Meko Inh 150 mekophar tablets and tuberculosis treatment (100 tablets)

Dosage form Box of 100 capsules
Specifications Isoniazid

Ingredient

Composition information	Content
Isoniazid	150mg

Uses

indications

Meko inhabitators are indicated in the following cases:

Treatment of tuberculosis or tuberculosis outside the lungs.

Treatment of tuberculosis with primary symptoms.

Preventive:

Askoned as symptoms of primary symptoms are identified by a change in tuberculin reaction test on the skin (test mantoux).

People are at risk of triggering tuberculosis (young children, people from the country with high endemic tuberculosis, corticosteroid or immunosuppressant drugs, or other forms of immunosuppressive inhibitors, people living under prevention conditions).

Potential tuberculosis or tuberculosis bacteria are diagnosed with skin reactions with tuberculin.

History of tuberculosis treatment in the period before chemotherapy.

Treatment of non -typical Mycobacteria -sensitive infections (sensitivity determined by MIC). This method is based on a combination of positive antibiotics.

Official instructions based on the appropriate use of antibacterial drugs should be considered.

Pharmacology

The drug has a effect against Mycobacterium tuberculosis and some other typical Mycobacterium such as M. Bovis, M. Kansasii. The exact mechanism of Isoniazid is unknown, but it may be due to the synthetic inhibitors of mycolic acid is an important component of the sensitive bacterial cell wall, resulting in breaking the tuberculosis cell wall.

Isoniazid bactericidal depends on the concentration of the drug in the site of the damage and the sensitivity level of the bacteria. The minimum concentration of tuberculosis bacteria is 0.02 - 0.2 micrograms/ml.

M. Tuberculosis '' resistant and natural drug resistance to isoniazid in both in vivo and in vitro has been shown to take place in a ladder style. The anti -drug mechanism may be caused by anti -drug mutant bacteria.

Fast growing anti -drug strains if used for lone isoniazid to treat tuberculosis, but less if used for preventive purposes. To prevent drug resistance, it is necessary to use isoniazid with 3-4 other tuberculosis drugs and never be used alone.

pharmacokinetics

absorption:

Isoniazid absorbs quickly and completely according to the gastrointestinal tract. After taking the dose of 5mg/kg body weight is 1-2 hours, the maximum concentration in the serum is 3 - 5mg/ml. Food slowly absorbs and reduces the bioavailability of isoniazid.

Distribution:

About 10% - 15% of the drug is attached to plasma proteins. Isoniazid allocated to all organs, tissues and body fluids. The concentration of medication in the normal cerebrospinal fluid is only 20% of the concentration of drugs in plasma, but in meningitis this concentration increases to 65 - 90%.

The concentration of drugs achieved in pleura is 45% of the serum concentration. The drug is absorbed into tuberculosis cave, easily through the placenta and the fetus.

Metabolism and elimination:

Isoniazid metabolizes the liver with acetylation reaction, mainly forming acetylisoniazid and ionicotinic acid and is excreted in urine. Other metabolites of drugs (isonicotinyl glycine, isonicotinylhydrazin, n-methylisoniazid) are only small in urine.

Issoniazid's semi -discharged time in patients with normal liver and kidney function is from 1-4 hours depending on faster or slow metabolic metabolic people and longer in patients with severe liver function or severe kidney failure.

About 75 - 95% of the kidneys except for the kidneys within 24 hours in the form of inactive metabolites. A small amount is discharged through feces. The drug can be removed from the blood with artificial kidney or peritoneal fertilizer.

Before taking Meko Inh 150 mekophar tablets and tuberculosis treatment (100 tablets)

How to use

drink 1 hour before eating or after 2 hours. Can take medicine with meals, if the gastrointestinal irritation.

150mg tablet preparation form is not suitable for children under 6 years old, children under 6 years of age can use other forms of preparation more suitable.

Dosage

Preventive TB:

Children:

Take 5mg/kg/24 hours, maximum 300mg/24 hours, once a day for 6 - 12 months.

Adults:

Take 5mg/kg/24 hours (the usual dose is 300mg/24 hours), daily used for 6 - 12 months.

tuberculosis treatment:

Must use Isoniazid in combination with other anti -tuberculosis drugs, such as Streptomycin, Rifampicin, Pyrazinamid and Ethambutol according to national treatment regimens.

Common dose of treatment in adults and teenagers:

Coordinate with other anti -tuberculosis drugs (based on the national anti -tuberculosis program). Take 10mg/kg body weight, up to 300mg of isoniazid, used once a day; Or each week drink 2 or 3 times as prescribed by the treatment regimen.

