Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1201 Pancreatin 150 mg Capsule (equivalent to amylase 8000 units, lipase 10,000 units and protease 600 units) A09AA02-000-C10-01-XXX A/KK Treatment of pancreatic exocrine insufficiency - Initially 1 - 2 capsules with each meal. May increase to 5 - 15 capsules daily

Dosing is individualised and according to product insert/protocol
1202 Pancuronium Bromide 2 mg / ml lnjection M03AC01320P3001XX B Muscle relaxant as an adjunct to general anaesthesia ADULT: Initially 50 - 100 mcg/kg IV, then 10 - 20 mcg/kg as required. CHILD > 2 YEARS: Initially 60 - 100 mcg/kg then 10 - 20 mcg/kg. Intensive care, by IV, 60 mcg/kg every 60 - 90 minutes
1203 Pantoprazole 40 mg Tablet A02BC02-000-T10-01-XXX B i) Helicobacter pylori eradication
ii) Peptic ulcer disease
iii) Erosive and non-erosive reflux oesophagitis (GERD and NERD)
iv) Zollinger-Ellison Syndrome
v) Prevention of NSAID induced gastropathy		 - i) 40 mg twice daily in combination with any of the 2 antibiotics (Clarithromycin 500 mg twice daily, Amoxicillin 1 g twice daily or Metronidazole 400 mg twice daily) for 1-2 weeks
ii) 40 mg daily for 2 - 4 weeks
iii) 20 - 40 mg daily on morning for 4 weeks
iv) Initially 80 mg daily, dose can be titrated up or down as needed.
v) 20 mg daily. CHILD not recommended
1204 Pantoprazole 40mg Injection A02BC02-000-P30-01-XXX A/KK Short term use for symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
• Duodenal ulcer
• Gastric ulcer
• Moderate and severe reflux esophagitis
• Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions		 - 40 mg twice daily until oral administration can be resumed.
CHILD not recommended
1205 Papaverine HCl 120 mg/10ml Injection A03AD01110P3002XX A Relief of cerebral and peripheral ischaemia associated with arterial spasm and myocardial ischaemia complicated by arrhythmias ADULT: 30 - 120 mg may be repeated every 3 hours as necessary. CHILD: 6 mg/kg daily in 4 divided doses
1206 Paracetamol 10mg/ml Solution for IV Infusion N02BE01000P3101XX A Mild to moderate pain and pyrexia Body Weight (BW)
≤ 10kg: 7.5mg/kg, max: 30mg/kg
>10kg to ≤ 33kg: 15mg/kg, max 60mg/kg not exceeding 2g
>33kg to ≤ 50kg: 15mg/kg, max 60mg/kg not exceeding 3g
>50kg (with risk of hepatotoxicity): 1g, max 3g BW >50kg (without risk of hepatotoxicity): 1g, max 4g OR as in the product leaflet
1207 Paracetamol 120mg/5 ml Syrup N02BE01000L9001XX C+ Mild to moderate pain and pyrexia None CHILD:
up to 1 year: 60 - 120 mg.
1 - 5 years: 120 - 240 mg.
6 - 12 years: 240 - 480 mg per dose. Repeat every 4 - 6 hours when necessary. Maximum of 4 doses in 24 hours
1208 Paracetamol 125mg Suppository N02BE01000S2002XX C+ Symptomatic relief of fever and post operative pain whom cannot tolerate oral preparations. None ADULT & CHILDREN more than 12 years old: 500mg - 1g every 4-6 hours
CHILD 6 - 12 years : 250 - 500 mg; 1 - 5 years : 125 - 250 mg; 3 - 11 months : 80 mg inserted every 4 - 6 hours if necessary, maximum 4 doses in 24 hours.
INFANTS under 3 months should not be given Paracetamol unless advised by doctor; a dose of 10 mg/kg (5 mg/kg if jaundiced) is suitable.
1209 Paracetamol 250 mg Suppository N02BE01000S2001XX B Symptomatic relief of fever and post operative pain whom cannot tolerate oral preparations. None ADULT & CHILDREN more than 12 years old: 500mg - 1g every 4-6 hours
CHILD 6 - 12 years : 250 - 500 mg; 1 - 5 years : 125 - 250 mg; 3 - 11 months : 80 mg inserted every 4 - 6 hours if necessary, maximum 4 doses in 24 hours.
