Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
841 Itraconazole 10 mg/ml Oral Solution J02AC02-000-L99-01-XXX A* Treatment of: i) oral and/or oesophageal candidiasis ii) fluconazole resistant and/or oesophageal candidiasis None i) 200 mg daily for 1 week. If no response after 1 week, continue treatment for another week ii) 100 - 200 mg twice daily for 2 weeks. If no response after 2 weeks, continue treatment for another 2 weeks. The 400 mg daily dose should not be used for more than 14 days if there are no signs of improvement
842 Itraconazole 100 mg Capsule J02AC02-000-C10-01-CXX A/KK i) Dermatomycosis including pityriasis versicolor ii) Oral candidiasis iii) Palmar tinea manus and plantar tinea pedis iv) Fingernail onychomycosis v) Toenail onychomycosis vi) Vulvovaginal candidiasis None i) 200 mg once daily for 7 days ii) 100 mg daily for 15 days iii) 200 mg twice daily for 7 days iv) 200mg twice daily for 1 week per month for 2 months v) 200 mg twice daily for 1 week per month for 3 months vi)200 mg morning and evening for 1 day or 200 mg once daily for 3 days
843 Ivabradine 5mg Tablet C01EB17-110-T10-01-XX A* i) Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:
- in adults unable to tolerate or with a contraindication to the use of beta-blockers
- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
ii) Treatment of chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
None Initial dose 5 mg twice daily. May increase dose after 3-4 weeks to 7.5 mg twice daily depending on response. ELDERLY, initial dose 2.5 mg twice daily and titrate to a maximum of 7.5 mg twice daily
844 Ivabradine 7.5mg Tablet C01EB17-110-T10-02-XX A* i) Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm and heart rate ≥ 70 bpm. Ivabradine is indicated:
- in adults unable to tolerate or with a contraindication to the use of beta-blockers
- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose.
ii) Treatment of chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
None Initial dose 5 mg twice daily. May increase dose after 3-4 weeks to 7.5 mg twice daily depending on response. ELDERLY, initial dose 2.5 mg twice daily and titrate to a maximum of 7.5 mg twice daily
845 Ixekizumab 80mg Solution for Injection L04AC13-000-P50-01-XXX A* 1. Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy with involvement of special sites (face, joint, scalp, nail, genital, and palmoplantar psoriasis)
2. Alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies.
1. Severe plaque psoriasis:
i. As third-line therapy (after failed/intolerant/contraindicated to standard systemic drugs and/or phototherapy).
ii. To be prescribed by Dermatologist only

2. Active psoriatic arthritis: To be prescribed by Rheumatologist only
1. Severe plaque psoriasis: 160 mg by subcutaneous injection at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg every 4 weeks.

2. Active psoriatic arthritis: The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at week 0, followed by 80 mg (one injection) every 4 weeks thereafter. For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis (160mg at week 0, 80mg at week 2,4,6,8,10,12, and 80mg every 4 weeks thereafter).
846 Japanese Encephalitis (JE) (Live Attenuated) 4.0 - 5.8 log PFU Vaccine in 0.5ml vial injection J07BA02-000-P40-01-XXX C+ Prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over. Children in Sarawak at 9 and 21 months under the National Immunisastion Programme (NIP) 0.5 mL single injection of the reconstituted vaccine.
847 Kanamycin 1g Injection J01GB04-183-P40-01-XXX A* i) Treatment of gonorrhoea and neonatal meningitis.
ii) Treatment of TB patients who require reserved second line drugs but have no pre-existing renal complications.
None i) ADULT: 1 - 2 g daily IM in 1 - 2 equally divided doses. CHILD: 30 - 50 mg/kg/day in 1 - 2 divided doses;

