Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
91 Ampicillin Trihydrate 125 mg/5 ml Suspension J01CA01-012-F21-01-XXX B Treatment of susceptible bacterial infections (non beta-lactamase-producing organisms) None CHILD: 50 - 100 mg/kg/day 4 times daily. Under 1 year: 62.5 - 125 mg 4 times daily, 1 - 10 years: 125 - 250 mg 4 times daily
92 Anastrozole 1 mg Tablet L02BG03-000-T10-01-XXX A* Hormonal therapy in breast cancer in post-menopausal women if failed /contraindicated with Tamoxifen - 1 mg daily
93 Anidulafungin 100mg Injection J02AX06-000-P30-01-XXX A* Treatment of invasive candidiasis, including candidemia in adults when intolerance or resistance to Amphotericin B or Fluconazole None Loading dose of 200 mg on day 1, then 100 mg once daily thereafter for at least 14 days after the last positive culture.
94 Anifrolumab 300mg/2ml Concentrate for Solution for Infusion L04AA51-000-P33-01-xxx A* Indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy. i) Use is restricted to patients without lupus nephritis or central nervous system (CNS) lupus
ii) To be prescribed by Rheumatologists only
 The recommended dose is 300 mg, administered as an intravenous infusion over a 30-minute period, every 4 weeks.
In patients with a history of infusion-related reactions, premedication (e.g., an antihistamine) may be administered before the infusion of anifrolumab.
95 Anti Rhd Immunoglobulin Injection J06BB01-000-P30-01-XXX B Prevention of Rh(D) sensitisation to Rh(D)-negative woman:
i) Pregnancy/delivery of Rh(D)-positive infant
ii) Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole
iii) Transplacental haemorrhage resulting from antepartum haemorrhage, amniocentesis, chorionic biopsy or obstetric manipulative procedures e.g. external version or abdominal trauma		 - i) Antenatal prophylaxis: According to general recommendations, currently administered doses range from 50 – 330 micrograms or 250 - 1650 IU. For specific details, please refer to product's package insert.
ii) Postnatal prophylaxis: According to general recommendations, currently administered doses range from 100 – 300 micrograms or 500 – 1500 IU. For specific details, please refer to product's package insert.
96 Antilymphocyte/Antithymocyte Immunoglobulin (from Horse) Injection L04AA03-000-P30-01-XXX A* i) To be used when conventional anti-rejection therapy is not successful
ii) Treatment of aplastic anaemia not responding to oxymethalone after 3 months, in which there is persistent pancytopenia with repeated attacks of septicaemia and bleeding.
iii) Severe aplastic anaemia with the following parameters:
a) Granulocyte less than 0.5x109/L
b) Platelet less than 20x109/L
c) Reticulocyte less than 20x109/L
iv) As a conditioning regime prior to transplant.
v) Graft-versus-host disease treatment		 - 10 - 30 mg/kg body weight daily. Slow IV infusion (over at least 4 hours) diluted in 250 - 500 ml Normal Saline. For Graft versus host disease treatment:40 mg/kg/day
97 Antirabies Immunoglobulin Injection J06BB05-000-P30-01-XXX B Treatment of rabies, post-exposure None Human rabies immunoglobulin: 20 iu/kg; half by IM and half by infiltration around the wound.
Equine rabies immunoglobulin: 40iu/kg of body weigth in adults and children.

