Komposition:
Anwendung:
Wird bei der Behandlung verwendet:
Medizinisch geprüft von Oliinyk Elizabeth Ivanovna, Apotheke Zuletzt aktualisiert am 26.06.2023
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Pneumocystis Jirovecii Pneumonia
Bacide is indicated in the treatment of Pneumocystis jirovecii pneumonia in adults and pediatric patients two months of age and older.
Shigellosis
Bacide is indicated in the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei in adults and pediatric patients two months of age and older.
Urinary Tract Infections
Bacide is indicated in the treatment of severe or complicated urinary tract infections in adults and pediatric patients two months of age and older due to susceptible strains of Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii and Proteus species when oral administration of Bacide is not feasible and when the organism is not susceptible to single-agent antibacterials effective in the urinary tract.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bacide and other antibacterial drugs, Bacide should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.
Although appropriate culture and susceptibility studies should be performed, therapy may be started while awaiting the results of these studies.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bacide and other antibacterial drugs, Bacide should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Urinary Tract Infections
For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis, and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.
Acute Otitis Media
For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, in the judgment of the physician, Bacide offers some advantage over the use of other antimicrobial agents. To date, there is limited data on the safety of repeated use of Bacide in pediatric patients under two years of age. Bacide is not indicated for prophylactic or prolonged administration in otitis media at any age.
Acute Exacerbations Of Chronic Bronchitis In Adults
For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when, a physician deems that, Bacide could offer some advantage over the use of a single antimicrobial agent.
Travelers' Diarrhea In Adults
For the treatment of travelers' diarrhea due to susceptible strains of enterotoxigenic E. coli.
Shigellosis
For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.
Pneumocystis jiroveci Pneumonia
For the treatment of documented Pneumocystis jiroveci pneumonia. For prophylaxis against Pneumocystis jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing Pneumocystis jiroveci pneumonia.
Septrin Paediatric Suspension is indicated for the treatment of the following infections when owing to sensitive organisms :
Treatment and prevention of Pneumocystis jiroveci (P. carinii) pneumonitis
Treatment and prophylaxis of toxoplasmosis
Treatment of nocardiosis
The following infections may be treated with Septrin where there is bacterial evidence of sensitivity to Septrin and good reason to prefer the combination of antibiotics in Septrin to a single antibiotic:
Acute uncomplicated urinary tract infection
Acute otitis media
Acute exacerbation of chronic bronchitis
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage In Adults And Pediatric Patients (Two Months Of Age And Older)
The maximum recommended daily dose is 60 mL (960 mg trimethoprim) per day.
Table 1: Dosage in Adults and Pediatric Patients (Two Months of Age and Older) by Indication
| Dosage Guidelines | |||
| Infection | Total Daily Dose (based on trimethoprim content) | Frequency | Duration |
| Pneumocystis jirovecii Pneumonia* | 15-20 mg/kg (in 3 or 4 equally divided doses) | Every 6 to 8 hours | 14 days |
| Severe Urinary Tract Infections | 8-10 mg/kg (in 2 to 4 equally divided doses) | Every 6, 8 or 12 hours | 14 days |
| Shigellosis | 8-10 mg/kg (in 2 to 4 equally divided doses) | Every 6, 8 or 12 hours | 5 days |
| * A total daily dose of 10 to 15 mg/kg was sufficient in 10 adult patients with normal renal function in a published literature.1 |
Dosage Modifications In Patients With Impaired Renal Function
When renal function is impaired, a reduced dosage should be employed, as shown in Table 2.
Table 2: Impaired Renal Function Dosage Guidelines
| Creatinine Clearance (mL/min) | Recommended Dosage Regimen |
| Above 30 | Usual standard dosage regimen |
| 15 – 30 | ½ the usual dosage regimen |
| Below 15 | Use not recommended |
Important Administration Instructions
Administer the solution by intravenous infusion over a period of 60 to 90 minutes. Avoid administration by rapid infusion or bolus injection. Do NOT administer Bacide intramuscularly.
Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever the solution and container permit.
Method Of Preparation
Dilution Of Single- And Multiple-Dose Vials
Bacide must be diluted. Each 5 mL should be added to 125 mL of 5% dextrose in water. After diluting with 5% dextrose in water, the solution should not be refrigerated and should be used within 6 hours.
If a dilution of 5 mL per 100 mL of 5% dextrose in water is desired, it should be used within 4 hours.
In those instances where fluid restriction is desirable, each 5 mL may be added to 75 mL of 5% dextrose in water. Under these circumstances the solution should be mixed just prior to use and should be administered within 2 hours.
If upon visual inspection there is cloudiness or evidence of crystallization after mixing, the solution should be discarded and a fresh solution prepared.
Do NOT mix Bacide in 5% dextrose in water with drugs or solutions in the same container.
Multiple-Dose Vials (Handling)
After initial entry into the vial, the remaining contents must be used within 48 hours.
Infusion Systems For Intravenous Administration
The following infusion systems have been tested and found satisfactory: unit-dose glass containers; unit-dose polyvinyl chloride and polyolefin containers. No other systems have been tested and therefore no others can be recommended.
Bacide is contraindicated in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients and Acute Otitis Media in Pediatric Patients
Adults
The usual adult dosage in the treatment of urinary tract infections is one Bacide DS (double strength) tablet, two Bacide tablets, or four teaspoonfuls (20 mL) Bacide Suspension every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Pediatric Patients
The recommended dose for pediatric patients with urinary tract infections or acute otitis media is 8 mg/kg trimethoprim and 40 mg/kg sulfamethoxazole per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:
Pediatric Patients: Two Months of Age or Older
| Weight | Dose-Every 12 Hours | ||
| lb | kg | Teaspoonfuls | Tablets |
| 22 | 10 | 1 (5 mL) | |
| 44 | 20 | 2 (10 mL) | 1 |
| 66 | 30 | 3 (15 mL) | 1 ½ |
| 88 | 40 | 4 (20 mL) | 2 (or 1 DS Tablet) |
For Patients With Impaired Renal Function
When renal function is impaired, a reduced dosage should be employed using the following table:
| Creatinine Clearance (mL/min) | Recommended Dosage Regimen |
| Above 30 | Use Standard Regimen |
| 15-30 | ½ the Usual Regimen |
| Below 15 | Use Not Recommended |
Acute Exacerbations Of Chronic Bronchitis In Adults
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is one Bacide DS (double strength) tablet, two Bacide tablets, or four teaspoonfuls (20 mL) Bacide Suspension every 12 hours for 14 days.
Travelers' Diarrhea In Adults
For the treatment of travelers' diarrhea, the usual adult dosage is one Bacide DS (double strength) tablet, two Bacide tablets, or four teaspoonfuls (20 mL) of Bacide Suspension every 12 hours for 5 days.
Pneumocystis jiroveci Pneumonia
Treatment
Adults And Pediatric Patients
The recommended dosage for treatment of patients with documented P jiroveci pneumonia is 15 to 20 mg/kg trimethoprim and 75 to 100 mg/kg sulfamethoxazole per 24 hours given in equally divided doses every 6 hours for 14 to 21 days. The following table is a guideline for the upper limit of this dosage:
| Weight Dose - Every 6 Hours | |||
| lb | kg | Teaspoonfuls | Tablets |
| 18 | 8 | 1 (5 mL) | |
| 35 | 16 | 2 (10 mL) | 1 |
| 53 | 24 | 3 (15 mL) | 1 ½ |
| 70 | 32 | 4 (20 mL) | 2 (or 1 DS Tablet) |
| 88 | 40 | 5 (25 mL) | 2 ½ |
| 106 | 48 | 6 (30 mL) | 3 (or 1 ½ DS Tablets) |
| 141 | 64 | 8 (40 mL) | 4 (or 2 DS Tablets) |
| 176 | 80 | 10 (50 mL) | 5 (or 2 ½ DS Tablets) |
For the lower limit dose (15 mg/kg trimethoprim and 75 mg/kg sulfamethoxazole per 24 hours) administer 75% of the dose in the above table.
