Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
631 Fat Emulsion 20% for IV Infusion Injection B05BA02000P6002XX A Source of lipid in patients needing IV nutrition Dose to be individualised. ADULT usual lipid requirement 2-3 g/kg/day. INFANT 0.5-1 g/kg/day
632 Febuxostat 80 mg tablet M04AA03-000-T32-01-XXX A/KK Treatment of chronic hyperuricaemia in adult patients, in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis). i) As second line for patients who are allergic or intolerant to allopurinol, or
ii) Fail to achieve serum uric acid target despite dose escalation and good compliance to allopurinol
 The recommended starting dose is 40 mg once daily.
The recommended oral dose is 40 mg or 80 mg once daily.
If serum uric acid is > 6.0 mg/dL (357 µmol/L) after 2-4 weeks, 80 mg once daily may be considered.
633 Felodipine 10mg Extended Release Tablet C08CA02-000-T10-02-XX A/KK Hypertension None Initiate at 5 mg once daily. Usual dose, 5 - 10 mg once daily in the morning
634 Felodipine 5mg Extended Release Tablet C08CA02-000-T10-01-XX A/KK Hypertension None Initiate at 5 mg once daily. Usual dose, 5 - 10 mg once daily in the morning
635 Fenofibrate 145mg tablet C10AB05-000-T10-02-XXX A/KK i) As second line therapy after failed gemfibrozil in patients:
a) Hypercholesterolemia and hypertriglyceridemia alone or combined [type IIa,IIb,III and V dysplipidemias] in patients unresponsive to dietary and other non-pharmacological measures especially when there is evidence of associated risk factors
b) Treatment of secondary hyperlipoproteinemias if hyperlipoprotenemia persists despite effective treatment of underlying disease
c) Dyslipidemia in Type 2 Diabetes Mellitus

ii) Diabetic retinopathy - indicated for the reduction in the progression of diabetic retinopathy in patients with type 2 diabetes and existing diabetic retinopathy.		 For indication (2): For mild to moderate non-proliferative diabetic retinopathy only. 145mg once daily, with or without food
636 Fentanyl 12mcg/h Transdermal Patch N02AB03-136-M70-05-XXX A* As a second line drug in the management of opioid responsive, moderate to severe chronic cancer pain. None ADULT and CHILD over 2 years previously treated with a strong opioid analgesic, initial dose based on previous 24-hour opioid requirement (consult product literature). If necessary dose should be adjusted at 72-hour intervals in steps of 12-25 mcg/hr
637 Fentanyl 25 mcg/h Transdermal Patch N02AB03-136-M70-01-XXX A*, A/KK Category Prescriber A*:
i) As a second line drug in the management of opioid responsive, moderate chronic cancer pain

Category Prescriber A/KK:
ii) As a second line drug in the management of opioid responsive, severe chronic cancer pain		 Indikasi ii)
Category Prescriber A/KK: To be prescribed by Family Medicine Specialists trained in pain management		 Patients who have not previously received a strong opioid analgesic, initial dose , one 25 mcg/hour patch to be replaced after 72 hours. Patients who have received a strong opioid analgesic, initial dose based on previous 24 hours opioid requirement (oral morphine sulphate 90 mg over 24 hours = one 25 mcg/hour patch). Not recommended in children.
638 Fentanyl 50mcg/h Transdermal Patch N02AB03-136-M70-02-XXX A* As a second line drug in the management of opioid responsive, moderate to severe chronic cancer pain None Patients who have not previously received a strong opioid analgesic, initial dose , one 25 mcg/hour patch to be replaced after 72 hours. Patients who have received a strong opioid analgesic, initial dose based on previous 24 hours opioid requirement (oral morphine sulphate 90 mg over 24 hours = one 25 mcg/hour patch). Not recommended in children.
639 Fentanyl Citrate 50mcg/ml Injection N01AH01-136-P30-01-XXX A Short duration analgesia during pre-medication induction and maintenance of anaesthesia, and in the immediate post-operative period. Dose should be individualized according to age, body weight, physical status, underlying pathological conditions and type of surgery and anaesthesia. ADULT: Premedication: IM 50 - 100 mcg, 30 - 60 mins prior to surgery. Adjunct to general anaesthesia: Induction IV 50 - 100mcg, repeat 2 - 3 mins intervals until desired effect is achieved. IV/IM 25 - 50mcg in elderly and poor risk patients. Maintenance: IV/IM 25 - 50mcg. Adjunct to regional anaesthesia: IM/slow IV 50 - 100mcg when additinal analgesia is required. Post-operatively (recovery room): IM 50 - 100mcg for pain control, tachypnoea and emergency delirium. May be repeated in 1- 2 hours as needed. CHILD (2 - 12 years): Induction & maintenance: 2 - 3 mcg/kg.
640 Ferric derisomaltose 100 mg/ml solution for injection /infusion B03AC00-000-P30-01-XXX A* Indicated for the treatment of iron deficiency in the following conditions:
- when oral iron preparations are ineffective or cannot be used
- where there is a clinical need to deliver iron rapidly

