部份中文PROSTARMON・F 处方资料（仅供参考）
治疗类别名称
前列腺素F2α配方
商標名
PROSTARMON・F
一般名
ジノプロスト(Dinoprost)
化学名
(5Z)-7-｛(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxyoct-1-en-1-yl]-cyclopentyl｝hept-5-enoic acid
構造式
分子式
C20H34O5
分子量
354.48
性状
本品是一种白色蜡状肿块或粉末，或以液体粘性无色至淡黄色清澈，没有异味。
此产品是N，非常易溶于N-二甲基甲酰胺，甲醇，乙醇（99.5），或可溶于乙醚，极微溶于水。
适应症
I.静脉注射给药
1.引产妊娠晚期
·陣痛促進
·分娩促進
2.肠道蠕动在下面增加
●在恢复的情况下，在胃肠道手术术后延长肠麻痹
●如果你没有在麻痹性肠梗阻的等保守治疗，观察效果
II。外用药卵膜
治疗性流产
用法与用量
以原处方为准
包装
注射
1毫升/1000微克：10管，50管
2毫升/2000微克：10管
制造和销售
小野制药有限公司
完整处方资料附件：http://www.info.pmda.go.jp/go/pack/2499401A2050_1_12/
Treatment category name
Prostaglandin F2α formula
Brand name
Prostaglandin Rumon
· Female Injection
Common name
Dinoprost drug (dinoprost drug)
Chemical Name
(5R) -7 - {(1R, 2R, 3R, 5S) -3,5-dihydroxy-2- [ 5-enoic acid
Molecular formula
C20H34O5
Molecular weight
354.48
behavior
This product is a white waxy mass or powder, or viscous liquid colorless to pale yellow clear, no smell.
This product is N, very soluble in N-dimethylformamide, methanol, ethanol (99.5), or soluble in ether, very slightly soluble in water.
composition
part
Dinoprost drugs
content
Mu] g
capacity
1 ml
Of additive (1 ampoule)
0.3 mg of sodium citrate hydrate, 3.4 mg of sodium acetate hydrate, an isotonic agent, and a pH adjuster
Taboo
Induced abortion This drug in late pregnancy, to promote the development of labor force, for the purpose of promoting the development of labor,
Pelvic stenosis, cephalopelvic disproportion, the patient's pelvic position, etc. abnormal fetal position [normal vaginal delivery does not continue, there is a risk of damage to the mother and fetus]
Total placenta previa [placenta expulsion from the fetus prior to the expected risk to the fetus]
Bronchial asthma patients or a history of [bronchoconstrictive airway resistance increase, there is deterioration or the risk of induced asthma attack]
Oxytocin, and the administration of progesterone (PGE2) in patients (see "Interactions" section)
The history of allergy in patients with this drug composition
Through the use of the agent to enhance the purpose of intestinal peristalsis
The history of allergy in patients with this drug composition
Bronchial asthma patients or a history of [bronchoconstrictive airway resistance increase, there is deterioration or the risk of induced asthma attack]
Women are suspected of being pregnant or pregnant
(See "Pregnant women, mothers, giving lactating mothers, etc.")
Through the use of the agent for the purpose of therapeutic abortion
Placenta previa, ectopic pregnancy, etc., the risk of bleeding by the operation [not vaginal delivery, there is the risk of bleeding]
The heat generated by the patient due to pelvic infection [inflammation, the possibility of increased infection]
Bronchial asthma or contraction in patients [bronchial airway resistance increased history, with increased or induced asthma attack risk. ]
The history of allergy in patients with this drug composition
Effect or effect
I. Intravenous administration
1. Induction of labor, promotion of labor development and delivery promotion in late pregnancy
2. Intestinal motility in the following increase
● In case of recovery, prolonged intestinal paralysis after gastrointestinal surgery
● If you do not have a conservative treatment such as paralytic ileus, observe the effect
II. External use of the egg membrane
Therapeutic abortion
I. Administration by injection
Labor, promotion of labor and delivery promotion in late pregnancy induction
In the general 1 ~ 2 ml drops or continuous infusion in the vein.
* Intravenous infusion
It was diluted intravenously with 1 mL of the 5% glucose injection or sugar solution at a rate of 0.1 μg / kg / min as a normal dinoprost drug to 500 mL. The amount and type of infusion are appropriately selected depending on the patient & apos; s conditional dilution.
* Intravenous syringe pump (continuous infusion)
A physiological saline solution was added to 1 mL of this drug by intravenous injection at a rate of 0.1 μg / kg / min as a normal dinoprost drug (0.05 to 0.15 μg / kg / min) to dilute to 50 mL.
It is adjusted according to the symptoms.
Intestinal peristalsis hyperthyroidism
500 ml of the usual infusion of 1000 to 2,000 g (1 to 2 ml of this drug) was given to a dinoprost drug intravenously for 1 to 2 days at a dose rate of 10 to 20 μg / min.
