Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1111 Nicotine 4mg Gum N07BA01000M9902XX A/KK For the treatment of tobacco dependence by relieving nicotine withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. Smokes ≤ 20 sticks/day, chew 2mg gum.
Smokes ≥ 20 sticks/day, chew 4 mg gum. (MAX 24 pieces /day for up to 12 week.)
1112 Nicotine 7mg/24hr Transdermal Patch N07BA01000M7001XX A/KK For the treatment of tobacco dependence by relieving nicotine withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. The patch should be apply to an intact area of the skin upon waking up in the morning and removed at 24hrs.

Smokers of >10 cigarettes/day:
21 mg/day for 6 wk, then 14 mg/day for 2 wk; finish w/ 7 mg/day for 2 wk.

Smokers of ≤10 cigarettes/day:
14 mg/day for 6 wk, then 7 mg/day for 2 wk.
1113 Nicotinic Acid 50 mg Tablet A11HA01000T1001XX B For prophylaxis and treatment of Vitamin B3 deficiency Prophylactic: 15 - 30 mg daily. Therapeutic: 50 - 250 mg daily. Maximum single dose: 200 mg. Maximum dose in 24 hours: 800 mg
1114 Nicotinic Acid 500 mg Tablet C10AD02000T1001XX B Hyperlipidaemia 100 - 200 mg 3 times daily, gradually increased over 2 - 4 weeks to 1 - 2 g 3 times daily with or after meals. CHILD: 100 - 250 mg/day in 3 divided doses with meals, increase 100 mg/day weekly or 250 mg/day every 2 - 3 weeks as tolerated. Maximum: 10 mg/kg/day
1115 Nifedipine 10 mg Tablet C08CA05000T1001XX B Hypertension Initial dose of 10 mg twice daily. Usual range 10 - 30 mg 3 times daily. Maximum: 120 - 180 mg per day. Elderly: Dose reduction may be necessary.
1116 Nilotinib 150mg capsule L01XE08110T1001XX A* For the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase (CP). 300mg twice daily. Dose adjustments or modifications:For neutropenia & thrombocytopenia
1117 Nilotinib 200 mg Capsule L01XE08110C1001XX A* Treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in adults who: i) Failed imatinib ie no cytogenic response and no haematological response by 12 months ii) Have molecular resistance to Imatinib as shown by molecular mutation studies iii) Are intolerant to Imatinib 400 mg twice daily, 12 hours apart. No food should be taken two hours before and 1 hour after taking the dose
1118 Nimodipine 10 mg/50 ml Infusion Solution C08CA06000P9901XX A* Prophylaxis & treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin IV infusion of 1 mg/hour for a period of 2 hours (about 15 mcg/kg/hour). IV therapy should be started no later than 4 days after haemorrhage & continue for up to 10 - 14 days
1119 Nimodipine 30 mg Tablet C08CA06000T1001XX A* Prophylaxis & treatment of ischaemic neurological deficits caused by cerebral vasospasm following subarachnoid haemorrhage of aneurysmal origin 360 mg daily in divided doses for 7 days
1120 Nintedanib 100mg Capsule L01XE31-189-C40-01-XXX A* i) For the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults
ii) Indicated in adults for the treatment of other chronic fibrosing lung disease (ILDs) with a progressive phenotype		 For indication (ii):
• FVC at least 40% of predicted value, and
• DLCO 30% to 89% of predicted value
• To be prescribed by Consultant Respiratory Physician and Rheumatologist only
 i) The recommended dose is 150 mg twice daily administered approximately 12 hours apart.
The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.

ii) 150mg twice a day
1121 Nintedanib 150mg Capsule L01XE31-189-C40-02-XXX A* i) For the treatment of Idiopathic Pulmonary Fibrosis (IPF) in adults
ii) Indicated in adults for the treatment of other chronic fibrosing lung disease (ILDs) with a progressive phenotype		 For indication (ii):
• FVC at least 40% of predicted value, and
• DLCO 30% to 89% of predicted value
• To be prescribed by Consultant Respiratory Physician and Rheumatologist only		 i) The recommended dose is 150 mg twice daily administered approximately 12 hours apart.
The 100 mg twice daily dose is only recommended to be used in patients who do not tolerate the 150 mg twice daily dose.

ii) 150mg twice a day
1122 Nirsevimab 100 mg/mL Solution for Injection in Pre-filled Syringe J06BD08-000-P50-01-xxx A* Indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:
i. Neonates and infants during their first RSV season.
ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.		 i. Infants at high risk, including those with:
• Prematurity: born at ≤32 weeks gestational age.
• Bronchopulmonary dysplasia (BPD) or chronic lung disease (CLD)
• Congenital heart disease (CHD)
• Immunocompromised (immunodeficiency)

ii. Not indicated for neonates and young infants <6 months of age whose mothers received an RSV vaccine during the third trimester at least 14 days before delivery, as maternal vaccination is expected to provide passive protection against severe RSV disease.