The diagnosis must be based on laboratory tests.		 For cases where less number of administration and fewer medical visits or quick achievement of Hb target are imperative / crucial Intravenous bolus injection:
Up to 500 mg up to three times a week at an administration rate of up to 250 mg iron/minute.

Intravenous drip infusion:
Up to 20 mg iron/kg body weight or as weekly infusions until the cumulative iron dose has been administered.
If the cumulative iron dose exceeds 20 mg iron/kg body weight, the dose must be split in two administrations with an interval of at least one week.
641 Ferrous controlled release 525 mg, Vitamin B1, Vitamin B2, Vitamin B6, Vitamin B12, Vitamin C, Niacinamide, Calcium Pantothenate, Folic Acid 800 mcg Tablet B03AE10903T1001XX A/KK Anemia due to iron deficiency, megaloblastic anemia where there is an associated deficiency of Vitamin C and Vitamin B-complex particularly in pregnancy. In primary health clinic, the indication is restricted to anemia due to iron deficiency in pregnant women ONLY. One tablet daily
642 Ferrous Fumarate 200 mg Tablet B03AA02138T1001XX C+ Prevention and treatment of iron-deficiency anaemias Adult: Usual dose range: Up to 600 mg daily. May increase up to 1.2 g daily if necessary. Child: As syrup containing 140 mg(45 mg iron)/5ml. Preterm neonate: 0.6-2.4 ml/kg daily; up to 6 years old: 2.5-5ml twice daily
643 Ferrous iron (elemental iron ≥ 100mg), vitamin & mineral Capsule B03AE02-903-C10-01-XXX B i) Iron deficiency anaemia
ii) Nutritional deficiency anaemia and anaemia associated with pregnancy, worm infestation etc.
iii) Prophylaxis against iron deficiency and megaloblastic anaemia of pregnancy during the second and third trimester of pregnancy		 1 capsule daily
644 Filgrastim (G-CSF) 30 MU/ml Injection L03AA02000P3001XX A* i) Prevention and treatment of febrile neutropenia due to cancer chemotherapy (except chronic myeloid leukaemia and myelodysplastic syndrome)
ii) Haemopoeitic stem cell transplantation (HSCT)/stem cell harvesting		 i) Adult: SC or IV 5 mcg/kg/day. Initiation: 24 - 72 hours after chemotherapy. Duration: Until a clinically adequate neutrophil recovery is achieved (absolute neutrophil count of at least 1 x 109/L on 2 consecutive days)
ii) Refer to protocol
645 Filgrastim 30 MU in 0.5 ml Injection L03AA02000P5001XX A* i) Prevention and treatment of febrile neutropenia due to cancer chemotherapy (except chronic myeloid leukaemia and myelodysplastic syndrome)
ii) Haemopoeitic stem cell transplantation (HSCT) / stem cell harvesting		 i) ADULT: 5 mcg/kg/day by SC or IV. Initiation: 24 - 72 hours after chemotherapy. Duration: Until a clinically adequate neutrophil recovery is achieved (absolute neutrophil count of at least 1 x 109/L on 2 consecutive days)
ii) Refer to protocol
646 Finasteride 5mg Tablet G04CB01-000-T10-01-XXX A* Treatment and control of benign prostatic hyperplasia Consultant/specialists for specific indications only, including Geriatricians 5mg once daily.
647 Fingolimod 0.5mg Capsule L04AA27-110-C10-01-XXX A* Treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability None 0.5mg orally once daily
648 Flecainide Acetate 100mg Tablet C01BC04-122-T10-01-XX A* i) Sustained monomorphic ventricular tachycardias ii) Preexcited atrial fibrillation associated with Wolff-Parkinson White Syndrome iii) Reciprocating Atrio-Ventricular tachycardias (AVT) associated with Wolff-Parkinson White Syndrome iv) Supraventricular tachycardias due to Intra-Atrio Ventricular Nodul Reentry None Ventricular arrhythmias: 100 mg twice daily, maximum 400 mg/day (usually reserved for rapid control or in heavily built patients), reduced after 3 - 5 days if possible. Supraventricular arrhythmias: 50 mg twice daily, increased if required to maximum of 150 mg twice daily
649 Fluconazole 100 mg Capsule J02AC01-000-C10-02-XX A i) Cryptococcosis
a) cryptococcal meningitis and infections of other sites (e.g.,pulmonary, cutaneous)
b) Prevention of relapse of cryptococcal meningitis in patients in AIDS after a full course of primary therapy

