Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
121 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.
122 Asciminib 20mg Film Coated Tablet L01EA06-110-T32-01-xxx A* Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors. i. As a third line treatment for adult Ph+ CML-CP patients with pre-existing CV risks and/or CV events.
ii. To be prescribed by Haematologist only.
40 mg twice daily at approximately 12‐hour intervals.
123 Asciminib 40mg Film Coated Tablet L01EA06-110-T32-02-xxx A* Asciminib is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors. i. As a third line treatment for adult Ph+ CML-CP patients with pre-existing CV risks and/or CV events.
ii. To be prescribed by Haematologist only.
40 mg twice daily at approximately 12‐hour intervals.
124 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.
125 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.
126 Asenapine 10mg Sublingual Tablet N05AH05-253-T70-02-XXX A* For second or third line treatment in adult for:
i) Schizophrenia
ii) Bipolar Disorder - Monotherapy: Acute treatment of manic or mixed episodes associated with Bipolar I disorder. - Adjunctive therapy: As adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder.		 None i) Schizophrenia: - Acute treatment in adults: Recommended starting and target dose of asenapine is 5mg given twice daily. - Maintenance dose: 5mg twice daily.

ii) Bipolar Disorder: - Monotherapy: 10mg twice daily. Adjunctive therapy: 5mg twice daily with lithium or valproate. Dose can be increased to 10mg twice daily based on clinical response.
127 Asenapine 5mg Sublingual Tablet N05AH05-253-T70-01-XXX A* For second or third line treatment in adult for:
i) Schizophrenia
ii) Bipolar Disorder - Monotherapy: Acute treatment of manic or mixed episodes associated with Bipolar I disorder. - Adjunctive therapy: As adjunctive therapy with either lithium or valproate for the acute treatment of manic or mixed episodes associated with Bipolar I Disorder.		 None i) Schizophrenia: - Acute treatment in adults: Recommended starting and target dose of asenapine is 5mg given twice daily. - Maintenance dose: 5mg twice daily.
ii) Bipolar Disorder: - Monotherapy: 10mg twice daily. Adjunctive therapy: 5mg twice daily with lithium or valproate. Dose can be increased to 10mg twice daily based on clinical response.
128 Atazanavir 300mg and Ritonavir 100mg Film Coated Tablet J05AR23-964-T32-01-xxx A* Treatment of HIV-1 infected, antiretroviral treatment experienced adults, in combination with other antiretroviral medicinal products. For Infectious Disease Physicians use, in patients with treatment failure on NNRTI regimen. One tablet (Atazanavir 300mg and Ritonavir 100mg) taken orally once daily with food.
129 Atazanavir 300mg capsule J05AE08-183-C11-01-XXX A* Treatment of HIV-1 infected, antiretroviral treatment experienced adults, in combination with other antiretroviral medicinal products. For Infectious Disease Consultant use, in patients with treatment failure on NNRTI regime. The recommended dose is 300mg once daily taken with ritonavir 100mg once daily and with food. Ritonavir is used as a booster of atazanavir pharmacokinetics. If atazanavir with ritonavir is co- administrated with didanosine, it is recommended that didanosine be taken 2 hours after atazanavir with ritonavir taken with food.
130 Atenolol 100 mg Tablet C07AB03-000-T10-02-XXX B i) Hypertension
ii) Arrhythmias
iii) Angina pectoris
iii) Myocardial infarction		 None i), ii) & iii) 50 - 100 mg daily
iv) Dosing is individualised and according to product insert / protocol.
131 Atenolol 50 mg Tablet C07AB03-000-T10-01-XXX B i) Hypertension
ii) Arrhythmias
iii) Angina pectoris
iii) Myocardial infarction		 None i), ii) & iii) 50 - 100 mg daily
iv) Dosing is individualised and according to product insert / protocol.
132 Atezolizumab 60mg/ml Concentrate for Solution for Infusion L01XC32-000-P33-01-xxx A* Atezolizumab, in combination with Bevacizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy Only for patients with Child-Pugh A The recommended dose of atezolizumab in combination therapy is 1200 mg administered every 3 weeks, all doses administered as IV infusion.