Normal dose of children's treatment:

Coordinate with other anti -tuberculosis drugs (based on the national anti -tuberculosis program). Take 10mg/kg, 3 times/week or 15mg/kg, 2 times/week.

Hepatic failure:

Isoniazid should be used carefully and under tight supervision in patients with weakened liver function.

kidney failure:

In medium renal impaired patients (the creatinine clearance between 30 and 60ml/minute), should be cautious when using isoniazid.

Severe liver failure:

Isoniazid treatment is contraindicated.

In patients with jurors, ISONIAZID should be taken at the end of the split.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose?

Overdose:

ISONiazid dose 1.5g or more is at risk of toxicity, 10 - 15g dose may be deadly if not emergency, or death dose is over 200mg/kg body weight.

Symptoms of overdose include nausea, vomiting, dizziness, lisp, loss of orientation, increased reflexes, blurred vision, hallucinations and usually occur within 30 minutes to 3 hours after taking the drug.

If severe poisoning, respiratory inhibitors and central neurological inhibition, can quickly pass from stunning to coma, prolonged convulsions, metabolic acidosis, aceton urine and hyperglycemia. If the patient is not treated or treated without thorough treatment, can die.

Isoniazid causes convulsions is caused by a reduction in gamma-aminobutyric acid levels (GABA) in the central nervous system, due to Isoniazid inhibiting the activity of pyridoxal-5-phosphate in the brain.

How to handle:

In the overdose of Isoniazid, the first thing is to ensure a full respiratory maintenance.

Seism can be treated by intravenous diazepam intravenous or barbiturates with short -effect time, combined with pyridoxin hydrochloride. The dose of pyridoxin hydrochloride is equal to the dose of isoniazid used. Usually the first intravenous injection 1 - 4g pyridoxin hydrochloride, then every 30 minutes intramuscularly until the whole bureaucracy is used.

If the seizures are controlled and overdose of the new isoniazid occurs within 2-3 hours, the stomach is needed. Monitor gas/blood, electrolytes, glucose and urea in serum. Sodium bicarbonate infusion to prevent metabolic acidosis and repeat if needed.

In some patients, there is still a coma after the treatment of convulsions with diazepam and pyridoxin, after about 36 - 42 hours of coma will inject 1 more dose from 3 - 5g pyridoxin hydrochloride again, about 30 minutes later, the patient will wake up completely. However, if using an overdose of pyridoxin, it can also cause unwanted effects on the nervousness.

Therefore, it is necessary to consider when using pyridoxin for treatment or coma caused by isoniazid. The maximum dose of pyridoxin is unknown. The dose in the range is 70 - 357mg/kg injected within 1 hour, and 52g intravenously used during the overdose of Isoniazid without poisoned symptoms of pyridoxin.

Diuretics must also be used as soon as possible to help quickly waste the drug from the kidneys from the body, and continue for hours after clinical symptoms have been improved to ensure all the discharges of Isoniazid and prevent the phenomenon of re -poisoning.

monitor the fluid balance and translate. Artificial kidney and peritoneal dialysis should be used with diuretics. In addition, there must be anti -oxygen deficiency, hypotension and choking pneumonia. Anti -metabolic acidosis.

Actively monitor for timely management measures.

What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

Side Effects

When using Meko inh 150 , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Digestive system: Nausea, vomiting, diarrhea , dry mouth, epigastric pain.

Uncommon, 1/1000

Liver system - bile: hepatitis (yellow eye, hygiene of transaminase).

Osteoarthritis: back pain, joint pain

Rare, 1/10000

Skin and subcutaneous tissue: poisoned epidermal necrosis, symptoms of body leukemia.

Unknown frequency:

Blood and lymphatic system: granulocytosis, anemia including hemolytic anemia, red blood cell anemia and non -regenerated anemia, eosinants, thrombocytopenia, bleeding disorders and blood clots, blood methemoglobin.

The immune system: lupus syndrome.

Metabolism and nutrition: Pellagra disease, increased blood glucose.

Mental: Mental disorders.

Nervous system: peripheral neuropathy, optic neuritis, convulsions, increased reflexes.

Eye: Atrophy of optic nerves.

Vascular system: Vascular inflammation.

Digestive system: pancreatitis , constipation.

Liver system - bile: abnormal liver function, jaundice.

Skin and subcutaneous tissue: Hair loss, allergic reactions on the skin, hemorrhage, skin rash, peeling dermatitis.

