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Formulari Ubat KKM (FUKKM)
# | Generic Name | MDC | Category | Indications | Pres. Restrictions | Dosage |
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1 | Adalimumab 40mg Injection | L04AB04-000-P50-01-XXX | A* | i) Third line treatment of: - Severe rheumatoid arthritis - Psoriatic arthritis - Ankylosing spondylitis after failure of conventional DMARDs or other biologics ii)Treatment of adults with moderate to severe chronic plaque psoriasis who have not responded to, have contraindication or are unable to tolerate phototherapy and/or systemic therapies including acitretin, methotreaxate and cyclosporine iii) Crohn's Disease a) For treatment of moderately to severely active Crohn's Disease in adult patients who have inadequate response to conventional therapy b) For treatment of moderately to severely active Crohn?s Disease in adult patients who have lost response to or are intolerant to infliximab iv) Ulcerative Colitis - For treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies | None | i)Severe rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis : Subcutaneous 40 mg every other week ii)Chronic plaque psoriasis : Initial, 80 mg SC, followed by 40 mg SC every other week starting one week after the initial dose iii) & iv) Crohn's disease & Ulcerative colitis: 160mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) and 80mg at week 2. After induction treatment, the recommended maintenance dose is 40mg every other week via subcutaneous injection. |
2 | 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. |
3 | Baricitinib 2mg film-coated tablets | L04AA37-000-T32-01-XXX | A* | 1. Treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. May be used as monotherapy or in combination with methotrexate. 2. Indicated for the treatment of severe atopic dermatitis in adult patients who are candidates for systemic therapy. | 1. Severe active rheumatoid arthritis: To be prescribed by Rheumatologist only 2. Severe atopic dermatitis: i. As fourth line of treatment in patients who have failed / have contraindications / experienced adverse events to: • Intensive and optimized topical treatment • Phototherapy • At least two immunosuppressants ii. To be prescribed by Dermatologists only. | 1. Severe active rheumatoid arthritis: 4mg once daily 2. Severe atopic dermatitis: The recommended dose of baricitinib is 4 mg once daily with or without food and may be taken at any time of the day. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily should be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering. Baricitinib can be used with or without concomitant topical therapies (Refer package insert) |
4 | Baricitinib 4mg film-coated tablets | L04AA37-000-T32-02-XXX | A* | 1. Treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. May be used as monotherapy or in combination with methotrexate. 2. Indicated for the treatment of severe atopic dermatitis in adult patients who are candidates for systemic therapy. | 1. Severe active rheumatoid arthritis: To be prescribed by Rheumatologist only 2. Severe atopic dermatitis: i. As fourth line of treatment in patients who have failed / have contraindications / experienced adverse events to: • Intensive and optimized topical treatment • Phototherapy • At least two immunosuppressants ii. To be prescribed by Dermatologists only. | 1. Severe active rheumatoid arthritis: 4mg once daily 2. Severe atopic dermatitis: The recommended dose of baricitinib is 4 mg once daily with or without food and may be taken at any time of the day. A dose of 2 mg once daily is appropriate for patients such as those aged ≥ 75 years and may be appropriate for patients with a history of chronic or recurrent infections. A dose of 2 mg once daily should be considered for patients who have achieved sustained control of disease activity with 4 mg once daily and are eligible for dose tapering. Baricitinib can be used with or without concomitant topical therapies (Refer package insert) |
