Formulari Ubat KKM (FUKKM)

# Generic Name MDC Category Indications Pres. Restrictions Dosage
901 Levodopa 200 mg, Benserazide 50 mg Tablet N04BA02977T1001XX B Parkinson's Disease Initial: 100/25 mg 1-2 times/day, increase every 3-4 days until therapeutic effect, optimal dosage: 400/100 mg to 800/200 mg/day divided into 4-6 doses. Dose: 200/50 mg used only when maintenance therapy is reached and not to exceed levodopa 1000-1200 mg/benserazide 250-300 mg per day
902 Levodopa 200 mg, Carbidopa 50 mg & Entacapone 200 mg Tablet N04BA03977T1004XX A* Idiopathic Parkinson's disease The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacapone). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg.
903 Levodopa 250 mg and Carbidopa 25 mg Tablet N04BA02000T1002XX B Parkinson's disease Patients not receiving Levodopa before, initially 100 - 125 mg 3 - 4 times daily adjusted according to response. Maintenance: 0.75 - 2 g in divided doses. In patients previously treated with Levodopa the dose should be about 20 - 25% of the dose previous being taken
904 Levodopa 50 mg, Carbidopa 12.5 mg & Entacapone 200 mg Tablet N04BA03977T1001XX A* Idiopathic Parkinson's disease The optimum daily dosage must be determined by careful titration of levodopa in each patient. The daily dose should preferably be optimised using 1 of the 4 available tablet strengths (50/12.5/200mg, 100/25/200mg, 150/37.5/200mg or 200/50/200mg levodopa/carbidopa/entacapone). Patients should be instructed to take only 1 tablet/dose administration. While the experience with total daily dosage >200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2000 mg and therefore the maximum dose, for the strengths of 50/12.5/200 mg, 100/25/200 mg and 150/37.5/200 mg, is 10 tablets/day. Ten (10) tablets of the strength 150/37.5/200 mg equals carbidopa 375 mg/day. Therefore, using a maximum recommended daily dose of carbidopa 375 mg, the maximum daily dose of 200/50/200 mg is 7 tablets per day. The maximum total daily levodopa dose administered should not exceed 1500 mg.
905 Levofloxacin 0.5% ophthalmic solution S01AX19-000-D20-01-XX A* For the treatment of bacterial conjunctivitis caused by susceptible strains of the designated microorganisms. None Adult dose: 1 drop a time 3 times daily. The dosage may be adjusted according to the patient's symptoms. Route of administration: ophthalmic use only.
906 Levofloxacin 250mg Tablet J01MA12000T1001XX A* Community acquired pneumonia 500 mg daily for 7 - 14 days
907 Levofloxacin 500mg Injection J01MA12000P3001XX A* Community Acquired Pneumonia 500 mg daily for 7 - 14 days
908 Levofloxacin 500mg Tablet J01MA12-000-T10-02-XXX A* Community acquired pneumonia 500 mg daily for 7 - 14 days
909 Levonorgestrel 1.5mg Tablet G03AC03-000-T10-01-XXX A* Emergency contraception within 72 hours of unprotected sexual intercourse for the female victim of sexual violence to prevent unwanted pregnancy None 1.5 mg as a single dose as soon as possible, preferably within 12 hours but no later than 72 hours after unprotected sexual intercourse.
910 Levonorgestrel 150mcg and Ethinyloestradiol 30mcg Tablet G03AA07-954-T10-01-XXX C+ Contraception None 1 tablet daily for 21 days from first day of the cycle, followed by 7 tab free days
911 Levonorgestrel 52mg Intrauterine System G02BA03-000-P10-01-XXX A* i. Contraception.
ii. Idiopathic menorrhagia.
iii. Protection from endometrial hyperplasia during oestrogen replacement therapy.		 None One unit intrauterine device to be inserted into the uterine cavity within 7 days of the onset of menstruation or immediately after first trimester abortion. Postpartum insertion should be postponed until 6 weeks after delivery.Can be inserted at any time of amenorrheic woman. One unit IUD is effective for 5 years
912 Levothyroxine Sodium 100 mcg Tablet H03AA01520T1001XX B Hypothyroidism Start at low dose and increase at 2-4 weeks interval. Adult: Initially, 50-100 mcg/day may increase by 25-50 mcg at approximately 3 to 4 weeks intervals until the thyroid deficiency is corrected. Maintenance: 100-200 mcg/day. CHILD; 0 - 3 months: 10 - 15 mcg/kg/day; 3 - 6 months: 8 - 10 mcg/kg/day; 6 - 12 months: 6 - 8 mcg/kg/day; 1 - 5 years: 5 - 6 mcg/kg/day; 6 - 12 years: 4 - 5 mcg/kg/day; more than 12 years: 2 -3 mcg/kg/day
913 Levothyroxine Sodium 25 mcg Tablet H03AA01152T1003XX B Hypothyroidism Start at low dose and increase at 2-4 weeks interval. Usual recommended dose for i) Treatment of benign euthyroid goitre: 75-200mcg. ii) Prophylaxis of relapse after surgery for euthyroid goitre: 75-200mcg iii) Substitution therapy in hypothyroidism: ADULT Initially, 25-50mcg/day. Maintenance: 100-200mcg/day. CHILDREN Initially 12.5-50mcg/day, Maintenance: 100-150mcg/m2 body surface area iv) Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism: 50-100mcg v) Suppression therapy in thyroid cancer: 150-300mcg
914 Levothyroxine Sodium 50 mcg Tablet H03AA01520T1002XX B Hypothyroidism Start at low dose and increase at 2-4 weeks interval. Usual recommended dose for i) Treatment of benign euthyroid goitre: 75-200mcg. ii) Prophylaxis of relapse after surgery for euthyroid goitre: 75-200mcg iii) Substitution therapy in hypothyroidism: ADULT Initially, 25-50mcg/day. Maintenance: 100-200mcg/day. CHILDREN Initially 12.5-50mcg/day, Maintenance: 100-150mcg/m2 body surface area iv) Concomitant supplementation during anti-thyroid drug treatment of hyperthyroidism: 50-100mcg v) Suppression therapy in thyroid cancer: 150-300mcg
915 Lidocaine (Lignocaine) Hydrochloride 2% with Epinephrine (1:80,000) Injection N01BB02-110-P30-01-xxx B Infiltration and nerve-block dental local anaesthesia None The dosage should be adjusted individually according to the area to be anaesthetised, vascularisation of the tissues and anaesthetic technique to be used.

