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Amoxsan

AMOXSAN®
Capsule, Dry Syrup, Pediatric Drops, Dispersible Tablet

COMPOSITIONS

Capsule	:	Each capsule contains Amoxicillin Trihydrate equivalent to 250 mg/500 mg of Amoxicillin.
Dry Syrup	:	When dispersed with drinking water, each 5 ml contains Amoxicillin Trihydrate equivalent to 125 mg/250 mg of Amoxicillin.
Pediatric Drops	:	When dispersed with drinking water, each ml contains Amoxicillin Trihydrate equivalent to 100 mg of Amoxicillin.
Dispersible Tablet	:	Each tablet contains Amoxiclllin Trihydrate equivalent to 250 mg of Amoxicillin.

PHARMACOLOGY
Amoxicillin is a derivative of semisynthetic penicillin which is acid stable. Its bactericidal activity is similar to that of ampicillin.
Amoxicillin is rapidly and well absorbed from the gastrointestinal tract, irrespective of the presence of food, giving a high blood level after one hour. Its absorption is better than that of ampicillin, Amoxicillin is mainly excreted through the kidneys, in the urine Amoxicillin is recovered in active form.
Amoxicillin is effective against Gram-positive and Gram-negative organisms. Among those bacteria which are sensitive to Amoxicillin are:

Staphylococcus Streptococcus Diplococcus pneumoniae Bacillus anthracis Enterococcus Corynebacterium diphtheriae Salmonella sp

Shigella sp H. Influenzae Proteus mirabilis E. coli N. gonorrhoeae N. meningitidis

INDICATIONS

• Respiratory tract infections:
  
• Tonsillitis, sinusitis, laryngitis, pharyngitis, otitis media, bronchitis, bronchiectasis. pneumonia.
  
• Genitourinary tract Infections:
  
• Pyelonephritis, cystitis, urethritis, gonorrhoea.
  
• Skin and soft tissue Infections:
  
• Wounds, cellulitis, furunculosis, pyoderma.

CONTRA-INDICATIONS

• Hypersensitivity to beta-lactam antibiotics e.g. penicillins, cephalosporins.
  
• Babies born of mothers hypersensitive to penicillin.

ADVERSE REACTIONS

• Hypersensitivity reactions such as erythematous maculopapular rashes, urticaria, skin rashes, serum sickness.
  
• Serious and fatal hypersensitivity reaction is anaphylaxis, especially in patient with hypersensitivity condition to penicillin.
  
• Gastrointestinal disturbances, such as nausea, vomiting and diarrhoea.
  
• Haematological reactions (usually reversible).
  

PRECAUTIONS

• Before initiating therapy with Amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillin.
  
• Amoxicillin must be used with caution in pregnant and lactating women.
  
• Periodic assessment of renal, hepatic and hematopoietic functions should be made during prolonged therapy.
  
• Patient with renal disorder must be monitored for its plasma and urine level.
  
• As with other antibiotics, Amoxicillin administration may cause superinfection (the common causes are Pseudomonas, Enterobacterium, S. aureus and Candida). If it occurs, treatment should be discontinued and appropriate therapy should be instituted.
  
• Not for meningitis or body joint treatment (since oral Amoxicillin does not penetrate the cerebrospinal or sinovial liquid).
  
• Caution should be taken when this drug is administered to patients with lymphatic leukemia due to Amoxicillin-induced skin rash susceptibility.
  
• Amoxicillin administration may cause severe colitis.
  

DRUG INTERACTIONS

• Probenecid may increase and prolong blood level of Amoxicillin.
  
• Concomitant use with allopurinol may result in increased skin reactions.
  

DOSAGES

• Moderate Infections
  
• Adults and children ≥ 20 kg: 250 mg - 500 mg every 8 hours.
  
• Children with body weight of ‹ 20 kg: 20-40 mg/kg body weight/day in divided doses every 8 hours.
  
• For more severe infections higher doses may be given.
  
• For patients receiving peritoneal dialysis, recommended maximum dose is 500 mg/day.
  
