Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1291 Pramipexole Dihydrochloride Extended Release 1.5mg Tablet N04BC05110T5003XX A Treatment for signs and symptoms of advanced idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa Dose escalation: 0.375 mg/day on week 1, 0.75 mg/day on week 2, 1.5 mg/day on week 3. Increase by 0.75 mg at weekly intervals if needed up to a max of 4.5 mg/day. Patient on l-dopa: reduce dose. Renal Impairment: CrCl 30-50 mL/min Initially 0.375 mg every other day. May be increased by 0.375 mg at weekly intervals to max 2.25 mg/day
1292 Prasugrel HCl 10 mg Tablet B01AC22110T1002XX A* Co-administered with aspirin, is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary syndromes who are to be managed with percutaneous coronary intervention (PCI) as follows: STEMI with or without diabetes, UA and NSTEMI with diabetes, age <75yrs old, weight >60kg, without history of TIA stroke and clinically suspected clopidogrel resistance subset. (Only to be used in Cardiology Centre as third line treatment/ adjunctive therapy). Initiate treatment with a single 60mg oral loading dose. Continue at 10mg/5mg once daily with or without food. Patients should also take aspirin (75 mg - 325 mg) daily.
1293 Pravastatin Sodium 20 mg Tablet C10AA03520T1001XX A/KK Hypercholesterolaemia and coronary heart disease intolerant or not responsive to other forms of therapy. In health clinics, Pravastatin is restricted to HIV patients on HAART. 10 - 20 mg once daily. Maximum: 40 mg daily. In patients concomitantly taking cyclosporine, with or without other immunosuppressive drugs: Initial dose is 10mg/day and titration to higher doses should be performed with caution. Maximum dose 20mg/day.
1294 Prazosin HCl 1 mg Tablet C02CA01110T1001XX B Hypertension Initially 0.5 mg 2 - 3 times daily, the initial dose on retiring to bed at night; increased to 1 mg 2 - 3 times daily after 3 - 7 days: further increased if necessary to maximum 20 mg daily
1295 Prazosin HCl 2 mg Tablet C02CA01110T1002XX B Hypertension Initially 0.5 mg 2 - 3 times daily, the initial dose on retiring to bed at night; increased to 1 mg 2 - 3 times daily after 3 - 7 days: further increased if necessary to maximum 20 mg daily
1296 Prazosin HCl 5 mg Tablet C02CA01110T1003XX B Hypertension Initially 0.5 mg 2 - 3 times daily, the initial dose on retiring to bed at night; increased to 1 mg 2 - 3 times daily after 3 - 7 days: further increased if necessary to maximum 20 mg daily
1297 Pre/Post Natal Vitamin & Mineral Capsule A11AA03903C1001XX C+ Vitamin and mineral supplement for use during pregnancy and lactation 1 capsule daily or based on individual requirements
1298 Pre/Post Natal Vitamin & Mineral Tablet A11AA03903T1001XX C+ Vitamin and mineral supplement for use during pregnancy and lactation 1 tablet daily or based on individual requirements
1299 Prednisolone 2.5mg/5 ml Syrup H02AB06-000-L90-02-XX B i) Replacement therapy for primary and secondary adrenocortical insufficiency
ii) Other therapies as listed in the product package insert		 None CHILD: 0.5mg - 2mg/kg/day in divided doses every 6-8 hours or as a single daily.

Dose is individualised based on indication and product package insert/protocol
1300 Prednisolone 5mg Tablet H02AB06-000-T10-01-XX B i) Replacement therapy for primary and secondary adrenocortical insufficiency
ii) Adrenogenital syndrome
iii) Other therapy		 None i) 5 - 25 mg daily in divided doses
ii) 10 - 20 mg/m2 body surface daily in divided doses
iii) ADULT: 5 - 60 mg daily. CHILD: 0.5 - 2 mg/kg/day in divided doses every 6 - 8 hours or as a single daily
1301 Prednisolone 5mg/5 ml Syrup H02AB06-000-L90-04-xxx B i) Replacement therapy for primary and secondary adrenocortical insufficiency
ii) Other therapies as listed in the product package insert		 None CHILD: 0.5mg - 2mg/kg/day in divided doses every 6-8 hours or as a single daily.

Dose is individualised based on indication and product package insert/protocol
1302 Prednisolone Acetate 1% ophthalmic suspension S01BA04-122-D20-01-XXX A For steroid responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe. None 1 to 2 drops to be instilled into the conjunctival sac 2 to 4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 2 drops every hour. Care should be taken not to discontinue therapy prematurely.
1303 Pregabalin 150 mg Capsules N03AX16-000-C10-02-XXX A*, A/KK Kategori preskriber A*:
i. Fibromyalgia
ii. Epilepsy

Kategori preskriber A/KK:
iii. Neuropathic pain		 Consultant/specialists for specific indications only, including Geriatricians

Indication iii:
In primary care setting, for patients who cannot tolerate gabapentin at high doses.		 The dose range is 150 to 600 mg per day given in either two or three divided doses.

