Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1171 Oxymetazoline HCI 0.01% Nasal Drops R01AA05-110-D60-03-XXX A* Acute cold, paranasal sinusitis, syringitis, otitis media. None Newborn (up to 4 weeks): 1 drop. Infant (1 - 12 month): 1 - 2 drop. Doses to be given twice or three times daily
1172 Oxymetazoline HCl 0.025% (Paediatric) Nasal Drops R01AA05-110-D60-01-XXX A/KK Acute colds, paranasal sinusitis and otitis media None 1 - 2 drops twice daily in each nostril for child more than 1 year
1173 Oxymetazoline HCl 0.025% (Paediatric) Nasal Spray R01AA05-110-A41-01-XXX A Acute colds, paranasal sinusitis and otitis media None 2 - 3 sprays into each nostril twice daily for child more than 1 year
1174 Oxymetazoline HCl 0.05% (Adult) Nasal Drops R01AA05-110-D60-02-XXX A/KK Acute colds, paranasal sinusitis and otitis media None 1 - 2 drops twice daily in each nostril
1175 Oxymetazoline HCl 0.05% (Adult) Nasal Spray R01AA05-110-A41-02-XXX A Acute colds, paranasal sinusitis and otitis media None 2 - 3 sprays into each nostril twice daily, maximum 6 sprays per nostril/day
1176 Oxymetholone 50 mg Tablet A14AA05000T1001XX A Anaemias caused by the administration of myelotoxic drugs, treatment of AIDS-wasting syndrome ADULT and CHILD: 1 - 5 mg/kg daily in one daily dose. Usual effective dose 1 - 2 mg/kg/day, given for a minimum trial of 3 - 6 months because response may be delayed
1177 Oxytetracycline with Polymyxin B Sulphate Eye Ointment S01AA30-947-G51-01-XXX B Treatment of superficial ocular infections involving the conjunctiva and/or cornea due to susceptible microorganisms None Apply into the conjunctival sac 4 times daily
1178 Oxytocin 10units/ml Injection H01BB02-000-P30-01-XXX B i) Induction of labour
ii) Inadequate uterine effort
iii) Management of third stage of labour
iv) Prevention and treatment of post-partum haemorrhage
v) As adjunctive therapy for the management of incomplete, inevitable or missed abortion		 None i & ii) Intiate at 2 milliunits/min, may be increased by 4 miliunits/min gradually at 30 minute intervals. Dose may be decreased once a contraction pattern similar to normal labour is achieved and labor has progressed to 5 - 6 cm dilation. Maximum dose of oxytocin for multiparae - 16 miliunits/min and nulliparae-32 miliunits/min.

iii) IV/IM: 5 -10 units
iv) IV : 5-10 units followed by IV infusion at 10 units/hour
v) Initial: 5 units given via slow inj over 5 minutes, may be followed by an infusion at a rate of 20-40 milliunits/minute as necessary

The dosing is individualized based on maternal, fetal response and product insert / protocol
1179 Oxytocin 5 units & Ergometrine Maleate 0.5 mg/ml Injection G02AC01-900-P30-01-XXX C+ i)Prevention and treatment of postpartum haemorrhage associated with uterine atony.
ii)Active management of third stage of labour		 None i) 1 ml IM, may be repeated after 2 hours. Should not exceed 3 ml within 24 hours
ii) For routine management of third stage of labour, 1 ml IM following delivery of the anterior shoulder or immediately after delivery of the child
1180 Paclitaxel 6mg/ml Injection L01CD01-000-P30-01-XXX A* i) Breast carcinoma:
Initial treatment of advanced or metastatic and also second line after failure of standard therapy.

ii) Ovarian carcinoma:
First Line in combination with a platinum compound for advanced metastatic carcinoma of the ovary;
Second line for advanced metastatic carcinoma of the ovary

iii) Non-small cell lung carcinoma:
First line in combination with platinum compound or as single agent		 i) 175 mg/m2 IV over 3 hours every 3 weeks

ii) 175 mg/m2 IV over 3 hour followed by cisplatin 75 mg/m2 in every 3 weeks or 135 mg/m2 IV over 24 hours followed by cisplatin 75 mg/m2 every 3 weeks

iii) 135 mg/m2 IV over 24 hours followed by cisplatin 75 mg/m2 every 3 weeks
1181 Palbociclib 100mg Capsules L01XE33-000-C11-02-XXX A* Indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women. None 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days.

