Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1021 Methylprednisolone Acetate 40mg injection H02AB04-134-P30-01-XX A* i) Intramuscular administration: anti-inflammatory treatment, treatment of hematological and oncological disorders, endocrine disorders
ii) Intrasynovial, periarticular, intrabursal or soft tissue administration: Indicated as adjunctive therapy for short term administration in : Synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, post-traumatic osteoarthritis
iii) Intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, psoriatic plaques, lichen simplex chronicus (neurodermatitis) *Restricted to patients experiencing side effects with triamcinolone acetonide		 None i. Intramuscular route a) Asthma: may be used in place of a short burst of oral steroids in vomiting or non-adherent patients. The recommended dose is 80- 120mg intramuscularly as a one-dose b) Adrenogenital syndrome: 40mg every two weeks c) Rheumatoid arthritis (maintenance): 40-120mg weekly d) Dermatologic lesions (acute severe dermatitis, chronic contact dermatitis, seborrheic dermatitis): 40-120mg weekly for 1-4 weeks ii. Intraarticular route Recommended dose is 4 to 80 milligrams, depending upon the size of the joint. Injections may be repeated at intervals of 1 to 5 or more weeks in chronic cases iii.Intralesional route 20 to 60 milligrams methylprednisolone acetate injected into the lesion
1022 Methylprednisolone Sodium Succinate 0.5g Injection H02AB04-520-P40-01-XX A Suppression of inflammatory and allergic disorders, cerebral oedema, immunosuppression treatment of haematological and oncological disorders, treatment of shock states and endocrine disorders None 15 - 30 mg/kg daily. Large doses may be repeated 4 - 6 hourly for up to 48 hours
1023 Methylprednisolone Sodium Succinate 1g Injection H02AB04-520-P40-02-XX A Suppression of inflammatory and allergic disorders, cerebral oedema, immunosuppression treatment of haematological and oncological disorders, treatment of shock states and endocrine disorders None 15 - 30 mg/kg daily. Large doses may be repeated 4 - 6 hourly for up to 48 hours
1024 Metoclopramide HCl 10mg Tablet A03FA01-110-T10-01XXX B Use in adults for:
i) Prevention of delayed chemotherapy induced nausea and vomiting (CINV)
ii) Prevention of radiotherapy induced nausea and vomiting (RINV)
iii) Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting

Use in children aged 1-18 years for:
i) Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option		 None Adult:
The recommended single dose is 10mg, repeated up to three times daily.
The maximum recommended daily dose is 30mg or 0.5mg/kg body weight. The maximum recommended treatment duration is 5 days.
Prevention of delayed CINV (children aged 1-18 years):
The recommended dose is 0.1-0.5mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5mg/kg body weight.

Dosing table
CHILD age 1-3 years old (body weight 10-14kg): 1mg TDS, 3-5 years old (body weight 15-19kg): 2mg TDS, 5-9 years old (body weight 20-29kg): 2.5mg TDS, 9-18 years old (body weight 30-60kg): 5mg TDS, 15-18 years old (body weight > 60kg): 10mg TDS.

Tablets are not suitable for use in children weighing less than 30kg. Other pharmaceutical forms may be more appropriate for administration to this population.
1025 Metoclopramide HCl 1mg/ml Syrup A03FA01-110-L90-01-XX B Use in adults for:
i) Prevention of delayed chemotherapy induced nausea and vomiting (CINV)
ii) Prevention of radiotherapy induced nausea and vomiting (RINV)
iii) Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting

Use in children aged 1-18 years for:
i) Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option		 None Adult:
the recommended single dose is 10mg, repeated up to three times daily.
The maximum recommended daily dose is 30mg or 0.5mg/kg body weight. The maximum recommended treatment duration is 5 days.

Prevention of delayed CINV (children aged 1-18 years):
The recommended dose is 0.1-0.5mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5mg/kg body weight.

Dosing table
CHILD age 1-3 years old (body weight 10-14kg): 1mg TDS, 3-5 years old (body weight 15-19kg): 2mg TDS, 5-9 years old (body weight 20-29kg): 2.5mg TDS, 9-18 years old (body weight 30-60kg): 5mg TDS, 15-18 years old (body weight > 60kg): 10mg TDS.
Tablets are not suitable for use in children weighing less than 30kg. Other pharmaceutical forms may be more appropriate for administration to this population.
1026 Metoclopramide HCl 5mg/ml Injection A03FA01-110-P30-01-XX B Use in adults for:
i) Prevention of post-operative nausea and vomiting
ii) Symptomatic treatment of nausea and vomiting, including nausea and vomiting induced by migraine attacks
iii) Prevention of radiotherapy-induced nausea and vomiting

