Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
211 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
212 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).
213 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.
214 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
215 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
216 Budesonide / Glycopyrronium / Formoterol fumarate dihydrate 160 / 7.2 / 5 mcg per actuation Pressurised Inhalation Suspension R03AL11-989-A21-01-xxx A* Maintenance treatment in adult patients with moderate to very severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long‐acting beta2‐agonist or combination of a long-acting beta2‐agonist and a long‐acting muscarinic antagonist. i. To be prescribed by Consultant Respiratory Physician only.
ii. Restricted to confirmed COPD cases diagnosed according to spirometry criteria.
 The recommended and maximum dose is two inhalations twice daily.
217 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.
218 Budesonide 160mcg and Formoterol 4.5mcg Inhalation R03AKO7-989-A21-01-XXX A*, A/KK Prescriber category A/KK:
i) Regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta2-agonist) is appropriate:
- Patients not adequately controlled with inhaled corticosteroids and "as needed" inhaled short-acting beta2-agonists. or
- Patients already adequately controlled on both inhaled corticosteroids and long- acting beta2-agonists.

ii) As a reliever treatment for mild asthma patients who do not adhere to regular inhaled corticosteroid


Prescriber category A*:
iii) Treatment of COPD patients with a blood eosinophil count of 300 cells/microliter and more
iv) 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 i) Asthma Maintenance therapy: Adult ≥18 yr 160 mcg to 320 mcg bd. Some patients may require up to a max of 640 mcg bd. Adolescent 12-17 yr 160 mcg to 320 mcg bd. Childn 6-11 yr 160 mcg bd, <6 yr Not recommended.

Maintenance & relief Adult and adolescent ≥12 yr 320 mcg/day either as 160 mcg bd or 320 mcg od either morning or evening. For some patients a maintenance dose of 320 mcg bd may be appropriate. Patients should take 160 mcg additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 960 mcg should be taken on any single occasion. A total daily dose of more than 1280 mcg is not normally needed, however a total daily dose of up to 1920 mcg could be used for a limited period. Patients using more than 1280 mcg daily should seek medical advice, should be reassessed & their maintenance therapy reconsidered.

ii) Asthma reliever-only therapy: 160 mcg as needed, but no more than 960 mcg to be taken on any single occasion.

Children <12 yr: Not recommended


iii & iv) COPD: Adult ≥18 yr 320 mcg bd.
219 Budesonide 1mg/2ml Nebuliser Solution R03BA02-000-A30-02-XXX B Treatment of asthma in patients where use of a pressurized inhaler or dry powder formulation is unsatisfactory or inappropriate. None ADULT : Initially 1 - 2 mg twice daily.
CHILD 3 months - 12 years of age : 500 mcg - 1 mg. Maintenance dose : half of the above doses
220 Budesonide 200mcg/dose Inhalation R03BA02-000-A21-02-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.
221 Budesonide 500 mcg/2 ml Nebuliser Solution R03BA02-000-A30-01-XXX B Treatment of asthma in patients where use of a pressurized inhaler or dry powder formulation is unsatisfactory or inappropriate. None ADULT : Initially 1 - 2 mg twice daily.
CHILD 3 months - 12 years of age : 500 mcg - 1 mg. Maintenance dose : half of the above doses
222 Budesonide 64mcg Nasal Spray R01AD05-000-A41-03-XXX A/KK Seasonal allergic, perennial rhinitis and nasal polyposis None ADULT and CHILD 6 years and older. Rhinitis : 2 spray into each nostril once daily in the morning or 1 spray into each nostril twice daily. Nasal polyps : 2 spray twice daily
223 Budesonide 9mg Prolonged Release Tablets A07EA06-000-T52-01-xxx A* Budesonide is indicated in adults for induction of remission in patients with mild to moderate active ulcerative colitis (UC) where 5-ASA treatment is not sufficient None The recommended daily dose for induction of remission is one 9 mg tablet in the morning, for up to 8 weeks.
When treatment is discontinued, it may be useful to gradually reduce the dose.
224 Bumetanide 0.5 mg/ml Injection C03CA02-000-P30-01-XX A* Oedema used in furosemide allergic patient None IV injection: 1 - 2 mg repeated after 20 mins. IV infusion: 2 - 5 mg over 30 - 60 mins
225 Bumetanide 1 mg Tablet C03CA02000T1001XX A* Oedema used in furosemide allergic patient None 1 mg in the early evening.
Max: 10mg daily
226 Bupivacaine 0.5 % Heavy Injection N01BB01-110-P30-03-XXX A Used for spinal anaesthesia None ADULT: 2 - 4 ml. Not to exceed 2 mg/kg in a single dose
227 Bupivacaine 0.5 % Injection N01BB01-110-P30-02-XXX B For peripheral sympathetic nerve and epidural (excluding caudal) anaesthesia and obstetrics anaesthesia None Regional nerve block or epidural block: 15 - 30 ml. Nerve block of finger or toe: 2 - 6 ml. Maximum: 2 mg/kg body weight in any 4 hours period, equivalent to 25 - 30 ml in adults of average weight
228 Bupivacaine 0.5 % with Adrenaline 1:200,000 Injection N01BB51-975-P30-01-XXX B Regional nerve block or epidural block. None 10 - 40 ml (0.25 %) or maximum : 2 mg/kg body weight in any 4 hours period, equivalent to 25 - 30 ml of 0.5% solution
229 Buprenorphine 10mcg/hr transdermal patch N02AE01-110-M70-01-XXX A* Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Not suitable for the treatment of acute pain. For elderly patients or patients with comorbidities/difficult to swallow Once weekly transdermal patch/for hospital use only. Patient aged 18 years and over. Initial dose: 5 mcg/hr For elderly: Renal impairment. No special dose adjustments necessary in patients with renal impairment Hepatic impairment Patients with hepatic insufficiency should be carefully monitored during the treatment with buprenorphine patch. Alternate therapy should be considered. Patch should be used with cautions in severe hepatic impairment patient
230 Buprenorphine 5mcg/hr transdermal patch N02AE01-110-M70-03XX A* Treatment of non-malignant pain of moderate intensity when an opioid is necessary for obtaining adequate analgesia. Not suitable for the treatment of acute pain. For elderly patients or patients with comorbidities/difficult to swallow Once weekly transdermal patch/for hospital use only. Patient aged 18 years and over. Initial dose: 5 mcg/hr For elderly: Renal impairment. No special dose adjustments necessary in patients with renal impairment Hepatic impairment Patients with hepatic insufficiency should be carefully monitored during the treatment with buprenorphine patch. Alternate therapy should be considered. Patch should be used with cautions in severe hepatic impairment patient
231 Busulfan 2mg Tablet L01AB01-000-T10-01-XXX A i) Chronic myeloid leukaemia (CML) and other myeloproliferative diseases;
ii) Haemopoietic stem cell transplant (HSCT)- refer to specific protocols		 None i) ADULT: Initial: 2 - 4 mg daily. Maintenance: 0.5 - 2 mg daily. Stop when white blood cell less than 20 x 109/L. CHILD: 60 mcg/kg body weight daily ii) CHILD: Induction 60 mcg/kg body weight daily (maximum 4 mg) if leucocytes more than 20,000/mm3 and platelets more than 100,000/mm3. Maintenance 10 - 30mcg/kg (maximum 2 mg daily)
232 Busulfan 6mg/ml Injection L01AB01-000-P30-01-XXX A* For use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (HSCT) for chronic myelogenous leukemia.