5 | Celecoxib 200 mg Capsule | M01AH01-000-C10-01-XXX | A/KK | i) Osteoarthritis ii) Rheumatoid Arthritis iii) Acute pain iv) Ankylosing Spondylitis | i) ADULTS: 200 mg once daily. May increase to 200 mg bid, if necessary. CHILD not recommended ii) 100mg twice daily, increased if necessary to 200 mg 2 times daily; CHILD not recommended iii) 400mg as a single dose on first day followed by 200mg once daily on subsequent days iv) Initial, 200 mg once daily or 100 mg twice daily; if no effect after 6 weeks, may increase to max. 400 mg daily in 1-2 divided doses. If no response following 2 weeks of treatment with 400 mg/day, consider discontinuation and alternative treatment | |
6 | Celecoxib 400 mg Capsule | M01AH01-000-C10-02-XXX | A* | i) Osteoarthritis ii) Rheumatoid Arthritis iii) Acute pain iv) Ankylosing Spondylitis | i) ADULTS: 200 mg once daily. CHILD not recommended ii) 100 mg twice daily, increased if necessary to 200 mg 2 times daily; CHILD not recommended iii) 400 mg as a single dose on first day followed by 200 mg once daily on subsequent days iv) Initial, 200 mg once daily or 100 mg twice daily; if no effect after 6 weeks, may increase to max. 400 mg daily in 1-2 divided doses. If no response following 2 weeks of treatment with 400 mg/day, consider discontinuation and alternative treatment | |
7 | Ciclosporin 100 mg Capsule | L04AD01000C1002XX | A* | i) Patients in whom donor specific transplantation cannot be carried out and in young children to minimise side-effects of steroids ii) Follow-up cases of bone marrow transplant iii) Patients with severe rheumatoid arthritis not responding to other second line drugs iv) Patients with idiopathic nephrotic syndrome who are steroid toxic or poor response to cyclophosphamide v) Severe aplastic anemia, pure red cell aplasia vi) Cases of recalcitrant psoriasis and atopic eczema vii) Treatment of chronic ocular inflammatory disorders/uveitis | i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 months before being tapered off to zero by 1 year of transplantation iii) 3 mg/kg/day in 2 divided doses for first 6 weeks. May increased gradually to maximum 5 mg/kg. Treatment withdrawn if no response after 3 months iv) ADULT: 5 mg/kg/day in 2 divided doses. CHILD: 6 mg/kg/day in 2 divided doses. Patients with permitted levels of kidney failure, the starting dose must not more than 2.5 mg/kg/day v) 12 mg/kg/day vi) 2.5 mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5 mg/kg/day vii) 5 mg/kg/day in 2 divided doses, may increase to 7 mg/kg/day in resistant cases. Maintenance: Less than 5 mg/kg/day especially during remission | |
8 | Ciclosporin 100 mg/ml Oral Solution | L04AD01000L5002XX | A* | i) Patients in whom donor specific transplantation cannot be carried out and in young children to minimise side-effects of steroids ii) Follow-up cases of bone marrow transplant iii) Patients with severe Rheumatoid arthritis not responding to other second line drugs iv) Patients with idiopathic nephrotic syndrome who are steroid toxic or poor response to cyclophosphamide v) Severe aplastic anaemia, pure red cell aplasia vi) Cases of recalcitrant psoriasis and atopic eczema | i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 months before being tapered off to zero by 1 year of transplantation iii) 3 mg/kg/day in 2 divided doses for first 6 weeks. May increased gradually to maximum 5 mg/kg. Treatment withdrawn if no response after 3 months iv) ADULT: 5 mg/kg/day in 2 divided doses. CHILD: 6 mg/kg/day in 2 divided doses. Patients with permitted levels of kidney failure, the starting dose must not more than 2.5 mg/kg/day v) 12 mg/kg/day vi) 2.5 mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5 mg/kg/day | |
9 | Ciclosporin 25 mg Capsule | L04AD01000C1001XX | A* | i) Patients in whom donor specific transplantation cannot be carried out and in young children to minimise side-effects of steroids ii) Follow-up cases of bone marrow transplant iii) Patients with severe rheumatoid arthritis not responding to other second line drugs iv) Patients with idiopathic nephrotic syndrome who are steroid toxic or poor response to cyclophosphamide v) Severe aplastic anemia, pure red cell aplasia vi) Cases of recalcitrant psoriasis and atopic eczema vii) Treatment of chronic ocular inflammatory disorders/uveitis | i & ii) Initially 12.5 - 15 mg/kg/day, beginning on the day before transplant. Maintenance approx 12.5 mg/kg/day for 3 - 6 months before being tapered off to zero by 1 year of transplantation iii) 3 mg/kg/day in 2 divided doses for first 6 weeks. May increased gradually to maximum 5 mg/kg. Treatment withdrawn if no response after 3 months iv) ADULT: 5 mg/kg/day in 2 divided doses. CHILD: 6 mg/kg/day in 2 divided doses. Patients with permitted levels of kidney failure, the starting dose must not more than 2.5 mg/kg/day v) 12 mg/kg/day vi) 2.5 mg/kg/day in 2 divided doses increasing if there is no improvement after 4 weeks by 0.5 -1 mg/kg/month up to maximum 5 mg/kg/day vii) 5 mg/kg/day in 2 divided doses, may increase to 7 mg/kg/day in resistant cases. Maintenance: Less than 5 mg/kg/day especially during remission | |
