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Risedronate Tablets

Risedronate Tablets

The main component of this product is amikacin sulfate, its chemical name is: O-3-amino-3-deoxy-α-D-glucopyranosyl-(1→4)-O-[6-amino- 6-Deoxy-α-D-glucopyranosyl-(1→6)]-N3-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-L-streptamine sulfate salt. Excipients: sodium dihydrogen phosphate, sodium acetate, sodium citrate, sodium bisulfite, water for injection.

Since this product is stable to most aminoglycoside inactivating enzymes, it is particularly suitable for the treatment of severe infections caused by Gram-negative bacilli against kanamycin, gentamicin or tobramycin-resistant strains.

  • 产品详情

【Drug Name】

Common name: ciprofloxacin hydrochloride tablets

English name: Ciprofloxacin Hydrochloride Tablets

Pinyin: Yansuan Huanbingshaxing Pian

Ingredients

The main component of this product is: ciprofloxacin hydrochloride, its chemical name is: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3 - Quinoline carboxylic acid hydrochloride monohydrate.

Its chemical structure is:

Molecular formula: C17H18FN3O3HCI2H2 O

Molecular Weight: 385.82

【Properties】 This product is a film-coated tablet, which is white to yellowish after removing the coating.

Indications used for sensitive bacteria

(1) Urogenital infections, including simple, complicated urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis, or cervicitis (including those produced by enzyme-producing strains).

(2) Respiratory tract infections, including acute bronchial infections and lung infections caused by sensitive gram-negative bacilli.

(3) Gastrointestinal tract infections caused by Shigella spp., Salmonella spp., Enterotoxin-producing Escherichia coli, Aeromonas hydrophila, and Vibrio parahaemolyticus.

(4) Typhoid fever.

(5) bone and joint infections.

(6) Skin and soft tissue infections.

(7) Systemic infections such as sepsis.

[Specifications] according to ciprofloxacin 0.25g

Dosage Oral.

(1) Adults' usual dose: 0.5 to 1.5g per day, divided into 2 to 3 times.

(2) bone and joint infections: 1 to 1.5g a day, 2 to 3 times, treatment for 4 to 6 weeks or longer.

(3) pneumonia and skin and soft tissue infections: 1 to 1.5g a day, 2 to 3 times, 7 to 14 days of treatment.

(4) Intestinal infection: 1g on one day, divided into 2 times, and the course of treatment is 5 to 7 days.

(5) Typhoid fever: 1.5g a day, divided into 2 to 3 times, treatment 10 to 14 days.

(7) Urinary tract infection: acute simple lower urinary tract infection, 0.5g a day, 2 times service, treatment 5 to 7 days; complex urinary tract infection, day 1g, 2 times, treatment 7 to 14 days .

(8) simple gonorrhea: a single oral 0.5g.

【Adverse reactions】

(1) Gastrointestinal reactions are more common and may manifest as abdominal discomfort or pain, diarrhea, nausea, or vomiting.

(2) The central nervous system may have dizziness, headache, lethargy or insomnia.

(3) allergic reactions: skin rash, skin itching, occasional exudative erythema multiforme and angioneurotic edema. A few patients have photosensitivity reactions.

(4) Occasional: 1 Seizures, mental disorders, irritability, confusion, hallucinations, tremor; 2 hematuria, fever, rash, and other interstitial nephritis; 3 crystalline urine, more common in high-dose applications; 4 joints pain.

(5) A small number of patients may have elevated serum transaminases and blood urea nitrogen and decreased peripheral blood leukocytes, which are mostly mild and transient.

Taboo banned patients with allergies to this product and quinolones.

【Precautions】

(1) Due to the current prevalence of E. coli resistance to fluoroquinolones, urine culture specimens should be taken prior to administration and adjusted for bacterial susceptibility results.

(2) This product should be taken on an empty stomach. Although the food can delay its absorption, its total absorption (bioavailability) has not been reduced, so it can also be taken after meals to reduce gastrointestinal reactions; .

(3) Crystalluria may occur when the product is used in large doses or when the urinary pH is above 7. In order to avoid the occurrence of crystalline urine, it is advisable to drink more water and maintain a urine output of 1200 ml or more for 24 hours.

(4) In patients with impaired renal function, the dosage should be adjusted according to renal function.

(5) Moderate and severe photosensitizing reactions can occur with fluoroquinolones. When using this product, excessive exposure to sunlight should be avoided. If photosensitized reaction occurs, it should be stopped.

(7) When liver function declines, if it is severe (cirrhosis of ascites) can reduce drug clearance, blood concentration increases, liver and kidney function are reduced, especially obvious, both need to weigh the advantages and disadvantages of the application, and adjust the dose.

(8) Patients with existing central nervous system disorders, such as epilepsy and epilepsy, should be avoided. The indications should be carefully weighed against the pros and cons.

