Medication info

Sandoz Pregabalin Capsule 150 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Pregabalin›Strength being verified
Manufacturer / importer
한국산도스(주)
Appearance
White or almost white powder in a hard capsule with a white upper part and white lower part
Packaging
28 capsules (7 capsules/PTPX4)
Approval status
Approval withdrawn

MFDS item code 201504305 · Approved 2015.06.30

This product's status changed to Approval withdrawn on 2023.06.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of peripheral and central neuropathic pain, adjunct for partial seizures in epilepsy, improvement of fibromyalgia
Who uses it
Adults · Children
Adult dosage
This medication is pregabalin and is taken orally in two divided doses daily, regardless of food. 1. Neuropathic pain 1) Peripheral neuropathic pain - The starting dose is 150 mg per day, which can increase to 300 mg per day within 3 to 7 days, and can be raised up to a maximum of 600 mg per day at weekly intervals thereafter. 2) Central neuropathic pain - The starting dose is 150 mg per day.
Children's dosage
There is insufficient safety and efficacy data for children under 12 years of age and adolescents aged 12-17 years; hence, administration is not recommended.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

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

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

This medication is used to treat pain caused by peripheral and central neuropathic conditions in adults, and is used as an adjunct for partial seizures in epilepsy patients with or without secondary generalized symptoms. It is also effective in relieving pain associated with fibromyalgia. This medication helps improve symptoms of various nerve-related disorders.

Dosage and Administration

Adult dosage

This medication is pregabalin and is taken orally in two divided doses daily, regardless of food. 1. Neuropathic pain 1) Peripheral neuropathic pain - The starting dose is 150 mg per day, which can increase to 300 mg per day within 3 to 7 days, and can be raised up to a maximum of 600 mg per day at weekly intervals thereafter. 2) Central neuropathic pain - The starting dose is 150 mg per day.

Children's dosage

There is insufficient safety and efficacy data for children under 12 years of age and adolescents aged 12-17 years; hence, administration is not recommended.

Precautions

During treatment with this medication, patients should be closely monitored for suicidal thoughts or behavior, depression, and abnormal changes in mood and behavior as it is an anticonvulsant. This medication should not be administered to patients with hypersensitivity to the active ingredient pregabalin or those with specific genetic lactose intolerance. Patients with diabetes may require dose adjustments for blood sugar control due to weight gain, and administration should be stopped immediately if symptoms of angioedema occur. Elderly patients may experience symptoms such as dizziness, drowsiness, and confusion, so caution is needed when starting treatment; visual disturbances may also occur. Abrupt discontinuation of this medication may result in withdrawal symptoms such as insomnia, headache, and anxiety; thus, dosage should be reduced gradually. Given the potential for drug abuse and dependence, patients with a history of mental health disorders should be monitored closely. Patients with reduced kidney function may require dose adjustments, and caution should be used when administering to patients with heart failure. The risk of respiratory depression may be increased when used with other CNS depressants, particularly opioids. This medication should not be given to pregnant women, especially in the early stages, unless there are exceptional circumstances, due to the risk of fetal deformities; women of childbearing age should use effective contraception. During breastfeeding, as this medication is excreted in breast milk, it may be necessary to consider discontinuation of breastfeeding or the medication itself. This medication may cause dizziness and drowsiness; thus, patients should avoid engaging in hazardous activities such as driving or operating machinery until they understand how the medication affects them. Severe skin reactions have been rarely reported, so patients should immediately inform healthcare providers if skin rashes or symptoms occur. In case of overdose, symptoms such as confusion, drowsiness, depression, or seizures may occur, and treatment may require procedures such as hemodialysis if necessary. Particular caution is needed for children, elderly, and patients with reduced kidney function, and the medication should be stored out of reach of children.

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 high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, difficulty breathing or asthma attacks, respiratory difficulties accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, vision disturbances, paralysis, urine retention

Mild side effects

  • Dizziness
  • drowsiness
  • confusion
  • disturbed sense of direction
  • irritability
  • depression
  • euphoria
  • decreased libido
  • insomnia
  • depersonalization
Show 23 more
  • dysesthesia
  • restlessness
  • anxiety
  • mood swings
  • emotional blunting
  • emotional elevation
  • difficulty finding appropriate terms
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • loss of inhibition
  • apathy
  • ataxia
  • motor coordination disorders
  • balance disorders
  • amnesia
  • attention deficit
  • memory impairment
  • tremor
  • speech disturbances
  • sensory abnormalities
  • sensory loss

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is also advisable to store the medication at temperatures between 15°C and 30°C, avoiding extreme heat or cold, to maintain its effectiveness and safety.

Appearance and packaging

Appearance

White or almost white powder in a hard capsule with a white upper part and white lower part

Package unit

28 capsules (7 capsules/PTPX4)

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.