iii. To be prescribed by Neonatologists, Paediatric Infectious Disease and Paediatric Cardiologists only
 First RSV season:
i. Body weight <5kg: 50 mg intramuscularly
ii. Body weight ≥5kg: 100 mg intramuscularly
Second RSV season: 200 mg intramuscularly

Refer to package insert for full details on dose for specific population or condition
1123 Nirsevimab 50 mg/0.5 mL Solution for Injection in Pre-filled Syringe J06BD08-000-P50-02-xxx A* Indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in:
i. Neonates and infants during their first RSV season.
ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.		 i. Infants at high risk, including those with:
• Prematurity: born at ≤32 weeks gestational age.
• Bronchopulmonary dysplasia (BPD) or chronic lung disease (CLD)
• Congenital heart disease (CHD)
• Immunocompromised (immunodeficiency)

ii. Not indicated for neonates and young infants <6 months of age whose mothers received an RSV vaccine during the third trimester at least 14 days before delivery, as maternal vaccination is expected to provide passive protection against severe RSV disease.

iii. To be prescribed by Neonatologists, Paediatric Infectious Disease and Paediatric Cardiologists only
 First RSV season:
i. Body weight <5kg: 50 mg intramuscularly
ii. Body weight ≥5kg: 100 mg intramuscularly
Second RSV season: 200 mg intramuscularly

Refer to package insert for full details on dose for specific population or condition
1124 Nitrazepam 5 mg Tablet N05CD02000T1001XX B Epilepsy (infantile spasms) 5 - 10 mg at bedtime. ELDERLY or debilitated 2.5 - 5 mg. CHILD not recommended. Increasing slowly according to response
1125 Nitrofurantoin 100mg Tablet J01XE01-000-T10-02-XXX B Uncomplicated lower urinary tract infections None Acute uncomplicated urinary tract infections Adult: 50-100 mg 4 times daily for 7 days. Dual-release preparation: 100 mg bid. Child: >3 mth and older children: 3 mg/kg daily in 4 divided doses. Prophylaxis of uncomplicated urinary tract infections Adult: 50-100 mg at bedtime. Child: >3 mth and older children: 1 mg/kg once daily.
1126 Nivolumab 10mg/mL Concentrate for Solution for Infusion L01XC17-000-P33-01-xxx A* As monotherapy for the treatment of advanced (unresectable or metastatic) melanoma in adults. None 3 mg/kg administered intravenously over 30 minutes every 2 weeks.
1127 Noradrenaline Acid Tartrate (Norepinephrine Bitartrate) 1 mg/ml Injection C01CA03-123-P30-01-XXX A, A/KK Category A:
i) For blood pressure control in certain acute hypotensive states (e.g.pheochromocytomectomy, sympathectomy, poliomyelitis, spinal anesthesia, myocardial infarction, septicemia, blood transfusion, and drug reactions).
ii) As an adjunct in the treatment of cardiac arrest and profound hypotension

Category A/KK:
Septic shock and shock where peripheral vascular resistance is low		 Category A: None
Category A/KK: Use only for emergency cases in health clinic with Medical Officers (MO) upon consultation with Family Medicine Specialist (FMS)		 Infuse and titrate to desired pressure response.
Range: 0.05 - 0.5 mcg/kg/minute
1128 Norethisterone 0.35 mg Tablet G03AC01000T1001XX C+ Contraception 1 tablet daily starting on the first day of the menstrual bleeding
1129 Norethisterone Enanthate 200 mg/ml Injection G03AC01257P3001XX B Contraception By deep IM injection only. First injection is within first 5 days of the cycle. The next 3 injections are given at 8 weeks interval after which the injection interval should be extended to 12 weeks
1130 Nystatin 100,000 units/g Cream D01AA01-000-G10-01-XXX C Prevention and treatment of cutaneous infections caused by Candida albicans None Apply liberally to affected area twice daily or as required. After lesion has disappeared continue treatment for 10 days to prevent relapses. Nail infection: Cut nails as short as possible. Apply cream once daily until growth of new nail has set in
1131 Nystatin 100,000units/ml Suspension A07AA02-000-L80-01-XXX B Treatment of candidal infection of the oral cavity None ADULT and CHILDREN
One to six ml (100,000 to 600,000 units) four times daily after food

INFANTS
One ml (equivalent to 100,000 units) four times daily after food.

