Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
661 Fluorouracil 50 mg/ml Injection L01BC02000P4001XX A* Solid tumours. Ophtalmological indication: trabeculectomy Intravenous Infusion: 15 mg/kg bodyweight (to a maximum of 1 g daily) diluted in 300-500mL of 5% glucose given over a period of 4 hours. 12 mg/kg bodyweight daily for 3 consecutive days. Providing there are no signs of toxic effects, the patient may then be given 6mg/kg I.V. on the 5th, 7th and 9th days. If after the 9th day there is still no sign of toxicity, the patient may be placed on maintenance therapy. Maintenance Therapy: 5 - 10mg/kg bodyweight by I.V. injection once a week.
662 Fluoxetine HCl 20 mg Capsule N06AB03-110-C10-01-XXX A/KK i) Depression
ii) Obsessive-compulsive disorder		 None i) 20 mg once daily increased after 3 weeks if necessary, usual dose 20 - 60 mg
(ELDERLY 20 - 40 mg) once daily max 80 mg once daily (ELDERLY max 60 mg once daily).

ii) Initially 20 mg once daily increased after 2 weeks if necessary, usual dose 20 - 60 mg (ELDERLY 20 - 40 mg) once daily, max 80 mg (ELDERLY max 60 mg) once daily, discontinue if no improvement within 10 weeks.
CHILD and ADOLESCENT under 18 years are not recommended
663 Flupenthixol Decanoate 20mg/ml lnjection N05AF01135P2001XX B Chronic psychoses By deep IM, initial test dose of 5-20 mg, then after at least 7 days. 20 - 40 mg repeated at intervals of 2 - 4 weeks. Maximum 400 mg weekly. Usual maintenance dose 50 mg every 4 weeks to 300 mg every 2 weeks. ELDERLY, initially quarter to half adult dose. CHILD not recommended. Deep IM recommended. Not for IV use
664 Fluphenazine Decanoate 25mg/ml Injection N05AB02135P3001XX B Long term management of psychotic disorders By deep IM : Test dose 12.5 mg (6.25 mg in ELDERLY), then after 4-7 days 12.5 mg-100 mg repeated at intervals of 14-35 days, adjusted according to response. CHILD not recommended
665 Flutamide 250mg Tablet L02BB01000T1001XX A* Androgen deprivation therapy in advanced prostate cancer in combination with luteinising hormone-releasing hormone (LHRH) analogue therapy or surgical castration. 250 mg 3 times daily
666 Fluticasone Furoate 27.5mcg/dose Nasal Spray R01AD08-139-A41-01-XXX A* Treatment of nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) and ocular symptoms (itching/burning, tearing/watering, and redness of the eye) of seasonal and perennial allergic rhinitis. None Adults/Adolescents (≥12 years) : 1-2 sprays (27.5 mcg/spray) in each nostril once daily.
Children (2-11 years) : 1-2 sprays (27.5 mcg/spray) in each nostril once daily
667 Fluticasone Propionate 125mcg and Formoterol Fumarate Dihydrate 5mcg per actuation pressurized inhalation, suspension R03AK11-989-A21-01-XXX A/KK Indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
- For patients not adequately controlled with inhaled corticosteroids and "as required" inhaled short-acting β2 agonist.
- For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.		 None Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
668 Fluticasone Propionate 125mcg/dose Inhaler R03BA05-133-A21-01-XXX B Prophylactic treatment for asthma None ADULT and CHILD more than 16 years
i) Mild asthma : 100 mcg - 250 mcg twice daily
ii) Moderate asthma : 250 - 500 mcg twice daily
iii) Severe asthma : 500 mcg - 1000 mcg twice daily.
Alternatively, the starting dose of fluticasone dipropionate may be gauged at half the total daily dose of beclomethasone dipropionate or equivalent administered by inhalation.
669 Fluticasone Propionate 250mcg and Formoterol Fumarate Dihydrate 10mcg per actuation pressurized inhalation, suspension R03AK11-989-A21-02-XXX A/KK Indicated in the regular treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long-acting β2 agonist) is appropriate:
i) For patients not adequately controlled with inhaled corticosteroids and 'as required' inhaled short-acting β2 agonist.
ii) For patients already adequately controlled on both an inhaled corticosteroid and a long-acting β2 agonist.		 None Two inhalations (puffs) twice daily normally taken in the morning and in the evening.
670 Fluvoxamine 100mg Tablet N06AB08-253-T10-02-XXX B i) Depression
ii) Obsessive Compulsive Disorder (OCD)		 i) Initial: 50 – 100 mg per day in the evening
Increase gradually if necessary up to a maximum of 300mg per day Dose over 150mg per day given in 2 – 3 divided doses
Recommended dose to prevent recurrence: 100mg per day

ii) ADULT
Initial: 50mg per day for 3 – 4 days
Increase gradually if necessary up to a maximum of 300mg per day Dose over 150mg per day given in 2 – 3 divided doses

