Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
1591 Topiramate 50 mg Tablet N03AX11-000-T10-02-XXX A* As adjunctive therapy for adults and children (2 years and above) with:
i) partial onset seizures and generalized tonic-clonic seizures
ii) seizures associated with Lennox Gastaut syndrome.		 ADULT: Usual daily dose: 200-400 mg/day.
CHILD: Daily doses up to 30mg/kg/day

Dosing is according to product insert.
1592 Trace Elements and Electrolytes (Adult) Solution B05XA30905P3001XX A* Only to be used to cover daily loss of electrolyte and trace elements for patient on parenteral nutrition 10 ml added to 500-1000 ml solution, given by IV infusion
1593 Trace Elements and Electrolytes (Paediatric) Solution B05XA30905P3002XX A* Only to be used to cover daily loss of electrolyte and trace elements for patient on parenteral nutrition According to the needs of the patient. INFANT and CHILD weighing 15 kg or less: Basal requirements of the included trace elements are covered by 1 ml/kg/day to a maximum dose of 15 ml. CHILD weighing 15 kg or more, a daily dose of 15 ml, should meet basic trace element requirements. However, for patients weighing more than 40 kg the adult preparation trace element should be used
1594 Tramadol HCl 50mg Capsule N02AX02-110-C10-01-XXX A/KK Moderate to severe acute or chronic pain (eg. Post-operative pain, chronic cancer pain and analgesia/pain relief for patients with impaired renal function) ADULT: 50mg initially, can take another 50mg after 30 - 60 min if pain not relieved. Max 400 mg daily. CHILD: 1mg/kg/dose repeated every 6 hours (Max: 2mg/kg/dose and 100mg/dose)
1595 Tramadol HCl 50mg Tablet N02AX02-110-T10-01-XXX A/KK Moderate to severe acute or chronic pain (e.g. Post-operative pain, chronic cancer pain and analgesia/pain relief for patients with impaired renal function) None ADULT: 50mg initially, can take another 50mg after 30 - 60 min if pain not relieved. Max 400 mg daily.
CHILD: 1mg/kg/dose repeated every 6 hours (Max: 2mg/kg/dose and 100mg/dose
1596 Tramadol HCl 50mg/ml Injection N02AX02-110-P30-01-XXX A/KK Moderate to severe acute or chronic pain (eg. Post-operative pain, chronic cancer pain and analgesia/pain relief for patients with impaired renal function) None ADULT: IV/IM/SC 50 - 100mg. (IV inj over 2-3 min or IV infusion). Initially 100 mg then 50 - 100 mg every 4 - 6 hours. . Max: 400 mg daily.
CHILD (1 year and above): 1 - 2mg/kg/dose
1597 Tranexamic Acid 100mg/ml Injection B02AA02000P3001XX B Haemorrhage associated with excessive fibrinolysis ADULT: Slow IV 0.5-1 g (10 - 15 mg/kg) 3 times daily. Continuous infusion at a rate of 25 - 50 mg/kg daily. CHILD: slow IV 10 mg/kg/day 2-3 times daily
1598 Tranexamic Acid 250 mg Capsule B02AA02000C1001XX B Haemorrhage associated with excessive fibrinolysis ADULT: 1-1.5 g (15-25 mg/kg) 2-4 times daily. CHILD: 25 mg/kg/day 2-3 times daily. Menorrhagia (initiated when menstruation has started), 1 g 3 times daily for up to 4 days; maximum 4 g daily
1599 Trastuzumab 440mg Injection L01XC03-000-P40-01-XXX A* i) Used only in adjuvant setting for patients with HER2 over-expressed breast cancer, that is HER2 3+ by immunohistochemistry and over-expressed by FISH (Fluorescence in situ hybridization) and high risk group

ii) Treatment of HER2-positive non-metastatic breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab, for locally advanced (including inflammatory) breast cancer or tumours >2cm in diameter.		 ii) To be prescribed by oncologists only i) Initial loading dose is 4 mg/kg administered as a 90 minutes IV infusion. Subsequent doses is 2 mg/kg administered as 30 minutes IV infusion weekly for 51 weeks

