Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1291 Protein Free Haemodialysate Dental Adhesive Paste D03AX00000G6001XX A Painful and inflammatory affliction on the oral mucosa, gums and lips, teething pain, denture pressure sores, oral and maxillofacial surgery and dressing after scaling Apply to lesions 3 - 5 times daily
1292 Pyrantel Pamoate 125 mg Tablet P02CC01127T1001XX C Intestinal nematodes ADULT and CHILD : 2 years and older - single dose 10mg/kg body weight once. Maximum 1 g
1293 Pyrantel Pamoate 250 mg Tablet P02CC01127T1002XX C Intestinal nematodes ADULT and CHILD : 2 years and older - single dose 10mg/kg body weight once. Maximum 1 g
1294 Pyrazinamide 500 mg Tablet J04AK01000T1001XX B Tuberculosis Adult: 20-40mg/kg daily (max 1500mg) or 50mg/kg biweekly (max 2000mg). Children: 20-30mg/kg daily or 30-40mg/kg thrice weekly.
1295 Pyridostigmine Bromide 60 mg Tablet N07AA02320T1001XX B Myasthenia gravis ADULT: 30 - 120 mg at suitable intervals throughout the day, total daily dose 0.3 - 1.2 g. CHILD up to 6 years initially 30 mg, 6 - 12 years initially 60 mg, usual total daily dose 30 - 360 mg
1296 Pyridoxine HCl 10 mg Tablet A11HA02110T1001XX C+ i)Pyridoxine-dependent convulsions in infant ii)Sideroblastic anaemia iii)B6-deficient anaemia in adult iv) Prophylaxis to peripheral neuritis in isoniazid therapy v) Nausea and vomiting of pregnancy and irradiation sickness i) INFANT 4 mg/kg daily for short periods ii) 100 - 400 mg daily in divided doses iii) ADULT 20 - 50 mg up to 3 times daily iv) Prophylaxis 10 mg daily, therapeutic 50 mg 3 times daily v) 20 - 100 mg daily
1297 Pyridoxine HCl 50 mg/2 ml Injection A11HA02110P3001XX B i) Pyridoxine-dependent convulsions in infancy ii) Sideroblastic anaemia iii) B6-deficient anaemia in adult iv) Prophylaxis to peripheral neuritis in isoniazid therapy v) Nausea and vomiting of pregnancy and irradiation sickness i) INFANT 4 mg/kg daily for short periods ii) 100 - 400 mg daily in divided doses iii) ADULT 20 - 50 mg up to 3 times daily iv) Prophylaxis 10 mg daily, therapeutic 50 mg 3 times daily v) 20 - 100 mg daily
1298 Quetiapine Fumarate 100 mg Immediate Release Tablet N05AH04138T1002XX A* i) Schizophrenia ii) Short term treatment of acute manic episodes associated with bipolar I disorder, either monotherapy or adjunct to lithium or divalproex iii) Treatment of depressive episodes associated with bipolar disorder i) Initial titration schedule over 4 days: 25 mg twice daily on Day 1, increase in steps of 25 - 50 mg 2 to 3 times daily on Days 2 and 3 to reach target dose of 300 - 400 mg daily by Day 4, given in 2 - 3 divided doses. Institute further dose adjustments, if indicated, at intervals of 2 days or more, in steps of 25 - 50 mg twice daily ii) 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) & 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of not more than 200 mg/day. Adjust dose within the range of 200 - 800 mg/day depending on clinical response and tolerability of the patient. Usual effective dose range: 400 - 800 mg/day iii) 50 mg ORALLY once a day on Day 1, then 100 mg once daily on Day 2, then 200 mg once daily on Day 3, then 300 mg once daily on Day 4 (all doses given at bedtime); patients requiring higher doses should receive 400 mg on Day 5, increased to 600 mg on Day 8 (week 1)
1299 Quetiapine Fumarate 200 mg Extended Release Tablet N05AH04138T5002XX A* i)Schizophrenia ii) Moderate to severe manic episodes in bipolar disorder iii) Major depressive episodes in bipolar disorder i) & ii) 300 mg once daily on Day 1 then 600 mg on Day 2. Maintenance dose: 400 to 800 mg once daily. Maximum dose: 800 mg daily iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily. In elderly or hepatic impairment:Start with 50mg/ day, may be increased in increments of 50mg /day to an effective dose.
