Medication info

Sandoz Pregabalin Capsule 75 mg

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201504306 · 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This product's status changed to Approval withdrawn on 2023.06.29.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, adjunctive therapy for partial seizures in epilepsy, improvement of fibromyalgia
Who uses it
Adults · Children
Adult dosage
This medication is to be taken orally, divided into two doses per day, regardless of meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day, can be increased to 300 mg per day after 3 to 7 days, and if necessary, further increased to a maximum of 600 mg per day at intervals of 7 days. - Central neuropathic pain: Starting dose of 150 mg per day, increased to 300 mg per day after 1 week, and additional increases can be made
Children's dosage
The safety and efficacy data for pediatric patients under 12 years of age and adolescents aged 12 to 17 are insufficient, so administration is not recommended.

Ingredients

Importer
한국산도스(주)

Efficacy & effects

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

  • Peripheral neuropathic pain
  • central neuropathic pain
  • partial seizures accompanied by secondary generalization
  • partial seizures not accompanied by secondary generalization
  • fibromyalgia
View approved original text

This medication is used to treat neuropathic pain originating from the peripheral and central nervous systems in adults. It is also effective as an adjunct for partial seizures in epilepsy patients, with or without secondary generalized symptoms. It also helps alleviate pain caused by fibromyalgia. In summary, this drug is used for neuropathic pain, adjunctive treatment of partial seizures in epilepsy, and improvement of fibromyalgia symptoms.

Dosage and Administration

Adult dosage

This medication is to be taken orally, divided into two doses per day, regardless of meals. 1. Neuropathic pain - Peripheral neuropathic pain: Starting dose of 150 mg per day, can be increased to 300 mg per day after 3 to 7 days, and if necessary, further increased to a maximum of 600 mg per day at intervals of 7 days. - Central neuropathic pain: Starting dose of 150 mg per day, increased to 300 mg per day after 1 week, and additional increases can be made

Children's dosage

The safety and efficacy data for pediatric patients under 12 years of age and adolescents aged 12 to 17 are insufficient, so administration is not recommended.

Precautions

This drug, as an anticonvulsant, may increase the risk of suicidal thoughts or behavior, so it is essential to carefully monitor mood changes or unusual behavior during treatment. Patients with hypersensitivity to this drug or genetic lactose metabolism disorders should not take it. Diabetic patients should be cautious as weight gain may require adjustments to their blood glucose-controlling medications. If allergic reactions such as angioedema occur, immediately discontinue the drug. Elderly patients should be especially careful at the beginning of treatment due to the heightened risk of falls from dizziness or drowsiness. Some patients may experience blurred vision or changes in eyesight; if symptoms appear, consult a physician. When discontinuing the drug, withdrawal symptoms such as insomnia, headache, and anxiety may occur, so it should be tapered gradually in consultation with healthcare providers. This medication has a potential for abuse, so patients with a history of psychiatric disorders or substance abuse should be closely monitored. Patients with impaired kidney function may require dose adjustments. Caution should be exercised when administering to patients with cardiovascular diseases, particularly those with congestive heart failure. Combining this drug with other medications that have central nervous system depressant effects may increase the risk of respiratory depression, so careful monitoring is advised. Pregnant women should avoid this medication during early pregnancy due to the risk of fetal malformation, and women of childbearing age should use effective contraception. Breastfeeding may transfer this drug to breast milk, so mothers should either discontinue breastfeeding or consult a physician. It is advisable to avoid hazardous activities such as driving or operating machinery until dizziness or drowsiness resolves. If severe allergic reactions such as skin rash, edema, or difficulty breathing occur during use, immediately cease the drug and visit a medical institution. In cases of overdose, symptoms may include drowsiness, confusion, and depression; treatment such as hemodialysis may be necessary if required. Keep this medication out of reach of children and do not transfer it to another container.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • facial swelling
  • cold sweat
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • anaphylaxis-like symptoms
  • mucocutaneous syndrome
  • shock
  • respiratory depression
Show 15 more
  • loss of consciousness
  • mental disorders
  • paralysis (facial paralysis)
  • severe edema
  • decreased urine output
  • renal failure
  • pulmonary edema
  • tongue swelling
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • congestive heart failure
  • angioedema
  • difficulty breathing
  • severe allergic reactions
  • severe

Mild side effects

  • Pharyngitis
  • neutropenia
  • increased appetite
  • loss of appetite
  • hypoglycemia
  • confusion
  • altered sense of direction
  • irritability
  • depression
  • euphoria
Show 23 more
  • decreased libido
  • insomnia
  • depersonalization
  • sexual sensation disorder
  • restlessness
  • anxiety
  • mood swings
  • emotional lability
  • emotional elevation
  • difficulty in finding appropriate words
  • hallucinations
  • abnormal dreams
  • increased libido
  • panic attacks
  • disinhibition
  • apathy
  • dizziness
  • drowsiness
  • ataxia
  • abnormal motor coordination
  • balance disorders
  • amnesia
  • attention span

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. Additionally, it is important to store it at a cool temperature between 15 to 30 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

A hard capsule with a white or nearly white powder on the upper part in reddish brown and the lower part in white

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.