Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1621 Ustekinumab 90 mg/ml Injection L04AC05000P3002XX A* Treatment of moderate to severe plaque psoriasis in adults who failed to, or who have contraindication to, or are intolerant to conventional systemic therapies including ciclosporin, methotrexate and photochemotherapy (PUVA). Body weight less than 100kg: Initial dose of 45 mg SC, followed by 45 mg 4 weeks later, then every 12 weeks thereafter. Body weight more than 100 kg: initial dose 90 mg SC, followed by 90 mg 4 weeks later, & then every 12 weeks thereafter.
1622 Valganciclovir 450mg Tablet J05AB14-110-T10-01-XXX A* For the prevention of cytomegalovirus (CMV) disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor None For adult patients who have received other than kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 100 days post-transplantation. For adult patients who have received a kidney transplant, the recommended dose is 900 mg (two 450 mg tablets) once a day starting within 10 days of transplantation until 200 days post-transplantation.
1623 Valproic Acid and Sodium Valproate (ER) 500mg Tablet N03AG01-520-T50-01-XX B i) In the treatment of generalized or partial epilepsy, particularly with the following patterns of seizures:absence, myoclonic, tonic-clonic, atonic-mixed as well as, for partial epilepsy:simple or complex seizures, secondary generalized seizures, specific syndrome (West, Lennox-Gastatut).
ii) Treatment and prevention of mania associated with bipolar disorders.		 None i) Adults: Dosage should start at 500mg daily increasing by 200mg at three-day intervals until control is achieved. This is generally within the dosage range 1000mg to 2000mg per day.
Children: >20KG: 500mg/day (irrespective of weight) with spaced increases until control is achieved.

ii) Initial dose of 1000mg/day, to be increase rapidly as possible to achieve lowest therapeutic dose, which produce desired clinical effects. Recommend initial dose is 1000mg & 2000mg daily. Max dose 3000mg daily.
1624 Valsartan 160 mg and Hydrochlorothiazide 12.5 mg Tablet C09DA03935T1005XX A/KK Hypertension in patients intolerant to ACE inhibitors Initial: Valsartan/Hydrochlorothiazide 80/12.5mg once daily
Max: Valsartan/Hydrochlorothiazide 320/25mg once daily

Dosing is individualised and according to product insert / protocol.
1625 Valsartan 160 mg Tablet C09CA03000T1002XX A/KK Patients intolerant to ACE inhibitors in:
i) Heart failure
ii) Post myocardial infarction
iii) Hypertension		 i) Initial: 40mg twice daily.
Titrate up to highest tolerated dose.
Max: 320mg daily in divided doses

ii) Initial: 20mg twice daily
Titrate up to 160mg over next few weeks.
Max: 160mg twice daily

iii) 80mg or 160mg once daily
Max: 320mg daily

Dosing is individualised and according to package insert / protocol.
1626 Valsartan 80 mg and Hydrochlorothiazide 12.5 mg Tablet C09DA03-935-T10-01-XXX A/KK Hypertension in patients intolerant to ACE inhibitors Initial: Valsartan/Hydrochlorothiazide 80/12.5mg once daily
Max: Valsartan/Hydrochlorothiazide 320/25mg once daily

Dosing is individualised and according to product insert / protocol.
1627 Valsartan 80 mg Tablet C09CA03-000-T10-01-XXX A/KK Patients intolerant to ACE inhibitors in:
i) Heart failure
ii) Post myocardial infarction
iii) Hypertension		 i) Initial: 40mg twice daily.
Titrate up to highest tolerated dose.
Max: 320mg daily in divided doses

ii) Initial: 20mg twice daily
Titrate up to 160mg over next few weeks.
Max: 160mg twice daily

iii) 80mg or 160mg once daily
Max: 320mg daily

Dosing is individualised and according to package insert / protocol.
1628 Vancomycin HCl 500mg Injection J01XA01-110-P40-01-XXX A* i. Treatment of infections due to susceptible gram-positive organisms which cannot be treated with other agents (eg. MRSA and Enterococcus sp.)
ii. Treatment of severe staphylococcal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins.		 None Slow IV infusion.
ADULT: 15-20mg/kg q 8-12 hours, not to exceed 2gm per dose.
NEONATE up to 1 week, 15 mg/kg initially, then 10 mg/kg every 12 hours.
INFANT 1 - 4 weeks, 15 mg/kg initially then 10 mg/kg every 8 hours.
CHILD over 1 month, 10 mg/kg every 6 hours
1629 Varenicline Tartrate 0.5mg Tablet N07BA03123T1001XX A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then 0.5 mg twice daily for Day 4-7, then 1 mg twice daily; duration of treatment is 12 weeks
1630 Varenicline Tartrate 1mg Tablet N07BA03123T1002XX A/KK Smoking cessation treatment 0.5 mg once daily for Day 1-3, then 0.5 mg twice daily for Day 4-7, then 1 mg twice daily; duration of treatment is 12 weeks
1631 Varicella Virus Vaccine Live Attenuated Injection J07BK01000P4001XX A* Immunisation against varicella virus infection. 0.5ml by SC. Dosing is according to product insert.
1632 Vasopressin 20 units/ml Injection H01BA01000P3001XX A i) Pituitary diabetes insipidus ii) Oesophageal variceal bleeding i) 5 - 20 units SC or IM every 4 hours ii) 20 units in 100 - 200 ml 5% dextrose saline over 15 minutes as infusion which may be repeated after at intervals of 1 - 2 hours. Maximum: 4 doses
1633 Vedolizumab 300mg powder for concentrate for solution for infusion L04AA33-000-P41-01-XXX A* i) Indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to tumour necrosis factor-alpha (TNF-α) antagonist.

