Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
151 Azithromycin 200 mg/5 ml Granules J01FA10-011-F10-01-XXX A*, A/KK PRESCRIBER CATEGORY A*: Treatment of complicated respiratory tract infections.

PRESCRIBER CATEGORY A/KK: Treatment of pertussis		 None CHILD 36 - 45 kg: 400 mg, 26 - 35 kg: 300mg, 15 - 25 kg 200 mg, less than 15 kg: 10 mg/kg. To be taken daily for 3 days or to be taken as a single dose on day 1, then half the daily dose on days 2 - 5
152 Azithromycin 250 mg Tablet J01FA10-011-T10-01-XX A*, A/KK PRESCRIBER CATEGORY A*:
(i) Treatment of complicated respiratory tract infections;
(ii) Prophylaxis against Mycobacterium avium complex in patients with advanced HIV

PRESCRIBER CATEGORY A/KK:
(iii) Adult treatment of uncomplicated genital infections due to Chlamydia trichomatis or susceptible Neisseria gonorrhoea.
(iv) Treatment of pertussis
(v) Outpatient treatment of community associated pneumonia (CAP) with comorbidities
(vi) Acute bacterial rhinosinusitis in pregnant patients with antibiotic allergy
(vii) Yaws (treatment & prophylaxis)		 None i) 500 mg daily for 3 days;
ii) 1 g weekly
iii) 1 g as a single dose;
iv) 500mg in a single dose on day 1 then 250mg per day on days 2-5
153 Azithromycin 500 mg Injection J01FA10-011-P40-01-XXX A* i) Severe atypical pneumonia

ii) Treatment of pelvic inflammatory diseases (PID) caused by susceptible organisms in patients who require initial IV therapy		 None i) 500 mg IV as a single daily dose for a minimum of two days followed by 500 mg oral dose as a single daily dose to complete a 7 - 10 days course

ii) 500 mg as a single dose by the IV route for 1 or 2 days followed by oral azithromycin at a single daily dose of 250 mg to complete a 7-day course of therapy.
154 Bacampicillin 400mg Tablet J01CA06-000-T10-01-XXX B Infections caused by ampicillin-sensitive gram positive& gram negative microorganisms None ADULT: 400 mg twice daily. Severe infection: 800 mg twice daily. CHILD more than 25 kg: 12.5 - 25 mg/kg 12 hourly
155 Baclofen 10mg Tablet M03BX01-000-T10-01-XXX B Spasticity of the skeletal muscle None ADULT:5 mg 3 times daily.
Max: 80 mg daily (20mg 4 times a day).

CHILD: starting dose: 0.3mg/kg/day in divided dose, titrate up cautiously in 1 -2 weeks interval.
Usual maintenance dose: 0.75 - 2 mg/kg daily (age more than 10 years, maximum: 2.5 mg/kg daily). The dose should not exceed 40 mg/day in children below 8 years of age, but a maximum dose of 60 mg/day may be given in children over 8 years of age.

Dosing is individualised and according to product insert/protocol
156 Balanced Salt Solution B05CB10-907-L50-01-XXX A For irrigation during ocular surgery None Irrigate as directed
157 Balanced Salt Solution PLUS (fortified with sodium bicarbonate, glucose & glutathione) B05CB10-905-L50-01-XXX A For irrigation during intraocular surgery especially in patients with poor cornea endothelium and poorly controlled diabetes None Irrigate as directed
158 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.

3. Treatment of severe alopecia areata in adult patients.		 Indikasi 1. Severe active rheumatoid arthritis:
To be prescribed by Rheumatologist only

Indikasi 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.

Indikasi 3. Severe alopecia areata:
i. Reserved for patients who have demonstrated an inadequate therapeutic response, intolerance, or a documented contraindication to first-line conventional systemic therapies, which includes corticosteroids or non-targeted immunosuppressants.
ii. To be prescribed by Dermatologists only.
 Indikasi 1. Severe active rheumatoid arthritis:
4mg once daily

Indikasi 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)

Indikasi 3. Severe alopecia areata:
Administer 4 mg once daily, tapering to 2 mg for maintenance once sustained control is achieved. Initiate at 2 mg once daily for patients aged ≥ 65 years, those with chronic or recurrent infections, or those at elevated risk for VTE, MACE, or malignancy; this starting dose may be escalated to 4 mg if disease control remains inadequate.
159 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.

3. Treatment of severe alopecia areata in adult patients.		 Indikasi 1. Severe active rheumatoid arthritis:
To be prescribed by Rheumatologist only

Indikasi 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.

