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Lampiran 1 PINDAAN BIL. 3 TAHUN 2010 KEPADA FORMULARI UBAT KKM

1. UBAT–UBAT BARU YANG DILULUSKAN MASUK KE DALAM FORMULARI UBAT KKM

No MDC Generic Name

Brand name Price quoted

Prescriber Category

Details

1 N05AL05000T1001XX

Amisulpride 100 mg Tablet (Solian®) Cost RM 41.36 /box of 30’s

A* Indication Treatment of psychoses, particularly acute or chronic schizophrenia disorders characterized by positive symptoms(e.g. delusion, hallucinations, thought disorders) and/or negative symptoms(e.g. blunted emotions, emotional and social withdrawal) including when the negative symptoms predominate Dose Predominantly negative episodes: 50-300 mg once daily adjusted according to the patient’s response. Mixed episodes with positive and negative symptoms: 400-800 mg/day in 2 divided doses adjusted according to the patient’s response. Should be taken on an empty stomach (Preferably taken before meals) Precaution Renal insufficiency (dose reductions), epilepsy, Parkinson's disease; concomitant use of dopamine agonists, previous hypersensitivity to other benzamide derivatives (sulpiride, metoclopramide, tiapride, sultopride), elderly patients (increased risk of adverse effects; reduced renal function may be present requiring dose adjustment), coadministration with other agents which depress the central nervous system or lower blood pressure Contraindication Hypersensitivity to amisulpride, pheochromocytoma, prolactinomas and breast cancer, pregnancy, lactation, children under 15 years of age Interaction Amiodarone; increased risk of cardio toxicity (QT prolongation, torsades de pointes, cardiac arrest). If concurrent use cannot be avoided, cautious dosing and telemetric monitoring is advised . Amitriptyline, chloral hydrate, chloroquine, chlorpromazine, cisapride, clarithromycin, erythromycin, fluconazole, fluoxetine, imipramine, isoflurane, mefloquine, octreotide, prochlorperazine, sulfamethoxazole, thioridazine, trifluoperazine, trimethoprim and vasopressin; increased risk of cardio toxicity (QT prolongation, torsades de pointes, cardiac arrest)

2 N05AL05000T1002XX

Amisulpride 400 mg Tablet (Solian®) Cost RM 155.08 /box of 30’s

A*

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No MDC Generic Name Brand name Price quoted

Prescriber Category

Details

Adverse effect Insomnia, anxiety, agitation, extrapyramidal symptoms, galactorrhea, gynecomastia, amenorrhea, breast pain, impotence, gastrointestinal disorder, weight gain

3 R06AE09110T1001XX

Levocetirizine Dihydrochloride 5 mg Tablet (Xyzal®) Cost RM 0.45/ tablet

A* Indication Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) and chronic idopathic urticaria Dose Children above 6 years and adults: 5 mg orally once daily (Swallow whole, do not chew/crush). Precaution Concurrent alcohol use; should be avoided due to potential increase in CNS depression and sedation, concurrent use of other central nervous system depressants; should be avoided due to potential increase in CNS depression and sedation, renal function, impaired; increased risk of adverse reactions, dosage adjustment required Contraindication Hemodialysis patients, hypersensitivity to levocetirizine, cetirizine, or any component of the product, end-stage renal disease, (CrCl less than 10 mL/min), renally impaired pediatric patients between 6 months and 11 years old Interaction Ritonavir; increased exposure of levocetirizine Adverse effect Asthenia, somnolence, nasopharyngitis, pharyngitis, xerostomia, fatigue, fever

4 A10BD08926T1001XX

Vildagliptin 50 mg and Metformin HCl 850 mg Tablet (Galvus®Met) Cost RM 1.50/ tablet

A* Indication Treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets. Dose 50 mg/850 mg or 50 mg/1000 mg twice daily. Maximum daily dose is 100 mg vildagliptin plus 2000 mg metformin hydrochloride. Precaution Hypoxic states, metabolic acidosis, surgical procedures. Monitor liver & renal function. Cardiac failure, skin disorder. Elderly and children less than 18 years old.

