Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
691 Gabapentin 600 mg Tablet N03AX12-000-T10-01-XXX A* i) Add-on therapy for intractable partial epilepsy, refractory to standard anti-epileptic drugs
ii) Treatment of various types of neuropathic pain, both peripheral (which includes diabetic neuropathy, post-herpetic neuralgia, trigeminal neuralgia) in adult over 18 years		 None ADULT & CHILD > 12 yrs: 900-3600mg/day. Therapy may be initiated by administered 300mg TDS on day 1, or by titrating the dose as: 300mg once on day 1, 300mg BD on day 2, 300mg TDS on day 3. Thereafter, may be increased in 3 equally divided doses up to max 3600mg/day.CHILD 3-12 yr: Initially 10-15 mg/kg/day in 3 divided dose. Effective dose: CHILD 3 to less than 5 yrs: 40mg/kg/day in 3 divided doses, CHILD 5-12 yrs: 25-35mg/kg/day in 3 divided doses ii) ADULT: 900mg/day in 3 equally divided doses. Max 3600mg/day
692 Gadobenate Dimeglumine Injection Solution V08CA08996P3001XX A* i) MRI of the liver for the detection of focal liver lesions in patients with known or suspected primary liver cancer (e.g. Hepatocellular carcinoma) or metastatic disease;
ii) MRI of the brain and spine where it improves the detection of lesion and provides diagnostic information additional to that obtained with unenhanced MRI;
iii) Contrast-enhanced MR-angiography where it improves the diagnostic accuracy for detecting clinically significant steno-occlusive vascular disease in patients with suspected or known vascular disease of the abdominal or peripheral arteries.		 i) MRI of liver: 0.05ml/kg body weight. This corresponds to 0.1ml/kg of the 0.5M solution
ii) MRI of brain & spine: 0.1mmol/kg body weight. This corresponds to 0.2ml/kg of the 0.5M solution
iii) MRA: 0.1mmol/kg body weight. This corresponds to 0.2ml/kg of the 0.5M solution
693 Gadobutrol 1 mmol/ml injection V08CA09000P3001XX A* In adults, adolescents and children aged 2 years and older with diagnostic difficulty especially in patients with renal impairment for: i) Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI). ii) Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesion to classify these lesions as benign or malignant. iii)Contrast enhancement in Magnetic Resonance Angiography (CE-MRA). A single intravenous injection of 0.1 mmol/kg (equivalent to 0.1 ml/kg body weight). Max: 0.3 mmol/kg (equivalent to 0.3 ml/kg body weight)
694 Gadoterate Meglumine (Gadoteric Acid) 0.5 mmol/ ml Injection V08CA02254P3001XX A High risk patients undergoing Magnetic Resonance Imaging for cerebral and spinal disease, diseases of the vertebral column and other whole body pathology The recommended dose is 0.1 mmol/kg (equivalent to 0.2 mL/kg in adults, children and infants. In angiography, depending on the results of the examination being performed, a second injection may be administered during the same session if necessary
695 Gadoxetic acid disodium 0.25 mmol/ml solution for injection (10ml pre-filled syringe) V08CA10520P3001XX A* For use in adults for the enhancement of magnetic resonance imaging (MRI) of focal liver lesions 0.1ml/kg body weight (equivalent to 25 µmol per kg body weight). Not recommended for patients younger than 18 years
696 Gamma Benzene Hexachloride 1% Cream/Lotion P03AB02100G1002XX A/KK i) Only for scabies in adult weighing more than 50kg. Use should be restricted to patients who have failed treatment with or cannot tolerate other medications that pose less risk.
ii) Treatment of head lice.		 i) Only for single application. Adult: Apply a thin layer of 1% topical preparation onto all skin areas from the neck to toes. Completely wash off from the body with warm water after 8-12 hr.
ii) Apply lotion into the scalp and hair. Leave the lotion for 4 minutes. Remove the lice using comb afterwards.
697 Ganciclovir Sodium 50mg/ ml Injection J05AB06520P3001XX A* Treatment of cytomegalovirus (CMV) disease in immunocompromised patients, prevention of CMV disease during immunosuppressive therapy following organ transplantation Initial: 5 mg/kg infused over 1 hour 12 hourly for 14 - 21 days (CMV retinitis treatment) or 7 - 14 days (CMV disease prevention). Long term maintenance: 6 mg/kg daily for 5 days/week or 5 mg/kg daily for 7 days/week
698 Ganirelix 0.25 mg/0.5ml Injection H01CC01000P2001XX A* Prevention of premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction technique Given by SC 0.25 mg once daily, starting on day 6 of ovarian stimulation and continued until ovulation induction
699 Gefitinib 250 mg tablet L01XE02000T1001XX A* i) First line treatment of adult patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have activating mutations of the EGFR TK.

ii) For second line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have previously failed chemotherapy, and who have activating mutation of epidermal growth factor receptor (EGFR).		 Indication (i):
- Adenocarcinoma histology
- Patient's ECOG Performance Status 0-1
- Must be prescribed by an oncologist or oncology-trained respiratory physician.

