Anda di sini
Formulari Ubat KKM (FUKKM)
| # | Generic Name | MDC | Category | Indications | Pres. Restrictions | Dosage |
|---|---|---|---|---|---|---|
| 1171 | 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. |
| 1172 | 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. |
| 1173 | 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. |
| 1174 | 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. |
| 1175 | 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. |
| 1176 | 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 |
| 1177 | 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 |
| 1178 | 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 |
| 1179 | 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 |
| 1180 | 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 |
| 1181 | 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 | |
| 1182 | 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 |
| 1183 | 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 |
| 1184 | 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 |
| 1185 | 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 iv) As second-line treatment of AIDS-related Kaposi’s sarcoma | i) 175 mg/m2 IV over 3 hours every 3 weeks ii) First-line: 175 mg/m2 IV over 3 hour followed by a platinum compound every 3 weeks or 135 mg/m2 IV over 24 hours followed by a platinum compound every 3 weeks Second-line: 175 mg/m2 over 3 hours every 3 weeks iii) 175 mg/m2 IV over 3 hours followed by a platinum compound every 3 weeks iv) 100mg/m2 IV over 3 hours every 2 weeks Dosing is individualised and according to product insert/protocol. | |
| 1186 | 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 |
| 1187 | 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. |
| 1188 | 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 |
| 1189 | 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. |
| 1190 | 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 |
| 1191 | 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. |
| 1192 | 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 |
| 1193 | 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 |
| 1194 | 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 |
| 1195 | 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 | |
| 1196 | 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 |
| 1197 | 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 | |
| 1198 | 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 | |
| 1199 | 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 | |
| 1200 | 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 |