Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
271 Cariprazine Hydrochloride 3.0mg Capsule N05AX15-110-C11-02-xxx A* For treatment of schizophrenia in adult patients. As a second-line therapy for patients especially in cases with predominant negative symptoms. Once-daily for 1.5mg, 3.0mg, 4.5mg, 6.0mg

Dose in Renal Impairment:
No dose adjustment for mild to moderate renal impairment. NOT recommended for severe impairment (CrCL< 30mL/min).

Dose in Liver Failure:
No dose adjustment for mild to moderate hepatic impairment. NOT recommended for severe impairment (Child-Pugh score between 10-15).
272 Cariprazine Hydrochloride 4.5mg Capsule N05AX15-110-C11-03-xxx A* For treatment of schizophrenia in adult patients. As a second-line therapy for patients especially in cases with predominant negative symptoms. Once-daily for 1.5mg, 3.0mg, 4.5mg, 6.0mg

Dose in Renal Impairment:
No dose adjustment for mild to moderate renal impairment. NOT recommended for severe impairment (CrCL< 30mL/min).

Dose in Liver Failure:
No dose adjustment for mild to moderate hepatic impairment. NOT recommended for severe impairment (Child-Pugh score between 10-15).
273 Cariprazine Hydrochloride 6.0mg Capsule N05AX15-110-C11-04-xxx A* For treatment of schizophrenia in adult patients. As a second-line therapy for patients especially in cases with predominant negative symptoms. Once-daily for 1.5mg, 3.0mg, 4.5mg, 6.0mg

Dose in Renal Impairment:
No dose adjustment for mild to moderate renal impairment. NOT recommended for severe impairment (CrCL< 30mL/min).

Dose in Liver Failure:
No dose adjustment for mild to moderate hepatic impairment. NOT recommended for severe impairment (Child-Pugh score between 10-15).
274 Carvedilol 25mg Tablet C07AG02-000-T10-02-XX A/KK i) Treatment of all patients with stable and symptomatic, mild, moderate and severe chronic heart failure in combination with ACEis and diuretics
ii) Hypertension
iii) Angina pectoris		 None i) Initial: 3.125mg twice daily for 2 weeks
Maintenance: Titrate up to as tolerated
Max:
<85 kg: 25 mg twice daily
>85 kg: 50 mg twice daily

ii) Initial: 12.5mg once daily
Maintenance: 25mg once daily
Max. 50mg daily in 1 or 2 divided doses

iii) Initial: 12.5mg once daily
Maintenance: 25mg once daily
Max. 100mg daily in 1 or 2 divided doses

Dosing is individualised and according to product insert / protocol.
275 Carvedilol 6.25mg Tablet C07AG02-000-T10-01-XX A/KK i) Treatment of all patients with stable and symptomatic, mild, moderate and severe chronic heart failure in combination with ACEis and diuretics
ii) Hypertension
iii) Angina pectoris		 None i) Initial: 3.125mg twice daily for 2 weeks
Maintenance: Titrate up to as tolerated
Max:
<85 kg: 25 mg twice daily
>85 kg: 50 mg twice daily

ii) Initial: 12.5mg once daily
Maintenance: 25mg once daily
Max. 50mg daily in 1 or 2 divided doses

iii) Initial: 12.5mg once daily
Maintenance: 25mg once daily
Max. 100mg daily in 1 or 2 divided doses

