Medication info
Strongsest Semi Tablet

Strongsest Semi Tablet

Prescription medicationTablet경구
Ingredient · strength
Tramadol Hydrochloride›18.75mg / 1 tabletAcetaminophen›162.5mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Pale yellow oblong film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201903286 · Approved 2019.05.21 · Insurance code 642307790

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults · Children
Adult dose
Children over 12 years and adults: The dosage should be adjusted according to the severity of the patient’s pain and treatment response. It is recommended to administer 4 tablets as an initial dose and subsequent doses at least 6 hours apart, not exceeding 16 tablets per day. The effective minimum dosage should be administered for the shortest possible duration. This medication should not be used for longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the need for continued administration of this medication. Elderly patients Usual adult doses should be administered. However, in patients over 75 years of age, it has been observed that the half-life of tramadol is increased by 17% when administered orally, so it should be administered at intervals of at least 6 hours. Patients with renal impairment In moderate renal impairment patients (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment patients (creatinine clearance of less than 10 ml/min) should not be given this medication. Tramadol is removed very slowly during blood dialysis and filtration, therefore there is no need to re-administer this medication after dialysis to maintain analgesic effects. Patients with hepatic impairment In moderate hepatic impairment patients, consideration should be given to extending dosage intervals. This medication should not be administered to patients with severe hepatic impairment.
Child dose
Children over 12 years and adults: The dosage should be adjusted according to the severity of the patient’s pain and treatment response. It is recommended to administer 4 tablets as an initial dose, and subsequent doses should be at least 6 hours apart, but should not exceed 16 tablets per day.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic pain

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

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

How to take

Adult dose

Children over 12 years and adults: The dosage should be adjusted according to the severity of the patient’s pain and treatment response. It is recommended to administer 4 tablets as an initial dose and subsequent doses at least 6 hours apart, not exceeding 16 tablets per day. The effective minimum dosage should be administered for the shortest possible duration. This medication should not be used for longer than necessary, and if prolonged use is required due to the nature and severity of the disease, regular monitoring should be conducted to confirm the need for continued administration of this medication. Elderly patients Usual adult doses should be administered. However, in patients over 75 years of age, it has been observed that the half-life of tramadol is increased by 17% when administered orally, so it should be administered at intervals of at least 6 hours. Patients with renal impairment In moderate renal impairment patients (creatinine clearance of 10-30 ml/min), the dosing interval should be extended to 12 hours. Severe renal impairment patients (creatinine clearance of less than 10 ml/min) should not be given this medication. Tramadol is removed very slowly during blood dialysis and filtration, therefore there is no need to re-administer this medication after dialysis to maintain analgesic effects. Patients with hepatic impairment In moderate hepatic impairment patients, consideration should be given to extending dosage intervals. This medication should not be administered to patients with severe hepatic impairment.

Child dose

Children over 12 years and adults: The dosage should be adjusted according to the severity of the patient’s pain and treatment response. It is recommended to administer 4 tablets as an initial dose, and subsequent doses should be at least 6 hours apart, but should not exceed 16 tablets per day.

Precautions

This medication may pose a risk of liver damage in individuals who regularly consume three or more alcoholic drinks a day, so consultation with a doctor or pharmacist is necessary. This medication can rarely cause serious skin reactions, so if a rash or hypersensitivity reaction occurs, treatment should be discontinued immediately and a doctor should be notified. Tramadol, one of the components of this medication, can increase the risk of seizures if taken beyond the recommended dosage, and the risk may be further heightened when combined with certain antidepressants or other narcotic analgesics. Rarely, fatal allergic reactions such as anaphylaxis have been reported, so medical consultation is required if any allergic symptoms occur. In patients with acute or severe bronchial asthma, potentially life-threatening respiratory depression may occur, so administration to these patients should be done in a facility with special equipment. Taking this medication with alcohol or central nervous system depressants can lead to severe sedation, respiratory depression, coma, or even death, so it should be avoided or closely monitored. Patients with increased intracranial pressure or head injury should be cautious as this medication may further elevate brain pressure due to respiratory depression during its use. This medication may cause dependence similar to morphine, so caution should be exercised regarding the potential for dependence and abuse when used for an extended period. As the acetaminophen component is metabolized in the liver, patients with impaired liver function must consult a doctor before use and should not exceed the daily recommended dosage. Some individuals may metabolize this medication quickly, leading to unexpectedly high drug concentrations and respiratory depression; dosage adjustments or alternative medications may be necessary in such cases. This medication should not be administered to children under the age of 12 or adolescents under 18 who have undergone tonsillectomy and adenoidectomy. Patients with sleep apnea or hypoxia should be continuously evaluated for worsening symptoms while taking this medication, and dosage should be reduced or discontinued if necessary. Elderly patients or those at risk for hyponatremia should be monitored for the potential development of hyponatremia while using this medication. This medication is contraindicated in certain patients and should not be used by individuals with hypersensitivity, central nervous system drug intoxication, severe respiratory depression, head injury, or those taking MAO inhibitors. Drowsiness or dizziness may occur during use, so caution is advised when driving or operating machinery. In case of overdose, severe side effects such as respiratory depression, seizures, and liver damage may occur, requiring immediate emergency treatment. This medication interacts with many other drugs, increasing the risk of seizures, serotonin syndrome, and respiratory depression when used in conjunction with others, so all medications being taken should be disclosed to a doctor. During pregnancy or lactation, the use of this medication should be carefully considered due to its potential effects on the fetus or newborn, and especially nursing mothers should consult their doctor regarding whether to continue breastfeeding while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), tightness in the chest, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory irregularities accompanied by cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Decreased appetite
  • insomnia
  • depression
  • dizziness
  • headache
  • drowsiness
  • nausea
  • vomiting
  • constipation
  • dry mouth
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  • diarrhea
  • indigestion
  • abdominal pain
  • abdominal discomfort
  • flatulence
  • pruritus
  • sweating
  • rash
  • fatigue
  • flushing
  • hypoglycemia
  • anxiety
  • nervousness
  • emotional instability
  • euphoria
  • reduced libido
  • sleep disturbances
  • confusion
  • disorientation
  • excitement
  • abnormal dreams
  • drug abuse
  • hallucinations
  • withdrawal syndrome
  • migraine
  • somnolence
  • sensory impairment
  • tremors
  • sensory abnormality

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 the optimal storage temperature is between 1 degree Celsius and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness longer.

Appearance and packaging

Appearance

Pale yellow oblong 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

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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.