Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1471 Sodium Citrate 3.8% Solution B05CB02136H3001XX B Sterile solution for irrigation or washout of infected bladder Dose depending on clinical cases
1472 Sodium Citrate, Citric Acid Mixture 3 g/10 ml B05CB02136L2101XX B Citrates and citric acid solutions are used to correct the acidosis of certain renal tubular disorders to treat metabolic acidosis for long-term urine alkalinization for prevention and treatment of uric acid and calcium kidney stones and as nonparticulate neutralizing buffers ADULT 10 - 20 ml. CHILD up to 1 year 2.5 ml tds; 1-5 year 5 ml tds; 6-12 years 10 ml tds. To be taken well diluted with water
1473 Sodium Cromoglycate 2% Eye Drops S01GX01-520-D20-01-XXX A/KK Prevention and treatment of allergic conjunctivitis including seasonal and perennial allergic conjunctivitis and vernal keratoconjunctivitis None 1 or 2 drops 4 times daily
1474 Sodium Dichloroisocyanurate Tablet V07AV00-000-T10-01-XXX C Low and medium level disinfectant None 50 - 10,000 ppm av chlorine
1475 Sodium Fusidate 2% Ointment D06AX01520G5001XX A Skin infections caused by staphylococci, streptococci, corynebacterium minutissumun and other sodium fusidate-sensitive organisms Apply to affected area 2 - 3 times daily
1476 Sodium Fusidate 250 mg Tablet J01XC01520T1001XX A* Treatment of infections caused by susceptible organisms especially Staphylococcal infections including Methicillin Resistant Staphylococcus aureus (MRSA) ADULT: 500 mg 3 times daily, skin and soft tissue infection: 250 - 500 mg twice daily
1477 Sodium glycerophosphate for addition into infusion solution, 20ml vial B05XA14171P3001XX A Indicated in adult patients and infants as a supplement in intravenous nutrition to meet the requirement of phosphate. Adults: The recommended dosage is individual. The recommended daily dosage of phosphate during intravenous nutrition would normally be 10-20mmol. This can be met by using 10-20ml of sodium glycerophosphate to the infusion solution or to the admixture for which compatibility has been proved. Infants: The recommended dosage is individual. The recommended dose for infants and neonates is 1.0-1.5 mmol/kg bodyweight/day.
1478 Sodium Hypochlorite Solution V07AV00000L9903XX C Low-level disinfectant and antiseptic Antiseptic: less than 0.5%. Disinfectant: 5%
1479 Sodium Iodide (Iodide-131) Injection V09FX03200P3001XX A* Used in the determination of various thyroid functions 5 - 50 millicuries
1480 Sodium Iodide (Iodine-131) Capsule V09FX03200C1001XX A* Determination of various thyroid functions 5 - 10 milicuries (5 mCi for whole body scan)
1481 Sodium Iodide (Iodine-131) Capsule (Therapeutic) V10XA01200C1001XX A* i) Thyrotoxicosis ii) Thyroid carcinoma i) 2 - 30 millicuries ii) 80 - 300 millicuries
1482 Sodium Iodide (Iodine-131) Solution V10XA01200L9901XX A* i) Thyrotoxicosis ii) Thyroid carcinoma i) 5-25 millicuries ii) 30-150 millicuries
1483 Sodium Nitrite 30mg/ml Injection V03AB08-220-P30-01-XX B For cyanide poisoning None Adult: 300 mg sodium nitrite IV over 3 minutes followed after 5 minutes with 12.5g sodium thiosulphate IV administered over 10 minutes. CHILD: 4 - 10 mg/kg of sodium nitrite (max: 300 mg) followed by 400 mg/kg of sodium thiosulfate, as a 25 or 50% solution (max: 12.5 g). Methaemoglobin concentration should not exceed 30-40%. If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses.
1484 Sodium Nitroprusside 10 mg/ml Injection C02DD01520P3001XX A i) Hypertensive crisis ii) Controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures i) By IV infusion, initially 0.5-1.5 mcg/kg/min, then adjusted before increasement of 0.5 mcg/kg/min every 5 mins within range 0.5-8 mcg/kg/min (lower doses in patients already receiving other antihypertensives); stop if marked response not obtained with max dose in 10 minutes. Use only in infusion with 5 % Dextrose IV. ii) By IV infusion, max: 1.5 mcg/kg/min
1485 Sodium Phosphate (Phosphorus-32) Injection V10XX01162P3001XX A* Polycythemia vera, chronic myeloid and chronic lymphocytic leukaemia and palliative treatment of bone metastases Initially 5 millicuries, follow if necessary by a dose of not more than 3 or 4 millicurie at intervals of not less than 2 months
1486 Sodium picosulfate, magnesium oxide & citric acid powder for oral solution A06AB58-921-L50-01-XXX A/KK i) To clean the bowel prior to X-ray examination or endoscopy.
ii) To clean the bowel prior to surgery when judged clinically necessary.		 ADULTS:
a) Split-Dose Dosing Regimen (Preferred Method)
• First dose should be taken during the evening before the procedure (e.g. 5:00 to 9:00 PM) followed by five 250 ml drinks (upper line on the dosing cup) of clear liquids before bed. Clear liquids should be consumed within 5 hours.
• Second dose to be taken the next day approximately 5 hours before the procedure followed by at least three 250ml drinks of clear liquids before the procedure. Clear liquids should be consumed within 5 hours up until 2 hour before the time of the procedure.

