THERAPY FDC (Fixed-Dose Combination) TO TB PATIENTS

THERAPY FDC (Fixed-Dose Combination) TO TB PATIENTS

(Natalia Ni Putu O.P.S.D. - 078 115 061)

Tuberculosis (TB) is an infectious disease directly caused by the bacteria (Mycobacterium tuberculosis). Most of the TB germs attack the lungs but can also on other organs. Currently TB is still a very important health issue. WHO report of 2004 data shows that in 2003 there were 8.8 million new TB cases, 3.9 million are sputum smear (smear Basil) is positive, the prevalence of 16.2 million with 1.9 million deaths annually. Indonesia is a country with a TB case in the world's third largest after India and China. In 2002 the reported number of cases with smear-positive TB in India is 1,820,369 people, 1,447,947 Chinese in Indonesia and 581 847 people.

TB treatment is given in two stages, namely intensive and continuation phases. In the intensive phase (early) patients received a daily basis and need to be monitored directly in order to prevent the occurrence of drug resistance. When the intensive phase of treatment is given correctly, the patient usually becomes contagious infectious within two weeks. The majority of smear positive TB patients became smear negative within 2 months. In the advanced stage patients received fewer medications but within a longer period of time. Advanced stages it is important to kill the germs persistent so as to prevent recurrence.

The type and nature of Anti Tuberculosis Drugs (OAT), namely: (a) Isoniazid (H) is bakterisid, (b) Rifampicin (R) is bakterisid, (c) Pyrazinamide (Z) is bakterisid, (d) Streptomycin (S) is bakterisid , (e) Ethambutol (E) is bacteriostatic. OAT provision tailored to the patient's condition with its own rules of use. There are two categories of alloys OAT in Indonesia, namely: (a) Category I: 2 (HRZE) / 4 (HR) 3, (b) category II: 2 (HRZE) S / (HRZE) / 5 (HR) 3E3. Category I is given to new patients smear-positive pulmonary TB, smear-negative pulmonary TB patients chest X-ray positive, extra-pulmonary TB patients. Category II is given to smear-positive TB patients who had been treated previously.

Along with the development of knowledge in pharmacology, has now created a combination tablet, known as OAT OAT "fixed-dose combination" or for short-OAT FDC (FDC are often called). With the FDC is expected TB patient compliance in taking OAT can be improved so that it will improve the patient's recovery.

Symptom

TB disease have symptoms as follows: btuk continuously and phlegm for 3 weeks or more, bloody sputum, shortness of breath and chest pain, weakness, decreased appetite, weight loss, night sweats, although not active, fever fever of more than 1 month.

Target

As for the targeted treatment of TB disease is the bacteria causing the disease is Mycobacterium tuberculosis. These rod-shaped germ, resistant to acid therefore also called Basil Hold acid (BTA). In addition the bacteria living in areas with high oxygen content, so the place is a lung primary.

Purpose

By providing the FDC TB patients are expected to be easier in patients taking OAT due to fewer number of tablets. Moreover, it can minimize the side effects of OAT. This is because the formula FDC dose weight-adjusted drug the patient and the number of components that must be taken of the patient. With the FDC, the level of patient compliance in taking medication to be higher due to the influence of mental patients from seeing the number of tablets to be taken, not as much compared with the provision of OAT in separate tablets.

Therapeutic Strategies

Therapeutic strategy for TB disease is known as the DOTS strategy (Directly Observed Treatment Short-course). This therapeutic strategy recommended by WHO in 1995 as penganggulangan TB. DOTS consists of five components, namely (a) political commitment, (b) microscopic examination of sputum quality assured, (c) short-term treatment standards for all TB cases with the proper treatment of cases, including the direct supervision of treatment, (d) guarantee OAT availability of quality, (e) recording and reporting system that is able to provide an assessment of patient outcomes and overall program performance. The main focus of DOTS is the discovery and recovery of patients, priority is given to the type of infectious TB patients. This strategy will decide the transmission of TB and thus reduce the incidence of TB in the community.