ii) ADULT: 2 g daily IM in 2 equally divided doses twice a week or 1 g once daily 3 days a week
848 Ketamine 10 mg/ml Injection N01AX03-110-P30-01-XXX B Sole anaesthetic for short procedures or induction of anaesthesia in certain types of patients (e.g in shock states) - IV Initially, 1-4.5 mg/kg IV, a dose of 2 mg/kg produces anesth for 5-10 mins. IM Initially, 6.5-13 mg/kg IM, a dose of 10 mg/kg produces anesth for 12-25 mins.
849 Ketamine 50 mg/ml Injection N01AX03-110-P30-02-XXX B Sole anaesthetic for short procedures or induction of anaesthesia in certain types of patients (e.g in shock states) - IV Initially, 1-4.5 mg/kg IV, a dose of 2 mg/kg produces anesthesia for 5-10 mins. IM Initially, 6.5-13 mg/kg IM, a dose of 10 mg/kg produces anesthesia for 12-25 mins.
850 Ketoconazole 2% Shampoo D01AC08-000-L52-01-XXX A/KK Dandruff, seborrhoeic dermatitis and pityriasis versicolor. None Seborrhoeic dermatitis & dandruff: Apply twice weekly for 2 to 4 weeks.
Pityriasis versicolor: Apply once daily for up to 5 days.
Prophylaxis: Once every 1 or 2 weeks. Both left for 3-5minutes before rinsing.
851 Ketoconazole 200 mg Tablet J02AB02000T1001XX A/KK i) Pityriasis versicolor ii) Systemic mycosis (other skin mycoses) iii) Nail infections i) 200 mg with meal once daily for 10 days ii) 200 - 400 mg daily for 4 weeks - 6 months iii) 200 - 400 mg daily for 6 - 12 months.
852 Ketoprofen 2.5% Gel M02AA10-000-G30-01-XXX A/KK Local treatment of osteoarticular & muscular painful disorders of rheumatic or traumatic origin: Contusions, distortions, muscle strains, stiff neck, lumbago. - Apply onto affected areas 2-4 times daily up to 10 days.
853 Ketoprofen 30mg Transdermal Plaster M02AA10000M7001XX A Treatment of signs & symptoms of arthritis deformans, periarthritis humero-scapularis, tendinitis, peritendinitis, sore muscle, swelling, pain resulting from trauma (eg. contusion, distorsion, sprain). Apply 1 plaster to the affected area twice daily
854 Ketoprofen 50mg/ml Injection M01AE03000P3001XX A* To be used only in treatment of acute inflammatory conditions By deep IM into gluteal muscle, 50-100 mg every 4 hours. Maximum 200 mg in 24 hours for up to 3 days. Child not recommended
855 Ketorolac Tromethamine 30mg/ml Injection M01AB15239P3001XX A* Short term management of moderate to severe postoperative pain ADULT : 60mg as a single dose via IM inj or 30mg as a single IV dose. Alternatively, 30mg every 6 hr via IM or IV admin up to a max of 120mg daily.
856 L-Asparaginase 10,000 IU Injection L01XX02000P3001XX A* i) Acute lymphoblastic leukemia
ii) Non-hodgkin's lymphoma
i) 5,000 iu/m2 for 10 days during induction, 10,000 iu/m2 also used with high dose methotrexate rescue in consolidation phase of acute lymphoblastic leukemia
ii) CHILD: 5,000 - 25,000 iu/m2 per dose depending on protocol
857 Labetalol HCl 100mg Tablet C07AG01-110-T10-01-XX B i) Mild, moderate or severe hypertension
ii) Hypertension in pregnancy
None i) & ii)
Initial: 100mg twice daily
Maintenance: 200-400mg twice daily
Max. 2400mg daily in 3 or 4 divided doses

Dosing is individualised and according to product insert / protocol.
858 Labetalol HCl 5mg/ml Injection C07AG01-110-P30-01-XX B Hypertension crisis None ADULT: 20mg injected slowly for at least 2 min, followed by 40-80mg dose every 10 min, if necessary upto 300 mg. Patient should remain supine during and 3 hr after the procedure.
859 Lactobacillus Acidophilus 100million viable cells & Estriol 0.03mg vaginal tablet G03CC06-953-T10-01-XXX A/KK i)Atrophic vaginitis due to estrogen deficiency during menopause and post-menopause, or as co-medication to systemic hormone replacement therapy
ii)Restoration of the Lactobacillus flora after local and/or systemic treatment with anti-infective agents or chemotherapeutic agents
None Atrophic vaginitis : 1 vaginal tablet daily for 6-12 days followed by a maintenance dose of 1 vaginal tablet for 1-2 days per week Restoration therapy: 1-2 vaginal tablet daily for 6-12 days Administration The vaginal tablets should be inserted deeply into the vagina in the evenings before bedtime. ?In cases of a very dry vagina, vaginal tablet can be moistened with 1 or 2 drops of water before insertion into the vagina. ?During menstruation, treatment should be interrupted and resumed afterwards Should not use vaginal douches or rinses during treatment
860 Lactulose 3.35g/5 ml Liquid A06AD11-000-L50-01-XXX C+ i) Constipation
ii) Hepatic encephalopathy
None i) ADULT 15-45 ml daily in 1-2 divided doses adjusted to patient's need. Maintenance dose: 15-30ml daily in 1-2 divided doses.
CHILD 0.5 ml/kg/dose once or twice daily.

