Medication info
Regabacapsule 75 mg (Pregabalin)

Regabacapsule 75 mg (Pregabalin)

Prescription medicationHard capsule경구
Ingredient · strength
Pregabalin›75mg / 1 capsule
Manufacturer / importer
위더스제약(주)
Appearance
Hard capsule with a reddish-brown upper part and a white lower part containing white or pale yellow powder
Packaging
30 capsules/bottle, 100 capsules/bottle
Approval status
Active

MFDS item code 201603420 · Approved 2016.06.14 · Insurance code 660702970

Summary

Main use
Treatment of peripheral and central neuropathic pain, adjunctive therapy for partial seizures in epilepsy, improvement of fibromyalgia
Who takes it
Adults · Children
Adult dose
This drug should be taken orally in two divided doses, regardless of food, with a total daily dose. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Starting dose is 150 mg per day. The dose may be increased to 300 mg per day within 3 to 7 days. After that, it may be escalated to a maximum of 600 mg per day at intervals of 7 days. - Central Neuropathic Pain: Starting dose is 150 mg per day. After one week, it may be increased to 300 mg per day.
Child dose
Administration is not recommended for children under 12 years of age and adolescents aged 12 to 17 due to insufficient safety and efficacy data.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

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

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

This drug is used to treat peripheral and central neuropathic pain in adults. It also helps as an adjunct in patients with epilepsy experiencing partial seizures. Moreover, it is used to alleviate the symptoms of fibromyalgia. Overall, it effectively aids in improving nerve-related pain and seizures.

How to take

Adult dose

This drug should be taken orally in two divided doses, regardless of food, with a total daily dose. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Starting dose is 150 mg per day. The dose may be increased to 300 mg per day within 3 to 7 days. After that, it may be escalated to a maximum of 600 mg per day at intervals of 7 days. - Central Neuropathic Pain: Starting dose is 150 mg per day. After one week, it may be increased to 300 mg per day.

Child dose

Administration is not recommended for children under 12 years of age and adolescents aged 12 to 17 due to insufficient safety and efficacy data.

Precautions

This drug may increase the risk of suicidal thoughts or behaviors, so if there are signs of depression or mood changes during treatment, it is crucial to inform your healthcare provider immediately. It is not advisable to use this drug if there is a hypersensitivity to it or if there are genetic problems such as lactose intolerance. Diabetic patients may experience difficulty controlling blood sugar levels due to weight gain, which could necessitate adjustments in diabetes medication dosages. If symptoms of angioedema occur, the drug should be discontinued immediately and a doctor consulted. Elderly patients should be cautious during initial administration due to the risk of falls caused by dizziness or drowsiness. Blurred vision or changes in vision may occur, and abnormal symptoms should be reported. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as insomnia, headaches, and anxiety, so it should be tapered off per doctor's instructions. Patients with a history of substance abuse may have a higher risk of misuse of this drug, hence it should be administered with caution. Patients with impaired kidney function may require dosage adjustments. Those with cardiac conditions should be cautious when taking this medication. Concomitant use with opioid analgesics could increase the risk of central nervous system depression, so caution is advised. Patients with respiratory or neurological conditions or the elderly may be at risk for severe respiratory depression, so consulting healthcare providers is essential. During early pregnancy, there is a risk of fetal malformations, so women who are pregnant or planning to become pregnant must consult a physician. While breastfeeding, this drug can pass into breast milk; hence, the option of discontinuing breastfeeding or the drug should be considered. There is a risk of accidents due to dizziness and drowsiness when driving or operating machinery, so caution should be exercised until symptoms improve. Severe skin reactions can occur rarely; therefore, if a skin rash or swelling appears, immediate cessation of the drug and a visit to the hospital are required. In case of overdose, confusion, drowsiness, and depressive symptoms may arise, and treatments such as dialysis may be required if necessary. This drug should be kept out of reach of children, and it is advisable not to transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, breathing difficulties, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urinary issues

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • spatial disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • hypersensitivity
  • restlessness
  • anxiety
  • mood fluctuations
  • emotional dullness
  • emotional elevation
  • difficulty in finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • loss of impulse control
  • apathy
  • ataxia
  • coordination problems
  • balance disorders
  • amnesia
  • attention deficit
  • memory impairment
  • tremors
  • speech disturbances
  • sensory abnormalities
  • sensory loss

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

Storage

This drug should be stored in a tightly closed container to prevent air or moisture ingress. Additionally, it is best stored at a temperature between 15 degrees and 30 degrees Celsius, avoiding extremes of cold or heat.

Appearance and packaging

Appearance

Hard capsule with a reddish-brown upper part and a white lower part containing white or pale yellow 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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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.