Tivogg 5 DAVI medicine for prophylaxis (6 blisters x 10 tablets)
Dosage form Box of 6 blisters x 10 tablets
Specifications Davipharm
Uses
indications
Tivogg drug indicated in the following cases:
sodium warfarin is a coagulants of Coumarin group, indirect effect, easy to soluble in water, so it can be used in injection or oral. Warfarin prevents the synthesis of a number of hepatic coagulation factors including factor II (prothrombin), VII (Proconvertin), IX (Christmas element or plasma thromboplastin) and X (Stuart-Prower) by inhibiting the synthesis of reducing vitamin K, which is an essential substance for gamma-carboxylation That blood clotting.
There is no reducing vitamin K, carboxylation of the rest of glutamic acid of coagulation factors II, VII, IX and X does not take place and these proteins cannot become active coagulation factors.
warfarin also inhibits proteins C and S anti -coagulation. Unlike heparin, Warfarin has no anticoagulants in vitro.
After starting with warfarin treatment, the blood concentration of the VII activity (the half -life of plasma is 4-7 hours) is first inhibited, followed by the IX factor (the half -life of plasma 20 - 24 hours) and X (the sale of plasma in blood in 48 - 72 hours) and finally factor II (Selling time in plasma 60 hours or longer).
When stopping warfarin or taking vitamins, the blood concentration of blood clotting factors depends on vitamin K returns to the concentration before treatment. Warfarin prevents blood clots when stagnant and can prevent blood clots from spreading.
The drug does not have a direct effect on the blood clot that has been formed and does not have or has very little effect on the pathogenesis of arterial thrombosis due to the interaction between platelets and abnormal vascular walls.
Because warfarin affects the synthesis of coagulation factors related to both internal and exogenous blood clots, the drug extends prothrombin (PT) and the time of thromboplastin is partially activated (APTT).
Dynamic pharmacokinetics
warfarin is a racemic mixture of two r-warfarin and s-warfarin homonyms, of which S-Warfarin isomers have 2.5 times stronger anticoagulant effect than R-Warfarin
but faster excretion.
absorption
Warfarin sodium absorbs fast and a lot in the gastrointestinal tract, but the absorption rate changes a lot between individuals. Warfarin absorption depends on the solubility speed. The speed and level of absorption of the drug can change between the markets sold on the market.
Food reduces absorption speed, but does not reduce the level of absorption. Warfarin also absorbed through the skin and severe poisoning occurred when exposed to many times with mice poison containing warfarin.
The peak of Warfarin in plasma is achieved within 4 hours, in healthy people, the peak concentration reaches 90 minutes after drinking.
However, the plasma warfarin concentration is not necessarily related to anti -thrombotic effects and does not help in adjusting the dosage of anticoagulants.
If intravenously, the peak concentration can be achieved earlier when taken. However, Warfarin intravenous injection does not increase anticoagulant or earlier effects.
After taking enough Warfarin doses, the drug works early on the synthesis of vitamin K -dependent coagulation factors (within 24 hours) to reduce these factors before the drug has a clear treatment. Anti -thrombotic effects may not have up to 2-7 days after the beginning of Warfarin therapy.
Similarly, when stopping warfarin, there is a potential time until the blood concentration of blood clotting factors depends on vitamin K return to normal. Warfarin oral, intramuscularly or intravenously begins the same anti -thrombotic effect. Warfarin dose exceeds the necessary dose to affect the synthesis of IX and X factors does not work faster but can extend the time after stopping the drug.
distribution
There is no difference in the apparent distribution of the warfarin solution when using intravenous and oral intravenously. The distribution volume of Warfarin is about 0.14 kg. The 6 - 12 -hour distribution phase can be distinguished after using an intravenous warfarin solution quickly or orally.
The distribution of R-Warfarin and S-Warfarin is predicted as the same and the same as Racemic mixture. 99% Warfarin attaches to plasma proteins, mainly albumin.
Research on animals shows that in addition to the liver, the drug is distributed into the lungs, spleen and kidneys. Warfarin through the placenta and the concentration of drugs in fetal plasma can be equal to the concentration of drugs in the mother's plasma.
In humans, the research data is small, and shows that the drug is not distributed into breast milk.
transformation
Warfarin is excreted almost completely in the form of metabolites. Sodium warfarin is optical selective optical metabolic by microsom enzymes (Cytochrom P450) into non -active hydroxyl metabolites (main roads) and by reductase into warfarin alcohol).
Warfarin alcohol metabolites have the lowest anticoagulant activity. The metabolites are mainly eliminated through urine; and a small part of honey. Warfarin's identified metabolites include dehydrowarfarin, two optical isomer alcohols, 4-6-7- 8- and 10-hydroxywarfarin.
The cytochrom P450 iszymes involved in the metabolism of warfarin including 2C9, 2019, 2C8, 1A2, and 3A4. In which 2C9 is the form of cytochrom P450 in the liver that changes the anticoagulant effect in Vivo of Warfarin. The activity level of CYP2C9 depends on genetics and varies according to each person. Patients with homozygousness with alleles CYP2C9*1 (about 80% of whites) have normal enzyme activity (that is, strong metabolic) and standard treatment regimens suitable for this type of person.
About 11 or 7% of whites have Alen CYP2C9*2 of the type of intermediate metabolism or have Alen CYP2C9*3 of the type of poor warfarin metabolism.
S-warfarin's clearance, a form of drugs with strong effects, is reduced in these objects. Therefore, these patients have an increase in the risk of excessive bleeding and anticoagulants (ie Inr exceeds 3) and requires a lower doses of Warfarin, especially when starting treatment. Alen CYP2C9+2 and CYP2C9+3 reduces the metabolism of warfarin by 30-50 and 90%, respectively.