Use in children aged 1 to 18 years for:
i) Prevention of delayed chemotherapy-induced nausea and vomiting as a second-line option
ii) Prevention of post-operative nausea and vomiting as a second-line option		 None All indications (adult): A single 10mg dose is recommended for the prevention of post-operative nausea and vomiting.
The recommended dose for the symptomatic treatment of nausea and vomiting, including nausea and vomiting induced by migraine attacks and for the prevention of radiotherapy-induced nausea and vomiting is 10mg per dose, 1 to 3 times daily. The maximum recommended daily dose is 30mg or 0.5mg/kg.
Treatment duration when administering by injection should be as short as possible and a switch to administration via oral or rectal route should be instituted as quickly as possible.

All indications (children aged 1 to 18 years of age)
The recommended dosage is 0.1 to 0.15mg/kg, 1 to 3 times daily, by intravenous route. The maximum daily dose is 0.5mg/kg.

Dosing table:
CHILD age 1-3 years old (body weight 10-14kg): 1mg TDS, 3-5 years old (body weight 15-19kg): 2mg TDS, 5-9 years old (body weight 20-29kg): 2.5mg TDS, 9-18 years old (body weight 30-60kg): 5mg TDS, 15-18 years old (body weight > 60kg): 10mg TDS.

For the prevention of delayed CINV, the maximum treatment duration is 5 days.
For the prevention of post-operative nausea and vomiting, the maximum treatment duration is 48 hours.
1027 Metolazone 2.5 mg Tablet C03BA08000T1002XX A* Oedema in congestive cardiac failure, nephrotic syndrome and impaired renal function Adult: 5-10 mg daily, increased if necessary to 20 mg daily. Max: 80 mg in 24 hr. Elderly: Initially, 2.5 mg/day or every other day. Should be taken with food. Take after breakfast.
1028 Metoprolol Tartrate 100 mg Tablet C07AB02123T1002XX B i) Hypertension
ii) Angina pectoris
iii) Myocardial infarct
iv) Cardiac arrhythmias
v) Migraine prophylaxis
vi) Hyperthyroidism		 i) Initial: 100mg daily in 1 or 2 divided doses
Maintenance: 200mg daily in divided doses
Max. 400mg daily

ii) 50-100mg 2-3 times daily
Max. 400mg daily

iii) Initial: 50mg twice daily
Maintenance: 100mg twice daily

iv) Initial: 50mg 2-3 times daily
Maintenance: 300mg daily in divided doses

v) 100-200mg daily in 2 divided doses

vi) 150-200mg daily in 3-4 divided doses

Dosing is invidualised and according to product insert/protocol.
1029 Metoprolol Tartrate 50 mg Tablet C07AB02123T1001XX B i) Hypertension
ii) Angina pectoris
iii) Myocardial infarct
iv) Cardiac arrhythmias
v) Migraine prophylaxis
vi) Hyperthyroidism		 i) Initial: 100mg daily in 1 or 2 divided doses
Maintenance: 200mg daily in divided doses
Max. 400mg daily

ii) 50-100mg 2-3 times daily
Max. 400mg daily

iii) Initial: 50mg twice daily
Maintenance: 100mg twice daily

iv) Initial: 50mg 2-3 times daily
Maintenance: 300mg daily in divided doses

v) 100-200mg daily in 2 divided doses

vi) 150-200mg daily in 3-4 divided doses

Dosing is invidualised and according to product insert/protocol.
1030 Metronidazole 200mg Tablet P01AB01-000-T10-01-XXX B Anaerobic infection None Anaerobic bacterial infections Adult: Initially, 800 mg followed by 400 mg 8 hly for about 7 days. Other recommended doses: 500 mg 8 hrly or 7.5 mg/kg 6 hrly (max: 4 g in 24 hr). Child: 7.5 mg/kg 8 hrly. Elderly: Use lower end of adult dose recommendations. Do not admin as a single dose. Prophylaxis of postoperative anaerobic bacterial infections Adult: 400 mg by mouth 8 hrly in the 24 hr prior to surgery followed postoperatively by IV or rectal admin until oral therapy is possible. Other sources recommend that oral doses be initiated only 2 hr prior to surgery and that number of doses for all admin routes be limited to a total of 4. Elderly: Dose reduction may be necessary. Tab: Should be taken with food.
1031 Metronidazole 200mg/5ml Suspension P01AB01-000-L80-01-XX B Anaerobic infection None CHILD: 7.5 mg/kg 3 times daily for 7 days
1032 Metronidazole 500mg/100ml Injection J01XD01-000-P99-01-XXX A Anaerobic infections None ADULT: 500 mg IV infusion 8 hourly. CHILD: 7.5 mg/kg body weight every 8 hours. Neonates: 15mg/kg LD, followed by 7.5mg/kg every 12 hourly. 1 month to 18 years: 7.5mg/kg (maximum 500mg) every 8 hours.
1033 Micafungin Sodium 50mg Injection J02AX05-520-P41-01-XXX A* i) Treatment of invasive candidiasis, including candidemia in adults when intolerance or resistance to Amphotericin B or Fluconazole.
ii) Treatment of invasive candidiasis in children.		 None i) Dosage for adults, adolescents ≥ 16 years of age and the elderly for the treatment of invasive candidiasis:
- Body weight > 40kg: 100mg/day*
- Body weight ≤ 40kg: 2mg/kg/day*
*If patient's response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40kg or 4mg/kg/day in patients weighing ≤ 40kg.
Treatment duration for invasive candidiasis: should be a minimum of 14 days. The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.

