Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1621 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.
1622 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.
1623 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
1624 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.
1625 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
1626 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.
1627 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
1628 Vitamin B Complex Tablet A11EA00901T1001XX C+ Prophylaxis and treatment of vitamin B deficiency 1-2 tablets daily
1629 Vitamin B1, B6, B12 Tablet A11DB00901T1001XX B For deficiency or raised requirement of Vitamin B1, B6, B12 1 tablets 3 times daily swallowed unchewed.
1630 Vitamin K1 1 mg/ml Injection B02BA01000P3001XX C+ Vitamin K deficiency in neonates Prophylaxis of vitamin K deficiency bleeding in neonates Child: Neonate: 0.5-1 mg, given as a single dose via IM inj. Alternatively, 2 mg may be given orally, followed by a 2nd dose of 2 mg after 4-7 days.
Intravenous Vitamin K deficiency bleeding in neonates Child: Infant: 1 mg by IV/IM/SC inj, further doses may be given if necessary.
1631 Vitamin K1 10 mg/ml Injection B02BA01000P3002XX B Haemorrhage associated with hypoprothrombinaemia caused by overdose of anticoagulants 0.5 - 20 mg by very slow IV at a rate not exceeding 1 mg per minute
1632 Voriconazole 200 mg Injection J02AC03-000-P30-01-XXX A* i) Treatment of immunocompromised patients with progressive, possibly life-threatening infections such as invasive aspergillosis, fluconazole-resistant serious invasive candidiasis, serious fungal infections caused by Scedosporium species and Fusarium species ii)Prevention of breakthrough fungal infections in febrile high-risk neutropenic patients None Adult and Children 12 years and greater: Loading dose: 6 mg/kg 12 hourly for first 24 hours. Maintenance: i) 4 mg/kg 12 hourly ii) 3 mg/kg 12 hourly. Dose may be increased to 4 mg/kg 12 hourly if response is inadequate. Children aged 2years to <12years with normal hepatic and renal function: No loading dose needed; 7mg/kg 12hourly
1633 Voriconazole 200 mg Tablet J02AC03-000-T10-02-XXX A* i) Treatment of immunocompromised patients with progressive, possibly life-threatening infections such as invasive aspergillosis, fluconazole-resistant serious invasive candidiasis, candidiasis of the oesophagus, serious fungal infections caused by Scedosporium species and Fusarium species ii) Prevention of breakthrough fungal infections in febrile high-risk neutropenic patients None Adult and Children 12 years and greater and over 40 kg: Loading dose: 400 mg 12 hourly for first 24 hours. Maintenance: 200 - 300 mg 12 hourly. Less than 40 kg: Loading dose: 200 mg 12 hourly for first 24 hours. Maintenance: 100 - 150 mg 12 hourly. Children aged 2years to <12years with normal hepatic and renal function: No loading dose needed; 200mg 12hourly
1634 Voriconazole 50 mg Tablet J02AC03-000-T10-01-XXX A* i) Treatment of immunocompromised patients with progressive, possibly life-threatening infections such as invasive aspergillosis, fluconazole-resistant serious invasive candidiasis, candidiasis of the oesophagus, serious fungal infections caused by Scedosporium species and Fusarium species ii) Prevention of breakthrough fungal infections in febrile high-risk neutropenic patients None ADULT and CHILDREN 12 years and greater and over 40 kg: Loading dose: 400 mg 12 hourly for first 24 hours. Maintenance: 200 - 300 mg 12 hourly. Less than 40 kg: Loading dose: 200 mg 12 hourly for first 24 hours. Maintenance: 100 - 150 mg 12 hourly
1635 Vortioxetine 10mg tablet N06AX26-330-T32-01-XXX A* Treatment of major depressive episodes in adults. Consultant/specialists for specific indications only, including Geriatricians and Neurologists 10mg once daily in adults less than 65 years of age.
Depending on the individual patient response, the dose may be increased to a maximum of 20mg vortioxetine once daily or decreased to a minimum of 5mg vortioxetine once daily.
After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the anti-depressive response.
1636 Warfarin Sodium 1 mg Tablet B01AA03520T1001XX B Treatment and prophylaxis of thromboembolic disorders Initially 2 to 5mg per day.
Maintenance dose 2-10mg daily according to the INR

Dosing is individualised based on patient’s INR and according product insert/protocol/ guideline.
1637 Warfarin Sodium 2 mg Tablet B01AA03520T1002XX B Treatment and prophylaxis of thromboembolic disorders Initially 2 to 5mg per day.
Maintenance dose 2-10mg daily according to the INR

Dosing is individualised based on patient’s INR and according product insert/protocol/ guideline.
1638 Warfarin Sodium 3mg Tablet B01AA03520T1003XX B Treatment and prophylaxis of thromboembolic disorders Initially 2 to 5mg per day.
Maintenance dose 2-10mg daily according to the INR

Dosing is individualised based on patient’s INR and according product insert/protocol/ guideline.
1639 Warfarin Sodium 5 mg Tablet B01AA03520T1004XX B Treatment and prophylaxis of thromboembolic disorders Initially 2 to 5mg per day.
Maintenance dose 2-10mg daily according to the INR

