Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Dosage
121 Atomoxetine HCl 60mg Capsule N06BA09110C1005XX 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 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
122 Atorvastatin 20 mg Tablet C10AA05000T1002XX A/KK Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy 10 mg once daily. Maximum: 80 mg daily
123 Atorvastatin 40 mg Tablet C10AA05000T1001XX A/KK Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy 10 mg once daily. Maximum: 80 mg daily
124 Atorvastatin 80 mg Tablet C10AA05000T1004XX A/KK Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy 10 mg once daily. Maximum: 80 mg daily
125 Atosiban 7.5 mg/ml Injection G02CX01122P3001XX 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. Initial intravenous bolus dose of 6.75mg (using 7.5mg/ml solution for injection). Immediately followed by a continuous high dose infusion (loading infusion 300 mcg/min using 7.5mg/ml concentrate for solution for infusion) during three hours, followed by lower infusion of 100mcg/min up to 45 hours. Duration of treatment should not exceed 48 hours. Total dose given during a full course should not exceed 330mg of the active substance.
126 Atracurium Besylate 10 mg /ml in 2.5 ml Injection M03AC04197P3001XX A* Muscle relaxant in general anaesthesia, Endotracheal intubation, Aid controlled ventilation. 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.
127 Atracurium Besylate 10 mg /ml in 5 ml Injection M03AC04197P3002XX A* Muscle relaxant in general anaesthesia, Endotracheal intubation, Aid controlled ventilation. 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.
128 Atropine Sulphate 0.3%, Cocaine HCl 1.7%, Adrenaline Acid Tartrate 0.03% Mydriatic Injection S01F000183P3001XX A Subconjunctival injection to dilate pupils resistant to topical mydriatics 1 - 2 drops
129 Atropine Sulphate 1% Eye Drops S01FA01183D2001XX B Determination of refraction, strabismus, iritis and iridocyclitis, after extra or intracapsular extraction of lens PREOPERATIVE MYDRIASIS : one drop of a 1% solution supplemented with one drop of 2.5 or 10% phenylephrine prior to surgery. ANTERIOR UVEITIS or POSTOPERATIVE MYDRIASIS : one drop of a 1% or 2% solution up to 3 times a day
130 Atropine Sulphate 1mg/ml Injection A03BA01183P3001XX 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 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.
131 Azacitidine Powder for suspension for injection 100mg/vial L01BC07000P4001XX 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)
132 Azathioprine 50 mg Tablet L04AX01000T1001XX 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.
133 Azelaic Acid 20% Cream D10AX03000G1001XX A* Acne vulgaris Apply twice daily (sensitive skin, once daily for 1st week). Treatment should not exceed 6 months
134 Azithromycin 200 mg/5 ml Granules J01FA10011F1001XX A* Treatment of complicated respiratory tract infections not responding to standard macrolides 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
135 Azithromycin 250 mg Tablet J01FA10011T1001XX A* Category of prescriber A/KK is only approved for indication (i): (i) Adult treatment of uncomplicated genital infections due to Chlamydia trichomatis or susceptible Neisseria gonorrhoea. The following indication is still under category of prescriber A*: (ii) Treatment of complicated respiratory tract infection not responding to standard macrolides; (iii) Prophylaxis against Mycobacterium avium complex in patients with advanced HIV. i) 1 g as a single dose; ii) 500 mg daily for 3 days; iii) 1 g weekly
136 Azithromycin 500 mg Injection J01FA10011P4001XX A* Only for treatment of severe atypical pneumonia 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
137 Bacampicillin 400 mg Tablet J01CA06000T1001XX B Infections caused by ampicillin-sensitive gram positive& gram negative microorganisms ADULT: 400 mg twice daily. Severe infection: 800 mg twice daily. CHILD more than 25 kg: 12.5 - 25 mg/kg 12 hourly
138 Baclofen 10 mg Tablet M03BX01000T1001XX B Spasticity of the skeletal muscle ADULT: 5 mg 3 times daily. Max: 80 mg daily. CHILD: 0.75 - 2 mg/kg daily (more than 10 years, maximum: 2.5 mg/kg daily)
139 Balanced Salt Solution B05CB10907L5001XX A For irrigation during ocular surgery Irrigate as directed