Reproduction system and mammary gland: female mammary glands in men.

Instructions on how to handle ADR

ISONIAZID's unwanted effects are often lost when stopping the drug. However, there are also unwanted effects that last long, such as the case of hepatitis.

Risk factors that increase the unwanted effects of the drug include the elderly, people with diabetes, people with a history of psychosis, kidney failure, liver failure, alcohol addiction, malnutrition, high blood urea, HIV -infected people, people taking epilepsy drugs such as Hydantoin. It is necessary to evaluate liver function before using isoniazid in these people.

To reduce the unwanted effect of Isoniazid for the nervous system, you must regularly use additional B vitamins, daily with a dose of 10mg/day. If there is peripheral neuritis, use vitamin B, dose 50mg/time, 3 times a day.

If there are symptoms of hepatitis (discomfort, fatigue, anorexia, nausea), it is necessary to suspend the drug to evaluate.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Meko Inh 150 Contraindications to the following cases:

People who are sensitive to isoniazid or with any ingredients of the drug.

People with a history of liver damage due to isoniazid.

People with severe liver failure, severe hepatitis.

People with multiple neuritis and people with epilepsy.

Women who are breastfeeding in combination with carbamazepin and disulfiram.

Be cautious when using

People with malnutrition, people who are susceptible to nervous systems (for example, diabetes, alcoholism). Need to simultaneously use pyridoxin in these people.

For people with severe impaired renal function (creatinine clearance below 25ml/minute), the dose of isoniazid must be reduced, especially the slow metabolic isoniazide.

Be cautious with people with porphyrin.

During the treatment of Isoniazid and drinking alcohol or in combination with rifampicin, there is a risk of increasing liver toxicity.

Should consider, if pancreatitis caused by isoniazid is shown, the drug should be avoided.

The ability to drive and operate machinery

Preparations can cause seizures, mental disorders and optic neuritis. Should be cautious when using this preparation for train drivers, operating machines, people working on high and other cases.

Pregnancy

Although Isoniazid is often considered safe during pregnancy, potentially increasing the risk of fetal defects occurs when Isoniazid is used in the early stages of pregnancy. If it is not possible to eliminate the risks that may occur, it is advisable to consider and balance with treatment benefits.

Lactation period

Isoniazid is secreted into breast milk with concentrations equivalent to the mother's plasma concentration (6 - 12 mcg/ml). This can lead to infants absorb up to 2mg/kg/day.

Additional pyridoxin is recommended for nursing and breastfeeding women to minimize side effects.

Drug interaction

incentive combination:

carbamazepin: Increasing carbamazepine levels in plasma with signs of overdose, by inhibiting the metabolism of the liver.

disulfiram: movement and mental disorders.

Combining used warning requirements:

Aluminum (salt and hydroxid): Reducing the absorption of Isoniazid, it is necessary to take these two drugs more than 2 hours apart (if possible).

Volaratical Halogen anesthesia: Isoniazid's liver toxicity (increasing the formation of toxic metabolites of Isoniazid). A warning about the stop treatment with Isoniazid a week before surgery and use only after 15 days.

glucocorticoid (prednisolon): reduces the level of Isoniazid in plasma.

ketoconazole : Reducing the concentration of ketoconazole in plasma. The distance between 2 antibacterial doses is at least 12 hours. Monitor the concentration of ketoconazole in plasma and adjust the dose appropriately.

phenytoin: overdose of phenytoin (reduced metabolic metabolism). Clinical monitoring closely, the dose of phenytoin concentration in plasma and can adjust the dose during treatment and after stopping treatment with isoniazid.
pyrazinamide : Increases liver toxic effects.
rifampicin (induction of other enzymes): Increasing isoniazid's liver toxicity (increasing the formation of toxic metabolites of Isoniazid). Clinically and biological monitoring of this combination. In the case of hepatitis, stop treatment with Isoniazid.

Stavudine: Increased risk of peripheral neuropathy by increasing unwanted effects.

Special problem of Inr imbalance: Many cases of increased activity of oral anticoagulant drugs are reported in patients with antibiotics. Infections often suffer from severe inflammation, age and total condition of the patient, it seems to be the factors of this risk.

In these cases, it seems that it is difficult to separate between infections and treatment with the possibility of an Inr imbalance. However, some priority antibiotic subgroups are less likely to use, including fluoroquinolones, macrolides, tetracycline, cotrimoxazol and some cephalosporins.

Storage

Store in a dry place, avoid light, temperature not exceeding 30 ° C.

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