10 | Cyclophosphamide 1 g Injection | L01AA01000P4002XX | A | i) Solid tumours ii) Leukaemia, non-Hodgkin's lymphoma, multiple myeloma iii) Severe lupus nephritis (Class III and IV) iv) Other systemic vasculitis v) Systemic lupus erythematosus, rheumatoid arthritis, polyarteritis nodosa, wegener granulomatosis vi) Pemphigus vulgaris. | i) & ii) ADULT: 600 - 750 mg/m2 IV once every 3 weeks as part of combination regime. CHILD: Dose variable depending on disease and protocol. Range 600 mg/m2 to 2 g/m2 infusion over 1 hour to 6 hours (lower doses can be given as bolus). Care with pre and post-hydration. Mesna to be given with doses more than 1 g/m2. Higher doses are used in haematopoetic stem cell transplant-refer to specific protocols iii) 750 mg/m2 BSA monthly for 18 months iv) 750 mg/m2 BSA monthly for 6 months. Dose can be adjusted up to 1,000 mg/m2 BSA to achieve adequate leucocyte suppression v) 500 - 1000 mg intravenously (Regime varies according to indication). Starting dose may be given fortnightly then at monthly intervals followed by 3 monthly intervals; vi) 500 mg infusion on the 2nd day of the dexamethasone-cyclophosphamide pulsed regime, the cycle is repeated every 4 weeks up to 6 cycles or till remission followed by oral cyclophosphamide | |
11 | Cyclophosphamide 200 mg Injection | L01AA01000P4001XX | A | i) Solid tumours ii) Leukaemia, non-Hodgkin's lymphoma, multiple myeloma iii) Severe lupus nephritis (Class III and IV) iv) Other systemic vasculitis v) Systemic lupus erythematosus, rheumatoid arthritis, polyarteritis nodosa, wegener granulomatosis vi) Pemphigus vulgaris. | i)& ii) ADULT: 600 - 750 mg/m2 IV once every 3 weeks as part of combination regime. CHILD: Dose variable depending on disease and protocol. Range 600 mg/m2 to 2 g/m2 infusion over 1 hour to 6 hours (lower doses can be given as bolus). Care with pre and post-hydration. Mesna to be given with doses more than 1 g/m2. Higher doses are used in haematopoetic stem cell transplant-refer to specific protocols iii) 750 mg/m2 BSA monthly for 18 months iv) 750 mg/m2 BSA monthly for 6 months. Dose can be adjusted up to 1,000 mg/m2 BSA to achieve adequate leucocyte suppression v) 500 - 1000 mg intravenously (Regime varies according to indication). Starting dose may be given fortnightly then at monthly intervals followed by 3 monthly intervals; vi) 500 mg infusion on the 2nd day of the dexamethasone-cyclophosphamide pulsed regime, the cycle is repeated every 4 weeks up to 6 cycles or till remission followed by oral cyclophosphamide | |
12 | Cyclophosphamide 50 mg Tablet | L01AA01000T1001XX | A | i) Solid tumours, leukaemia, lymphoma, autoimmune disorders, autoimmune bullous diseases, connective tissue disease, pyoderma gangrenosum ii) For severe lupus nephritis (Class III & IV), systemic vasculitis and steroid resistant/dependent nephrotic syndrome iii) Systemic lupus erythematosus (SLE), rheumatoid arthritis, polyarteritis nodosa, wegener granulomatosis | i) ADULT: 50 - 100 mg/day. Monitor full blood count (FBC), liver function, urine microscopy and renal function. CHILD, up to 1 year: 10 - 20 mg daily, 1 - 5 years: 30 - 50 mg daily, 6 - 12 years: 50 - 100 mg daily ii) 2 mg/kg/day for 3 - 4 months iii) 1 - 1.5 mg/kg/day orally in divided doses | |