CHILD (8 years on and adolescents)
Initial: 25mg per day, preferably at bedtime
Increase in 25mg increments every 4 – 7 days if necessary up to a maximum of 200mg per day
Dose over 50mg per day given in 2 divided doses

Dosing is individualised and according to product insert/ protocol.
Should not be used in patients under 18 years old except for the treatment of OCD. If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for appearance of suicidal symptoms.
671 Fluvoxamine 50mg Tablet N06AB08-253-T10-01-XXX B i) Depression
ii) Obsessive Compulsive Disorder (OCD)		 i) Initial: 50 – 100 mg per day in the evening
Increase gradually if necessary up to a maximum of 300mg per day Dose over 150mg per day given in 2 – 3 divided doses
Recommended dose to prevent recurrence: 100mg per day

ii) ADULT
Initial: 50mg per day for 3 – 4 days
Increase gradually if necessary up to a maximum of 300mg per day Dose over 150mg per day given in 2 – 3 divided doses

CHILD (8 years on and adolescents)
Initial: 25mg per day, preferably at bedtime
Increase in 25mg increments every 4 – 7 days if necessary up to a maximum of 200mg per day
Dose over 50mg per day given in 2 divided doses

Dosing is individualised and according to product insert/ protocol.
Should not be used in patients under 18 years old except for the treatment of OCD. If, based on clinical need, a decision to treat is nevertheless taken; the patient should be carefully monitored for appearance of suicidal symptoms.
672 Folic Acid 5 mg Tablet B03BB01000T1001XX C+ i) For the prevention and treatment of folate deficiency states
ii) For the prevention of neural tube defect in the foetus		 i) ADULT initially 10-20mg mg daily for 14 days or until haematopoietic response obtained. Daily maintenance: 2.5 mg-10mg .CHILD up to 1 year:250 mcg/kg daily; 1 to 5 years:2.5mg/day;6-12 years: 5mg/day ii) 5 mg daily starting before pregnancy and continued through the first trimester
673 Follitropin Alpha (Recombinant Human FSH) 300IU/0.5ml Injection G03GA05-000-P30-02-XXX A* For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).		 None i) 75 - 150 IU daily, should commence within the first 7 days of the menstrual cycle and increased by 37.5 IU or 75 IU at 7 or 14 days interval. Max daily dose 225 IU
ii) 150 - 225 IU daily commencing on days 2 or 3 of the cycle. Max daily dose 450 IU.

Dosing is individualised and according to product insert/protocol.
674 Follitropin Alpha (Recombinant Human FSH) 75IU Injection G03GA05-000-P30-01-XXX A* For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).		 None i) 75 - 150 IU daily, should commence within the first 7 days of the menstrual cycle and increased by 37.5 IU or 75 IU at 7 or 14 days interval. Max daily dose 225 IU
ii) 150 - 225 IU daily commencing on days 2 or 3 of the cycle. Max daily dose 450 IU.

Dosing is individualised and according to product insert/protocol
675 Follitropin Beta (Recombinant Human FSH) 300IU Injection G03GA06-000-P30-02-XXX A* In females:
For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).

In males:
iii.Deficient spermatogenesis due to hypogonadotrophic hypogonadism.		 None i. Recommended starting dose: 50 IU daily, maintaining the starting dose for at least 7 days.
ii. Recommended starting dose: 100-225IU daily, maintaining the starting dose for at least the first 4 days.
iii. 450 IU per week preferrably divided into 3 doses i.e. 150 IU three times a week (concomitantly with hCG).

Dosing is individualised and according to product insert/protocol
676 Follitropin Beta (Recombinant Human FSH) 50IU Injection G03GA06-000-P30-01-XXX A* In females:
For the treatment of infertility in the following clinical situations:
i. Anovulation, including polycystic ovarian syndrome (PCOS), in women who have been unresponsive to treatment with clomiphene citrate.
ii. Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART).

In males:
iii.Deficient spermatogenesis due to hypogonadotrophic hypogonadism.		 None i. Recommended starting dose: 50 IU daily, maintaining the starting dose for at least 7 days.
ii. Recommended starting dose: 100-225IU daily, maintaining the starting dose for at least the first 4 days.
iii. 450 IU per week preferrably divided into 3 doses i.e. 150 IU three times a week (concomitantly with hCG).