b) Day-Before Dosing Regimen (Alternative Method)
(Alternative dosing method for patients for whom the Split-Dosing is inappropriate).
• First dose to be taken in the afternoon or early evening (e.g., 4:00 to 6:00 PM) before the procedure followed by five 250 ml drinks (upper line on the dosing cup) of clear liquids before the next dose. Clear liquids should be consumed within 5 hours.
• Second dose to be taken approximately 6 hours later in the late evening (e.g., 10:00 PM to 12:00 AM), the night before the procedure followed by three 250 ml drinks of clear liquids before bed. Clear liquids should be consumed within 5 hours.

CHILDREN:
The first dose reconstituted in water as directed, taken before 8 am on the day before the procedure. Second dose 6 to 8 hours later.
• 1 - 2 years: 1⁄4 sachet morning, 1⁄4 sachet afternoon
• 2 - 4 years: 1⁄2 sachet morning, 1⁄2 sachet afternoon
• 4 - 9 years: 1 sachet morning, 1⁄2 sachet afternoon
• 9 and above: adult dose
1487 Sodium Polystyrene Sulphonate Powder V03AE01520F2101XX A Treatment and prevention of hyperkalaemia associated with anuria or severe oliguria, in dialysis patients or those on prolonged peritoneal dialysis ADULT : Oral : 15 g 1 - 4 times/day. Rectal : 30 g in 100 ml 2% methylcellulose and 100 ml water as a daily retention enema. Retain for 9 hours followed by non-sodium cleansing enema. CHILD : 1 g/kg in 1 - 4 doses in acute hyperkalemia. Maintenance : 0.5 g/kg/daily
1488 Sodium Tetradecyl Sulphate 1 % Injection C05BB04183P3001XX A* Sclerotherapy of oesophageal varices, haemorrhoids and varicose veins 0.5-2 mL into the submucosal layer at the base of the oesophageal varix or the haemorrhoid; several injections may be given at different sites, max. total injected 10-15 mL of 1% per treatment
1489 Sodium Tetradecyl Sulphate 3 % Injection C05BB04183P3002XX A* Sclerotherapy of oesophageal varices, haemorrhoids and varicose veins 0.5-2 mL into the submucosal layer at the base of the oesophageal varix or the haemorrhoid, several injections may be given at different sites, max. total injected 10-15 mL of 1% per treatment
1490 Sodium Thiosulphate 500 mg/ml Injection V03AB06181P3001XX B For cyanide poisoning None ADULT: To be given after 300 mg of sodium nitrite has been admin over 5-20 min: 12.5 g of sodium thiosulfate (50 ml of a 25% solution or 25 ml of a 50% solution) given over 10 min.
Methaemoglobin concentration should not exceed 30-40%.
If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses.