13 | Etanercept 25 mg Injection | L04AA11-000-P40-01-XXX | A* | i) Moderately to severe rheumatoid arthritis as monotherapy or in combination with methotrexate in patients with inadequate response to methotrexate alone. ii) Active polyarticular-course juvenile idiopathic arthritis in children 2-17 years with inadequate response to, or who have proved intolerant of methotrexate. iii) Psoriatic arthritis as monotherapy or in combination with methotrexate in patients inadequate response to methotrexate alone. iv) Active ankylosing spondylitis in adults | Adult & geriatric dose: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis; 50 mg SC once-weekly for once-weekly dosing or 25 mg SC twice weekly (individual doses should be separated by 72 to 96 hours) for twice-weekly dosing. Paediatric dose (2 to 17 years): Juvenile idiopathic arthritis; 0.8 mg/kg (max. 25 mg/dose) SC once weekly for once-weekly dosing or 0.4 mg/kg (max. 25 mg/dose) SC twice weekly (individual doses should be separated by 72 to 96 hours) for twice-weekly dosing. | |
14 | Etanercept 50 mg Injection | L04AB01-000-P40-02-XXX | A* | i) Moderately to severe rheumatoid arthritis as monotherapy or in combination with methotrexate in patients with inadequate response to methotrexate alone. ii) Active polyarticular-course juvenile idiopathic arthritis in children 2-17 years with inadequate response to, or who have proved intolerant of methotrexate. iii) Psoriatic arthritis as monotherapy or in combination with methotrexate in patients inadequate response to methotrexate alone. iv) Active ankylosing spondylitis in adults | Adult & geriatric dose: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis; 50 mg SC once-weekly for once-weekly dosing or 25 mg SC twice weekly (individual doses should be separated by 72 to 96 hours) for twice-weekly dosing. Paediatric dose (2 to 17 years): Juvenile idiopathic arthritis; 0.8 mg/kg (max. 25 mg/dose) SC once weekly for once-weekly dosing or 0.4 mg/kg (max. 25 mg/dose) SC twice weekly (individual doses should be separated by 72 to 96 hours) for twice-weekly dosing. | |
15 | Etoricoxib 120 mg Tablet | M01AH05000T1002XX | A* | i)Acute and chronic treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute gouty arthritis iii)Acute pain | i) OA: 60 mg once daily. RA: 90 mg once daily ii & iii) Acute gouty arthritis and acute pain: 120 mg once daily (Given the exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment) | |
16 | Etoricoxib 60 mg Tablet | M01AH05000T1003XX | A* | i)Acute and chronic treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute gouty arthritis iii)Acute pain | i) OA: 60 mg once daily. RA: 60mg once daily and may be increased to 90mg once daily if needed.Once the patient is stabilized, down-titration to 60mg once daily may be appropriate. ii & iii) Acute gouty arthritis and acute pain: 120 mg once daily (Given the exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment) | |
17 | Etoricoxib 90 mg Tablet | M01AH05000T1001XX | A/KK | i)Acute and chronic treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) ii)Acute gouty arthritis iii)Acute pain | i) OA: 60 mg once daily. RA: 60mg once daily and may be increased to 90mg once daily if needed.Once the patient is stabilized, down-titration to 60mg once daily may be appropriate. ii & iii) Acute gouty arthritis and acute pain: 120 mg once daily (Given the exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment) | |
18 | Golimumab 100mg/ml Solution for Injection | L04AB06000P5001XX | A* | i) Rheumatoid arthritis (RA): In combination with methotrexate (MTX), is indicated for: - The treatment of moderate to severe active rheumatoid arthritis in adult patients when the response to DMARD therapy including MTX has been inadequate. - The treatment of active, severe and progressive rheumatoid arthritis in adult patients not previously treated with MTX. ii) Psoriatic arthritis (PsA): Golimumab alone or in combination with MTX, is indicated for: The treatment of active psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate. iii) Ankylosing spondylitis (AS): Golimumab (used alone) is indicated for: The treatment of active ankylosing spondylitis in adult patients when the response to conventional therapy has been inadequate. | i) Rheumatoid arthritis 50mg given as a subcutaneous injection once a month, on the same date each month. ii) Psoriatic arthritis 50mg given as a subcutaneous injection once a month, on the same date each month. iii) Ankylosing spondylitis 50mg given as a subcutaneous injection once a month, on the same date each month. | |