ii) Initial loading dose of 8 mg/kg body weight, followed by 6 mg/kg body weight 3 weeks later and then 6 mg/kg repeated at 3-weekly intervals administered as infusions over approximately 90 minutes. If the prior dose was well tolerated, the dose can be administered as a 30-minute infusion.
1600 Trastuzumab 600mg/5ml Solution for Injection (for subcutaneous) L01XC03-000-P30-01-XX A* Used only in adjuvant setting for patients with HER2 over-expressed breast cancer, that is HER2 3+ by immunohistochemistry and over-expressed by FISH (Fluorescence in situ hybridization) and high risk group. None The recommended fixed dose of trastuzumab 600mg is 600mg irrespective of the patient's body weight. No loading dose is required. This dose should be administered over 2-5 minutes every three weeks.
1601 Travoprost 0.004% & Timolol 0.5% Eye Drops S01ED51-990-D20-03-XXX A* To decrease intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to other topical anti glaucomas None 1 drop in the affected eye(s) once daily
1602 Tretinoin 0.01% Gel D10AD01000G3001XX A/KK Acne vulgaris, recalcitrant cases of acne (comedonal type) Apply thinly to the affected area once daily or twice daily. Avoid exposure to sunlight. Duration of treatment: 8-12 weeks is required before any noticeable response
1603 Tretinoin 0.05% Cream D10AD01-000-G10-01-XXX A/KK Acne vulgaris and recalcitrant cases of acne (comedonal type) None Apply once daily to the affected area, at bedtime, after cleansing with soap and water.
1604 Tretinoin 0.1% Cream D10AD01000G1002XX A Acne vulgaris and recalcitrant cases of acne (comedonal type) Apply thinly to the affected area once daily or twice daily. Avoid exposure to sunlight. Duration of treatment: 8 - 12 weeks is required before any noticeable response
1605 Triamcinolone Acetonide 0.1% Oral Paste A01AC01-351-G31-01-XXX B As an adjunctive treatment and for the temporary relief of symptoms associated with inflammatory or ulcerative lesions of oral mucosa resulting from trauma. - Apply thin film to affected areas 2 to 3 times daily
1606 Triamcinolone Acetonide 10 mg/ml Injection H02AB08-351-P30-01-XXX A Inflammation of joints, bursae and tendon sheaths - Smaller joints: 2.5 - 5 mg and larger joints: 5 - 15 mg. Treatment should be limited to 1 mg/injection site to prevent cutaneous atrophy
1607 Triamcinolone Acetonide 40 mg/ml Injection H02AB08-351-P30-02-XXX A/KK Allergies, dermatoses, rheumatoid arthritis and inflammatory opthalmic diseases - 40-80 mg deep into the gluteal muscle
1608 Trifluoperazine HCI 5 mg Tablet N05AB06-110-T10-01-XXX B i) Schizophrenia, other psychotic disorder
ii) Treatment of behavioural disorders in adults and in children		 ADULT: Initially 5 mg twice daily, increase by 5 mg after 1 week, then at 3-day intervals. Maximum 40 mg/day. CHILD up to 12 years: Initially up to 5 mg daily in divided doses adjusted to response, age and body weight.

