Medication info
Pregabalin Capsule 50 mg (Pregabalin)

Pregabalin Capsule 50 mg (Pregabalin)

Prescription medicationHard capsule경구
Ingredient · strength
Pregabalin›50mg / 1 capsule
Manufacturer / importer
명인제약(주)
Appearance
A hard capsule with a dark blue upper and white lower, containing a white powder that is white or light yellow in color.
Packaging
30 capsules/bottle
Approval status
Active

MFDS item code 201804578 · Approved 2018.11.19 · Insurance code 651904680

Summary

Main use
Relief of peripheral and central neuropathic pain, adjunctive treatment of partial seizures in epilepsy, improvement of fibromyalgia
Who takes it
Adults · Children
Adult dose
This medication should be taken orally in two divided doses per day, regardless of meals. 1. Neuropathic Pain - Peripheral Neuropathic Pain: An initial dose of 150 mg per day may be given, and it can be increased to 300 mg per day after 3 to 7 days. Subsequently, it may be further increased up to a maximum of 600 mg at intervals of 7 days as needed. - Central Neuropathic Pain: An initial dose of 150 mg per day
Child dose
Administration is not recommended for children under 12 years of age and adolescents aged 12 to 17 years due to insufficient safety and efficacy data.

Ingredients

Manufacturer
명인제약(주)

Efficacy & effects

Relief of peripheral and central neuropathic pain, adjunctive treatment of partial seizures in epilepsy, 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. It is also used as an adjunct for partial seizures in patients with epilepsy, applicable in both cases whether accompanied by secondary generalized symptoms or not. Additionally, it is effective for the treatment of fibromyalgia. This medication is used to improve symptoms of various neurological-related disorders.

How to take

Adult dose

This medication should be taken orally in two divided doses per day, regardless of meals. 1. Neuropathic Pain - Peripheral Neuropathic Pain: An initial dose of 150 mg per day may be given, and it can be increased to 300 mg per day after 3 to 7 days. Subsequently, it may be further increased up to a maximum of 600 mg at intervals of 7 days as needed. - Central Neuropathic Pain: An initial dose of 150 mg per day

Child dose

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

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so immediately inform a healthcare professional if mood changes or depressive symptoms arise during use. Do not take this medication if there is hypersensitivity to it or if there are specific genetic issues such as lactose intolerance. Diabetic patients should be cautious as weight gain may require adjustment of blood glucose control medication. If any symptoms of angioedema appear, discontinue this medication immediately, and elderly patients should be careful of the risk of falls due to dizziness or drowsiness. Vision blur or changes in eyesight may occur, so consult a healthcare professional if symptoms arise. Abrupt discontinuation of this medication may lead to withdrawal symptoms such as insomnia, headaches, or anxiety, so adjustments should be made in consultation with a healthcare professional. Patients with a history of substance abuse may have a higher risk of abuse with this medication and should take it cautiously while carefully observing signs of drug misuse. Patients with reduced kidney function may require dosage adjustments. Patients with heart disease should be carefully monitored when taking this medication. Taking this medication along with other central nervous system depressants may increase the risk of respiratory depression and other side effects, so caution is warranted. In the early stages of pregnancy, there is a risk of fetal malformation, so pregnant women should not take it unless absolutely necessary, and women of childbearing age should use effective contraception. Breastfeeding mothers should consult a healthcare professional regarding the possibility of transfer to breast milk and whether to discontinue breastfeeding or the medication. Caution should be exercised while driving or operating machinery due to the risk of accidents from dizziness and drowsiness. This medication may cause serious skin adverse reactions, so if symptoms such as skin rash or fever occur, discontinue use immediately and consult a healthcare professional. In case of overdose, symptoms such as confusion, drowsiness, depression, and seizures may occur, and immediate hospital visit for proper treatment is necessary. This medication should be kept out of the reach of children, and it is advisable to avoid transferring it to another container as it may reduce quality or pose risk of accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by high fever, blisters, shedding of skin, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attacks, breathing abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy throughout the body, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disorientation
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
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  • sexual arousal disorder
  • restlessness
  • anxiety
  • mood disturbances
  • emotional lability
  • difficulty finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • flatness
  • ataxia
  • coordination disorder
  • balance disturbance
  • memory loss
  • attention deficit
  • memory impairment
  • tremor
  • speech disorder
  • sensory abnormalities
  • sensory deficits

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. Additionally, it is best to store it at room temperature between 15 and 30 degrees Celsius.

Appearance and packaging

Appearance

A hard capsule with a dark blue upper and white lower, containing a white powder that is white or light yellow in color.

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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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.