Medication info
Gabamed Capsule 50mg (Pregabalin)

Gabamed Capsule 50mg (Pregabalin)

Prescription medicationHard capsule경구
Ingredient · strength
Pregabalin›50mg / 1 capsule
Manufacturer / importer
엔비케이제약(주)
Appearance
A hard capsule with a white powder, blue upper part and a white lower part.
Packaging
30 capsules/bottle
Approval status
Active

MFDS item code 202000453 · Approved 2020.01.29 · Insurance code 054800640

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 medication is taken orally in two divided doses per day, regardless of meals. The dosing may vary depending on the patient group: 1. Peripheral Neuropathic Pain: An initial dose of 150 mg per day may be given, which can be increased to 300 mg per day within 3-7 days. If necessary, it can be increased to a maximum of 600 mg per day at 7-day intervals. 2. Central Neuropathic Pain: An initial dose of 150 mg per day may be given, which can be increased to 300 mg after one week based on individual response and tolerance. After an additional week, it may be increased to a target daily dose of 600 mg, considering tolerance at that target dose. 3. Epilepsy: An initial dose of 150 mg per day may be given, which can be increased to 300 mg after one week based on individual response and tolerance. If required, it may be increased to a maximum of 600 mg at 7-day intervals. 4. Fibromyalgia: The recommended dose for fibromyalgia is between 300 mg to 450 mg per day. The initial dose is 75 mg twice daily (150 mg per day), which may be increased to 300 mg per day (150 mg twice daily) based on efficacy and tolerance within one week. If sufficient benefit is not experienced at 300 mg, the dose may be increased to 450 mg per day (225 mg twice daily) within one week. Doses of 600 mg have been studied, but evidence for additional benefit or sufficient tolerance at that dose is lacking. Given dose-dependent adverse reactions, dosing above 450 mg per day is not recommended. 5. Discontinuation: Based on current clinical experience, the medication should be gradually discontinued over at least one week. 6. Patients with impaired kidney function: This medication is primarily excreted by the kidneys in unchanged form following systemic circulation. The clearance of this medication directly affects the creatinine clearance; thus, dose reduction should be individualized based on creatinine clearance among patients with impaired renal function. The formula to determine creatinine clearance is as follows: Creatinine clearance (mL/min)* = [140 - age (years)] x weight (kg) / 72 x serum creatinine level (mg/dL) *For females, multiply the calculated result by 0.85. This medication is effectively removed from the plasma by hemodialysis (about 50% within 4 hours). For patients undergoing hemodialysis, the daily dose should be adjusted according to kidney function, and additional doses should be administered immediately after every 4 hours of hemodialysis. 7. Liver function impairment: Dose adjustment is not necessary for patients with liver function impairment. 8. Elderly patients (age 65 and over): Dose reduction may be necessary for elderly patients with impaired kidney function.
Child dose
Safety and efficacy data are insufficient for children under 12 years old and adolescents aged 12 to 17, so administration is not recommended.

Ingredients

Manufacturer
엔비케이제약(주)

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 with secondary generalization
  • partial seizures without secondary generalization
  • fibromyalgia.
View approved original text

This medication is used to treat peripheral and central neuropathic pain in adults. Additionally, it is effective as an adjunct for partial seizures in epilepsy, regardless of whether secondary generalized symptoms are present. It also helps alleviate the symptoms of fibromyalgia. This medication shows promising therapeutic effects in various neurological-related disorders.

