Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
991 Mesalazine 1g/100ml enema A07EC02-259-G20-02-XXX A For induction and maintenance of remission in patients with mild to moderately active ulcerative proctitis or left sided colitis 1 tube of enema at bedtime
992 Mesalazine 2g Prolonged Release Granules A07EC02-259-F21-01-XXX A* Treatment of mild to moderate ulcerative colitis and Crohn’s disease For adults and children 6 years and above Ulcerative colitis:
a) Treatment of active disease:
• Adults: up to 4 g given once daily or in divided doses.
• Children 6 years of age and older: starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses.
The total dose should not exceed 4 g/day.
b) Maintenance treatment: • Adults: 2g once daily. Can be taken in divided doses. • Children 6 years of age and older: starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day.

Crohn’s disease:
a) Treatment of active disease:
• Adults: up to 4g daily in divided doses.
• Children 6 years of age and older: starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day.
b) Maintenance treatment:
• Adults: up to 4g daily in divided doses.
• Children 6 years of age and older: starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 4 g/day.
993 Mesalazine 2g/30ml Enema A07EC02-259-G2-001-XXX A For induction and maintenance of remission in patients with mild to moderately active ulcerative proctitis or left sided colitis None 60 ml (4g) at bedtime, retained overnight, approximately 8 hours
994 Mesalazine 500mg MR Tablet A07EC02-259-T10-02-XXX A Inflammatory bowel disease of ulcerative colitis and Crohn's disease. None Active
ADULT: up to 4g given once daily or in divided doses
CHILD: starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. Total daily dose 4g/day

Maintenance
ADULT: 1.5g to 2g mesalazine once daily or divided doses
CHILD: starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. Total daily dose 2g/day

Dose is according to product insert and dependent on the product/brand used.
995 Mesna 100 mg/ml Injection V03AF01520P3001XX A For prevention of urotoxic effects of oxazaphosphorines e.g. ifosfamide and cyclophosphamide IV injection at a dosage of 20% of the corresponding oxazaphosphorine dose at the times 0 hour (concurrently with the oxazaphosphorine), 4 hours and 8 hours thereafter. CHILD: Dose given at greater frequency (e.g. 6 times) and a shorter intervals (e.g. 3 hours)
996 Metformin HCl 500 mg Extended Release Tablet A10BA02-110-T50-01-XXX B Diabetes mellitus who experienced gastrointestinal side effects with normal metformin 500 mg once daily. Maximum dose 2000 mg once daily with evening meal
997 Metformin HCl 500 mg Tablet A10BA02110T1001XX B Diabetes mellitus Initial: 500mg orally twice daily with food. Maintenance: Titrate in 500mg increments weekly, doses up to 2000 mg daily may be divided into 2 equal doses.
998 Metformin HCl 750 mg Extended Release Tablet A10BA02110T5003XX A/KK Diabetes mellitus who experienced gastrointestinal side effects with normal metformin 500 mg once daily. Maximum dose 2000 mg once daily with evening meal
999 Methadone 5mg/ml Syrup N07BC02-110-L90-01-XXX A/KK Detoxification treatment or maintenance treatment of narcotic addiction. None Initial 10-20mg per day, increasing by 10-20mg per day until there are no signs of withdrawal or intoxication. Usual dose 40-60mg/day
1000 Methotrexate 100mg/mL Injection L01BA01520P3005XX A i) Solid tumours
ii) Gestational trophoblastic disease
iii) Acute leukaemias, lymphomas		 i) 50 mg/m2 once every 3 weeks in combination with other drugs (for this dose, use the 50 mg preparation)

ii) 50 mg IV Day 1, 3, 5, 9 every 3 weeks.
For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime

iii) High dose regimes: 500 - 3000 mg/m2 per dose may be used, employing the 500 mg preparations.
CHILD: Central nervous system prophylaxis for acute leukaemia 2 gm/m2 over 24 hours with folinic acid rescue, 3 doses for B-cell lineage. 4 doses for T-lineage all every 3 weeks. Relapse acute lymphoblastic leukaemia (ALL): 1 gm/m2 over 36 hours with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50 mg/m2 every 2 weeks. B-cell lymphoma: 3 gm/m2 over 3 hours with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. THE 500 MG STRENGTH IS NOT FOR INTRATHECAL USE
1001 Methotrexate 2.5 mg Tablet L01BA01000T1001XX A i. Antineoplastic Chemotherapy
- Treatment of gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole.
- Palliation of acute lymphocytic leukemia
- Treatment and prophylaxis of meningeal leukemia.
- Palliation of acute lymphoblastic (stem-cell) leukemias in children.
- Alone or in combination with other anticancer agents in the management of breast cancer, epidermoid cancers of the head and neck, and lung cancer, particularly squamous cells and small cell types.
- Treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in those cases in children; and in advanced cases of mycosis fungoides.