To be prescribed by paediatric oncologist and consultant haematologist trained in transplant only.		 In selected cases with high risk of liver toxicity and intolerance to oral busulfan. 0.8 mg/kg of ideal body weight or actual body weight, whichever is lower via central venous catheter as a 2-hour infusion on the basis of every 6 hours for 4 days, for a total of 16 doses. For obese or severely obese patients, IV Busulfan should be administered based on adjusted ideal body weight
233 Cabergoline 0.5mg Tablet G02CB03-000-T10-01-XXX A* i) Inhibition of physiological lactation soon after parturition
ii) Suppression of established lactation
iii) Treatment of hyperprolactinaemic disorders		 None i) 1 mg as a single dose during the first post-partum day
ii) 0.25 mg every 12 hours for 2 days
iii) Initial: 0.5 mg/week given in one or two divided weekly doses. May gradually increase dose by 0.5 mg/week no sooner than every 4 weeks until an optimal therapeutic response is achieved. Usual dose range: 0.25 mg to 2 mg/week (higher doses >1 mg /week may be divided in as many as 3 to 4 divided doses)
234 Calamine Cream D04AX00000G1001XX C+ Soothes and relieves nappy rashes, prickly heat, minor skin irritations, insect bites and sunburn, Pruritic skin conditions. Apply to the affected area as required, 1-3 times daily
235 Calamine Lotion D04AX00000L8001XX C+ Soothes and relieves nappy rashes, prickly heat, minor skin irritations, insect bites and sunburn, Pruritic skin conditions. Apply to the skin as required and allow to dry, 1-3 times daily
236 Calamine with 0.25 - 0.5% Menthol Lotion D04AX00952L6001XX C Soothes and relieves nappy rashes, prickly heat, minor skin irritations, insect bites and sunburn, Pruritic skin conditions. Apply to the skin as required and allow to dry, 1 - 3 times daily
237 Calamine with 0.5% Phenol Cream D04AX00-952-G10-01-XXX C Relief symptoms of mild sunburn and other minor skin conditions (such as dry and itchy skin) None Apply to the affected area as required
238 Calcipotriol 50 mcg/g & Betamethasone Dipropionate 0.5 mg/g Gel D05AX52-952-G30-01-XXX A* Topical treatment of scalp and non-scalp plaque psoriasis vulgaris in adults None Should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for non-scalp areas. The body surface area treated with calcipotriol containing products should not exceed 30% and maximum dose should not exceed 15g or 100g/ week
239 Calcipotriol 50 mcg/g & Betamethasone Dipropionate 0.5 mg/g Ointment D05AX52-952-G50-01-XXX A* Resistant plaque psoriasis None Apply once daily up to 4 weeks with maximum weekly dose of 100g and maximum treatment area 30% of body surface
240 Calcipotriol 50mcg/g Cream D05AX02-000-G10-01-XXX A* Psoriasis vulgaris. None ADULT Apply to the affected skin lesions twice daily. Maintenance therapy may be achieved with less frequent application. The weekly dose should not exceed 100 g.
CHILD over 6 years, apply twice daily. 6-12 years maximum 50gm weekly, over 12 years maximum 75gm weekly.

The dosing is individualized according to product insert / protocol

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