Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1321 Propofol 20mg/ml (2%) emulsion for injection of infusion N01AX10-000-P99-02-XXX A* i) Induction & maintenance of general anaesthesia.
ii) Sedation of ventilated patients in intensive care.		 - Adult: IV Induction and maintenance of general anesth Induction: 40 mg every 10 sec. Maintenance: 4-12 mg/kg/hr or intermittent boluses of 20-50 mg. Sedation In diagnostic and surgical procedures: Initial: 6-9 mg/kg/hr by infusion. Maintenance: 1.5-4.5 mg/kg/hr. For ventilated patients: 0.3-4 mg/kg/hr. Monitor lipid concentrations if duration of sedation >3 days.
1322 Propranolol HCl 1 mg/ml Injection C07AA05110P3001XX A Arrhythmias and thyrotoxicosis crisis Slow IV injection in a dose of 1 mg over 1 minute, repeated if necessary every 2 minutes until a maximum of 10 mg has been given in conscious patients and 5 mg in patients under anaesthesia. CHILD: 25 - 50 mcg/kg slow IV with appropriate monitoring
1323 Propranolol HCl 10 mg Tablet C07AA05110T1001XX B i) Hypertension
ii) Angina pectoris
iii) Myocardial infarct
iv) Cardiac arrhythmias
v) Migraine prophylaxis
vi) Hyperthyroidism
vii) Hypertrophic obstructive cardiomyopathy		 i) Initial: 40-80 mg twice daily
Maintenance: 160-320 mg daily.
Max. 640 mg daily

ii) Initial: 40 mg 2-3 times daily
Maintenance: 120-240 mg daily
Max. 480mg daily

iii) Initial (within 5-21 days of MI): 40 mg 4 times daily for 2-3 days
Maintenance: 80 mg twice daily

iv) 10-40 mg 3-4 times daily
Max. 240 mg/day.

v) Initial: 40 mg 2-3 times
Maintenance: 80-160 mg daily
Max. 240 mg/day.

vi) 10-40 mg 3-4 times daily.
Max. 240 mg/day.

vii) 10-40 mg 3-4 times daily

Dosing is individualised and according to product insert / protocol.
1324 Propranolol HCl 40 mg Tablet C07AA05110T1002XX B i) Hypertension
ii) Angina pectoris
iii) Myocardial infarct
iv) Cardiac arrhythmias
v) Migraine prophylaxis
vi) Hyperthyroidism
vii) Hypertrophic obstructive cardiomyopathy
viii) Portal hypertension		 i) Initial: 40-80 mg twice daily
Maintenance: 160-320 mg daily.
Max. 640 mg daily

ii) Initial: 40 mg 2-3 times daily
Maintenance: 120-240 mg daily
Max. 480mg daily

iii) Initial (within 5-21 days of MI): 40 mg 4 times daily for 2-3 days
Maintenance: 80 mg twice daily

iv) 10 - 40 mg 3 - 4 times daily.
Max. 240 mg/day.

v) Initial: 40 mg 2-3 times.
Maintenance: 80-160 mg daily.
Max. 240 mg/day.

vi) 10-40 mg 3-4 times daily.
Max. 240 mg/day.

vii) 10-40 mg 3-4 times daily

viii) Initial: 40 mg twice daily
Maintenance: 40-80mg 3 times daily
Max. 320mg daily

Dosing is individualised and according to product insert / protocol.
1325 Propylthiouracil 50 mg Tablet H03BA02000T1001XX B Hyperthyroidism None ADULT Initially 300-600mg daily in divided doses, at 8 hourly intervals (can be given up to 600-1,200mg/daily in divided doses).
Maintenance 50-200mg daily when the condition is controlled, probably within 1 to 3 months.