The management of this drug seriously does this by considering the extent of stress as well as other treatments.
Administered 3 days to switch to other therapies immediately stop the administration observed, or even no effect.
Symptoms, and adjusted according to weight.
II. External use of the egg membrane
The therapeutic abortion
Pregnancy 12 weeks or later
Diluted in 4 mL of physiological saline solution to 1 mL of this drug, the liquid was injected several times between the uterine wall and the egg membrane.
Chemical injection catheterization
The catheter is usually used. The catheter is inserted through the cervix and through the cystic portion of the cervix of the catheter to the lower uterine segment, filled with saline to the capsule portion, closing the mouth of the cervix after the liquid escapes and the vaginal catheter to prevent leakage. Then fix the catheter inside the Hetepu thigh.
Injection of liquid
Initial dose
Dilute the solution by injecting 1 mL of the dinoprost drug (250 μg / mL) into the saline solution, slightly above the internal volume of the catheter, so that it does not remain in the catheter (typically about 3.5 mL in Cat.
Second and later
If this drug is administered after the second injection, but the repeated application of dilution solution 3 ~ 4mL (750 ~ 1, 000μg) principle every two hours, uterine contraction, other reactions are too strong due to initial administration, Apply 2 ml (to 500 μg) of the next dose after weight loss or 4 hours later.
The administration of the drug is carried out in principle at intervals of two hours and seconds, but with adjusting the appropriate dosage and dosing intervals between 1 and 4 hours while observing the effect and according to the other reactions of the agent.
Drug Delivery In this application, each time, it is noted that the internal volume of the catheter is slightly higher than the continuous infusion of physiological saline solution.
Pregnancy is less than 12 weeks
Hydatidiform mole, general anesthesia is a very difficult complication, for difficult cases or resection surgery, if the cervix before prolonged treatment. Time after the injection of this drug, atropine sulfate, pain medication after the need for anesthesia effect has occurred since the implementation.
Tube insertion
Usually use F4 ~ 5 synthetic resin tube, it should meet the physiological saline before use, the lumen. Cut pliers tube, slowly inserted into the uterine cavity than the external cervix about 7cm position.
In addition to injecting the liquid drug under direct vision, the gauze is filled to surround the tube to prevent the discharge of the tube into the vaginal cavity. The syringe is connected to the tube and, in addition, to the inside of the thigh.
Injection of liquid
Split injection method
According to the 12 weeks of pregnancy or higher, add physiological saline solution to 1mL of this drug using 4mL of diluted liquid split spray.
• Initial dose injection of 1 mL of dilution (dinoprost drug 250 μg / mL) was also injected into the saline solution of the chemical just above the volume of the continuous tube space so as not to remain in the tube.
Diluent 3 ~ 4 ml (750 ~ 1,000 g) every other hour as a general rule, uterine contraction is due to the initial
Management, in the case of other reactions
• Repeated injections for the second and subsequent injections are too strong for the next government to lose weight or delay time to 2ml (500μg).
The drug is administered at a total dose of 3,000 μg as a general rule, also at intervals of 1 hour, as appropriate for the dosage and administration time, while observing the effect and adjusting other responses according to the interval of the agent.
• In this method of administration it is important to note that the volume of the internal space of the tube is slightly higher each time the infusion of the drug infusion continues.
Once the injection method
● Do not dilute the normal dinoprost drugs 1,000μg / 1mL containing injection, an injection slowly 2000 ~ 3000μg (2 ~ 3 ml). Appropriate increase or decrease the dose, while observing the effect, and according to the agency's response.
• Continuous infusion of saline over the volume of the internal volume injected later in the cartridge. If the end of the liquid injection tube is discharged.
* The labor force to promote the development of labor, when this drug labor promotion for the purpose of management, the use of sophisticated continuous infusion device management induction.
Careful management
I. Intravenous administration
In the case of labor, promotion of labor and delivery promotion of induction of late pregnancy
Glaucoma, elevated ocular hypertension in animal eyes [animal experiment (rabbit) has been reported]
Patients with heart disease [risk of vasoconstriction with worsening cardiac function]
Hypertension [increased blood pressure]
Patients with [uterine history, such as caesarean section or uterine incision has become fragile, there is the risk of uterine rupture and excessive labor intensity occurs. ]
Multiple pregnancy, the production of female patients [there is the uterus becomes fragile, too strong labor when the risk of uterine rupture]
In the case of enhanced intestinal peristalsis,
Glaucoma, elevated ocular hypertension in animal eyes [animal experiment (rabbit) has been reported]
Patients with heart disease [risk of vasoconstriction with worsening cardiac function]
Hypertension [increased blood pressure]
Infants and young children [use experience less security has not been established]
II. External use of the egg membrane
In the case of a therapeutic abortion,
Glaucoma, elevated ocular hypertension in animal eyes [animal experiment (rabbit) has been reported]
Patients with heart disease [risk of vasoconstriction with worsening cardiac function]
Hypertension [increased blood pressure]
Patients with cervicitis or vaginitis [inflammation, there is the possibility of increased infection]
A history of patients, such as caesarean section or uterine incision [have said the uterus has become fragile, there is the risk of uterine rupture and excessive labor intensity occurs]
Multiple pregnancy, the production of female patients [there is the uterus becomes fragile, too strong labor when the risk of uterine rupture]
Clinical significant adverse reactions
I. Intravenous administration
In the case of labor, promotion of labor and delivery promotion of induction of late pregnancy
Ventricular fibrillation, cardiac arrest, shock
Ventricular fibrillation, cardiac arrest, because it may shock (whether it is unknown frequency ※) appears, and if any abnormalities are observed, the government should discontinue and appropriate treatment.
