Shin Poong


Full Prescribing Info
Tramadol hydrochloride.
Each mL contains Tramadol HCl 50 mg.
Use for the relief of moderate to severe pain.
Dosage/Direction for Use
For adults, administer 50 mg-100 mg intramuscularly or intravenously. If necessary, administer every 4-5 hours repeatedly. The maximum dose is 600 mg daily. The dosage may be adjusted according to the age and symptoms.
Patients with acute alcohol intoxication.
Patients with intoxication of drugs which act on the central nervous system, such as hypnotics, analgesics, or psychotic drugs.
Patients with severe respiratory depression especially in the presence of cyanosis and on excessive bronchial secretion.
Patients with a risk of stupor due to head injuries or head lesions.
Patients receiving MAO inhibitors.
Patients with condition in which intracranial pressure is raised.
Special Precautions
Due to use of this drug, nausea, rarely vomiting, drowsiness, lightheadedness, headache and stagger may occur.
It should be used with extreme caution in patients with decreased respiratory reserve and should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
Delayed respiratory depression may occur following epidural or intra-tracheal administration.
Patients receiving this drug should be cautioned against engaging in hazardous occupation requiring alertness such as machinery operation or driving.
This drug is not indicated for minor pain.
During long-term treatment with Tramadol HCl, the possibility of dependence cannot be entirely excluded. Therefore, the physician is to decide on the duration of treatment and whether the preparation is to be withdrawn temporarily.
Dosage should be reduced in elderly and debilitated patients.
Care Administration: Patients with concomitant administration of morphine or repeated administration. (As morphine antagonistic action has been reported in animal study, this drug may cause withdrawal symptom).
Patients with cholangia (Oddi's sphincter was constricted in high doses).
Patients with hepatic disorders.
Patients with alcoholism.
Patients with renal disorders.
Patients with hypothyroidism, adrenocortal insufficiency, prostatic hypertrophy, shock, or inflammatory or obstructive bowel disorders.
Patients with myasthenia gravis.
Use in Children: Safety in infants and children has not been established. It is advisable not to use this product. Administration during labor may cause respiratory depression in the newborn infant. Babies born to opioid-dependent mothers may suffer withdrawal symptoms.
Use In Pregnancy & Lactation
Safety during pregnancy has not been established. Therefore, this drug should be administered to pregnant patients or women suspected of being pregnant, only if the expected therapeutic effect is thought to outweigh the possible risk.
Cautions should be exercised when this drug is administered to a nursing mother.
Adverse Reactions
Hypersensitivity: Shock-like symptoms rarely occur. Administration should be discontinued if such a case.
Respiratory: Respiratory depression may occasionally occur. If these symptoms occur artificial Respiration or administration of Dimorpholamine should be made.
Cardiovascular: Occasionally palpitation, chills, chest pain, decreases in blood pressure arrhythmia, rarely affection on cardiovascular system may occur.
CNS: Drowsiness, lethargy, headache, lightheadedness, excitement, tremor, tinnitus, irritability, fatigue, sweating, dizziness, paraesthesia, disorientation, depression, urinary retention and thirst may infrequently occur.
Gastrointestinal: Occasionally vomiting, nausea, gastrointestinal fullness, borborygmus may occur.
Dependence: The drug dependence was not recognized in animal studies. But in case of prolonged use and increased-dose, close observation and careful administration should be initiated.
Others: Pyrexia, flushing, chills, urticarial, injection site irritation and excessive bronchial secretion may occur.
Treatment of Adverse Reactions: In acute poisoning by an opioid taken by mouth, the stomach should be emptied. A laxative may be given to aid peristalsis.
Intensive supportive therapy may be required to correct respiratory failure and shock.
NALOXONE Hydrochloride, a specific antagonist, used to counteract very rapidly the severe respiratory depression and coma produced by excessive doses of opioid analgesic. A dose of 0.4 to 2 mg is given by intravenous injection, repeated at intervals of 2 to 3 minutes. If necessary, up to 10 mg. It may also be given subcutaneously or intramuscularly or by intravenous infusion.
NALORPHIBE Hydrobromide reverses severe opioid- induced respiratory depression but may exacerbate respiratory depression such as that induced by alcohol or other central non-opioid Depressants. A close of 5 to 10 mg is given by intravenous injection, repeated every 10 to 15 minutes as necessary until respiration is restored or maximum total dosage of 40 mg has been given. Treatment may be repeated if a relapsed occurs. Single dose of up to 40 mg have occasionally been given in severe poisoning. It may also be given intramuscularly or subcutaneously.
LEVAILORPHAN Tartrate also reverses severe opioid-induce respiratory depression but may exacerbate respiratory depressions such as that induced by alcohol or other central non-opioid depressants. For the treatment of overdosage, an initial dose of 1 to 2 mg followed by 1 or 2 doses of 0.5 mg at intervals of 5 to 15 minutes is given intravenously but it may also be given subcutaneously or intramuscularly. It has also been used to reserve opioid central depression resulting from the use of opioids during surgery and to reverse neonatal respiratory depression following administration of opioid analgesics to the mother during labor.
Drug Interactions
On the concomitant administration of this drug with substances which act on the central nervous system (e.g. tranquilizers, hypnotics, alcohols) the sedative effects may be intensified.
Caution For Usage
The product should be administered with caution, avoiding areas where nerves run. The site of injection should be different for repeated injection.
If patients complain of severe pain or blood flows back into the syringe when the needle is inserted, the needle should be withdrawn immediately and the site of injection changed.
Precipitation may occur when used with barbituric acid derivatives in the same syringe, do not mix in one syringe.
Others: In case of prolonged use and increased dose, administered carefully.
Store below 25°C.
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AX02 - tramadol ; Belongs to the class of other opioids. Used to relieve pain.
Tramalin soln for inj 50 mg/mL
1 mL x 50 × 1's (P115/ampoule)
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