Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1141 Olopatadine Hydrochloride 0.1% Ophthalmic Solution S01GX09110D2001XX A* Treatment and prevention of ocular itchiness in allergic conjunctivitis None 1-2 drops in the affected eye twice daily
1142 Olopatadine Hydrochloride 0.2% Ophthalmic Solution S01GX09-110-D20-02-XXX A* Treatment and prevention of ocular itchiness in allergic conjunctivitis None One drop in each affected eye once a day
1143 Omalizumab 150mg powder and solvent for solution R03DX05-000-P30-01-XXX A* i) For adults and adolescents (≥12 years), for severe persistent allergic asthma whose symptoms are inadequately controlled with inhaled corticosetroids;
ii) For Children (6 to <12 years of age):
As add-on therapy to improve asthma control with severe persistent allergic asthma who have positive skin test or in vitro reactivity to a perennial aero allergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta 2 agonist.		 None i) Adult & adolescent ≥12 yr, 150-375 mg SC every 2-4 wk, according to body wt & baseline serum total IgE level.. For subcutaneous administration only. Do not administer by the intravenous or intramuscular route. ii) Appropriate dose and dosing frequency of omalizumab is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to initial dosing, patients should have their IgE level determined for their dose assignment. Based on these measurements 150-375mg in 1 -3 injections may be needed for each administration. Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dosing table should not be given omalizumab. For subcutaneous administration only.
1144 Omeprazole 10 mg Capsule A02BC01000C1001XX A/KK i) Reflux oesophagitis
ii) For eradication of Helicobacter pylori infection
iii) Benign peptic ulcer not responding to conventional therapy
iv) Zollinger-Ellison Syndrome		 i) 20 - 80 mg 1 - 2 times daily up to 8 - 12 weeks
ii) 20 mg twice daily in combination with any of the 2 antibiotics (clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily or metronidazole 400 mg twice daily) for 1 - 2 weeks
iii) 20 mg once daily for 4 - 6 weeks
iv) ADULT: 20 - 120 mg once daily adjusted according to the patient's response.
CHILD 0.4 - 0.8 mg/kg/day
1145 Omeprazole 20 mg Capsule A02BC01000C1002XX A/KK i) Reflux oesophagitis
ii) For eradication of Helicobacter pylori infection
iii) Benign peptic ulcer not responding to conventional therapy
iv) Zollinger-Ellison Syndrome		 i) 20 - 80 mg 1 - 2 times daily up to 8 - 12 weeks
ii) 20 mg twice daily in combination with any of the 2 antibiotics (clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily or metronidazole 400 mg twice daily) for 1 - 2 weeks
iii) 20 mg once daily for 4 - 6 weeks
iv) ADULT: 20 - 120 mg once daily adjusted according to the patient's response.
CHILD 0.4 - 0.8 mg/kg/day
1146 Omeprazole 40mg Injection A02BC01000P4001XX A* i) Reflux oesophagitis, eradication of H. Pylori infection, benign peptic ulcer not responding to conventional therapy, Zollinger-Ellison Syndrome
ii) Endoscopically confirmed peptic ulcer		 i) 40 mg IV once daily when oral therapy is inappropriate
ii) 40- 160 mg by IV in single or divided doses
1147 Ondansetron 2mg/ml Injection A04AA01-110-P30-01-XX A i) Prevention of nausea and vomiting induced by chemotherapy and radiotherapy
ii) Postoperative nausea and vomiting		 None i) 8 mg given by IV infusion over 15 minutes or by IM immediately before treatment followed by 8 mg orally every 12 hours for up to 5 days. CHILD 5 mg/m2 body surface IV over 15 minutes immediately before chemotherapy followed by 4 mg orally every 12 hours for up to 5 days
ii) Prevention : 4 mg given by IV at induction of anaesthesia. CHILD over 2 years, 100 mcg/kg (max 4mg) by slow IV before, during or after induction of anaesthesia. Treatment of postoperative: 4 mg by IM or slow. CHILD over 2 years 100 mcg/kg (maximum 4mg) by slow IV
1148 Ondansetron 4mg Tablet A04AA01-110-T10-01-XX A i) Prevention of nausea and vomiting induced by chemotherapy and radiotherapy
ii) Postoperative nausea and vomiting		 None i) 8 mg 1 - 2 hours before treatment then 8 mg every 12 hours for up to 5 days. CHILD, treatment by infusion followed by 4 mg by mouth every 12 hours for up to 5 days
ii) Prevention of postoperative nausea and vomiting, 16 mg 1 hour before anaesthesia or 8 mg 1 hour before anaesthesia followed by 8 mg at intervals of 8 hours for a further 2 doses
1149 Ondansetron 8mg Tablet A04AA01-110-T10-02-XX A i) Prevention of nausea and vomiting induced by chemotherapy and radiotherapy
ii) Postoperative nausea and vomiting		 None i) 8 mg 1 - 2 hours before treatment then 8 mg every 12 hours for up to 5 days. CHILD, treatment by infusion followed by 4 mg by mouth every 12 hours for up to 5 days
ii) Prevention of postoperative nausea and vomiting, 16 mg 1 hour before anaesthesia or 8 mg 1 hour before anaesthesia followed by 8 mg at intervals of 8 hours for a further 2 doses
1150 Ondansetron 8mg/4ml Injection A04AA01-110-P30-02-XXX A i) Prevention of nausea and vomiting induced by chemotherapy and radiotherapy.
ii) Postoperative nausea and vomiting		 None i) 8 mg given by IV infusion over 15 minutes or by IM immediately before treatment followed by 8 mg orally every 12 hours for up to 5 days. CHILD 5 mg/m2 body surface IV over 15 minutes immediately before chemotherapy followed by 4 mg orally every 12 hours for up to 5 days
ii) Prevention : 4 mg given by IV at induction of anaesthesia. CHILD over 2 years, 100 mcg/kg (max 4mg) by slow IV before, during or after induction of anaesthesia. Treatment of postoperative: 4 mg by IM or slow. CHILD over 2 years 100 mcg/kg (maximum 4mg) by slow IV
1151 Oral Rehydration Salt A07CA00-905-F21-01-XXX C Replacement of fluid and electrolytes loss in diarrhoea None Dissolve 1 sachet in 200 or 250mL of water according to product insert.
The amount to give depends on hydration status.
ADULT: 200-400mL (1 - 2 sachets) for every loose motion / diarrhoea / vomiting
CHILD (2 yrs & above): 100-200mL (1 sachet) for every loose motion / diarrhoea / vomiting. In severe dehydration 100ml/kg for 3-4 hours.
INFANT (up to 2 yrs): 1 - 1.5 times their usual feed volume (50-100mL) each diarrhoea/vomiting