1300 Quetiapine Fumarate 200 mg Immediate Release Tablet N05AH04138T1004XX A* i) Schizophrenia ii) Short term treatment of acute manic episodes associated with bipolar I disorder, either monotherapy or adjunct to lithium or divalproex iii) Treatment of depressive episodes associated with bipolar disorder i) Initial titration schedule over 4 days: 25 mg twice daily on Day 1, increase in steps of 25 - 50 mg 2 to 3 times daily on Days 2 and 3 to reach target dose of 300 - 400 mg daily by Day 4, given in 2 - 3 divided doses. Institute further dose adjustments, if indicated, at intervals of 2 days or more, in steps of 25 - 50 mg twice daily ii) 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) & 400 mg (Day 4). Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of not more than 200 mg/day. Adjust dose within the range of 200 - 800 mg/day depending on clinical response and tolerability of the patient. Usual effective dose range: 400 - 800 mg/day iii) 50 mg ORALLY once a day on Day 1, then 100 mg once daily on Day 2, then 200 mg once daily on Day 3, then 300 mg once daily on Day 4 (all doses given at bedtime); patients requiring higher doses should receive 400 mg on Day 5, increased to 600 mg on Day 8 (week 1)
1301 Quetiapine Fumarate 300 mg Extended Release Tablet N05AH04138T5003XX A* i) Schizophrenia ii) Moderate to severe manic episodes in bipolar disorder iii) Major depressive episodes in bipolar disorder i) & ii) 300 mg once daily on Day 1 and 600 mg on Day 2. Maintenance dose: 400 ? 800 mg once daily. Maximum dose: 800 mg daily iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily
1302 Quetiapine Fumarate 400 mg Extended Release Tablet N05AH04138T5004XX A* i) Schizophrenia ii) Moderate to severe manic episodes in bipolar disorder iii) Major depressive episodes in bipolar disorder i) & ii) 300 mg once daily on Day 1 and 600 mg on Day 2. Maintenance dose: 400 ? 800 mg once daily. Maximum dose: 800 mg daily iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily
1303 Quetiapine Fumarate 50 mg Extended Release Tablet N05AH04138T5001XX A* i)Schizophrenia ii)Moderate to severe manic episodes in bipolar disorder iii)Major depressive episodes in bipolar disorder i) & ii) 300 mg once daily on Day 1 then 600 mg on Day 2. Maintenance dose: 400 to 800 mg once daily. Maximum dose: 800 mg daily. iii)50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily. In elderly or hepatic impairment: Start with 50mg/ day, may be increased in increments of 50mg /day to an effective dose.
1304 Quinine Dihydrochloride 600 mg/2 ml Injection P01BC01110P3001XX B Severe and complicated malaria By slow intravenous infusion (over 4 hours). ADULT : 20 mg/kg followed by 10 mg/kg every 8 hours. CHILD : 20 mg/kg followed by 10 mg/kg every 12 hours, initial dose should be half in patients who have received quinine, quinidine or mefloquine during the previous 12 or 24 hours
1305 Quinine Sulphate 300 mg Tablet P01BC01183T1001XX B Severe and complicated malaria 300 - 600 mg daily. Treatment : 1.2 - 2 g daily in divided doses. CHILDS less than 1 year : 100 - 200 mg daily, 1 - 3 years : 200 - 300 mg daily, 4 - 6 years: up to 500 mg daily, more than 7 years : up to 1 g daily. All above doses are given for 7 days in 2 - 3 divided doses
1306 Rabies Vaccine Injection J07BG01000P4001XX B Pre-exposure and post-exposure vaccination against rabies. 1ml by IM. Dosing is according to product insert based on patient’s needs (pre and post exposure).
