Ritodrine Hydrochloride for Injection

Pharmacological studies have shown that ritodrine hydrochloride acts on the β2 receptors of uterine smooth muscle, thereby inhibiting the contraction frequency and intensity of uterine smooth muscle. It is an oral, intramuscular and intravenous drug that effectively prolongs pregnancy and prevents premature birth. Carcinogenicity, teratogenicity, and effects on fertility: Rats were orally administered ritodrine hydrochloride 1mg/kg, 10mg/kg and 150mg/kg daily for 82 weeks. Benign and malignant tumors were found in all dose groups. Since there was no significant difference between the treatment group and the control group and there was no dose-related trend, it was inferred that there was no sign of carcinogenicity. In the reproduction study of rats and rabbits, the results showed that ritodrine hydrochloride had no effect on reproduction.

The main ingredient of this product is ritodrine hydrochloride, and the excipients it contains are mannitol and sodium hydroxide. Chemical name: p-Hydroxy-α-[1-[(p-hydroxyphenylethyl)amino]ethyl]benzyl alcohol hydrochloride. Chemical structure: Molecular formula: C17H21NO3·HCl Molecular weight: 323.82

This product is white or off-white loose mass or powder; it has a special smell and tastes bitter.

Prevent premature birth after 20 weeks of pregnancy. Currently, the effectiveness and safety of this product for cervical opening greater than 4 cm or more than 80% of full opening have not been established.

Diagnosed with premature delivery and suitable for this product, initially use intravenous drip followed by oral maintenance treatment, closely monitor uterine contraction and side effects to determine the best dosage. Intravenous drip: According to the situation of the pregnant woman, the frequency of uterine contraction, heart rate, blood pressure and fetal heart rate should be monitored frequently during drip. Take 2 vials of this product totaling 100 mg and dilute it with 500 ml of intravenous drip solution to 100 mg/500 ml (0.2 mg/ml). Keep the left side posture during intravenous drip to reduce the risk of hypotension. Closely observe the drip rate, use a controllable infusion device or adjust the number of drops per minute. At the beginning, the drip rate should be controlled to a dose of 0.05 mg/min (5 drops/min, 20 drops/ml), and increase by 0.05 mg/min (increase 5 drops/min) every 10 minutes until the desired effect is achieved, usually maintained at 0.15 mg/min-0.35 mg/min (15-35 drops/min), and continue to infuse for at least 12-18 hours after uterine contractions stop. The infusion solution should be 5% glucose solution, and normal saline solution can be used for diabetic patients. The prepared infusion solution should not be used if it changes color, contains sediment, particles, or is prepared for more than 48 hours. Ritodrine hydrochloride for injection Infusion dose mg/min Infusion solution preparation concentration Infusion rate drops/min 0.05 0.10 0.15 0.25 0.35 100 mg/500 ml (0.2 mg/ml) 5 10 1 5 2 5 3 5 20 drops are equivalent to 1 ml of infusion solution. Tablets (see tablet instructions) or doctor's advice can be used for maintenance treatment.

The adverse reactions of this product are related to the β-sympathetic nerve action and can usually be controlled by adjusting the dose. Intravenous infusion often causes an increase in the heart rate of pregnant women and fetuses. For healthy pregnant women, the heart rate should not exceed 140 beats/minute. Appropriate reduction of the dose or cessation of the infusion will quickly return to normal. Serious adverse reactions: pulmonary edema, pulmonary edema combined with heart failure, leukopenia, agranulocytosis, arrhythmia, in the case of multiple pregnancies, there have been reports of arrhythmia turning into cardiac arrest immediately after the administration of anesthetics, rhabdomyolysis (muscle pain, weakness, increased CPK, increased myoglobin in blood and urine), neonatal intestinal occlusion, neonatal ventricular septal hypertrophy, low serum potassium caused by β2 receptor agonists, shock, jaundice, Stenvens-John

This product is contraindicated for use in pregnant women who are less than 20 weeks pregnant. It is also contraindicated for use in situations where prolonged pregnancy poses a risk to the pregnant woman and the fetus, including: - Heavy bleeding before delivery for any reason, especially placenta previa and placental abruption. - Eclampsia and severe preeclampsia. - Fetal death in the womb. - Chorioamnionitis. - Pregnant women with heart disease and conditions that endanger heart function. - Pulmonary hypertension. - Pregnant women with hyperthyroidism. - Uncontrolled diabetes. - Severe hypertension. - Allergic to any ingredient in this product.