Indication (ii)
- Adenocarcinoma histology
- Patient's ECOG Performance Status 0-1
- Must be prescribed by an oncologist or oncology-trained respiratory physician.
- Must not have received prior TKI for this condition.		 250mg tablet once a day, taken with or without food
700 Gemcitabine HCl 1 g Injection L01BC05110P4002XX A* i) Non-small cell lung cancer
ii) pancreatic cancer
iii) ovarian cancer
iv) breast cancer
v) bladder cancer		 i) Alone or with cisplatin: 1000 mg/m2 day 1 & 8 every 3 weeks or 1000 mg/m2 day 1, day 8, day 15 every 4 weeks
ii) Initially 1000 mg/m2 weekly for 7 weeks followed by 1 week rest. Subsequent cycles 1000 mg/ m2 weekly for 3 weeks followed by 1 week rest
iii) Gemcitabine 1000 mg/m2 as 30 minutes IV infusion day 1 & 8 of each 21-day cycle followed by carboplatin on day 1 to attain a target AUC of 4 mg/ml/minute
iv) 1250 mg/m2 on days 1 and 8 of each 21-day cycle, with paclitaxel 175 mg/m2 given as a 3-hour infusion before gemcitabine on day 1 of each 21- day cycle
v) With cisplatin: 1000 mg/m2, given by 30 minutes intravenous infusion on days 1, 8 and 15, followed by one-week rest period for a 28- day cycle. This four-week cycle is then repeated.

Dosing is according to product insert/ protocol.
701 Gemcitabine HCl 200 mg Injection L01BC05110P4001XX A* (i) Non-small cell lung cancer
(ii) pancreatic cancer
(iii) ovarian cancer
(iv) breast cancer
(v) bladder cancer		 i) Alone or with cisplatin: 1000 mg/m2 day 1 & 8 every 3 weeks or 1000 mg/m2 day 1, day 8, day 15 every 4 weeks
ii) Initially 1000 mg/m2 weekly for 7 weeks followed by 1 week rest. Subsequent cycles 1000 mg/ m2 weekly for 3 weeks followed by 1 week rest
iii) Gemcitabine 1000 mg/m2 as 30 minutes IV infusion day 1 & 8 of each 21-day cycle followed by carboplatin on day 1 to attain a target AUC of 4 mg/ml/minute
iv) 1250 mg/m2 on days 1 and 8 of each 21-day cycle, with paclitaxel 175 mg/m2 given as a 3-hour infusion before gemcitabine on day 1 of each 21- day cycle
v) With cisplatin: 1000 mg/m2, given by 30 minutes intravenous infusion on days 1, 8 and 15, followed by one-week rest period for a 28- day cycle. This four-week cycle is then repeated.

Dosing is according to product insert/ protocol.
702 Gemeprost (Prostagladin E1 Synthetic Analogue) 1mg Pessary G02AD03-000-S10-01-XXX A i. Softening and dilatation of the Cervix uteri prior to trans-cervical intra-uterine operative procedures in pregnant patients in the first trimester of gestation.
ii. Therapeutic termination of pregnancy in patients in the second trimester of gestation, in licensed institutions.
iii. Induction of abortion of second trimester pregnancies complicated by intrauterine foetal death.		 None i. One pessary 3 hours before surgery
ii & iii. One pessary 3-hourly to a maximum of 5 administrations over 24 hours. A second course may be given after 24 hours from the initial commencement of treatment.
703 Gemfibrozil 300mg Capsule C10AB04-000-C10-01-XX A/KK Treatment of hyperlipoprotinaemias (TYPES IIA, IIB, III, IV, V) None ADULT: 1200 mg/day in 2 divided doses, 30 minutes before breakfast and dinner. Dose range from 0.9-1.5 g daily
704 Gentamicin 0.1% Cream D06AX07-183-G10-01-XXX A* For the treatment of primary and secondary skin infections caused by susceptible bacteria. None Apply 2 - 3 times daily
705 Gentamicin 0.3% Eye Drops S01AA11-183-D20-01-XXX A/KK Bacterial eye infections caused by susceptible organisms None 1 drops every 4 hours, in severe infection dosage may be increased up to 1 drops every hour

