Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1351 Ranitidine 150 mg Tablet A02BA02110T1001XX B i) Benign gastric and duodenal ulcer ii) Reflux oesophagitis iii) Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome i) 150 mg twice daily (at morning and night) or 300 mg on night for 4-8 weeks. Maintenance: 150-300 mg on night ii) 150 mg twice daily or 300 mg on night for 8-12 weeks iii) 150 mg daily or twice daily iv) 150 mg and may be increased as necessary to 6 g/day
1352 Ranitidine 150 mg/10 ml Syrup A02BA02110L9001XX B Peptic ulcer disease CHILD 2-4 mg/kg 2 times daily. Maximum 300 mg daily
1353 Ranitidine 25 mg/ml Injection A02BA02110P3001XX B i) Benign gastric/ duodenal ulceration, reflux oesophagitis, Zollinger Ellison Syndrome ii) Stress ulcer prophylaxis in post-operative and high risk patients i) ADULT: Slow IV injection of 50 mg diluted to 20 ml and given over at least 2 minutes. May be repeated every 6-8 hours or IV infusion at rate of 25 mg/hour for 2 hours, may be repeated at 6-8 hours intervals or IM. CHILD: 1 mg/kg/dose 6-8 hourly. ii) Initial slow IV injection of 50 mg, then continuous infusion of 125-250 mcg/kg/hour
1354 Ranitidine 300 mg Tablet A02BA02110T1002XX B i) Benign gastric and duodenal ulcer ii) Reflux oesophagitis iii) Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome i) 150 mg twice daily (at morning and night) or 300 mg on night for 4-8 weeks. Maintenance: 150-300 mg on night ii) 150 mg twice daily or 300 mg on night for 8-12 weeks iii) 150 mg daily or twice daily iv) 150 mg and may be increased as necessary to 6 g/day
1355 Ravidasvir 200mg tablet J05AP00-110-T10-01-XXX A/KK To be used in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults In non-cirrhotic patients or compensated cirrhosis patients who are treatment naïve to NS5A inhibitor 200 mg once daily, to be taken orally with or without food.
Patients without cirrhosis: Ravidasvir plus sofosbuvir for 12 weeks.
Patients with compensated cirrhosis: Ravidasvir plus sofosbuvir for 24 weeks
1356 Recombinant Factor IX (rFIX) 1000 IU injection B02BD09-000-P40-03-XXX A* Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) - Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of observed recovery (units/kg per units/dL).
Average dose for secondary prophylaxis for previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days

Dosing is individualised and according to product insert/protocol.
1357 Recombinant Factor IX (rFIX) 2000 IU injection B02BD09-000-P40-04-XXX A* Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) - Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of observed recovery (units/kg per units/dL). Average dose for secondary prophylaxis for previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days

Dosing is individualised and according to product insert/protocol.
1358 Recombinant Factor IX (rFIX) 250 IU injection B02BD09-000-P40-01-XXX A* Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) - Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of observed recovery (units/kg per units/dL). Average dose for secondary prophylaxis for previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days

Dosing is individualised and according to product insert/protocol.
1359 Recombinant Factor IX (rFIX) 500 IU injection B02BD09-000-P40-02-XXX A* Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency) - Number of factor IX units required = body weight (kg) x desired factor IX increase (% or units/dL) x reciprocal of observed recovery (units/kg per units/dL). Average dose for secondary prophylaxis for previously treated adult patients (PTP) was 40 units/kg (range 13 to 78 units/kg) at intervals of 3 to 4 days

Dosing is individualised and according to product insert/protocol.
1360 Recombinant factor VIII 1000 IU Injection B02BD02-000-P40-03-XXX A* i) Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A
ii) Surgical prophylaxis in adults and children with hemophilia A
iii) Routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with no pre-existing joint damage. Not indicated fot the treatment of von willebrand's disease		 None The dosage and duration of treatment should be individualised and taking into account the severity of factor VIII deficiency, location and extent of bleeding and patient's clinical condition.
Dose can be calculated by using:
- Required dose (IU) = body weight (kg) x desired factor VIII rise (IU/dl or % of normal) x 0.5 (IU/kg) or
- Expected factor VIII rise (% of normal) = 2 x (dose administered)/ bodyweight (kg)

Dose administered should be titrated to patient's clinical response
1361 Recombinant factor VIII 250 IU Injection B02BD02000P4001XX A* i) Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A.
ii) Surgical prophylaxis in adults and children with hemophilia A
iii) Routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with no pre-existing joint damage. Not indicated fot the treatment of von willebrand's disease.		 The dosage and duration of treatment should be individualised and taking into account the severity of factor VIII deficiency, location and extent of bleeding and patient's clinical condition.

Dose can be calculated by using:
- Required dose (IU) = body weight (kg) x desired factor VIII rise (IU/dl or % of normal) x 0.5 (IU/kg) or
- Expected factor VIII rise (% of normal) = 2 x (dose administered)/ bodyweight (kg)

Dose administered should be titrated to patient's clinical response
1362 Recombinant Factor VIII 500 IU Injection B02BD02000P4002XX A* i) Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A
ii) Surgical prophylaxis in adults and children with hemophilia A
iii) Routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with no pre-existing joint damage. Not indicated for the treatment of von willebrand's disease.		 The dosage and duration of treatment should be individualised and taking into account the severity of factor VIII deficiency, location and extent of bleeding and patient's clinical condition.