Elderly reduce initial dose by at least half.
1609 Trimetazidine 20 mg Tablet C01EB15110T1001XX B Prophylactic treatment of episodes of angina pectoris 20 mg 3 times daily
1610 Trimetazidine 35mg MR Tablet C01EB15110T5001XX B Prophylactic treatment of episodes of angina pectoris 35 mg twice daily in the morning and evening with meals
1611 Trimethoprim 100mg Tablet J01EA01-000-T10-01-XXX B Treatment of urinary tract infections due to susceptible pathogens None ADULT: 200 mg daily in 1 or 2 divided doses or 300 mg daily as a single dose. Acute infection: 200 mg twice daily. CHILD: 6-8 mg/kg/day in 2 divided doses. 6 - 12 years: 100 mg twice daily; 6 months - 5 years: 50 mg twice daily. 6 weeks - 5 months: 25mg twice daily
1612 Trimethoprim 300mg Tablet J01EA01-000-T10-02-XXX B Treatment of urinary tract infections due to susceptible pathogens None ADULT: 200 mg daily in 1 or 2 divided doses or 300 mg daily as a single dose. Acute infection: 200 mg twice daily. CHILD: 6 - 12 years: 100 mg twice daily; 6 months - 5 years: 50 mg twice daily. 6 weeks - 5 months: 25mg twice daily
1613 Trioxsalen 5 mg Tablet D05BA01000T1001XX A Vitiligo 5 - 10 mg daily, 2 - 4 hours before exposure to sunlight. To increase pigmentation: 10 mg daily, 2 hours prior to UV irradiation
1614 Triprolidine HCl 1.25mg and Pseudoephedrine HCl 30mg/5ml Syrup R01BA52-110-L90-01-XXX B Decongestion of the upper respiratory tract in common cold, hay fever, allergic and vasomotor rhinitis and sinusitis. Doses to be taken twice daily or three times daily None Adult and children over 12 years: 10ml 3 times a day (max 4 times a day).
CHILD:
6 - 12 years: 5 ml (6-8 hourly).
2 - 5 years: 2.5 ml (6-8 hourly).
1615 Triprolidine HCl 2.5mg and Pseudoephedrine HCl 60mg Tablet R01BA52-988-T10-02-XXX B Decongestion of the upper respiratory tract in common cold, hay fever, allergic and vasomotor rhinitis and aerotitis None ADULT 2.5 mg every 4 - 6 hours; maximum dose 10 mg/day.
CHILD (syrup) 6 - 12 years : 1.25 mg every 4 - 6 hours; maximum dose 5 mg/day 4 - 6 years : 0.938 mg every 4 - 6 hours; maximum dose 3.744 mg/day 2 - 4 years : 0.625 mg every 4 - 6 hours; maximum dose 2.5 mg/day
1616 Triptorelin 3.75 mg Injection L02AE04000P2001XX A i) Treatment of confirmed central precocious puberty (preterm sexual development) (before 8 years in girls and 10 years in boys)
ii) Genital and extragenital endometriosis (stage I to stage IV). Treatment should not be administered for more than 6 months. It is not recommended to start a second treatment course with triptorelin or another GnRH analogue.		 1 intramuscular injection every 4 weeks. The treatment must be started in the first 5 days of the menstrual cycle. The duration of treatment depends on the initial severity of the endometriosis and the changes observed in the clinical features. In principle, the treatment should be administered for at least 4 months and for at most 6 months. It is not recommended to start a second treatment course with triptorelin or another GnRH analogue.
1617 Triptoreline 11.25mg Powder and Solvent for Suspension for Injection L02AE04-127-P40-01-xxx A i. Treatment of confirmed central precocious puberty (preterm sexual development) (before 8 years in girls and 10 years in boys)
ii. Genital and extragenital endometriosis (stage I to stage IV). Treatment should not be administered for more than 6 months. It is not recommended to start a second treatment course with triptorelin or another GnRH analogue.
iii. Treatment of locally advanced prostate cancer when used alone or as concomitant and adjuvant radiotherapy.
iv. Treatment of metastatic prostate cancer.		 Indikasi i: First-line treatment for central precocious puberty
Indikasi ii: Second-line treatment for genital and extragenital endometriosis		 indikasi i:
Children over 20 kg in body weight: One intramuscular injection of triptorelin 11.25 mg administered every 3 months.

Treatment should be stopped around the physiological age of puberty in boys and girls and it is recommended that treatment is not continued in girls with a bone maturation of more than 12 to 13 years. There are limited data available in boys relating to the optimum time to stop treatment based on bone age, however it is advised that treatment is stopped in boys with a bone maturation age of 13 to 14 years.

Indikasi ii:
One intramuscular injection of triptorelin repeated every 3 months. The subcutaneous administration has not been studied in women. The treatment must be started in the first five days of the menstrual cycle.

Duration of treatment: This depends on the initial severity of the endometriosis and the changes observed in the clinical features (functional and anatomical) during treatment. The treatment should not be administered for more than 6 months

Indikasi iii & iv:
11.25mg every 3 months
1618 Tropicamide 1% Eye Drops S01FA06-000-D20-02-XXX A/KK Topical use to produce cycloplegic refraction for diagnostic purposes None 1 - 2 drops several times a day
1619 Trospium Chloride 20mg coated tablet G04BD09-100-C10-01-XXX A* Symptomatic treatment for urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder (eg. Idiopathic or neurologic detrusor overactivity) Place in therapy: As first line treatment for overactive bladder in patients with Parkinsonism, Alzheimer's or other cognitive disease 1 tablet twice daily. Tablet should be swallowed whole with a glass of water before meals on empty stomach. Severe renal impairment (CrCl between 10 & 30 mL/min/1.73 m2): 1 tab daily or every other day
1620 Tuberculin PPD Injection V04CF01000P3001XX B For routine Mantoux (tuberculin sensitivity) test 10 units is injected intradermally

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