Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
181 Betamethasone 17-Valerate 0.01-0.05% Ointment D07AC01-256-G50-01-XXX B Eczema, prurigo nodularis, limited psoriasis in appropriate in sites None Apply sparingly to affected area 2 - 3 times daily then reduced to once daily when improvement occurs
182 Betamethasone 17-Valerate 0.1% Cream D07AC01-256-G10-02-XXX A/KK Potent topical corticosteroid indicated for adults, elderly and child over 1 year for relief of inflammatory and pruritic manifestation of steroid responsive dermatoses. None Apply sparingly to affected area 2 times daily then reduced to once daily when improvement occurs
183 Betamethasone 17-Valerate 0.1% Ointment D07AC01-256-G50-02-XXX A/KK Potent topical corticosteroid indicated for adults, elderly and child over 1 year for relief of inflammatory and pruritic manifestation of steroid responsive dermatoses None Apply sparingly to affected area 2 times daily then reduced to once daily when improvement occurs.
184 Betamethasone Disodium Phosphate and Neomycin Sulphate 0.5% Ear/Eye Drops S03CA06-991-D10-01-XXX B Eye: Infected inflammatory conditions of the eyes.

Ear: Allergic dermatosis in the ear		 None Eye: 1 drops 3-4 times daily.

Ear: 4 drops 3-4 times daily
185 Bevacizumab 25 mg/mL Solution for Infusion L01XC07-000-P30-01-002, L01XC07-000-P30-01-003 A* Bevacizumab, in combination with atezolizumab, is indicated for the treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Note:
Currently, innovator bevacizumab product ie. Avastin is the only product with DCA approved indication for treatment of hepatocellular carcinoma.		 Only for patients with Child-Pugh A The recommended dosage is 15 mg/kg intravenously after administration of atezolizumab intravenously on the same day, every 3 weeks until disease progression or unacceptable toxicity.
186 Bicalutamide 50 mg Tablet L02BB03000T1001XX A* Androgen deprivation therapy in advanced prostate cancer in combination with luteinising hormone-releasing hormone (LHRH) analogue therapy or surgical castration. 50 mg once daily. (morning or evening), with or without food. Take on the same time each day. Adult: When used with gonadorelin analogue: Usual dose: 50 mg once daily. May be started with or at least 3 days before starting gonadorelin analogue therapy.
187 Bimatoprost 0.01% ophthalmic solution S01EE03-000-D20-02XXX A* Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta blockers). To be used as 2nd line One drop in the affected eye(s) once daily, administered in the evening.
188 Bisacodyl 10mg Suppository A06AB02-000-S20-02-XXX C i) Constipation
ii) Bowel preparation for radiological procedures and surgery		 None i) ADULT and CHILD (over 10 years): 10 mg per rectal;
CHILD (4 to 10 years): 5 mg per rectal.

ii) ADULT and CHILD (over 10 years: )10 to 20 mg;
CHILD (4 to 10 years): 5 mg the following morning before procedures insert rectally
189 Bisacodyl 5 mg Tablet A06AB02-000-T10-01-XXX C i) Constipation
ii) Bowel preparation for radiological procedures and surgery		 None i) ADULT and CHILD (over 10 years): 5 to 10 mg;
CHILD (4 to 10 years): 5 mg.
To be taken at night for effect on the following morning.

ii) ADULT and CHILD (over 10 years): 10 mg in the morning and 10 mg in the evening the day before procedures;
CHILD (4 to 10 years): 5 mg the night before procedures.
190 Bisacodyl 5mg Suppository A06AB02-000-S20-01-XX C i) Constipation
ii) Bowel preparation for radiological procedures and surgery		 None i) ADULT and CHILD (over 10 years): 10 mg per rectal;
CHILD (4 to 10 years): 5 mg per rectal.

ii) ADULT and CHILD (over 10 years: )10 to 20 mg;
CHILD (4 to 10 years): 5 mg the following morning before procedures insert rectally
191 Bisoprolol Fumarate 2.5 mg Tablet C07AB07-000-T10-01-XXX B i) Hypertension
ii)Coronary heart disease (angina pectoris)
iii) Treatment of stable congestive cardiac failure in addition to ACEI's and diuretics		 None 1.25 mg once daily, gradually titrate to maximum tolerable dose