Dosing is individualised and according to product insert / protocol.
276 Caspofungin Acetate 50 mg Injection J02AX04-122-P40-01-XXX A* i) Confirmed systemic fungal infection in patients who are refractory or intolerant to other fungal therapies.
ii) For pediatric patient (12 month and older) for the following indications :
a) Empirical therapy for presumed fungal infections in febrile, neutropenic patients
b) Treatment of invasive candidiasis, including candidemia and the following Candida infections ; intra-abdominal abscesses, peritonitis and pleural space infections
c) Treatment of esophageal candidiasis
d) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of others therapy (eg : Amphotericin B)		 None i) Invasive aspergillosis & invasive candidiasis: ADULT: Initially, 70 mg infused over 1 hour followed by subsequent doses of 50 mg/day. Oesophageal candidiasis: ADULT: 50 mg by slow IV infusion over approximately 1 hour ii) For all indications, a loading dose of 70mg/m2 on D1 followed by maintenance dose of 50mg/m2 od.
277 Caspofungin Acetate 70 mg Injection J02AX04-122-P40-02-XXX A* i) Confirmed systemic fungal infection in patients who are refractory or intolerant to other fungal therapies.
ii) For pediatric patient (12 month and older) for the following indications :
a) Empirical therapy for presumed fungal infections in febrile, neutropenic patients
b) Treatment of invasive candidiasis, including candidemia and the following Candida infections ; intra-abdominal abscesses, peritonitis and pleural space infections
c) Treatment of esophageal candidiasis
d) Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of others therapy (eg : Amphotericin B)		 None i) Invasive aspergillosis & invasive candidiasis: ADULT: Initially, 70 mg infused over 1 hour followed by subsequent doses of 50 mg/day. Oesophageal candidiasis: ADULT: 50 mg by slow IV infusion over approximately 1 hour daily ii) Child (12months to 17 years) : For all indication) A single 70mg/m2 loading dose (not to exceed an actual dose of 70mg) by slow IV infusion over 1hour; followed by 50mg/m2 (not to exceed an actual dose of 70mg)
278 Cefaclor 125mg/5ml Suspension J01DC04-000-F21-01-XXX A Infections caused by susceptible organisms including Staphylococcus aureus and H. influenzae, treatment of sinusitis and infections involving the respiratory tract, skin and skin structure, bone and joint, and urinary tract CHILD:>1 mth: 20 mg/kg daily in 3 divided doses, increased to 40 mg/kg daily if necessary, <1 yr: 62.5 mg tid, 1-5 yr: 125 mg tid, >5 yr: 250 mg tid. Maximum: 1 g daily
279 Cefaclor 500mg Capsule J01DC04-000-C10-02-XXX A Infections caused by susceptible organisms including Staphylococcus aureus and H. influenzae, treatment of sinusitis and infections involving the respiratory tract, skin and skin structure, bone and joint, and urinary tract None ADULT: 250 mg 3 times daily for 10 days. For severe infections, double the dosage. Maximum: 4 g daily. CHILD:>1 mth: 20 mg/kg daily in 3 divided doses, increased to 40 mg/kg daily if necessary, <1 yr: 62.5 mg tid, 1-5 yr: 125 mg tid, >5 yr: 250 mg tid . Maximum: 1 g daily
280 Cefazolin Sodium 1g Injection J01DB04-520-P30-01-XXX A Infection caused by cefazolin-sensitive microorganism, infection of the respiratory tract, urogenital tract, skin and soft tissue, bile duct, bones and joint, endocarditis, systemic septic infection, peri-operative/ surgical prophylaxis None ADULT: Uncomplicated infections: 500 - 1000 mg 2 - 3 times daily. Moderately severe and severe infections: 500 - 1000 mg 3 - 4 times daily. Severe life-threatening infections: 1 - 1.5 g 4 times daily. Rarely, dose up to 12 g daily. CHILDREN >1 month: 25-50mg/kg/day in 3-4 divided dose