ii) Systemic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infections. These include infections of the peritoneum, endocardium, eye, and pulmonary and urinary tracts.

iii) Mucosal candidiasis.
a) Oropharyngeal candidiasis
b) Chronic oral atrophic candidiasis (denture sore mouth)
c) Oesophageal, non‐invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis
d) Prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after a full course of primary therapy

iv) Genital candidiasis.
a) Vaginal candidiasis (acute or recurrent)
b) Prophylaxis of recurrent vaginal candidiasis (three or more episodes a year)
c) Candidal balanitis.

v) Prevention of fungal infections in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy.

vi) Dermatomycosis
a) Tinea pedis, tinea corporis, tinea cruris and dermal Candida infections
b) Tinea versicolor		 None i) a) 400mg on Day1 followed by 200mg to 400mg once daily usually at least 6 to 8 weeks for cryptococcal meningitis.
CHILD ≥4 weeks-11 years:
Treatment:6-12mg/kgoncedaily.
b) 200 mg once daily indefinitely.
CHILD:- Maintenance: 6mg/kg once daily

ii) 400 mg on Day 1 followed by 200 mg once daily
CHILD ≥ 4weeks-11years: 6-12mg/kg once daily.

iii) a) 50mg to 100mg once daily for 7 to 14 days
CHILD:- Loading dose: 6mg/kg on Day 1 followed by 3mg/kg daily.
b) 50 mg once daily for 14 days concurrently with local antiseptic measures to the denture
c) 50 mg to 100 mg once daily for 14 to 30 days.
CHILD:-
0-14days: Initially, 6mg/kg, followed by 3mg/kg every 72 hours.
Max: 12 mg/kg 72 hourly.
15-27 days: Initially, 6mg/kg, followed by 3 mg/kg every 48 hours.
Max: 12 mg/kg 48 hourly.
28 days-11 years: Initially, 6 mg/kg, followed by 3 mg/kg once daily.
d)150 mg once weekly.

iv) a) 150 mg as a single oral dose.
b) 150 mg once-monthly dose may be used for usually4 to 12 months
c) 150 mg as a single oral dose.

v) 50 mg to 400 mg once daily

vi) a) 150 mg once weekly or 50 mg once daily for normally 2 to 6 weeks
b)300mg once weekly for 2weeks; a third weekly dose of 300-400mg.
An alternate dosing regimen is 50mg once daily for 2 to 4 weeks.

Dosing is individualised and according to product insert/protocol.
650 Fluconazole 2 mg/ml Injection J02AC01-000-P99-01-XXX A i) Cryptococcosis
a) cryptococcal meningitis and infections of other sites (e.g.,pulmonary, cutaneous)
b) Prevention of relapse of cryptococcal meningitis in patients in AIDS after a full course of primary therapy

ii) Systemic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infections. These include infections of the peritoneum, endocardium, eye, and pulmonary and urinary tracts.

iii) Mucosal candidiasis.
a) Oropharyngeal candidiasis
b) Chronic oral atrophic candidiasis (denture sore mouth)
c) Oesophageal, non‐invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis
d) Prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after a full course of primary therapy

iv) Genital candidiasis.
a) Vaginal candidiasis (acute or recurrent)
b) Prophylaxis of recurrent vaginal candidiasis (three or more episodes a year)
c) Candidal balanitis.

v) Prevention of fungal infections in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy.