INFANTS under 3 months should not be given Paracetamol unless advised by doctor; a dose of 10 mg/kg (5 mg/kg if jaundiced) is suitable.
1210 Paracetamol 250 mg/5 ml Syrup N02BE01000L8002XX C+ Mild to moderate pain and pyrexia None CHILD: 6 - 12 years: 250 - 500 mg per dose. Repeat every 4 - 6 hours when necessary. Maximum of 4 doses in 24 hours
1211 Paracetamol 500 mg Tablet N02BE01000T1001XX C+ Mild to moderate pain and pyrexia None ADULT: 500 - 1000 mg every 4 - 6 hours, maximum of 4 g daily
1212 Paraffin Mole Alba (White Soft Paraffin) D02AC00000G5001XX C Xerosis and ichthyosis Apply to the affected area
1213 Paraffin Mole Flava D02AC00000G5002XX C Xerosis and ichthyosis Apply to the affected area
1214 Parecoxib Sodium 40mg Injection M01AH04520P3001XX A* Management of post operative pain in the immediate post operative setting only 40 mg followed by 20 or 40 mg every 6 to 12 hours, as required, not exceeding daily dosage of 80 mg. There is limited clinical experience with parecoxib treatment beyond three days. Reduce the initial dose by 50% in elderly less than 50 kg, with a maximum daily dosage of 40 mg.
1215 Pazopanib Hydrochloride 200 mg Tablet L01XE11110T1001XX A* For treatment of advanced and/or metastatic renal cell carcinoma (RCC) Restriction: i) KPS ≥ 70% ii) Clear cell histology iii) No brain metastasis iv) Haemoglobin ≥ 9g/dl v) Creatinine ≤2x the ULN vi) Corrected calcium < 12mg/dl vii) Platelet count of >100x103/uL viii) Neutrophil count >1,500/mm3 Recommended dose is 800 mg ORALLY once daily. Should be taken without food (at least one hour before or two hours after meal). The dose should not exceed 800 mg.
1216 Pazopanib Hydrochloride 400 mg Tablet L01XE11110T1002XX A* For treatment of advanced and/or metastatic renal cell carcinoma (RCC) Restriction: i) KPS ≥ 70% ii) Clear cell histology iii) No brain metastasis iv) Haemoglobin ≥ 9g/dl v) Creatinine ≤2x the ULN vi) Corrected calcium < 12mg/dl vii) Platelet count of >100x103/uL viii) Neutrophil count >1,500/mm3 Recommended dose is 800 mg ORALLY once daily. Should be taken without food (at least one hour before or two hours after meal). The dose should not exceed 800 mg.
1217 Pegfilgrastim Pre-filled Syringe 6 mg/0.6 ml (10 mg/ml) L03AA13000P5001XX A* Reduction in the duration of neutropenia, the incidence of febrile neutropenia and the incidence of infection as manifested by febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) Adults (≥18 years): One 6 mg dose (a single pre-filled syringe) of pegfilgrastim for each chemotherapy cycle, administered as a subcutaneous injection approximately 24 hours following cytotoxic chemotherapy. Renal impairment: Pharmacokinetics of pegfilgrastim is not expected to be affected by renal impairment. Hepatic impairment: Pharmacokinetics of pegfilgrastim is not expected to be affected by hepatic impairment. Paediatric population: Insufficient data to recommend the use of pegfilgrastim in children and adolescents under 18 years of age.
1218 Peginterferon Alpha-2a 135 mcg Prefilled Syringe L03AB11-000-P50-02-XXX A* i) Chronic hepatitis C alone or in combination with other antiviral drugs
ii) For the treatment of both HbeAg-positive and HbeAg-negative chronic hepatitis B with compensated liver disease and evidence of viral replication who are not responding or tolerating oral antiviral therapy		 Initiated by Hepatologist and Gasteroenterologist only. i) 180 mg once weekly.
Treatment duration may vary depending on HCV genotype.

