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7. Pengarah Hospital Universiti Kebangsaan Malaysia Bandar Tun Razak Kuala Lumpur (u.p Ketua Pegawai Farmasi) 8. Pengarah Hospital Universiti Sains Malaysia Kubang Kerian Kelantan (u.p Ketua Pegawai Farmasi) 9. Pengarah Farmasi Bahagian Perkhidmatan Kesihatan Kementerian Pertahanan Malaysia Jalan Padang Tembak 50634 Kuala Lumpur 10. Pegawai Farmasi Bahagian Pembangunan Kesihatan Keluarga Aras 5, Blok E6, Parcel E Presint 1, Pusat Pentadbiran Kerajaan Persekutuan 62509 Putrajaya 11. Pengarah Pusat Darah Negara Jalan Tun Razak 50400 Kuala Lumpur (u.p Pegawai Farmasi) 12. Unit Teknikal Bantuan Perubatan Pejabat Timbalan Ketua Pengarah Kesihatan (Perubatan) Aras 7, Blok E1, Parcel E Presint 1, Pusat Pentadbiran Kerajaan Persekutuan 62509 Putrajaya 13. Pegawai Farmasi Bahagian Kesihatan dan Perubatan jabatan Hal Ehwal Orang Asli KM.24, Jalan Pahang 53100 Gombak, Selangor 14. Penolong Pegawai Perpustakaan Aras 4, Blok E7, Parcel E Presint 1, Pusat Pentadbiran Kerajaan Persekutuan 62509 Putrajaya 15. Penolong Pegawai Perpustakaan Institut Pengurusan Kesihatan Kementerian Kesihatan Malaysia Jalan BangsarKuala Lumpur 16. Semua Ketua Unit Bahagian Perkhidmatan Farmasi anis/azuwana/masitah TERHAD - Edaran dalaman sahaja PINDAAN BIL. 1 TAHUN 2011 KEPADA FORMULARI UBAT KKM LAMPIRAN 1 1. UBAT-UBAT YANG DIMANSUHKAN DARI FORMULARI UBAT KKM No MDC Generic Name Trade Name, Category, Dosage Remarks 1 B01AB06390P5001XX Nadroparin Calcium 0.2ml Injection As in the MOH formulary Manufacturer has discontinued the production of all strengths of Nadroparin Calcium Injection 2 B01AB06390P5002XX Nadroparin Calcium 0.3ml Injection 3 B01AB06390P5003XX Nadroparin Calcium 0.4ml Injection 4 B01AB06390P5004XX Nadroparin Calcium 0.6ml Injection 5 N05AH04138T1002XX Quetiapine Fumarate 100mg Tablet As in the MOH formulary 6 N05AH04138T1004XX Quetiapine Fumarate 200mg Tablet All the strengths of the extendedrelease formulation are now available in the MOH Drug Formulary and thus will improve patient’s compliance and reduce the treatment cost. However, quetiapine fumarate 100mg tablet can be purchased until tender expires (23rd October 2011) and both quetiapine fumarate 100mg and 200mg tablets can be used until stock finished. Pindaan FUKKM Bil. 1/2011 (Mac 2011) 1/17 TERHAD - Edaran dalaman sahaja LAMPIRAN 2 2. UBAT–UBAT BARU YANG DILULUSKAN MASUK KE DALAM FORMULARI UBAT KKM No MDC 1 C02KX010 00T1001XX Generic Name Brand name Price quoted Bosentan 125 mg tablet (Tracleer®) Cost RM 9,262.50/60’s Prescriber Category A* Details Indication For the treatment of pulmonary arterial hypertension (PAH) in patients with WHO Class III or IV symptoms, to improve exercise ability and decrease the rate of clinical worsening (To be used by those who are trained and specialized in treating and managing PAH) Dose: Initially 62.5 mg bd for 4 weeks, then increase to the maintenance dose of 125 mg bd Precaution Monitor liver function before starting therapy & periodically thereafter. Discontinue use if liver aminotransferase elevations accompanied by clinical symptoms of liver injury occur. Monitor Hb levels after 1 and 3 months of treatment and 3 months thereafter. Perform urine or serum pregnancy tests monthly in women of childbearing potential Contraindication Pregnancy & breastfeeding, co-administration with cyclosporine A or glyburide or hypersensitivity to bosentan Interaction Hormonal contraceptives (decreases the efficacy of hormonal contraceptive agents), cyclosporine A (increases plasma concentrations of bosentan thus increase chance of bosentan side effects),glyburide (increase risk of liver enzyme elevations, also decrease plasma concentration of glyburide and other oral hypoglycemic agents), ketoconazole, itraconazole, fluconazole (increase plasma concentration of bosentan), statins (decrease plasma concentrations of statins), warfarin (decreases plasma concentration of warfarin), sildenafil (reduction in sildenafil plasma concentration), tacrolimus (increases plasma concentration of bosentan), rifampicin (increases bosentan trough levels), lopinavir/ ritonavir or other ritonavir-containing HIV regimens (increase plasma concentration of bosentan) Adverse effect Potential liver injury, haematologic changes (decrease in hemoglobin concentration), fluid retention, pulmonary veno-occlusive disease (PVOD), headache, dizziness, gastrointestinal disturbances, dry mouth, rectal haemorrhage, nasopharyngitis, flushing, edema, hypotension, palpitations, dyspepsia, fatigue, pruritus Pindaan FUKKM Bil. 1/2011 (Mac 2011) 2/17 TERHAD - Edaran dalaman sahaja No MDC 2 B02BD020 00P4001 XX Generic Name Brand name Price quoted Factor VIII (Recombinant) Octocog Alfa 250 IU Injection Prescriber Category A* (Advate®) Cost 250 IU: RM 590/250 IU 3 B02BD020 00P4002 XX Factor VIII (Recombinant) Octocog Alfa 500 IU Injection A* (Advate®) Cost 500 IU: RM 1,180/500 IU Details Indication Treatment and prophylaxis of bleeding in patients with hemophilia A (Congenital Factor VIII deficiency). It does not contain von Willebrand factor and is not indicated in von Willebrand’s disease. Dose: The usual dose for prophylaxis is between 20 to 40 IU per kg of body weight, administered at intervals of 2 to 3 days. For treatment of bleeds, the dose injected is individualized by the doctor and is given every 8, 12 or 24 hours for at least one day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved. In patients under the age of 6, doses of 20 to 50 IU of Factor VIII per kg body weight 3 to 4 times weekly are recommended. Precaution Monitor patients for development of antibodies to factor VIII. Pregnancy & lactation. Early signs of allergic reactions such as rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, general feeling of being unwell, and dizziness (These symptoms can constitute an early symptom of an anaphylactic shock, manifestations of which may additionally include extreme dizziness, loss of consciousness, and extreme difficulty in breathing) Contraindication Hypersensitivity to mouse or hamster protein Interaction No interactions with other medicinal products are known Adverse effect Dizziness, fever, headache, itching, increased sweating, unusual taste in the mouth, hot flushes, migraines, memory impairment, chills, diarrhoea, nausea, vomiting, shortness of breath, laryngitis, infection of the lymphatic vessels, whitening of skin, eye inflammation, rashes, excessive sweating, foot and leg swelling, increase in enzymes that track liver function, decrease in haematocrit and pain in the upper abdomen or lower chest. During surgery: catheter-related infection, decreased red cell blood count, swelling of limbs and joints, prolonged bleeding after drain removal, decreased Factor VIII level and post-operative haematoma. 4 B03AE109 03T1001XX Ferrous Controlled Release 500 mg, Vitamin B1, B2, B6, B12, Vitamin C 500 mg, Niacinamide, Calcium A Indication Anaemia due to iron deficiency, megaloblastic anaemia when there is an associated deficiency of vitamin C and vitamin B-complex particularly Pindaan FUKKM Bil. 1/2011 (Mac 2011) 3/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Panthothenate and Folic Acid 800 mcg Tablet Prescriber Category Details in pregnancy Dose: One tablet daily (Iberet-Folic-500®) Precaution Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemia where vitamin B12 is deficient. There is the possibility of dark feces. Not suitable to patients who received repeated blood transfusion or non-iron deficiency anemia. Long-term usage may cause iron accumulation. Use in the elderly: Elderly people who have tendency of vitamin B12 deficiency must have regular monitoring of vitamin B12 serum concentration while taking this drug. Cost RM 0.635/tablet Contraindication Patients with hypersensitivity to any of the ingredients of this drug, patients with thalassemia, sideroblastic anemia, hemochromatosis, and hemosiderosis. Should not be used in paediatric patients and also contraindicated in the rare instance of hypersensitivity to folic acid Interaction Magnesium trisilicate and antacid which contains carbonate will inhibit the absorption of iron. Ferrous sulfate affects tetracycline absorption. Levodopa may produce reversed effect due to pyridoxine. Administration with milk or egg may inhibit the absorption of iron. Adverse effect Rare, occasionally with nausea, vomiting, constipation or diarrhea, gastric pain at high doses 5 L04AX0400 0C1001XX Lenalidomide 5 mg Capsule A* (Revlimid®) Dose: Recommended starting dose: 25 mg once daily on days 1 to 21 of repeated 28 day cycle with dexamethasone 40 mg once daily on days 1 to 4, 9 to 12 and 17 to 20 of each 28 day cycle for the first 4 cycles of therapy, thereafter dexamethasone 40 mg once daily on day 1 to 4 every 28 day cycle Cost Revlimid Assistance Program (RAP): 2 + 4 + 7 (2 cycles FOC + 4 cycles pay + 7 cycles FOC) RM 20,071/21’s 6 L04AX0400 0C1002XX Lenalidomide 10 mg Capsule (Revlimid®) Cost Indication In combination with dexamethesone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy A* Precaution Perform complete blood cell count including WBC, platelet count, Hb & haematorcrit weekly for the first 8 week of treatment & monthly thereafter. Renal impairment. Monitor for Pindaan FUKKM Bil. 1/2011 (Mac 2011) 4/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Revlimid Assistance Program (RAP): 2 + 4 + 7 (2 cycles FOC + 4 cycles pay + 7 cycles FOC) Prescriber Category thromboembolism, signs of bleeding (petechiae & epistaxes), thyroid function, risk of tumour lysis syndrome. Lactose intolerance. May impair ability to drive or operate machinery. RM 21,004.00/21’s 7 L04AX0400 0C1003XX Lenalidomide 15 mg Capsule A* (Revlimid®) Cost Revlimid Assistance Program (RAP): 2 + 4 + 7 (2 cycles FOC + 4 cycles pay + 7 cycles FOC) L04AX0400 0C1004XX Lenalidomide 25 mg Capsule A* Adverse effect Neutropenia, thrombocytopenia, anaemia, gastrointestinal disturbances, rash, muscle cramp, muscle weakness, fatigue, asthenia, peripheral oedema, insomnia; atrial fibrillation, palpitations, cerebrovascular accident, syncope, neuropathy, dizziness, ageusia, dysgeusia, paraesthesia, headache, tremor, hypoaesthesia, somnolence, memory impairment, eye disorders, vertigo, respiratory, thoracic & mediastinal disorders, renal failure, cushingoidlike symptoms, metabolism & nutrition disorders, infections, vascular disorders, erectile dysfunction, gynaecomastia, metrorrhagia, nipple pain. (Revlimid®) Cost Revlimid Assistance Program (RAP): 2 + 4 + 7 (2 cycles FOC + 4 cycles pay + 7 cycles FOC) RM 24,307.00/21’s 9 N01BB029 84A4101X X Lignocaine HCl 5% and Phenylephrine HCl 0.5% Nasal Spray (Co-Phenylcaine Forte Spray®) Cost RM 198/50 ml Flexishort nozzle: RM 350/50’s Contraindication Because lenalidomide is similar in structure to thalidomide, a known human teratogen, lenalidomide is contraindicated in pregnant women and in women capable of becoming pregnant. When there is no alternative, females of childbearing potential may be treated with lenalidomide, provided that adequate precautions Interaction Erythropoietic agents, other agents associated with increased risk of thrombosis (eg. Hormone replacement therapy), oral contraceptive, warfarin, digoxin RM 23,383.00/21’s 8 Details A* Indication Preparation of nasal mucosa for surgery (eg. Cautery to Little’s area), aid the treatment of acute nose bleeds and removal of foreign bodies from the nose, topical anaesthesia of the pharynx prior to direct or indirect laryngoscopy, topical anaesthesia and local vasoconstriction prior to endoscopy of the upper airways Dose: Adults and children over 12 years : 5 squirts per nostril. Children: 8 to 12 years 3 squirts per nostril, 4 to 8 years 2 squirts per nostril, 2 to 4 years 1 squirt per nostril. Doses are to be administered once only. Precaution Elderly and debilitated: should reduce dose. Eating and drinking: Food /drink should not be ingested within 2 hours of local anaesthetic use. Patients with cardiovascular disease, hypertension, severe bradycardia, conduction Pindaan FUKKM Bil. 1/2011 (Mac 2011) 5/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Prescriber Category Details disturbances or severe digitalis intoxication. Patients with impaired kidney or liver function. Asthmatic patients: contains sodium metabisulfite. Genetic predisposition to malignant hyperthermia and pre-existing abnormal neurological conditions. Should not be used in pregnancy. May be used as directed in breastfeeding mothers. Contraindication Known hypersensitivity to either of the active ingredients or any of the non active ingredients, hypersensitivity to other local anaesthetics of the amide type and to other sympathomimetic agents, pregnancy, children less than 2 years old Interaction Propranolol or cimetidine may reduce the clearance of lignocaine. Antiarrhythmic drugs:lignocaine can have additive effects or antagonistic effects. Suxamethonium: lignocaine prolongs the action of suxamethonium. Phenytoin: lignocaine and phenytoin have additive cardiac depressant effects. Antidepressants: may interact with phenylephrine Adverse effect Phenylepherine may rarely cause tremor or palpitations. Rarely nervousness, nausea, vomiting, tinnitus, dizziness, numbness or disorientation may occur following rapid absorption of lignocaine. The most commonly noted side effect is a transient bitter taste in the mouth lasting 1-2 minutes. 