Ritodrine Hydrochloride Tablets

Pharmacological studies have shown that ritodrine hydrochloride acts on the beta 2 receptors of uterine smooth muscle, thereby inhibiting the contraction frequency and intensity of uterine smooth muscle. It is an effective drug for oral, intramuscular and intravenous injection to prolong pregnancy and prevent premature birth. Carcinogenicity, teratogenicity, and effects on fertility: Rats were orally administered ritodrine hydrochloride at 1 mg/kg, 10 mg/kg and 150 mg/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 fertility.

Ritodrine hydrochloride.

This product is white round tablets.

Prevent premature birth after 20 weeks of pregnancy. The effectiveness and safety of this product when the cervical opening is greater than 4 cm or more than 80% open has not yet 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. Oral treatment begins 30 minutes before the end of intravenous drip, the initial 24-hour oral dose is 1 tablet (10 mg) every 2 hours, and thereafter 1-2 tablets (10-20 mg) every 4-6 hours, with a total daily dose of no more than 12 tablets (120 mg). The commonly used daily maintenance dose is between 80-120 mg (8-12 tablets), administered evenly in divided doses. Oral medication can be continued as long as the doctor deems it necessary to prolong the pregnancy. Or follow the doctor's advice.

The adverse reactions of this product are related to the b-sympathetic nerve effect 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 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 are reports of arrhythmia turning into cardiac arrest immediately after the administration of anesthetics, rhabdomyolysis (muscle pain, weakness, CPK increase, increased myoglobin in blood and urine), neonatal intestinal occlusion, neonatal ventricular septal hypertrophy, low serum potassium caused by β2 receptor agonists, shock, jaundice, Stenvens-Johnson syndrome. Other adverse reactions: Cardiovascular system: supraventricular tachycardia, palpitations, tachycardia, sometimes facial flushing, chest pain, dyspnea, rare electrocardiogram abnormalities (ST-T abnormalities), facial pain. Fetal tachycardia and arrhythmia. Liver: Sometimes there is damage to liver function (increase in GOT, GPT, etc.). Blood system: Rarely thrombocytopenia. Psychoneural system: Sometimes there is tremor, numbness, headache, heat in the extremities, weakness, rarely sweating, and dizziness. Digestive system: Sometimes there is nausea, vomiting, constipation, and swelling of the salivary glands with increased amylase. Allergies: Sometimes there is rash, itching, rarely erythema, and swelling. Administration site: Sometimes there is vascular pain and phlebitis. Others: Transient increase in blood sugar, increase in CPK, sometimes changes in urine sugar, fever, and rarely cold sweats. Pregnant women who have used b-sympathomimetics have symptoms of hypocalcemia, hypoglycemia, and intestinal obstruction in their babies, but these are rare.

This product is used for pregnant women over 20 weeks of pregnancy: it is contraindicated in cases where prolonged pregnancy poses a risk to the pregnant woman and the fetus, including: 1. Heavy bleeding before delivery for any reason, especially placenta previa and placental abruption. 2. Eclampsia and severe preeclampsia. 3. Fetal death in the womb. 4. Chorioamnionitis. 5. Pregnant women with heart disease and conditions that endanger heart function. 6. Pulmonary hypertension. 7. Pregnant women with hyperthyroidism. 8. Uncontrolled diabetes. 9. Severe hypertension. 10. 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 maintenance dose of human, 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 intravenously or 10 and 100 mg/kg/day orally were given to rats and rabbits at 6-15 days and 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, and there was no effect on the perinatal and postnatal development of rat pups. 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 does 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. Randomly selected and followed up a small number of children to 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 gestational period are more likely to have neurological or other disabilities than infants born at or after the full gestational period. It has been reported that ritodrine can be secreted into breast milk in rats, therefore, if the drug is used before delivery, it is recommended to avoid breastfeeding immediately after delivery. Elderly precautions: Not yet clear.

1. Avoid using it with beta-receptor agonists and inhibitors. 2. Using corticosteroids at the same time may cause pulmonary edema. 3. It may cause hypertension in the presence of parasympathetic blockers such as atropine. 4. When used with other parasympathetic amines, the cardiovascular effects are enhanced. However, 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. 5. Anesthetics used in surgery should consider that the effects on patients with hypotension may be enhanced.

Store at room temperature (preferably below 30°C).

20mg

36 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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