133 Atomoxetine HCl 10mg Capsule N06BA09-110-C10-01-XXX A* Attention deficit hyperactivity disorder (ADHD) in children 6 years and older who do not respond to methylphenidate or who have intolerable effects or have tics. Diagnosis should be made according to DSM IV criteria or the guidelines in ICD-10 None CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 mg/kg/day for at least 7 days, then increased according to response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70 kg: Initially 40 mg/day for at least 7 days then increased according to response. Maintenance: 80 mg/day. Max 100 mg/ day
134 Atomoxetine HCl 18mg Capsule N06BA09-110-C10-02-XXX A* Attention deficit hyperactivity disorder (ADHD) in children 6 years and older who do not respond to methylphenidate or who have intolerable effects or have tics. Diagnosis should be made according to DSM IV criteria or the guidelines in ICD-10 None CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 mg/kg/day for at least 7 days, then increased according to response. Maintenance: 1.2 mg/kg/day. ADULTS and ADOLESCENTS more than 70 kg: Initially 40 mg/day for at least 7 days then increased according to response. Maintenance: 80 mg/day. Max 100 mg/ day
135 Atomoxetine HCl 25mg Capsule N06BA09-110-C10-03-XXX A* Attention deficit hyperactivity disorder (ADHD) in children 6 years and older who do not respond to methylphenidate or who have intolerable effects or have tics. Diagnosis should be made according to DSM IV criteria or the guidelines in ICD-10 None CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 mg/kg/day for at least 7 days, then increased according to response. Maintenance: 1.2 mg/kg/day. ADULTS and ADOLESCENTS more than 70 kg: Initially 40 mg/day for at least 7 days then increased according to response. Maintenance: 80 mg/day. Max 100 mg/ day
136 Atomoxetine HCl 40mg Capsule N06BA09-110-C10-04-XXX A* Attention deficit hyperactivity disorder (ADHD) in children 6 years and older who do not respond to methylphenidate or who have intolerable effects or have tics. Diagnosis should be made according to DSM IV criteria or the guidelines in ICD-10 None CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 mg/kg/day for at least 7 days, then increased according to response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70 kg: Initially 40 mg/day for at least 7 days then increased according to response. Maintenance: 80 mg/day. Max 100 mg/ day
137 Atomoxetine HCl 60mg Capsule N06BA09-110-C10-05-XXX A* Attention deficit hyperactivity disorder (ADHD) in children 6 years and older who do not respond to methylphenidate or who have intolerable effects or have tics. Diagnosis should be made according to DSM IV criteria or the guidelines in ICD-10 None CHILD and ADOLESCENTS up to 70 kg: Initially 0.5 mg/kg/day for at least 7 days, then increased according to response. Maintenance: 1.2 mg/kg/day.
ADULTS and ADOLESCENTS more than 70 kg: Initially 40 mg/day for at least 7 days then increased according to response. Maintenance: 80 mg/day. Max 100 mg/ day
138 Atorvastatin 20 mg Tablet C10AA05-000-T10-02-XXX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 None i) & ii)
10 mg once daily.
Maximum: 80 mg daily
139 Atorvastatin 40 mg Tablet C10AA05-000-T10-01-XXX B i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 None i) & ii)
10 mg once daily.
Maximum: 80 mg daily
140 Atorvastatin 80 mg Tablet C10AA05-000-T10-04-XXX A/KK i) Hypercholesterolaemia
ii) Prevention of cardiovascular disease		 None i) & ii)
10 mg once daily.
Maximum: 80 mg daily
141 Atosiban 7.5mg/ml Injection G02CX01-122-P30-01-XXX A* To delay imminent preterm birth in pregnant women with:
i)Regular uterine contractions of at least 30 seconds duration at a rate of ≥ 4 per 30 minutes
ii) A cervical dilation of 1 to 3 cm (0 - 3 nulliparas) and effacement of ≥ 50%
iii) Age ≥ 18 years
iv) A gestational age from 28 until 33 completed weeks
v) A normal foetal heart rate.		 None Initial intravenous bolus dose of 6.75mg (as 7.5 mg/ml solution)
Immediately followed by a continuous loading intravenous infusion at 18mg/hr for 3 hours and then followed by intravenous infusion at 6mg/hr up to 45 hours.

The total duration of treatment should not exceed 48 hours and the total dose per treatment course should not exceed 330mg of the active substance.

The dosing is individualized according to product insert / protocol.
142 Atracurium Besylate 10 mg/ml in 2.5 ml Injection M03AC04-197-P30-01-XXX A* Muscle relaxant in general anaesthesia, Endotracheal intubation, Aid controlled ventilation. - Adult & children >2 mth 0.3-0.6 mg/kg IV.
Endotracheal intubation dose: 0.5-0.6 mg/kg.
Supplementary dose: 0.1-0.2 mg/kg as required.
Continuous infusion rates of 0.3-0.6 mg/kg/hr to maintain neuromuscular block during long surgical procedure.