For infiltration or terminal anaesthesia, 1ml suffices in most cases. In the case of nerve-block anaesthesia, the dose will be 1.5 to 2ml.
916 Lignocaine (Lidocaine) 1% Injection N01BB02-110-P30-02-XXX C+ Local or regional anaesthesia for episiotomy repairs None According to patients weight and nature of procedures, maximum 200mg. For most obstetric procedures, the preparation is diluted to 0.5%, which gives the maximum effect with the least toxicity. [lignocaine 1%, 1 part and normal saline or sterile distilled water, 1 part]
917 Lignocaine (Lidocaine) 10 % w/w Spray N01BB02-110-A40-01-XXX B i) For surface anaesthesia in dental practice, in otorhinolaryngology and paracentesis
ii) For obstetric and gynaecology- related procedures as supplementary pain control		 None i) & ii) Spray to affected part
918 Lignocaine (Lidocaine) 100mg/ml Injection C01BB01-110-P30-02-XXX B Ventricular tachycardia and ventricullar fibrillation. To be diluted before use None 50-100 mg IV as a bolus, repeated after 5 minutes if necessary. Maintenance : 1-4 mg/min by IV infusion under ECG monitoring
919 Lignocaine (Lidocaine) 2% Intramuscular/ Subcutaneous Injection N01BB02-110-P30-01-XXX B For local or regional anaesthesia and nerve block. Not for IV use. None Local anesthesia: ADULT Maximum: 100 mg; CHILD Maximum: 3 mg/kg
920 Lignocaine (Lidocaine) 2% Jelly N01BB02-110-G40-01-XXX B Use for endotracheal tubes and instruments, painful procedures in the ear, nose and throat, burns, wounds, abrasions, lacerations; catheterisation of the male and female urethra and for symptomatic treatment of cystitis and urethritis None Apply to affected area 10 mins before catheterization.
921 Lignocaine (Lidocaine) 2% Viscous Solution N01BB02-110-L50-01-XXX A i) To relief pain associated with irritated or inflamed mucous membranes of the:
a) mouth;
b) pharynx (post-tonsillectomy)
c) upper gastrointestinal tract (e.g esophagitis).

ii) Use for instrumentation of the respiratory and digestive tracts (e.g. bronchoscopy, oesophagoscopy).		 - i) a) For anaesthesia of the mouth: Rinse the mouth with 5-15 ml (100- 300 mg lignocaine), then the solution is spat out. In dental practice, 10 ml solution (200 mg lidocaine) are used. The solution should be spat out when adequate anaesthesia has been achieved (after approx. 1 minute).
b) For anaesthesia of the pharynx: Gargle with 5-10 ml (100-200 mg lignocaine), after which the solution is slowly swallowed.
c) Painful conditions in the upper GI tract: 5-15 ml (100-300 mg lignocaine) are rapidly swallowed all at once.
*Daily dose should not exceed 1200 mg (Total of 60 ml)

ii) Instrumentations into the stomach: 10-15 ml (200-300 mg lignocaine) are swallowed.