Dosing is individualised based on patient’s INR and according product insert/protocol/ guideline.
1640 Water for Injection V07AB00000P3001XX C+ As a diluent and vehicle for the administration of medications According to the needs of the patient
1641 Zidovudine 1% Injection J05AF01-000-P30-01-XXX A To reduce the rate of maternal-foetal transmission of HIV in:
i) HIV-positive pregnant women over 14 weeks of gestation;
ii) Their newborn infants
None i) Prophylaxis of maternal-foetal HIV transmission during labour and delivery Adult: Loading dose: 2 mg/kg, followed by continuous infusion of 1 mg/kg/hr until umbilical cord is clamped. If caesarean section is planned, start the IV infusion 4 hr before the operation. Renal and Hepatic impairment: Dose reduction may be needed. HIV infection (to be discuss: not in indication) Adult: 1-2 mg/kg every 4 hr, given as 2-4 mg/ml infusion over 1 hr. Child: As continuous infusion: 20 mg/m2/hr. Alternatively, as intermittent infusion: 120 mg/m2 every 6 hr. Renal impairment: Haemodialysis or peritoneal dialysis: 1 mg/kg every 6-8 hr. ii) Prophylaxis of HIV infection in neonates Child: Neonates: 1.5 mg/kg every 6 hr. Start treatment within 12 hr after birth and continue for 1st 6 wk of life. Dose to be given via IV infusion over 30 minutes. Renal impairment: Dose adjustment may be needed.
1642 Zidovudine 10 mg/ml Syrup J05AF01-000-L90-01-XXX A* i) Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts less than 500 cu. mm;
ii) Neonatal prophylaxis
None i) HIV infection Adult: 600 mg daily in divided doses, in combination with other antiretroviral agents. Child: 6 wk - 12 yr: 160 mg/m2 every 8 hr. Max: 200 mg every 8 hr. May be used in combination with other anti-retrovirals. Renal and Hepatic impairment: Dose reduction may be needed. ii) Prophylaxis of HIV infection in neonates Child: Neonates: 2 mg/kg every 6 hr for 1st 6 wk of life, starting within 12 hr after birth. Renal and hepatic impairment: Dose adjustment may be needed.
1643 Zidovudine 100 mg Capsule J05AF01-000-C10-01-XXX A/KK i) Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts less than 500 cu. mm;
ii) Neonatal prophylaxis
None i) HIV infection Adult: 600 mg daily in divided doses, in combination with other antiretroviral agents. Child: 6 wk - 12 yr: 160 mg/m2 every 8 hr. Max: 200 mg every 8 hr. May be used in combination with other anti-retrovirals. Renal and Hepatic impairment: Dose reduction may be needed.

ii) Prophylaxis of HIV infection in neonates Child: Neonates: 2 mg/kg every 6 hr for 1st 6 wk of life, starting within 12 hr after birth. Renal and hepatic impairment: Dose adjustment may be needed.
1644 Zidovudine 300 mg Tablet J05AF01-000-T10-01-XXX A* i) Management of patients with asymptomatic and symptomatic (early or advanced) HIV infections with CD4 cell counts < 500 cu. mm;
ii) HIV positive pregnant mothers
None HIV infection Adult: 600 mg daily in divided doses, in combination with other antiretroviral agents. Child: 6 wk - 12 yr: 160 mg/m2 every 8 hr. Max: 200 mg every 8 hr. May be used in combination with other anti-retrovirals. ii)Prophylaxis of maternal-foetal HIV transmission Adult: 100 mg 5 times daily or 200 mg tid or 300 mg bid. Start treatment after 14th wk of gestation until the start of labour. Haemodialysis or peritoneal dialysis (CrCl <10 ml/min: 100 mg every 6-8 hr.
1645 Zidovudine 300mg & Lamivudine 150mg Tablet J05AR01-964-T10-01-XXX A/KK HIV infection in combination with at least one other antiretroviral drug None ADULT and CHILD over 12 years: 1 tablet twice daily
1646 Zinc Oxide Cream D02AB00000G1001XX C+ Skin protective in various skin conditions such as nappy rash, eczema and problem skin Apply 3 times daily or as required
1647 Zinc Oxide Ointment D02AB00240G5001XX C Skin protective in various skin conditions such as nappy rash and eczema Apply 3 times daily or as required
1648 Zinc oxide, benzyl benzoate and balsam peru suppository C05AX04931S1001XX C For relief of pruritus, burning and soreness in patients with haemorrhoids and perianal conditions Insert 1 suppository night and morning after bowel movements; do not use for longer than 7 days OR please refer to the product insert.
1649 Zoledronic Acid 4 mg Injection M05BA08000P3001XX A* i) Treatment of hypercalcaemia of malignancy
ii) Prevention of skeletal related events (SREs) in patients with multiple myeloma involving multiple bone lesions
iii) Prevention of skeletal related events (SREs) for metastatic cancers of solid tumours
i) 4mg single dose
ii) 4mg every 3-4 weeks
iii) 4mg reconstituted and should be given as a 15- minute IV infusion every 12 weeks (as advised in MaHTAS 2018 Report)
1650 Zolpidem Tartrate 10 mg Tablet N05CF02123T1001XX A For treatment of insomnia ADULT: 10mg daily at bedtime
ELDERLY OR DEBILITATED SUBJECTS: 5mg daily at bed time
Max. dose: 10mg daily

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