10 L01BC0800 0P3001XX Decitabine 50 mg Injection (Dacogen®) Cost RM 3,325/vial of 500 mg A* Indication Myelodysplastic syndromes (MDS) including: Previously treated and untreated de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System (IPSS) groups Dose: 2 15 mg/m by continuous IV infusion over 3 hours repeated every 8 hours for 3 days. Repeat this treatment cycle every 6 weeks for a minimum of 4 cycles. However, complete or partial response may take longer than 4 cycles. Treatment may be continued as long as there is continued benefit Precaution Fertilization: males should not father a child Pindaan FUKKM Bil. 1/2011 (Mac 2011) 6/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Prescriber Category Details while receiving decitabine and for 2 months afterwards. Hepatic impairment: potential exacerbation of toxicity. Myelosuppression. Renal impairment: potential exacerbation of toxicity Contraindication Patients with a known hypersensitivity to decitabine Interaction No formal assessments of drug-drug interactions between decitabine and other agents have been conducted Adverse effect Edema, heart murmur, peripheral edema, cellulitis, ecchymosis, erythema, pallor, petechiae, pruritus, rash, skin lesion, hyperglycemia, hyperkalemia, hypoalbuminemia, hypokalemia, hypomagnesemia, hyponatremia, serum bicarbonate level abnormal, abdominal pain, constipation, decrease in appetite, diarrhea, indigestion, loss of appetite, nausea, petechiae, oral mucosal, stomatitis, vomiting, leukopenia, alkaline phosphatase raised, ascites, hyperbilirubinemia, increased liver aminotransferase level, lymphadenopathy, arthralgia, backache, pain in limb, dizziness, dysesthesia, headache, lethargy, anxiety, fatigue, insomnia, serum blood urea nitrogen raised, cough, decreased breath sounds, hypoxia, pharyngitis, respiratory crackles, candidiasis, fever, pain, sepsis, shivering or rigors, tenderness, atrial fibrillation, cardiac arrest, heart failure, myocardial infarction, anemia, febrile neutropenia, neutropenia, thrombocytopenia, cerebral hemorrhage, intracranial hemorrhage, pneumonia, pulmonary edema, infection due to Mycobacterium avium, infectious disease 11 N01BB539 74P3001X X Mepivacaine HCl 2% with Adrenaline (1:100,000) Injection (Scandonest 2% Special®) Cost 1.8 ml (36 mg): RM 180/100’s + 100’s needles 2.2 ml (44 mg): RM 188/100’s + 100’s needles B Indication For local anaesthesia including infiltration and nerve blocks Dose: Adult: Single site in the jaw: 36 mg (1.8ml). Entire oral cavity: 180 mg (9 ml). Max: 400 mg (20 ml) per single dental procedure Precaution Rate of injection should not be too rapid. Avoid prolonged use. In elderly, child, debilitated patients, epilepsy, impaired respiratory function or cardiac conduction, shock, hepatic impairment, renal disease. In pregnancy and lactation. Pindaan FUKKM Bil. 1/2011 (Mac 2011) 7/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Prescriber Category Details Contraindication Complete heart block, porphyria. Interaction Potentially Fatal: Administration of mepivacaine solutions containing epinephrine or norepinephrine to patients receiving MAOIs or tricyclic antidepressants (TCAs) may lead to severe hypertension. Antiarrhythmics (risk of myocardial depression). Adverse effect Restlessness, excitement, nervousness, paraesthesias, dizziness, tinnitus, blurred vision, nausea, vomiting, muscle twitching, tremors, convulsions, numbness of the tongue and perioral region, lightheadedness, drowsiness, respiratory failure, coma, hypotension. Potentially Fatal: Myocardial depression, bradycardia, cardiac arrhythmias, cardiac arrest. 12 N01BB031 10P3001X X (Scandonest 3% Plain®) Indication For dental local anaesthesia including infiltration and nerve blocks on patients in whom adrenalin might be contraindicated Cost 1.8 ml (54 mg): RM 188/100’s + 100’s needles Dose: Adult: Single site in the jaw: 54 mg (1.8 ml). Entire oral cavity: 270 mg (9 ml). Max: 400 mg (13.3 ml) per single dental procedure 2.2 ml (66 mg): RM 198/100’s + 100’s needles Precaution Rate of injection should not be too rapid. Avoid prolonged use. In elderly, child, debilitated patients, epilepsy, impaired respiratory function or cardiac conduction, shock, hepatic impairment, renal disease. In pregnancy and lactation Mepivacaine HCl 3% Injection B Contraindication Complete heart block, porphyria. Interaction Mepivacaine has an additive effect with alcuronii chloridum Adverse effect Restlessness, excitement, nervousness, paraesthesias, dizziness, tinnitus, blurred vision, nausea, vomiting, muscle twitching, tremors, convulsions, numbness of the tongue and perioral region, lightheadedness, drowsiness, respiratory failure, coma, hypotension. Potentially Fatal: Myocardial depression, bradycardia, cardiac arrhythmias, cardiac arrest. 