ii) ADULT: 30-45 ml 2-4 times daily, dose adjusted to produce 2-3 soft stools daily.
CHILD: 1 ml/kg/dose 3-4 times daily.
861 Lamivudine 100mg Tablet J05AF05-000-T10-01-XXX A* Management of chronic hepatitis B infection associated with evidence of hepatitis B viral replication and active liver inflammation None Adult:†100 mg once daily. For patients with concomitant†HIV†infection: 300 mg once daily or in 2 divided doses.†Child: >2 yr: 3 mg/kg once daily. Max: 100 mg/day.
862 Lamivudine 10mg/ml Oral Solution J05AF05-000-L99-01-XXX A* HIV infection in combination with other antiretroviral agents None ADULT: 150 mg twice daily or 300 mg once daily. INFANT under 1 month: 2 mg/kg twice daily. CHILD 3 month or over: 4 mg/kg twice daily. Maximum 300 mg daily
863 Lamivudine 150mg Tablet J05AF05-000-T10-02-XXX A/KK HIV infection in combination with other antiretroviral agents None ADULT: 150 mg twice daily or 300 mg once daily. INFANT under 1 month: 2 mg/kg twice daily. CHILD 3 month or over: 4 mg/kg twice daily. Maximum 300 mg daily
864 Lamotrigine 100mg Tablet N03AX09-000-T10-02-XX A i) Adjunctive or monotherapy for partial seizures and generalised tonic-clonic seizures not satisfactorily controlled with other antiepileptic drugs ii) Prevention of mood episodes in adult 18 years and above with bipolar disorder, predominately by preventing depressive episodes None i) Up to 200 mg daily in single or divided dosage ii) 25- 200 mg daily
865 Lamotrigine 25mg Dispersible/Chewable Tablet N03AX09-000-T20-01-XX A Add-on therapy in intractable partial seizures None 25 mg daily - 50 mg twice daily
866 Lamotrigine 50mg Tablet N03AX09-000-T10-01-XX A i) Adjunctive or monotherapy for partial seizures and generalised tonic-clonic seizures not satisfactorily controlled with other antiepileptic drugs ii) Prevention of mood episodes in adult 18 years and above with bipolar disorder, predominately by preventing depressive episodes None i) Up to 200 mg daily in single or divided dosage ii) 25- 200 mg daily
867 Lamotrigine 5mg Dispersible/Chewable Tablet N03AX09-000-T20-02-XX A Management of seizures in children aged 2 - 12 years None a) Add-on therapy in patients not taking Valproate: week 1 and 2: 2 mg/kg/day twice daily, week 3 and 4: 5 mg/kg/day twice daily. Maintenance: 5 - 15 mg/kg/day twice daily b) Add-on therapy in patients taking Valproate or other anti-epileptic drugs, week 1 and 2: 0.2 mg/kg/day as a single dose (children less than 25 kg may take 5 mg on alternate days), week 3 and 4: 0.5 mg/kg/day as a single dose. Maintenance dose: 1 -5 mg/kg/day once daily or twice daily
868 Lanreotide acetate 120mg prolonged-release solution for injection H01CB03-122-P30-04-XXX A* i) Treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumours (GEPNETs) of midgut, pancreatic or unknown origin where hindgut sites of origin have been excluded, in adult patients with unresectable locally advanced or metastatic disease

ii) Treatment of the clinical symptoms of neuroendocrine (particularly carcinoid) tumours
None i) 120 mg administered every 28 days
ii) 60 mg to 120 mg administered every 28 days
869 Lanreotide acetate 60mg prolonged-release solution for injection H01CB03-122-P30-02-XXX A* Treatment of the clinical symptoms of neuroendocrine (particularly carcinoid) tumours None 60 mg to 120 mg administered every 28 days
870 Lanreotide acetate 90mg prolonged-release solution for injection H01CB03-122-P30-03-XXX A* Treatment of the clinical symptoms of neuroendocrine (particularly carcinoid) tumours None 60 mg to 120 mg administered every 28 days

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