Difficulty breathing
Wheezing, because of breathing difficulties. (Frequency unknown ※) sometimes appears, the government should stop in this case.
Too strong a labor force
There is excessive intensity of labor (0.4%) that may occur. In addition, the uterus ruptures it, as it has already been reported, has brought a laceration of the cervix, carefully monitored, and if any abnormalities are observed, discontinue dosing and take appropriate measures.
Signs of fetal distress
The signs of asphyxia are as follows: fetal asphyxia (1.1%), bradycardia (1.3%), tachycardia (0.8%), amniotic fluid (1.5%) turbidity] because it may lead to careful monitoring and detection of abnormalities If you observe, stop losing weight or manage. Appropriate measures, such as rapid post-delivery, remain the same if the administration is interrupted to observe such symptoms.
In the case of enhanced intestinal peristalsis,
Ventricular fibrillation, cardiac arrest, shock
Ventricular fibrillation, cardiac arrest, because it may shock (whether it is unknown frequency ※) appears, and if any abnormalities are observed, the government should discontinue and appropriate treatment.
Difficulty breathing
Wheezing, because of breathing difficulties. (Frequency unknown ※) sometimes appears, the government should stop in this case.
II. External use of the egg membrane
In the case of a therapeutic abortion,
Ventricular fibrillation, cardiac arrest, shock
Ventricular fibrillation, cardiac arrest, as it may oscillate (either in unknown frequency *), and if any abnormality is observed, the government should discontinue treatment and appropriate treatment.
Difficulty breathing
Wheezing, because of breathing difficulties. (Frequency unknown ※) sometimes appears, the government should stop in this case.
Pharmacology
Mechanism of action
PGF2α has a physiological uterine contraction in order to induce an effective uterine contraction every year, to induction of labor, delivery through intravenous infusion to promote end of pregnancy, extravaginal injection of early and mid-pregnancy has been found useful in the treatment of abortion. In addition, PGF2? Behavior in the digestive tract of the longitudinal muscles of the circular muscle, it is recognized that the results of peristalsis to promote the role of clinical shortening the exhaust time is also to improve the effect of postoperative enteroparalysis observed.
Pharmacological effects
On the uterus
Shown at concentrations greater than 0.6 ng / mL with the isolated rat uterine smooth muscle (extracorporeal) contractile action.
Induction of labor
• Continuous intravenous infusion (5 to 10 μg / kg / min) in rats 21 days of gestation. Then, to enhance uterine contraction automatically. 9)
Continuous infusion (0.5 to 5.0 μg / kg / min.) In the 21-day gestation day followed by a significant reduction in the time to delivery of the first cub compared to the non-administered group
● Transition from continuous intravenous infusion of more regular labor (0.05 ~ 0.15μg / kg / min.) Then the low-pressure irregular labor of pregnant women at the end of gestation is when natural labor comes close to uterine contractions
Abortion
External use of amniotic membrane to the second trimester (0.25 ~ 1.0 mg / kg) then rats showed a contraction of the uterus, abortion is allowed. But also decreased serum progesterone concentration.
Upper gastrointestinal effects
Shrinkage (in vitro) of the concentration of the smooth muscle in the stomach, ileum, colon of 1 ng / ml to the isolated guinea pig is shown.
Intestinal transport of hypercoagulable action
When the continuous intravenous infusion (10 ~ 20μg / kg / min) in the paralyzed rat intestinal movement to reduce intestinal motor paralysis, observed a significant enhancement of intestinal transport capacity. 12)
Digestive function of hyperthyroidism
Intravenous anesthesia, ileal, internal pressure measurement, and EMG were observed by applying pressure to continuous balloon infusion (5 to 10 micrograms / kg / min) of balloon ascending colon, and peristaltic induction was observed according to the dog's jejunum.
Postoperative gastrointestinal motility enhancement
According to electromyographic results, surgical patients with duodenal, jejunum, and ileal digestive stomachs, but colonic exercise suppression was considered to be by continuous intravenous injection of PGF2α (0.3 to 0.5 microgram / kg / min) Digestion was recognized as a dose-dependent increase in each site of the tube significantly, and this action was lost for 5 to 10 minutes after the administration was interrupted.