Dose is according to product insert and dependent on the product / brand used as well as patient comorbidities e.g. heart failure and chronic kidney disease.
1152 Orphenadrine 100mg Tablet M03BC01-110-T10-01-XXX A Painful muscle spasm None 100mg BD. In severe cases, doses may increase to 300mg in any 24-hour period.
1153 Ortho-phthalaldehyde 0.55% Solution V07AV00000L9909XX A High level disinfectant for sensitive endoscopes or semi-critical reusable medical devices Manual reprocessing, at least 12 minute immersion time at room temperature (20 degree celcius) is required. Automatic endoscope reprocessor, at least 5 minute immersion time at a minimum of 25 degree celcius is required
1154 Oseltamivir 60mg/5ml oral suspension. J05AH02-000-L80-01-XXX A/KK i) For treatment of patients with suspected or confirmed influenza and severe disease (requiring hospitalization or evidence of lower respiratory tract infection).
ii) For treatment of patients with suspected or confirmed influenza and with co-morbidity and associated with increased risk of influenza complications. Not to be used as prophylaxis.		 None Children ≥ 1 year (for 5 days):
a) ≤15 kg: 30mg twice daily
b) >15kg to 23kg:45mg twice daily
c) >23kg to 40kg: 60mg twice daily

Children with body weight more than 40kg who are able to swallow capsule is recommended to be dosed as adults.
1155 Oseltamivir 75mg capsule. J05AH02-000-C10-01-XXX A/KK i) For treatment of patients with suspected or confirmed influenza and severe disease (requiring hospitalization or evidence of lower respiratory tract infection).
ii) For treatment of patients with suspected or confirmed influenza and with co-morbidity and associated with increased risk of influenza complications. Not to be used as prophylaxis.		 None Recommended dose in adults and adolescents ≥ 13 years of age and body weight >40kg is 75mg twice daily for 5 days.
Dosing adjustment for renal impaired patient, follow manufacturer's recommendations in product insert.
1156 Osimertinib 40mg Tablet L01XE35-000-T32-01-XXX A* 1. The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy

2. As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.		 Indication 1:
Second-line therapy, in patients who progressed from first-line EGFR TKI therapy.
To be prescribed by oncologists and oncology-trained respiratory physicians

Indication 2:
To be prescribed by Oncologist and Consultant Respiratory Physician only.		 80 mg once a day until disease progression or unacceptable toxicity, taken with or without food at the same time each day.
If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
1157 Osimertinib 80mg Tablet L01XE35-000-T32-02-XXX A* 1. The treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after EGFR TKI therapy

2. As monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.		 Indication 1:
Second-line therapy, in patients who progressed from first-line EGFR TKI therapy.
To be prescribed by oncologists and oncology-trained respiratory physicians