Dosing is individualised and according to product insert/protocol
706 Gentamicin 0.3% Eye Ointment S01AA11-183-G51-01-XXX A/KK Bacterial eye infections caused by susceptible organisms None Apply a small amount (approx. 1/2-inch ribbon) into affected eye(s) 2-3 times daily.
707 Gentamicin Sulphate 10mg/ml Injection J01GB03-183-P30-02-XXX B Infections due to susceptible organisms None ADULT: 3 - 5 mg/kg/day 8 hourly IM or IV. CHILD up to 2 weeks: 3mg/kg every 12 hours; 2 weeks - 12 years: 2 mg/kg 8 hourly
708 Gentamicin Sulphate 40mg/ml Injection J01GB03-183-P30-03-XXX B Infections due to susceptible organisms None ADULT: 3 - 5 mg/kg/day 8 hourly IM or IV. CHILD up to 2 weeks: 3mg/kg every 12 hours; 2 weeks - 12 years: 2 mg/kg 8 hourly
709 Gentamicin Sulphate and Betamethasone Disodium Phosphate Eye/Ear Drops S01CA05-990-D20-01-XXX A/KK Eye:
i. Corticosteroid-responsive allergic and inflammatory conditions of the palpebral and bulbar
conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, corneal injuries, superficial punctuate keratitis, vernal keratoconjunctivitis and as an adjunct in the treatment of superficial occular infections caused by susceptible organisms.
ii. Topical treatment of blepharitis, blepharoconjunctivitis, conjunctivitis, dacryocystitis, keratitis, keratoconjunctivitis and acute meibomianitis.

Ear:
i. Allergic otitis externa, infective otitis and other corticosteroid-responsive disorders of the external
auditory meatus.
ii. Indicated in the treatment of mastoidectomy cavity infections, chronic suppurative otitis media,
subacute purulent otitis media with tympanic membrane perforation and external otitis.		 None Eye:
Mild to moderate infections: 1 drop to the eye(s) every 4 hours. Severe infections: 1 drop to the eye(s) every hour.

Ear:
3 or 4 drops to the ear canal 3 times a day, with dosage gradually being decreased as inflammation subsides.
710 Gliclazide 30 mg Modified Release Tablet A10BB09000T5002XX B Diabetes mellitus type 2 Initially, 30mg daily at breakfast time, may increase in successive steps to 60, 90 or 120mg daily at 1 month intervals. Max daily dose: 120mg
711 Gliclazide 60 mg Modified Release Tablet A10BB09000T5001XX B Diabetes mellitus type 2 Initially, 30mg daily at breakfast time, may increase in successive steps to 60, 90 or 120mg daily at 1 month intervals (except in patients whose blood glucose level was not reduced after 2 weeks of treatment). Max daily dose: 120mg
712 Gliclazide 80 mg Tablet A10BB09000T1001XX B Diabetes mellitus type 2 Initially 40-80mg daily. A single dose should not exceed 160mg and when higher doses are required, a twice daily split dosage is advised and should be divided. Maximum daily dose: 320mg. For elderly, starting dose should be 40mg twice daily.
713 Glucagon (Lyophilised) 1mg/ml Injection H04AA01000P4001XX B Management of hypoglycaemia Adult, children > 20kg: 1mg by SC, IM or IV. Children < 20kg : 0.5mg. If patient does not respond within 10 minutes, administer IV glucose. Repeat in 20 minutes if necessary.
714 Glutaraldehyde 2% Solution V07AV00000L9905XX A High level disinfection for heat sensitive equipments such as endoscopes 20 minutes or more immersion is recommended for endoscopes before the session and between patients after thorough cleaning based on manufacturer recommendation
715 Glycerin A06AX01000L5001XX C+ As a lubricant and osmotic dehydrating agent Apply to area when required
716 Glycerin 25% and Sodium Chloride 15% Enema A06AG20921G2001XX C+ Constipation 1 enema as required
717 Glycerin 25% w/w in aqueous cream D02AX000G1001XXX C As an emollient for the symptomatic relief of dry skin conditions and as soap-substitute for skin-bathing. None Apply to the affected area as required
718 Glyceryl Trinitrate 0.5mg Sublingual Tablet C01DA02-221-T10-01-XXX C Prophylaxis and treatment of angina and left ventricular failure None 0.5-1 mg sublingually may be repeated every 5 minutes until relief is obtained. Seek physician if the pain persists after a total of 3 tablets in a 15 minutes period.
719 Glyceryl Trinitrate 5mg/ml Injection C01DA02-221-P30-01-XXX A, A/KK Prescriber Category A:
i) Angina pectoris.
ii) Congestive heart failure.
iii) Production of controlled hypotension during surgery.

Prescriber Category A/KK:
iv) Control of hypertensive episodes.		 None Initial:
5-25mcg/min

Dosing is individualised and according to product insert or protocol.
720 Glyceryl Trinitrate Aerosol Spray 400mcg (metered dose) C01DA02-221-A10-01-XXX B i) Angina pectoris
ii) Variant angina		 None 1-2 metered sprays sublingual every 5 minutes as required or 5-10minutes prior to activities that might precipitate an acute attack.

Dosing is according to product insert or protocol.

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