Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1261 Piperacillin 4g & Tazobactam 500mg Injection J01CR05-961-P30-01-XXX A* Febrile neutropenia, lower respiratory tract infection and severe sepsis None Adult and children more than 12 years: 4.5g 6 hourly, for neutropenia adult and children more than 50kg: 4.5g 6 hourly. Children less than 50kg: 90mg/kg 6 hourly
1262 Piperacillin Sodium 4g Injection J01CA12-520-P40-02-XXX A Infections due to Pseudomonas aeruginosa None ADULT: 100 - 150 mg/kg IM/IV in divided doses. Increase to 200 - 300 mg/kg in severe infections & at least 16 g in life-threatening infections. Single dose over 2 g: IV route only. Maximum: 24 g/day. CHILD: 50-75 mg/kg/dose every 6 - 8 hourly
1263 Piracetam 1 g Injection N06BX03000P3001XX A* Treatment of cerebral functional impairment 30 - 160 mg/kg/day orally or parenterally 2 times daily or 3 to 4 times daily. Maximum: 24 g/day
1264 Piracetam 1.2 g Tablet N06BX03000T1001XX A* Mild cognitive impairment, post concussional head syndrome, head injury disorder, chronic vertigo and myoclonus Initially 7.2 g daily in 2 - 3 divided doses, increased according to response by 4.8 g daily every 3 - 4 days to maximum of 20 g daily. CHILD under 16 years not recommended
1265 Piracetam 20% Solution N06BX03000L5001XX A* Children with learning disability, progressive myoclonic epilepsy and hypoxia 30 - 160 mg/kg/day orally. To be given 2 times daily or 3 - 4 times daily. Maximum 24 g/day
1266 Piribedil 50 mg Tablet N04BC08000T5001XX A* Parkinson disease As monotherapy: 150 - 250 mg as 3 - 5 divided doses daily. As combination with L-dopa therapy: 50 - 150 mg daily (50 mg per 250 mg of L-dopa)
1267 Piroxicam 10 mg Capsule M01AC01-000-C10-01-XXX A/KK Musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis, in soft-tissue disorders. - Max: 20 mg daily as a single dose, or in divided doses if necessary
1268 Pizotifen 0.5 mg Tablet N02CX01253T1001XX B Prophylactic treatment of vascular headache Starting with 0.5mg daily, the dosage should be progressively increased. The average maintenance dosage is 1.5mg daily in divided doses or as a single dose at night. Max dose: 4.5 mg/day and 3 mg/dose. Child: >2 yr: Up to 1.5 mg daily in divided doses. Max dose: 1 mg/dose.
1269 Pneumococcal 15-valent Conjugate Vaccine, adsorbed J07AL02-963-P30-02-xxx C+ Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in infants and children. Immunisation for newborn cohort eligible for National Immunisation Programme (NIP) 2-dose primary series (2+1): A series consisting of 3 doses, each of 0.5 ml may be given.

Dosing is according to Immunisation Schedule under NIP
1270 Pneumococcal Polysaccharide and Non-Typeable Haemophilus Influenzae (NTHi) Protein D Conjugate Vaccine (10-valent, adsorbed) J07AL01-000-P30-01-XXX C+ Active immunisation of infants and children against disease caused by Streptococcus pneumoniae vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive serotype 19A (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) and against acute otitis media caused by Non-Typeable Haemophilus influenzae. Immunisation for newborn cohort eligible for National Immunisation Programme (NIP)
 2-dose primary series (2+1): A series consisting of 3 doses, each of 0.5 ml may be given.

Dosing is according to Immunisation Schedule under NIP
1271 Pneumococcal polysaccharide conjugate vaccine (adsorbed) 13-valent injection J07AL01-000-P30-02-XXX A*, C+ 1. Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (including invasive disease, pneumonia and acute otitis media) in infants, children and adolescents from 2 months to 17 years of age:
- PRESCRIBER CATEGORY C+: National Immunisation Programme (NIP)
- PRESCRIBER CATEGORY A*: Immunisation other than NIP

2. Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults aged 18 years and older.
- PRESCRIBER CATEGORY A*		 INDICATION (1):
i. Immunisation for newborn cohort eligible for National Immunisation Programme (NIP) (Prescriber Category: C+)

ii. Paediatric population without history of vaccination or not eligible for NIP, who have associated risk in IPD with following conditions (Prescriber Category: A*):
a) Infants/children from 2 months of age with one of the following conditions:
• Functional or anatomical asplenia;
• Cochlear implant;
• Congenital immunodeficiency;
• Haematopoietic and solid organ transplant;
• Cerebrospinal fluid leakage

b) High risk infants/children from 2 months old with one of the following conditions:
• Immunosuppression (including asymptomatic HIV)
• Nephrotic syndrome
• Chronic lung or heart disease (adapted from Paediatric Protocols for Malaysia Hospital, 3rd Edition)
• Chronic liver disease


INDICATION (2) (Prescriber Category: A*):
i. Adult population aged 18 years and above with associated risk in IPD with following conditions:
a) Functional or anatomical asplenia;
b) Cochlear implant;
c) Congenital immune-deficiency;
d) Haematopoietic and solid organ transplant.

ii. Adult population aged 60 years and above with associated risk in IPD with following conditions:
a) Chronic lung diseases, including chronic obstructive pulmonary disease (COPD), emphysema & asthma (requiring frequent hospital visit & use of multiple medications);
b) Chronic liver disease including cirrhosis, biliary atresia, chronic hepatitis;
c) Chronic cardiac disease, including congestive heart failure, congenital heart disease, and cardiomyopathies.
 For indication 1(i):
2-dose primary series (2+1): A series consisting of 3 doses, each of 0.5 ml may be given.
Dosing is according to Immunisation Schedule under NIP.

For other indications:
ADULT: to be administered as a single dose to adults 18 years and older including those previously vaccinated with a pneumococcal polysaccharide vaccine.
The need for re-vaccination with a subsequent dose of PCV13 has not been established.

INFANT:
Infants aged 2-6 months:
i) Three-dose primary series: The recommended immunisation series consists of four doses, each of 0.5 mL. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 12-15 months of age, or
ii) Two-dose primary series: A series consisting of three doses, each of 0.5 mL may be considered. The first dose may be given from the age of 2 months, with a second dose 2 months later. The third (booster) dose is recommended between 11-15 months of age.

Preterm infants (<37 weeks gestation): The recommended immunisation series consists of four doses, each of 0.5 mL. The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age.

Unvaccinated infants and children ≥ 7 months of age
Infants aged 7-11 months: Two doses, each of 0.5 ml, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.

CHILDREN:
Children aged 12-23 months: Two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Children and adolescents aged 2 years to 17 years: One single dose of 0.5 ml.
Young Children (12-59 months) completely immunized with PCV (7 valent): One dose of 0.5 mL of Pneumococcal polysaccharide conjugate vaccine (adsorbed), 13-valent to elicit immune responses to the 6 additional serotypes. This dose of PCV 13 should be administered at least 8 weeks after the final dose of Prevenar (7 valent)
Children 5-17 years: One single dose of 0.5 ml if they have been previously vaccinated with one or more doses of Pneumococcal polysaccharide conjugate vaccine (adsorbed). This dose should be administered at least 8 weeks after the final dose of PCV (7-valent).
1272 Pneumococcal Vaccine (Polyvalent) Note: refers to 23-valent polysaccharide vaccine (update in progress) J07AL01-000-P30-03-XXX A Prevention of pneumococcal infections in high risk subjects from the age of 2 years including patient with a history of splenectomy or scheduled splenectomy None Primary injection: 1 single injection (0.5 ml) only.
Booster: Must not be given within 5 years except in very high risk patient who received the vaccine while under immunosuppressive treatment
1273 Poliomyelitis Oral Live Vaccine J07BF02000D5001XX C+ Immunisation against poliomyelitis 0.1ml (two drops) by oral. Dosing is according to local and WHO recommendations.
1274 Polyethylene Glycol/Macrogol 4000 Powder A06AD15-000-F21-01-XXX A Bowel cleansing prior to colonoscopy, radiological examination or colonic surgery. Suitable for patients with heart failure or renal failure None 1 sachet dissolved in 1 L of water and to be consumed within 1 hour. Usual dose: 3-4 L of oral solution are required. When morning surgery is planned, the oral solution is given in the late afternoon the day prior. If surgery is scheduled in afternoon, the oral solution should be given on the same day for ingestion to be completed three hours before surgery.
1275 Polymyxin B Sulphate 10,000U, Neomycin Sulphate 5mg and Hydrocortisone 10mg Ear Drops S02CA03-991-D10-01-XXX B Treatment of bacterial infection and inflammation of the external auditory meatus None 3-4 drops 3 – 4 times daily.