In the DOTS strategy, TB treatment is done either by providing a separate OAT in tablet-OAT and the provision of FDC. Both types of OAT can be obtained at the health services include health centers, government hospitals and private hospitals lung, Clinical Centre of Lung Diseases (BP4), other medical clinics and private practice physician. In Indonesia OAT is provided free of charge and availability is guaranteed by the government. In addition TB patients are also required to have a PMO (Drinking Drugs Controller) so as to ensure compliance in patients taking OAT. Every TB patient should have a medical card and identity card of the patient. Both cards are obtained when patients seek treatment at health care units. The second function is as a report card on patient outcomes so that the course of treatment can be well controlled.

Choice of drugs

The types of FDC tablets are grouped into two, namely: FDC FDC for adults and for children. FDC tablet comprising a tablet for adults and 2FDC 4FDC. 4FDC tablets contain 4 kinds of drugs are: 75 mg Isoniasid (INH), rifampicin 150 mg, 400 mg Pyrazinamide, and Ethambutol 275 mg. These tablets are used for daily treatment in intensive phase and for the inserts. 2 FDC tablets contain two kinds of drugs are: 150 mg Isoniasid (INH) and rifampicin 150 mg. These tablets are used for the treatment of intermittent 3 times a week in advanced stages. Both tablets and tablet 4FDC 2FDC gift tailored to patient weight. To complement the available category II regimens of other drugs, namely: tablets @ 400 mg ethambutol and streptomycin injection (@ 750 mg vial).

FDC tablets untu children consisted of tablets and 2FDC 3FDC. Both types of tablets given to TB patients aged children 0-14 years old. 3FDC tablets contain three kinds of drugs are: INH 30 mg, 60 mg rifampicin, 150 mg and Pyrazinamide. These tablets are used for daily treatment in the intensive phase. 2FDC tablets contain two kinds of drugs are: 30 mg 600 mg INH and Rifampin. These tablets are used for treatment every day in the advanced stages. Similarly, the administration in adult patients, giving the number of FDC in pediatric patients is also tailored to the child's weight.

Dose and the rules of use FDC weight-adjusted patients. For adult TB patients in category I can be seen in the table below.

Weight Loss


Intensive phase of every day

for 56 days


Advanced stage 3 times

week for 16 weeks

30-37 kg


2 tablets 4FDC


2 tablets 2FDC

38-54 kg


3 tablets 4FDC


3 tablets 2FDC

55-70 kg


4 tablets 4FDC


4 tablets 2FDC

≥ 71 kg


5 tablet 4FDC


5 tablet 2FDC

As for the adult TB patients in category II, the dose and the rules of use FDC to be provided are:

Weight loss


Intensive phase of every day


Advanced stage 3 times a week for 20 weeks

Over the past 56 days


For 28 days

30-37 kg


2 tabs 4FDC

+ 500 mg Streptomycin inj.


2 tabs 4FDC


2 + 2 2FDC tab tab Ethambutol

38-54 kg


3 + 4FDC tab 750 mg Streptomycin inj.


3 tab 4FDC


3 + 3 2FDC tab tab Ethambutol

55-70 kg


4FDC tab 4 + 1000 mg Streptomycin inj.


4 tab 4FDC


4 + 4 2FDC tab tab Ethambutol

≥ 71 kg


5 tab 4FDC + Streptomycin inj.


5 tab 4FDC


5 + 5 2FDC tab tab Ethambutol

Note:

Each vial contains 750 mg Streptomycin dissolved in 3 ml aquabidest. This dose may be considered as 3 doses of 250 mg is used for patients with weight group 38-54 kg. For another group of patients with BB, the dose adjusted by the number of tablets taken, for example, for patients who require only 2 tablets, also only requires two injections sterptomisisn ml (1 ml = 250 mg. For patients over 60 years old given injections of streptomycin maximum of 500 mg / day. Injection streptomycin was given after the patients completed the drug ingestion.

If at the end of intensive phase of TB treatment in patients with positive sputum smear conversion does not happen then inserts a given OAT 4FDC tablet every day for 28 days.

