Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
241 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.
242 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
243 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
244 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
245 Calcium Carbonate 500 mg Capsule A12AA04-121-C10-01-XXX B i) Hyperphosphatemia (phosphate binder) in chronic kidney disease patients
ii) Calcium supplementation		 None i) Total dose of elemental calcium from calcium-based phosphate binder not to exceed 1,500 mg/day.
Dosing is individualised based on serum phosphate level and according to product insert/protocol

ii) 500 mg to 4g per day as calcium carbonate in 1-3 divided doses (500mg capsule contains 200mg elemental calcium)
Dosing is individualised based on serum calcium level and according to product insert/protocol
246 Calcium Carbonate 500 mg Tablet A12AA04-121-T10-01-XXX B i) Hyperphosphatemia (phosphate binder) in chronic kidney disease patients
ii) Calcium supplementation		 None i) Total dose of elemental calcium from calcium-based phosphate binder not to exceed 1,500 mg/day.
Dosing is individualised based on serum phosphate level and according to product insert/protocol

ii) 500 mg to 4g per day as calcium carbonate in 1-3 divided doses (500mg capsule contains 200mg elemental calcium)
Dosing is individualised based on serum calcium level and according to product insert/protocol
247 Calcium Chloride Dihydrate, Sodium Chloride, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate,Potassium Chloride, and Malic Acid Solution B05BB01-905-P60-02-XXX A Replacement of extracellular fluid losses in the case of isotonic dehydration, where acidosis is present or imminent. None The maximum infusion rate depends on the needs of the patient in fluid replacement and electrolytes, patient's weight, clinical condition, and biological status. Adults, elderly, adolescents:500ml-3L/24hr. Babies, children: 20ml to 100ml/kg/24 hr.
248 Calcium Disodium Edetate 200 mg Injection V03AB03-999-P30-01-XXX A Lead Poisoning None IM (Lead encephalopathy): 1000 mg/m(2)/day IM in divided equal doses 8 to 12 hours apart, for 5 days. Therapy is interrupted for 2 to 4 days, and followed by an additional 5-day course of therapy, if indicated. Do not exceed the recommended daily dosage. IV: 1000 mg/m(2)/day administered IV over 8 to 12 hours for 5 days. Therapy is interrupted for 2 to 4 days, and followed by an additional 5-day course of therapy, if indicated.
249 Calcium Gluconate 10% Injection A12AA03-000-P30-01-XXX B i)Acute hypocalcaemia
ii)Hypocalcaemic tetany
iii)Cardiac resuscitation		 None i) ADULT: 1 to 2 g (2.2 to 4.4 mmol).
CHILD: 50mg/kg/dose (0.5ml/kg/dose) IV short infusion over at least 10 to 20 minutes, per dose. Max: 20ml per dose;
ii) ADULT: 1g (2.2 mmol) by slow IV injection followed by continuous infusion of 4 g (8.8 mmol) daily;
iii) IV or intracardiac injection, 1g (2.2mmol).

Dosing is individualised and according to product insert/protocol.
250 Calcium Lactate 300 mg Tablet A12AA05-125-T10-01-XXX C For prophylaxis of calcium deficiency and treatment of chronic hypocalcaemia None ADULT: 300mg - 600mg (as elemental Ca) daily in in divided doses;

Dosing is individualised and according to product insert/protocol
251 Calcium Polystyrene Sulphonate Powder V03AE01-999-F21-01-XXX A*, A/KK PRESCRIBER CATEGORY A*:
Hyperkalemia resulting from acute or chronic renal failure

PRESCRIBER CATEGORY A/KK:
For asymptomatic mild hyperkalemia without ECG changes		 None ADULT: 15 – 30g daily in 2-3 divided doses. Each dose should be suspended in 30 – 50ml of water and administered orally at least 3 hours before or 3 hours after other oral medications.

CHILD: 0.125-0.25g/kg orally or rectally 4 times per day (max: 10g/dose).
NEONATE: 0.125-0.25g/kg rectally 4 times/day. Evacuate the resin 8-12 hours after the last dose with glycerine enema.
(Oral route is CONTRAINDICATED in neonates).


Dosing is individualised and according to product insert/protocol
252 Calfactant 35mg/ml intratracheal suspension R07AA02-000-L91-04-XXX A* For the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS and for the treatment (“rescue”) of premature infants who develop RDS.

Prophylaxis: Indicated for premature infants <29 weeks of gestational age at significant risk for RDS. Should be administered as soon as possible, preferably within 30 minutes after birth.

