Medication info

Pregabalin Capsule 50 mg

Prescription medicationHard capsule경구Expired
Ingredient · strength
Pregabalin›50mg / 1 capsule
Manufacturer / importer
신일제약(주)
Appearance
A hard capsule with purple upper part and white lower part containing white powder.
Packaging
30 capsules/bottle
Approval status
Expired

MFDS item code 201906160 · Approved 2019.08.29

This product's status changed to Expired on 2024.08.29. 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 for epilepsy (partial seizure) and improvement of fibromyalgia.
Who takes it
Adults · Children
Adult dose
This medication is administered orally in two divided doses throughout the day, regardless of meals. 1. Neuropathic Pain - Peripheral neuropathic pain: starting dose is 150 mg once daily; after 3 to 7 days, can be increased to 300 mg once daily, and if needed, can be further increased to a maximum of 600 mg once daily at intervals of 7 days. - Central neuropathic pain: starting dose is 150 mg once daily; after 1 week, it can be increased to 300 mg once daily.
Child dose
There is insufficient safety and efficacy data available for children under 12 years and adolescents aged 12-17, hence administration is not recommended.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Treatment of peripheral and central neuropathic pain, adjunctive effect for epilepsy (partial seizure) and improvement of fibromyalgia.

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

This medication is used effectively to alleviate peripheral and central neuropathic pain in adults. It also assists in the adjunctive treatment of partial seizures in patients with epilepsy, helping to reduce the frequency of seizures. Additionally, it is used to alleviate pain and discomfort caused by fibromyalgia. This medication is widely used for neurological disorders and pain relief, contributing to an improved quality of life for patients.

How to take

Adult dose

This medication is administered orally in two divided doses throughout the day, regardless of meals. 1. Neuropathic Pain - Peripheral neuropathic pain: starting dose is 150 mg once daily; after 3 to 7 days, can be increased to 300 mg once daily, and if needed, can be further increased to a maximum of 600 mg once daily at intervals of 7 days. - Central neuropathic pain: starting dose is 150 mg once daily; after 1 week, it can be increased to 300 mg once daily.

Child dose

There is insufficient safety and efficacy data available for children under 12 years and adolescents aged 12-17, hence administration is not recommended.

Precautions

This medication may increase the risk of suicidal ideation or behavior; therefore, patients should immediately inform their healthcare provider of any changes in mood or behavior during treatment. Patients with hypersensitivity to this drug or a genetic problem of lactose intolerance should not take it. Diabetic patients should be cautious as weight gain may necessitate adjustments in blood sugar control medications. If symptoms of angioedema occur, the medication should be discontinued immediately, and consultation with a healthcare provider is necessary. Elderly patients should be cautious due to the higher risk of falls from dizziness or drowsiness. Temporary visual blurring or changes in vision may occur; if symptoms are severe, discontinuation of the medication should be considered. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as insomnia, headache, nausea, and anxiety; therefore, it should be tapered off gradually under the guidance of a healthcare provider. Patients with a history of drug abuse may be at a higher risk of misuse of this medication and should use it cautiously. Patients with impaired renal function may require dosage adjustments. Patients with heart disease should be cautious as this medication may worsen symptoms of heart failure during administration. When used in conjunction with other medications that have central nervous system depressant effects, the risk of drowsiness or respiratory depression may increase. During early pregnancy, there is a risk of birth defects; thus, women who are pregnant or planning to become pregnant must consult with a healthcare provider. This medication may pass into breast milk, so it is recommended to discontinue breastfeeding or the medication while nursing. Patients should avoid hazardous activities such as driving or operating machinery until dizziness or drowsiness has resolved after taking this medication. In cases of overdose, symptoms such as altered consciousness, drowsiness, and confusion may occur, and immediate emergency treatment is necessary. Keep out of reach of children and ensure it is not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, cold sweat, symptoms resembling anaphylaxis, angioedema, difficulty breathing, respiratory depression, pulmonary edema, loss of consciousness, vision abnormalities, visual field loss, jaundice, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), severe allergic reactions, serious neurological symptoms (loss of consciousness, mental disorders, paralysis, seizures), congestive heart failure, decreased urination, renal failure, urinary retention, nephropathy

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • derealization
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
Show 23 more
  • hyperesthesia
  • restlessness
  • agitation
  • mood swings
  • emotional dullness
  • emotional lability
  • difficulty finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • abnormal coordination
  • balance disorders
  • memory loss
  • attention deficit
  • memory impairment
  • tremors
  • dysarthria
  • 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 exposure to air or moisture. It is recommended to keep the storage temperature between 15 and 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with purple upper part and white lower part containing white 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.