Note: Please refer to package insert for recommendations by the manufacturer.
98 Antithymocyte Immunoglobulin (from rabbit) Injection L04AA04-000-P30-01-XXX A* i)Prophylaxis of acute graft rejection
ii)Treatment of acute graft rejection
iii)Prophylaxis of acute and chronic graft versus host disease
iv)Treatment of steroid-resistant, acute graft versus host disease
v)Treatment of aplastic anemia		 - i)1.0 - 1.5 mg/kg/day for 2 - 9 days after transplantation of a kidney, pancreas or liver, for 2 - 5 days after heart transplantation ii)1.5 mg/kg/day for 3 - 14 days iii)2.5 - 5.0 mg/kg/day for 4 days iv)2.5 - 5.0 mg/kg/day for 5 days v)2.5 - 3.5 mg/kg/day for 5 days
99 Antivenene Cobra Injection J06AA03-000-P30-02-XXX B Treatment of patients who exhibit manifestations of systemic envenoming following a bite by Cobra (Naja kaouthia). - Initial dose of 100ml of reconstituted antivenene given by slow intravenous infusion (2ml/min). Subsequent dose can be given every 12 hours according to the clinical symptoms. As product may differ from batches and manufacturer, it is strongly recommended to refer to the product insert on dosing recommendation.
100 Antivenene Pit Viper Injection J06AA03-000-P30-01-XXX B Treatment of patients who exhibit manifestations of systemic envenoming following a bite by Malayan Pit Viper (Calloselasma rhodostoma). - Initial dose of 30ml of reconstituted antivenene given by slow intravenous infusion (2ml/min). Subsequent dose can be given every 6 hours according to the clinical symptoms. As product may differ from batches and manufacturer, it is strongly recommended to refer to the product insert on dosing recommendation.
101 Antivenene Serum (Sea snake) 1000 units Injection J06AA03-000-P30-03-XXX B Treatment of patients who exhibit manifestations of systemic envenoming following a bite by sea snake. - 1000 units by IV infusion over 1/2 to 1 hour. In severe cases 3000 -10000 units may be required
102 Apixaban 2.5mg film coated tablet. B01AF02-000-T32-01-XXX A* Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). None 5 mg taken orally twice daily. Dose reduction: 2.5mg taken orally twice daily in NVAF patients with at least two of the following characteristics: age ≥80 years old, body weight≤60kg, or serum creatinine≥1.5mg/dL (133micromole/L).
103 Apixaban 5mg film coated tablet. B01AF02-000-T32-02-XXX A* Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). None 5 mg taken orally twice daily. Dose reduction: 2.5mg taken orally twice daily in NVAF patients with at least two of the following characteristics: age ≥80 years old, body weight≤60kg, or serum creatinine≥1.5mg/dL (133micromole/L).
104 Aprepitant 125 mg Capsule A04AD12-000-C10-02-XXX A* In combination with other antiemetic agents for prevention of delayed nausea and vomiting associated with initial and repeat course of highly emetogenic chemotherapy - 125 mg 1 hour prior to chemotherapy on Day 1. To be given as part of a 3-day regimen that includes a corticosteroid and a 5-HT3 antagonist
105 Aprepitant 80 mg Capsule A04AD12-000-C10-01-XXX A* In combination with other antiemetic agents for prevention of delayed nausea and vomitting associated with initial and repeat course of highly emetogenic chemotherapy - 80 mg once daily in the morning on Days 2 and Day 3. To be given as part of a 3-day regimen that includes a corticosteroid & a 5-HT3 antagonist
106 Aqueous Cream D02AX00-000-G10-01-XXX C+ As an emollient for dry skin. Can be used as soap substitute for bathing. None As a soap or apply to the skin as an emollient cream
107 Aripiprazole 10mg Tablet N05AX12-000-T10-01-XXX A* i) Treatment of acute episodes of schizophrenia and for maintenance of clinical improvement during continuation therapy.
ii) Treatment of acute manic episodes associated with bipolar I disorder		 None Schizophrenia: 10 or 15 mg/day. Maintenance dose: 15 mg/day. Bipolar mania: Starting dose: 15 or 30 mg/day. Dose adjustment should occur at intervals of not less than 24 hour
108 Aripiprazole 15mg Tablet N05AX12-000-T10-02-XXX A* i) Treatment of acute episodes of schizophrenia and for maintenance of clinical improvement during continuation therapy.
ii) Treatment of acute manic episodes associated with bipolar I disorder		 None Schizophrenia: 10 or 15 mg/day. Maintenance dose: 15 mg/day. Bipolar mania: Starting dose: 15 or 30 mg/day. Dose adjustment should occur at intervals of not less than 24 hour
109 Aripiprazole 400 mg powder and solvent for prolonged-release suspension for injection N05AX12-010-P20-01-XXX A* Maintenance treatment of schizophrenia in adult patients stabilized with oral aripiprazole As second-line therapy among patients with poor or uncertain adherence to oral antipsychotics. Recommended starting and maintenance dose is 400 mg to be administered once monthly as a single injection (no sooner than 26 days after the previous injection).