140 Balanced Salt Solution PLUS (fortified with sodium bicarbonate, glucose & glutathione) B05CB10905L5001XX A For irrigation during intraocular surgery especially in patients with poor cornea endothelium and poorly controlled diabetes Irrigate as directed
141 Barium Sulphate Suspension V08BA01183L8001XX B For x-ray examination of the alimentary tract: i) Oesophagus ii) Stomach and duodenum iii) Colon i) Up to 150 ml of a 50% - 200% suspension orally ii) Up to 300 ml of a 30% - 200% suspension orally iii) Up to 2 litre of a 30% - 200% suspension orally
142 Basiliximab 20 mg Injection L04AC02000P3001XX A* Prophylaxis of acute organ rejection in de novo renal transplantation. ADULT & CHILD 2 years and above & 35 kg or more:20 mg /dose. 2 years or more but less than 35kg:10 mg/dose. First dose given within 2 hours before start of transplantation and second dose 4th day after transplant
143 BCG 81 mg/3 ml L03AX03000P3001XX A* Superficial bladder cancer 81 mg intravesically once weekly for 6 weeks, followed by treatments at 3, 6, 12, 18, and 24 months after initial treatment
144 BCG Vaccine Freeze-Dried Injection J07AN01000P4001XX C+ For the prevention of tuberculosis 0.1 ml by intradermal injection. INFANT under 12 months: 0.05 ml
145 Beclomethasone Dipropionate 100 mcg/dose Inhaler R03BA01133A2101XX B Prophylaxis of asthma especially if not fully controlled by bronchodilators Adults: The usual maintenance dose is one to two inhalations (200-400 mcg) twice daily.If needed,the dose can be increased up to 1600 mcg/day divided in two to four doses : Children 6-12 years old: One inhalation (200 mcg) two times daily and dose may be increased up to 800 mcg/day in divided two to four doses if necessary.
146 Beclomethasone dipropionate 100mcg and formoterol fumarate dihydrate 6mcg pressurized inhalation solution R03AK07986A2101XX A/KK i) Regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2 agonist) is appropriate in: a) Patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2 agonist, or b) Patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists. The following indication (COPD) is categorised as A* - To be initiated by Consultant/ Specialists from disciplines related to the listed indication only: ii) Symptomatic treatment of patients with severe COPD (FEV1 < 50% predicted normal) and a history of repeated exacerbation, who have significant symptoms despite regular therapy with long-acting bronchodilators. For asthma, the dosage is based on treatment approach: i) Maintenance therapy (taken as regular maintenance treatment with a separate as needed rapid-acting bronchodilator): Dose recommendations for adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations. ii) Maintenance and reliever therapy (taken as regular maintenance treatment and as needed in response to asthma symptoms): Dose recommendations for adults 18 years and above: The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. The maximum daily dose is 8 inhalations. For COPD: 2 puffs two times a day.
147 Beclomethasone Dipropionate 200 mcg/dose Inhaler R03BA01133A2102XX A/KK Prophylaxis of asthma especially if not fully controlled by bronchodilators ADULT : 1 - 2 puff twice daily. May increase to 2 puff 2 - 4 times daily CHILD : 1 puff twice daily. May increase to 1 puff 2 - 4 times daily
148 Bendamustine Hydrochloride 100mg/vial powder for concentrate for solution for infusion L01AA09110P3302XX A* Bendamustine is indicated for monotherapy in patients with indolent B-cell non-Hodgkin?s lymphomas (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Monotherapy for iNHL refractory to rituximab: 120mg/m2 body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks.
149 Bendamustine Hydrochloride 25mg/vial powder for concentrate for solution for infusion L01AA09110P3301XX A* Bendamustine is indicated for monotherapy in patients with indolent B-cell non-Hodgkin?s lymphomas (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Monotherapy for iNHL refractory to rituximab: 120mg/m2 body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks.
150 Benzalkonium 0.01% - 0.02% Cream D08AJ01000G1001XX B Prevention and treatment of nappy rash Wash and dry baby's bottom. Apply by spreading the cream evenly paying particular attention to the fold of the skin, after every nappy change

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