281 Cefepime 1g Injection J01DE01-110-P40-02-XXX A* Febrile neutropenia, septicaemia, lower respiratory tract infection, urinary tract infection, skin and skin structure infections, gynaecologic and intra-abdominal infections None ADULT: 1 - 2 g twice daily for most infections. For severe infections including febrile neutropenia: 2 g 3 times daily. CHILD:2 mth - 16 yr: ≤40 kg: 50 mg/kg every 8-12 hr for 7-10 days
282 Cefoperazone Sodium 1g Injection J01DD12-520-P40-02-XXX A Infections due to gram-negative bacteria None ADULT: 1 - 2 g twice daily IM or IV. By IV, adult dose may be doubled. Maximum: 16 g daily in divided doses. CHILD & INFANT: 50 - 200 mg/kg/day in 2 - 4 divided doses. NEONATE less than 8 days: 50 - 200 mg/kg/day 12 hourly
283 Cefoperazone Sodium 2g Injection J01DD12-520-P40-03-XXX A Infections due to gram-negative bacteria None ADULT: 1 - 2 g twice daily IM or IV. By IV, adult dose may be doubled. Maximum: 16 g daily in divided doses. CHILD & INFANT: 50 - 200 mg/kg/day in 2 - 4 divided doses. NEONATE less than 8 days: 50 - 200 mg/kg/day 12 hourly
284 Cefoperazone Sodium 500mg & Sulbactam Sodium 500mg Injection J01DD62-000-P40-01-XXX A i) Treatment of infections due to multi-drug resistance pathogens producing B-lactamase
ii) Treatment of infections caused by Acinetobacter species		 None ADULT: 1 - 2 g twice daily. In severe or refractory infections the daily dosage of sulbactam/cefoperazone may be increased up to 8g (4g cefoperazone activity) CHILD: 40 - 80 mg/kg/day in 2 to 4 equally divided doses; in serious or refractory infections, may increase to 160mg/kg/d in 2 - 4 equally divided doses.
285 Cefotaxime 1g Injection J01DD01-520-P40-02-XXX A Infections due to gram-negative bacteria None ADULT: 1 g 12 hourly (up to 12 g/day in severe cases). CHILD: 50 - 180 mg/kg/day in 4 - 6 divided doses
286 Cefotaxime 500mg Injection J01DD01-520-P40-01-XXX A Infections due to gram-negative bacteria None ADULT: 1 g 12 hourly (up to 12 g/day in severe cases). CHILD: 50 - 180 mg/kg/day in 4 - 6 divided doses
287 Ceftaroline Fosamil 600mg Powder for concentrate for solution for infusion J01D102-000-P40-01-XXX A* Treatment of complicated skin and soft tissue infections (cSSTI) in adults Restricted for only complicated SSTI in patients who are unable to tolerate or not responding to vancomycin. 600mg administered every 12 hours by intravenous infusion over 60 minutes for 5-14 days. Dose adjustment in renal impairment: - CrCl > 30 to ≤50 ml/min : 400mg (IV) every 12 hours (over 60 minutes) - CrCl ≥ 15 ≤ 30 ml/min: 300mg (IV) every 2 hours (over 60 minutes) - CrCl < 30ml/min including hemodialysis*: 200mg (IV) every 12 hours (over 60 minutes) * Ceftaroline is hemodialyzable, thus should be administered after hemodialysis.
288 Ceftazidime 1g Injection J01DD02-520-P40-03-XXX A Severe gram negative bacterial infections none ADULT: 1 g 8 hourly or 2 g 12 hourly. In severe infections: 2 g 8 hourly. CHILD: 25 - 150 mg/kg/day in 2 - 3 divided doses
289 Ceftazidime 2g & Avibactam 0.5g Injection J01DD52-961-P41-01-XXX A* i. Complicated intra-abdominal infection, in combination with metronidazole;
ii. Complicated urinary tract infection, including pyelonephritis;
iii. Hospital-acquired pneumonia, including ventilator-associated pneumonia.		 i. To be restricted to carbapenem-resistant Enterobacteriaceae (CRE) as an alternative to polymyxin.
ii. Treatment initiated after proven susceptibility to ceftazidime/avibactam via C&S testing.
iii. To be prescribed by Infectious Disease Specialist only
 Ceftazidime 2g / Avibactam 0.5g vial three times daily by intravenous infusion over 2 hours in patients 18 years or older for 5 to 14 days
290 Ceftazidime 2g Injection J01DD02-520-P40-04-XX A Severe gram negative bacterial infections None ADULT: 1 g 8 hourly or 2 g 12 hourly. In severe infections: 2 g 8 hourly. CHILD: 25 - 150 mg/kg/day in 2 - 3 divided doses
291 Ceftolozane 1000mg & Tazobactam 500mg Injection J01DI54-000-P40-01-001 A* For the treatment of patients 18 years or older with the following infections.