ii. Psoriasis Chemotherapy
Symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation.

iii. Rheumatoid arthritis		 Dosing is individualised and according to product insert / protocol
1002 Methotrexate 25mg/mL Injection L01BA01520P3001XX A i) Solid tumours
ii) Gestational trophoblastic disease
iii) Acute leukaemia/lymphomas
iv) Rheumatoid arthritis, psoriatic arthropathy, severe/erythrodermic psoriasis		 i) 50 mg/m2 once every 2 - 3 weeks in combination with other drugs
ii) 50 mg IV Day 1, 3, 5, 9 every 3 weeks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime
iii) High dose regimes: 500 - 3000 mg/m2 per dose may be used, employing the 500 mg preparations. CHILD: Central nervous system prophylaxis for acute leukaemia 2 gm/m2 over 24 hours with folinic acid rescue, 3 doses for B-cell lineage. 4 doses for T-lineage all every 3 weeks. Relapse acute lymphoblastic leukaemia (ALL): 1 gm/m2 over 36 hours with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50 mg/m2 every 2 weeks. B-cell lymphoma: 3 gm/m2 over 3 hours with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. The 500 mg strength is not for intrathecal (IT) use. Dosage for intrathecal treatment and prophylaxis in leukaemia: less than 1 year: 5 mg, 1 - 2 years: 7.5 mg, 2 - 3 years: 10 mg, more than 3 years: 12.5 mg. IT preparation must be clearly stated/verified. ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE
iv) Dose used by rheumatologist: 10 - 15 mg IM injection or oral weekly. Dose used by dermatologist: 10 - 25 mg IM injection weekly
1003 Methoxsalen 1% Lotion D05AD02000L6001XX A Repigmenting agent in vitiligo in conjuction with controlled doses of UVA or sunlight Apply 0.1% lotion to area to be exposed to the UVA light ( need to dilute the 1% lotion to 0.1% lotion, otherwise the skin will burn)
1004 Methoxsalen 10 mg Capsule D05BA02000C1001XX A Protection before exposure to sunlight, psoriasis and vitiligo 0.2 - 0.6 mg/kg/body weight. For repigmentation of larger lesions (greater than 6 cm sq): 20 mg/day 2 hours before exposure. Take with food or milk
1005 Methoxy Polyethylene Glycol-epoetin Beta 100 mcg/0.3 ml Injection in Prefilled Syringe B03XA03000P5001XX A* Treatment of anaemia associated with chronic renal failure.
Prescribing restriction: Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Non Erythropoiesis Stimulating Agent (ESA)-treated patients : 0.6 mcg/kg, once every two weeks (IV or SC). When the Hb is >11g/dl, administration can be reduced to once monthly using the dose equal to twice the previous two weekly dose. ESA-treated patients : 120-360 mcg once monthly or 60-180 mcg every two weeks.
1006 Methoxy Polyethylene Glycol-epoetin Beta 120 mcg/0.3 ml Injection in Prefilled Syringe B03XA03000P5005XX A* Treatment of anaemia associated with chronic renal failure.
Prescribing restriction: Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Non Erythropoiesis Stimulating Agent (ESA)-treated patients : 0.6 mcg/kg, once every two weeks (IV or SC). When the Hb is >11g/dl, administration can be reduced to once monthly using the dose equal to twice the previous two weekly dose. ESA-treated patients : 120-360 mcg once monthly or 60-180 mcg every two weeks.
1007 Methoxy Polyethylene Glycol-epoetin Beta 150 mcg/0.3 ml Injection in Prefilled Syringe B03XA03000P5006XX A* Treatment of anaemia associated with chronic renal failure.
Prescribing restriction: Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Non Erythropoiesis Stimulating Agent (ESA)-treated patients : 0.6 mcg/kg, once every two weeks (IV or SC). When the Hb is >11g/dl, administration can be reduced to once monthly using the dose equal to twice the previous two weekly dose. ESA-treated patients : 120-360 mcg once monthly or 60-180 mcg every two weeks
1008 Methoxy Polyethylene Glycol-epoetin Beta 200 mcg/0.3 ml Injection in Prefilled Syringe B03XA03000P5007XX A* Treatment of anaemia associated with chronic renal failure.
Prescribing restriction: Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Non Erythropoiesis Stimulating Agent (ESA)-treated patients : 0.6 mcg/kg, once every two weeks (IV or SC). When the Hb is >11g/dl, administration can be reduced to once monthly using the dose equal to twice the previous two weekly dose. ESA-treated patients : 120-360 mcg once monthly or 60-180 mcg every two weeks.
1009 Methoxy Polyethylene Glycol-epoetin Beta 50 mcg/0.3 ml Injection in Prefilled Syringe B03XA03000P5002XX A* Treatment of anaemia associated with chronic renal failure.
Prescribing restriction: Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Non Erythropoiesis Stimulating Agent (ESA)-treated patients : 0.6 mcg/kg, once every two weeks (IV or SC). When the Hb is >11g/dl, administration can be reduced to once monthly using the dose equal to twice the previous two weekly dose. ESA-treated patients : 120-360 mcg once monthly or 60-180 mcg every two weeks
1010 Methoxy Polyethylene Glycol-epoetin Beta 75 mcg/0.3 ml Injection in Prefilled Syringe B03XA03000P5004XX A* Treatment of anaemia associated with chronic renal failure.
Prescribing restriction: Patients who require higher doses of erythropoietin if it is more cost saving to use a long-acting agent instead of short-acting agents.		 Non Erythropoiesis Stimulating Agent (ESA)-treated patients : 0.6 mcg/kg, once every two weeks (IV or SC). When the Hb is >11g/dl, administration can be reduced to once monthly using the dose equal to twice the previous two weekly dose. ESA-treated patients : 120-360 mcg once monthly or 60-180 mcg every two weeks
1011 Methyl Salicylate 25% Cream M02AC00-969-G10-09-XXX C+ Relief of minor aches and pains of muscles and joints associated with simple backache, arthritis and rheumatic conditions. None Apply to the affected area, 3-4 times daily.
1012 Methyl Salicylate 25% Ointment M02AC00-259-G54-01-XXX C+ Relief of minor aches and pains of muscles and joints associated with simple backache, arthritis and rheumatic conditions. None Apply to the affected area, 3-4 times daily.
1013 Methyldopa 250 mg Tablet C02AB01110T1001XX B Hypertension Adult: 250 mg 2 - 3 times daily, gradually increased at intervals of 2 or more days, maximum; 3 g/day. Elderly: initially 125 mg twice daily, increased gradually, maximum; 2 g daily. Child: Initially, 10 mg/kg or 300 mg/m2 daily in 2-4 divided doses; increase as necessary. Max: 65 mg/kg, 2 g/m2 or 3 g daily, whichever is least.
1014 Methylene Blue (Methylthioninium chloride) 0.5% Injection V03AB17-100-P30-02-XXX B i) For treatment of idiopathic and drug-induced methaemoglobinemia
ii) As dye in diagnostic procedures		 None i) Adult and children: 1 to 2 mg/kg IV over 5 minutes.
This dosage can be repeated if necessary after one hour.

