Medication info

Pregabalin Capsule 75 mg (Pregabalin)

Prescription medicationApproval withdrawn
Ingredient · strength
Pregabalin›Strength being verified
Manufacturer / importer
한국유나이티드제약(주)
Appearance
A hard capsule with a brown-red upper part and a white lower part containing white powder that is white or light yellow.
Packaging
Domestic: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle Export: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle, 60 capsules (10 capsules/PTPX6)
Approval status
Approval withdrawn

MFDS item code 201109145 · Approved 2011.10.25

This product's status changed to Approval withdrawn on 2023.05.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of peripheral and central neuropathic pain, adjunctive treatment for partial seizures, improvement of fibromyalgia.
Who uses it
Adults · Children
Adult dosage
This medication is administered orally, divided into 2 doses per day, regardless of meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day can be administered, with a potential increase to 300 mg per day after 3-7 days, and if necessary, may be increased up to 600 mg per day at 7-day intervals. - Central neuropathic pain: Starting dose of 150 mg per day can be given, with an increase to 300 mg after a week. Further increase to a maximum of 600 mg may be possible a week later, based on patient response.
Children's dosage
Administration in children under 12 years and adolescents aged 12-17 is not recommended due to insufficient safety and efficacy data.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

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

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

This medication is used to relieve peripheral and central neuropathic pain in adults. It is also used as an adjunctive treatment for patients with epilepsy who experience partial seizures, aiding in seizure control. Furthermore, it is effective in alleviating pain associated with fibromyalgia. It is used to improve a variety of neuropathic pain and abnormal symptoms.

Dosage and Administration

Adult dosage

This medication is administered orally, divided into 2 doses per day, regardless of meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day can be administered, with a potential increase to 300 mg per day after 3-7 days, and if necessary, may be increased up to 600 mg per day at 7-day intervals. - Central neuropathic pain: Starting dose of 150 mg per day can be given, with an increase to 300 mg after a week. Further increase to a maximum of 600 mg may be possible a week later, based on patient response.

Children's dosage

Administration in children under 12 years and adolescents aged 12-17 is not recommended due to insufficient safety and efficacy data.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors, so if symptoms of depression or mood changes occur during treatment, consult a doctor immediately. Do not take if you are allergic to any of the ingredients in this medication, and patients with specific genetic lactose metabolism disorders should avoid it as well. Diabetic patients may experience weight gain after taking this medication, which may require dosage adjustment of blood sugar control medications. If symptoms of angioedema, such as swelling around the face or neck, occur, stop taking the medication immediately and inform a healthcare professional. Elderly patients should be cautious as this medication may cause dizziness or drowsiness, increasing the risk of accidents such as falls. This medication may cause temporary blurred vision or changes in vision; if these symptoms occur, consult a doctor. Withdrawal symptoms, such as headaches, anxiety, and insomnia, may occur if the medication is discontinued abruptly, so gradual tapering is recommended, under the supervision of a healthcare professional. This medication has a risk of abuse, so patients should disclose their mental health status and medication history accurately to their healthcare provider. Patients with decreased kidney function may require dosage adjustments. Patients with severe heart disease should use caution when taking this medication. When taken with other CNS depressants, the risk of drowsiness or respiratory depression may increase, so caution is advised. Early pregnancy poses a risk of fetal malformations; therefore, pregnant women or those planning to become pregnant should consult a doctor, and fertile women should use effective contraception. Breastfeeding may transfer this medication into breast milk and affect the baby, so consult a healthcare provider regarding breastfeeding. This medication can cause dizziness and drowsiness, so it is advisable to avoid driving or operating dangerous machinery after taking it. In cases of overdose, severe drowsiness, confusion, depression, etc., may occur; seek medical attention immediately.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (skin or eyes turning yellow), profound lethargy, sudden and severe headache, lightning headache, seizures, confusion of awareness, vision abnormalities, paralysis, urinary issues.

Mild side effects

  • Dizziness
  • drowsiness
  • rhinitis
  • increased appetite
  • decreased appetite
  • hypoglycemia
  • confusion
  • disorientation
  • irritability
  • depression
Show 22 more
  • exhilaration
  • decreased libido
  • insomnia
  • depersonalization
  • sexual dysfunction
  • restlessness
  • anxiety
  • mood fluctuations
  • emotional lability
  • difficulties finding appropriate terms
  • hallucination
  • abnormal dreams
  • increased libido
  • panic attacks
  • impulsivity
  • apathy
  • ataxia
  • motor coordination impairment
  • balance disorders
  • amnesia
  • attention deficit
  • memory impairment.

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture exposure. It is important to maintain storage temperature between 15 to 30 degrees Celsius to preserve the efficacy and safety of the medication.

Appearance and packaging

Appearance

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

Package unit

Domestic: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle Export: 10 capsules/bottle, 30 capsules/bottle, 60 capsules/bottle, 60 capsules (10 capsules/PTPX6)

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.