Treatment: Indicated for infants ≤72 hours of age with RDS (confirmed by clinical and radiologic findings) and requiring endotracheal intubation.		 None 3mL/kg body weight at birth to be administered every 12 hours for total up to 3 doses.
253 Capecitabine 150 mg Tablet L01BC06000T1002XX A* i) Metastatic breast cancer;
ii) Treatment of colorectal cancer in adjuvant and metastatic setting;
iii) advanced oesophagogastric cancer in combination with a platinum-based regimen.		 i. As monotherapy or in combination with docetaxel: 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
ii. As monotherapy: 1250 mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 7-day rest period. As combination: 1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
iii. In combination with a platinum: 1000 mg/m2 twice daily for 14 days followed by a 7 day rest period.

Dosing is individualised and according to product insert/ treatment protocol.
254 Capecitabine 500 mg Tablet L01BC06000T1001XX A* i) Metastatic breast cancer;
ii) Treatment of colorectal cancer in adjuvant and metastatic setting;
iii) advanced oesophagogastric cancer in combination with a platinum-based regimen.		 i. As monotherapy or in combination with docetaxel: 1250 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
ii. As monotherapy: 1250 mg/m2 twice daily (morning and evening) for 2 weeks, followed by a 7-day rest period. As combination: 1000 mg/m2 twice daily for 2 weeks followed by a 7-day rest period.
iii. In combination with a platinum: 1000 mg/m2 twice daily for 14 days followed by a 7 day rest period.

Dosing is individualised and according to product insert/ treatment protocol.
255 Captopril 25 mg Tablet C09AA01000T1002XX B i) Hypertension
ii) Congestive heart failure
iii) Post-myocardial infarction
iv) Diabetic kidney disease		 None i) Initial: 25-75mg in 2-3 divided doses
Maintenance: 100-150mg in 2-3 divided doses

ii) Initial: 6.25-12.5mg 2-3 times daily
Maintenance: 75-150mg daily in divided doses

iii) Initial: 6.25mg followed by 12.5mg and then 25mg
Maintenance: 75-150mg daily in 2-3 divided doses

iv) 75-100 mg in divided doses

Dosing is individualised and according to product insert / protocol.
256 Carbachol 0.01% Intraocular Solution S01EB02-100-D20-01-XXX A For intraocular use for miosis during surgery None Instill no more than 0.5 ml gently into the anterior chamber
257 Carbamazepine 100 mg/5 ml (2% w/v) Syrup N03AF01-000-L90-01-XXX A Epilepsy None ADULT:
Initially, 100-200 mg once or twice daily gradually increased by increments of 100-200 mg every 2 week.
Maintenance: 0.8-1.2 g daily in divided doses.
Max: Adult: 1.6 g daily

CHILD:
10-15 years: 0.6-1 g daily
5-10 years: 400-600 mg daily
1-5 years: 200-400 mg daily
less than or equal to 1 year: 100-200 mg daily.
Alternatively, 10-20 mg/kg body weight daily in divided doses.
258 Carbamazepine 200 mg CR Tablet N03AF01-000-T50-01-XXX A i) Epilepsy
ii) Trigeminal Neuralgia
iii) Idiopathic glossopharyngeal neuralgia
iv) Acute mania and maintenance of bipolar affective disorder to prevent or attenuate recurrence		 None ADULT:
Initial, 200 mg twice daily for the first week, may increase dosage by 200 mg/day at weekly intervals until optimal response is obtained. Maximum 1.6 g/day.

CHILD:
usual maximum dosage 1000 mg/day in children 12-15 years of age, 1200 mg/day in patients above 15 years of age
259 Carbamazepine 200 mg Tablet N03AF01-000-T10-01-XXX B i) Epilepsy
ii) Trigeminal neuralgia		 i) ADULT: 100 - 200 mg 1 - 3 times daily increased gradually to usual dose of 0.8 - 1.2 g daily in divided doses.
CHILD:
Up to 1 year: 100 - 200 mg daily
1 - 5 yrs: 200 - 400 mg daily
5 - 10 years: 400 - 600 mg daily
10 - 15 years: 0.6 - 1 g daily

ii) The initial dosage of 200 to 400mg should be slowly raised daily until freedom from pain is achieved (normally at 200mg 3 to 4 times daily). The dosage should then be gradually reduced to the lowest possible maintenance level. In elderly patients, an initial dose of 100mg twice daily is recommended.
260 Carbamazepine 400 mg CR Tablet N03AF01-000-T50-02-XXX A i) Epilepsy
ii) Trigeminal Neuralgia
iii) Idiopathic glossopharyngeal neuralgia
iv) Acute mania and maintenance of bipolar affective disorder to prevent or attenuate recurrence		 None ADULT:
Initial, 200 mg twice daily for the first week, may increase dosage by 200 mg/day at weekly intervals until optimal response is obtained. Maximum 1.6 g/day.

