Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
931 Linezolid 2mg/ml Injection J01XX08-000-P30-01-XXX A* MRSA patient with severe sepsis requiring intensive care and not clinically responding to vancomycin None ADULT: 600 mg twice daily for 10 - 14 days. CHILD: 10 mg/kg 3 times daily. PREMATURE NEONATES less than 7 days: 10 mg/kg twice daily
932 Linezolid 600mg Tablet J01XX08-000-T10-01-XXX A* MRSA patient with severe sepsis requiring intensive care and not clinically responding to vancomycin. None ADULT: Above 12 years 600 mg every 12 hours for 10-14 days. CHILD :10 mg/kg 3 times daily. PREMATURE NEONATES less than 7 days: 10 mg/kg twice daily
933 Liquid Paraffin A06AA01-000-L50-01-XX C Constipation None ADULT: 10-30 ml daily at night.
CHILD: not recommended.
934 Lithium Carbonate 300mg Tablet N05AN01121T1001XX A i) Prophylaxis and treatment of acute mania and hypomania episodes ii)Prophylaxis of manic depression in bipolar illness or bipolar depression and recurrent depression Dose depends on the preparation used. Doses should be adjusted to produce a serum-lithium concentration of 0.4-1 mmol/l.
935 Loperamide 2mg Capsule A07DA03-110-C10-01-XX B i. Adjunct to rehydration in:
a. acute diarrhea in adult; and
b. chronic diarrhea in adult

ii. In patients with an ileostomy, it can be used to reduce the number and volume of stools and to harden their consistency		 None 6 – 8 mg per day up to max. of 16mg per day

Dosing is individualised and according to product insert / protocol
936 Lopinavir 100mg and Ritonavir 25mg Tablet J05AE06-964-T10-02-XXX A Second line treatment for HAART regimen in combination with other anti-retroviral agents None Adult:
- Therapy-naive patients: 400/100 mg bd or 800/200 mg once daily;
- Therapy-experienced patients: 400/100 mg bd.
- Concomitant therapy (efavirenz, nevirapine, amprenavir, fosamprenavir or nelfinavir) 400/100 mg bd.

Children >40 kg or w/ BSA >1.4 m2 as adult dose.
937 Lopinavir 200 mg and Ritonavir 50 mg Tablet J05AE06-964-T10-01-XXX A Second line treatment for HAART regimen in combination with other anti-retroviral agents None Adult:
- Therapy-naive patients: 400/100 mg bd or 800/200 mg once daily;
- Therapy-experienced patients: 400/100 mg bd.
- Concomitant therapy (efavirenz, nevirapine, amprenavir, fosamprenavir or nelfinavir) 400/100 mg bd.