FDC dosage and the rules of use for children, namely:

Weight Loss


Intensive phase of every day

for 2 months


Advanced stages of every day

for 4 months

≤ 7 kg


1 tablet 3FDC


1 tablet 2FDC

8-9 kg


1.5 tablet 3FDC


1.5 tablet 2FDC

10-14 kg


2 tablets 3FDC


2 tablets 2FDC

15-19 kg


3 tablets 3FDC


3 tablets 2FDC

20-24 kg


4 tablets 3FDC


4 tablets 2FDC

25-29 kg


5 tablet 3FDC


5 tablet 2FDC

OAT-FDC are available in blister packs. There are 28 tablets per blister. 4FDC and 2FDC tablets packed in a box containing 24 blisters @ 28 tablets. For ethambutol 400 mg tablets packaged in a box contains 24 blister @ 28 tablets. Streptomisisn injection packaged in a box containing 50 vials @ 750 mg. Required for the use of streptomycin injection aquabidest and 5 ml disposable syringe and sterile needles. Aquabidest available in @ 5 ml vial packaged in a box containing 100 vials.

Side effect of OAT-FDC generally similar to side effects from the use of OAT in separate tablets. Some side effects that appear in the form of loss of appetite, nausea, sometimes accompanied by vomiting, abdominal pain, joint pain, itching and redness of the skin, tingling to a burning sensation in the feet, balance disorders. Besides the side effects of hepatotoxicity may occur due to a hypersensitivity reaction or an overdose. Side effect of OAT is expected to occur in approximately 3-6% of patients who received treatment with the FDC. If the FDC is known with certainty that the cause of side effects as mentioned previously and the drug can not be returned, then the patient is given OAT in the form of a separate tablet (OAT kombipak).

TB treatment should be considered for patients who are in special conditions such as pregnant patients, patients with certain diseases such as diabetes, kidney failure, have a chronic liver disorder. For the treatment of TB in pregnant women to consider the use of streptomycin. Streptomycin can not be used in pregnancy. This is because streptomycin is ototoxic permanent and can penetrate the placenta barrier. This situation can result in hearing loss and balance that settled on the baby to be born.

DM patients should always be controlled in response to treatment. If the patient is also suffering from tuberculosis should be considered in the use of rifampicin, as rifampicin may reduce the effectiveness of oral antidiabetika sulfonyl urea goals that need to increase the dose antidiabetika. DM patients are receiving anti-insulin diabetic retinopathy complications sometimes occur, therefore it should be noted for pemberia ethambutol because it can aggravate the incident.

TB patients with kidney failure should not use streptomycin and ethambutol in the treatment. This is because both drugs are excreted through the kidneys. If it be possible that the drug can not be excreted from the body due to the inability of the kidneys. The result would cause toxic effects in the body. Therefore, it can be given treatment with INH, rifampin, and pyrazinamide for TB patients with renal failure. All three drugs are excreted in the bile and can be converted into compounds that are not toxic. OAT alloy is safest to TB patients with renal failure is 2HRZ/4HR.

TB treatment in patients with chronic liver disorders could be done if the patient has liver examination. If the value of SGOT and SGPT increased more than 3 times the OAT is administered and when it is in the treatment should be stopped. If the increase is less than 3 times the treatment can still be done with strict supervision. Patients with liver disorders should not be given pyrazinamide. OAT alloys are recommended for TB patients with liver disorders that 2RHES/6RH or 2HES/10HE.

Prevention of TB disease can be done with a healthy lifestyle by eating nutritious foods and regular, adequate rest, regular exercise, avoid smoking, alcoholic beverages, drugs, avoid stress. Then to prevent the transmission of TB, the TB patients are expected to cover mouth when coughing and not spit in any place. Other prevention efforts is to make immunization BCG (Bacillus Calmette-Guerin) which will provide active immunity to TB disease. In addition keep the immune system are also important in anticipation of TB disease. With a strong immune system is not easy to develop opportunistic infections (TB).

Not only the anniversary of the AIDS who have TB but also have the anniversary which falls on March 24. This year's anniversary of the world TB Day theme of "Every Breath Counts, Stop TB now". This theme emphasizes the word "breath" which means not only respiration, but also the center of all human activities. So, if the "breath" broken man because of TB it will damage the whole of human activity. This theme is reminiscent of the dangers of TB and the urgency of its eradication.