Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1651 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.
1652 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
1653 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
1654 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
1655 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
1656 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 ADULT
Initially 10 mg once daily, may be increased to max: 20 mg once daily or decreased to min: 5 mg once daily.

ELDERLY
Initially 5 mg once daily.
1657 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.
1658 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.
1659 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.
1660 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.
1661 Water for Injection V07AB00000P3001XX C+ As a diluent and vehicle for the administration of medications According to the needs of the patient
1662 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.
1663 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.
1664 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.
1665 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.
1666 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
1667 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
1668 Zinc Oxide Ointment D02AB00240G5001XX C Skin protective in various skin conditions such as nappy rash and eczema Apply 3 times daily or as required
1669 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.
1670 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)
1671 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
1672 Zonisamide 100mg tablet N03AX15-000-T10-01-XXX A* As adjunctive therapy in the treatment of partial seizures in adults with epilepsy. As adjunctive therapy in the treatment of partial seizures in adults with epilepsy when 1st line and 2nd line therapy failed. For adults, usually 100 to 200mg of zonisomide is to be administered orally 1 to 3 times a day initially. The dose is gradually increased at every one to two weeks up to 200-400mg daily, in 1 to 3 divided dose. The maximum daily dose should not exceed 600mg per day.
1673 Zuclopenthixol 20 mg/ml Drops N05AF05000D5001XX A* i) Acute schizophrenia and other acute psychoses, including agitation
ii) Chronic schizophrenia and other chronic psychoses
iii) Mania		 i) & iii) 10-50mg daily
Max. dose: 100-150mg daily in 2-3 divided doses
ii) 20-40mg daily
1674 Zuclopenthixol Acetate 50 mg/ml Injection N05AF05122P3001XX A* Initial treatment of acute psychoses, including mania, and exacerbations of chronic psychoses in patients not responding to available standard drugs 50-150mg IM repeated if necessary, preferably within a time interval of 2-3 days.
Additional injection may be needed 24-48 hours following the first injection
1675 Zuclopenthixol Decanoate 200 mg/ml Injection N05AF05135P2001XX B Maintenance treatment of schizophrenia and other psychoses, especially with symptoms such as hallucinations, delusions and thought disturbances along with agitation, restlessness, hostility and aggressiveness in patients not responding to available standard drugs By deep IM injection test dose 100 mg followed after 7 - 28 days by 100 - 200 mg or more followed by 200 - 400 mg at intervals of 2 - 4 weeks adjusted according to response. Maximum 600 mg weekly. Child not recommended

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