Dosing is individualised and according to product insert/protocol.
1132 Nystatin 500,000 units Tablet A07AA02-000-T10-01-XXX B Prevention and treatment of candidiasis of the skin and mucous membranes, protection against candidas overgrowth during antimicrobial /corticosteroid therapy and as selective decontamination regimens None ADULT: 500,000 -1,000,000 units 6 hourly, according to severity of infections. CHILD: 100,000-500,000 units 6 hourly
1133 Octreotide 0.05mg/ml Injection H01CB02-122-P30-02-XXX A i) Acromegaly treatment in patients in whom surgery or radiotherapy is inappropriate or ineffective- based on level of growth hormone and high IGF-1 and residual pituitary tumor
ii) Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumors:
• Carcinoid tumors with features of the carcinoid syndrome.
• VIPomas, Glucagonomas
• Gastrinomas/Zollinger-Ellison syndrome
• Insulinomas
• GRFomas.
iii) Prevention of complications following pancreatic surgery
iv) Emergency management of bleeding gastro-eosophageal varices in patients with cirrhosis		 None i) Initially 0.05-0.1mg SC every 8 or 12 hours. Optimal daily dose is 0.3mg, not to exceed maximum dose of 1.5mg/day.
ii) Initially 0.05 mg once or twice daily, gradually increase to 0.1-0.2mg 3 times daily. Higher doses may be required in exceptional circumstances.
iii) 0.1 mg 3 times daily for 7 consecutive days, starting on the day of operation, at least 1 hour before laparotomy
iv) ADULT: 50mcg bolus, followed by continuous infusion of 25-50mcg/hour for 2-5 days.
CHILD: IV 1-5 mcg/kg/hour

The dosing is individualized according to product insert / protocol
1134 Octreotide 0.1mg/ml Injection H01CB02-122-P30-01-XXX A i) Acromegaly treatment in patients in whom surgery or radiotherapy is inappropriate or ineffective- based on level of growth hormone and high IGF-1 and residual pituitary tumor
ii) Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumors:
• Carcinoid tumors with features of the carcinoid syndrome.
• VIPomas, Glucagonomas
• Gastrinomas/Zollinger-Ellison syndrome
• Insulinomas
• GRFomas.
iii) Prevention of complications following pancreatic surgery
iv) Emergency management of bleeding gastro-eosophageal varices in patients with cirrhosis		 None i) Initially 0.05-0.1mg SC every 8 or 12 hours. Optimal daily dose is 0.3mg, not to exceed maximum dose of 1.5mg/day.
ii) Initially 0.05 mg once or twice daily, gradually increase to 0.1-0.2mg 3 times daily. Higher doses may be required in exceptional circumstances.
iii) 0.1 mg 3 times daily for 7 consecutive days, starting on the day of operation, at least 1 hour before laparotomy
iv) ADULT: 50mcg bolus, followed by continuous infusion of 25-50mcg/hour for 2-5 days.
CHILD: IV 1-5 mcg/kg/hour

The dosing is individualized according to product insert / protocol
1135 Octreotide Acetate 20mg Injection H01CB02-122-P20-01-XXX A* i) Acromegaly treatment in patients in whom surgery or radiotherapy is inappropriate or ineffective- based on level of growth hormone and high IGF-1 and residual pituitary tumor.
ii)Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumors:
• Carcinoid tumors with features of the carcinoid syndrome.
• VIPomas, Glucagonomas
• Gastrinomas/Zollinger-Ellison syndrome.
• Insulinomas, GRFomas.
iii) Treatment of patients with advanced neuroendocrine tumors of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded.		 None 10 - 30 mg every 4 weeks as deep intragluteal injection
1136 Octreotide Acetate 30mg Injection H01CB02-122-P20-02-XXX A* i) Acromegaly treatment in patients in whom surgery or radiotherapy is inappropriate or ineffective- based on level of growth hormone and high IGF-1 and residual pituitary tumor.
ii) Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocrine tumors:
• Carcinoid tumors with features of the carcinoid syndrome.
• VIPomas, Glucagonomas
• Gastrinomas/Zollinger-Ellison syndrome.
• Insulinomas, GRFomas.
iii) Treatment of patients with advanced neuroendocrine tumors of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded.		 None 10 - 30 mg every 4 weeks as deep intragluteal injection
1137 Ofatumumab 20mg/0.4mL Injection in Prefilled Syringe L01XC10-000-P50-01-xxx A* Indicated for the treatment of relapsing form of multiple sclerosis (RMS), to include relapsing-remitting disease and active secondary progressive disease, in adults. To be prescribed by Consultant Neurologist only The recommended dose is 20 mg at weeks 0,1 and 2 followed by 20 mg once monthly starting at week 4, administered as subcutaneous injection.
1138 Ofloxacin 0.3% Otic Solution S02AA00-000-D10-01-XXX A/KK i. Acute otitis media with tympanostomy tubes
ii. Chronic suppurative otitis media with perforated tympanic membranes and iii. Otitis externa		 None CHILD: 1 - 12 years: 5 drops twice daily for 10 days. ADULT and CHILD over 12 years: 6 - 10 drops twice daily and remain in the ear about 10 minutes
1139 Ofloxacin 100 mg Tablet J01MA01000T1001XX A i) As second-line treatment of leprosy ii) As second-line treatment for tuberculosis and multidrug resistant tuberculosis (MDR-TB) iii) Sequential therapy for UTI and pyelonephritis i) 400 mg/day ii) 400 mg twice daily iii) 200 mg twice daily
1140 Ofloxacin 200 mg Injection J01MA01000P4001XX A Sequential therapy for UTI and pyelonephritis 200 mg IV twice daily for 3 - 5 days followed with 200 mg tablet twice daily for 3 - 5 days as maintenance dose (if necessary)

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