CHILD: To be given after 4-10 mg/kg of sodium nitrite (max: 300 mg) has been admin: 400 mg/kg of sodium thiosulfate, as a 25 or 50% solution (max: 12.5 g). Methaemoglobin concentration should not exceed 30-40%.
If symptoms of cyanide toxicity recur, the doses of nitrite and thiosulfate may be repeated after 30 min at half the initial doses.
1491 Sodium Valproate 200mg Tablet N03AG01-520-T10-01-XXX B i. Epilepsy
ii. Treatment and prevention of mania associated with bipolar disorders		 None i. Epilepsy:
ADULT: Initially 600 mg/day in 2 - 3 divided doses, dose may be increased by 200 mg at 3-day intervals to max 2.5 g/day. Usual maintenance dose: 1-2 g/day (20-30 mg/kg/day).
CHILD:
- More than 20 kg. Initially 400 mg/day with spaced increases until control is achieved (usually 20-30 mg/kg/day), dose may be increased to 35 mg/kg/day.
- Less than 20 kg 20 mg/kg/day, in severe cases the dose may be increased provided plasma concentration can be monitored.

ii. Treatment and prevention of mania associated with bipolar disorders:
ADULT: The recommended initial dose is 1000mg/day. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose, which produces the desired clinical effects. The recommended maintenance dosage for the treatment of bipolar disorder is between 1000mg and 2000mg daily. In exceptional cases, the dose may be increased to not more than 3000mg daily.
1492 Sodium Valproate 200mg/5ml Syrup N03AG01-520-L90-01-XXX B i) Treatment of generalized or partial epilepsy.
ii) Treatment and prevention of mania associated with bipolar disorder		 None i. Epilepsy:
ADULT: Initially 600 mg/day in 2 - 3 divided doses, dose may be increased by 200 mg at 3-day intervals to max 2.5 g/day. Usual maintenance dose: 1-2 g/day (20-30 mg/kg/day).
CHILD:
- More than 20 kg. Initially 400 mg/day with spaced increases until control is achieved (usually 20-30 mg/kg/day), dose may be increased to 35 mg/kg/day.
- Less than 20 kg 20 mg/kg/day, in severe cases the dose may be increased provided plasma concentration can be monitored.

ii. Treatment and prevention of mania associated with bipolar disorders:
ADULT: The recommended initial dose is 1000mg/day. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose, which produces the desired clinical effects. The recommended maintenance dosage for the treatment of bipolar disorder is between 1000mg and 2000mg daily. In exceptional cases, the dose may be increased to not more than 3000mg daily.
1493 Sodium Valproate 400mg Injection N03AG01-520-P40-01-XX B Status epilepticus None ADULT and CHILD above 10 years: 10 to 15 mg/kg/day IV, may increase 5 to 10 mg/kg/week to achieve optimal clinical response (Maximum 60 mg/kg/day or less with a therapeutic range of 50 to 100 mcg/mL)
1494 Sodium Zirconium Cyclosilicate 5g Powder for Oral Suspension V03AE10-520-F22-01-xxx A* For the treatment of hyperkalaemia in adult patients As a second-line therapy for chronic hyperkalaemia. When normokalaemia has been achieved, the minimal effective dose of SZC to prevent recurrence of hyperkalaemia should be established. A starting dose of 5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level. No more than 10 g once daily should be used for maintenance therapy.
1495 Sofosbuvir 400mg & velpatasvir 100mg film coated tablet J05AP55-964-T32-01-XXX A*, A/KK For the treatment of chronic hepatitis C virus (HCV) infection in adults PRESCRIBER CATEGORY A/KK:
i. Non-cirrhotic patients who are treatment naïve to NS5A inhibitor, or

