Medication info

Pregabalin Capsule 150 mg (Pregabalin)

Prescription medicationApproval withdrawn
Ingredient · strength
Pregabalin›Strength being verified
Manufacturer / importer
한국유나이티드제약(주)
Appearance
A hard capsule with a white upper part and a white lower part containing white or light yellow powder.
Packaging
Domestic: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle Export: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle, 60 capsules (10 capsules/PTPX6)
Approval status
Approval withdrawn

MFDS item code 201109146 · Approved 2011.10.25

This product's status changed to Approval withdrawn on 2023.05.12. 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 therapy for partial seizures in epilepsy, improvement of fibromyalgia
Who uses it
Adults · Children
Adult dosage
This medication, as Pregabalin, is administered orally in divided doses twice a day irrespective of food. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Starting dose 150 mg per day, can be increased to 300 mg per day within 3 to 7 days, and if necessary, can be increased to a maximum of 600 mg per day at intervals of 7 days. - Central Neuropathic Pain: Starting dose 150 mg per day, can be increased to 300 mg per day after 1 week.
Children's dosage
The use of this medication is not recommended for children under 12 years of age or adolescents aged 12 to 17 due to insufficient safety and efficacy data.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Treatment of peripheral and central neuropathic pain, adjunctive therapy for partial seizures in epilepsy, improvement of fibromyalgia

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

This medication is used for peripheral and central neuropathic pain in adults, as an adjunctive treatment for partial seizures in epilepsy, and for the treatment of fibromyalgia.

Dosage and Administration

Adult dosage

This medication, as Pregabalin, is administered orally in divided doses twice a day irrespective of food. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Starting dose 150 mg per day, can be increased to 300 mg per day within 3 to 7 days, and if necessary, can be increased to a maximum of 600 mg per day at intervals of 7 days. - Central Neuropathic Pain: Starting dose 150 mg per day, can be increased to 300 mg per day after 1 week.

Children's dosage

The use of this medication is not recommended for children under 12 years of age or adolescents aged 12 to 17 due to insufficient safety and efficacy data.

Precautions

This medication may increase the risk of suicidal thoughts or behavior. If you experience signs of depression, mood changes, or unusual behavior while taking this drug, consult your doctor immediately. Patients with allergies to any component of this medication or specific genetic lactose intolerance disorders should not take it. Diabetic patients may need dose adjustments of blood glucose control medications due to weight gain. If symptoms of angioedema occur, stop the medication immediately. Elderly patients should be cautious due to risks of falls or injuries from dizziness or drowsiness. Temporary blurred vision or changes in vision can occur, and if symptoms persist, consult a doctor. When stopping this medication, withdrawal symptoms such as insomnia, headache, nausea, and anxiety may appear, so it should be gradually adjusted under medical guidance. There is a risk of drug abuse or dependence, so mental health status and drug use history should be disclosed to healthcare providers for close monitoring. Patients with reduced kidney function may require dose adjustments, and those with heart disease must consult a physician before taking it. There is a higher risk of respiratory depression when combined with other central nervous system depressants, so caution is advised. Pregnant women should avoid taking this medication during early pregnancy due to the risk of fetal malformations, and women of childbearing age should use effective contraception. Nursing mothers should discuss with their doctor whether to discontinue breastfeeding or the medication, as this drug may pass into breast milk. This medication can cause dizziness and drowsiness, so caution is required when performing hazardous activities like driving or operating machinery. In case of overdose, symptoms such as confusion, drowsiness, or depression may occur, and treatment such as hemodialysis may be necessary if needed. Keep out of reach of children, and avoid transferring to other containers. If severe rashes, fever, or difficulty breathing occur, discontinue use and notify healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • angioedema
  • facial swelling
  • facial paralysis
  • cold sweat
  • chest tightness
  • difficulty breathing
  • respiratory distress
  • respiratory depression
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  • severe allergic reactions
  • severe skin adverse reactions
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • mucocutaneous syndrome
  • erythema multiforme
  • liver abnormalities (jaundice)
  • loss of consciousness
  • visual disturbances
  • visual field defects
  • myoclonus
  • loss of consciousness
  • mental disorders
  • severe neurological symptoms
  • paralysis

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • spatial disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
Show 22 more
  • dysesthesia
  • restlessness
  • anxiety
  • mood swings
  • emotional lability
  • difficulty finding appropriate words
  • hallucinations
  • unusual dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • motor coordination disorders
  • balance disorders
  • amnesia
  • attention deficits
  • memory impairment
  • tremors
  • speech disturbances
  • sensory abnormalities
  • hypesthesia

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 also important to store it at room temperature between 15 and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

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

Package unit

Domestic: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle Export: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle, 60 capsules (10 capsules/PTPX6)

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.