1307 Raloxifene HCl 60 mg Tablet G03XC01110T1001XX A* Prevention and treatment of postmenopausal osteoporosis 1 tablet daily
1308 Raltegravir 400 mg tablet J05AX08500T1001XX A* Raltgeravir combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in patients who are contraindicated to boosted Protease Inhibitor or who are intolerant to boosted Protease Inhibitor. 400mg administered orally, twice daily with or without food, to be given combination with other antiretroviral agent.
1309 Ramipril 2.5 mg Tablet C09AA05000T1001XX A i) Hypertension and congestive heart failure ii) Post-myocardial infarction iii) Reducing risk of myocardial infarction, stroke or cardiovascular death in diabetics or patients with increased cardiovascular risks i) Hypertension: Initially 2.5 mg once daily, increased at intervals of 1 - 2 weeks to maximum 10 mg once daily; Congestive heart failure:Initially 1.25 mg once daily. Max: 10 mg/day ii) Initially 2.5 mg twice daily for 2 days then increased to maximum 5 mg twice daily iii) Initially 1.25 - 2.5 mg once daily, increased to 5 mg once daily after 1 week, maximum dose: 10 mg once daily after 3 weeks
1310 Ramipril 5 mg Tablet C09AA05000T1002XX A i) Hypertension and congestive heart failure ii) Post-myocardial infarction iii) Reducing risk of myocardial infarction, stroke or cardiovascular death in diabetics or patients with increased cardiovascular risks i) Hypertension: Initially 2.5 mg once daily, increased at intervals of 1 - 2 weeks to maximum 10 mg once daily; Congestive heart failure:Initially 1.25 mg once daily. Max: 10 mg/day ii) Initially 2.5 mg twice daily for 2 days then increased to maximum 5 mg twice daily iii) Initially 1.25 - 2.5 mg once daily, increased to 5 mg once daily after 1 week, maximum dose: 10 mg once daily after 3 weeks
1311 Ranibizumab 10 mg/ml Intravitreal Injection S01LA04000P3001XX A* i) Treatment of Neovascular (wet) Age-Related Macular Degeneration (ARMD). ii) Treatment of visual impairment due to diabetic macular edema (DME). iii) Treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). iv) Treatment of visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM). Note: Indication ii) and iii) approved to be used by retinal specialist only (PFUKKM 1/2015) 0.5 mg (0.05ml) as a single intravitreal Injection.Interval between 2 doses should not be shorter than 1 month, then monitor for visual acuity monthly. Treatment is given monthly & continued until max visual acuity is achieved, confirmed by stable visual acuity for 3 consecutive monthly assessments.
1312 Ranitidine 150 mg Tablet A02BA02110T1001XX B i) Benign gastric and duodenal ulcer ii) Reflux oesophagitis iii) Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome i) 150 mg twice daily (at morning and night) or 300 mg on night for 4-8 weeks. Maintenance: 150-300 mg on night ii) 150 mg twice daily or 300 mg on night for 8-12 weeks iii) 150 mg daily or twice daily iv) 150 mg and may be increased as necessary to 6 g/day
1313 Ranitidine 150 mg/10 ml Syrup A02BA02110L9001XX B Peptic ulcer disease CHILD 2-4 mg/kg 2 times daily. Maximum 300 mg daily
1314 Ranitidine 25 mg/ml Injection A02BA02110P3001XX B i) Benign gastric/ duodenal ulceration, reflux oesophagitis, Zollinger Ellison Syndrome ii) Stress ulcer prophylaxis in post-operative and high risk patients i) ADULT: Slow IV injection of 50 mg diluted to 20 ml and given over at least 2 minutes. May be repeated every 6-8 hours or IV infusion at rate of 25 mg/hour for 2 hours, may be repeated at 6-8 hours intervals or IM. CHILD: 1 mg/kg/dose 6-8 hourly. ii) Initial slow IV injection of 50 mg, then continuous infusion of 125-250 mcg/kg/hour
1315 Ranitidine 300 mg Tablet A02BA02110T1002XX B i) Benign gastric and duodenal ulcer ii) Reflux oesophagitis iii) Non-ulcer dyspepsia iv) Zollinger-Ellison Syndrome i) 150 mg twice daily (at morning and night) or 300 mg on night for 4-8 weeks. Maintenance: 150-300 mg on night ii) 150 mg twice daily or 300 mg on night for 8-12 weeks iii) 150 mg daily or twice daily iv) 150 mg and may be increased as necessary to 6 g/day