13 J01MA141 10T1001XX Moxifloxacin 400mg Tablet (Avelox®) A* Indication Second line therapy for Severe Community Acquired Pneumonia (CAP) patients with comorbidity or with recent antibiotic therapy, Pindaan FUKKM Bil. 1/2011 (Mac 2011) 8/17 TERHAD - Edaran dalaman sahaja No 14 MDC J01MA141 10P3001X X Generic Name Brand name Price quoted Cost RM 49.50/5’s Prescriber Category Moxifloxacin 400mg Injection (Avelox®) Cost RM 110/vial of 250ml A* Details suspected infections of resistant pathogens including Streptococcus pneumoniae, Haemophilus influenzae & Mycoplasma pneumoniae. Dose: IV or Oral: 400 mg once daily. The recommended total treatment duration for sequential administration (intravenous followed by oral therapy) is 7 to 14 days Precaution Maintain adequate fluid intake. Exposure to strong sunlight/sunlamp. Epilepsy, history of CNS disorders. Diabetes mellitus. Not recommended in severe hepatic impairment. May worsen myasthenia gravis. Discontinue in case of tendon pain, inflammation or rupture. Increased risk of tendon inflammation/rupture especially in elderly taking corticosteroids and in kidney, heart, and lung transport recipients. High level of resistance with S. aureus infections. Caution in patients with proarrhythmic conditions e.g. clinically significant bradycardia or acute myocardial infarction. Existing QT prolongation, bradycardia, heart failure with reduced left ventricular ejection fraction, uncorrected hypokalaemia. Avoid concomitant usage with drugs that are known to prolong QT interval. Prolonged use may increase risk of fungal or bacterial superinfection. Contraindication Hypersensitivity to quinolones. Children less than 18 years old. Pregnancy & lactation. Interaction Atenolol, sotalol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid, antacids preparations containing magnesium, aluminium, ferrous, zinc, sucralfate, multivitamins. Warfarin, charcoal, cisapride, erythromycin, antipsychotics, tricyclic antidepressants, antiretroviral drugs, NSAIDs, anti-arrhythmics, terfenadine, quinines and cyclosporine. Adverse effect Diarrhea, nausea, headache, dry eyes, reduced visual acuity, photosensitivity, prolonged qt interval, torsades de pointes, Stevens-Johnson Syndrome, toxic epidermal necrolysis, agranulocytosis, aplastic anemia, hemolytic anemia, pancytopenia, thrombocytopenia (less than 0.1% ), hepatic necrosis, hepatitis, liver failure, anaphylactoid reaction, immune hypersensitivity reaction, pain at injection site, rupture of tendon, tendinitis, seizure, acute renal failure, extrinsic allergic alveolitis, serum sickness due to drug, abnormal ECG, abnormal hepatic function test, anxiety, anorexia, vaginitis Pindaan FUKKM Bil. 1/2011 (Mac 2011) 9/17 TERHAD - Edaran dalaman sahaja LAMPIRAN 3 3. TAMBAHAN DAN PINDAAN FORMULASI/ KATEGORI/ BENTUK DOSEJ/ INDIKASI YANG DILULUSKAN UNTUK DIMASUKKAN KE DALAM FORMULARI UBAT KKM A. Tambah Formulasi/ Kekuatan No MDC 1 N03AX1400 0P3001XX Generic Name Brand name Price quoted Levetiracetam 100 mg/ ml Injection (Keppra®) Cost RM 102/vial of 500 mg (5 ml) Prescriber Category A* Details Indications i) Monotherapy therapy in the treatment of partial onset seizures with or without secondary generalization in patients from age 16 years of age with newly diagnosed epilepsy ii) Adjunctive treatment in partial onset seizures with or without secondary generalization in adults and children from 4 years of age with epilepsy; juvenile myoclonic epilepsy and idiopathic generalized tonic clonic epilepsy from 12 years of age. To be initiated when conventional IV antiepileptic drugs failed to achieve control, or oral form is temporarily not feasible in seizure emergencies only Dose i) ADULTS and ADOLESCENT (from 16 years): Starting dose: 250 mg twice daily, Increase dose to 500 mg twice daily after 2 week. Dose can be further increased by 250 mg twice daily every 2 weeks depending upon the clinical response. Max: 1500 mg twice daily. ii) ADULT more than 18 years and ADOLESCENT (12 to 17 years) more than or equal to 50 kg: Initially 500 mg twice daily may be increased up to 1500 mg twice daily. Dose changes can be made in 500 mg twice daily increments or decrements 2 to 4 weekly. CHILD (4 to 11 years) and ADOLESCENT (12 to 17 years) less than 50 kg : Initially 10 mg/kg twice daily, may be increased up to 30 mg/kg twice daily. Dose changes should not exceed increments or decrements of 10 mg/kg twice daily every 2 weeks. CHILD more than or equal to 50 kg: Adult dose Precautions If levetiracetam has to be discontinued, it is recommended to withdraw it gradually (e.g. in adults: 500 mg twice daily decrements every two to four weeks; in children: dose decrease should not exceed decrements of 10 mg/kg twice daily every two weeks). The administration of Keppra to patients with renal impairment may require dose adaptation. In patients with severely impaired hepatic function, assessment of renal function is recommended before dose selection. Suicide, suicide attempt and suicidal ideation have been reported in patients treated with levetiracetam. Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician Contraindications Hypersensitivity to levetiracetam or other pyrrolidone derivatives or any of the excipients Pindaan FUKKM Bil. 1/2011 (Mac 2011) 10/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Prescriber Category Details Interactions Antidepressants: anticonvulsant effect of antiepileptics possibly antagonised by MAOIs and tricyclic-related antidepressants (convulsive threshold lowered). Anticonvulsant effect of antiepileptics antagonised by SSRIs and tricyclics (convulsive threshold lowered). Avoid concomitant use of antiepileptics with St John’s wort . Antimalarials: possible increased risk of convulsions when antiepileptics given with chloroquine and hydroxychloroquine. Anticonvulsant effect of antiepileptics antagonised by mefloquine Adverse effects Asthenia, somnolence/fatigue, thrombocytopenia, abdominal pain, diarrhoea, dyspepsia, nausea, vomiting, amnesia, ataxia, convulsion, dizziness, headache, hyperkinesia, tremor, balance disorder, disturbance in attention, memory impairment, aggression, agitation, depression, emotional lability/mood swings, hostility, insomnia, irritability, nervousness, personality disorders, thinking abnormal, anorexia, weight increase. The risk of anorexia is higher when topiramate is co administered with levetiracetam, vertigo, diplopia, vision blurred, myalgia, accidental injury, infection, nasopharyngitis, cough increased, eczema, pruritus, rash 2 N02AA0511 0C1001XX Oxycodone HCl 5 mg Immediate Release Capsules A* (Oxynorm®) Cost RM 22.12/28’s 3 N02AA0511 0C1002XX Oxycodone HCl 10 mg Immediate Release Capsules A* Cost RM 37.52/28’s N02AA0511 0C1003XX Oxycodone HCl 20 mg Immediate Release Capsules Dose Initially 5 mg every 4 to 6 hours, increased if necessary according to severity of pain, usual max. 400 mg daily, but some patients may require higher doses Precautions/ Contraindications/ Interactions/ Adverse effects Same as Oxycodone HCl 10 mg Prolonged Release Tablet (Oxynorm®) 4 Indications i)As a second line drug in the management of opioid responsive, moderate to severe chronic cancer pain ii)As a step-down analgesic drug in post-operative procedures (Initiated by palliative medicine physicians, oncologists, anaesthesiologists, haematologists and pain specialists only) A* (Oxynorm®) Cost RM 70.56/28’s 5 N02AA0511 0T5003XX Oxycodone HCl 40 mg Prolonged Release Tablet (Oxycontin®) A* Indications Management of moderate to severe chronic cancer pain non-responsive to morphine (Initiated by palliative medicine physicians, oncologists, anaesthesiologists, haematologists and pain specialists only) Pindaan FUKKM Bil. 1/2011 (Mac 2011) 11/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Cost RM 256.20/28’s Prescriber Category Details Dose Initially, 10 mg every 12 hours, increased if necessary according to severity of pain, usual max. 200 mg every 12 hours, but some patients may require higher doses Precautions/ Contraindications/ Interactions/ Adverse effects Same as Oxycodone HCl 10 mg Prolonged Release Tablet 6 N05AX1300 0P2002XX Paliperidone 50 mg Prolonged Release Injection A* (Invega Sustenna®) Dose Initiation: Deltoid IM 150 mg eq on Day1, followed by deltoid IM 100 mg eq on one week later. Maintenance: Monthly dose of 75 mg eq ( this can be increased or decreased based on individual patient’s tolerability and/or efficacy). These monthly maintenace dose can be administered in either the deltoid or gluteal muscle Cost RM 720/ prefilled syringe 7 N05AX1300 0P2003XX Paliperidone 75 mg Prolonged Release Injection A* (Invega Sustenna®) Cost RM 720/ prefilled syringe 8 N05AX1300 0P2004XX Paliperidone 100 mg Prolonged Release Injection A* Interactions Centrally acting drugs, alcohol, levodopa & other dopamine agonists, carbamazepine. Drugs known to prolong QT interval Cost RM 860/ prefilled syringe N05AX1300 0P2005XX Paliperidone 150 mg Prolonged Release Injection (Invega Sustenna®) Cost RM 860/ prefilled syringe Precautions Neuroleptic malignant syndrome, congenital long QT syndrome, tardive dyskinesia, hyperglycemia & diabetes mellitus, hyperprolactinemia, cardiovascular or cerebrovascular disease or conditions predisposing to hypotension. Monitor complete blood count regularly. History of seizures & cardiac arrhythmias, risk for aspiration pneumonia. Conditions that contribute to core body temperature elevation or dehydration. Parkinson's disease, dementia with Lewy bodies. Pregnancy. Elderly. Adolescents & children. May impair ability to drive or operate machinery Contraindications Moderate to severe renal impairment, dementia-related psychosis, lactation (Invega Sustenna®) 9 Indications Second or third line treatment of acute and maintenance treatment of schizophrenia in adults A* Adverse effects Insomnia, headache, agitation, somnolence, sedation, dizziness, injection site pain, akathisia, extrapyrimidal disorder, constipation, nausea, vomiting, nasopharyngitis, bradycardia, bundle