ii) Indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to tumour necrosis factor-alpha (TNFα) antagonist.		 None 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
1634 Venetoclax 100mg Film Coated Tablet L01XX52-000-T32-01-XXX A* Indicated in combination with azacitidine, or decitabine, or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. To be prescribed by Consultant Haematologist only. The recommended dosage and ramp-up of venetoclax depends on the combination agent. Follow the dosing schedule, including the 3-day or 4-day dose ramp-up, as following:
Day 1: 100mg,
Day 2: 200mg,
Day 3: 400mg,
Day 4 and beyond: 400mg orally once daily of each 28-day cycle in combination with azacitidine or decitabine OR 600mg orally once daily of each 28-day cycle in combination with low-dose cytarabine.
Continue venetoclax, in combination with azacitidine or decitabine or low-dose cytarabine until disease progression or unacceptable toxicity.
1635 Venetoclax 10mg Film Coated Tablet L01XX52-000-T32-02-XXX A* Indicated in combination with azacitidine, or decitabine, or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. To be prescribed by Consultant Haematologist only. The recommended dosage and ramp-up of venetoclax depends on the combination agent. Follow the dosing schedule, including the 3-day or 4-day dose ramp-up, as following:
Day 1: 100mg,
Day 2: 200mg,
Day 3: 400mg,
Day 4 and beyond: 400mg orally once daily of each 28-day cycle in combination with azacitidine or decitabine OR 600mg orally once daily of each 28-day cycle in combination with low-dose cytarabine.
Continue venetoclax, in combination with azacitidine or decitabine or low-dose cytarabine until disease progression or unacceptable toxicity.
1636 Venetoclax 50mg Film Coated Tablet L01XX52-000-T32-03-XXX A* Indicated in combination with azacitidine, or decitabine, or low dose cytarabine for the treatment of newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. To be prescribed by Consultant Haematologist only. The recommended dosage and ramp-up of venetoclax depends on the combination agent. Follow the dosing schedule, including the 3-day or 4-day dose ramp-up, as following:
Day 1: 100mg,
Day 2: 200mg,
Day 3: 400mg,
Day 4 and beyond: 400mg orally once daily of each 28-day cycle in combination with azacitidine or decitabine OR 600mg orally once daily of each 28-day cycle in combination with low-dose cytarabine.
Continue venetoclax, in combination with azacitidine or decitabine or low-dose cytarabine until disease progression or unacceptable toxicity.
1637 Venlafaxine HCl 150 mg Extended Release Capsule N06AX16110C2002XX A* i) Depression ii) Generalized anxiety disorder iii) Social anxiety disorder (social phobia) iv) Panic disorder i), ii) & iii) ADULT: 75 mg once daily. May increase dose by 75 mg/day every 4 days to a maximum dose of 225 mg/day, (severe depression: max: 375mg/day) iv) 37.5 mg/day for the first 4-7 days after which the dose should be increased to 75 mg once daily. CHILD and ADOLESCENT under 18 years not recommended.
1638 Venlafaxine HCl 75 mg Extended Release Capsule N06AX16110C2001XX A* i) Depression
ii) Generalized anxiety disorder
iii) Social anxiety disorder (social phobia)
iv) Panic disorder		 i), ii) & iii) ADULT: 75 mg once daily. May increase dose by 75 mg/day every 4 days to a maximum dose of 225 mg/day, (severe depression: max: 375mg/day) iv) 37.5 mg/day for the first 4-7 days after which the dose should be increased to 75 mg once daily. CHILD and ADOLESCENT under 18 years not recommended
1639 Verapamil HCl 2.5 mg/ml Injection C08DA01110P3001XX A/KK Supraventricular tachycardia Initially 5-10mg given by slow IV over at least 2 minutes. The dose can be repeated 10mg 30 minutes after the first dose if the initial response is not adequate.
1640 Verapamil HCl 40 mg Tablet C08DA01-110-T10-01-XXX B i) Supraventricular tachyarrhythmias (SVT) prophylaxis
ii) Angina
iii) Hypertension		 i) 120-480mg in 2-3 divided doses
ii) 80mg – 120mg 3 times daily
iii) Initial: 240 mg daily in 2-3 divided doses. Max: 480 mg daily
1641 Vildagliptin 50 mg and Metformin HCl 1000 mg Tablet A10BD08926T1002XX A/KK FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. 50 mg/850 mg or 50 mg/1000 mg twice daily. Maximum daily dose is 100 mg vildagliptin plus 2000 mg metformin hydrochloride.
1642 Vildagliptin 50 mg and Metformin HCl 500 mg Tablet A10BD08926T1003XX A/KK FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. 50/500mg or 50/850mg or 50/1000mg twice daily. Maximum daily dose is 100mg vildagliptin and 2000mg metformin.
1643 Vildagliptin 50 mg and Metformin HCl 850 mg Tablet A10BD08926T1001XX A/KK FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea. - Treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. 50 mg/850 mg or 50 mg/1000 mg twice daily. Maximum daily dose is 100 mg vildagliptin plus 2000 mg metformin hydrochloride.
1644 Vildagliptin 50mg Tablet A10BH02-000-T10-01-XXX A/KK FUKKM restriction: As add-on therapy for patient who failed therapy and/or contraindicated/unable to tolerate metformin and/or sulphonylurea.
i) As second line therapy in type 2 diabetes patients inadequately controlled on maximal tolerated dose of metformin monotherapy and high risk of hypoglycaemia;
ii) As second line therapy in type 2 diabetes patients inadequately controlled on maximal tolerated dose of sulphonylurea and intolerant/contraindicated for metformin therapy;
iii) As third line therapy in type 2 diabetes patients inadequately controlled with dual OAD combination therapy with sulphonylurea and metformin;
iv) As a monotherapy in type 2 diabetes mellitus patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;
v) An adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus: As a dual therapy in combination with insulin in patients with insufficient glycaemic control. Insulin dose and regimen should be optimized before addition of vildagliptin.		 None ADULT over 18 years: 50mg bd when combine with metformin, 50 mg od when combine with sulphonylurea
1645 Vinblastine Sulphate 10 mg Injection L01CA01183P3002XX A Hodgkin's disease, choriocarcinoma resistant to other chemotherapeutic agents, non-small cell lung cancer, Langerhans cell histiocytosis Adult: Initially, 3.7 mg/m2, increase dose weekly based on WBC counts in increments of about 1.8 mg/m2 until leukocyte count decreases to about 3000/mm3, or maximum weekly dose of 18.5 mg/m2 reached. Usual dose: 5.5-7.4 mg/m2 per week. Do not administer next dose, even though 7 days have lapsed unless the leukocyte count has returned to at least 4000/mm3. Child: Initial 2.5 mg/m2 of BSA, increased dose at weekly intervals in increments of about 1.25 mg/m2 until leukocyte count decreases to about 3000/ mm3, or maximum weekly dose of 12.5 mg/m2 reached. Do not increase dose once leukocyte count reaches approximately 3000 cells/mm3, instead, a dose of 1 increment smaller to be admin at wkly intervals for maintenance. Do not administer next dose, even though 7 days have lapsed unless the leukocyte count has returned to at least 4000/mm3.
1646 Vincristine Sulphate 1 mg/ml Injection L01CA02183P3001XX A i) Solid tumours
ii) Gestational trophoblastic disease
iii) Lymphoma
iv) Multiple myeloma
v) Acute lymphoblastic leukemia		 ADULT
1.4 mg/m2 injection