(8) It is strictly prohibited for food and feed processing.

Pregnancy and lactation women medication

Animal experiments have not confirmed the teratogenic effects of quinolones, but there is no clear conclusion about the study of pregnant women. In view of the fact that the drug can cause joint disease in underage animals, it is prohibited for pregnant women. Breastfeeding women should stop breastfeeding while applying this product.

Pediatric Use

The safety of this product in infants and young children under the age of 18 has not been determined. However, when used in several young animals, this product can cause joint disease. Therefore, it should not be used for children and adolescents under the age of 18.

[Geriatric Use] Older patients often have impaired renal function. This product is partially excreted by the kidneys and needs to be reduced.

【medicine interactions】

(1) Urinary alkalis can reduce the solubility of this product in the urine, resulting in crystalline urine and nephrotoxicity.

(2) An acid medicine containing aluminum or magnesium can reduce the oral absorption of this product. It is recommended to avoid using it together. When it is unavoidable, it should be taken 2 hours before taking the product or 6 hours after taking the product.

(3) The combination of this product with theophylline may be due to the competitive inhibition of the binding site of cytochrome P450, leading to a significant reduction in hepatic elimination of theophylline, prolongation of blood elimination half-life (T1/2β), and elevated plasma concentration. There are symptoms of theophylline poisoning, such as nausea, vomiting, tremors, anxiety, agitation, convulsions, heart palpitations, etc., so the combination of theophylline plasma concentration and dose adjustment should be determined.

(4) When cyclosporine is used in combination with this product, its blood drug concentration increases, and the blood concentration of cyclosporine must be monitored and the dose adjusted.

(5) This product can increase the anticoagulant effect of the latter when used with the anticoagulant warfarin. The prothrombin time of the patient should be closely monitored when used together.

(7) probenecid can reduce the secretion of this product from the renal tubules about 50%, combined with the product due to increased blood concentration and toxicity.

(8) The product interferes with the metabolism of caffeine, resulting in reduced caffeine elimination, prolonged blood elimination half-life (T1/2β), and possible central nervous system toxicity.

(8) Didanosine (DDI) can reduce the oral absorption of this product, because the aluminum and magnesium contained in its preparation can be chelated with this product, so it should not be used together.

[Drug Overdose] This experiment was not performed and there is no reliable reference.

Pharmacology and Toxicology

Pharmacological effects

This product has a broad-spectrum antibacterial effect, especially against aerobic gram-negative bacilli, has a good antibacterial effect on the following bacteria in vitro: most bacteria of the Enterobacteriaceae family, including citrate, sewer, gas production Enterobacteriaceae, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, and the like. It also has antibacterial activity against multiple drug-resistant bacteria. Penicillin-resistant Neisseria gonorrhoeae, Haemophilus influenzae-producing strains and Moraxella all have high antibacterial activity. It has antibacterial effect on most strains of Pseudomonas, such as Pseudomonas aeruginosa. This product has antibacterial activity against methicillin-sensitive Staphylococcus and only moderate antibacterial activity against Streptococcus pneumoniae, Streptococcus hemolyticus, and Enterococcus faecalis. It also has good effects on Chlamydia trachomatis, Mycoplasma, Legionella, and antibacterial activity against Mycobacterium tuberculosis and atypical mycobacteria. Antibacterial activity against anaerobic bacteria is poor.

Ciprofloxacin is a bactericidal agent that acts on the A subunit of the bacterial DNA helicase, inhibits DNA synthesis and replication and leads to bacterial death.

Toxicological research

The experiment was not conducted and there is no reliable reference.

【Pharmacokinetics】

After oral administration of 0.2g or 0.5g of this product, healthy individuals had peak plasma concentrations (Cmax) of 1.21 μg/ml and 2.5 μg/ml, respectively, and peak time (Tmax) of 1 to 2 hours. Widely distributed to various tissues, body fluids (including cerebrospinal fluid), the concentration of the tissue often exceeds the plasma concentration, protein binding rate of about 20% to 40%. Blood elimination half-life (T1/2β) is 4 hours. It can be metabolized in the liver and metabolites still have weaker activity. 24 hours after oral administration, 40% to 50% of the dose excreted by the kidneys was administered. About 15% is excreted as metabolites. At the same time, some drugs are excreted via bile and feces.

[Storage] shading, sealed and stored.

【Packing】

Polyvinyl chloride solid pharmaceutical hard film, pharmaceutical packaging aluminum foil, each plate 9 pieces, 1 plate per box, 50 pieces per box; 10 pieces per plate, 1 plate per box, 50 pieces per box; each plate 12 pieces, 1 plate per box.

【Valid period】30 months.

[Executive standard] "China Pharmacopoeia" 2010 edition II.

[Approval number] National drug prefix H41024142

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