Medication info

Pregabalin Capsule 25 mg (Pregabalin)

Prescription medicationHard capsuleExpired
Ingredient · strength
Pregabalin›25mg / 1 capsule
Manufacturer / importer
(주)씨엠지제약
Appearance
Hard capsule with light yellow upper and white lower shell filled with white powder
Packaging
30 capsules per bottle
Approval status
Expired

MFDS item code 201907582 · Approved 2019.10.30

This product's status changed to Expired on 2024.10.30. 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 effect in partial seizures in epilepsy, improvement of fibromyalgia
Who uses it
Adults · Children
Adult dosage
This medication is to be taken orally, divided into 2 doses per day regardless of food. 1. Neuropathic pain - Peripheral neuropathic pain: The initial dose is 150 mg per day, which may be increased to 300 mg per day after 3 to 7 days. If necessary, subsequent increases to a maximum of 600 mg per day can be done at intervals of 7 days. - Central neuropathic pain: The initial dose is 150 mg per day, which may be increased to 300 mg per day after 1 week.
Children's dosage
There is insufficient safety and efficacy data to recommend use in children under 12 years and adolescents aged 12 to 17.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

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

  • 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 utilized as an adjunctive therapy for partial seizures in patients with epilepsy, effective whether secondary systemic symptoms are present or not. Additionally, it aids in the treatment of fibromyalgia. In summary, this drug is used for the relief of neuropathic pain, seizure control in epilepsy, and improvement of fibromyalgia symptoms.

Dosage and Administration

Adult dosage

This medication is to be taken orally, divided into 2 doses per day regardless of food. 1. Neuropathic pain - Peripheral neuropathic pain: The initial dose is 150 mg per day, which may be increased to 300 mg per day after 3 to 7 days. If necessary, subsequent increases to a maximum of 600 mg per day can be done at intervals of 7 days. - Central neuropathic pain: The initial dose is 150 mg per day, which may be increased to 300 mg per day after 1 week.

Children's dosage

There is insufficient safety and efficacy data to recommend use in children under 12 years and adolescents aged 12 to 17.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so if changes in mood or unusual behaviors occur during treatment, it should be reported to a healthcare professional immediately. Patients who are hypersensitive to this medication or have genetic issues such as lactose intolerance should not take it. Diabetic patients may require dosage adjustment for blood glucose control due to weight gain, and if symptoms of angioedema appear, the medication should be discontinued immediately. Elderly patients should be cautious of risks of falls due to dizziness or drowsiness, and vision changes may occur. Suddenly stopping this medication can lead to withdrawal symptoms such as insomnia, headaches, nausea, and anxiety, so it should be tapered gradually under medical supervision. Patients with a history of drug abuse should be careful as the risk of misuse with this medication may be increased. Patients with impaired renal function may require dosage adjustments. Patients with heart disease should use this medication cautiously due to potential risk of congestive heart failure. Caution should be taken when used in combination with opioid analgesics as it may increase the risk of central nervous system depression. In early pregnancy, there is a risk of fetal malformation, so this medication should be avoided in pregnant women, and women of childbearing age should use effective contraception. Breastfeeding women should evaluate whether to discontinue breastfeeding or the medication as it may transmit through breast milk and affect infants. This medication may cause dizziness and drowsiness, so changes in symptoms should be observed before driving or operating hazardous machinery. Severe skin reactions may occur rarely, so if symptoms such as rashes, redness, or blisters develop, treatment should be stopped immediately and a healthcare provider should be consulted. Overdose may cause confusion, drowsiness, seizures, and may require treatment such as blood dialysis if necessary. Keep out of reach of children, and do not transfer to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, peeling skin, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, lightning-like headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • spatial disorientation
  • irritability
  • depression
  • euphoria
  • reduced libido
  • insomnia
  • depersonalization
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  • sexual dysfunction
  • restlessness
  • anxiety
  • mood swings
  • emotional blunting
  • emotional highs
  • difficulty finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • motor coordination abnormalities
  • imbalance
  • memory loss
  • attention deficits
  • memory impairment
  • tremors
  • dysarthria
  • sensory abnormalities
  • sensory loss

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is advisable to maintain a storage temperature between 15 to 30 degrees Celsius for safe efficacy.

Appearance and packaging

Appearance

Hard capsule with light yellow upper and white lower shell filled with white powder

Package unit

30 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.