Prophylaxis
Adults
The recommended dosage for prophylaxis in adults is one Bacide DS (double strength) tablet daily.
Pediatric Patients
For pediatric patients, the recommended dose is 150 mg/m /day trimethoprim 2 with 750 mg/m²/day sulfamethoxazole given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 320 mg trimethoprim and 1,600 mg sulfamethoxazole. The following table is a guideline for the attainment of this dosage in pediatric patients:
| Body Surface Area Dose-every 12 hours | ||
| (m²) | Teaspoonfuls | Tablets |
| 0.26 | 12 (2.5 mL) | |
| 0.53 | 1 (5 mL) | 12 |
| 1.06 | 2 (10 mL) | 1 |
Method of administration: oral.
It may be preferable to take Septrin with some food or drink to minimise the possibility of gastrointestinal disturbances.
Standard dosage recommendations for acute infections
Children aged 12 years and under:
| STANDARD DOSAGE | |
| Age | Paediatric Suspension |
| 6 to 12 years | 10 ml every 12 hours |
| 6 months to 5 years | 5 ml every 12 hours |
| 6 weeks to 5 months | 2.5 ml every 12 hours |
This dosage approximates to 6 mg trimethoprim and 30 mg sulfamethoxazole per kilogram body weight per 24 hours.
Treatment should be continued until the patient has been symptom free for two days; the majority will require treatment for at least 5 days. If clinical improvement is not evident after 7 days' therapy, the patient should be reassessed.
As an alternative to Standard Dosage for acute uncomplicated lower urinary tract infections, short-term therapy of 1 to 3 days' duration has been shown to be effective.
Special dosage recommendations
(Standard dosage applies unless otherwise specified)
Pneumocystis jiroveci (P. carinii) pneumonitis:
Treatment: A higher dosage is recommended using 20 mg trimethoprim and 100 mg sulfamethoxazole per kg of body weight per day in two or more divided doses for two weeks. The aim is to obtain peak plasma or serum levels of trimethoprim of greater than or equal to 5 microgram/ml (verified in patients receiving 1-hour infusions of intravenous Septrin). (See 4.8 Undesirable Effects).
Prevention:
The following dose schedules may be used for the duration of the period at risk (see Standard dosage recommendations for acute infections subsection of 4.2):
− Standard dosage taken in two divided doses, seven days per week
− Standard dosage taken in two divided doses, three times per week on alternate days
− Standard dosage taken in two divided doses, three times per week on consecutive days
− Standard dosage taken as a single dose, three times per week on consecutive days
The daily dose given on a treatment day approximates to 150 mg trimethoprim/m2/day and 750 mg sulfamethoxazole/m2/day. The total daily dose should not exceed 320 mg trimethoprim and 1600 mg sulfamethoxazole.
Nocardiosis: There is no consensus on the most appropriate dosage. Adult doses of 6 to 8 tablets daily for up to 3 months have been used (one tablet contains 400 mg sulfamethoxazole and 80 mg trimethoprim).
Toxoplasmosis: There is no consensus on the most appropriate dosage for the treatment or prophylaxis of this condition. The decision should be based on clinical experience. For prophylaxis, however, the dosages suggested for prevention of Pneumocystis jiroveci pneumonitis may be appropriate.
Children aged 12 years and under with renal impairment:
No data are available relating to dosage in children aged 12 years and under with impaired renal function.
Children aged 12 years and under with hepatic impairment:
No data are available relating to dosage in children aged 12 years and under with impaired hepatic function.
