Samhcheondang Glycopyrrolate Injection 0.2 mg

Adult administration

Administer by intramuscular or intravenous injection; it may be administered undiluted. 1. During anesthesia 1) Adults ① Preoperative administration: Inject 0.004mg (0.02mL) of glycopyrrolate per kg of body weight intramuscularly at the recommended dose 30-60 minutes before the anticipated induction of anesthesia or when administering preanesthetic medication (narcotics and/or sedatives). ② Intraoperative administration: Administer to prevent vagal reflexes induced by drugs or associated with arrhythmia. Inject 0.1mg (0.5mL) intravenously as a single dose; repeat every 2-3 minutes as needed. Determine the number of doses after identifying the cause of the arrhythmia, and take appropriate measures during surgery and anesthesia to correct parasympathetic imbalance. ③ Administration to reverse neuromuscular blockade: Inject 0.2mg (1mL) of glycopyrrolate intravenously for every 1.0mg of neostigmine or 5.0mg of pyridostigmine. To minimize cardiac adverse effects, the drugs may be administered simultaneously by intravenous injection and mixed together. 2. Adjunctive treatment of peptic ulcer Inject 0.1mg (0.5mL) of glycopyrrolate subcutaneously, intramuscularly, or intravenously 3-4 times daily at 4-hour intervals. If a stronger effect is required, 0.2mg (1.0mL) may be administered.

Child administration

1. During anesthesia 2) Children ① Preoperative administration: In children aged 1 month-12 years, inject 0.004mg (0.02mL) of glycopyrrolate per kg of body weight intramuscularly at the recommended dose 30-60 minutes before the anticipated induction of anesthesia or when administering preanesthetic medication (narcotics and/or sedatives). In children aged 1 month-2 years, 0.008mg (0.04mL) per kg of body weight may be administered. ② Intraoperative administration: Inject 0.004mg (0.02mL) per kg of body weight intravenously; do not exceed 0.1mg (0.5mL) per dose. If repeated, administer at intervals of 2-3 minutes. ③ Administration to reverse neuromuscular blockade: Inject 0.2mg (1mL) of glycopyrrolate intravenously for every 1.0mg of neostigmine or 5.0mg of pyridostigmine. To minimize cardiac adverse effects, the drugs may be administered simultaneously by intravenous injection and mixed together.

This drug should not be used in certain patients. For instance, it should not be administered to individuals allergic to this medication, newborns, or premature infants. When used as an adjunct for the treatment of peptic ulcers, patients with glaucoma, obstructive uropathy, obstructive gastrointestinal diseases, or paralytic ileus should avoid this medication. Furthermore, it is preferable not to use this drug in elderly individuals, frail persons, patients with acute bleeding, severe ulcerative colitis, myasthenia gravis patients, or children under 12 years of age. Pregnant or nursing women, patients with coronary artery disease, congestive heart failure, arrhythmia, hypertension, hyperthyroidism, and asthma should use this medication cautiously. Additionally, elderly patients, those with autonomic nervous system disorders, liver or kidney disease, ulcerative colitis, and hiatal hernia patients should be monitored when used as an adjunct for peptic ulcers. This drug can cause side effects such as dry mouth, urinary disorders, blurred vision due to mydriasis, increased intraocular pressure, tachycardia, palpitations, reduced sweating, loss of taste, headache, irritability, drowsiness, dizziness, insomnia, nausea, vomiting, constipation, edema, allergic reactions, hives, and confusion or agitation in the elderly. Be cautious using this drug in high-temperature environments, as reduced sweating can increase the risk of heatstroke. In patients who have undergone intestinal surgery, if diarrhea occurs, it should be determined whether to discontinue the medication considering the possibility of intestinal obstruction. Also, this drug may cause drowsiness or visual impairments, so driving or operating hazardous machinery should be avoided. In the case of overdose, neuromuscular blockade symptoms may arise, and immediate treatment is required. During overdose, specific drugs are used to inhibit anticholinergic effects, and heart rate and bowel movements must be closely monitored. If central nervous system symptoms occur, treatment with other medications is necessary, and artificial respiration may be required if needed. This drug can be combined with certain medications but should not be used with medications whose stability has not been confirmed above pH 6. Additionally, caution should be exercised as there is a risk of ventricular arrhythmias during anesthesia. Finally, the benzyl alcohol contained in this drug can cause life-threatening respiratory problems in premature infants, so it should be used carefully. The ampule injection carries a risk of glass fragment contamination, so caution is required during use, particularly when administering to children or the elderly.

• Dry mouth
• urinary disorders
• urinary retention
• blurred vision due to mydriasis
• increased intraocular pressure
• tachycardia
• palpitations
• decreased sweating
• loss of taste
• headache

This medication should be stored in a sealed container to prevent exposure to air, and the storage temperature should be maintained between 1 and 30 degrees Celsius at room temperature. This will help maintain the medication's effectiveness for a longer period.

Appearance

Colorless, transparent liquid contained in a colorless, transparent ampule

Package unit

50 ampules/box [(1 mL/ampule)]