How to take

Adult dose

This medication is taken orally in two divided doses per day, regardless of meals. The dosing may vary depending on the patient group: 1. Peripheral Neuropathic Pain: An initial dose of 150 mg per day may be given, which can be increased to 300 mg per day within 3-7 days. If necessary, it can be increased to a maximum of 600 mg per day at 7-day intervals. 2. Central Neuropathic Pain: An initial dose of 150 mg per day may be given, which can be increased to 300 mg after one week based on individual response and tolerance. After an additional week, it may be increased to a target daily dose of 600 mg, considering tolerance at that target dose. 3. Epilepsy: An initial dose of 150 mg per day may be given, which can be increased to 300 mg after one week based on individual response and tolerance. If required, it may be increased to a maximum of 600 mg at 7-day intervals. 4. Fibromyalgia: The recommended dose for fibromyalgia is between 300 mg to 450 mg per day. The initial dose is 75 mg twice daily (150 mg per day), which may be increased to 300 mg per day (150 mg twice daily) based on efficacy and tolerance within one week. If sufficient benefit is not experienced at 300 mg, the dose may be increased to 450 mg per day (225 mg twice daily) within one week. Doses of 600 mg have been studied, but evidence for additional benefit or sufficient tolerance at that dose is lacking. Given dose-dependent adverse reactions, dosing above 450 mg per day is not recommended. 5. Discontinuation: Based on current clinical experience, the medication should be gradually discontinued over at least one week. 6. Patients with impaired kidney function: This medication is primarily excreted by the kidneys in unchanged form following systemic circulation. The clearance of this medication directly affects the creatinine clearance; thus, dose reduction should be individualized based on creatinine clearance among patients with impaired renal function. The formula to determine creatinine clearance is as follows: Creatinine clearance (mL/min)* = [140 - age (years)] x weight (kg) / 72 x serum creatinine level (mg/dL) *For females, multiply the calculated result by 0.85. This medication is effectively removed from the plasma by hemodialysis (about 50% within 4 hours). For patients undergoing hemodialysis, the daily dose should be adjusted according to kidney function, and additional doses should be administered immediately after every 4 hours of hemodialysis. 7. Liver function impairment: Dose adjustment is not necessary for patients with liver function impairment. 8. Elderly patients (age 65 and over): Dose reduction may be necessary for elderly patients with impaired kidney function.

Child dose

Safety and efficacy data are insufficient for children under 12 years old and adolescents aged 12 to 17, so administration is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors; therefore, mood changes or depressive symptoms should be closely monitored during use. Patients with hypersensitivity to this medication or specific genetic metabolic disorders should not use it. Diabetic patients should be cautious as weight gain may require adjustments in blood sugar control medications. If allergic reactions such as angioedema occur, discontinue use immediately. Elderly patients may be at risk of falls due to side effects like dizziness or drowsiness, so extra caution is needed, especially during the initial phase of treatment. There may be visual blurring or changes in vision; if such symptoms occur, consult with healthcare professionals. Sudden discontinuation of this medication may result in withdrawal symptoms such as insomnia, headache, and anxiety; therefore, gradual tapering according to a physician's instructions is necessary. The risk of drug abuse exists, especially for patients with a history of mental disorders or drug abuse, who require special caution. Patients with impaired kidney function may need dose adjustments for this medication. Patients with severe heart conditions should carefully consider the use of this medication. Caution is warranted when used with other medications that have central nervous system depressant effects due to the risk of respiratory depression. During early pregnancy, there is a risk of fetal malformations; therefore, women of childbearing age should use effective contraception while using this medication. This medication can be transmitted through breast milk, so considerations should be made to either discontinue breastfeeding or the medication. Dizziness and drowsiness may occur while driving or operating machinery; caution is advised. In case of overdose, symptoms such as confusion, drowsiness, or depression may occur; immediate medical attention is required. Keep this medication out of the reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, angioedema, facial swelling, chest tightness, difficulty breathing, angioedema, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, Stevens-Johnson syndrome, toxic epidermal necrolysis, mucosal rash syndrome, symptoms similar to anaphylaxis, severe allergic reactions, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, cough with fever.

Mild side effects

  • Dizziness
  • drowsiness
  • rhinitis
  • increased appetite
  • decreased appetite
  • hypoglycemia
  • confusion
  • disorientation
  • irritability
  • depression
Show 23 more
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
  • hyperesthesia
  • restlessness
  • anxiety
  • mood swings
  • emotional numbness
  • emotional elevation
  • difficulty in finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulse control problems
  • flatness
  • ataxia
  • motor coordination disorders
  • balance disorders
  • amnesia
  • attention disorders
  • memory disorders.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, preferably at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication and ensure safe use.

Appearance and packaging

Appearance

A hard capsule with a white powder, blue upper part and a white lower part.

Package unit

30 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.

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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.