Palbociclib should be taken with food. For dose modification, refer package insert
1182 Palbociclib 100mg Film Coated Tablets L01EF01-000-T32-02-xxx A* Indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. None 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib tablets may be taken with or without food.
1183 Palbociclib 125mg Capsules L01XE33-000-C11-03-XXX A* Indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women. None 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days.

Palbociclib should be taken with food. For dose modification, refer package insert
1184 Palbociclib 125mg Film Coated Tablets L01EF01-000-T32-03-xxx A* Indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. None 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib tablets may be taken with or without food.
1185 Palbociclib 75mg capsules L01XE33-000-C11-01-XXX A* Indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women. None 125 mg capsule taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days.

Palbociclib should be taken with food. For dose modification, refer package insert
1186 Palbociclib 75mg Film Coated Tablets L01EF01-000-T32-01-xxx A* Indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. None 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib tablets may be taken with or without food.
1187 Paliperidone 100mg Prolonged Release Injection N05AX13-000-P20-04-XXX A* Second or third line treatment of acute and maintenance treatment of schizophrenia in adults None 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 maintenance dose can be administered in either the deltoid or gluteal muscle
1188 Paliperidone 150mg Prolonged Release Injection N05AX13-000-P20-05-XXX A* Second or third line treatment of acute and maintenance treatment of schizophrenia in adults None 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
1189 Paliperidone 175mg/0.875ml Prolonged-Release for Intramuscular Injection N05AX13-126-P20-01-001 A* For the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months. None Apply 3.5 as a dose multiplier to the previous 1-month injection dose, and administer every 3 months
1190 Paliperidone 263mg/1.315ml Prolonged-Release for Intramuscular Injection N05AX13-126-P20-02-001 A* For the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months. Apply 3.5 as a dose multiplier to the previous 1-month injection dose, and administer every 3 months
1191 Paliperidone 350mg/1.750ml Prolonged-Release for Intramuscular Injection N05AX13-126-P20-03-001 A* For the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months. None Apply 3.5 as a dose multiplier to the previous 1-month injection dose, and administer every 3 months
1192 Paliperidone 3mg Extended Released Tablet N05AX13-000-T50-01-XX A* Second or third line treatment of schizophrenia ADULT 6 mg once daily in the morning, adjusted if necessary; usual range 3 -12 mg daily. Renal impairment (creatinine clearance between 10-50 mL/min) 3 mg once daily. Avoid if creatinine clearance less than 10mL/min
1193 Paliperidone 50mg Prolonged Release Injection N05AX13-000-P20-02-XXX A* Second or third line treatment of acute and maintenance treatment of schizophrenia in adults 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
1194 Paliperidone 525mg/2.625ml Prolonged-Release for Intramuscular Injection N05AX13-126-P20-04-001 A* For the maintenance treatment of schizophrenia in adult patients who have been adequately treated with the 1-month paliperidone palmitate injectable product for at least four months. Apply 3.5 as a dose multiplier to the previous 1-month injection dose, and administer every 3 months
1195 Paliperidone 6 mg Extended Released Tablet N05AX13000T5002XX A* Second or third line treatment of schizophrenia ADULT 6 mg once daily in the morning, adjusted if necessary; usual range 3 -12 mg daily. Renal impairment (creatinine clearance between 10-50 mL/min) 3 mg once daily. Avoid if creatinine clearance less than 10mL/min
1196 Paliperidone 75 mg Prolonged Release Injection N05AX13000P2003XX A* Second or third line treatment of acute and maintenance treatment of schizophrenia in adults 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
1197 Paliperidone 9 mg Extended Released Tablet N05AX13000T5004XX A* Second or third line treatment of schizophrenia ADULT 6 mg once daily in the morning, adjusted if necessary; usual range 3 -12 mg daily. Renal impairment (creatinine clearance between 10-50 mL/min) 3 mg once daily. Avoid if creatinine clearance less than 10mL/min
1198 Palivizumab 100mg Injection J06BB16000P3001XX A* For the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in paediatric patients at high risk of RSV disease 15 mg/kg IM once a month during season of RSV risk
1199 Pamidronate Disodium 30 mg Injection M05BA03520P3001XX A* Hypercalcaemia of malignancy (tumour -induced hypercalcaemia) Dose depends on the initial serum calcium levels. Doses range from a single infusion of 30 - 90 mg
1200 Pamidronate Disodium 90 mg Injection M05BA03520P3002XX A* Hypercalcaemia of malignancy (tumour -induced hypercalcaemia) Dose depends on the initial serum calcium levels. Doses range from a single infusion of 30 - 90 mg

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