vi) Dermatomycosis
a) Tinea pedis, tinea corporis, tinea cruris and dermal Candida infections
b) Tinea versicolor		 None i) a) 400mg on Day1 followed by 200mg to 400mg once daily usually at least 6 to 8 weeks for cryptococcal meningitis.
CHILD ≥4 weeks-11 years:
Treatment:6-12mg/kgoncedaily.
b) 200 mg once daily indefinitely.
CHILD:- Maintenance: 6mg/kg once daily

ii) 400 mg on Day 1 followed by 200 mg once daily
CHILD ≥ 4weeks-11years: 6-12mg/kg once daily.

iii) a) 50mg to 100mg once daily for 7 to 14 days
CHILD:- Loading dose: 6mg/kg on Day 1 followed by 3mg/kg daily.
b) 50 mg once daily for 14 days concurrently with local antiseptic measures to the denture
c) 50 mg to 100 mg once daily for 14 to 30 days.
CHILD:-
0-14days: Initially, 6mg/kg, followed by 3mg/kg every 72 hours.
Max: 12 mg/kg 72 hourly.
15-27 days: Initially, 6mg/kg, followed by 3 mg/kg every 48 hours.
Max: 12 mg/kg 48 hourly.
28 days-11 years: Initially, 6 mg/kg, followed by 3 mg/kg once daily.
d)150 mg once weekly.

iv) a) 150 mg as a single oral dose.
b) 150 mg once-monthly dose may be used for usually4 to 12 months
c) 150 mg as a single oral dose.

v) 50 mg to 400 mg once daily

vi) a) 150 mg once weekly or 50 mg once daily for normally 2 to 6 weeks
b)300mg once weekly for 2weeks; a third weekly dose of 300-400mg.
An alternate dosing regimen is 50mg once daily for 2 to 4 weeks.

Dosing is individualised and according to product insert/protocol.
651 Fluconazole 50 mg Capsule J02AC01-000-C10-01-XXX A i) Cryptococcosis
a) cryptococcal meningitis and infections of other sites (e.g.,pulmonary, cutaneous)
b) Prevention of relapse of cryptococcal meningitis in patients in AIDS after a full course of primary therapy

ii) Systemic candidiasis, including candidemia, disseminated candidiasis and other forms of invasive candidal infections. These include infections of the peritoneum, endocardium, eye, and pulmonary and urinary tracts.

iii) Mucosal candidiasis.
a) Oropharyngeal candidiasis
b) Chronic oral atrophic candidiasis (denture sore mouth)
c) Oesophageal, non‐invasive bronchopulmonary infections, candiduria, mucocutaneous candidiasis
d) Prevention of relapse of oropharyngeal candidiasis in patients with AIDS, after a full course of primary therapy

iv) Genital candidiasis.
a) Vaginal candidiasis (acute or recurrent)
b) Prophylaxis of recurrent vaginal candidiasis (three or more episodes a year)
c) Candidal balanitis.

v) Prevention of fungal infections in patients with malignancy who are predisposed to such infections as a result of cytotoxic chemotherapy or radiotherapy.

vi) Dermatomycosis
a) Tinea pedis, tinea corporis, tinea cruris and dermal Candida infections
b) Tinea versicolor		 None i) a) 400mg on Day1 followed by 200mg to 400mg once daily usually at least 6 to 8 weeks for cryptococcal meningitis.
CHILD ≥4 weeks-11 years:
Treatment:6-12mg/kgoncedaily.
b) 200 mg once daily indefinitely.
CHILD:- Maintenance: 6mg/kg once daily

ii) 400 mg on Day 1 followed by 200 mg once daily
CHILD ≥ 4weeks-11years: 6-12mg/kg once daily.

iii) a) 50mg to 100mg once daily for 7 to 14 days
CHILD:- Loading dose: 6mg/kg on Day 1 followed by 3mg/kg daily.
b) 50 mg once daily for 14 days concurrently with local antiseptic measures to the denture
c) 50 mg to 100 mg once daily for 14 to 30 days.
CHILD:-
0-14days: Initially, 6mg/kg, followed by 3mg/kg every 72 hours.
Max: 12 mg/kg 72 hourly.
15-27 days: Initially, 6mg/kg, followed by 3 mg/kg every 48 hours.
Max: 12 mg/kg 48 hourly.
28 days-11 years: Initially, 6 mg/kg, followed by 3 mg/kg once daily.
d)150 mg once weekly.

iv) a) 150 mg as a single oral dose.
b) 150 mg once-monthly dose may be used for usually4 to 12 months
c) 150 mg as a single oral dose.

v) 50 mg to 400 mg once daily

vi) a) 150 mg once weekly or 50 mg once daily for normally 2 to 6 weeks
b)300mg once weekly for 2weeks; a third weekly dose of 300-400mg.
An alternate dosing regimen is 50mg once daily for 2 to 4 weeks.