Indikasi 3. Severe alopecia areata:
i. Reserved for patients who have demonstrated an inadequate therapeutic response, intolerance, or a documented contraindication to first-line conventional systemic therapies, which includes corticosteroids or non-targeted immunosuppressants.
ii. To be prescribed by Dermatologists only.
 Indikasi 1. Severe active rheumatoid arthritis:
4mg once daily

Indikasi 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)

Indikasi 3. Severe alopecia areata:
Administer 4 mg once daily, tapering to 2 mg for maintenance once sustained control is achieved. Initiate at 2 mg once daily for patients aged ≥ 65 years, those with chronic or recurrent infections, or those at elevated risk for VTE, MACE, or malignancy; this starting dose may be escalated to 4 mg if disease control remains inadequate.
160 Barium Sulphate Suspension V08BA01-183-L80-01-XXX B For x-ray examination of the alimentary tract:
i) Oesophagus
ii) Stomach and duodenum
iii) Colon		 - i) Up to 150 ml of a 50% - 200% suspension orally
ii) Up to 300 ml of a 30% - 200% suspension orally
iii) Up to 2 litre of a 30% - 200% suspension orally
161 Basiliximab 20mg Injection L04AC02-000-P30-01-XXX A* Prophylaxis of acute organ rejection in de novo renal transplantation. None ADULT & CHILD 2 years and above & 35 kg or more:20 mg /dose. 2 years or more but less than 35kg:10 mg/dose. First dose given within 2 hours before start of transplantation and second dose 4th day after transplant
162 BCG (Bacillus Calmette-Guérin) Intravesical Injection L03AX03-000-P30-01-XXX A* Superficial bladder cancer None 80mg intravesically once weekly for 8 weeks.

Dosing is individualised and according to product inserts/protocols.
163 BCG Vaccine Freeze-Dried Injection J07AN01-000-P40-01-XXX C+ For the prevention of tuberculosis. None 0.05 to 0.1 ml by intradermal. Dosing is according to Immunisation Schedule under NIP.
164 Beclomethasone Dipropionate 100 mcg/dose Inhaler R03BA01-133-A21-01-XXX B Prophylaxis of asthma especially if not fully controlled by bronchodilators None Adults: The usual maintenance dose is one to two inhalations (200-400 mcg) twice daily.If needed,the dose can be increased up to 1600 mcg/day divided in two to four doses : Children 6-12 years old: One inhalation (200 mcg) two times daily and dose may be increased up to 800 mcg/day in divided two to four doses if necessary.
165 Beclomethasone dipropionate 100mcg and formoterol fumarate dihydrate 6mcg pressurized inhalation solution R03AK07-986-A21-01-XXX A*, A/KK Prescriber category A/KK:
i) Regular treatment of asthma where use of a combination product (inhaled corticosteroid and long-acting beta2 agonist) is appropriate in:
a) Patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2 agonist, or
b) Patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

Prescriber category A*:
ii) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
iii) Treatment of COPD patients with blood eosinophil count of 100 cells/microliter and more with history of repeated exacerbation despite regular treatment with long-acting bronchodilators.		 None For asthma, the dosage is based on treatment approach:
i) Maintenance therapy (taken as regular maintenance treatment with a separate as needed rapid-acting bronchodilator):
Dose recommendations for adults 18 years and above: One or two inhalations twice daily. The maximum daily dose is 4 inhalations.
ii) Maintenance and reliever therapy (taken as regular maintenance treatment and as needed in response to asthma symptoms):
Dose recommendations for adults 18 years and above: The recommended maintenance dose is 1 inhalation twice daily (one inhalation in the morning and one inhalation in the evening). Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. The maximum daily dose is 8 inhalations.