Children >40 kg or w/ BSA >1.4 m2 as adult dose.
938 Lopinavir 80mg & Ritonavir 20mg (per ml) Oral Solution J05AE06-964-L99-01-XXX A Management of patients with asymptomatic and symptomatic (early or advanced) HIV Infection with CD4 cell counts <50 cubic mm None Tab Adult Therapy-naive patients 400/100 mg bd or 800/200 mg once daily. Therapy-experienced patients 400/100 mg bd. Concomitant therapy (efavirenz, nevirapine, amprenavir, fosamprenavir or nelfinavir) 400/100 mg bd. Can be used w/ no dose adjustment. Childn >40 kg or w/ BSA >1.4 m2 Adult dose. Oral Soln Childn 6 mth-12 yr, 15-40 kg 10/2.5 mg/kg bd; 7 to <15 kg 12/3 mg/kg bd. Max: 5 mL bd in childn >40 kg. W/ efavirenz or nevirapine 15-45 kg 11/2.75 mg/kg bd; 7 to <15 kg 13/3.25 mg/kg.
939 Loratadine 10mg Tablet R06AX13-000-T10-01-XXX B Allergic rhinitis and allergic dermatoses None ADULT and CHILD over 6 years 10 mg once daily.
CHILD 2 - 6 years: 5 mg once daily
940 Loratadine 1mg/ml Syrup R06AX13-000-L90-01-XXX B Allergic rhinitis, chronic urticaria and other allergic dermatological disorders None ADULT and CHILD over 6 years : 10 mg once daily. CHILD 2 - 6 years: 5 mg once daily
941 Loratadine 5mg and Pseudoephedrine Sulphate 120mg Tablet R01BA52-988-T10-01-XXX A/KK For treatment of allergic rhinitis and allergic dermatoses None ADULT and CHILD over 12 years 1 tablet twice daily
942 Lorazepam 1mg Tablet N05BA06-000-T10-01-XXX A/KK i) Severe anxiety
ii) Insomnia		 None i) 1 - 4 mg increase to 10 mg daily in divided doses. ELDERLY (or delibitated) half adult dose
ii) 1 - 2 mg at bedtime Not recommended in children
943 Lorlatinib 100mg Film-Coated Tablet L01ED05-000-T32-02-XXX A* As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). To be prescribed by Oncologist only 100 mg taken orally once daily. Continue treatment as long as the patient is deriving clinical benefit from therapy
944 Lorlatinib 25mg Film-Coated Tablet L01ED05-000-T32-01-XXX A* As monotherapy for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). To be prescribed by Oncologist only 100 mg taken orally once daily. Continue treatment as long as the patient is deriving clinical benefit from therapy
945 Losartan 100 mg Tablet C09CA01-500-T10-02-XXX B Patients intolerant to ACE inhibitors in:
i) Hypertensive patient with left ventricular hypertrophy
ii) Type 2 Diabetes Mellitus with chronic kidney disease
iii) Hypertension		 - i), ii) & iii)
Initial: 50mg once daily Max: 100mg once daily

Dosing is individualised and according to product insert / protocol.
946 Losartan 100mg & Hydrochlorothiazide 25mg Tablet C09DA01-935-T10-04-XXX A* i) Hypertension in patients intolerant to ACE inhibitors
ii) Hypertensive patient with left ventricular hypertrophy		 None i) & ii)
Initial: Losartan/Hydrochlorothiazide 50/12.5mg once daily
Max: Losartan/Hydrochlorothiazide 100/25mg once daily

Dosing is individualised and according to product insert / protocol.
947 Losartan 100mg and Hydrochlorothiazide 12.5mg Tablet C09DA01-935-T10-03-XXX A* i) Hypertension in patients intolerant to ACE inhibitors
ii) Hypertensive patient with left ventricular hypertrophy		 None i) & ii)
Initial: Losartan/Hydrochlorothiazide 50/12.5mg once daily
Max: Losartan/Hydrochlorothiazide 100/25mg once daily

Dosing is individualised and according to product insert / protocol.
948 Losartan 50mg and Hydrochlorothiazide 12.5mg Tablet C09DA01-935-T10-01-XXX A/KK i) Hypertension in patients intolerant to ACE inhibitors
ii) Hypertensive patient with left ventricular hypertrophy		 None i) & ii)
Initial: Losartan/Hydrochlorothiazide 50/12.5mg once daily
Max: Losartan/Hydrochlorothiazide 100/25mg once daily

Dosing is individualised and according to product insert / protocol.
949 Losartan 50mg Tablet C09CA01-500-T10-01-XXX B Patients intolerant to ACE inhibitors in:
i) Hypertensive patient with left ventricular hypertrophy
ii) Type 2 Diabetes Mellitus with chronic kidney disease
iii) Hypertension		 - i), ii) & iii)
Initial: 50mg once daily Max: 100mg once daily