Dosing is according to Product Insert
1304 Pregabalin 50 mg capsule N03AX16-000-C10-03-XXX A*, A/KK Kategori preskriber A*:
i. Fibromyalgia
ii. Epilepsy

Kategori preskriber A/KK:
iii. Neuropathic pain		 Consultant/specialists for specific indications only, including Geriatricians

Indication iii:
In primary care setting, for patients who cannot tolerate gabapentin at high doses.		 The dose range is 150 to 600 mg per day given in either two or three divided doses.

Dosing is according to Product Insert
1305 Pregabalin 75mg Capsule N03AX16-000-C10-01-XXX A*, A/KK Kategori preskriber A*:
i. Fibromyalgia
ii. Epilepsy

Kategori preskriber A/KK:
iii. Neuropathic pain		 Consultant/specialists for specific indications only, including Geriatricians

Indication iii:
In primary care setting, for patients who cannot tolerate gabapentin at high doses.		 The dose range is 150 to 600 mg per day given in either two or three divided doses.

Dosing is according to Product Insert
1306 Primaquine 7.5mg base Tablet P01BA03-162-T10-01-XXX B i) Treatment of malaria
ii) Prophylaxis together with a schizonticide such as chloroquine		 None 0.5mg/kg/day up to 30mg daily
1307 Probenecid 500 mg Tablet M04AB01000T1001XX A Hyperuricemia associated with gout and gouty arthritis (for cases allergic to allopurinol or serum uric acid not controlled by allopurinol alone) 500 mg to 1000 mg twice daily
1308 Procaine Penicillin Fortified 4 MU Injection J01CE09702P4002XX B Treatment of infections due to Penicillin G-sensitive organisms ADULT: 300,000 - 900,000 units (300 - 900 mg) IM daily. CHILD: Up to 1 year: 150 mg IM daily. 1 - 5 years: 300 mg IM daily. 6 - 12 years: 600 mg IM daily
1309 Procarbazine HCl 50 mg Capsule L01XB01110C1001XX A Lymphomas Adult: Monotherapy: Initially, 50 mg/day, increased by 50 mg daily to 250-300 mg daily in divided doses. Continue doses until max response is achieved or appearance of signs of toxicity. Maintenance: 50-150 mg/day or 1-2 mg/kg daily until a cumulative dose of at least 6 g. Combination Therapy: 100 mg/m2 on days 1-14 of each 4- or 6-wk cycle. Child: Initially, 50 mg/m2 daily, up to 100 mg/m2 adjust according to response.
1310 Prochlorperazine Maleate 5mg Tablet N05AB04253T1002XX B i) Severe nausea and vomiting
ii) Vertigo/labyrinthine disorders		 Nausea and vomiting Adult: As maleate or mesilate: 20 mg, further doses are given if needed. Recommended buccal dose: As maleate: 3-6 mg bid. Vertigo Adult: As maleate or mesilate: 15-30 mg daily, given in divided doses. May reduce gradually to 5-10 mg daily. Recommended buccal dose: 3-6 mg bid. May be taken with or without food.
1311 Prochlorperazine Mesylate 12.5 mg/ml Injection N05AB04253P3001XX B i) Severe nausea and vomiting
ii) Vertigo/labyrinthine disorders		 Deep IM injection, 12.5 mg repeated if necessary after 6 hours and then followed by an oral dose. Not recommended in children
1312 Procyclidine HCl 5 mg/ ml Injection N04AA04110P3001XX B i) All forms of Parkinson's disease (idiopathic paralysis agitants), post-encephalitis and arteriosclerosis
ii) To control troublesome extrapyramidal symptoms induced by neuroleptic drugs including pseudo-parkinsonism, acute dystonic reactions and akathisia		 i) Initial dose 2.5mg TDS, increasing by 2.5-5mg/day at intervals of 2 or 3 days until the optimum clinical response is achieved. Usual maintenance dose: 15-30mg/day. Max: 60mg/day

ii) Initial dose 2.5mg TDS, increasing by 2.5mg daily until symptoms are relieved. Usual maintenance dose: 10-30mg/day. IV Emergency: 5-10 mg. IM Emergency: 5-10 mg as a single dose, may repeat after 20 mins if needed. Max: 20 mg/day.
1313 Progesterone 100 mg capsule G03DA04000-C10-01XX A* Oral:
(i) Progesterone insufficiency
(ii) Luteal insufficiency
(iii)Menopause treatment associated with estrogen therapy, Prevent risk of endometrial hyperplasia

Vaginal:
(iv) Progesterone substitution for ovarian proved women during complete deficiency
(v) Supplementation of the luteal phase during in vitro fertilization cycles (IVF)
(vi)Supplementation of the luteal phase during spontaneous or induced cycles
(vii)Threatened abortion or prevention of repeated abortions due to luteal insufficiency		 - Oral route:
(i) Daily dose of 200 to 300mg in two divided doses
(ii)Daily dose of 200 to 300mg for 10 days per month, usually from 17th to the 26th day of the cycle.
(iii) 200mg daily for 12 to 14 days in a month, the two last weeks of each cycle.