Dose can be calculated by using:
- Required dose (IU) = body weight (kg) x desired factor VIII rise (IU/dl or % of normal) x 0.5 (IU/kg) or
- Expected factor VIII rise (% of normal) = 2 x (dose administered)/ bodyweight (kg)

Dose administered should be titrated to patient's clinical response.
1363 Remifentanil 5 mg Injection N01AH06110P4001XX A* i) As an analgesic agent for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery. ii)Continuation of analgesia into the immediate post-operative period under close supervision, during transition to longer acting analgesia. iii)Provision of analgesia and sedation in mechanically ventilated intensive care patients. For IV use only. ADULT: Induction:Bolus infusion: 1µg/kg over 30-60 seconds; Continuous infusion: 0.5-1µg/kg/min; Maintenance: Continuous infusion: 0.025 to 2 µg/kg/min. CHILD (1-12 years of age): Induction: Insufficient data; Neonates: IV infusion 0.4-1.0 mcg/kg/minute depending on the anaesthetic method and adjust according to patient response, supplemental IV inj of 1 mcg/kg dose may be given. 1-12 yr: initially 0.1-1 mcg/kg by IV inj over at least 30 seconds (excluded if not needed), followed by IV infusion 0.05-1.3 mcg/kg/minute depending on the anaesthetic method and adjust according to patient response, supplemental IV bolus inj may be admin during infusion. 12-18 yr: 0.1-1 mcg/kg IV inj over at least 30 seconds (excluded if not needed), followed by IV infusion of 0.05-2 mcg/kg/minute depending on anaesthetic method and adjust according to patient response, supplemental IV bolus inj may be admin during infusion.
1364 Ribavirin 200mg Capsule J05AB04-000-C10-01-XXX A* For the treatment of chronic hepatitis C None ADULT (more than 18 years old): 50mg/kg/day Recommended: Body weight: ≤ 75kg should receive 1000mg daily as two 200mg capsules in the morning and three 200mg capsules in the evening Body weight: >75kg should receive 1200mg as three 200mg capsules in the morning and three 200mg capsules in the evening Genotype 1,4: 48 weeks Genotype: 24 weeks duration should be individualized in accordance with the baseline characteristics of the disease.
1365 Ribociclib 200mg tablet L01XE42-105-T32-01-XXX A* In combination with:
- an aromatase inhibitor for the treatment of postmenopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.		 600 mg daily for 21 consecutive days followed by 7 days off treatment.
Can be taken with or without food. For dose modification, refer package insert.
1366 Riboflavine 3 mg Tablet A11HA04-000-T10-01-XXX C Treatment of riboflavine deficiency states - ADULT: Treatment dose: Up to 30 mg daily in divided doses.
Maintenance dose: 1 to 3 mg daily in divided doses

CHILD: 3-10 mg/day in divided doses.
1367 Rifampicin 100 mg/5 ml Syrup J04AB02-000-L90-01-XXX A Tuberculosis and leprosy None CHILD: 20 mg/kg body weight daily in 1 - 2 doses. Up to 1 year: 10 mg/kg body weight in a single daily dose
1368 Rifampicin 150 mg, Isoniazid 75 mg, Pyrazinamide 400 mg & Ethambutol HCl 275 mg Tablet J04AM06-000-T10-01-XXX B Treatment of both pulmonary and extrapulmonary tuberculosis, in the intensive treatment phase None ADULT: 30 - 37 kg: 2 tablets daily, 38 - 54 kg: 3 tablets daily, 55 - 70 kg: 4 tablets daily, more than 70 kg: 5 tablets daily
1369 Rifampicin 150mg & Isoniazid 75mg tablet J04AM02-000-T10-01-XXX B For pulmonary tuberculosis in which organisms are susceptible in continuation phase treatment for 4 months None 30-37kg: 2 tablets once daily, 38-54kg: 3 tablets once daily, 55-70kg: 4 tablets once daily, Above 70kg: 5 tabs once daily
1370 Rifampicin 150mg Capsule J04AB02-000-C10-01-XXX B i) Tuberculosis
ii) Leprosy
iii) Prophylaxis for meningococcal meningitis
iv)Staphylococcus biofilm related prosthetic joint infection or any biofilm sensitive to rifampicin in combination therapy with another antibiotic		 None i) ADULT: 450 - 600 mg as a single morning dose.
CHILD: 10 - 20 mg/kg body weight daily in 1 - 2 doses. Directly observed therapy (DOT): 10 mg/kg twice weekly or 3 times/week. Maximum: 600 mg
ii) ADULT: 600 mg/day
CHILD: 10mg/kg
iii) ADULT: 600 mg twice daily for 2 days
CHILD: 10mg/kg twice daily for 2 days
INFANT: 5mg/kg twice daily for 2 days
iv) ADULT: 600mg OD
CHILD: 10-20mg/kg/day in 1-2 divided doses