branch block, postural orthostatic tachycardia syndrome, tachycardia, blood cholesterol increased, blood glucose increased, convulsion, dizziness postural, drooling, dysarthria, dyskinesia, dystonia, hypertonia, lethargy, neuroleptic malignant syndrome, oromandibular dystonia, parkinsonism, psychomotor hyperactivity, syncope, oculogyric crisis, eye rolling, vision blurred, amenorrhea, erectile dysfunction, galactorrhea, gynecomastia, menstruation irregular, sexual dysfunction Pindaan FUKKM Bil. 1/2011 (Mac 2011) 12/17 TERHAD - Edaran dalaman sahaja No MDC 10 G03DA0400 0C1001XX Generic Name Brand name Price quoted Progesterone 100mg capsule Prescriber Category A* Details Indications Supplementation of the luteal phase during IVF cycles and frozen embryo transfer cycle (Utrogestan®) Dose Vaginal route, 4 to 6 capsules (in 2 to 3 divided doses) per day starting from the day of the HCG injection until the 12th week of pregnancy. Cost RM 1.25/ capsule Precautions Delay evacuation of dead egg or interruption of non progressive pregnancy. May impair ability to drive or operate machinery. Contraindications Vaginal: Unknown Interactions Unknown Adverse effects Local discomfort (erythema/ burning or itching), bloating, vaginal discharge, spotting, metrorrhagia, breast fullness 11 J07BB02963 P5001XX Influenzae Vaccine (Inactivated,Trival ent) Type A (H1N1) 9 mcg, Type A (H3N2) 9 mcg & Type B 9 mcg Haemagglutinin Injection B Indications Prevention of influenza and influenza related complications in high risk adult patients, in particular individuals who have chronic cardiovascular, pulmonary, metabolic or renal disease, or who are immunocompromized and elderly patients Dose 18 to 59 years: Single dose of 0.1ml 9mcg/strain intradermally. More than or equal to 60 years: Single dose of 0.1ml 15mcg/strain intradermally (Intanza®) Precautions History concerning possible hypersensitivity to the vaccine or similar vaccine, presence of any contraindications to immunization, febrile or acute disease, immunocompromised persons, Cost RM 35/prefilled syringe 12 J07BB02963 P5002XX Influenzae Vaccine (Inactivated,Trival ent) Type A (H1N1) 15 mcg, Type A (H3N2) 15 mcg & Type B 15 mcg Haemagglutinin Injection (Intanza®) Cost RM 40/prefilled syringe B ® hypersensitivity to formaldehyde, Triton X-100 and neomycin, active neurologic disorder, avoid vaccinating persons who are known to have experienced GuillainBarré syndrome (GBS) within 6 to 8 weeks after a previous influenza vaccination. Pregnant Women: Should be given to pregnant women following an assessment of the risks and benefits in the person to be vaccinated. Nursing Women: Caution must be exercised when administered to a nursing mother. Paediatrics: Not indicated for persons less than 18 years of age. Contraindications History of severe allergic reaction to any component of the vaccine or after previous administration of the vaccine or a vaccine containing the same components or constituents. Pindaan FUKKM Bil. 1/2011 (Mac 2011) 13/17 TERHAD - Edaran dalaman sahaja No MDC Generic Name Brand name Price quoted Prescriber Category Details Interactions Immunosuppressive treatments may interfere with the development of the expected immune response. Adverse effects Injection site reactions (erythema, swelling, induration, pruritus, pain, echymosis), systemic reactions (headache, myalgia, malaise, shivering, fever), arthralgia, asthenia (including fatigue), increased sweating, paresthesia, rash, transient thrombocytopenia, lymphadenopathy. Allergic reactions: urticaria, dyspnea, angioneurotic edema, anaphylaxis including shock. Guillain-Barré syndrome (GBS), neuritis, neuralgia, convulsions, encephalomyelitis, vasculitis, such as HenochSchonlein purpura, with transient renal involvement in certain cases 13 A10BB0900 0T5001XX Gliclazide 60 mg Modified Release Tablet B (Diamicron MR®) Cost RM 24.72/60’s Indications As monotherapy or in combination with other oral antidiabetic agents in type 2 diabetes in adults when dietary measures, physical exercise and weight loss alone are not sufficient to control blood glucose Dose Initially 30 mg daily, adjusted according to response every 4 weeks (after 2 weeks if no decrease in blood glucose). Max. 120 mg daily Precautions/ Contraindications/ Interactions/ Adverse effects Same as Gliclazide 30 mg Modified Release Tablet B. Tukar kategori Preskriber No MDC Generic name 1 J07BM01000P3001 XX Human Papillomavirus (Types 6, 11, 16, 18) Vaccine Injection Old Category A New Category A/KK A A/KK Other Details As in MOH Formulary (Gardasil®) Cost RM 180.00/prefilled syringe 2 J07BM02000P3001 XX Human Papillomavirus (Types 16, 18) Vaccine Injection As in MOH Formulary (Cervarix®) Cost