19 | Hydroxychloroquine Sulphate 200 mg Tablet | P01BA02-183-T10-01-XXX | A | i) SLE and mixed connective tissue disease for skin, joint and serosa ii) Second line therapy for acute rheumatoid arthritis | None | i) Initially 400 mg daily in divided dose. Maintenance : 200 - 400 mg daily ii) ADULT : 400 - 600 mg daily. Maintenance: 200 - 400 mg daily. CHILD : up to 6.5 mg/kg daily (maximum 400mg daily) |
20 | Infliximab 100 mg Injection | L04AB02000P4001XX | A* | i) Rheumatoid arthritis (moderate to severe), in combination with methotrexate ii) Ankylosing spondylitis in patients with active disease despite treatment with methotrexate iii) Crohn's Disease in patients who have an inadequate response to conventional therapies. iv) Fistulizing Crohn's Disease in patients who have an inadequate response to conventional therapies v) Ulcerative Colitis in patients who have an inadequate response to conventional therapies | i) Rheumatoid arthritis: ADULT over 18 years old: 3 mg/kg at 0, 2, 6 weeks, then every 8 weeks; May increase to 10 mg/kg or increase dosing frequency to 4 weekly for patients with incomplete response. Discontinue if no response by 12 weeks of initial infusion or after dose adjustment ii) Ankylosing spondylitis: ADULT over 18 years: 5 mg/kg IV over 2 hour given at week 0, 2, and 6 then every 6-8 weeks. Discontinue if no response by 6 weeks of initial infusion. iii), iv) & v) 5 mg/kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter | |
21 | Leflunomide 10mg Tablet | L04AA13000T1001XX | A* | i) Persistent active rheumatoid arthritis ii) Active psoriatic arthritis | Loading dose: 100 mg once daily for 3 days. Maintenance: 10-20 mg once daily | |
22 | Leflunomide 20mg Tablet | L04AA13000T1002XX | A* | i) Persistent active rheumatoid arthritis ii) Active psoriatic arthritis | Loading dose: 100 mg once daily for 3 days. Maintenance: 10-20 mg once daily. | |
23 | Meloxicam 7.5mg Tablet | M01AC06-000-T10-01-XXX | A/KK | Only for patients not responding to other NSAIDs in the treatment of: i) painful osteoarthritis ii) rheumatoid arthritis | - | i) initially 7.5 mg daily. May be increased to 15 mg daily ii) initially 15 mg daily. May be reduced to 7.5 mg daily. Maximum 15 mg daily. Child under 12 years not recommended |
24 | Methotrexate 2.5 mg Tablet | L01BA01000T1001XX | A | i. Antineoplastic Chemotherapy - Treatment of gestational choriocarcinoma, and in patients with chorioadenoma destruens and hydatidiform mole. - Palliation of acute lymphocytic leukemia - Treatment and prophylaxis of meningeal leukemia. - Palliation of acute lymphoblastic (stem-cell) leukemias in children. - Alone or in combination with other anticancer agents in the management of breast cancer, epidermoid cancers of the head and neck, and lung cancer, particularly squamous cells and small cell types. - Treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in those cases in children; and in advanced cases of mycosis fungoides. ii. Psoriasis Chemotherapy Symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. iii. Rheumatoid arthritis | Dosing is individualised and according to product insert / protocol | |
25 | Methotrexate 25mg/mL Injection | L01BA01520P3001XX | A | i) Solid tumours ii) Gestational trophoblastic disease iii) Acute leukaemia/lymphomas iv) Rheumatoid arthritis, psoriatic arthropathy, severe/erythrodermic psoriasis | i) 50 mg/m2 once every 2 - 3 weeks in combination with other drugs ii) 50 mg IV Day 1, 3, 5, 9 every 3 weeks. For high risk gestational trophoblastic disease, use 100 mg/m2 as part of EMA-CO regime iii) High dose regimes: 500 - 3000 mg/m2 per dose may be used, employing the 500 mg preparations. CHILD: Central nervous system prophylaxis for acute leukaemia 2 gm/m2 over 24 hours with folinic acid rescue, 3 doses for B-cell lineage. 4 doses for T-lineage all every 3 weeks. Relapse acute lymphoblastic leukaemia (ALL): 1 gm/m2 over 36 hours with folinic acid rescue every 3 weeks for 9 doses, maintenance: 50 mg/m2 every 2 weeks. B-cell lymphoma: 3 gm/m2 over 3 hours with folinic acid rescue for three doses. Methotrexate level monitoring recommended when using high dose regimens. The 500 mg strength is not for intrathecal (IT) use. Dosage for intrathecal treatment and prophylaxis in leukaemia: less than 1 year: 5 mg, 1 - 2 years: 7.5 mg, 2 - 3 years: 10 mg, more than 3 years: 12.5 mg. IT preparation must be clearly stated/verified. ENSURE THAT PREPARATION IS SUITABLE FOR INTRATHECAL USE iv) Dose used by rheumatologist: 10 - 15 mg IM injection or oral weekly. Dose used by dermatologist: 10 - 25 mg IM injection weekly | |