CHILD:
usual maximum dosage 1000 mg/day in children 12-15 years of age, 1200 mg/day in patients above 15 years of age
261 Carbamide (Urea) 10 % Cream D02AE01000G1001XX B Contact irritant dermatitis, infantile eczemas, acute and chronic allergic eczemas, icthyosis, hyperkeratotic Apply sparingly and rub into affected area 2 - 3 times daily and when required after cleansing skin
262 Carbetocin 100 mcg/ ml Injection H01BB03-000-P20-01-XXX A* Prevention of uterine atony and postpartum hemorrhage following elective cesarean section under epidural or spinal anaesthesia A single IV dose of 100mcg (1ml) is adminitered by bolus injection, slowly over 1minute, only when delivery of the infant has been completed by caesarean section under epidural or spinal anaesthesia, before or after delivery of the placenta.
263 Carbimazole 5 mg Tablet H03BB01000T1001XX B Hyperthyroidism ADULT: Initially, 10-60mg daily in divided doses given 8 hourly. Maintenance: 5 to 20mg daily. CHILDREN > 6 years: Initially 15mg daily in divided doses. CHILDREN 1-6 years: Initially 7.5mg daily in divided doses
264 Carboplatin 10mg/mL Injection L01XA02000P4001XX A* i) Solid tumours;
ii) Salvage therapy for lymphoma		 360 - 400 mg/m2 BSA, by IV infusion over 15 mins to 1 hour on Day 1 every 4 weeks. Alternatively, prescription may be based on Area Under Curve (AUC) calculations. CHILD: 500-600 mg/m2 over 1 hour once every 3 weeks. Salvage regimes in lymphomas - refer to specific protocols. Starting dose in renal impairment, please refer to product insert.
265 Carboprost Tromethamine 250mcg Injection G02AD04-999-P30-01XXX A* Treatment of refractory postpartum haemorrhage unresponsive to conventional methods of management. None Initially 250 mcg deep IM inj. The dose may be repeated at intervals of 15-90 min if necessary. Max total dose: 2000 mcg (8 doses).
266 Cardioplegia solution containing Potassium Chloride, Magnesium chloride & Procaine HCl Injection B05XA16-934-P30-01-XXX A* For myocardial preservation(prevent myocardial damage) during cardiac surgery None Dilute 20 ml to 1 L of Ringer solution (cooled to 2-8 ∞C prior to use). Initial rapid instillation into aortic root at 300 ml/m≤ body surface area/min for 3 minutes. Should myocardial activity persist or recur instill at 300ml/m≤ body surface area/min for 2 minutes
267 Cariprazine Hydrochloride 1.5mg Capsule N05AX15-110-C11-01-xxx A* For treatment of schizophrenia in adult patients. As a second-line therapy for patients especially in cases with predominant negative symptoms. Once-daily for 1.5mg, 3.0mg, 4.5mg, 6.0mg

Dose in Renal Impairment:
No dose adjustment for mild to moderate renal impairment. NOT recommended for severe impairment (CrCL< 30mL/min).

Dose in Liver Failure:
No dose adjustment for mild to moderate hepatic impairment. NOT recommended for severe impairment (Child-Pugh score between 10-15).
268 Cariprazine Hydrochloride 3.0mg Capsule N05AX15-110-C11-02-xxx A* For treatment of schizophrenia in adult patients. As a second-line therapy for patients especially in cases with predominant negative symptoms. Once-daily for 1.5mg, 3.0mg, 4.5mg, 6.0mg

Dose in Renal Impairment:
No dose adjustment for mild to moderate renal impairment. NOT recommended for severe impairment (CrCL< 30mL/min).

Dose in Liver Failure:
No dose adjustment for mild to moderate hepatic impairment. NOT recommended for severe impairment (Child-Pugh score between 10-15).
269 Cariprazine Hydrochloride 4.5mg Capsule N05AX15-110-C11-03-xxx A* For treatment of schizophrenia in adult patients. As a second-line therapy for patients especially in cases with predominant negative symptoms. Once-daily for 1.5mg, 3.0mg, 4.5mg, 6.0mg

Dose in Renal Impairment:
No dose adjustment for mild to moderate renal impairment. NOT recommended for severe impairment (CrCL< 30mL/min).

Dose in Liver Failure:
No dose adjustment for mild to moderate hepatic impairment. NOT recommended for severe impairment (Child-Pugh score between 10-15).
270 Cariprazine Hydrochloride 6.0mg Capsule N05AX15-110-C11-04-xxx A* For treatment of schizophrenia in adult patients. As a second-line therapy for patients especially in cases with predominant negative symptoms. Once-daily for 1.5mg, 3.0mg, 4.5mg, 6.0mg

Dose in Renal Impairment:
No dose adjustment for mild to moderate renal impairment. NOT recommended for severe impairment (CrCL< 30mL/min).

Dose in Liver Failure:
No dose adjustment for mild to moderate hepatic impairment. NOT recommended for severe impairment (Child-Pugh score between 10-15).

Halaman-halaman