ii) Dosage for children:
- Body weight ≤ 40kg: 2mg/kg/day;
- Body weight > 40kg: 100mg/day
1034 Miconazole 2% Cream D01AC02221G1001XX C i) Fungal infections: Tinea pedis, Tinea corporis, Tinea capitis and other dermatophyte infections caused by Trichophyton and Epidermophyton species;
ii) Antifungal agent that has been in various candida infections including vaginal candidiasis.		 To be used as 2nd line treatment at health facilities without medical officer. Apply sparingly and rub gently onto affected area 1-2 times daily continuing for 14 days after lesions have healed
1035 Miconazole Nitrate 2% Powder D01AC02221F2001XX A Skin infections caused by dermatophytes or Candida Dust powder over infected area 1 - 2 times daily
1036 Midazolam 5mg/5ml Injection N05CD08-110-P30-01-XX A, A/KK Prescriber Category A:
Pre-operative sedation, induction of general anaesthesia, premedication and sedation in ICU and sedation for minor procedures

Prescriber Category A/KK:
For induction of intubation and sedation post-intubation		 None Pre-operative sedation, induction of general anaesthesia, premedication and sedation in ICU and sedation for minor procedures :
Usual sedative range 2.5 - 7.5 mg (about 70 mcg/kg by IV injection over 30 seconds). Premedication by IM injection 70 - 100 mcg/kg 30 -60 minutes before surgery; ELDERLY: 1 - 1.5 mg/kg. Induction: Induction by slow IV infusion 200 - 300 mcg/kg (ELDERLY 100 - 200 mcg/kg. CHILD over 7 years 150 - 200 mcg/kg); Maximum: 0.35mg/kg. Sedation in ICU 0.03 - 0.2 mg/kg/hour

For induction of intubation and sedation post-intubation :
Induction: Induction by slow IV infusion 200 - 300 mcg/kg (ELDERLY 100 - 200 mcg/kg. CHILD over 7 years 150 - 200 mcg/kg); Maximum: 0.35mg/kg.
Sedation: 0.03 - 0.2 mg/kg/hour
1037 Midazolam 5mg/ml Injection N05CD08110P3002XX A, A/KK Prescriber Category A:
Pre-operative sedation, induction of general anaesthesia, premedication and sedation in ICU and sedation for minor procedures

Prescriber Category A/KK:
For induction of intubation and sedation post-intubation		 None Pre-operative sedation, induction of general anaesthesia, premedication and sedation in ICU and sedation for minor procedures :
Usual sedative range 2.5 - 7.5 mg (about 70 mcg/kg by IV injection over 30 seconds). Premedication by IM injection 70 - 100 mcg/kg 30 -60 minutes before surgery; ELDERLY: 1 - 1.5 mg/kg. Induction: Induction by slow IV infusion 200 - 300 mcg/kg (ELDERLY 100 - 200 mcg/kg. CHILD over 7 years 150 - 200 mcg/kg); Maximum: 0.35mg/kg. Sedation in ICU 0.03 - 0.2 mg/kg/hour