ii) A dose of 5 mg/kg diluted in 500 mL of glucose 5% infused over 1 hour has been used successfully to stain and identify the parathyroid glands.

Dosing is individualised and according to product insert/protocol.
1015 Methylene Blue (Methylthioninium chloride) 1% Injection V03AB17-100-P30-01-XX B For treatment of idiopathic and drug-induced methaemoglobinemia None Adult and children: 1 to 2 mg/kg IV over 5 minutes.
This dosage can be repeated if necessary after one hour.

Dosing is individualised and according to product insert/protocol.
1016 Methylphenidate HCl 10 mg Tablet N06BA04110T1001XX A Attention deficit hyperactivity disorder (ADHD) CHILD over 6 years, initially 5 mg 1 - 2 times daily, increased if necessary at weekly intervals by 5 - 10 mg daily to maximum of 60 mg daily in divided doses; discontinue if no response after 1 month, also suspend periodically to assess child's condition (usually finally discontinued during or after puberty)
1017 Methylphenidate HCl 18 mg Extended-release Tablet N06BA04110T5002XX A* Attention deficit hyperactivity disorder (ADHD) CHILD over 6 years: Individualize dosage, to be taken once daily in the morning. Dose may be adjusted in increments to a maximum of 54 mg/day, at weekly interval. Patient new to methylphenidate: starting dose 18 mg once daily; adults 18mg or 36mg once daily. Patient currently using methylphenidate: 18 - 36 mg. Maximum 54 mg/day. Discontinue if no response after 1 month
1018 Methylphenidate HCl 20 mg LA Capsule N06BA04110C2003XX A* Attention deficit hyperactivity disorder (ADHD) 20 mg once daily to be taken in the morning. Dosage be adjusted in increments to a maximum of 60 mg/day
1019 Methylphenidate HCl 36 mg Extended-release Tablet N06BA04110T5003XX A* Attention deficit hyperactivity disorder (ADHD) CHILD over 6 years: Individualize dosage, to be taken once daily in the morning. Dose may be adjusted in increments to a maximum of 54 mg/day, at weekly interval. Patient new to methylphenidate: starting dose 18 mg once daily; adults 18mg or 36mg once daily. Patient currently using methylphenidate: 18 - 36 mg. Maximum 54 mg/day. Discontinue if no response after 1 month
1020 Methylphenidate HCl 40mg LA Capsule N06BA04110C2002XX A* Attention deficit hyperactivity disorder (ADHD) 20 mg once daily to be taken in the morning. Dosage be adjusted in increments to a maximum of 60 mg/day

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