For COPD:
2 puffs two times a day.
166 Beclomethasone Dipropionate 200mcg/dose Inhaler R03BA01-133-A21-02-XXX A/KK Prophylaxis of asthma especially if not fully controlled by bronchodilators None ADULT : 1 - 2 puff twice daily. May increase to 2 puff 2 - 4 times daily CHILD : 1 puff twice daily. May increase to 1 puff 2 - 4 times daily
167 Bedaquiline 100mg Tablet J04AK05-138-T34-01-XXX A* Indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents. To be prescribed by Respiratory Physicians only. Week 1 to 2: 400mg once daily,
Week 3 to 24: 200mg three times per week
168 Bendamustine Hydrochloride 100mg/vial powder for concentrate for solution for infusion L01AA09-110-P43-01-XXX A* Bendamustine is indicated for monotherapy in patients with indolent B-cell non-Hodgkin's lymphomas (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Monotherapy for iNHL refractory to rituximab: 120mg/m2 body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks.
169 Bendamustine Hydrochloride 25mg/vial powder for concentrate for solution for infusion L01AA09-110-P43-02-XXX A* Bendamustine is indicated for monotherapy in patients with indolent B-cell non-Hodgkin's lymphomas (iNHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Monotherapy for iNHL refractory to rituximab: 120mg/m2 body surface area bendamustine hydrochloride on days 1 and 2; every 3 weeks.
170 Benralizumab 30mg Solution for Injection in Pre-filled Pen R03DX10-000-P50-01-xxx A* Benralizumab is indicated as an add-on maintenance treatment in adult patients from 18 years with severe eosinophilic asthma characterised by the following criteria:
a) At least two exacerbations in the past 12 months on the current standard therapy (high-dose inhaled corticosteroids plus long-acting bronchodilators) and/or need for treatment with systemic corticosteroids.
b) Eosinophil count in the blood of ≥0.3 G/L (corresponding to ≥300 cells/μL).		 To be prescribed by Respiratory Physician (Pulmonologist) only 30 mg of benralizumab every 4 weeks for the first 3 doses, and then every 8 weeks thereafter administered as subcutaneous injection
171 Benzalkonium 0.01% - 0.02% Cream D08AJ01000G1001XX B Prevention and treatment of nappy rash Wash and dry baby's bottom. Apply by spreading the cream evenly paying particular attention to the fold of the skin, after every nappy change
172 Benzathine Penicillin 2.4 MIU (1.8 g) Injection J01CE08-702-P40-01-XXX B i) Treatment of mild to moderately severe infections due to Penicillin G-sensitive organisms ii) Treatment of syphillis None i) ADULT: 1.2 mega units IM ii) For syphillis: 2.4 mega units weekly for 1 - 3 weeks
173 Benzhexol 2 mg Tablet N04AA01110T1001XX B i) Symptomatic treatment of paralysis agitans and of parkinsonism, arteriosclerotic, idiopathic, or post-encephalitic origin
ii) Alleviate extrapyramidal syndrome induced by phenothiazine derivatives or reserpine
iii) Spasmodic torticollis, facial spasms and other dyskinesia		 i) & iii)
Initial: 1-2mg daily
Maintenance: Gradual increment to 6-10mg daily according to response

ii) 5-15mg daily

Dosing is individualised and according to product insert / protocol.
174 Benzoic Acid Compound Half Strength (Paed) Ointment D01AE12952G5001XX C Tinea infections of the skin Apply sparingly to affected area once or twice daily
175 Benzoic Acid Compound Ointment D01AE12952G5002XX C Tinea infections of thickened skin of palms and soles Apply sparingly to affected area once or twice daily
176 Benzoin Compound Tincture D08AX00000L5001XX C Infected skin, lesions, cuts, abrasions, wounds and burns Apply undiluted to the skin 1 or 2 times daily. Duration of therapy, may be weeks to months depending on the infection being treated
177 Benzoyl Peroxide 10% Gel D10AE01241G3002XX B Mild to moderate acne vulgaris Apply 1-2 times daily preferably after washing with soap and water
178 Benzoyl Peroxide 5% Gel D10AE01241G3001XX B Mild to moderate acne vulgaris Apply 1-2 times daily preferably after washing with soap and water
179 Benzydamine HCl 0.15% Solution A01AD02-110-M20-01-XXX B For relief of painful condition of the oral cavity None Used as a 30 seconds gargle or rinse, undiluted. ADULT 15 ml. CHILD less 12 years 5-15 ml. Uninterrupted treatment should not be more than 7 days
180 Benzydamine HCl 3.0mg/ml throat spray A01AD02-110-A42-01-XXX A* Temporary relief of painful conditions of the mouth and throat including tonsillitis, sore throat, radiation mucositis, aphthous ulcers, pharyngitis, swelling, redness, inflammatory conditions, post-orosurgical and periodontal procedures. (For pediatric and otorhinolaringology use. Restrict to patients who are not able to gargle) None ADULTS and CHILDREN OVER 12 YEARS: 2-4 sprays (1-2mg) directly onto the sore/inflamed area and swallow gently. Repeat every 1 1/2 to 3 hours as necessary. CHILDREN 6-12 YEARS: 2 sprays (1mg) directly onto sore/ inflamed area and swallow gently. Repeat every 11/2 to 3 hours as necessary. CHILDREN UNDER 6 YEARS: Not recommended. Uninterrupted treatment should not exceed seven days, unless under medical supervision

Pages