Dosing is individualised and according to product insert/protocol.
677 Fondaparinux Sodium 12.5mg/ml Injection in Prefilled Syringe B01AX05520P5002XX A* i) Treatment of acute Deep Vein Thrombosis (DVT)
ii) Treatment of acute Pulmonary Embolism (PE)		 The recommended dose to be administered by SC injection once daily is: 5mg for body weight less than 50kg, 7.5mg for body weight 50 to 100kg, 10mg for body weight greater than 100kg. Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (INR 2 to 3). Concomitant treatment with vitamin K antagonists should be initiated as soon as possible, usually within 72 hours. The usual duration of treatment is 5 to 9 days
678 Fondaparinux Sodium 2.5 mg/0.5 ml Injection B01AX05520P5001XX A*, A Prescribing Category A*:
i) Prevention of venous thromboembolic events (VTE) in orthopedic surgery (e.g. hip fracture, major knee or hip replacement surgery), abdominal surgery in patients at risk of thromboembolic complication.

Precribing Category A:
i) Treatment of unstable angina or non-ST segment elevation myocardial infarction [UA/NSTEMI] in patients for whom urgent invasive management (PCI) is not indicated.
ii) Treatment of ST segment elevation myocardial infarction (STEMI) in patients managed with thrombolytics or are not receiving other forms of reperfusion therapy		 None Prescribing Category A*:
i) 2.5 mg once daily given by SC, administered 6 hr following surgical closure provided homeostasis has been established. Usual duration of therapy is 5 to 9 days; for hip fracture patients, an extended course of up to 24 days is recommended.

Precribing Category A:
i) ADULT more than 18 years: 2.5 mg once daily given by SC, initiated as soon as possible after diagnosis and continued for up to 8 days or until hospital discharge. If patient needs to undergo PCI, unfractionated heparin to be admin as per local practice protocol, taking into account the patient's bleeding risk and time of last dose of fondaparinux. Fondaparinux may be restarted no earlier than 2 hr after sheath removal.
ii) ADULT more than 18 years: 2.5 mg once daily; first dose to be given IV (directly through an existing IV line or as infusion in 25 or 50 ml of 0.9% saline over 1-2 min), subsequent doses to be given SC. Treatment to be initiated as soon as diagnosis is made and continued up to a max of 8 days or until hospital discharge, whichever comes earlier. If patient needs to undergo non-primary PCI, unfractionated heparin to be admin as per local practice protocol, taking into account the patient's bleeding risk and time of last dose of fondaparinux. Fondaparinux may be restarted no earlier than 3 hr after sheath removal
679 Fosfomycin trometamol 3g granules J01XX01-239-F10-01-XXX A* i. Treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in females of 18 years of age and older caused by multidrug resistant (MDR) Escherichia coli or Enterococcus faecalis who are candidates for carbapenems or colistin.
ii. Perioperative antibiotic prophylaxis for transrectal prostate biopsy in adult man.		 Indikasi ii:
1. As second-line therapy
2. Only for culture proven multidrug-resistant organism susceptible to Fosfomycin
 Indikasi i:
Acute uncomplicated lower UTI:
- 1 sachet as single dose.

Recurrent or other clinically problematic cystitis
- Up to 2 doses every 24 hr.

On empty stomach at bedtime.

Indikasi ii:
1 sachet of fosfomycin 3g approx. 3 hours before, and 24 hours after the procedure.
680 Frusemide 10mg/ml Injection C03CA01-000-P30-01-XXX B Oedema None Initial: 20-50mg once via slow IV or IM
Maintenance: Increase by 20mg every 2 hours and titrate to an effective dose if necessary.

CHILD: 0.5 - 1.5 mg/kg 6-24hourly.

Dosing is individualised and according to product insert / protocol.
681 Frusemide 10mg/ml oral solution C03CA01-000-L90-01-XXX B Oedema None ADULT:
Initial: 20-80mg daily.
Max. 600mg/day.

CHILD:
1-3mg/kg daily.
Max. 40mg/day.

