Medication info
Soultra Tablet

Soultra Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›37.5mg / 1 tabletAcetaminophen›325mg / 1 tablet
Manufacturer / importer
주식회사더유제약
Appearance
Light yellow oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202000541 · Approved 2020.02.03 · Insurance code 057000740

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
For children over 12 years and adults, dosage should be adjusted based on the patient's level of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent doses spaced at least 6 hours apart. Do not exceed 8 tablets per day. The lowest effective dose should be administered for the shortest duration possible, and long-term administration should be avoided unless necessary due to the nature and severity of the illness, in which case regular monitoring of the continuation of this medication should be conducted. For the elderly, administer the standard adult dosage; however, for those over 75 years old, the interval between doses should be extended.
Child dose
For children over 12 years, dosage should be adjusted based on the patient's level of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent doses spaced at least 6 hours apart. Do not exceed 8 tablets per day.

Ingredients

Manufacturer
주식회사더유제약

Efficacy & effects

Relief of moderate to severe acute and chronic pain

  • Moderate acute pain
  • moderate chronic pain
View approved original text

This medication is used to relieve acute and chronic pain ranging from moderate to severe.

How to take

Adult dose

For children over 12 years and adults, dosage should be adjusted based on the patient's level of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent doses spaced at least 6 hours apart. Do not exceed 8 tablets per day. The lowest effective dose should be administered for the shortest duration possible, and long-term administration should be avoided unless necessary due to the nature and severity of the illness, in which case regular monitoring of the continuation of this medication should be conducted. For the elderly, administer the standard adult dosage; however, for those over 75 years old, the interval between doses should be extended.

Child dose

For children over 12 years, dosage should be adjusted based on the patient's level of pain and treatment response. An initial dose of 2 tablets is recommended, with subsequent doses spaced at least 6 hours apart. Do not exceed 8 tablets per day.

Precautions

This medication may cause liver damage if taken regularly by individuals who consume more than three alcoholic drinks daily; therefore, it is essential to consult a doctor or pharmacist. During the course of taking this medication, severe skin reactions such as rashes, pustules, or intense inflammation may occur; if such symptoms appear, discontinue use immediately and consult a healthcare professional. One of the ingredients in this medication may trigger seizures, so patients with a history of seizures or high seizure risk require special caution. Rarely, a life-threatening allergic reaction may occur while taking this medication; therefore, seek immediate medical attention if symptoms such as difficulty breathing, hives, or severe swelling manifest. Patients with severe respiratory conditions should receive this medication only in a medical facility with appropriate equipment due to an increased risk of respiratory depression. Co-administration of this medication with alcohol or sedatives should be avoided as it can lead to severe drowsiness, respiratory depression, or even coma. Patients with head injuries or brain diseases should exercise caution when using this medication as it may cause serious side effects like increased intracranial pressure. This medication may cause physical and psychological dependence; therefore, careful monitoring for the development of dependence should be conducted during long-term use. Patients with impaired liver function must consult with a physician before taking this medication, and strict adherence to the prescribed daily dosage is necessary to minimize the risk of hepatotoxicity. In patients with specific genetic traits, the risk of respiratory depression may increase; thus, dosage adjustments or alternative medications may be necessary based on genetic testing results. Children under 12 years of age and adolescents under 18 years of age after certain surgeries should not be administered this medication due to a particularly high risk of respiratory depression in this age group. Patients with sleep apnea or hypoxia should continuously monitor for symptom exacerbation while taking this medication and adjust or discontinue dosage if necessary. Sodium levels in the blood may decrease while taking this medication, so elderly patients or those with relevant risk factors should have their serum sodium levels checked regularly. Patients with a prior allergic reaction to any of the components, those in a severe respiratory depression state, those with head trauma, or those taking certain medications should not receive this medication prior to administration. The risk of side effects increases when this medication is used with other central nervous system depressants; thus, when co-administering, the lowest effective dose should be used for the shortest duration and patient condition should be closely monitored. Pregnant or breastfeeding women must consult a doctor before taking this medication, as it may pose risks of side effects to the fetus or neonate. This medication may cause drowsiness or dizziness; therefore, it is recommended to avoid driving or operating dangerous machinery after taking it. In case of overdose, serious respiratory depression, seizures, or liver damage may occur; therefore, the dosage must be strictly adhered to, and immediate medical attention should be sought if an overdose is suspected. This medication should be stored in a secure location out of reach of children to prevent accidental ingestion or misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash accompanied by fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanied respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, vision abnormalities, paralysis, urination

Mild side effects

  • Loss of appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • dyspepsia
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • decreased libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitability
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • hypersomnia
  • sensory loss
  • tremors
  • paresthesia
  • attention deficit

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

Storage

This medication should be stored in a tightly sealed container to prevent air exposure, and it is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Light yellow oval film-coated tablet

Package unit

30 tablets/bottle, 300 tablets/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

No questions yet.

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.