may be necessary due to weight gain. If serious allergic reactions such as angioedema occur, the medication should be discontinued immediately. Elderly patients should be especially careful during the initial dosing due to risks of falls or injuries from dizziness or drowsiness. Blurred vision or changes in eyesight may occur, and if such symptoms arise, discontinuation of the medication may be considered. When discontinuing pregabalin, withdrawal symptoms such as insomnia, headaches, and anxiety may occur, so consultation with healthcare professionals is recommended. Patients with a history of drug abuse are at a high risk for abuse with this medication and should take special precautions. Patients with impaired kidney function may require dosage adjustments. Patients with heart conditions should also take this medication with caution and consult a healthcare professional if symptoms of heart failure appear. When used in combination with other central nervous system depressants or opioid analgesics, the risk of respiratory suppression may increase, so caution is needed. During early pregnancy, there may be a risk of fetal malformations, so it is advisable for pregnant women to avoid taking it, and women of childbearing age should use effective contraception. Women who are breastfeeding should consider stopping breastfeeding or discontinuing the medication, as the drug may be transferred into breast milk. Hazardous activities such as driving or operating machinery should be avoided until dizziness or drowsiness has fully resolved. If severe skin reactions occur, the medication should be stopped immediately and a healthcare professional should be notified. In case of overdose, symptoms such as confusion, drowsiness, and depression may occur, and immediate treatment at a hospital should be sought. Keep out of reach of children and do not transfer to a different container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema, facial swelling, and swelling around the mouth and upper airway), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, skin peeling, pain in oral or ocular mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), systemic severe lethargy

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • derealization
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  • altered sexual sensation
  • restlessness
  • anxiety
  • mood swings
  • emotional flatness
  • emotional elevation
  • difficulty finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • abnormal motor coordination
  • balance disorder
  • amnesia
  • attention deficit
  • memory impairment
  • tremor
  • speech disorders
  • sensory disturbances
  • sensory loss

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture, and keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Light pink oval tablets

Package unit

30 tablets/bottle, 100 tablets/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.

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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.