i) Treatment of complicated Intra-abdominal Infections (cIAI), to be used in combination with metronidazole.
ii) Treatment of complicated Urinary Tract Infections (cUTI) including Pyelonephritis.
iii) Nosocomial Pneumonia, including Ventilator Associated Pneumonia		 Indication (i) & (ii):
Confirmed carbapenem-resistant Pseudomonas aeruginosa as an alternative to Polymyxins (Polymyxin sparing).

Indication (iii):
i) Confirmed carbapenem-resistant Pseudomonas aeruginosa as an alternative to Polymyxins (Polymyxin sparing).
ii) Treatment initiated after proven susceptibility to ceftolozane/tazobactam via C&S testing
iii) To be prescribed by Infectious Disease Specialist only
 1.5g (ceftolozane 1g and tazobactam 0.5g) administered every 8 hours by intravenous infusion over 1 hour in patients 18 years or older with normal renal function or mild renal impairment.
i) 1.5g every 8 hours for 4-14 days
ii) 1.5g every 8 hours for 7 days
iii) 3g (Ceftolozane 2g and Tazobactam 1g) every 8 hours by intravenous infusion over 1 hour in patients 18 years or older, for 8 to 14 days
292 Ceftriaxone 0.25g Injection J01DD04-520-P40-01-XXX A/KK i) Gonorrhoea
ii) Chancroid		 None i) 250 mg by deep IM injection
ii) single IM injection 250 mg only. For severe infection up to 100 mg/kg/day
293 Ceftriaxone 0.5 g Injection J01DD04-520-P40-02-XXX A, A/KK PRESCRIBER CATEGORY A
Infections caused by susceptible organisms

PRESCRIBER CATEGORY A/KK
Gonorrhoea		 None ADULT: 1 - 2 g once daily.
Severe infection: 4 g daily at 12 hour intervals.
Gonorrhea 500mg IM as single dose

NEONATE up to 2 weeks: 20 - 50 mg/kg body weight daily, not to exceed 50 mg/kg
INFANT & CHILD, 3 weeks - 12 years: 20 - 80 mg/kg body weight daily.
CHILD with body weight 50 kg or more: adult dose.
294 Ceftriaxone 1g Injection J01DD04-520-P40-03-XXX A Infections caused by susceptible organisms None ADULT: 1 - 2 g once daily.
Severe infection: 4 g daily at 12 hour intervals.
NEONATE up to 2 weeks: 20 - 50 mg/kg body weight daily, not to exceed 50 mg/kg
INFANT & CHILD, 3 weeks - 12 years: 20 - 80 mg/kg body weight daily.
CHILD with body weight 50 kg or more: adult dose.
295 Cefuroxime Axetil 125 mg Tablet J01DC02-233-T10-01-XXX A/KK Upper and lower respiratory tract, genito-urinary tract, skin & soft tissue and urinary tract infections (UTI) ADULT:
Most infections: 250 mg twice daily
Severe infections: 500mg twice daily

CHILD:
Most infections: 125mg twice daily or 30 mg/kg/day in 2 divided doses, up to 500 mg daily
Severe infections: 250mg twice daily

Dosing is individualised and according to package insert
296 Cefuroxime Axetil 125mg/5ml Suspension J01DC02233-F21-01-XXX A Infections caused by susceptible organisms None 30 mg/kg/day in 2 divided doses, up to 500 mg daily.
297 Cefuroxime Axetil 250 mg Tablet J01DC02-233-T10-02-XXX A/KK Upper and lower respiratory tract, genito-urinary tract, skin & soft tissue and urinary tract infections (UTI) None ADULT:
Most infections: 250 mg twice daily
Severe infections: 500mg twice daily

CHILD:
Most infections: 125mg twice daily or 30 mg/kg/day in 2 divided doses, up to 500 mg daily
Severe infections: 250mg twice daily

Dosing is individualised and according to package insert
298 Cefuroxime Axetil 500 mg Tablet J01DC02-233-T10-03-XXX A/KK Upper and lower respiratory tract, genito-urinary tract, skin & soft tissue and urinary tract infections (UTI) None ADULT:
Most infections: 250 mg twice daily
Severe infections: 500mg twice daily

CHILD:
Most infections: 125mg twice daily or 30 mg/kg/day in 2 divided doses, up to 500 mg daily
Severe infections: 250mg twice daily

Dosing is individualised and according to package insert
299 Cefuroxime Sodium 1.5 g Injection J01DC02-520-P40-03-XXX A Infections caused by susceptible organisms, surgical prophylaxis None ADULT: 750 mg every 6 - 8 hours as IM or IV. Severe infections: 1.5 g every 6 - 8 hours as IV. CHILD: 30 - 100 mg/kg/day in 3 - 4 divided doses or 2-3 divided doses in neonates. Surgical prophylaxis: 1.5 g IV
300 Cefuroxime Sodium 750 mg Injection J01DC02-520-P40-02-XXX A Infections caused by susceptible organisms, surgical prophylaxis None ADULT: 750 mg every 6 - 8 hours as IM or IV. Severe infections: 1.5 g every 6 - 8 hours as IV. CHILD: 30 - 100 mg/kg/day in 3 - 4 divided doses or 2-3 divided doses in neonates. Surgical prophylaxis: 1.5 g IV

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