Medication info
N-Sitrasemi Sustained Release Tablet (Tramadol Hydrochloride, Acetaminophen)

N-Sitrasemi Sustained Release Tablet (Tramadol Hydrochloride, Acetaminophen)

Prescription medicationTablet경구
Ingredient · strength
Acetaminophen›162.5mgTramadol Hydrochloride›37.5mg
Manufacturer / importer
한림제약(주)
Appearance
[Domestic Use] Yellow circular film-coated sustained-release tablets [Export Use] Yellow rectangular film-coated sustained-release tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201601516 · Approved 2016.03.15 · Insurance code 645305470

Summary

Main use
Relief of moderate to severe acute and chronic pain
Who takes it
Adults
Adult dose
Adjust the dosage according to the patient's level of pain and treatment response. Administer an initial dose of 2 tablets, followed by intervals of at least 12 hours. Do not exceed 8 tablets per day. Regular monitoring is conducted during long-term administration. For elderly patients, administer the usual adult dosage, but for those over 75 years of age, administer at intervals of at least 12 hours.

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Relief of moderate to severe acute and chronic 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

Adjust the dosage according to the patient's level of pain and treatment response. Administer an initial dose of 2 tablets, followed by intervals of at least 12 hours. Do not exceed 8 tablets per day. Regular monitoring is conducted during long-term administration. For elderly patients, administer the usual adult dosage, but for those over 75 years of age, administer at intervals of at least 12 hours.

Precautions

This medication may cause liver damage, so individuals who consume large amounts of alcohol daily must consult with a doctor or pharmacist before taking it. One of the ingredients in this medication may rarely cause serious skin reactions, so if a skin rash or allergic symptoms appear, stop taking the medication immediately and inform medical personnel. The analgesic component in this medication may increase the risk of seizures if the recommended dosage is exceeded, so the dosage must be strictly adhered to; there is an increased risk of seizures when taken in combination with certain antidepressants or other medications. In patients with severe respiratory disease, this medication may pose a risk of respiratory depression, thus administration must be under the supervision of medical personnel, and it should not be used in patients with severe dyspnea. Co-administration with alcohol or central nervous system depressants may cause severe sedation, respiratory depression, or coma, so caution is advised when taking them together. Patients with head injuries or brain diseases are at risk of altered consciousness when taking this medication, so it should be avoided or used cautiously. This medication may lead to physical and psychological dependence when used for long periods, so the duration and dosage must be strictly followed as directed by a doctor. Patients with impaired liver function should consult a doctor before taking this medication, and care should be taken not to use other acetaminophen products to avoid the risk of liver damage. This medication should not be administered to children under 12 years of age or to pediatric patients under 18 years of age after certain surgeries, and adolescents should avoid use if there are specific risk factors. Drowsiness and dizziness may occur during use, so caution is needed when driving or operating dangerous machinery. In case of overdose, serious respiratory depression or liver damage may occur; therefore, contact a medical institution immediately for appropriate treatment. Pregnant or nursing women should consult with a doctor before taking this medication, especially during breastfeeding, as the medication may pass to the baby and pose risks.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, chest tightness, seizures, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, severe allergic reactions, liver abnormalities (jaundice), very severe headaches, confusion, vision abnormalities, paralysis, significantly reduced urine output, severe edema accompanied by increased blood pressure, increased risk of seizures, life-threatening respiratory depression, hyponatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH).

Mild side effects

  • Weakness
  • fatigue
  • flushing
  • occasional chest pain
  • stiffness
  • fainting
  • withdrawal symptoms
  • hypertension
  • worsening of hypertension
  • hypotension
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  • arrhythmia
  • palpitations
  • dizziness
  • headaches
  • tremors
  • occasional ataxia
  • seizures
  • increased tension
  • migraines
  • worsening of migraines
  • involuntary muscle contractions
  • sensory abnormalities
  • confusion
  • dizziness
  • abdominal pain
  • constipation
  • diarrhea
  • dyspepsia
  • flatulence
  • dry mouth
  • nausea
  • vomiting
  • occasional dysphagia
  • bloody stools
  • tongue swelling
  • decreased appetite
  • anxiety.

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

Storage

This medication is susceptible to the effects of air and moisture, so it must be stored in a tightly sealed container. It is important to maintain storage temperature between 1 to 30 degrees Celsius to ensure the efficacy and safety of the medication.

Appearance and packaging

Appearance

[Domestic Use] Yellow circular film-coated sustained-release tablets [Export Use] Yellow rectangular film-coated sustained-release tablets

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.