Medication info

Pregabalin Capsule 25 mg (Pregabalin)

Prescription medicationHard capsule경구Expired
Ingredient · strength
Pregabalin›25mg / 1 capsule
Manufacturer / importer
신일제약(주)
Appearance
A hard capsule with a light yellow upper part and a white lower part containing white powder.
Packaging
30 capsules/bottle
Approval status
Expired

MFDS item code 201906159 · Approved 2019.08.29

This product's status changed to Expired on 2024.08.29. 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 epilepsy (partial seizures), improvement of fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication is pregabalin and is taken orally twice daily without regard to food. 1. Neuropathic Pain 1) Peripheral Neuropathic Pain: Starting dose is 150 mg per day, and may be increased to 300 mg per day after 3 to 7 days, and further increased to a maximum of 600 mg per day at 7-day intervals if necessary. 2) Central Neuropathic Pain: Initial...
Child dose
The safety and efficacy data for pediatric patients under 12 years of age and adolescents aged 12 to 17 are insufficient, therefore use is not recommended.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

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

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

This medication is used to relieve peripheral and central neuropathic pain in adults. Additionally, it is utilized as an adjunctive treatment for partial seizures in patients with epilepsy, whether they have secondary generalized symptoms or not. Furthermore, it is effective in treating pain caused by fibromyalgia. This medication assists in pain relief and the management of neurological disorders for the patients.

How to take

Adult dose

This medication is pregabalin and is taken orally twice daily without regard to food. 1. Neuropathic Pain 1) Peripheral Neuropathic Pain: Starting dose is 150 mg per day, and may be increased to 300 mg per day after 3 to 7 days, and further increased to a maximum of 600 mg per day at 7-day intervals if necessary. 2) Central Neuropathic Pain: Initial...

Child dose

The safety and efficacy data for pediatric patients under 12 years of age and adolescents aged 12 to 17 are insufficient, therefore use is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so if any depression or mood changes occur during treatment, it must be reported to a healthcare provider immediately. Patients allergic to any components of this medication or with specific genetic lactose metabolism disorders should not take it. Diabetic patients may need to adjust their blood sugar control medications due to weight gain. If severe allergic reactions, such as angioedema, occur, the use of this medication should be stopped immediately. Elderly patients may be at higher risk of falls or accidents due to dizziness or drowsiness when taking this medication, so caution should be exercised. Blurred vision or changes in vision may occur; if any abnormal symptoms appear, consult a healthcare provider. If this medication is stopped suddenly, withdrawal symptoms such as insomnia, headaches, and anxiety may occur, so it should be tapered off gradually according to the healthcare provider's instructions. Patients with a history of drug abuse may be at a higher risk for misuse and dependence on this medication and should be managed carefully. Patients with impaired kidney function may require dosage adjustments. Patients with severe heart conditions should exercise caution when taking this medication. Caution is warranted when taking this medication with other central nervous system depressants or opioids, as the risk of respiratory depression may increase. In early pregnancy, there is a risk of fetal malformation, so pregnant women should avoid taking this medication, and women of childbearing potential should use effective contraception. Women who are breastfeeding should consider stopping breastfeeding or discontinuing this medication, as it can be passed into breast milk and may affect the infant. This medication may cause dizziness and drowsiness; caution is advised before driving or operating machinery. Severe skin reactions may occur rarely, so if skin rashes or swelling occur, discontinue use immediately and consult a healthcare provider. In case of overdose, confusion, drowsiness, seizures, etc., may occur, and treatment such as hemodialysis may be necessary if required. Keep this medication out of the reach of children, and it is safest not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in the oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, consciousness confusion, visual disturbances, paralysis, urinary issues

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disturbances in spatial awareness
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • sexual sensation disorders
  • restlessness
  • anxiety
  • mood changes
  • emotional lability
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • motor coordination issues
  • balance disorders
  • memory loss
  • attention deficits
  • memory disorders
  • tremors
  • speech disturbances
  • 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 closed container to prevent exposure to air or moisture, and it is best maintained at room temperature between 15 to 30 degrees Celsius. Storing this way will maintain the medication's efficacy and prevent deterioration.

Appearance and packaging

Appearance

A hard capsule with a light yellow upper part and a white lower part containing white powder.

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.

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.