Precautions for children: Not applicable. Precautions for pregnancy and lactation: Teratogenic effect in pregnancy (pregnancy category B) According to reports, in reproduction studies with rats and rabbits, animals were given 1/9 (1 mg/kg), 1/3 (3 mg/kg) and 1 (9 mg/kg) times the maximum daily dose of human intravenous drip (animals were given pills), and animals were given 5 and 50 times the maximum daily oral dose of human maintenance, that is, 10 and 100 mg/kg. The results showed that ritodrine hydrochloride had no effect on fertility and fetus. Single doses of 1, 3 and 9 mg/kg/day or oral 10 and 100 mg/kg/day were given to rats and rabbits at 6-18 days of pregnancy, respectively, and there was no adverse effect on the fetus. Intravenous 1 and 8 mg/kg/day or oral 10 and 100 mg/kg/day were given to animals at 15-21 days of pregnancy. There was no effect on the perinatal and postnatal development of rat pups, and a slight increase in rat fetal weight was observed. Oral administration does not affect fertility and reproductive behavior. A lethal dose given to pregnant rats will not cause immediate fetal death. There are no adequate and well-controlled studies on the effects of ritodrine on women before 20 weeks of pregnancy. Therefore, this drug should not be used in pregnant women before the 20th week of pregnancy. Studies that give ritodrine to pregnant women after the 20th week of pregnancy have shown that there is no increased risk of fetal malformations. A small number of children were randomly selected to follow up until 2 years old, showing no effects on growth, development or organ maturation. However, although clinical studies have not proven that permanent effects on the fetus come from ritodrine, this possibility cannot be ruled out. Therefore, ritodrine can only be used when the indications are clear. Some studies have shown that infants born before 36 weeks of pregnancy account for less than 10% of all births, but account for 75% of perinatal deaths and half of all infants with neurological disabilities. Relevant data show that infants born at any time before the entire pregnancy period are more likely to have neurological or other disabilities than infants born at or after the full pregnancy period. It has been reported that ritodrine can be secreted into breast milk in rats, therefore, in cases where the drug is used before delivery, it is recommended to avoid breastfeeding immediately after delivery. Elderly Precautions: Not applicable.

1. Avoid using it at the same time with beta-receptor agonists and inhibitors. 2. The simultaneous use of corticosteroids may lead to pulmonary edema. 3. The simultaneous use of the following drugs may aggravate the cardiovascular effects, especially arrhythmias or hypotension. ① Magnesium sulfate ② Diazoxide ③ Pethidine ④ Powerful anesthetics 4. Hypertension may occur in the presence of parasympathetic blockers such as atropine. 5. When used simultaneously with other sympathetic amines, the cardiovascular effects are enhanced. But this can be avoided as long as there is enough time interval. Because 90% of ritodrine is excreted from the body within 24 hours of administration. 6. Anesthetics used in surgery should consider that the effects on patients with hypotension may be enhanced.

Sealed and stored at room temperature.

50mg

24 months

Hainan Zhuotai Pharmaceutical Co., Ltd.

• Founded in:

  2016-07-01

• Address:

  No. 2, Yaogu 2nd Road, Yaogu Industrial Park, National Technology and Industrial Development Zone, Haikou City, Hainan Province

• Tax NO.:

  91460100MA5RD0M01X

• Registered Funds:

  95.8 million yuan

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