Product Information:
| Product name |
Roxithromycin Tablets |
| Specification |
150mg |
| Package |
Customizable |
| Standard |
BP. USP. |
| Shelf life |
3 Years |
| Storage |
Cool & Dry Place |
Indication:
It is used to treat infections caused by roxithromycin sensitive pathogens.
Ear, nose, throat infection: tonsillitis, pharyngitis, sinusitis
Respiratory tract infection: acute bronchitis, pneumonia
Skin and soft tissue infections: pustulosis
Genitourinary tract infection: non gonococcal urethritis
Usage and dosage:
This product should be taken 15 minutes before meals or on an empty stomach (such as 3 hours after meals) with a sufficient amount of liquid and swallowed completely. Taking this product on an empty stomach is the most effective.
The dosage and method of administration depend on the severity of infection, the sensitivity of pathogens to drugs and the overall health status of patients. The general course of treatment is 5-10 days.
Adults can take 300mg film coated tablets once a day, 150mg one tablet twice a day, or 150mg two tablets once a day. Patients with body weight less than 40 kg were not suitable to take 300 mg once.
Dosage for patients with impaired liver function - the daily dosage for patients with severely impaired liver function should be halved (see [precautions]).
Dosage for patients with impaired renal function - based on available pharmacokinetic studies, it is generally not necessary to adjust the dosage for patients with impaired renal function.
However, it is recommended to monitor the serum roxithromycin concentration in patients with impaired renal function. If necessary, the dosage should be reduced or the medication interval should be extended.
If the liver and kidney function are seriously damaged, the serum roxithromycin concentration should be routinely monitored, and the dose should be adjusted if necessary.
Dosage in elderly patients - if the impairment of renal function is purely age-related, it is generally not necessary to reduce the dosage.
The duration of medication depends on clinical and bacteriological results. If signs of infection subside, treatment should continue for at least two more days.
The treatment of streptococcal infection should be at least 10 days to prevent recurrence and late complications. This also applies to the treatment of non gonococcal urethritis.
However, roxithromycin should not be taken for more than 4 weeks unless there is available clinical experience.
Adverse reactions:
Allergic reaction:
Occasionally (≥ 0.1% - < 1%), the use of roxithromycin treatment can lead to allergic reactions of different severity. Most of these allergic reactions are skin and mucous membrane reactions, such as redness, redness and swelling with or without pruritus or purpura, swelling of the face, tongue and / or throat, dyspnea and even fatal shock. In these cases, roxithromycin should be stopped immediately; in some cases, appropriate treatment (such as electric shock therapy) should be given immediately.
Gastrointestinal adverse reactions: 1
Roxithromycin often (≥ 1% - < 10%) can lead to gastrointestinal disorders, such as nausea, retching and / or vomiting, stomachache and diarrhea. In rare cases (≥ 0.01% - < 0.1%), it can lead to bloody diarrhea or pseudomembranous enteritis.
Effects on liver and bile duct: 1
Occasionally (≥ 0.1% - < 1%), it was reported that the levels of serum transaminase (alt, AST), gamma glutamyl transpeptidase, alkaline phosphatase and bilirubin increased temporarily. In rare cases (≥ 0.01% - < 0.1%), hepatocyte damage with cholestasis (hepatitis) has been observed.
Pancreas:
In rare cases (≥ 0.01% - < 0.1%), signs of pancreatitis were observed during or after roxithromycin treatment. Once treatment stops, these signs are reversible.
Heart:
In extremely rare (< 0.01%) cases, QT prolongation and arrhythmias such as ventricular tachycardia and torsade de pointe were reported (see [precautions] and [drug interactions]).
Nervous system:
In rare cases (≥ 0.01% - < 0.1%), headache, dizziness or paresthesia may occur. In rare cases (≥ 0.01% - < 0.1%), there were also reports of taste and / or olfactory disorders.
Other information:
The use of any antibiotic drugs will lead to the proliferation of pathogens that are not sensitive to the drugs used. Therefore, it is important to pay attention to any signs of secondary infection caused by these pathogens. Any secondary infection should be treated properly.
In rare cases (≥ 0.01% - < 0.1%), dual infection caused by Candida may occur, such as oral and vaginal mucosal infection.
Treatment of adverse reactions
Pseudomembranous enteritis
For such cases, doctors must consider stopping roxithromycin treatment according to the situation, and if necessary, appropriate treatment should be carried out immediately (such as the use of special antibiotics and chemotherapy that have been clinically confirmed to be effective). Drugs that inhibit peristalsis should not be taken.
Severe acute anaphylaxis (e.g. anaphylaxis)
In this case, roxithromycin must be stopped immediately, and routine first aid measures must be taken (such as antihistamines, corticosteroids, sympathomics, and ventilation if necessary)
Matters needing attention:
Roxithromycin should be given to patients after careful evaluation of the risks and benefits of:
- congenital or acquired QT interval prolongation
- hypokalemia, hypomagnesemia
- clinically relevant bradycardia
- symptomatic heart failure
- History of arrhythmia
- taking drugs that can prolong QT interval at the same time (see drug interaction).
During the extended use of roxithromycin, liver function and renal function should be monitored.
Patients with impaired liver function should not take roxithromycin. However, if roxithromycin therapy is clearly required, laboratory parameters of liver function need to be monitored. For patients with severe liver damage, the dose should be halved (see usage and dosage).
If severe and persistent diarrhea occurs during treatment or within the first week after the start of treatment, pseudomembranous enteritis should be considered (see [adverse reactions]).
Impact on the ability to drive and operate the machine
Even when properly administered, the drug can still sufficiently affect the reaction (e.g. Vertigo - see [adverse reactions]), thereby impairing the patient's ability to drive, operate the machine, or work without firm support. These effects are more common at the beginning of treatment, after dose increase, and when shared with alcohol.
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