• For treatment of Gonococcus urethritis: 3000 mg as a single dose.
  
• Dry syrup is recommended for children › 8 kg: 125mg-250 mg every 8 hours.
  
• Pediatric drops are recommended for children under 6 months of age.
  Usually dosage for ail indication except infections of the lower respiratory tract:
  
• ‹ 6 kg : 0.25 ml - 0.50 ml every 8 hours.
  
• 6 - 8 kg: 0.50 ml -1.0 ml every 8 hours.
  
Infections of the lower respiratory tract:

• ‹ 6 kg : 0.50 ml -1.0 ml every 8 hours.
  
• 6-8 kg: 1.0ml-1.5 ml every 8 hours.
  

Direction for suspension and dispersible tablet preparation

• Dry Syrup, for volume 60 ml.
  
• Pour drinking water until slightly below mark. Close bottle tightly. Hold bottle upside-down and shake until all granules are dispersed. Add sufficient drinking water up to mark (60 ml) and shake well.
  
• Pediatric Drops, for volume 15 ml.
  
• Pour 8 ml of drinking water. Close bottle tightly. Hold bottle upside-down and shake until all powder are dispersed.
  After reconstitution with drinking water, the suspension must be used within 7 days.
  Store in a refrigerator (2°- 8°C) or in a place away from light.
  
• Dispersible Tablet
  
• Dissolve one dispersible tablet into a spoonful of drinking water (teaspoonful or spoonful) wait for about 30-40 seconds until the tablet is completely dispersed into small granules. The suspension may be directly given to patient, followed by drinking water.
  

SPECIAL DOSAGE RECOMMENDATIONS FOR SPECIFIC INFECTIONS

Renal function impairment condition

For patients with renal impairment monitoring of drug concentration in plasma and urine should be undertaken. Suggested dosages: Moderate renal impairment with creatinine clearance 10-30 ml/min; 1 g followed by 500 mg every 12 hours. Severe renal Impairment with creatinine clearance 10 ml/min; 1 g followed by 500 mg every 24 hours.

SPECIFIC DOSAGE RECOMMENDATIONS

Typhoid and paratyphoid	Adults: 4g daily in divided doses for 14-21 days. Children: 100 mg/kg body weight/day in divided doses for 14 - 21 days
Typhoid carrier states	3 - 4 g daily in divided doses for a minimum of one month.
Gonorrhoea	A single dose of 3 g + 1 g probenecid where infection is caused by penicillin sensitive organisms.
Uncomplicated urinary tract infections	A single dose of 3 g.
Syphilis	250 mg every 6 hours has been used in all stages of syphilis. Duration of treatment varied from 4 weeks up to 5 months according to the stage of disease and serological response.
Severe or recurrent lower respiratory tract infection	3 g twice daily is recommended in appropriate cases for the treatment of severe or recurrent purulent infection of the respiratory tract.
Dental abscess	3 g twice daily with 8 hours between doses
Otitis media	In severe or recurrent otitis media, especially where compliance may be a problem, 750 mg twice daily for two days, may be used In children 3-10 years of age.

ON MEDICAL PRESCRIPTION ONLY

PRESENTATIONS

Capsule	:	Box of 10 strips 9 10 capsules.
Dry Syrup	:	Bottle containing dry syrup to be dispersed with drinking water up to 60 ml.
Pediatric Drops	:	Bottle containing dry syrup to be dispersed with drinking water up to 15 ml.
Dispersible Tablet	:	Box of 10 strips @ 10 tablets.

Reg. No.:

AMOXSAN® 250 Capsule	:
AMOXSAN® 500 Capsule	:
AMOXSAN® Dry Syrup	:	DKL0732401438A1
AMOXSAN® Forte Dry Syrup	:	DKL0732401438B1
AMOXSAN® Pediatric Drops	:	DKL0732401336A1
AMOXSAN® Dispersible Tablet	:	DKL0732401281A1

STORAGE
Store at room temperature (25°- 30°C), away from light.