Indications (i) & (ii):
The daily dose should not exceed 1200mg (60mL)
If combined with other lignocaine products, the total dose of lignocaine on one dosing occasion should not exceed 400mg.
922 Lignocaine (Lidocaine) 2% with Chlorhexidine 0.05% Gel N01BB52-974-G30-01-XXX B To provide local anaesthesia and lubrication during catheterization, exploration by sound and other endourethral operations and examinations, cytoscopy and symptomatic treatment of painful cystitis and urethritis None Adult Male:
Instil 20 mL slowly into the urethra until it reaches external sphincter, proximal to the prostrate. Subsequently, apply compression at the corona for several mins. Fill the length of the urethra w/ the remaining gel.
Sounding procedure or cytoscopy: Instill 40 mL (in 3-4 portions) into the insertion area then allow 5-10 mins for anaesthesia to take effect.

Adult Female:
Prior to urological procedure, instill 5-10 mL in small portions to fill the whole urethra & allow anaesth to take effect in 3-5 mins.

Children <12 yr:
- Up to 6 mg/kg.
923 Lignocaine (Lidocaine) 20 mg/ml Injection C01BB01110P3001XX B Ventricular tachycardia and ventricular fibrillation. For IV use. To be diluted before use None 50-100 mg IV as a bolus, repeated after 5 minutes if necessary. Maintenance : 1-4 mg/min by IV infusion under ECG monitoring
924 Lignocaine (Lidocaine) 25mg and Prilocaine 25mg Cream N01BB52-974-G10-01-XXX A Surface anaesthesia of the skin in connection with needle insertion and for superficial surgical procedures None Apply a thick layer under occlusive dressing

Dosing is according to product insert.
925 Lignocaine (Lidocaine) 4 % Solution N01BB02-110-L50-02-XXX B i) Anaesthesia of mucous membranes
ii) Use for instrumentation of the respiratory and digestive tracts		 None i) & ii) Dosing is according to product insert/protocol.
926 Lignocaine (Lidocaine) 5% and Phenylephrine HCl 0.5% Nasal Spray N01BB02-984-A41-01-XXX A* Preparation of nasal mucosa for surgery (eg. Cautery to Little's area), aid the treatment of acute nose bleeds and removal of foreign bodies from the nose, topical anaesthesia of the pharynx prior to direct or indirect laryngoscopy, topical anaesthesia and local vasoconstriction prior to endoscopy of the upper airways None Adults and children over 12 years : 5 squirts per nostril. Children: 8 to 12 years 3 squirts per nostril, 4 to 8 years 2 squirts per nostril, 2 to 4 years 1 squirt per nostril. Doses are to be administered once only.
927 Lignocaine (Lidocaine) Medicated Plaster 5% w/w N01BB02-110-M60-01-XXX A* Indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN). i) For elderly patients with polymedication status whom certain treatment was contraindicated or not tolerated.
ii)Prescribed by pain specialist only.		 1 patch /day (Adults & elderly. Cover the painful area once daily for up to 12 hr w/in 24-hr period. Subsequent plaster-free interval: At least 12 hr. Not more than 3 plasters should be used at the same time)
928 Lignocaine (Lidocaine), Aluminium Acetate, Zinc Oxide and Hydrocortisone Ointment C05AX03-931-G50-01-XXX A/KK Anorectal pain, pruritis, inflammation and irritation None Apply once or twice daily. Not for prolonged use
929 Lignocaine (Lidocaine), Aluminium Acetate, Zinc Oxide and Hydrocortisone Suppository C05AX03-931-S20-01-XXX B Treatment of pain, itching and discomfort arising from irritated anorectal issues None 1 suppository once or twice daily and as required after each bowel action.
Max: 5 suppositories/day.
930 Linagliptin 5 mg tablet A10BH05-000-T32-01-xxx A/KK Indicated as adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus, as monotherapy when metformin is contraindicated or not tolerated and as add-on therapy to other glucose-lowering agents when adequate glycaemic control is not achieved despite dose optimisation. None 5 mg once daily

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