143 Atracurium Besylate 10mg/ml in 5ml Injection M03AC04-197-P30-02-XXX A* Muscle relaxant in general anaesthesia, Endotracheal intubation, Aid controlled ventilation. None Adult & childn >2 mth 0.3-0.6 mg/kg IV. Endotracheal intubation dose: 0.5-0.6 mg/kg. Supplementary dose: 0.1-0.2 mg/kg as required. Continuous infusion rates of 0.3-0.6 mg/kg/hr to maintain neuromuscular block during long surgical procedure.
144 Atropine Sulphate 0.3%, Cocaine HCl 1.7%, Adrenaline Acid Tartrate (Epinephrine) 0.03% Mydriatic Injection S01F000-183-P30-01-XXX A Subconjunctival injection to dilate pupils resistant to topical mydriatics None 1 - 2 drops
145 Atropine Sulphate 1% Eye Drops S01FA01-183-D20-01-XXX B Determination of refraction, strabismus, iritis and iridocyclitis, after extra or intracapsular extraction of lens None Use in adults
- For uveitis: 1 drop in the eye(s), 3 times daily.
- For refraction: 1 drop in the eye(s), repeated 1 hour before the examination
146 Atropine Sulphate 1mg/ml Injection A03BA01-183-P30-01-XXX B i) Reduce vagal inhibition,salivary and bronchiol secretion in anaesthesia
ii) Reversal of excessive bradycardia
iii) Reversal of effect of competitive muscle relaxants
iv) Overdosage with other compounds having muscarinic action
v) Organophosphate poisoning		 None i) Adult: 300-600 mcg IM/SC 30-60 minutes before anaesthesia. Alternatively, 300-600 mcg IV immediately before induction of anaesthesia. Child: >20 kg: 300-600 mcg; 12-16 kg: 300 mcg; 7-9 kg: 200 mcg; >3 kg: 100 mcg. Doses to be given via IM/SC admin 30-60 minutes before anaesthesia.
ii) Adult: 500 mcg every 3-5 minutes. Total: 3 mg. Max Dosage: 0.04 mg/kg body weight.
iii) Adult 0.6-1.2 mg before or with anticholinesterase
iv) Adult: 0.6-1 mg IV/IM/SC, repeated every 2 hr.
v) Adult: 2 mg IV/IM, every 10-30 minutes until muscarinic effects disappear or atropine toxicity appears. In severe cases, dose can be given as often as every 5 minutes. In moderate to severe poisoning, a state of atropinisation is maintained for at least 2 days and continued for as long as symptoms are present. Child: 20 mcg/kg given every 5-10 minutes.
147 Azacitidine Powder for suspension for injection 100mg/vial L01BC07-000-P40-01-XXX A* First line therapy for intermediate-2 and high risk MDS, CMMOL with 10-29% blasts with no transplant option and elderly AML with 20-30% blasts and multilineage dysplasia. - Recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75mg/m2 of body surface area. Injected subcutaneously.
Daily for 7 days, followed by a rest period of 21 days (28 day treatment cycle).
148 Azathioprine 50 mg Tablet L04AX01-000-T10-01-XXX A i) Prophylaxis of rejection in organ and tissue transplant
ii) Auto-immune diseases
iii) Rheumatoid arthritis		 - i) Adult: 1-5 mg/kg/day. Adjust dose according to clinical response and haematological tolerance. Dose may also be given via IV administration.
ii) Adult: 1-3 mg/kg/day. Discontinue treatment if there is no improvement after 12 week.
iii) Adult: Initially, 1 mg/kg/day given in 1-2 divided doses for 6-8 week, may increase by 0.5 mg/kg every 4 week until response or up to 2.5 mg/kg/day. Maintenance: Reduce dose gradually to achieve the lowest effective dose.
149 Azelaic Acid 20% Cream D10AX03-000-G10-01-XXX A* Acne vulgaris - Apply twice daily (sensitive skin, once daily for 1st week). Treatment should not exceed 6 months
150 Azelastine Hydrochloride 137mcg & Fluticasone Propionate 50mcg Nasal Spray R01AD58-984-A41-01-XXX A* Symptomatic treatment of moderate to severe allergic rhinitis and rhino-conjunctivitis in adults and children 12 years and older where use of a combination (intranasal antihistamine and glucocorticoid) is appropriate As a second line treatment: only for those whose symptoms remain uncontrolled on oral antihistamine or intranasal corticosteroids (INS) monotherapy, or on a combination of oral antihistamine plus INS One actuation in each nostril twice daily

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