Medication info
Pregabalin Capsule 25 mg (Pregabalin)

Pregabalin Capsule 25 mg (Pregabalin)

Prescription medicationHard capsule경구
Ingredient · strength
Pregabalin›25mg / 1 capsule
Manufacturer / importer
(주)새한제약
Appearance
A hard capsule with a light yellow upper part and a white lower part, containing white or grayish-white crystalline powder.
Packaging
30 capsules/bottle
Approval status
Active

MFDS item code 201902603 · Approved 2019.04.25 · Insurance code 651300990

Summary

Main use
Relief of peripheral and central neuropathic pain and fibromyalgia, adjunctive treatment for partial seizures in epilepsy.
Who takes it
Adults · Children
Adult dose
This medication is Pregabalin and is taken orally, divided into two doses per day, regardless of food. 1. Neuropathic pain 1) Peripheral neuropathic pain Initial dose: 150 mg per day; can be increased to 300 mg daily after 3 to 7 days, and up to 600 mg daily subsequently at 7-day intervals if needed. 2) Central neuropathic pain Initial dose: 150 mg per day.
Child dose
For children under 12 years of age and adolescents aged 12 to 17 years, safety and efficacy data is insufficient, thus use is not recommended.

Ingredients

Manufacturer
(주)새한제약

Efficacy & effects

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

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

This medication is used to treat peripheral and central neuropathic pain in adults. It is also used as an adjunct for partial seizures in patients with epilepsy, effective regardless of the presence of secondary generalized symptoms. Additionally, it assists in alleviating symptoms in fibromyalgia patients. In other words, this drug is used to treat neuropathic pain, specific types of epilepsy, and chronic pain syndromes.

How to take

Adult dose

This medication is Pregabalin and is taken orally, divided into two doses per day, regardless of food. 1. Neuropathic pain 1) Peripheral neuropathic pain Initial dose: 150 mg per day; can be increased to 300 mg daily after 3 to 7 days, and up to 600 mg daily subsequently at 7-day intervals if needed. 2) Central neuropathic pain Initial dose: 150 mg per day.

Child dose

For children under 12 years of age and adolescents aged 12 to 17 years, safety and efficacy data is insufficient, thus use is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behavior, so close observation for mood changes or unusual behavior is necessary during treatment. Patients with hypersensitivity to this medication should not take it. Diabetic patients may experience difficulties in blood sugar control due to weight gain, thus adjustments in diabetes medication may be necessary. If allergic reactions such as angioedema occur, the medication should be discontinued immediately. Elderly patients are at higher risk of accidents due to dizziness or drowsiness, thus caution is required. Blurred vision or changes in eyesight may occur, which can improve after discontinuation of the medication. Caution is recommended during the discontinuation of other antiepileptic medications. Discontinuing the medication suddenly may lead to withdrawal symptoms such as insomnia, headache, and anxiety, and should be discussed with a physician. Patients with a history of substance abuse should take this medication with caution due to a higher risk of misuse. Patients with impaired kidney function may require dosage adjustment. Patients with severe heart disease need to be cautious when using this medication. When taken with central nervous system depressants (e.g., opioids), there is a risk of respiratory depression that should be watched closely. In early pregnancy, there is a risk of fetal malformation, so it is advisable for pregnant women to avoid taking this medication, and sexually active women should use effective contraception. Dizziness or drowsiness may occur during treatment, so driving or operating hazardous machinery should be avoided. Serious skin reactions, such as Stevens-Johnson syndrome, have been reported rarely; if symptoms of skin abnormality occur, discontinue use immediately and consult with healthcare providers. This medication is primarily excreted in urine, and the possibility of interaction with other drugs is low, but taking it with alcohol or central nervous system depressants may increase drowsiness or respiratory depression. Breastfeeding women should be advised to discontinue breastfeeding or the medication, as it may be passed into breast milk. In case of overdose, symptoms such as drowsiness, confusion, and depression may occur; immediate medical attention is required, and treatments such as dialysis may be necessary. Keep out of reach of children, and do not transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision disturbances, paralysis, urine retention.

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • sexual arousal disorder
  • restlessness
  • anxiety
  • mood disturbances
  • emotional lability
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • dyskinesia
  • balance disorders
  • amnesia
  • attention deficits
  • memory impairment
  • tremors
  • speech disturbances
  • sensory disturbances
  • sensory loss.

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

Storage

This medication should be stored in a sealed container to prevent contact with air or moisture, and the safe storage temperature is between 15 to 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

A hard capsule with a light yellow upper part and a white lower part, containing white or grayish-white crystalline 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.