(i) & (ii): Max: 20mg/ day
(iii): Max 10mg/ day
192 Bisoprolol Fumarate 5 mg Tablet C07AB07-000-T10-02-XXX B i) Hypertension
ii)Coronary heart disease (angina pectoris)
iii) Treatment of stable congestive cardiac failure in addition to ACEI's and diuretics		 None 1.25 mg once daily, gradually titrate to maximum tolerable dose

(i) & (ii): Max: 20mg/ day
(iii): Max 10mg/ day
193 Bleomycin 15 mg Injection L01DC01110P4001XX A i) Solid tumours
ii) Lymphomas		 15 - 30 mg weekly in divided doses or 10 - 20 mg/m2 once or twice weekly or 10 mg/m2 slow bolus in 15 minutes D1 and D15. Total dosage:should not exceed 300 mg. CHILD: 10 - 15 mg/m2 over 6 hours every 3 - 4 weeks (Routes: SC, IM, IV (either as bolus or as infusion over 24 hours), intra-arterial, intra-pleural)
194 Bortezomib 3.5 mg Injection L01XX32000P3001XX A* Treatment of multiple myeloma 1.3 mg/m2 bodysurfacearea twice weekly for two weekson days 1, 4, 8, and 11 in a 21-day treatment cycle.
At least 3 days should elapse between consecutive doses of bortezomib.
195 Bosentan 125 mg tablet C02KX01-000-T10-01-XXX A* Treatment of pulmonary arterial hypertension (PAH) in patients of WHO functional class II-IV. None Initially 62.5 mg bd for 4 weeks, then increase to the maintenance dose of 125 mg bd
196 Brentuximab Vedotin 50mg Powder for Concentrate for Solution for Infusion L01XC12-000-F24-01-xxx A* i. Treatment of adult patients with CD30+ Hodgkin Lymphoma (HL) at increased risk of relapse or progression following autologous stem cell transplant (ASCT).

ii. Treatment of adult patients with relapsed or refractory CD30+ HL:
a. following autologous stem cell transplant (ASCT) or
b. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.

iii. Treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL)		 Indications (i), (ii) & (iii): To be prescribed by Haematologist only
Indication (iii): Second-line therapy after failing one line of salvage therapy		 Indication i: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Brentuximab treatment should start following recovery from ASCT based on clinical judgment. These patients should receive up to 16 cycles.