ii) 180 mcg weekly SC for 48 weeks

Dosage, including treatment duration, is individualised and according to product insert/protocol
1219 Peginterferon Alpha-2a 180 mcg Prefilled Syringe L03AB11-000-P50-01-XXX A* i) Chronic hepatitis C alone or in combination with other antiviral drugs
ii) For the treatment of both HbeAg-positive and HbeAg-negative chronic hepatitis B with compensated liver disease and evidence of viral replication who are not responding or tolerating oral antiviral therapy		 Initiated by Hepatologist and Gasteroenterologist only) i) 180 mg once weekly.
Treatment duration may vary depending on HCV genotype.

ii) 180 mcg weekly SC for 48 weeks

Dosage, including treatment duration, is individualised and according to product insert/protocol
1220 Pegylated Interferon Alpha-2b 100mcg Injection L03AB10-000-P50-03-XXX A* Treatment of:
i) Chronic Hepatitis C
ii) Chronic Hepatitis B		 None i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once weekly for at least 6 months. Combination therapy: 1.5 mcg/kg/week SC in combination with ribavirin capsules.

ii) 1-1.5 mcg/kg once weekly for at least 24 weeks and up to 52 weeks.
1221 Pegylated Interferon Alpha-2b 120mcg Injection L03AB10-000-P50-04-XXX A* Treatment of:
i) Chronic Hepatitis C;
ii) Chronic Hepatitis B		 None i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once weekly for at least 6 months. Combination therapy: 1.5 mcg/kg/week SC in combination with ribavirin capsules.

ii) 1-1.5 mcg/kg once weekly for at least 24 weeks and up to 52 weeks.
1222 Pegylated Interferon Alpha-2b 150mcg Injection L03AB10-000-P50-05-XXX A* Treatment of:
i) Chronic Hepatitis C;
ii) Chronic Hepatitis B		 None i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once weekly for at least 6 months. Combination therapy: 1.5 mcg/kg/week SC in combination with ribavirin capsules.

ii) 1-1.5 mcg/kg once weekly for at least 24 weeks and up to 52 weeks.
1223 Pegylated Interferon Alpha-2b 50mcg Injection L03AB10-000-P50-01-XXX A* Treatment of:
i) Chronic Hepatitis C
ii) Chronic Hepatitis B		 None i) Monotherapy: SC at a dose of 0.5 or 1 mcg/kg once weekly for at least 6 months. Combination therapy: 1.5 mcg/kg/week SC in combination with ribavirin capsules.

ii) 1-1.5 mcg/kg once weekly for at least 24 weeks and up to 52 weeks.
1224 Pegylated Liposomal Doxorubicin HCl 20 mg/vial L01DB01110P3003XX A* i) For patients with platinum-resistant ovarian cancer where the disease relapses within 6 months after completion of the initial platinum-based chemotherapy
ii) For patients with platinum-sensitive ovarian cancer where the disease responds to first-line platinum-based therapy but relapses 12 months or more after completion of the initial platinum based chemotherapy.		 Indikasi (ii)
To be prescribed by Gynae Oncology Specialist only		 50 mg/m2 IV every 4 weeks for as long as the disease does not progress & patient continues to tolerate treatment.
For doses <90 mg: dilute in 250 ml Dextrose 5 % in Water.
For doses >90 mg: dilute in 500 ml Dextrose 5 % in Water.
To minimize the risk of infusion reactions, the initial dose is administered at a rate no greater than 1 mg/minute. Renal impairment: No dose adjustment required in patients with creatinine clearance 30-156 ml/min, no pharmacokinetic data are available in patients with creatinine clearance of less than 30 ml/min. Hepatic impairment: At initiation of therapy: Bilirubin 1.2 - 3.0 mg/dl, the first dose is reduced by 25 %, Bilirubin > 3.0 mg/dl, the first dose is reduced by 50 %.
1225 Pemetrexed Disodium 100 mg Injection L01BA04-016-P30-02-XXX A* i) As monotherapy for the 2nd line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology

ii) Malignant pleural mesothelioma		 500 mg/m2 BSA IV over 10 minutes on day 1 of each 21-day cycle.

Dosing is according to product insert / protocol.
1226 Pemetrexed Disodium 500 mg Injection L01BA04016P3001XX A* i) As monotherapy for the 2nd line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology
ii) Malignant pleural mesothelioma		 500 mg/m2 BSA IV over 10 minutes on day 1 of each 21-day cycle

Dosing is according to product insert / protocol.
1227 Pentamidine Isethionate 300mg Injection P01CX01-198-P30-01-XXX A* Only for the treatment of pneumonia due to Pneumocytosis carinii None 4 mg/kg once daily by slow IV infusion for at least 14 days
1228 Pentoxifylline 400 mg Tablet C04AD03000T1001XX A/KK Peripheral vascular disease 400 mg 2 - 3 times daily
1229 Peracetic Acid and Hydrogen Peroxide V07AV00000L9906XX A High level disinfectant or sterilant for heat labile endoscopes Immersion time based on manufacturer recommendation
1230 Perindopril 10mg and Indapamide 2.5mg film coated tablet C09BA04-900-T10-03-XXX A/KK As substitution therapy for treatment of essential hypertension, in patients already controlled with perindopril and indapamide given concurrently at the same dose level. None 1 tablet daily

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