Manufactured by:
PT SANBE FARMA
Bandung - Indonesia

For:
PT CAPRIFARMINDO LABS.
Bandung – Indonesia

Kedacillin

KEDACILLIN® for Injection
SODIUM SULBENICILLIN

Composition
KEDACILLIN for Injection is available in 1 g and 2 g vials, each of which contains :
The disodium salt equivalent to Sulbenicillin 1 g and 2 g (potency) respectively.
Sulbenicillin is a antibiotic, chemically 6 (2 - phenyl - 2 - sulphoacetamido) penicillanic acid.

Actions

1. Sulbenicillin is effective against gram-negative bacteria, including Pseudomonas aeruginosa and anaerobic Bacteroides, and is also effective against gram-positive bacteria sensitive to Penicillin - G.
2. Sulbenicillin is excreted into the urine and bile in high concentration.
   Therefore, urinary levels, well above those required to eradicate urinary pathogens, are achieved.

Indications
It is indicated the following infections due to Sulbenicillin susceptible Pseudomonas aeruginosa, Proteus, Retgerella, Klebsiella, Enterobacter, E. coli, Citrobacter cloacae, Pfeiffer's bacilli, Staphylococci, Streptococci, Pneumococcus and Bacteroides.

• Urinary tract infections : pyelonephritis, pyelitis, pyonephrosis, cystitis and urethritis.
• Bile-duct infections : cholecystitis and cholangitis.
• Respiratory tract infections : acute and chronic bronchitis, bronchiectasis, bronchopneumonia, pneumonia and pulmonary suppuration.
• Obstetrics and Gynecology : intrauterine infection, adnexitis, intrapelvic infection and Bartholinitis.
• Otorhinological infections : otitis media, sinusitis, parotitis, submaxillitis, furuncle of the ear and furuncle of the nose.
• Superfacial suppurative diseases : folliculitis, furuncle, carbuncle, abscess, panaris, phlegmon, tonsilitis, peritonsilitis, peritonsillar abscess, erysipelas, ophthalmia, blepharitis, corneal ulcer, dacryocystitis, stye, post-operative wound infection and traumatic and burn infections.
• Peritonitis.
• Septicemia and sub-acute bacterial endocarditis.

Administration and Dosage

• Usually, 2-4 g daily for adults or 40-80 mg/kg body weight daily for children, intravenously, divided into two to four doses.
• For severe and intractable infections caused by Pseudomonas aeruginosa and Proteus, increase the intravenous daily dose up to 20 g for adults or up to 400 mg/kg body weight for children, including new-born infants, according to condition. For septicemia and pneumonia patients, whose defensive power against infections if reduced by leucopenia, increase the intravenous daily dose up to 30 g.
• For intravenous injection, dissolve each 1 g of the product in 20 ml distilled water for injection or glucose solution for injection. If the single dose becomes over 5 g, dissolve in 100 to 500 ml of solution for infusion and administer by intravenous drip over 1 to 2 hours.
• For intramuscular use, KEDACILLIN (1 g in 3 ml) may be given intramuscularly but causes pain similar to other injectable Penicillins. For intramuscular use, a local anaesthetic such as Lidocaine or Mepivacaine must be included.
• The solution may become warm due to heat of dissolution but quality is not affected.

Contraindication
KEDACILLIN must not be administered to patients with known hypersensitivity to Penicillin.

Side effects
Though very rare, side effects such as gastrointestinal disturbance, eruption, eyelid edema, fever, facial pallor and intradermal positive reaction are likely to be observed as with other synthetic Penicillins.

Precautions

1. If the patient or his family has a history of allergic conditions such as bronchial asthma, eruption and urticaria, KEDACILLIN should be given cautiously. Anaphylactic reaction has been reported following administration of antibiotics of the Penicillin series.
2. KEDACILLIN should be administered carefully to patients with severe renal or hepatic damage.
3. As KEDACILLIN contains 4,8 mEq/g (potency) of sodium, KEDACILLIN should be given carefully by measuring electrolyte concentration periodically when the administration of high dosage for long term is required to the patients with cardiac or renal Insufficiency and hypertension.
4. Periodical examination of hepatic or renal function and blood picture is desirable since KEDACILLIN may increase SGOT, SGPT and BUN, and decrease erythrocyte and leucocyte.