Indication 2:
To be prescribed by Oncologist and Consultant Respiratory Physician only.		 80 mg once a day until disease progression or unacceptable toxicity, taken with or without food at the same time each day.
If dose reduction is necessary, then the dose should be reduced to 40 mg taken once daily.
1158 Oxaliplatin 5mg/mL Injection L01XA03000P4001XX A* Colorectal cancer 85 mg/m2 IV repeated every 2 weeks
1159 Oxybutynin Chloride 5 mg Tablet G04BD04110T1001XX A* For the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (ie urgency, frequency, urinary leakage, urge incontinence, dysuria) ADULT: Initially 5 mg 2 - 3 times daily increased if necessary to maximum 5 mg 4 times daily. ELDERLY: Initially 2.5 - 3 mg twice daily, increased to 5 mg twice daily according to response and tolerance. CHILD over 5 years, neurogenic bladder instability: 2.5 - 3 mg twice daily increased to 5 mg twice daily to maximum 3 times daily
1160 Oxycodone HCl 10mg Immediate Release Capsules N02AA05-110-C10-02-XXX A* i) Management of moderate to severe chronic cancer pain non-responsive to morphine in accordance with WHO step-wise ladder of chronic pain management

ii) As a step-down analgesic drug in post-operative procedures

iii) As a second line treatment of chronic non-cancer pain when treatments with adjuvant analgesics and non-pharmacological approach failed		 Indication (iii):
Initiated by Pain, Palliative Specialists and Geriatricians only		 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
1161 Oxycodone HCl 1mg/ml Oral Solution N02AA05-110-L50-01-XXX A* As a second-line drug in the management of responsive, moderate to severe pain in patients who
i. have difficulty swallowing or
ii. require a low dose oxycodone (<5mg).		 To be prescribed by palliative medicine physicians, oncologist, anaesthesiologist, haematologist and pain specialists only Initial dose for opioid naïve patients or patients presenting with severe pain uncontrolled by weaker opioids is 5 mg, 4-6 hourly. The dose should then be carefully titrated, as frequently as once a day if necessary, to achieve pain relief. Maximum daily dose is 400mg daily.

Dosing is individualised and according to product insert/protocol.

Should not be used in patients under 18 years.
1162 Oxycodone HCl 5mg Immediate Release Capsules N02AA05-110-C10-01-XXX A* i) Management of moderate to severe chronic cancer pain non-responsive to morphine in accordance with WHO step-wise ladder of chronic pain management

ii) As a step-down analgesic drug in post-operative procedures

iii) As a second line treatment of chronic non-cancer pain when treatments with adjuvant analgesics and non-pharmacological approach failed		 Indication (iii):
Initiated by Pain, Palliative Specialists and geriatricians only		 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
1163 Oxycodone Hydrochloride 10mg and Naloxone Hydrochloride Dihydrate 5mg Tablet N02AA55-900-T10-02-XXX A* The management of moderate to severe chronic pain unresponsive to non-narcotic analgesics. The opioid antagonist naloxone in the fixed combination is added to counteract and/or prevent opioid-induced constipation. Consultant/specialists for specific indications only, including Geriatricians Adults and paediatric patients from 18 years of age: The usual starting dose for opioid-naive patients or patients presenting with moderate to severe chronic pain uncontrolled by weaker opioids is one tablet 10mg/5mg at 12 hourly intervals, or one tablet 5mg/2.5mg 12-hourly for patients with mild hepatic impairment and patients with renal impairment.

The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief.
1164 Oxycodone Hydrochloride 10mg Controlled Release Tablet N02AA05-110-T53-01-XXX A* i) Management of moderate to severe chronic cancer pain non-responsive to morphine in accordance with WHO step-wise ladder of chronic pain management.

ii) As a second line treatment of chronic non-cancer pain when treatments with adjuvant analgesics and non-pharmacological approach failed		 Indication (ii):
Initiated by Pain, Palliative Specialists or Geriatricians only		 Adults, elderly and children over 12 years:
Usual starting dose for opioid-naive patients or patients presenting with moderate to severe pain uncontrolled by weaker opioids (especially if they are receiving concurrent sedatives, muscle relaxants or other CNS medicines):10mg 12 hourly.
The dose should then be carefully titrated with longitudinal patient monitoring, assessing whether the pain is opioid responsive and providing the patient significant pain relief.

