Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
211 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.
212 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
213 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.
214 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
215 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
216 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.
217 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
218 Bumetanide 1 mg Tablet C03CA02000T1001XX A* Oedema used in furosemide allergic patient None 1 mg in the early evening.
Max: 10mg daily
219 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
220 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
221 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
222 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
223 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
224 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)
225 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
226 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)
227 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
228 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
229 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
230 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
231 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
232 Calcipotriol 50mcg/g Ointment D05AX02-000-G50-01-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 100g.
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
233 Calcipotriol Hydrate 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
234 Calcipotriol Monohydrate 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
235 Calcipotriol Monohydrate 50mcg/g & Betamethasone Dipropionate 0.5mg/g Cutaneous Foam D05AX52-946-L62-01-XXX A* Resistant plaque psoriasis Second line topical treatment when unresponsive to topical steroid and coal tar Apply once daily up to 4 weeks with maximum daily dose of 15g and maximum treatment area 30% of body surface
236 Calcitonin (synthetic Salmon) 100 IU Injection H05BA01-000-P30-02-XXX A* Acute hypercalcaemia None 5-10 IU per kg body weight in 500mL physiological saline daily by i.v. infusion over at least 6 hours or by slow i.v. injection in 2-4 divided doses spread over the day. Renal impairment: Dosage adjustment needed.
237 Calcitonin (Synthetic Salmon) 50 IU Injection H05BA01-000-P30-01-XXX A* Acute hypercalcaemia None 5-10 IU per kg body weight in 500mL physiological saline daily by i.v. infusion over at least 6 hours or by slow i.v. injection in 2-4 divided doses spread over the day. Renal impairment: Dosage adjustment needed.
238 Calcitriol 0.25 mcg Capsule A11CC04-000-C10-01-XXX A/KK i) Osteoporosis
ii) Chronic kidney disease-mineral bone disorder
iii) Hypoparathyroidism and pseudohypoparathyroidism
iv) Rickets and osteomalacia		 None i) 0.25 mcg 2 times daily
ii) ADULT and CHILD 3 years and older:
Initial dose: 0.25 mcg.
In patients with normal or only slightly reduced serum calcium levels, doses of 0.25 mcg every other day is sufficient. Dosage may be increased if necessary to 0.5 mcg/day. Maintenance dose: 0.5-1mcg daily
CHILD less than 3 years: 10 to 15 ng/kg/day
iii) and iv) 0.25 mcg/day given in the morning
239 Calcitriol 1 mcg/ml Injection A11CC04-000-P30-01-XXX A* Management of hypocalcaemia and/or secondary hyperparathyroidism in patients undergoing chronic renal dialysis None Initially dose, depending on severity, 1 mcg (0.02 mg/kg) to 2 mcg 3 times weekly, approximately every other day
240 Calcitriol 2 mcg/ml Injection A11CC04-000-P30-02-XXX A* Management of hypocalcaemia and/or secondary hyperparathyroidism in patients undergoing chronic renal dialysis None Initially dose, depending on severity, 1 mg (0.02 mg/kg) to 2 mg 3 times weekly, approximately every other day

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