Store at room temperature (25-30°C).

Package
Box, 10 vials @ 1 g,
Box, 10 vials @ 2 g,

1 g, Reg.No. DKL7225100444B1.
2 g, Reg. No. DKL8625100444A1.

ON MEDICAL PRESCRIPTION ONLY

Manufactured by PT. Meiji Indonesia, Bangil
For PT. Takeda Indonesia, Bekasi, Indonesia
Licensed by Takeda Pharmaceutical Company Limited, Osaka, Japan

Kalmoxilin

Composition
Each capsule contains:
Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg
Each caplet contains :
Amoxicillin Trihydrate equivalent to Amoxicillin 500 mg
Each 5 ml of the suspension contains:
Amoxicillin Trihydrate equivalent to Amoxicillin 125 mg
Each 5 ml of the suspension contains :
Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg
Each vial contains:
Sodium Amoxicillin equivalent to Amoxicillin 1000 mg

Pharmacology
Amoxicillin is a semi synthetic derivative of penicillin which is active against Gram-positive and Gram-negative microorganisms.
Excretion is inhibited when is administered with probenecid, which cause prolonged
therapeutic effect.

Capsules, Caplets and Dry Syrup
Amoxicillin is stable in acid gastrointestinal. Amoxicillin is rapidly and welt absorbed through digestive tract, not depend on food availability.
Amoxicillin especially is excreted in unchanged form in urine.

Injection
Administration of 250 mg or 500 mg amoxicillin injection intramuscular, produces serum level about 5.5-10 ug/ml for 60 minutes.
The major route of excretion for amoxicillin injection is through the kidney. In normal renal function about 70 of amoxicillin will be excreted in unchanged form (rapid i.m. and i.v. administration) after 6 hours.

Indications
Amoxicillin injection is given if the oral administration is not possible.
Amoxicillin is indicated for the infections therapy caused by sensitive bactena strain :

• Skin and soft tissue Infections : Slaphylococcus sp. nonpeniclllinase-producing strains, Streptococcus sp., E. coli,
• Respiratory tract Infections: Haemophilus intluenzae. Streptococcus sp. including Streptococcus pneumoniae, Slaphylococcus sp. nonpenicillinase-producing strains, E. coli.
• Urogenital tract infections : E co//, P. mirabilis and Streptococcus faecalis.
• Gonorrhoea : N. gononrrhoea (nonpenicillinase-producing strains).

Dosage and Administration
Capsules, Caplets and Dry Syrup

• Adult and Children › 20 kg : 250 - 500 mg every 8 hours.
• Children ‹ 20 kg : 20 - 40 mg/kg body weight/day in divided dose, every 8 hours.
• Patient with renal dysfunction, necessary to reduce the dosage, The maximum recommended dose for patient with peritoneal dialysis is 500 mg/day.
• Gonococcus urethritis : 3 g as a single dose.

Injection
Patients with normal renal function:

• Upper respiratory tract infections, urogenital tract infections, skin and soft tissue infections:
• Adult: 250 mg every 6-8 hours, depends on patient's condition.
• Children (‹ 20 kg): 20 mg/kg/day In divided dose every 6-8 hours.
• In severe infection, dosage can be increased up to 500 mg every 6 - 8 hours
• (adult) and 40 mg/kg/day in divided dose every 6-8 hours (children).
• Lower respiratory tract infections :
• Adult: 500 mg every 6-8 hours.
• Children (‹ 20 kg); 40 mg/kg/day in divided dose every 6-8 hours.
• Bacterial septicemia:
• Adult: for more serious infections : 1 gram every 6 hours with intermittent i.v.
• injection or i.v. infuse for 30-60 minutes.
• Children (‹ 20 kg): 20 - 40 nig/kg every 6 hours.