Dosing is individualised and according to product insert/protocol
1276 Polymyxin B Sulphate 500,000 units Injection J01XB02-183-P40-01-001 A* i. Acute infections caused by susceptible strains of Pseudomonas Aeruginosa.
• Treatment of infections of the meninges and blood stream, caused by susceptible strains of Pseudomonas Aeruginosa.

ii. Indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated:
• H. influenzae, specifically meningeal infections.
• Aerobacter aerogenes, specifically bacteremia.
• Klebsiella pneumoniae, specifically bacteremia.		 • Use as targeted therapy. As 2nd line for empirical therapy.
• To be prescribed by Infectious Disease, General Medicine & ICU specialist only		 Loading dose: 25,000 units/kg/dose.
(Maximum dose: 2,000,000 units / 2MU).

Maintenance dose: 15,000 units/kg every 12 hours.
(Maximum dose per day: 2,000,000 units / 2MU).
1277 Ponatinib 15mg Film-coated Tablet L01XE24-110-T32-02-XXX A* i) Adult patients suffering from Philadelphia-positive (Ph+) chronic myeloid leukemia (chronic phase, accelerated phase or blast phase) for whom a treatment with other c-abl tyrosine kinase inhibitors is not appropriate.
ii) Adult patients suffering from T315I-positive Ph+ chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase).
iii) Adult patients suffering from Philadelphia-positive (Ph+) acute lymphoblastic leukaemia (ALL) for whom a treatment with other c-abl tyrosine kinase inhibitors is not appropriate, or
iv) Adult patients suffering from T315I-positive Ph+ acute lymphoblastic leukaemia (ALL)		 For indication (i):
i) As third line treatment for Ph+ CML resistant or intolerant to at least 2 tyrosine kinase inhibitors with mutation other than T315I.
ii) To be prescribed by Consultant Haematologist only.

For indication (ii):
To be prescribed by Consultant Haematologist only.

For indication (iii):
i) As a second-line treatment for Ph+ ALL resistant or intolerant to at least 1 tyrosine kinase inhibitor with a mutation other than T315I.
ii) To be prescribed by Haematologist only

For indication (iv):
To be prescribed by Haematologist only
 The recommended starting dose is 45 mg of ponatinib once daily.

Refer to the package insert for guidance on dose modifications or interruptions for the management of treatment-related toxicities, drug-drug interactions as well as consideration for dose reduction upon achievement of major cytogenetic response
1278 Posaconazole 100mg modified released (MR) tablet J02AC04-000-T51-01-XXX A* Prophylaxis of invasive fungal infections in the following adult patients:
i) Patient receiving remission-induction
chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections.

ii) Haematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.		 Loading dose of 300 mg (three 100 mg tablets) twice a day on the first day, then 300 mg (three 100 mg tablets) once a day thereafter.
1279 Potassium Chloride 0.15% w/v & Sodium Chloride 0.9% w/v Injection A06AD10-921-L99-02-XXX B Prevention and treatment of potassium, sodium and chloride depletion None Dosage depends on the age, weight, clinical and biological (acid-base balance) conditions of the patient and concomitant therapy. Maximum recommended dose of potassium is 2 to 3 mmol/kg/24hr
1280 Potassium Chloride 1 g/10 ml Injection B05XA01-100-P30-01-XXX B For the correction of severe hypokalaemia and when sufficient potassium cannot be taken by mouth None By slow IV infusion depending on the deficit or the daily maintenance requirements. 1 g diluted in 500 ml normal saline or glucose and given slowly over 2 - 3 hours
1281 Potassium Chloride 1 g/10 ml Mixture A12BA01-100-L21-01-XXX C Potassium depletion None 1 g once or twice daily until serum potassium is restored
1282 Potassium Chloride 600 mg SR Tablet A12BA01-100-T50-01-XXX B For the treatment and specific prevention of hypokalaemia None ADULT: 2 - 3 tablets daily. Severe deficiency: 9 - 12 tablets daily or according to the needs of the patient
1283 Potassium Citrate 3 g/10 ml and Citric Acid Mixture A12BA02-955-L21-01-XXX C For systemic or urinary alkalinization None ADULT: 10-20 ml 3 times daily, well diluted with water.
CHILD up to 1 year: 2.5 ml 3 times daily; 1 - 5 years: 5 ml 3 times daily; 6 - 12 years: 10 ml 3 times daily.

