GENERIC NAME
Compound Glycyrrhizin Injection
The preparation is a compound agent,each 20ml contains,glycyrrhizin 40mg (calculated as Monoammonium Glycyrrhizinate 40.83mg),L-Cysteine hydrochloride 20mg,Glycine 400mg.
PRODUCT DESCRIPTION
Compound Glycyrrhizin Injection is a clear, colorless solution in ampule.
PHARMACOLOGY
- antiinflammatory activity
(1)
antiallergic activity
Glycyrrhizin inhibit local hypersensitivity reactions in rabbits(Arthus Phenomenon) and Shwartsman Phenomenon.Glycyrrhizin enhance ?inhibition activity of corticosteroids on stress reaction, rivalry granulation formation and atrophy of thymus gland.
(2) inhibiting action on arachidonic acid metabolic enzyme
Glycyrrhizin can bind phospholipase A2 which is a priming enzyme of arachidonic acid metabolic pathway and lipoxygenase acting on arachidonic acid
- immunoregulation activity
Glycyrrhizin has following immunoregulation activity in vitro:1) accommodate T cells activation;2) induce γ- interferon;3)activate NK cells.4) promote T cells differentiation out of thymus gland.
- Inhibition effects on experimental hepatocyte impairment
In primary culture of rat hepatoma cell line in vitro,Glycyrrhizin inhibit hepatocyte damage induced by CCl4.
- Inhibit virus growth and deactivate virus
In mouse HMV infection experiments,glycyrrhizin prolong survival time.
L-Cysteine hydrochloride and glycine can inhibit or reduce abnormal serum electrolytes levels.
PHARMACOKINETICS
(1)Blood concentration
Following intravenous administration of 40ml(80mg glycyrrhizin) in healthy volunteers,blood concentration of glycyrrhizin decreases rapidly at 10 hours, then decreases gradually. glycyrrhetinic acid appears at 6 hours and reach peak at 24 hour,disappears at 48 hour.
(2) Eliminated in the urine
Following intravenous administration in healthy volunteers,glycyrrhizin in urine decreased gradually, Excretion in 27 hours is 1.2% of dosage. glycyrrhizic acid appears at 6 hours and reach peak at 22-27 hours.
INDICATIONS
Improvement of abnormal hepatic function in chronic hepatic diseases,dermatitis,Urticaria
DOSAGE AND ADMINISTRATION
The usual adult dosage for intravenous use is from 5 to 20ml once a day.The dosage may be adjusted depending on the patient’s age and symptoms.For chronic hepatic disease,the daily dosage is from 40 to 60ml once a day by intravenous injection or intravenous drip infusion.The dosage may be adjusted depending on the patient’s age and symptoms.If an increased dosage is required,the daily dosage should be kept within the limit of 100ml.
ADVERSE REACTION
Adverse reaction information was derived from 789 patients in 15 literatures and 4213 patients in clinical trial requested by Ministry of Health, Labour and Welfare of Japan.
Incidence not known.
- important adverse reaction
(1) shock, allergic shock(incidence not known): may occur (low blood pressure, unconsciousness,breath difficult,heart and lung failure, flush, puffiness or swelling of the face), so need medical attention closely,stop administrating the drug and dispose adequately when abnormal symptom appears.
(2)Anaphylaxis-like symptom(incidence not known): may occur (breath difficult, flush, puffiness or swelling of the face), so need medical attention closely, stop administrating the drug and dispose adequately when abnormal symptom appears.
(3)Pseudoaldosteronism(incidence not known):may occur when increase dosage and take continuously for a long time,symptoms are hypokalemia,blood pressure increase,fluid retention,gain weight.so need attention during administration, stop administrating the drug and dispose adequately when abnormal symptom appears.in addition,hypokalemia can induce debilitation and muscle weakness.
- other adverse reaction
the following symptoms may occur(see the table).the occurrence of hypokalemia and high blood pressure increases with increasing dosage.
|
0.1%-0.5% |
<0.1% |
| fluid,electrolytes |
hypokalemia, high blood pressure |
edema, debilitation,muscle pain |
| others |
|
rash,abnormal feeling of skin,headache, fever like feeling |
CONTRAINDICATIONS
- Compound Glycyrrhizin Injection is contraindicated in patients who have previously exhibited hypersensitivity to it.
- It is contraindicated in patients with aldosteronism,muscle desease,hypokalemia.
WARNINGS
1. careful use
Geriatric use should be careful.
2. general
(1)inquire should be thoroughly in case of shock
(2)prepare emergency set.
(3)keep patients calmly after administration,watch closely.
(4)Caution should be exercised when administering the drug with licorice since pseudoaldosteronism may occur.
3. be careful during administration
Caution should be exercised when giving intravenous use,drip slowly as far as possible.
4. It is reported that rhabdomyolysis may occur when taking licorice and glycyrrhizin orally.
PREGNANCY AND NURSING MOTHERS
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do.
OLDER ADULTS
Side effects such as hypokalemia may be especially likely to occur in elderly patients.
DRUG INTERACTION
drugs |
symptoms and disposal |
mechanism and results |
| loop diuretic |
hypokalemia(debilitation and muscle weakness),serum K+ should be monitored. |
diuretic increase the excretion of K+, may induce hypokalemia |
| ethacrynic acid |
| Furosemide |
| thiazide |
| trichlormethiazide |
| Chlortalidone |
STORAGE
Close tightly at room temperature
PACKAGING
Boxes of 10 ampoules
SHELF LIFE
tentatively set on 18 months |
