Medication info

Pregabalin Capsule 75mg (Pregabalin)

Prescription medicationHard capsule경구Expired
Ingredient · strength
Pregabalin›75mg / 1 capsule
Manufacturer / importer
대한뉴팜(주)
Appearance
A hard capsule with a reddish-brown upper part and a white lower part containing white powder.
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Expired

MFDS item code 201904606 · Approved 2019.07.08

This product's status changed to Expired on 2024.07.08. 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 taken orally in two divided doses daily without regard to meals. 1. Neuropathic pain 1) Peripheral neuropathic pain - Starting dose: 150 mg per day - After 3 to 7 days: can be increased to 300 mg per day - If necessary, can be increased to a maximum of 600 mg per day at intervals of 7 days. 2) Central neuropathic pain - Starting dose: 150 mg per day.
Child dose
The administration of this drug is not recommended for children under 12 years and adolescents aged 12 to 17 due to insufficient safety and efficacy data.

Ingredients

Manufacturer
대한뉴팜(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 with or without secondary generalization
  • 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 treatment for partial seizures in patients with epilepsy, both with and without secondary generalization. Additionally, it is effective in alleviating symptoms in patients with fibromyalgia. This medication aids in the improvement of symptoms associated with various neurological disorders.

How to take

Adult dose

This medication is taken orally in two divided doses daily without regard to meals. 1. Neuropathic pain 1) Peripheral neuropathic pain - Starting dose: 150 mg per day - After 3 to 7 days: can be increased to 300 mg per day - If necessary, can be increased to a maximum of 600 mg per day at intervals of 7 days. 2) Central neuropathic pain - Starting dose: 150 mg per day.

Child dose

The administration of this drug is not recommended for children under 12 years and adolescents aged 12 to 17 due to insufficient safety and efficacy data.

Precautions

This drug may increase the risk of suicidal thoughts or behavior, so careful monitoring is required for signs of depression or mood changes during treatment. It should not be used in patients with hypersensitivity to this medication. Diabetic patients should be cautious as weight gain may necessitate adjustments in blood sugar control medications. If symptoms of angioedema occur, discontinue use immediately and consult a healthcare professional. Elderly patients should be particularly cautious at the start of treatment due to the risk of falls from dizziness or drowsiness. Visual disturbances or changes in eyesight may occur, which may improve upon discontinuation of the medication. Caution should be exercised when switching to this drug from monotherapy, as sudden withdrawal may result in withdrawal symptoms such as insomnia, headaches, and anxiety. There is a potential for drug abuse or dependence, so caution is advised in patients with a history of central nervous system drug abuse. Patients with impaired kidney function may require dosage adjustments. Patients with heart disease should use this drug cautiously due to the risk of congestive heart failure. Caution should be exercised when using this drug in combination with opioid analgesics as it may increase the risk of central nervous system depression. Patients with compromised respiratory function or elderly patients may have an elevated risk of severe respiratory depression and may require dosage adjustments. During early pregnancy, there is a risk of fetal malformations; thus, this drug should not be used in pregnant women, and fertile women should use effective contraception. Breastfeeding women should consider discontinuing breastfeeding or the medication as it may transfer into breast milk and affect the infant. Activities requiring alertness such as driving or operating machinery should be avoided until dizziness and drowsiness subside. Severe skin reactions may rarely occur; thus, discontinue use immediately if any skin abnormalities occur. In the case of overdose, symptoms such as confusion, drowsiness, and depression may appear, and treatment like dialysis may be required if necessary. Store out of reach of children, and avoid transferring to other containers as it may not maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues.

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • spatial disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • abnormal sexual arousal
  • restlessness
  • anxiety
  • mood disturbances
  • emotional blunting
  • emotional elevation
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • movement coordination abnormalities
  • equilibrium disorders
  • memory loss
  • attention deficits
  • memory impairment
  • tremors
  • speech disorders
  • sensory disturbances
  • 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 is important to store it in a tightly sealed container. Additionally, it should be kept in a cool place, between 15°C to 30°C, to maintain its effectiveness.

Appearance and packaging

Appearance

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

Package unit

30 capsules/bottle, 100 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.