RM 53.80/prefilled syringe (Contract item) Pindaan FUKKM Bil. 1/2011 (Mac 2011) 14/17 TERHAD - Edaran dalaman sahaja C. Tambah Indikasi No MDC Generic name 1 C09CA0700 0T1002XX Telmisartan 80 mg Tablet Cost RM 1.225/tablet (Contract item) Old Indication Hypertension in patients who cannot tolerate ACE inhibitors because of cough New Indication i)Hypertension in patients who cannot tolerate ACE inhibitors because of cough ii)Reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors Pindaan FUKKM Bil. 1/2011 (Mac 2011) Other Details Dose i)40 to 80 mg once daily ii)80 mg once daily Others As in MOH Formulary 15/17 TERHAD - Edaran dalaman sahaja LAMPIRAN 4 4. Kemaskini Maklumat Ubat Rosiglitazone 4 mg dan 8 mg Tablet No MDC Generic name Old Details New Details Other Details 1 A10BG020 00T1002XX Rosiglitazone 4 mg Tablet A10BG020 00T1001XX Rosiglitazone 8 mg Tablet Indication Type 2 diabetes with insulin resistant features. Prescribed to new patients only if inadequate glycaemic control with all other combination of oral antidiabetic medications (such as sulphonylureas, metformin, acarbose or DPPIV inhibitors) and is the only suitable alternative. Use of rosiglitazone in combination with insulin (for new patients) is not recommended. Combined use with insulin should be limited to existing cases with stable glycaemic control and requires close monitoring in view of increased risk of fluid retention, weight gain and hypoglycaemia. In cases of existing use in patients with optimal glycaemic control, rosiglitazone should be continued with close monitoring of cardiovascular, osteoporosis and fracture risk. As in MOH drug formulary 2 Indication Diabetes mellitus with insulin resistant features, combined with sulphonylureas, metformin, acarbose and or insulin, delays introduction of insulin in type 2 diabetes mellitus already on maximal doses of two or more oral hypoglycaemic agents Contraindication Hepatic impairment, history of heart failure, combination with insulin (risk of heart failure), pregnancy and breast feeding, diabetic ketoacidosis, hypersensitivity to rosiglitazone product Precaution Active liver disease, alanine transaminase levels more than 2.5 times upper limit of normal, chronic heart failure (class I-II), diabetes mellitus type I, oedema, lack of adequate contraception in premenopausal anovulatory women. Potential increased risk of myocardial ischaemia, exacerbate heart failure and other concurrent CV diseases such as hypertension Contraindication Patients with cardiac failure (NYHA Class I-IV) or history of cardiac failure, known ischeamic heart disease, hepatic impairment, pregnancy and breastfeeding, diabetic ketoacidosis, hypersensitivity to rosiglitazone product Precaution Increased risk of myocardial ischeamia, exacerbate heart failure. Increased risk of fracture, especially in women. Active liver disease, alanine transaminase level more than 2.5 times upper limit of normal, type 1 diabetes, oedema (especially when used in combination with insulin), lack of adequate contraception in premenopausal anovulatory women Pindaan FUKKM Bil. 1/2011 (Mac 2011) 16/17 TERHAD - Edaran dalaman sahaja LAMPIRAN 5 5. PERMOHONAN-PERMOHONAN YANG TIDAK DILULUSKAN Proforma B BIL 1 NAMA UBAT Rosiglitazone Maleate 4mg Tablet PINDAAN YANG DICADANGKAN Tukar kategori preskriber daripada A* kepada A/KK ALASAN Reports on the cardiovascular safety of rosiglitazone have been highlighted and published recently and resulted in withdrawal or restricted use in many countries. The use of this rosiglitazone in primary care may be difficult to monitor, especially with current recommendations requiring doctors to closely monitor patients, regularly inform patients on safety issues such as cardiovascular risk, osteoporosis and fracture risk as well as attest to and document patient’s eligibility for starting and continuing this drug. National Pharmaceutical Control Bureau (NPCB) had issued a circular to restrict the use of this drug due to reports on elevated risks of cardiovascular events. Not supported by TDWC* of Endocrine Proforma D BIL NAMA UBAT ALASAN 1 Cefdinir 125mg/5ml Oral Suspension i) There are no overt advantages over current option. Most studies showed that it is as efficacious as other beta lactam antibiotics. ii) Currently available alternatives are sufficient to treat the indications applied for. iii) Not supported by TDWC* of Antimicrobial. 2 Prasugrel HCL 10mg Tablet i) There are no added advantages over the current alternative drug available in MOH drug formulary. ii) The currently available alternative is much cheaper compared to prasugrel tablet. *TDWC = Therapeutic Drug Working Committee Pindaan FUKKM Bil. 1/2011 (Mac 2011) 17/17