After the first injection, treatment with 10 mg to 20 mg oral aripiprazole should be continued for 14 consecutive days to maintain therapeutic aripiprazole concentrations during initiation of therapy.
110 Arsenic Trioxide 1 mg/ml Injection L01XX27-550-P30-01-XXX A* Relapsed acute promyelocytic leukaemia (APML). To be prescribed by consultant haematologist only. Induction : 0.15 mg/kg/day IV until bone marrow remission. Total induction dose ≤ 60 doses.
Consolidation : 0.15 mg/kg/day IV for 25 doses in 5 weeks (5 days per week, followed by 2 days interruption; treatment should begin 3-6 weeks after completion of induction therapy).
111 Artemether 20mg & Lumefantrine 120mg Tablet P01BE52-981-T10-01-XXX B Acute uncomplicated falciparum malaria None ADULT and CHILD over 12 years weighing over 35 kg : 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after 8 hours and then 4 tablets twice daily (morning and evening) on each of the following two days (total course comprises 24 tablets).

INFANT and CHILD weighing 5 kg to less than 35 kg : A 6 dose regimen with 1 to 3 tablets per dose, depending on bodyweight
112 Artesunate 100mg and Mefloquine HCI 220mg Tablet P01BF02-000-T10-02-XXX A Treatment of acute uncomplicated Plasmodium falciparummalaria, resulting either from P. falciparum mono-infection or mixed infection with P. vivax. None Weight 5-8kg, Age 6-11 months, Dose: One tablet 25/55mg OD x 3 days Weight : 9-17kg, Age 1-6 years, Dose : Two tablet 25/55mg OD x 3 days Weight :18-29kg, Age 7-12 years, Dose :One tablet 100/220mg OD x 3 days Weight ≥30kg, Age ≥13 years, Dose:Two tablet 100/220mg OD x 3 days
113 Artesunate 25mg and Mefloquine HCI 55mg Tablet P01BF02-000-T10-01-XXX A Treatment of acute uncomplicated Plasmodium falciparummalaria, resulting either from P. falciparum mono-infection or mixed infection with P. vivax. None Weight 5-8kg, Age 6-11 months, Dose: One tablet 25/55mg OD x 3 days Weight : 9-17kg, Age 1-6 years, Dose : Two tablet 25/55mg OD x 3 days Weight :18-29kg, Age 7-12 years, Dose :One tablet 100/220mg OD x 3 days Weight ≥30kg, Age ≥13 years, Dose:Two tablet 100/220mg OD x 3 days
114 Artesunate 60mg Injection P01BE03-000-P30-01-XXX B Treatment of severe malaria in adults and children. None 2.4mg of artesunate/kg body weight, by intravenous (IV) or intramuscular (IM) injection, at 0, 12 and 24 hours, then once daily until oral treatment can be substituted. For adults and children with severe malaria or who are unable to tolerate oral medicines, artesunate 2.4 mg/kg body weight IV or IM given on admission (time = 0), then at 12 hrs and 24 hrs, then once a day for 5-7 days is the recommended treatment.
115 Artificial tears/eye lubricant ophthalmic gel S01KA02-000-G32-XX-XXX B Symptomatic relief of severe dry eye conditions and as lens lubricant during ophthalmic diagnostic procedures None Instill 1-2 drops in affected eye(s) as needed. Refer to product information leaflet.
116 Artificial tears/eye lubricant ophthalmic ointment S01XA20-900-G51-XX-XXX A Moisturizes the ocular surface and provides soothing relief from symptoms associated with dry, irritated eyes. None Apply a small amount into the eye. Refer product information leaflet.
117 Artificial tears/eye lubricant ophthalmic solution S01XA20-000-D20-XX-XXX B Tear deficiency, ophthalmic lubricant; for relief of dry eyes and eye irritation None 1 - 2 drops several times a day. Refer to product information leaflet.
118 Ascorbic Acid 100mg Tablet A11GA01-000-T10-02-XXX C+ Vitamin C deficiency None ADULT: 100-250 mg once or twice daily CHILD: 100 mg three times daily for one week followed by 100mg daily until symptoms abate.
119 Ascorbic Acid 500mg Tablet A11GA01-000-T10-03-XXX C+ Vitamin C deficiency None ADULT: 100-250 mg once or twice daily

CHILD: 100 mg three times daily for one week followed by 100mg daily until symptoms abate.
120 Ascorbic Acid 500mg/2ml Injection A11GA01-000-P30-01-XXX B For prevention and treatment of scurvy None Therapeutic: Not less than 250 mg daily in divided doses

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