Patients with renal function Impairment:

Creatinine clearance › 30ml/minute	No dose adjustment is needed.
Moderate impairment (Creatinine clearance 10-30ml/minute)	1g injection amoxicillin followed by 500 mg injection amoxicillin 12 hourly.
Severe impairment (Creatinine clearance ‹ 10ml/minute)	1g injection amoxicillin followed by 500 mg injection amoxicillin 24 hourly.

Warnings and Precautions

• Careful inquiry should be made in patient with lymphatic leukemia because it can cause hypersensitivity reaction such as skin rash.
• Severe colitis can be occurred.
• Before initiating therapy with amoxicillin, sensitivity reaction with penicillin should be tested.
• Amoxicillin should be used by caution when administered to pregnant and nursing women.
• Prolonged therapy with amoxicillin should be accompanied with renal, hepatic and hematopoietic function assessment.
• Superinfection can be occured (usually caused by Enlerobacterium, Pseudomonas, Staphylococcus auraus, Candida). If this case is happened, treatment should be discontinued and others alternative antimicroba is given.
• Patient with renal dysfunction, plasma and urine level monitoring should be maintained. Dosage adjustment should be taken.
• Oral amoxicillin is not recommended for meningitis and bone and joint infections because the amoxicillin oral cannot penetrate In cerebrospinal and sinovial liquid.
• Injection amoxicillin should not be mixed with blood products or other proteinaceous fluids, e.g. protein hydrolysates or with intravena lipid emulsion.
• Prescribed concurrently with an aminoglycoside, should not be mixed In the same syringe/infuse fluid container because the activity of the aminoglycoside will decrease.
• During treatment with high doses of amoxicillin, particularly by bolus Injection, an adequate fluid intake and urinary output must be maintained.
• Amoxicillin injection is stable with commonly used intravena fluids at 23°C, if Infused over a period not exceeding 6 hours.
• Solutions should be changed after 1 hour if amoxicillin injection is administered in fluids containing dextrose or other carbohydrates, or within 3 hours in solutions containing sodium lactate.

Adverse Reactions

• Hypersensitivity reaction such as erythemalous maculopapular rashes, urticaria, serum sickness.
• Serious and fatal hypersensitivity reaction : anaphylaxis especially occurs In patient with hypersensitivity to penicillin.
• Gastrointestinal tract disturbance such as : vomiting, nausea, diarrhoea.
• Haematological reactions (usually reversible).
• Especially for injection administration can cause phlebitis and pain at injection site.

Contraindications
Patient with hypersensitivity or with known history of hypersensitivity to beta ladam
antibiotics (penicillin, cephalosphorin).

Drug Interactions

• Probenecide can increase and prolong amoxicillin concentration in plasma.
• It may increase skin reaction when amoxicillin is administered with allopurinol

Presentation

Capsule 250 mg	:	Box of 10 strips x 10 capsules	Reg. No. DKL7411607301A1
Caplet 500 mg	:	Box of 3 strips x 10 Caplets	Reg, No. DKL7811607404A1
	:	Box of 10 strips x 10 caplets	Reg. No. DKL7811607404A1
Dry syrup 125 mg/5 ml	:	Box of bottle 60 ml	Reg. No. DKL9911629538A1
Dry syrup 250 mg/5 ml	:	Box of bottle 60 ml	Reg.No.DKL7611600638A1
Injection 1000 mg	:	Box of 10 vials @ 1000 mg	Reg. No. DKL9611600644A1

Should be administered Immediately after reconstruction.
After reconstruction :

• Store at room temperature maximal 1 hour.
• Store at refrigerator maximal 3 hours.

Capsules, Caplets and Dry Syrup Store below 30°C.

Injection Store below 25°C.

On medical Prescription only

Injection Manufactured by: PT Bernofarm Pharmaceutical Surabaya - Indonesia For: PT. KALBEFARMA Tbk. Bekasi - Indonesia

Capsules, Caplets and Dry Syrup Manufactured by: PT DANKOS FARMA Jakarta - Indonesia For: PT. KALBEFARMA Tbk. Bekasi - Indonesia