5 A10BD08926T1002XX

Vildagliptin 50 mg and Metformin HCl 1000 mg Tablet (Galvus®Met) Cost RM 1.50/ tablet

A*

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No MDC Generic Name Brand name Price quoted

Prescriber Category

Details

Contraindication Diabetic ketoacidosis or pre-coma, renal failure or dysfunction (CrCl less than 60 mL/min), acute conditions with the potential to alter renal function (dehydration, severe infection, shock, intravascular administration of iodinated contrast agents), cardiac or respiratory failure, recent myocardial infarction, shock, hepatic impairment (alanine oraspartate transaminase more than 3 times upper limit of normal), acute alcohol intoxication, alcoholism. Pregnancy & lactation. Type 1 diabetes Interaction Diuretics (thiazides), corticosteroids, thyroid products, sympathomimetics, cationic drugs e.g. cimetidine, glucocorticoids, beta 2 agonists, ACE inhibitors, NSAIDs. Alcohol, iodinated contrast media Adverse effect Tremor, dizziness, headache, nausea, vomiting, diarrhoea, abdominal pain, loss of appetite, metallic taste

6 A10BD07926T1001XX

Sitagliptin 50 mg and Metformin HCl 500 mg Tablet (Janumet®) Cost RM 89.71/ box of 56’s

A* Indication i) Type 2 diabetes patients, especially the

elderly, with multiple co-morbidities that always experience hypoglycaemia with other antidiabetics who are a. Inadequately controlled on metformin or

sitagliptin alone or b. Already being treated with the

combination of sitagliptin and metformin ii) Newly diagnosed type 2 diabetes patients

with high baseline HbA1c and multiple co-morbidities who may experience hypoglycaemia with other antidiabetics

Dose 50 mg/500 mg twice daily. The recommended maximum daily dose is 100 mg sitagliptin plus 2000 mg metformin Precaution Not for use in type 1 diabetes mellitus or treatment of ketoacidosis. Renal & hepatic impairment. Sulfonylurea- or insulin-induced hypoglycemia, risk of lactic acidosis, hypoxic states, surgery, alcohol intoxication, decreased vitamin B12 absorption, loss of glycemic control. Elderly. Children less than 18 years old Contraindication Renal disease or dysfunction, acute or chronic metabolic acidosis including diabetic ketoacidosis, intravascular administration of

7 A10BD07926T1002XX

Sitagliptin 50 mg and Metformin HCl 850 mg Tablet (Janumet®) Cost RM 89.71/ box of 56’s

A*

8 A10BD07926T1003XX

Sitagliptin 50 mg and Metformin HCl 1000 mg Tablet (Janumet®) Cost RM 89.71/ box of 56’s

A*

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No MDC Generic Name Brand name Price quoted

Prescriber Category

Details

iodinated contrast materials. Pregnancy & lactation Interaction Metformin: Furosemide, nifedipine, cationic drugs (eg amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin). Thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium antagonists, isoniazide Adverse effect Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycaemia; abdominal pain, loss of appetite, metallic taste, upper respiratory tract infection, hypersensitivity reactions

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Lampiran 2

2. TAMBAHAN DAN PINDAAN FORMULASI/ KATEGORI/ BENTUK DOSEJ/ INDIKASI YANG DILULUSKAN UNTUK DIMASUKKAN KE DALAM FORMULARI UBAT KKM

A. Tambah Formulasi/ Kekuatan No MDC Generic Name

Brand name Price quoted

Prescriber Category

Details

1 N05AH04138T5002XX

Quetiapine Fumarate 200 mg Extended Release Tablet

(Seroquel XR®)

Cost RM 419.67/ box of 60’s

A* Indications i) Schizophrenia ii) Moderate to severe manic episodes in bipolar disorder iii) Major depressive episodes in bipolar disorder Dose 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. Precautions/ Contraindications/ Interactions/ Adverse effects Same as Quetiapine Fumarate Extended Release 50mg, 300mg & 400mg Tablets.

B. Tukar kategori Preskriber No MDC Generic name Old

Category New

Category Other Details

1 R03BB04320C9901XX Tiotropium Bromide Inhalation 18 mcg Capsules

Cost RM 112.50/ box of 30 capsules (Valid for 1 year from date of amendment : Letter from DKSH to Pharmaceutical Services Division dated 11/11/2010)

A* A/KK As in MOH Formulary

2 N05AX08000T1001XX Risperidone 1 mg tablet A/KK B As in MOH Formulary

3 N05AX08000T1002XX Risperidone 2 mg tablet A/KK B As in MOH Formulary

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Lampiran 3 3. TAMBAHAN UBAT KE DALAM SENARAI UBAT KLINIK 1MALAYSIA

No Generic Name Indication (as in MOH Drug Formulary) 1 Ammonium Bicarbonate, Tincture Ipecac,

etc Mixture

Cough

2 Bismuth Subgallate and Benzyl Benzoate Suppository

For relief of pruritus, burning and soreness in patients with haemorrhoids and perianal conditions