Patients with renal or hepatic impairment:
The recommended adult starting dose should be reduced by 1/3 to 1/2, and each patient should be titrated to adequate pain control according to their clinical situation.
1165 Oxycodone Hydrochloride 10mg/ml Injection N02AA05-110-P3-01XXX A* For the treatment of moderate to severe pain in patients with cancer and post-operative pain. For the treatment of severe pain requiring the use of a strong opioid. Consultant/specialists for specific indications only, including Geriatricians Adults over 18 years: The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. IV Bolus: Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes. Doses should not be administered more frequently than every 4 hours. IV Infusion: Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended. IV PCA: Dilute to 1 mg/ml in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes. SC Bolus: Use as 10 mg/ml concentration. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required. SC Infusion: Dilute in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naive patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses. Transferring patients between oral and parenteral oxycodone: The dose should be based on the following ratio: 2 mg of oral oxycodone is equivalent to 1 mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose.
1166 Oxycodone Hydrochloride 20mg and Naloxone Hydrochloride Dihydrate 10mg Tablet N02AA55-900-T10-03-XXX A* The management of moderate to severe chronic pain unresponsive to non-narcotic analgesics. The opioid antagonist naloxone in the fixed combination is added to counteract and/or prevent opioid-induced constipation. Consultant/specialists for specific indications only, including Geriatricians Adults and paediatric patients from 18 years of age: The usual starting dose for opioid-naive patients or patients presenting with moderate to severe chronic pain uncontrolled by weaker opioids is one tablet 10mg/5mg at 12 hourly intervals, or one tablet 5mg/2.5mg 12-hourly for patients with mild hepatic impairment and patients with renal impairment. The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief.
1167 Oxycodone Hydrochloride 20mg Controlled Release Tablet N02AA05-110-T53-02-XXX A* i) Management of moderate to severe chronic cancer pain non-responsive to morphine in accordance with WHO step-wise ladder of chronic pain management.

ii) As a second line treatment of chronic non-cancer pain when treatments with adjuvant analgesics and non-pharmacological approach failed		 Indication (ii):
Initiated by Pain, Palliative Specialists or Geriatricians only		 Adults, elderly and children over 12 years:
Usual starting dose for opioid-naive patients or patients presenting with moderate to severe pain uncontrolled by weaker opioids (especially if they are receiving concurrent sedatives, muscle relaxants or other CNS medicines): 10mg 12 hourly.
The dose should then be carefully titrated with longitudinal patient monitoring, assessing whether the pain is opioid responsive and providing the patient significant pain relief.

Patients with renal or hepatic impairment:
The recommended adult starting dose should be reduced by 1/3 to 1/2, and each patient should be titrated to adequate pain control according to their clinical situation.
1168 Oxycodone Hydrochloride 40mg and Naloxone Hydrochloride Dihydrate 20mg Tablet N02AA55-900-T10-04-XXX A* The management of moderate to severe chronic pain unresponsive to non-narcotic analgesics. The opioid antagonist naloxone in the fixed combination is added to counteract and/or prevent opioid-induced constipation. Consultant/specialists for specific indications only, including Geriatricians Adults and paediatric patients from 18 years of age: The usual starting dose for opioid-naive patients or patients presenting with moderate to severe chronic pain uncontrolled by weaker opioids is one tablet 10mg/5mg at 12 hourly intervals, or one tablet 5mg/2.5mg 12-hourly for patients with mild hepatic impairment and patients with renal impairment. The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief.
1169 Oxycodone Hydrochloride 40mg Controlled Release Tablet N02AA05-110-T53-03-XXX A* i) Management of moderate to severe chronic cancer pain non-responsive to morphine in accordance with WHO step-wise ladder of chronic pain management.

ii) As a second line treatment of chronic non-cancer pain when treatments with adjuvant analgesics and non-pharmacological approach failed		 Indication (ii):
Initiated by Pain, Palliative Specialists or geriatricians only		 Adults, elderly and children over 12 years:
Usual starting dose for opioid-naive patients or patients presenting with moderate to severe pain uncontrolled by weaker opioids (especially if they are receiving concurrent sedatives, muscle relaxants or other CNS medicines): 10mg 12 hourly.
The dose should then be carefully titrated with longitudinal patient monitoring, assessing whether the pain is opioid responsive and providing the patient significant pain relief.

Patients with renal or hepatic impairment:
The recommended adult starting dose should be reduced by 1/3 to 1/2, and each patient should be titrated to adequate pain control according to their clinical situation.
1170 Oxycodone Hydrochloride 5mg and Naloxone Hydrochloride Dihydrate 2.5mg Tablet N02AA55-900-T10-01-XXX A* The management of moderate to severe chronic pain unresponsive to non-narcotic analgesics. The opioid antagonist naloxone in the fixed combination is added to counteract and/or prevent opioid-induced constipation. Consultant/specialists for specific indications only, including Geriatricians Adults and paediatric patients from 18 years of age:
The usual starting dose for opioid-naive patients or patients presenting with moderate to severe chronic pain uncontrolled by weaker opioids is one tablet 10mg/5mg at 12 hourly intervals, or one tablet 5mg/2.5mg 12-hourly for patients with mild hepatic impairment and patients with renal impairment.
The dose should then be cautiously titrated, as frequently as every 1-2 days if necessary, to achieve pain relief.

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