Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1111 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
1112 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.
1113 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
1114 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
1115 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
1116 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
1117 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
1118 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
1119 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
1120 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.
1121 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.
1122 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
1123 Norethisterone 0.35 mg Tablet G03AC01000T1001XX C+ Contraception 1 tablet daily starting on the first day of the menstrual bleeding
1124 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
1125 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
1126 Nystatin 100,000units/ml Suspension A07AA02-000-L80-01-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 Treatment:
Adult & Children: 100,000 to 600,000 units 6 hourly;
Infant: 100,000 – 200,000 units 6 hourly;
Neonates: 100,000 units 8 hourly.

Prophylaxis:
Adult: 1,000,000 units daily;
Neonates and Infants: 100,000 units 2-3 times a day;
Children: 250,000 – 500,000 units 2-3 times a day.
1127 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
1128 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
1129 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
1130 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
1131 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
1132 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.
1133 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
1134 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
1135 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)
1136 Olanzapine 10 mg Disintegrating Tablet N05AH03-000-T40-02-XXX A* i) Acute and maintenance treatment of schizophrenia and other psychoses where positive and or negative symptoms are prominent
ii) Short-term use for acute mania episodes associated with Bipolar 1 disorder
iii) Prevention of recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.		 Consultant/specialists for specific indications only, including Geriatricians i) 5 - 10 mg once daily, increase to 10 mg once daily within 5 - 7 days, adjust by 5 - 10 mg/day at 1 week intervals, maximum 20 mg/day
ii) 10 - 15 mg once daily, increase by 5 mg/day at intervals of not less than 24 hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day
iii) Starting dose is 10mg/day, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day
1137 Olanzapine 10 mg Tablet N05AH03-000-T10-02-XXX B i) Acute and maintenance treatment of schizophrenia and other psychoses where positive and or negative symptoms are prominent
ii) Short-term use for acute mania episodes associated with Bipolar 1 disorder
iii) Prevention of recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.		 None i) 5 - 10 mg once daily, increase to 10 mg once daily within 5 - 7 days, adjust by 5 - 10 mg/day at 1 week intervals, maximum 20 mg/day
ii) 10 - 15 mg once daily, increase by 5 mg/day at intervals of not less than 24 hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day
iii) Starting dose is 10mg/day, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day
1138 Olanzapine 5 mg Tablet N05AH03-000-T10-01-XXX B i) Acute and maintenance treatment of schizophrenia and other psychoses where positive and or negative symptoms are prominent
ii) Short-term use for acute mania episodes associated with Bipolar 1 disorder
iii) Prevention of recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.		 None i) 5 - 10 mg once daily, increase to 10 mg once daily within 5 - 7 days, adjust by 5 - 10 mg/day at 1 week intervals, maximum 20 mg/day
ii) 10 - 15 mg once daily, increase by 5 mg/day at intervals of not less than 24 hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day
iii) Starting dose is 10mg/day, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day
1139 Olanzapine 5mg Disintegrating Tablet N05AH03-000-T40-01-XXX A* i) Acute and maintenance treatment of schizophrenia and other psychoses where positive and or negative symptoms are prominent
ii) Short-term use for acute mania episodes associated with Bipolar 1 disorder
iii) Prevention of recurrence of manic, mixed or depressive episodes in Bipolar I Disorder.		 Consultant/specialists for specific indications only, including Geriatricians i) 5 - 10 mg once daily, increase to 10 mg once daily within 5 - 7 days, adjust by 5 - 10 mg/day at 1 week intervals, maximum 20 mg/day
ii) 10 - 15 mg once daily, increase by 5 mg/day at intervals of not less than 24 hours. Maintenance 5 - 20 mg/day; maximum 20 mg/day
iii) Starting dose is 10mg/day, daily dosage may subsequently be adjusted on the basis of individual clinical status within the range 5-20 mg/day
1140 Olive Oil Ear Drops S02DC00-000-D10-01-XXX C Impacted wax softener None 3 - 4 drops 3 - 4 or as directed

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