Dosing is individualised and according to product insert/protocol.
652 Flucytosine 2.5 g/250 ml Injection J02AX01-000-P99-01-XXX A* Treatment of systemic fungal infection None ADULT: 100 - 200 mg/kg daily in 4 divided doses by IV infusion over 20 - 40 minutes not more than 7 days
653 Flucytosine 500 mg Tablet J02AX01-000-T10-01-XXX A* Only for the treatment of fungal meningitis None ADULT: 50 - 150 mg/kg/day in 4 divided doses
654 Fludarabine Phosphate 50 mg Injection L01BB05162P4001XX A* Treatment of B cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves.

First line treatment with fludarabine should only be initiated in patients with advanced disease, Rai stages III/IV (binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease related symptoms or evidence of progressive disease.		 None 25 mg/m2 daily for 5 consecutive days every 28 days. May be administered up to the achievement of a maximal response (usually 6 cycles) and then the drug should be discontinued. Reduce dose by up to 50% in patients with mild to moderate renal impairment (30-70ml/min)
655 Fludrocortisone Acetate 0.1 mg Tablet H02AA02122T1001XX A As an adjunct to glucocorticoids in the management of primary adrenocortical insufficiency in Addison's disease and treatment of salt-losing adrenogenital syndrome Adrenocorticoid insufficiency (chronic): ADULT 1 tablet daily.
Salt-losing adrenogenital syndrome: ADULT 1 - 2 tablets daily. CHILD and INFANT 0.5 - 1 tablet daily
Dosing is individualised and according to product insert / protocol.
656 Flumazenil 0.1mg/ml Injection V03AB25-000-P30-01-XX B i) Diagnosis and/or management of benzodiazepine overdose due to self-poisoning or accidental overdose ii) Reversal of sedation following anaesthesia with benzodiazepine None i) Initial, 0.2 mg IV over 30 seconds; if desired level of consciousness not obtained after an additional 30 seconds, give dose of 0.3 mg IV over 30 seconds; further doses of 0.5 mg IV over 30 seconds may be given at 1-minutes intervals if needed to maximum total dose of 3 mg; patients with only partial response to 3 mg may require additional slow titration to a total dose of 5 mg; if no response 5 minutes after receiving total dose of 5 mg, overdose is unlikely to be benzodiazepine and further treatment with flumazenil will not help ii) 0.2 mg IV over 15 seconds; if desired level of consciousness is not obtained after waiting 45 seconds, a second dose of 0.2 mg IV may be given and repeated at 60-seconds intervals as needed (up to a maximum of 4 additional times) to a maximum total dose of 1 mg; most patients respond to doses of 0.6 to 1 mg; in the event of resedation, repeated doses may be given at 20-minutes intervals if needed; for repeat treatment, no more than 1 mg (given as 0.5 mg/minute) should be given at any one time and no more than 3 mg should be given in any one hour
657 Flunarizine HCl 5 mg Capsule N07CA03-110-C10-01-XXX B i) Migraine prophylaxis
ii) Maintenance treatment of vestibular disturbances and of cerebral and peripheral disorders		 - i) ADULT: 5 - 10 mg daily preferably at night.
ELDERLY more than 65 years: 5 mg at night.
Maintenance 5-day treatment at the same daily dose

ii) 5 - 10 mg at night. If no improvement after 1 month, discontinue treatment
658 Fluorescein 1mg Ophthalmic Strip S01JA01-520-M99-01-XXX B Used in diagnostic examinations None Moisten tip with tear fluid from lower fornix, sterile water or ophthalmic solution and gently stroke across the conjunctiva
659 Fluorescein Sodium 10% Injection S01JA01-520-P30-01-XXX A Diagnostic fluorescein angiography or angioscopy of the fundus and of the iris vasculature None ADULT: Inject 5 mL of Fluorescein 10% solution for injection rapidly into the antecubital vein after taking precautions to avoid extravasation.

Dosing is individualised and according to product insert/protocol
660 Fluorometholone 0.1% Ophthalmic Suspension S01BA07-000-D20-01-XXX A* Treatment of steroid responsive ocular inflammation None 1-2 drops 2 to 4 times daily. During the initial 24-48 hr, dose may be increased to 2 drops 2 hourly.

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