CHILDREN 6-10 years: 50-150mg daily in divided doses.
CHILDREN > 10 years: 150-300mg or 150mg/m2 daily Maintenance 50-100mg daily, according to patient's response. Taken with food.
1326 Protamine Sulphate 10 mg/ml Injection V03AB14183P3001XX B Heparin overdose and following cardiac or arterial surgery or dialysis procedures when required to neutralize the effects of heparin administered during extracorporeal circulation 5 ml slow IV injected over 10 minutes. If administered within 15 minutes of heparin dose, 1 mg will neutralise approximately 100 units of heparin. If longer time has elapsed, less protamine is required. Not more than 50 mg should be injected at any one time. The dose is dependent on the amount and type of heparin to be neutralised, its route of administration and the time elapsed since it was last given and blood coagulation studies.
1327 Protein Free Haemodialysate 10% Jelly D03AX00000G4001XX A Trophic lesions in patients with arterial occlusive disease and with chronic venous insufficiency, burn injuries, impaired wound healing, decubitus ulcers and skin ulcer caused by irradiation Apply 3 - 5 times daily
1328 Protein Free Haemodialysate 20% Eye Gel S01XA20-000-G30-01-XXX A Eyes disorders e.g. burns, scalds, ulcers, prevention and treatment of radiation dermatitis, traumatic and ischaemic wound None Instill 1 drop 3 - 4 times daily
1329 Protein Free Haemodialysate 5% Ointment D03AX00000G5001XX A Trophic lesions in patients with arterial occlusive disease and with chronic venous insufficiency, burn injuries, impaired wound healing, decubitus ulcers and skin ulcer caused by irradiation Apply 3 - 5 times daily
1330 Protein Free Haemodialysate Dental Adhesive Paste D03AX00000G6001XX A Painful and inflammatory affliction on the oral mucosa, gums and lips, teething pain, denture pressure sores, oral and maxillofacial surgery and dressing after scaling Apply to lesions 3 - 5 times daily
1331 Pyrantel Pamoate 125mg Tablet P02CC01-127-T10-01-XXX C Intestinal nematodes None ADULT and CHILD : 2 years and older - single dose 10mg/kg body weight once. Maximum 1 g
1332 Pyrantel Pamoate 250mg Tablet P02CC01-127-T10-02-XXX C Intestinal nematodes None ADULT and CHILD : 2 years and older - single dose 10mg/kg body weight once. Maximum 1 g
1333 Pyrazinamide 500mg Tablet J04AK01-000-T10-01-XXX B Tuberculosis None Adult: 20-40mg/kg daily (max 1500mg) or 50mg/kg biweekly (max 2000mg). Children: 20-30mg/kg daily or 30-40mg/kg thrice weekly.
1334 Pyridostigmine Bromide 60 mg Tablet N07AA02320T1001XX B Myasthenia gravis ADULT: 30 - 120 mg at suitable intervals throughout the day, total daily dose 0.3 - 1.2 g. CHILD up to 6 years initially 30 mg, 6 - 12 years initially 60 mg, usual total daily dose 30 - 360 mg
1335 Pyridoxine HCl 10mg Tablet A11HA02-110-T10-01-XXX C+ i)Pyridoxine-dependent convulsions in infant
ii)Sideroblastic anaemia
iii)B6-deficient anaemia in adult
iv) Prophylaxis to peripheral neuritis in isoniazid therapy
v) Nausea and vomiting of pregnancy and irradiation sickness		 None i) INFANT 4 mg/kg daily for short periods
ii) 100 - 400 mg daily in divided doses
iii) ADULT 20 - 50 mg up to 3 times daily
iv) Prophylaxis 10 mg daily, therapeutic 50 mg 3 times daily
v) 20 - 100 mg daily
1336 Pyridoxine HCl Injection A11HA02-110-P30-01-XXX B i) Pyridoxine-dependent convulsions in infancy.
ii) Sideroblastic anaemia.
iii) B6-deficient anaemia in adult.
iv) Prophylaxis to peripheral neuritis in isoniazid therapy.
v) Nausea and vomiting of pregnancy and irradiation sickness		 None i) INFANT 4 mg/kg daily for short periods.
ii) 100 - 400 mg daily in divided doses.
iii) ADULT 20 - 50 mg up to 3 times daily.
iv) Prophylaxis 10 mg daily, therapeutic 50 mg 3 times daily v) 20 - 100 mg daily.
1337 Quetiapine Fumarate 100mg Immediate Release Tablet N05AH04-138-T10-02-XXX A* i) Schizophrenia
ii) Short term treatment of acute manic episodes associated with bipolar I disorder, either monotherapy or adjunct to lithium or divalproex
iii) Treatment of depressive episodes associated with bipolar disorder		 Consultant/specialists for specific indications only, including Geriatricians and Neurologists i) Initial titration schedule over 4 days: 25 mg twice daily on Day 1, increase in steps of 25 - 50 mg 2 to 3 times daily on Days 2 and 3 to reach target dose of 300 - 400 mg daily by Day 4, given in 2 - 3 divided doses. Institute further dose adjustments, if indicated, at intervals of 2 days or more, in steps of 25 - 50 mg twice daily
ii) 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) & 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of not more than 200 mg/day. Adjust dose within the range of 200 - 800 mg/day depending on clinical response and tolerability of the patient. Usual effective dose range: 400 - 800 mg/day
iii) 50 mg ORALLY once a day on Day 1, then 100 mg once daily on Day 2, then 200 mg once daily on Day 3, then 300 mg once daily on Day 4 (all doses given at bedtime); patients requiring higher doses should receive 400 mg on Day 5, increased to 600 mg on Day 8 (week 1)
1338 Quetiapine Fumarate 200mg Extended Release Tablet N05AH04-138-T50-02-XXX A* i)Schizophrenia
ii) Moderate to severe manic episodes in bipolar disorder
iii) Major depressive episodes in bipolar disorder		 Consultant/specialists for specific indications only, including Geriatricians and Neurologists i) & ii) 300 mg once daily on Day 1 then 600 mg on Day 2. Maintenance dose: 400 to 800 mg once daily. Maximum dose: 800 mg daily

iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily. In elderly or hepatic impairment:Start with 50mg/ day, may be increased in increments of 50mg /day to an effective dose.
1339 Quetiapine Fumarate 200mg Immediate Release Tablet N05AH04-138-T10-04-XXX A* i) Schizophrenia
ii) Short term treatment of acute manic episodes associated with bipolar I disorder, either monotherapy or adjunct to lithium or divalproex
iii) Treatment of depressive episodes associated with bipolar disorder		 Consultant/specialists for specific indications only, including Geriatricians and Neurologists i) Initial titration schedule over 4 days: 25 mg twice daily on Day 1, increase in steps of 25 - 50 mg 2 to 3 times daily on Days 2 and 3 to reach target dose of 300 - 400 mg daily by Day 4, given in 2 - 3 divided doses. Institute further dose adjustments, if indicated, at intervals of 2 days or more, in steps of 25 - 50 mg twice daily
ii) 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) & 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of not more than 200 mg/day. Adjust dose within the range of 200 - 800 mg/day depending on clinical response and tolerability of the patient. Usual effective dose range: 400 - 800 mg/day
iii) 50 mg ORALLY once a day on Day 1, then 100 mg once daily on Day 2, then 200 mg once daily on Day 3, then 300 mg once daily on Day 4 (all doses given at bedtime); patients requiring higher doses should receive 400 mg on Day 5, increased to 600 mg on Day 8 (week 1)
1340 Quetiapine Fumarate 300mg Extended Release Tablet N05AH04-138-T50-03-XXX A* i) Schizophrenia
ii) Moderate to severe manic episodes in bipolar disorder
iii) Major depressive episodes in bipolar disorder		 Consultant/specialists for specific indications only, including Geriatricians and Neurologists i) & ii) 300 mg once daily on Day 1 and 600 mg on Day 2. Maintenance dose: 400-800 mg once daily. Maximum dose: 800 mg daily
iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily
1341 Quetiapine Fumarate 400mg Extended Release Tablet N05AH04-138-T50-04-XXX A* i) Schizophrenia
ii) Moderate to severe manic episodes in bipolar disorder
iii) Major depressive episodes in bipolar disorder		 Consultant/specialists for specific indications only, including Geriatricians and Neurologists i) & ii) 300 mg once daily on Day 1 and 600 mg on Day 2. Maintenance dose: 400-800 mg once daily. Maximum dose: 800 mg daily
iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily
1342 Quetiapine Fumarate 50mg Extended Release Tablet N05AH04-138-T50-01-XXX A* i)Schizophrenia
ii)Moderate to severe manic episodes in bipolar disorder
iii)Major depressive episodes in bipolar disorder		 Consultant/specialists for specific indications only, including Geriatricians and Neurologists i) & ii) 300 mg once daily on Day 1 then 600 mg on Day 2. Maintenance dose: 400 to 800 mg once daily. Maximum dose: 800 mg daily.