26 | Methylprednisolone Acetate 40mg injection | H02AB04-134-P30-01-XX | A* | i) Intramuscular administration: anti-inflammatory treatment, treatment of hematological and oncological disorders, endocrine disorders ii) Intrasynovial, periarticular, intrabursal or soft tissue administration: Indicated as adjunctive therapy for short term administration in : Synovitis of osteoarthritis, rheumatoid arthritis, acute and subacute bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, post-traumatic osteoarthritis iii) Intralesional use in alopecia areata, discoid lupus erythematosus; keloids, localized hypertrophic, infiltrated inflammatory lesions of granuloma annulare, lichen planus, psoriatic plaques, lichen simplex chronicus (neurodermatitis) *Restricted to patients experiencing side effects with triamcinolone acetonide | None | i. Intramuscular route a) Asthma: may be used in place of a short burst of oral steroids in vomiting or non-adherent patients. The recommended dose is 80- 120mg intramuscularly as a one-dose b) Adrenogenital syndrome: 40mg every two weeks c) Rheumatoid arthritis (maintenance): 40-120mg weekly d) Dermatologic lesions (acute severe dermatitis, chronic contact dermatitis, seborrheic dermatitis): 40-120mg weekly for 1-4 weeks ii. Intraarticular route Recommended dose is 4 to 80 milligrams, depending upon the size of the joint. Injections may be repeated at intervals of 1 to 5 or more weeks in chronic cases iii.Intralesional route 20 to 60 milligrams methylprednisolone acetate injected into the lesion |
27 | Piroxicam 10 mg Capsule | M01AC01-000-C10-01-XXX | A/KK | Musculoskeletal and joint disorders such as ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis, in soft-tissue disorders. | - | Max: 20 mg daily as a single dose, or in divided doses if necessary |
28 | Rituximab 10mg/ml Injection | L01XC02000P3001XX | A* | i) Treatment of patients with relapsed or chemo-resistant low grade or follicular B-cell Non-Hodgkin's lymphoma ii) Adjunctive therapy with combination chemoagents for aggressive Non-Hodgkin Lymphoma iii) Severe active rheumatoid arthritis with inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) including one or more tumour necrosis factor (TNF) inhibitor therapies iv) Maintenance in relapsed/ refractory follicular lymphoma after response to induction therapy | i) 375 mg/m2 BSA administered as an IV infusion through a dedicated line once weekly for 4 weeks ii) Combination with CHOP (cyclophosphamide, doxorubicin, prednisone and vincristine) as 375 mg/m2 BSA on day 1 of each chemotherapy cycle for 8 cycles after IV administration of the glucocorticoid component of CHOP. iii) 1000 mg IV infusion followed by a second 1000 mg IV infusion two weeks later iv) 375mg/m2 BSA once every 3 months until disease progression or for a maximum period of two years. | |
29 | Salicylazosulphapyridine (Sulfasalazine) 500 mg Tablet | A07EC01000T1001XX | A/KK | i) Treatment of inflammatory bowel disease of ulcerative colitis and Crohn's disease ii) Rheumatoid arthritis | i) ADULT, acute attack 1-2 g 4 times daily until remission occurs (if necessary corticosteroids may also be given), reducing to a maintenance dose of 500 mg 4 times daily, CHILD over 2 years, acute attack 40-60 mg/kg daily, maintenance dose 20-30 mg/kg daily ii) ADULT, initially; 0.5-1 g/day, increase weekly to maintenance dose of 2 g/day in 2 divided doses, maximun 3 g/day. CHILD over 6 years, juvenile rheumatoid arthritis: 30-50 mg/kg/day in 2 divided doses up to a maximum of 2 g/day | |
30 | Tocilizumab 162mg/0.9ml solution for injection in prefilled syringe (for subcutaneous injection) | L04AC07000P3003XX | A* | Indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients: i) with inadequate respond or intolerance to conventional disease- modifying antirheumatic drugs (DMARDS) ii) who has failed antitumour necrosis factors (antiTNFs) iii) where TNF is contraindicated (patients with history of pulmonary tuberculosis [PTB]) It also can be used as monotherapy or with combination with methotrexate (MTX) and/ or other DMARDS. | Adult patients: 162mg given once every week as a subcutaneous injection. |