PRESCRIBER CATEGORY A*:
ii. With decompensated liver cirrhosis who are treatment naïve to NS5A inhibitor, or
iii. For direct-acting antiviral (DAA) experienced patients who failed to achieve sustained virological response (SVR) due to virological failure (preferably based on resistant associated substitution (RAS) report), or
iv. Uninfected recipients of liver and non-liver grafts of HCV-viremic donors who are treatment naïve to NS5A inhibitor, or
v. HCV-infected recipients post-liver transplant who are treatment naïve to NS5A inhibitor		 One tablet, taken orally, once daily with or without food.
Refer package insert for the recommended treatment and duration for all HCV genotypes
1496 Sofosbuvir 400mg tablet J05AP08-000-T32-01-XXX A/KK To be used in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults. None One 400 mg tablet, taken orally, once daily with food.
Sofosbuvir should be used in combination with other medicinal products. Monotherapy of sofosbuvir is not recommended.
1497 Solifenacin Succinate 5 mg Tablet G04BD08000T1001XX A* Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. 5mg od. Dose can be increased to 10mg if necessary.
1498 Somatropin 10mg (30IU) Injection H01AC01-000-P50-02-XXX A* To be used in children for:
i) Growth failure due to growth hormone deficiency (GHD)
ii) Growth failure in girls due to gonadal dysgenesis (Turner syndrome).
iii) Growth failure in short children born small gestational age (SGA)

To be used in adult for:
i) Adult onset growth hormone deficiency (GHD)
ii) Childhood onset growth hormone deficiency (GHD)		 None Children:
i) 0.7-1 mg/m2/day or 0.025-0.035 mg/kg/day SC/IM.
ii) 1.3-2mg/m2/day or 0.045-0.05 mg/kg/day SC.
iii) 0.035 mg/kg/day or 1 mg/m2/day SC.

Adult:
i) Start treatment with a low dose of 0.1-0.3 mg/day. Titrate dosage gradually at monthly intervals based on patient's need and serum IGF-1. Maintenance dose: Vary from person to person, but seldom exceed 1.0 mg/day (equal to 3 IU/day).
ii)0.2-0.5mg/day with subsequent dose adjustment on the basis of IGF-I concentration determination.

The dosing is individualized according to product insert / protocol.
1499 Somatropin 12mg Injection H01AC01-000-P30-02-XXX A* To be used in children for:
i. Growth failure due to inadequate endogenous growth hormone.
ii. Growth failure in girls due to gonadal dysgenesis (Turner syndrome).
iii. Growth failure in short children born small gestational age (SGA)

To be used in adult for:
i. Adult onset growth hormone deficiency (GHD)
ii. Childhood onset growth hormone insufficiency		 To be prescribed by adult and paediatric endocrinologists only Recommended dosing in paediatric patient:
i. 0.025 – 0.035 mg/kg/day or 0.7 – 1.0 mg/m2/day
ii. 0.045 – 0.050 mg/kg/day or 1.4 mg/m2/day
iii. 0.035 mg/kg/day or 1.0 mg/m2/day

Recommended dosing in adult patient:
i. Adult-onset GHD: therapy should start with a low dose, 0.15 – 0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
ii. Childhood onset GHD: the recommended dose to restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration
1500 Somatropin 5.3 mg injection H01AC01-000-P30-01-XXX A* To be used in children for:
i. Growth failure due to inadequate endogenous growth hormone.
ii. Growth failure in girls due to gonadal dysgenesis (Turner syndrome).
iii. Growth failure in short children born small gestational age (SGA)

To be used in adult for:
i. Adult onset growth hormone deficiency (GHD)
ii. Childhood onse		 To be prescribed by adult and paediatric endocrinologists only Recommended dosing in paediatric patient:
i. 0.025 – 0.035 mg/kg/day or 0.7 – 1.0 mg/m2/day
ii. 0.045 – 0.050 mg/kg/day or 1.4 mg/m2/day
iii. 0.035 mg/kg/day or 1.0 mg/m2/day

Recommended dosing in adult patient:
i. Adult-onset GHD: therapy should start with a low dose, 0.15 – 0.3 mg per day. The dose should be gradually increased according to individual patient requirements as determined by the IGF-I concentration.
ii. Childhood onset GHD: the recommended dose to restart is 0.2 – 0.5 mg per day. The dose should be gradually increased or decreased according to individual patient requirements as determined by the IGF-I concentration

Halaman-halaman