To be taken well diluted with water, after meals and at bedtime.
1284 Potassium Dihydrogen Phosphate Injection B05XA06-170-P30-01-XXX A For treatment of hypophosphataemia None Up to 10mmol phosphate administered over 12 hours
1285 Povidone Iodine 10% (equivalent to 1% iodine) Solution D08AG02000L9902XX B Skin operation prior to surgery, in cleansing open wounds, as an antiseptic for operative wounds infections To be applied undiluted in pre-operative skin disinfection and general antisepsis.
1286 Povidone Iodine 7.5% (equivalent to 0.75% iodine) Scrub D08AG02000L9901XX B As preoperative scrub for hands and skin Spread 5 ml over both hands and rub thoroughly for about 5 minutes. Rinse thoroughly. Repeat if desired. Pre-operative use on patient: Apply scrub and rub thoroughly for about 5 minutes. Rinse off using a sterile gauze saturated with water
1287 Pralidoxime 25mg/ml Injection V03AB04-000-P30-02-XX B Antidote in the treatment of organophosphorus insecticide poisoning and in the control of overdosage by anticholinergic drugs used in the treatment of myasthenia gravis None Adult: Used in combination with atropine. Admin atropine via IM/IV inj and repeat as needed until patient shows signs of atropine toxicity. Maintain atropinisation for at least 48 hr. As soon as the effects of atropine are observed, 1-2 g of pralidoxime (chloride, iodide or mesilate) may be given via IM/IV inj. Repeat dose after 1 hr, then every 8-12 hr, if necessary. In severe poisoning, continuous infusion of 200-500 mg/hr may be given, titrated according to response. Alternatively, pralidoxime chloride may be given at an initial dose of 30 mg/kg via IV infusion over 20 minutes or IV inj over 5 minutes, followed by IV infusion at 8 mg/kg/hr. Max: 12 g/24 hr. Child: As mesilate: 20-60 mg/kg. Renal impairment: Dose adjustment may be required.
1288 Pramipexole Dihydrochloride 0.125 mg Tablet N04BC05-110-T10-01-XXX A* i) Treatment for signs and symptoms of advanced idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa
ii) Symptomatic treatment of idiopathic Restless Legs Syndrome.		 i) Dose escalation: 0.125 mg 3 times daily on week 1 then 0.25 mg 3 times daily week 2 then 0.5 mg 3 times daily on week 3. Increase by 0.75 mg at weekly intervals if needed up to maximum of 4.5 mg/day. Patient on levodopa: Reduce dose. Renal impairment: In patient with creatinine clearance < 20ml/min, the daily dose of pramipexole should be started at 0.125 mg daily instead of 0.25mg and the maximum dose should not > 1.5 mg daily

ii) Dosing is according to Product Insert
1289 Pramipexole Dihydrochloride 0.375mg Extended Release Tablet N04BC05110T5001XX A Treatment for signs and symptoms of advanced idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa Dose escalation: 0.375 mg/day on week 1, 0.75 mg/day on week 2, 1.5 mg/day on week 3. Increase by 0.75 mg at weekly intervals if needed up to a max of 4.5 mg/day. Patient on l-dopa: reduce dose. Renal Impairment: CrCl 30-50 mL/min Initially 0.375 mg every other day. May be increased by 0.375 mg at weekly intervals to max 2.25 mg/day
1290 Pramipexole Dihydrochloride 1mg Tablet N04BC05-110-T10-02-XXX A* i) Treatment for signs and symptoms of advanced idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa
ii) Symptomatic treatment of idiopathic Restless Legs Syndrome.
i) Dose escalation: 0.125 mg 3 times daily on week 1 then 0.25 mg 3 times daily week 2 then 0.5 mg 3 times daily on week 3. Increase by 0.75 mg at weekly intervals if needed up to maximum of 4.5 mg/day. Patient on levodopa: Reduce dose. Renal impairment: In patient with creatinine clearance < 20ml/min, the daily dose of pramipexole should be started at 0.125 mg daily instead of 0.25mg and the maximum dose should not > 1.5 mg daily

ii) Dosing is according to Product Insert

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