Medication info

Gabapentin Capsule (Pregabalin)

Prescription medicationHard capsule경구Expired
Ingredient · strength
Pregabalin›150mg / 1 capsule
Manufacturer / importer
오스틴제약(주)
Appearance
A hard capsule with a white or off-white powder inside, with a white upper part and a white lower part.
Packaging
30 capsules per bottle, 60 capsules per bottle
Approval status
Expired

MFDS item code 201109312 · Approved 2011.10.31

This product's status changed to Expired on 2023.10.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of peripheral and central neuropathic pain, adjunctive treatment for partial seizures, treatment of fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication is administered orally in divided doses of the total daily dose taken twice a day and may be taken without regard to meals. 1. Neuropathic Pain 1) Peripheral Neuropathic Pain - Starting dose: 150 mg per day - After 3 to 7 days, dosage can be increased to 300 mg per day - If needed, it can be further increased to a maximum of 600 mg per day at 7-day intervals 2) Central Neuropathic Pain - Starting dose: 150 mg per day
Child dose
Safety and efficacy data are insufficient for children under 12 years of age and adolescents aged 12-17, so use is not recommended.

Ingredients

Manufacturer
오스틴제약(주)

Efficacy & effects

Relief of peripheral and central neuropathic pain, adjunctive treatment for partial seizures, treatment of fibromyalgia

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

This medication is used in adults to treat peripheral and central neuropathic pain. It is also utilized as an adjunctive treatment to control partial seizures in patients with epilepsy. Additionally, it is effective in alleviating symptoms of fibromyalgia. These benefits help in managing nerve-related pain and seizures.

How to take

Adult dose

This medication is administered orally in divided doses of the total daily dose taken twice a day and may be taken without regard to meals. 1. Neuropathic Pain 1) Peripheral Neuropathic Pain - Starting dose: 150 mg per day - After 3 to 7 days, dosage can be increased to 300 mg per day - If needed, it can be further increased to a maximum of 600 mg per day at 7-day intervals 2) Central Neuropathic Pain - Starting dose: 150 mg per day

Child dose

Safety and efficacy data are insufficient for children under 12 years of age and adolescents aged 12-17, so use is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so close monitoring for depression or mood changes is necessary during treatment. Individuals allergic to pregabalin or any components of this medication should not take it. Patients with lactose intolerance or certain genetic metabolic disorders should also avoid this medication. Diabetic patients may require adjustments to their blood sugar control medications due to weight gain. If symptoms of angioedema occur, discontinue the medication immediately and consult a healthcare provider. Elderly patients should be cautious due to the risk of falls and injury from dizziness or drowsiness. This medication may cause changes in vision, such as blurred vision, so any unusual symptoms should be reported. Withdrawal symptoms such as insomnia, headache, and anxiety may occur upon abrupt discontinuation, so gradual tapering is advised. Since there is a potential for drug abuse or dependence, strict adherence to healthcare provider instructions is necessary during use. Patients with impaired kidney function may need dose adjustments. Caution is advised for patients with heart disease when taking this medication. Combining this drug with other CNS depressants may increase the risks of drowsiness or respiratory depression. Pregnant women should avoid this medication due to the risk of fetal malformations, and women of childbearing potential should use effective contraception. Breastfeeding women should consider discontinuing breastfeeding or switching medications since this drug may pass into breast milk. There is a risk of dizziness and drowsiness affecting the ability to drive or operate machinery safely. Severe skin reactions may rarely occur, so discontinue use immediately if rash or redness develops. Overdose may result in confusion, drowsiness, seizures, and may require treatments such as dialysis. This medication should be kept out of reach of children and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweats
  • paleness
  • angioedema
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • anaphylaxis-like symptoms
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  • mucosal epidermal necrolysis
  • erythema multiforme
  • severe allergic reactions
  • severe skin adverse reactions
  • respiratory issues
  • pulmonary edema
  • liver abnormalities (jaundice)
  • sudden and severe headaches
  • lightning headaches
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • serious neurological disturbances

Mild side effects

  • Dizziness
  • drowsiness
  • rhinitis
  • increased appetite
  • decreased appetite
  • hypoglycemia
  • confusion
  • dysphoria
  • irritability
  • depression
Show 23 more
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
  • sexual dysesthesia
  • agitation
  • anxiety
  • mood swings
  • emotional blunting
  • emotional lability
  • difficulty finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • coordination disturbances
  • balance disorders
  • memory loss
  • attention deficits
  • memory impairment

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. This helps preserve the drug's efficacy and safety over a long period.

Appearance and packaging

Appearance

A hard capsule with a white or off-white powder inside, with a white upper part and a white lower part.

Package unit

30 capsules per bottle, 60 capsules per 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.