iii)50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily. In elderly or hepatic impairment: Start with 50mg/ day, may be increased in increments of 50mg /day to an effective dose.
1343 Quinine Dihydrochloride 600mg/2ml Injection P01BC01-110-P30-01-XXX B Severe and complicated malaria None By slow intravenous infusion (over 4 hours). ADULT : 20 mg/kg followed by 10 mg/kg every 8 hours. CHILD : 20 mg/kg followed by 10 mg/kg every 12 hours, initial dose should be half in patients who have received quinine, quinidine or mefloquine during the previous 12 or 24 hours
1344 Quinine Sulphate 300mg Tablet P01BC01-183-T10-01-XXX B Severe and complicated malaria None 300 - 600 mg daily. Treatment : 1.2 - 2 g daily in divided doses. CHILDS less than 1 year : 100 - 200 mg daily, 1 - 3 years : 200 - 300 mg daily, 4 - 6 years: up to 500 mg daily, more than 7 years : up to 1 g daily. All above doses are given for 7 days in 2 - 3 divided doses
1345 Rabies Vaccine Injection J07BG01000P4001XX B Pre-exposure and post-exposure vaccination against rabies. 1ml by IM. Dosing is according to product insert based on patient’s needs (pre and post exposure).
1346 Raloxifene HCl 60mg Tablet G03XC01-110-T10-01-XXX A* i. Treatment and prevention of osteoporosis in postmenopausal women.
ii. Risk reduction of invasive breast cancer in postmenopausal women with osteoporosis.		 - 1 tablet daily
1347 Raltegravir 400 mg tablet J05AX08500T1001XX A* Raltgeravir combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in patients who are contraindicated to boosted Protease Inhibitor or who are intolerant to boosted Protease Inhibitor. 400mg administered orally, twice daily with or without food, to be given combination with other antiretroviral agent.
1348 Ramipril 2.5 mg Tablet C09AA05000T1001XX A i) Hypertension
ii) Congestive heart failure
iii) Reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures in high-riskpatients
iv) Prevention of progressive renal impairment in patients with persistent proteinuria		 i) Initial: 2.5mg once daily
Maintenance: 2.5-5mg once daily
Max. 10mg daily in 1-2 divided doses

ii) Initial: 1.25mg once daily
Maintenance: 10mg in 2 divided doses

iii) Initial: 2.5mg twice daily
Maintenance: 5mg twice daily Max: 10mg daily

iv) Initial: 1.25mg once daily Maintenance: 5mg once daily

Dosing is individualised and according to product insert / protocol.
1349 Ramipril 5 mg Tablet C09AA05000T1002XX A i) Hypertension
ii) Congestive heart failure
iii) Reducing the risk of myocardial infarction, stroke, cardiovascular death or revascularisation procedures inhigh-riskpatients
iv) Prevention of progressive renal impairment in patients with persistent proteinuria		 i) Initial: 2.5mg once daily
Maintenance: 2.5-5mg once daily
Max. 10mg daily in 1-2 divided doses

ii) Initial: 1.25mg once daily
Maintenance: 10mg in 2 divided doses

iii) Initial: 2.5mg twice daily
Maintenance: 5mg twice daily Max: 10mg daily

iv) Initial: 1.25mg once daily
Maintenance: 5mg once daily

Dosing is individualised and according to product insert / protocol.
1350 Ranibizumab 10mg/ml Intravitreal Injection S01LA04-000-P30-01-XXX A* i) Treatment of Neovascular (wet) Age-Related Macular Degeneration (ARMD).
ii) Treatment of visual impairment due to diabetic macular edema (DME).
iii) Treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO).
iv) Treatment of visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).		 For all indications:
To be used by ophthalmologist only
 0.5 mg (0.05ml) as a single intravitreal Injection.Interval between 2 doses should not be shorter than 1 month, then monitor for visual acuity monthly. Treatment is given monthly & continued until max visual acuity is achieved, confirmed by stable visual acuity for 3 consecutive monthly assessments.

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