Medication info
Pregabalin Capsule 50 mg (Pregabalin)

Pregabalin Capsule 50 mg (Pregabalin)

Prescription medicationHard capsule경구
Ingredient · strength
Pregabalin›50mg / 1 capsule
Manufacturer / importer
코스맥스파마(주)
Appearance
A hard capsule with a white to pale yellow powder inside, dark blue on the upper part and white on the lower part
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201901231 · Approved 2019.02.26 · Insurance code 055100840

Summary

Main use
Improvement of neuropathic pain, epilepsy (partial seizures), and fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication is taken orally, divided into two doses per day, regardless of food. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Initial dose of 150 mg per day; can be increased to 300 mg after 3 to 7 days, and if necessary, can be raised to a maximum of 600 mg per day at 7-day intervals. - Central Neuropathic Pain: Initial dose of 150 mg per day; after one week, can be increased to 300 mg per day.
Child dose
Safety and efficacy data are insufficient for children under 12 years of age and adolescents aged 12 to 17 years; thus, administration is not recommended.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

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

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

This medication is used for the treatment of peripheral and central neuropathic pain in adults. It is also used as an adjunctive treatment for partial seizures in epilepsy patients, with or without secondary generalized symptoms. Moreover, it is effective for the treatment of fibromyalgia. In summary, this drug helps improve symptoms associated with neuropathic pain, epilepsy, and fibromyalgia.

How to take

Adult dose

This medication is taken orally, divided into two doses per day, regardless of food. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Initial dose of 150 mg per day; can be increased to 300 mg after 3 to 7 days, and if necessary, can be raised to a maximum of 600 mg per day at 7-day intervals. - Central Neuropathic Pain: Initial dose of 150 mg per day; after one week, can be increased to 300 mg per day.

Child dose

Safety and efficacy data are insufficient for children under 12 years of age and adolescents aged 12 to 17 years; thus, administration is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behavior; therefore, if mood changes or symptoms of depression occur during treatment, consult a physician immediately. Patients with hypersensitivity to this drug or genetic issues such as lactose intolerance should not take it. Diabetic patients may need to adjust their blood glucose medication doses due to weight gain after taking this drug. If symptoms of angioedema occur, discontinue use immediately. Elderly patients may need to be cautious as dizziness or drowsiness can increase the risk of falls. This drug may cause blurred vision or changes in vision, and if these symptoms occur, consult a physician. Discontinuing the medication abruptly can lead to withdrawal symptoms such as insomnia, headache, nausea, and anxiety; thus, it should be tapered off according to a physician's instructions. Patients with a history of substance abuse should be carefully monitored due to the potential risk of misuse. Patients with reduced kidney function may require dose adjustment. Patients with heart disease should be cautious regarding the potential for heart failure when taking this medication. Taking this drug with opioid analgesics may increase the risk of central nervous system depression, so caution is required when used together. This drug may cause respiratory depression, and patients with respiratory diseases or kidney disorders should exercise caution when using it. During early pregnancy, there is a risk of fetal malformation, so pregnant women should not take this medication, and women of childbearing age should use effective contraception. If breastfeeding, this medication may be secreted in breast milk and affect the baby, so breastfeeding should be discontinued or a physician should be consulted. When driving or operating machinery, due to risks from dizziness or drowsiness, caution should be exercised until these symptoms resolve after taking the drug. Severe skin reactions may rarely occur; if symptoms such as skin rash or swelling appear, discontinue use immediately and consult healthcare professionals. In cases of overdose, symptoms like confusion, drowsiness, and seizures may occur; seek appropriate medical treatment immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • loss of direction sense
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • sexual dysfunction
  • restlessness
  • anxiety
  • mood changes
  • emotional decline
  • emotional elevation
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsiveness
  • apathy
  • ataxia
  • coordination abnormality
  • equilibrium disturbance
  • amnesia
  • attention disorder
  • memory impairment
  • tremors
  • speech disorders
  • sensory abnormalities
  • sensory loss

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering. Additionally, it is important to store it at a cool temperature between 15 degrees Celsius and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

A hard capsule with a white to pale yellow powder inside, dark blue on the upper part and white on the lower part

Package unit

30 capsules/bottle, 100 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.