Medication info

Pregabalin 150 mg Capsule

Prescription medication경구Approval withdrawn
Ingredient · strength
Pregabalin›150mg / 1 capsule
Manufacturer / importer
하이플생명과학(주)
Appearance
A hard capsule with a white upper half and a white lower half containing a white powder that is white or light yellow in color.
Packaging
30 capsules/bottle, 60 capsules/bottle
Approval status
Approval withdrawn

MFDS item code 201905825 · 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This product's status changed to Approval withdrawn on 2024.03.28.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
Treatment of peripheral and central neuropathic pain, adjunctive treatment for partial seizures in epilepsy, alleviation of fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication, as pregabalin, is orally administered divided into two doses per day, without regard to food. 1. Neuropathic Pain Peripheral Neuropathic Pain: The initial dose is 150 mg per day; it can be increased to 300 mg per day after 3 to 7 days, and if necessary, it can be further increased to a maximum of 600 mg per day at 7-day intervals thereafter. Central Neuropathic Pain: The initial dose is 150 mg per day...
Child dose
Safety and efficacy data in children under 12 years and adolescents aged 12 to 17 are insufficient; therefore, administration is not recommended.

Ingredients

Manufacturer
하이플생명과학(주)

Efficacy & effects

Treatment of peripheral and central neuropathic pain, adjunctive treatment for partial seizures in epilepsy, alleviation of fibromyalgia

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

This medication is used to relieve peripheral and central neuropathic pain in adults. It is also utilized as an adjunctive treatment for partial seizures with or without secondary generalized symptoms in the treatment of epilepsy in adults. Additionally, it helps improve the symptoms of fibromyalgia. It is effectively used for various nerve-related diseases and pain management.

How to take

Adult dose

This medication, as pregabalin, is orally administered divided into two doses per day, without regard to food. 1. Neuropathic Pain Peripheral Neuropathic Pain: The initial dose is 150 mg per day; it can be increased to 300 mg per day after 3 to 7 days, and if necessary, it can be further increased to a maximum of 600 mg per day at 7-day intervals thereafter. Central Neuropathic Pain: The initial dose is 150 mg per day...

Child dose

Safety and efficacy data in children under 12 years and adolescents aged 12 to 17 are insufficient; therefore, administration is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or actions; therefore, if any mood changes or symptoms of depression occur during treatment, the patient must immediately inform their healthcare provider. Patients with hypersensitivity to this drug or certain genetic issues such as lactose intolerance should not take this medication. Diabetic patients should exercise caution as weight gain may necessitate adjustments in blood sugar control medications. If symptoms of angioedema (swelling of face or around the mouth) occur, discontinue use immediately. Elderly patients should be cautious, as this medication may increase the risk of falls due to dizziness or drowsiness. Temporary visual disturbances or changes in vision may occur, so consult a healthcare provider if these symptoms appear. Abrupt discontinuation of this drug may lead to withdrawal symptoms such as insomnia, headache, and anxiety; the dosage should be tapered off according to healthcare provider recommendations. Due to the risk of drug abuse, patients with a history of drug abuse or mental disorders must consult before taking this medication. Patients with impaired kidney function may require dosage adjustments. Patients with heart disease should be cautious, as symptoms of heart failure may worsen with this medication. Taking this medication with opioids increases the risk of central nervous system depression, so follow the doctor's advice closely. Patients with respiratory conditions, renal impairment, or the elderly may be at higher risk for severe respiratory depression and should be monitored. During early pregnancy, there is a risk of fetal malformations; thus, pregnant women should avoid taking this medication or do so very cautiously, and women of childbearing potential should use effective contraceptive methods. Breastfeeding women should discuss with their healthcare provider whether to continue or stop breastfeeding, as this medication can pass into breast milk. Driving or operating machinery may increase the risk of accidents due to dizziness or drowsiness after taking this medication, so caution is advised. Severe skin reactions (such as Stevens-Johnson syndrome) may occur, and if any rash or unusual symptoms develop, the patient should stop taking it immediately and notify their healthcare provider. This medication has little drug interaction; however, caution is needed when taking it with central nervous system depressants. In case of overdose, symptoms such as drowsiness, confusion, depression, seizures may occur, and immediate medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin abnormal reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, lightning-like pains

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disorientation
  • irritability
  • depression
  • euphoric feelings
  • reduced libido
  • insomnia
  • depersonalization
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  • altered sexual sensation
  • restlessness
  • anxiety
  • mood swings
  • emotional lows
  • emotional highs
  • difficulty finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • coordination problems
  • balance disturbances
  • memory loss
  • inattention
  • memory impairment
  • tremors
  • speech disorders
  • 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 should be stored in a tightly closed container. It is best kept at room temperature between 15 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

A hard capsule with a white upper half and a white lower half containing a 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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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.