Medication info

Pregabalin 75 mg Capsules

Prescription medicationHard capsule경구Approval withdrawn
Ingredient · strength
Pregabalin›75mg / 1 capsule
Manufacturer / importer
하이플생명과학(주)
Appearance
A hard capsule with a reddish-brown upper part and a white lower part containing white powder that is white or light yellow in color.
Packaging
30 capsules/bottle, 60 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 201905824 · Approved 2019.08.19

This product's status changed to Approval withdrawn on 2024.03.28. 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, adjuvant treatment of partial seizures, improvement of fibromyalgia.
Who takes it
Adults · Children
Adult dose
This medication is taken orally, divided into two doses daily, regardless of meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg once daily, may increase to 300 mg once daily after 3 to 7 days, and if necessary, may be increased to a maximum of 600 mg once daily at 7-day intervals. - Central neuropathic pain: Starting dose of 150 mg once daily, may increase to 300 mg once daily after one week.
Child dose
Safety and efficacy data are insufficient, and the medication is not recommended for patients under 12 years of age or adolescents aged 12 to less than 17 years.

Ingredients

Manufacturer
하이플생명과학(주)

Efficacy & effects

Relief of peripheral and central neuropathic pain, adjuvant treatment of partial seizures, 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 and is also used as an adjunct in the treatment of partial seizures in patients with epilepsy. It is effective in alleviating the symptoms of fibromyalgia, and as such, is widely used in the treatment of neuralgia and related disorders.

How to take

Adult dose

This medication is taken orally, divided into two doses daily, regardless of meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg once daily, may increase to 300 mg once daily after 3 to 7 days, and if necessary, may be increased to a maximum of 600 mg once daily at 7-day intervals. - Central neuropathic pain: Starting dose of 150 mg once daily, may increase to 300 mg once daily after one week.

Child dose

Safety and efficacy data are insufficient, and the medication is not recommended for patients under 12 years of age or adolescents aged 12 to less than 17 years.

Precautions

This medication may increase the risk of suicidal thoughts or behavior, so if symptoms of depression, mood changes, or unusual behavior occur during treatment, healthcare providers should be notified immediately. This medication should not be taken by individuals with allergies to any of its ingredients or specific genetic metabolic problems. Diabetic patients should be cautious as weight gain may require adjustments in the dosage of blood glucose-lowering medications. If symptoms of angioedema, such as swelling of the face or around the mouth, occur, use should be stopped immediately. Elderly individuals may experience dizziness, drowsiness, or mental confusion and should be particularly cautious until they become accustomed to the medication. Blurred vision or changes in vision may occur; if these symptoms appear, consult a physician. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as insomnia, headache, nausea, and anxiety, and dosage should be gradually reduced under medical supervision. Due to the risk of drug abuse or dependence, patients with a history of substance abuse should use this medication with caution. Patients with impaired kidney function may require dosage adjustments. Patients with heart disease should use this medication carefully, taking into account potential risks of congestive heart failure. Caution is advised when taking this medication alongside other central nervous system depressants due to an increased risk of respiratory depression. Pregnant women or those planning to become pregnant should consult their physician before taking this medication due to risks of fetal malformation, and effective contraceptive methods should be used. Nursing mothers should carefully consider the decision to breastfeed as this medication can transfer into breast milk and may affect the baby. There is a risk of accidents due to dizziness and drowsiness during driving or operating machinery after taking this medication; such activities should be avoided if these symptoms appear. In case of overdose, symptoms like confusion, drowsiness, depression, and seizures may occur, and emergency treatment should be sought immediately. When taken by children or the elderly, this medication should be stored out of the reach of children, and it is advisable not to transfer the capsules to other containers. Although rare, this medication may cause serious side effects such as skin rash, severe allergic reactions, and difficulty breathing; if any unusual symptoms occur, discontinuation and medical consultation are advised.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, facial swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, asthma attacks, respiratory issues alongside cough and fever, jaundice, severe fatigue, liver abnormalities (jaundice), sudden severe headache, lightning headache,

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • sense of direction disturbance
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • altered sexual sensation
  • restlessness
  • anxiety
  • mood lability
  • emotional blunting
  • mood elevation
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • abnormal coordination
  • balance disorder
  • memory impairment
  • attention deficit
  • memory loss
  • tremors
  • speech disturbances
  • sensory abnormalities
  • sensory loss

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

Storage

This medication should be stored in a tightly sealed container, protected from air and light, and kept at room temperature between 15 to 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

A hard capsule with a reddish-brown upper part and a white lower part containing white powder that is white or light yellow in color.

Package unit

30 capsules/bottle, 60 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.