CHILD
1 mg/m2 to 2 mg/m2 weekly (0.05 mg/kg for infants less than 10kg)

Dosing is according to product insert/protocol
1647 Vinorelbine 10mg/mL Injection L01CA04000P4002XX A* i) First line treatment in non-small cell lung cancer in combination with cisplatin/ifosfomide
ii) Metastatic breast cancer		 i) Single agent: Adult 30mg/m2 IV administered over 6-10 minutes once weekly Combination with cisplatin : 30mg/m2 IV administered over 6-10mintes once weekly combination with cisplatin IV on days and 29 and then every 6 weeks or Vinolrebine administered at a dose of 25mg/m2 IV weekly in combination with cisplatin given every 4 weeks at a dose of 100mg/m2
ii) 25 - 30 mg/m2 diluted in saline solution, infused over 6 - 10 minutes, administered weekly or vinolrebine maybe given as an 8mg/m2 IV BOLUS followed by 8mg/m2 as a 96-hour intravenous infusion.
1648 Vitamin A 50,000 IU Capsule A11CA01000C1001XX C Children with measles malnutrition and serious infections. Category C can use this drug for Orang Asli and in Sabah i) 0-5 months, 50,000 IU ii) 6-11 months, 100,000 IU iii) 1-5 years, 200,000 IU. Frequency twice daily
1649 Vitamin B Complex Tablet A11EA00901T1001XX C+ Prophylaxis and treatment of vitamin B deficiency 1-2 tablets daily
1650 Vitamin B1, B6, B12 Tablet A11DB00901T1001XX B For deficiency or raised requirement of Vitamin B1, B6, B12 1 tablets 3 times daily swallowed unchewed.

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