For induction of intubation and sedation post-intubation :
Induction: Induction by slow IV infusion 200 - 300 mcg/kg (ELDERLY 100 - 200 mcg/kg. CHILD over 7 years 150 - 200 mcg/kg); Maximum: 0.35mg/kg.
Sedation: 0.03 - 0.2 mg/kg/hour
1038 Midazolam 7.5mg Tablet N05CD08253T1001XX A/KK Pre and post-operative sedation None ADULT: Usually 7.5 - 15 mg at bedtime; or for premedication, 30 - 60 minutes before the procedure. For ELDERLY, debilitated or impaired liver/kidney function: 7.5 mg
1039 Minocycline 100 mg Capsule J01AA08-110-C10-02-XXX A* i. As second-line treatment for leprosy only
ii. Treatment of infections due to susceptible strains of the designated organism e.g. Carbapenem-resistant acinetobacter baumannii		 None i. 100 mg daily 6 - 18 months
ii. Initially, 200 mg followed by 100-200mg every 12 hours
1040 Minocycline 50 mg Capsule J01AA08-110-C10-01-XXX A* i. As second-line treatment for leprosy only
ii. Treatment of infections due to susceptible strains of the designated organism e.g. Carbapenem-resistant acinetobacter baumannii		 None i. 100 mg daily 6 - 18 months
ii. Initially, 200 mg followed by 100-200mg every 12 hours
1041 Minoxidil 5 mg Tablet C02DC01000T1001XX A* Severe hypertension ADULTS and CHILD above 12 years old: Initially 5 mg daily in single or divided doses (elderly 2.5 mg). May increase by 5 - 10 mg daily at intervals of 3 or more days until optimum control is achieved. Maximum 50 mg daily
1042 Mirabegron 50mg Prolonged Release Tablet G04BD12-000-T52-01-001 A* Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome. For patients who are not responsive, intolerant or unsuitable to use other existing agents. 50mg once daily.

Should be taken once daily, with liquid, swallowed whole and is not to be chewed, divided, or crushed
1043 Mirtazapine 15mg Orodispersible Tablet N06AX11-000-T40-01-XXX A* Major depression Consultant/specialists for specific indications only, including Geriatricians and Neurologists Initially 15 mg daily at bedtime increased according to response up to 45 mg daily as a single dose at bedtime or in 2 divided doses. CHILD and ADOLESCENT under 18 years not recommended
1044 Mirtazapine 30mg Orodispersible Tablet N06AX11-000-T40-02-XXX A* Major depression Consultant/specialists for specific indications only, including Geriatricians and Neurologists Initially 15 mg daily at bedtime increased according to response up to 45 mg daily as a single dose at bedtime or in 2 divided doses. CHILD and ADOLESCENT under 18 years not recommended
1045 Mirtazapine 30mg Tablet N06AX11-000-T32-01-XXX A* Major depression Consultant/specialists for specific indications only, including Geriatricians and Neurologists Initial: 15mg daily at bedtime
Maintenance: 15-45mg daily
1046 Mitomycin-C 10 mg Injection L01DC03000P4001XX A* i) Gastrointestinal, lung, breast, cervical cancers ii) Bladder tumours iii) Opthalmological conditions: conjunctival squamous neoplasia, squamous cell carcinoma of conjunctiva, trabeculectomy chronic lymphocytic leukaemia, chronic myelogenous leukaemia. Gastric, colorectal, lung cancer i) 10 - 20 mg/m2 body surface area (BSA) given as a single dose through a running IV infusion repeated every 6 - 8 weeks. The whole schedule may be repeated depending on the bone marrow ii) 10 - 40 mg daily or every other day (intravesical) iii) 0.4 mg topically as a single application for opthalmological conditions, duration: 1 to 3 minutes
1047 Mitoxantrone 20 mg/10ml Injection L01DB07110P3001XX A* Acute leukaemia, elderly patients with acute myeloid leukaemia (AML), relapsed/resistant acute leukaemia, non-Hodgkin's lymphoma (NHL) 10 - 12 mg/m2 IV daily for 3 days, in combination with other cytotoxic agents. Refer to protocol. CHILD: 5 - 10 mg/m2 daily for 3 - 5 days according to protocol. Treatment of acute leukaemia, ADULT: 8 - 12 mg/m2/day once daily for 4 - 5 days. CHILD more than 2 years: same as adult dose. CHILD 2 years: 0.4 mg/kg/day once daily for 3 - 5 days
1048 Mixed Gas-Gangrene Antitoxin 25,000 units/5 ml Injection J06AA05000P3001XX B Mixed gas-gangrene Prophylactic: 25,000 units IM or IV. Therapeutic: Not less than 75,000 units IV
1049 Moclobemide 150 mg Tablet N06AG02000T1001XX A* Treatment of depressive syndrome Initially 300 mg daily in divided doses. Gradually to increase up to 600 mg daily in divided doses depending on response. Usual range 150 - 600 mg daily. Not recommended in children
1050 Modified Fluid Gelatin 4% Injection B05AA06905P9901XX B For primary volume replacement in hypovolaemia, peri-operative stabilization of the circulation, haemodilution, extracorporeal circulation (haemodialysis and heart-lung machine) ADULT 500 - 1500 ml given as IV infusion

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