Medication info
Pregabalin Capsule 300 mg (Pregabalin)

Pregabalin Capsule 300 mg (Pregabalin)

Prescription medicationHard capsule경구
Ingredient · strength
Pregabalin›300mg / 1 capsule
Manufacturer / importer
한미약품(주)
Appearance
Brown hard capsule with a white powder in the upper part and a white lower part
Packaging
30 capsules/bottle, 300 capsules/bottle
Approval status
Active

MFDS item code 201500516 · Approved 2015.01.30 · Insurance code 643507110

Summary

Main use
Relief of peripheral and central neuropathic pain, adjunctive treatment for partial seizures in epilepsy, improvement of fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication is dosed as Pregabalin and taken orally, divided into two doses per day, regardless of meals. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Initial dose is 150 mg per day, can be increased to 300 mg within 3 to 7 days, with further increases up to a maximum of 600 mg per day possible at 7-day intervals. - Central Neuropathic Pain: Initial dose is 150 mg per day, for one week.
Child dose
Safety and efficacy data for children under 12 years of age and adolescents aged 12 to 17 are insufficient, and thus administration is not recommended.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

Relief of peripheral and central neuropathic pain, adjunctive treatment for partial seizures in epilepsy, improvement of fibromyalgia

  • Peripheral neuropathic pain
  • central neuropathic pain
  • partial seizures with or without secondary generalization
  • fibromyalgia
View approved original text

This medication is used in the treatment of peripheral and central neuropathic pain in adults. It is also very effective as an adjunct for partial seizures in epilepsy, both with or without secondary generalizations. Additionally, it helps to relieve pain in patients with fibromyalgia. It is used to improve various pain and spasms related to the nervous system.

How to take

Adult dose

This medication is dosed as Pregabalin and taken orally, divided into two doses per day, regardless of meals. 1. Neuropathic Pain - Peripheral Neuropathic Pain: Initial dose is 150 mg per day, can be increased to 300 mg within 3 to 7 days, with further increases up to a maximum of 600 mg per day possible at 7-day intervals. - Central Neuropathic Pain: Initial dose is 150 mg per day, for one week.

Child dose

Safety and efficacy data for children under 12 years of age and adolescents aged 12 to 17 are insufficient, and thus administration is not recommended.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so any changes in mood or behavior during treatment should be reported to healthcare professionals immediately. Patients with hypersensitivity to this medication should not take it. Diabetic patients should be cautious as weight gain may require adjustments to their blood sugar control medications. If allergic reactions such as swelling around the face, mouth, or neck (angioedema) occur, the medication should be discontinued immediately. Elderly patients may experience increased dizziness or drowsiness, which can elevate the risk of falls, especially during the initial dose. If any unusual symptoms such as blurred vision or changes in eyesight occur, patients should consult their healthcare provider. Abrupt discontinuation of this medication can lead to withdrawal symptoms such as insomnia, headache, and anxiety, so it should be tapered off gradually under medical guidance. Patients with a history of substance abuse should be monitored closely due to increased risk of misuse. Patients with reduced kidney function may need dose adjustments; kidney statuses should be assessed. Patients with heart failure should use caution when taking this medication, and those with heart conditions should consult their healthcare provider. Caution is advised when taking this medication along with opioid analgesics, as it can enhance central nervous system depressant effects and increase the risk of respiratory depression. Patients with weak respiratory function or the elderly may be at risk for severe respiratory depression, thus dose adjustment may be necessary. It is advisable to avoid this medication during early pregnancy due to the risk of congenital malformations in the fetus, and women of childbearing age should use effective contraceptive methods during treatment. Breastfeeding women are advised to discontinue breastfeeding as this medication can be transferred to breast milk and may affect the infant. Patients should be careful during activities that require alertness, such as driving or operating machinery, as dizziness or drowsiness may occur after taking this medication. If severe skin rashes or blisters develop, patients should stop taking the medication immediately and inform their healthcare provider. Overdose may result in drowsiness, confusion, depression, seizures, and may necessitate treatments such as hemodialysis if required. Keep this medication out of reach of children, and do not transfer it to another container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema, facial swelling, facial edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities associated with cough and fever, respiratory depression, yellowing of the skin or eyes (jaundice),

Mild side effects

Dizziness, drowsiness, confusion, disorientation, irritability, depression, euphoria, decreased libido, insomnia, depersonalization, sexual dysfunction, restlessness, anxiety, mood swings, emotional blunting, emotional elevation, difficulties in finding appropriate terms, hallucinations, abnormal dreams, increased libido, panic attacks, impulsivity, apathy, ataxia, impaired coordination, balance disorder, amnesia, attention deficit, memory impairment, tremors, dysarthria, somatosensory 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 protect it from air and moisture, in a cool place between 15°C and 30°C.

Appearance and packaging

Appearance

Brown hard capsule with a white powder in the upper part and a white lower part

Package unit

30 capsules/bottle, 300 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.