Vaginal route:
(iv) Taken with estrogen therapy: 100 mg given on the 13th and the 14th day of the cycle of transfer, then 200mg in divided doses from the 15th to the 25th day of the cycle. From 26th day and in the case of the onset of pregnancy, the dose is increased by 100mg per day each week, and rises to a maximum of 600mg per day divided into 3 intakes. This dosage will be continued until the 60th day and until the 12th week of pregnancy and no further.
(v) 400 mg to 600mg per day, prior to embryo transfer according to IVF protocol until the 12th week of pregnancy
(vi) 200mg - 300mg/day, from the 17th day of the cycle for 10 days
(vii)200 to 400mg daily in two divided doses
1314 Progesterone 8% Vaginal Gel G03DA04-000-G30-01-XXX A* Progesterone supplementation of the luteal phase - 125g of 8% gel (90 mg progesterone) intravaginally daily from the day of embryo transfer until confirmation of pregnancy in which the therapy should be continued for a total treatment duration of 30 days
1315 Prolase Tablet M09AB00000T1001XX B Oedema and inflammation in conjunction with other physical or chemotherapeutic measures 2 tablet 4 times daily for the first day, then 1 tablet 4 times daily for at least 5 days.
1316 Promethazine HCl 25 mg/ml Injection R06AD02-110-P30-01-XXX B i) Allergic conditions
ii) Treatment and prevention of vomiting including:
- motion sickness
- drug induced nausea
- prevention and control of nausea and vomiting associated with certain types of anaesthesia and surgery		 None i) Allergic Conditions
Adult and adolescent dose: 25mg intramuscular or intravenous. May be repeated within 2 hours if required.
Children 2 years and older: intramuscularly-0.125mg/kg body weight every 4 to 6 hours OR 0,5mg/kg bodyweight at bedtime as needed OR 6.25-12.5mg three times a day as needed OR 25mg at bedtime as needed.

ii. Treatment and prevention of vomiting:
- Motion Sickness
Adult and adolescent dose: 25mg twice a day as needed.
Children: 0.5mg/kg every 12 hours as needed OR 10 - 25mg twice a day as needed.

- Anti Emetic Therapy
Adult and adolescent dose: 25mg initially and then 10 -25mg every 4 - 6 hours as needed.
Children: 0.25-0.5mg/kg every 4 to 6 hours as needed OR 10 - 25mg every 4 to 6 hours as needed.
Dosing is individualised and according to product insert/protocol
1317 Promethazine HCl 5mg/5ml Syrup R06AD02-110-L90-01-XXX B Allergic conditions None CHILD 2 - 5 years: 5 - 15 mg daily 5 - 10 years : 10 - 25 mg daily
1318 Proparacaine HCI 0.5% Ophthalmic Drops S01HA04-110-D20-01-XXX B Topical anaesthesia in ophthalmic procedures None Deep anaesthesia:1 or 2 drops in the (eyes) every 5 to 10 minutes for 3 to 5 doses. For minor surgical procedures: instill 1 to 2 drops every 5 to 10 minutes for 1 to 3 doses. Tonometry and/or tonography procedure: 1 to 2 drops in each eye before procedure.
1319 Propiverine HCl 15 mg Tablet G04BD06110T1001XX A* Treatment of urinary incontinence, urgency and frequency in neurogenic detrusor overactivity (detrusor hyperreflexia) and in idiopathic detrusor overactivity (overactive bladder) ADULT: 15 mg twice daily to 3 times daily, increase to 4 times daily if required. Max dose: 60 mg daily. CHILD more than 5 years: 0.2 to 0.4 mg/kg per day in 2 divided doses
1320 Propofol 10mg/ml (1%) Injection N01AX10-000-P99-01-XX A* i) Induction & maintenance of general anaesthesia.
ii) Sedation of ventilated patients in intensive care		 - Adult: Induction: 20- 40 mg by injection or infusion every 10 sec. Usual dose: 1.5-2.5 mg/kg. Maintenance: 4-12 mg/kg/hr or intermittent bolus inj of 20-50 mg. Child: >8 yr: Induction dose of 2.5 mg/kg. Maintenance dose: 9-15 mg/kg/hr by IV infusion or intermittent bolus inj. Elderly: Including neurosurgical and debilitated patients: Infuse at a rate of 20 mg every 10 sec. Maintenance: 3-6 mg/kg/hr. Usual dose needed: 1-1.5 mg/kg. Duration of use : Can be administered for a maximum period of 7 days. Sedation: 0.3 - 4 mg/kg/hour up to 3 days

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