Medication info
New Capen Capsule 75 mg (Pregabalin)

New Capen Capsule 75 mg (Pregabalin)

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

MFDS item code 201804826 · Approved 2018.11.29 · Insurance code 648104160

Summary

Main use
Improvement of neuropathic pain and fibromyalgia, adjunctive treatment for epilepsy.
Who takes it
Adults · Children
Adult dose
This medication is taken orally, divided into two doses per day, irrespective of meals. For peripheral neuropathic pain: Starting dosage is 150 mg daily, with the possibility of increasing to 300 mg daily within 3 to 7 days. If necessary, the dosage can be further increased to a maximum of 600 mg daily at 7-day intervals. For central neuropathic pain: Starting dosage is 150 mg daily, with the possibility of increasing to 300 mg daily after one week.
Child dose
Safety and efficacy data for children under the age of 12 and adolescents aged 12-17 are insufficient, thus administration is not recommended.

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Improvement of neuropathic pain and fibromyalgia, adjunctive treatment for epilepsy.

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

This medication is used to alleviate peripheral and central neuropathic pain in adults. It is also utilized as an adjunctive treatment for partial seizures in epilepsy patients, whether or not accompanied by generalized symptoms. Lastly, it helps relieve pain in fibromyalgia patients. It is effectively used for the treatment of various neurological disorders.

How to take

Adult dose

This medication is taken orally, divided into two doses per day, irrespective of meals. For peripheral neuropathic pain: Starting dosage is 150 mg daily, with the possibility of increasing to 300 mg daily within 3 to 7 days. If necessary, the dosage can be further increased to a maximum of 600 mg daily at 7-day intervals. For central neuropathic pain: Starting dosage is 150 mg daily, with the possibility of increasing to 300 mg daily after one week.

Child dose

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

Precautions

This medication may increase the risk of suicidal thoughts or behaviors; therefore, if any symptoms of depression or mood changes occur during treatment, consult a healthcare professional immediately. Do not take this medication if you are allergic to any of its ingredients, and it should be avoided by patients with certain genetic metabolic disorders. Diabetic patients should be cautious as weight gain may necessitate dosage adjustment of blood sugar control medications. If hypersensitivity reactions such as angioedema occur, discontinue the medication immediately and inform your healthcare provider. Elderly patients may have an increased risk of falls due to dizziness or drowsiness, so particular caution is needed during the initiation of treatment. Transient visual disturbances or changes in vision may occur; consult a healthcare professional if symptoms persist. Withdrawal symptoms such as insomnia, headache, and anxiety can occur upon abrupt discontinuation, thus sudden cessation should be avoided. Patients with a history of substance abuse are at higher risk of misuse of this medication, so it should be taken cautiously, and signs of misuse should be closely monitored. Patients with impaired kidney function may require dosage adjustments. Patients with heart disease should take this medication with caution, and should inform their healthcare provider immediately if symptoms of heart failure occur. Caution is needed when taking with opioid analgesics due to increased risk of central nervous system depression. Patients with respiratory weakness or the elderly are at risk of severe respiratory suppression; therefore, dosage adjustment and monitoring are required. This medication should be avoided during early pregnancy due to the risk of fetal malformations, and fertile women should use effective contraception. During breastfeeding, this medication can be passed into breast milk, and safety has not been established; therefore, breastfeeding should be avoided or discussed with a healthcare professional. Caution is advised when driving or operating machinery due to the risk of accidents caused by dizziness and drowsiness. Severe skin reactions may rarely occur; discontinue usage immediately and inform your healthcare provider if any symptoms such as rash or swelling appear. In case of overdose, symptoms such as confusion, drowsiness, and seizures may occur; immediate medical attention is required, and treatments such as dialysis may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, angioedema, chest tightness, difficulty breathing, cold sweats, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities, sudden and severe headache, lightning headache, seizures, disorientation, visual disturbances.

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • sexual sensation disorder
  • restlessness
  • anxiety
  • mood swings
  • emotional blunting
  • emotional elevation
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • inability to restrain
  • apathy
  • ataxia
  • impaired coordination
  • balance disturbance
  • memory loss
  • attention disorders
  • memory impairment
  • tremor
  • 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 closed container to protect it from air and moisture. The appropriate storage temperature is between 15 to 30 degrees Celsius, and it should be kept in a location that is neither too hot nor too cold.

Appearance and packaging

Appearance

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

Package unit

30 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.