Dosing is individualised and according to product insert/protocol.
1371 Rifampicin 300mg Capsule J04AB02-000-C10-02-XXX B i) Tuberculosis
ii) Leprosy
iii) Prophylaxis for meningococcal meningitis
iv)Staphylococcus biofilm related prosthetic joint infection or any biofilm sensitive to rifampicin in combination therapy with another antibiotic		 None i) ADULT: 450 - 600 mg as a single morning dose.
CHILD: 10 - 20 mg/kg body weight daily in 1 - 2 doses. Directly observed therapy (DOT): 10 mg/kg twice weekly or 3 times/week. Maximum: 600 mg
ii) ADULT: 600 mg/day
CHILD: 10mg/kg
iii) ADULT: 600 mg twice daily for 2 days
CHILD: 10mg/kg twice daily for 2 days
INFANT: 5mg/kg twice daily for 2 days
iv) ADULT: 600mg OD
CHILD: 10-20mg/kg/day in 1-2 divided doses

Dosing is individualised and according to product insert/protocol.
1372 Rifampicin, Dapsone & Clofazimine J04AM02-961-T99-01-XXX B For the treatment of leprosy and tuberculosis None Rifampicin: 600 mg once monthly, Dapsone: 100 mg daily, Clofazimine: 300 mg once monthly and 50 mg daily (or 100 mg on alternate days)
1373 Ringers Solution (contained sodium chloride, potassium chloride and calcium chloride) B05XA30-905-P60-01-XXX B As a source of electrolytes and water for hydration/replenishing of chloride None According to the needs of the patient
1374 Risankizumab 150mg Solution for Injection L04AC18-000-P50-02-XXX A* Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy with major involvement of special site (face, scalp, genitals, palmoplantar) - As third-line therapy (after failing/intolerant/contraindicated to standard systemic drugs and/or phototherapy and/or IL-17 inhibitors)
- To be prescribed by Dermatologists only		 150 mg administered by subcutaneous injection at week 0, week 4, and every 12 weeks thereafter.
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
1375 Risperidone 1 mg Tablet N05AX08000T1001XX B i) Schizophrenia, including first episode psychosis, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions

ii) Short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation.		 i) ADULT:
Initial dose: 2 mg/day.
Maintenance dose: 4 to 6 mg. Max: 16mg/day
CHILD: Not recommended
ELDERLY:
Initial dose: 0.5 mg twice daily.
Maintenance: 1 to 2 mg twice daily.

ii) CHILD & ADOLESCENTS, 5-18 years
≥ 50 kg: Initial - 0.5 mg once daily Optimum dose: 1mg once daily
< 50 kg: Initial - 0.25 mg once daily Optimum dose: 0.5mg once daily

Dosing should be individualized according to product insert.
1376 Risperidone 1 mg/ml Oral Solution N05AX08000L5001XX A i) Schizophrenia, including first episode psychosis, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions

ii) Short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation.		 i) ADULT:
Initial dose: 2 mg/day.
Maintenance dose: 4 to 6 mg. Max: 16mg/day
CHILD: Not recommended
ELDERLY:
Initial dose: 0.5 mg twice daily.
Maintenance: 1 to 2 mg twice daily.

ii) CHILD & ADOLESCENTS, 5-18 years
≥ 50 kg: Initial - 0.5 mg once daily Optimum dose: 1mg once daily
< 50 kg: Initial - 0.25 mg once daily Optimum dose: 0.5mg once daily

Dosing should be individualized according to product insert.
1377 Risperidone 2 mg Tablet N05AX08000T1002XX B Schizophrenia ADULT:
Initial dose: 2 mg/day.
Maintenance dose: 4 to 6 mg. Max: 16mg/day
CHILD: Not recommended
ELDERLY:
Initial dose: 0.5 mg twice daily.
Maintenance: 1 to 2 mg twice daily.

Dosing should be individualized according to product insert.
1378 Risperidone 25 mg Injection (Long Acting) N05AX08000P3001XX A* Treatment of acute and chronic schizophrenic psychosis and other psychotic conditions, in which positive and negative symptoms are prominent. It also alleviates affective symptoms associated with schizophrenia 25 mg IM every 2 weeks. Dose increments (if required) to 37.5 mg or 50 mg can be considered after a minimum of 4 weeks on each dosage
1379 Risperidone 37.5 mg Injection (Long Acting) N05AX08000P3002XX A* Treatment of acute and chronic schizophrenic psychosis and other psychotic conditions, in which positive and negative symptoms are prominent. It also alleviates affective symptoms associated with schizophrenia 25 mg IM every 2 weeks. Dose increments (if required) to 37.5 mg or 50 mg can be considered after a minimum of 4 weeks on each dosage
1380 Risperidone 50 mg Injection (Long Acting) N05AX08000P3003XX A* Treatment of acute and chronic schizophrenic psychosis and other psychotic conditions, in which positive and negative symptoms are prominent. It also alleviates affective symptoms associated with schizophrenia 25 mg IM every 2 weeks. Dose increments (if required) to 37.5 mg or 50 mg can be considered after a minimum of 4 weeks on each dosage

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