Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
181 Beractant Intratracheal Suspension (200mg phospholipids in 8 ml vial) R07AA02-000-L80-01-XXX A* Treatment of newborn baby with birth weight of 700 g or greater undergoing mechanical ventilation for respiratory distress syndrome, whose heart rate and arterial oxygenation are continuously monitored None 100 mg/kg (4 ml/kg) body weight intratracheally up to 4 doses in 1st 48 hr. Doses should not be given more frequently than 6 hrly. To be administered as soon as possible.
182 Betahistine Dihydrochloride 24 mg Tablet N07CA01-110-T10-03-XXX A/KK i) Meniere's Syndrome as defined by the following core symptoms:
- Vertigo (with nausea/vomiting).
- Hearing loss (Hardness of hearing).
- Tinnitus (ringing in the ears)

ii) Symptomatic treatment of vestibular vertigo		 (Hanya terpakai untuk fasiliti kesihatan primer)
Short term (max. 2 months) treatment with Betahistine can be initiated by Family Medicine Specialist (FMS) for patients with Menieres syndrome and vestibular vertigo, pending referral/ evaluation by the Otorhinolaryngology team.		 24-48mg in divided doses daily
183 Betamethasone 17-Valerate 0.01-0.05% Cream D07AC01-256-G10-01-XXX B Topical corticosteroid indicated for the 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 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
185 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
186 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.
187 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
188 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.
189 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.
190 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.
191 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
192 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.
193 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
194 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
195 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
196 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)
197 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.
198 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
199 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).
200 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.
201 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.
202 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.
203 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.
204 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
205 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.
206 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.
207 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.
208 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
209 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).
210 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.

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