Medication info
Pregabalin 300 mg Capsule

Pregabalin 300 mg Capsule

Prescription medicationHard capsule경구
Ingredient · strength
Pregabalin›300mg / 1 capsule
Manufacturer / importer
환인제약(주)
Appearance
A hard capsule with a reddish-brown upper part and a white lower part containing a white or pale yellow powder.
Packaging
30 capsules/bottle, 100 capsules/bottle, (export 30 capsules (10 capsules/PTP × 3))
Approval status
Active

MFDS item code 201707653 · Approved 2017.10.30 · Insurance code 657203290

Summary

Main use
Treatment of peripheral and central neuropathic pain, adjunctive effect for partial seizures in epilepsy, improvement of fibromyalgia.
Who takes it
Adults · Children
Adult dose
This medication, as pregabalin, should be administered orally in divided doses twice daily, irrespective of meals. 1. Neuropathic Pain 1) Peripheral Neuropathic Pain Starting dose may be 150 mg once daily. After 3 to 7 days, the dose may be increased up to 300 mg per day. If necessary, the dose may be further increased up to a maximum of 600 mg per day at intervals of 7 days. 2) Central Neuropathic Pain Starting dose may be...
Child dose
There is insufficient safety and efficacy data for children under 12 years of age and adolescents aged 12 to 17 years, therefore, administration is not recommended.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

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

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

This medication effectively treats peripheral and central neuropathic pain in adults and is used as an adjunctive therapy for partial seizures in patients with epilepsy. It also helps in the treatment of fibromyalgia. Overall, it is utilized in managing neurological disorders and pain, improving the quality of life for patients.

How to take

Adult dose

This medication, as pregabalin, should be administered orally in divided doses twice daily, irrespective of meals. 1. Neuropathic Pain 1) Peripheral Neuropathic Pain Starting dose may be 150 mg once daily. After 3 to 7 days, the dose may be increased up to 300 mg per day. If necessary, the dose may be further increased up to a maximum of 600 mg per day at intervals of 7 days. 2) Central Neuropathic Pain Starting dose may be...

Child dose

There is insufficient safety and efficacy data for children under 12 years of age and adolescents aged 12 to 17 years, therefore, administration is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so careful monitoring for depression or abnormal mood changes is necessary while taking it. Patients with a hypersensitivity to this drug should not take it. Diabetic patients may need to adjust the dosage of their blood sugar control medications due to weight gain. If allergic reactions such as angioedema occur, the medication should be discontinued immediately. Elderly patients should be cautious initially, as dizziness or drowsiness may be more pronounced. There may be changes in vision, such as blurriness; in such cases, discontinuing the medication may improve the symptoms. Care should be taken when switching from other antiepileptic drugs to this medication alone. Withdrawal symptoms such as insomnia, headaches, nausea, and anxiety may occur if the medication is stopped abruptly. Patients with a history of substance abuse should be particularly cautious due to the risk of drug abuse. Patients with decreased kidney function may require dosage adjustments. Patients with heart conditions should use this medication with caution. Taking this medication with opioid analgesics may increase central nervous system depressant effects, so caution is warranted. Patients with compromised respiratory function or the elderly may be at risk for severe respiratory depression, so dosage adjustments may be necessary. During early pregnancy, there may be risks to the fetus, so women of childbearing potential should use effective contraception, and it is advisable to avoid the medication during pregnancy. Breastfeeding women are advised to discontinue breastfeeding or the medication as it may be transferred through breast milk. Caution is needed when driving or operating hazardous machinery due to the risk of dizziness or drowsiness. Severe skin reactions may occur rarely, so notify a healthcare provider immediately if skin abnormalities occur. In case of overdose, symptoms such as confusion, drowsiness, and depression may appear, requiring immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, facial swelling, upper airway swelling, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, Stevens-Johnson syndrome, toxic epidermal necrolysis, cold sweat, severe swelling, chest tightness, difficulty breathing, respiratory distress, respiratory depression, asthma attack, impaired respiration with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headaches.

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • impaired coordination
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • dysesthesia
  • restlessness
  • anxiety
  • mood swings
  • affective flattening
  • elevated mood
  • difficulty in finding the right words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • abnormal motor coordination
  • balance disorders
  • amnesia
  • attention deficit
  • memory impairment
  • tremors
  • speech disorders
  • sensory disturbances
  • 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 air and moisture from entering and should be kept at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy over time.

Appearance and packaging

Appearance

A hard capsule with a reddish-brown upper part and a white lower part containing a white or pale yellow powder.

Package unit

30 capsules/bottle, 100 capsules/bottle, (export 30 capsules (10 capsules/PTP × 3))

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.