3 Glyceryl Trinitrate 0.5 mg Tablet Prophylaxis and treatment of angina and left ventricular failure

4 Liquid Paraffin Constipation

5 Potassium Permanganate 1:20,000 Solution

Cleansing and deodorising suppurative eczematous reactions and wounds

6 Sodium Bicarbonate 5% w/v Ear Drops To soften the impacted ear wax

7 Sodium Chloride 0.9% Eye Drops

Irrigation of conjunctival sac

8 Thymol Compound Gargle For sore throat and minor mouth inflammation

Lampiran 4

No1234

*** 5678910

*** 111213141516171819202122232425262728293031

*** 323334

*** 353637383940414243444546

*** 474849

*** 50*** 51

525354

*** 5556575859

Sodium Chloride 0.9% Injection

Zink Oxide Cream

Sodium Chloride 0.9% with Dextrose 5% InjectionTetanus Toxoid Injection

Vitamin B Complex TabletWater For Injection (10ml) Water For Irrigation (500ml)

Thymol Compound Gargle

Bismuth Subgallate and Benzyl Benzoate Suppository

Glyceryl Trinitrate 0.5 mg Tablet

Liquid Paraffin

Potassium Permanganate 1:20,000 Solution

Sodium Bicarbonate 5% w/v Ear DropsSodium Bicarbonate, Magnesium Carbonate, Tincture Cardamom Compound Mixture

Folic Acid 5 mg Tablet Gamma Benzene Hexachloride 0.1 % LotionGlycerinGlycerin 25% and Sodium Chloride 15% Enema

Chlorpheniramine Maleate 2 mg/5 ml SyrupChlorpheniramine Maleate 4 mg TabletCrotamiton Cream 10%Diphenhydramine HCl 14 mg/5 ml and Ammonium Chloride 135 mg/5 ml ExpectorantEthyl Chloride Spray

Ammonium Bicarbonate, Tincture Ipecac, etc Mixture

Paracetamol 500 mg TabletPotassium Citrate 3 g/10 ml and Citric Acid MixturePotassium Permanganate 1:10,000 Solution

Salbutamol 0.5 % Inhalation Solution

Methyl Salicylate 25% OintmentNystatin 100,000 units/g CreamOral Rehydration SaltParacetamol 120 mg/5 ml SyrupParacetamol 125 mg Suppository

Hydrogen Peroxide 20 Volume SolutionHyoscine N-Butylbromide 10 mg Tablet

Magnesium Trisilicate MixtureMagnesium Trisilicate TabletMenthol 1.6% in Industrial Methylated Spirit Inhalation

Ferrous Fumarate 200 mg Tablet

SENARAI UBAT KLINIK 1MALAYSIA

Pindaan 2/2010

UBAT RAWATAN RINGAN

10 jenis ubat troli kecemasan

Ubat yang baru disenaraikan : ** *

Senarai ini mengandungi : 59 jenis ubat rawatan ringan

Acriflavin 0.1% LotionGeneric Name

Albendazole 200 mg /5 ml Suspension Albendazole 200 mg Tablet Alcohol 70% Solution

Sodium Chloride 0.9% Eye Drops

Calamine Cream

Aqueous Cream Ascorbic Acid 100 mg Tablet Benzoic Acid Compound Ointment Benzyl Benzoate 25% Emulsion (Adult)Bisacodyl 5 mg Tablet

Calamine Lotion Calcium Lactate 300 mg TabletCetrimide 1-2% LotionCharcoal, Activated 250 mg TabletChloramphenicol .5% Ear DropsChloramphenicol 0.5% Eye DropsChloramphenicol 1% Eye OintmentChlorhexidine Gluconate 4% ScrubChlorhexidine Gluconate 5% Solution

November 2010 Senarai Ubat Klinik 1Malaysia Pindaan 2/2010 Page 1 of 2

UBAT TROLI KECEMASAN KLINIK 1MALAYSIA

No Generic Name Min. Quantity (ampoule/vial)

Max. Quantity (ampoule/vial)

1 Atropine Sulphate 1mg/ml Injection 3 82 Hyoscine N-Butylbromide 20 mg/ml Injection 3 83 Dextrose 50% Injection (10ml) 3 84 Sodium Bicarbonate 8.4% 10ml Injection 3 85 Adrenaline Acid (Epinephrine) Tartrate 1 mg/ml

Injection3 8

6 Hydrocortisone 100 mg Injection 3 87 Lignocaine HCl (Lidocaine) 2% Injection 3 88 Aminophylline 25 mg/ml Injection 3 39 Chlorpheniramine Maleate 10 mg/ml Injection 3 810 Water For Injection (10ml) 2 5

November 2010 Senarai Ubat Klinik 1Malaysia Pindaan 2/2010 Page 2 of 2