1316 Recombinant factor VIII 250 IU Injection B02BD02000P4001XX A* i)Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ii)Surgical prophylaxis in adults and children with hemophilia A. iii)Routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with no pre-existing joint damage. Not indicated fot the treatment of von willebrand's disease. The dosage and duration of treatment should be individualised and taking into account the severity of factor VIII deficiency, location and extent of bleeding and patient's clinical condition. Dose can be calculated by using: i. Required dose (IU) = body weight (kg) x desired factor VIII rise (IU/dl or % of normal) x 0.5 (IU/kg) or ii. Expected factor VIII rise (% of normal) = 2 x (dose administered)/ bodyweight (kg) Dose administered should be titrated to patient's clinical response
1317 Recombinant Factor VIII 500 IU Injection B02BD02000P4002XX A* i)Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A. ii)Surgical prophylaxis in adults and children with hemophilia A. iii)Routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with no pre-existing joint damage. Not indicated for the treatment of von willebrand's disease. The dosage and duration of treatment should be individualised and taking into account the severity of factor VIII deficiency, location and extent of bleeding and patient's clinical condition. Dose can be calculated by using: i. Required dose (IU) = body weight (kg) x desired factor VIII rise (IU/dl or % of normal) x 0.5 (IU/kg) or ii. Expected factor VIII rise (% of normal) = 2 x (dose administered)/ bodyweight (kg) Dose administered should be titrated to patient's clinical response.
1318 Remifentanil 5 mg Injection N01AH06110P4001XX A* i) As an analgesic agent for use during induction and/or maintenance of general anaesthesia during surgical procedures including cardiac surgery. ii)Continuation of analgesia into the immediate post-operative period under close supervision, during transition to longer acting analgesia. iii)Provision of analgesia and sedation in mechanically ventilated intensive care patients. For IV use only. ADULT: Induction:Bolus infusion: 1µg/kg over 30-60 seconds; Continuous infusion: 0.5-1µg/kg/min; Maintenance: Continuous infusion: 0.025 to 2 µg/kg/min. CHILD (1-12 years of age): Induction: Insufficient data; Neonates: IV infusion 0.4-1.0 mcg/kg/minute depending on the anaesthetic method and adjust according to patient response, supplemental IV inj of 1 mcg/kg dose may be given. 1-12 yr: initially 0.1-1 mcg/kg by IV inj over at least 30 seconds (excluded if not needed), followed by IV infusion 0.05-1.3 mcg/kg/minute depending on the anaesthetic method and adjust according to patient response, supplemental IV bolus inj may be admin during infusion. 12-18 yr: 0.1-1 mcg/kg IV inj over at least 30 seconds (excluded if not needed), followed by IV infusion of 0.05-2 mcg/kg/minute depending on anaesthetic method and adjust according to patient response, supplemental IV bolus inj may be admin during infusion.
1319 Ribavirin 200 mg Capsule J05AB04000C1001XX A* For the treatment of chronic hepatitis C (in combination with interferon alfa-2a/2b) ADULT (more than 18 years old): 50mg/kg/day Recommended: Body weight: ≤ 75kg should receive 1000mg daily as two 200mg capsules in the morning and three 200mg capsules in the evening Body weight: >75kg should receive 1200mg as three 200mg capsules in the morning and three 200mg capsules in the evening Genotype 1,4: 48 weeks Genotype: 24 weeks duration should be individualized in accordance with the baseline characteristics of the disease.
1320 Ribociclib 200mg tablet L01XE42-105-T32-01-XXX A* In combination with: - an aromatase inhibitor for the treatment of postmenopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. 600 mg daily for 21 consecutive days followed by 7 days off treatment. Can be taken with or without food. For dose modification, refer package insert.

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