Indication ii & iii: The recommended dose is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. The recommended starting dose for the retreatment of patients who have previously responded to treatment with brentuximab is 1.8 mg/kg administered as an intravenous infusion over 30 minutes every 3 weeks. Alternatively, treatment may be started at the last tolerated dose. Treatment should be continued until disease progression or unacceptable toxicity. Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year).
197 Brexpiprazole 1mg Film Coated Tablet N05AX16-000-T32-03-xxx A* Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) To be prescribed by Psychiatrists only The recommended starting dose as adjunctive treatment is 0.5 mg or 1 mg once daily. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient’s clinical response and tolerability. Doses up to 3 mg/day have been studied in clinical trials.
198 Brexpiprazole 2mg Film Coated Tablet N05AX16-000-T32-04-xxx A* Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) To be prescribed by Psychiatrists only The recommended starting dose as adjunctive treatment is 0.5 mg or 1 mg once daily. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient’s clinical response and tolerability. Doses up to 3 mg/day have been studied in clinical trials.
199 Brexpiprazole 3mg Film Coated Tablet N05AX16-000-T32-05-xxx A* Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) To be prescribed by Psychiatrists only The recommended starting dose as adjunctive treatment is 0.5 mg or 1 mg once daily. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient’s clinical response and tolerability. Doses up to 3 mg/day have been studied in clinical trials.
200 Brexpiprazole 4mg Film Coated Tablet N05AX16-000-T32-06-xxx A* Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) To be prescribed by Psychiatrists only The recommended starting dose as adjunctive treatment is 0.5 mg or 1 mg once daily. Dose titration to 1 mg/day and up to the target dose of 2 mg/day should occur at intervals of up to 1 week based on the patient’s clinical response and tolerability. Doses up to 3 mg/day have been studied in clinical trials.
201 Brimonidine Tartrate 0.15% Ophthalmic S01EA05-123-D20-01-XXX A* Lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension None 1 drop in the affected eye(s) 3 times daily
202 Brinzolamide 1% and Brimonidine Tartrate 0.2% ophthalmic suspension S01EC54-990-D20-01-XXX A* Decrease of elevated intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. None 1 drop in the affected eye(s) 2 times daily.
203 Brinzolamide 1% ophthalmic suspension S01EC04-000-D20-01-XXX A* Indicated for the treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. For patients who require carbonic anhydrase inhibitor (CAI) but could not tolerate Dorzolamide. 1 drop 2 times daily.
Some patients may have a better response with one drop three times a day. The dose should not exceed 1 drop in the affected eye(s) 3 times daily.
204 Brolucizumab 120mg/mL solution for Injection S01LA06-000-P30-01-XXX A* Indicated in adults for the treatment of neovascular (wet) age related macular degeneration (nAMD). • For refractory cases of nAMD despite prior anti-VEGF
• To be prescribed by Ophthalmology Retina Specialist only		 The recommended dose is 6 mg brolucizumab (0.05 ml solution) administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. Thereafter, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. A disease activity assessment is suggested 16 weeks (4 months) after treatment start.
In patients without disease activity, treatment every 12 weeks (3 months) should be considered. In patients with disease activity, treatment every 8 weeks (2 months) should be considered.
If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, brolucizumab should be discontinued.
205 Bromazepam 3mg Tablet N05BA08-000-T10-02-XXX A Anxiety disorders None Adult: Initially, 6-18 mg daily in divided doses. Doses up to 60 mg daily have been used. Elderly: Max initial dose: 3 mg daily
206 Bromhexine HCl 4mg/2ml Injection R05CB02-110-P30-01-XXX A Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucous secretion and impaired mucous transport None 4mg IM or IV 2 - 3 times daily (maximum 12mg/day).
207 Bromhexine HCl 4mg/5ml Oral Solution R05CB02-110-L10-01-XXX B Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucous secretion and impaired mucous transport None Adult: 8-16 mg three times daily.
Children:
By body weight: 0.3 mg/kg/day 8 hourly for 7 days, then 0.15 mg/kg/day 8 hourly; or
Based on age: 6-12 years – 4mg three times daily; 2-6 years – 2mg three times daily; Less than 2 years – 1mg three times daily.
208 Bromhexine HCl 8mg Tablet R05CB02-110-T10-01-XXX C Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucous secretion and impaired mucous transport. Medical Assistant in health settings without Medical Officer is allowed to prescribe this medicine for adult use only.
 Adult: 8-16 mg three times daily.
Children:
By body weight: 0.3 mg/kg/day 8 hourly for 7 days, then 0.15 mg/kg/day 8 hourly; or
Based on age: 6-12 years – 4 mg three times daily; 2-6 years – 2 mg three times daily
209 Bromocriptine Mesilate 2.5mg Tablet G02CB01-196-T10-01-XXX A/KK i) Hypogonadism, galactorrhoea, infertility in men and women, cyclical benign breast and menstrual disorders
ii) Acromegaly
iii) Hyperprolactinaemia, prolactinomas
iv) Parkinson's disease		 None i) Initial dose of 1.25-2.5mg once daily at bedtime. Dose may be increased by 2.5mg/day every 3 to 7 days as tolerated to a total of 5 to 7.5mg daily in divided doses
ii) 1.25 - 2.5 mg at bedtime for 3 days and may be increased by 1.25 - 2.5 mg every 3 to 7 days up to 30 mg a day in divided doses
iii) Initial dose of 1.25mg, two or three times a day. Increase dosage gradually over several weeks to 10 - 20mg a day in divided doses. Higher doses may be required
iv) Initial dose of 1.25 mg one or two times a day. Dose may be increased by 2.5mg/day increments in 2 -to 4-week intervals as needed. Maintenance dose ranges from 10 to 30mg daily in divided doses.


Dosing is individualised and according to product insert/protocol
210 Budesonide 100mcg/dose Inhaler R03BA02-000-A21-01-XXX B Maintenance treatment of asthma as prophylactic therapy especially if not fully controlled by bronchodilators None ADULT:200 - 1600 mcg daily in 2-4 divided doses. Maintenance with twice daily dosing. CHILD more than 7 years: 200-800 mcg, 2 - 7 years: 200-400 mcg. To be inhaled in 2 - 4 divided doses.

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