Albiotin

ALBIOTIN^®
Clindamycin HCl

Composition
Each capsule contains :
Clindamycin HCl equivalent to Clindamycin 300 mg

Each capsule contains :
Clindamycin HCl equivalent to Clindamycin 150 mg

Each capsule contains :
Clindamycin HCl equivalent to Clindamycin 75 mg

Each 5 ml of suspension contains :
Clindamycin palmitate HCl equivalent to Clindamycin 75 mg


Pharmacology
Clindamycin is a semi-synthetic derivative of lincomycin. It is a primarily bacteriostatic. However, depending on the antibiotic concentration, the organism's susceptibility, and the size of the inoculum, bactericidal activity has been demonstrated against some organism. Clindamycin has been shown to have in vitro activity against isolates of the following organisms

• Aerobic gram positive cocci, including : Staphylococcus aureus. Staphylococcus epidermidis. Streptococci, and Pneumococci.
• Anaerobic gram negative bacilli, including : Bacteroides species and Fusobacterium species.
• Anaerobic gram positive nonsporeforming bacilli, including : Propionibacterium, Eubacterium, Actinomyces species.
• Anaerobic and microaerophilic gram positive cocci, including : Peptococcus species, Peptostreptococcus species, and Microaerophilic streptococci.

Clindamycin HCl is rapidly absorbed after oral administration. Absorption of an oral dose is virtually complete (90%), and the concomitant administration of food does not appreciably modify the serum concentration; serum levels have been uniform and predictable from person to person and dose to dose. A single oral dose of 150 mg produces peak serum level of 2.50 mcg/ml in 45 minutes. Serum level studies following multiple doses for up to 14 days show no evidence of accumulation or altered metabolism of drug.
Clindamycin is widely distributed in body fluids and tissues. The average biologic half-life is 2.4 hours. Approximately 10% of the bio-activity is excreted in the urine and 3.6 hours in the feces; the remainder is excreted as bio-inactive metabolites.
Blood levels studies comparing Clindamycin palmitate HCl, with Clindamycin HCl show that both products reach their peak active serum levels at the same time, indicating a rapid hydrolysis of the palmitate to the Clindamycin. Multiple-dose studies in newborns and infants up to 6 months of age show that the drug does not accumulate in the serum and is excreted rapidly.

Indications
ALBIOTIN^® is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. It is also indicated in the treatment oi serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci.

Contraindications
Individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

Dosage and administration 
ALBIOTIN^® capsules
Adults :
Serious Infections: 150 to 300 mg every 6 hours.
More severe Infections: 300 to 450 mg every 6 hours.

ALBIOTIN^® dry ,syrup
Children:
Serious Infections:
8 to 16 mg/kg/day divided into 3 or 4 equal doses.
More severe Infections: 16 to 20 mg/kg/day divided into 3 or 4 equal doses.


Warning and precautions

1. Diarrhea and colitis have been reported with the use of clindamycin. The appearance of marked diarrhea should be regarded as an indication that the product should be discontinued immediately.
2. Safety for use in pregnancy has not been established.
3. Should be used with caution in individuals with a history of gastrointestinal disease,  particularly colitis.
4. Patients with renal disease and/or hepatic disease should be dosed with caution and periodic liver and kidney function tests and blood counts should be performed.
5. For infection caused by β-hemolytic streptococci a minimum of 10 days treatment is recommended to prevent the occurrence of acute rheumatic lever or acute glomerulonephritis.
6. Should super infections and over growth of yeasts occur, appropriate measures should be taken.

Adverse reactions
In general ALBIOTIN^® is well tolerated. Side effects referable to the gastro-intestinal tract include abdominal discomfort, diarrhea, colitis, nausea, and vomiting.

Presentation
ALBIOTIN^® 300 mg capsules: Box of 3 strips x 10 capsules Reg. No. DKL9311613101C1
ALBIOTIN^® 150 mg capsules: Box of 3 strips x 10 capsules Reg. No. DKL9111613101B1
ALBIOTIN^®  75 mg capsules: Box of 3 strips x 10 capsules Reg. No. DKL9111613101A1
ALBIOTIN^® dry syrup: Bottle of 60 ml Reg. No. DKL9111613038A1

Protect from light.
Store at lemperature below 30°C.

ON MEDICAL PRESCRIPTION ONLY. 
HARUS DENGAN RESEP DOKTER

Manufactured by :
PT DANKOS FARMA, Jakarta· Indonesia

For:
PT KALBE FARMA Tbk., Bekasi - Indonesia

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