Dosing is individualised and according to product insert / protocol.
682 Frusemide 40mg Tablet C03CA01000-T10-01-XXX B Oedema None ADULT:
Initial: 20-80mg daily
Max. 600mg/day

CHILD:
1-3mg/kg daily
Max. 40mg/day

Dosing is individualised and according to product insert / protocol.
683 Fuller's Earth Powder V03AB00000F2101XX C Adsorbent in pesticide poisoning Adult: 100-150g every 2-4 hours. Child: 1-2g/kg. (100g of Fuller's Earth is mixed with 200ml water. Repeat until Fuller's Earth is seen in stool (normally between 4-6 hours)
684 Fusidic Acid 1% Eye Drops S01AA13-000-D20-01-XXX A Bacterial eye infections caused by susceptible organisms None 1 drop in conjunctival sac 12 hourly. To be continued for 2 days after the eye appears normal. On the first day of treatment, may be applied more frequently : 1 drop 4 hourly. Surgical prophylaxis : 1 drop every 12 hours, 24 - 48 hours before operation
685 Fusidic Acid 2% Cream D06AX01-000-G10-01-XXX B Treatment of impetigo, infected wounds, folliculitis, boils, sycosis barbae, carbuncles, hidradenitis, paronychia and erythrasma where skin infections caused by Staphylococci, Streptococci, Propionibacterium acnes, Corynebacterium minutissimum, and other organisms sensitive to fusidic acid. None Apply to affected area 2 - 3 times daily for a duration of 7 days. Do not use for more than 2 weeks.
686 Fusidic Acid 2% in Betamethasone Valerate 0.1% Cream D07CC01-948-G10-01-XXX A/KK Inflammatory dermatosis where bacterial infection is likely to occur eg atopic eczema, discoid eczema, stasis eczema, seborrhoic dermatitis, contact dermatitis, lichen simplex chronicus, psoriasis, discoid lupus erythematosus None Uncovered lesion- Apply 2 to 3 times daily. Covered lesions- Less frequent applications may be adequate
687 Fusidic Acid 500mg Injection J01XC01520P4001XX A* Treatment of severe staphylococcal infections especially Methicillin Resistant Staphylococcus aureus (MRSA). To be used in combination therapy only ADULT : 500 mg 3 times daily diluted to 250 - 500 ml infused slowly over 2 hours. Maximum : 2 g daily. CHILD and INFANT : 20 mg/kg/day divided into 3 equal doses infused slowly over 2 - 4 hours
688 Gabapentin 100 mg Tablet N03AX12-000-T10-02-XXX A* i) Add-on therapy for intractable partial epilepsy, refractory to standard anti-epileptic drugs
ii) Treatment of various types of neuropathic pain, both peripheral (which includes diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in adult more than 18 years		 None ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may be initiated by administering 300mg TDS on day 1, or by titrating the dose as: 300mg once on day 1, 300mg BD on day 2, 300mg TDS on day 3. Thereafter, then dose may be increased in 3 equally divided doses up to max 3600mg/day.CHILD 3-12 yr: Initially 10-15 mg/kg/day in 3 divided dose. Effective dose: CHILD 3 to less than 5 yrs: 40mg/kg/day in 3 divided doses, CHILD 5-12 yrs: 25-35mg/kg/day in 3 divided doses ii) ADULT: 900mg/day in 3 equally divided doses. Max 3600mg/day
689 Gabapentin 100mg Capsule N03AX12-000-C10-03-xxx A* i) Add-on therapy for intractable partial epilepsy, refractory to standard anti-epileptic drugs
ii) Treatment of various types of neuropathic pain, both peripheral (which includes diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in adult more than 18 years		 None ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may be initiated by administering 300mg TDS on day 1, or by titrating the dose as: 300mg once on day 1, 300mg BD on day 2, 300mg TDS on day 3. Thereafter, then dose may be increased in 3 equally divided doses up to max 3600mg/day.CHILD 3-12 yr: Initially 10-15 mg/kg/day in 3 divided dose. Effective dose: CHILD 3 to less than 5 yrs: 40mg/kg/day in 3 divided doses, CHILD 5-12 yrs: 25-35mg/kg/day in 3 divided doses ii) ADULT: 900mg/day in 3 equally divided doses. Max 3600mg/day
690 Gabapentin 300 mg Capsule N03AX12-000-C10-01-XX A*, A/KK PRESCRIBER CATEGORY A*: Add-on therapy for intractable partial epilepsy, refractory to standard anti-epileptic drugs.

PRESCRIBER CATEGORY A/KK: Treatment of various types of neuropathic pain, both peripheral (which includes diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in adult more than 18 years.		 None ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may be initiated by administered 300mg TDS on day 1, or by titrating the dose as: 300mg once on day 1, 300mg BD on day 2, 300mg TDS on day 3. Thereafter, may be increased in 3 equally divided doses up to max 3600mg/day.CHILD 3-12 yr: Initially 10-15 mg/kg/day in 3 divided dose. Effective dose: CHILD 3 to less than 5 yrs: 40mg/kg/day in 3 divided doses, CHILD 5-12 yrs: 25-35mg/kg/day in 3 divided doses ii) ADULT: 900mg/day in 3 equally divided doses. Max 3600mg/day

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