Dosing is individualised and according to product insert / protocol.
950 Lurasidone Hydrochloride 20 mg Film Coated Tablet N05AE05-110-T32-01-XXX A* i. Monotherapy treatment of adult and adolescent patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression)
ii. Adjunctive treatment with lithium or valproate in adult patients with a major depressive episode associated with bipolar I disorder (bipolar depression)		 For indications i and ii:
As a second-line treatment option for patients who are intolerant to, have an inadequate response to existing therapies, or are at risk of metabolic adverse effects associated with current treatment.		 Adult: 20 mg once daily (Max: 120mg / day)
Adolescents (13 – 17 years): 20mg once daily (Max: 80mg / day)
951 Lurasidone Hydrochloride 40mg Film Coated Tablet N05AE05-110-T32-02-XXX A* i. Monotherapy treatment of adult and adolescent patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression)
ii. Adjunctive treatment with lithium or valproate in adult patients with a major depressive episode associated with bipolar I disorder (bipolar depression)		 For indications i and ii:
As a second-line treatment option for patients who are intolerant to, have an inadequate response to existing therapies, or are at risk of metabolic adverse effects associated with current treatment		 Adult: 20 mg once daily (Max: 120mg / day)
Adolescents (13 – 17 years): 20mg once daily (Max: 80mg / day)
952 Lurasidone Hydrochloride 80 mg Film Coated Tablet N05AE05-110-T32-03-XXX A* i. Monotherapy treatment of adult and adolescent patients (13 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression)
ii. Adjunctive treatment with lithium or valproate in adult patients with a major depressive episode associated with bipolar I disorder (bipolar depression)		 For indications i and ii:
As a second-line treatment option for patients who are intolerant to, have an inadequate response to existing therapies, or are at risk of metabolic adverse effects associated with current treatment		 Adult: 20 mg once daily (Max: 120mg / day)
Adolescents (13 – 17 years): 20mg once daily (Max: 80mg / day)
953 Macitentan 10mg Film-coated Tablet C02KX04-000-T32-01-XXX A* As monotherapy or combination for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. To be prescribed by PAH-trained Respiratory Physician and Cardiologist only. Recommended daily dose macitentan is 10mg (1 tablet), with or without food. The film-coated tablets are not breakable and must be swallowed whole with water.
954 Magnesium Sulphate 45% Paste D11AX05-183-G60-01-XXX C Inflammatory skin conditions such as boils and carbuncles None Apply under dressing
955 Magnesium Sulphate 50% Injection B05XA05-183-P30-01-XXX C i)Treatment and prophylaxis of acute hypomagnesaemia
ii) Prevention and treatment of life-threatening seizures in the treatment of toxemias of pregnancy (pre-eclampsia and eclampsia)		 None i)Mild hypomagnesemia (ADULT): 1gm magnesium sulphate (8mEq) IM every 6 hours for 4 doses. Severe hypomagnesemia (ADULT): 0.25 g/kg IM over 4 hours. Alternative dose of 5g may be given by slow intravenous infusion over 3 hours

ii) Toxemia of pregnancy: An initial intravenous dose of 4gm of magnesium sulphate is recommended. Followed by an intramuscular dose of 4-5gm into each buttock. This may be followed by a dose of 4-5gm into alternate buttocks every 4 hours as needed. Alternatively, the initial dose IV dose may be followed by an infusion of 1-2gm/hr
956 Magnesium Trisilicate Mixture A02AA10-912-L21-01-XXX C Heartburn, dyspepsia None ADULT children over 12 years: 10-20ml 3 times daily or as required;
CHILD: 5-11 years: 5-10 ml three times a day or as required
957 Magnesium Trisilicate Tablet A02AA10-912-T10-01-XXX C Heartburn, dyspepsia - ADULT 1-2 tablet to be chewed up to 6 times a day before meals. CHILD over 6 years one tablet to be taken 3-4 times a day
958 Magnesium, Aluminium Hydroxide and Simethicone Suspension V07AB00-900-L80-01-XXX C For the relief from gastric acidity, indigestion, heartburn, flatulence and dyspepsia. - 5 to 10ml as required or one hour after food and at bedtime
959 Malathion 1% Shampoo P03AX03-000-L52-01-XXX C+ Lice infestation - Wet hair, apply shampoo and work up lather. Leave for 15 minutes and rinse, comb. Repeat if necessary after 7 - 9 days
960 Mannitol 10% Injection (10 g/100 ml) B05BC01-000-P30-01-XXX A Cerebral oedema 0.25- 2 g/kg IV of a 15% to 25% solution over 30-60 minutes. Safety and efficacy not established in children under 12 years of age

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