Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
121 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.
122 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.
123 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.
124 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.
125 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.
126 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.
127 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
128 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
129 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
130 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
131 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
132 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
133 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
134 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
135 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.
136 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.
137 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.
138 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
139 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
140 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.
141 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).
142 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.
143 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
144 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
145 Azithromycin 200 mg/5 ml Granules J01FA10-011-F10-01-XXX A*, A/KK PRESCRIBER CATEGORY A*: Treatment of complicated respiratory tract infections.

PRESCRIBER CATEGORY A/KK: Treatment of pertussis
None CHILD 36 - 45 kg: 400 mg, 26 - 35 kg: 300mg, 15 - 25 kg 200 mg, less than 15 kg: 10 mg/kg. To be taken daily for 3 days or to be taken as a single dose on day 1, then half the daily dose on days 2 - 5
146 Azithromycin 250 mg Tablet J01FA10-011-T10-01-XX A*, A/KK PRESCRIBER CATEGORY A*:
(i) Treatment of complicated respiratory tract infections;
(ii) Prophylaxis against Mycobacterium avium complex in patients with advanced HIV

PRESCRIBER CATEGORY A/KK:
(iii) Adult treatment of uncomplicated genital infections due to Chlamydia trichomatis or susceptible Neisseria gonorrhoea.
(iv) Treatment of pertussis
None i) 500 mg daily for 3 days;
ii) 1 g weekly
iii) 1 g as a single dose;
iv) 500mg in a single dose on day 1 then 250mg per day on days 2-5
147 Azithromycin 500 mg Injection J01FA10-011-P40-01-XXX A* i) Severe atypical pneumonia

ii) Treatment of pelvic inflammatory diseases (PID) caused by susceptible organisms in patients who require initial IV therapy
None i) 500 mg IV as a single daily dose for a minimum of two days followed by 500 mg oral dose as a single daily dose to complete a 7 - 10 days course

ii) 500 mg as a single dose by the IV route for 1 or 2 days followed by oral azithromycin at a single daily dose of 250 mg to complete a 7-day course of therapy.
148 Bacampicillin 400mg Tablet J01CA06-000-T10-01-XXX B Infections caused by ampicillin-sensitive gram positive& gram negative microorganisms None ADULT: 400 mg twice daily. Severe infection: 800 mg twice daily. CHILD more than 25 kg: 12.5 - 25 mg/kg 12 hourly
149 Baclofen 10mg Tablet M03BX01-000-T10-01-XXX B Spasticity of the skeletal muscle None ADULT:5 mg 3 times daily.
Max: 80 mg daily (20mg 4 times a day).

CHILD: starting dose: 0.3mg/kg/day in divided dose, titrate up cautiously in 1 -2 weeks interval.
Usual maintenance dose: 0.75 - 2 mg/kg daily (age more than 10 years, maximum: 2.5 mg/kg daily). The dose should not exceed 40 mg/day in children below 8 years of age, but a maximum dose of 60 mg/day may be given in children over 8 years of age.

Dosing is individualised and according to product insert/protocol
150 Balanced Salt Solution B05CB10-907-L50-01-XXX A For irrigation during ocular surgery None Irrigate as directed

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