Elimination
Warfarin's waste sale time after single dose is about 1 week; However, the effective sale period is 20 - 60 hours, on average about 40 hours.
The clearance of R-Warfarin is generally half the size of S-Warfarin, so, because the distribution of two similar isomers, the semi-waste time of R-Warfarin is longer than Swarfarin.
R -Warfarin's exhaust half -life is about 37 - 89 hours, while Swarfarin is about 21 - 43 hours. Research with radioactive isotopes shows that up to 92% of oral doses are found in urine.
A very small amount of warfarin is excreted in the form of unchanged urine. The form of urine excretion is metabolites.
Before taking Tivogg 5 DAVI medicine for prophylaxis (6 blisters x 10 tablets)
How to use
Tivogg 5mg medicine used by oral. Daily medication must be taken on time, drink once a day and should be taken in the afternoon to be able to change the dosage as soon as possible after the results of the INR.
DosageAdults and the elderly
Warfarin's common starting dose is 10 mg/day for 2 days, but this dose should be adjusted based on the requirements of each patient. Prothrombin should be determined before treatment with warfarin.
Warfarin's daily maintenance dose is used from 3 to 9 mg, used at the same time per day. The correct maintenance dose for each patient depends on prothrombin or other appropriate blood tests. The maintenance dose is ignored if the prothrombin time is excessive. Once the maintenance dose is stable during treatment, it is often necessary to adjust the maintenance dose.In case of emergency, anticoagulant treatment should be started with combination of heparin and warfarin. In cases of less urgency, such as in patients with or special risk of thrombosis, anticoagulant treatment may be started with single warfarin.
Shared Warfarin with heparin affects the results of control tests and should stop heparin at least 6 hours before the first test.
The treatment control is set by regular monitoring and then adjusting the maintenance dose of warfarin based on the obtained results.
Children: There is no information on the use of drugs in children.
What dodo when overdose? Handling measures must be slowly to avoid thrombosis.
Treatment depends on Inr and signs of bleeding if any:
If the INR is on the treatment area but below 5 and if the patient does not bleed or does not need to intervene quickly before surgery:
After high doses of vitamin K treatment, it takes a while for warfarin to work again. If you have to treat warfarin again, it is necessary to take into account the transition stage with heparin.
If random poisoning in addition to Warfarin treatment, the level of poisoning must be assessed based on Inr levels and have hemorrhage complications. Inr must be carried out for several consecutive days (2-5 days), which must be included in the long -lasting sale time because Warfarin is absorbed. As soon as the INR changes, vitamin K can adjust the anticoagulant effect.
What to do when you forget the dose? Do not take two doses the next day to compensate for the forgotten dose.
Side Effects
When using Tivogg, you may experience unwanted effects (ADR).
Unknown frequency:
The main risk of warfarin is that it can cause bleeding anywhere on the body. To avoid overdose of Warfarin, it is necessary to monitor Inr as recommended. If overdose, must handle (see more overdose management section).
If Inr is above treatment but less than 5, it is necessary to reduce the dose or stop until the INR returns to the level of treatment.
If Inr is equal to or above 5.0 but below 9.0, warfarin must be stopped. If the risk of bleeding is increased, Phytomenadion 1 - 2.5 mg may be given or may be up to 5 mg. If the INR is equal to or greater than 9.0, it is necessary to stop warfarin and drink Phytomenadion 2.5 - 5 mg.
If there is any massive bleeding, warfarin must be stopped, and slowly intravenously phytomenadion and fresh plasma, special solution containing element II, VII, IX and X, or the recombinant factor VIIA.
If INR is at the level of treatment that has bleeding, other causes such as kidney disease or gastrointestinal tract.
Skin necrosis and soft tissue are rare but very heavy. The cause may be due to thrombosis but the disease is unknown. Patients with protein C deficiency are at high risk.
Couumarin must be stopped when skin damage and must give vitamin K. Must give heparin to prevent coagulation. Fresh frozen plasma or concentrated solution C protein may also work. If necrosis, surgery.
Before starting treatment, it is always necessary to eliminate the risk of physical bleeding, such as ulcers, tumors in the gastrointestinal tract.
The drug can cause other unwanted effects. It is necessary to closely monitor and recommend the patient to notify the doctor with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
contraindicated
Tivogg drugs contraindicated in the following cases:
Be cautious when using
Most unwanted effects are reported by Warfarin as the result of excessive anticoagulant effects. Therefore, it is necessary to re -evaluate regular treatment and stop treatment when it is no longer necessary.
Starting treatment
track:
When starting with Warfarin according to the standard dose regimen, the INR should be tested daily or every 2 days in the first days of treatment. When the Inr value has stabilized within the target range, the Inr index can be checked in a longer cycle.
Should monitor the Inr more often in patients with excessive blood coagulation such as patients with severe hypertension, liver disease or kidney disease.
Patients with difficult to follow treatment should be monitored more often.
Blood coagulation:
Risk of bleeding:
The most unwanted effect of the most frequent report of all oral anticoagulants is bleeding. Be cautious when using warfarin in patients at risk of serious bleeding (such as with NSAID, recently suffering from stroke, infected endocarditis, have been gastrointestinal bleeding).
Risk factors of bleeding include high anticoagulant intensity (INR> 4.0), Age ≥ 65, Inr multiple changes, a history of gastrointestinal bleeding, uncontrolled hypertension, brain disease, serious heart disease, the risk of falling, anemia, malignant tumor, trauma, kidney failure, commonly used with other drugs.
Should monitor Inr regularly for all patients using warfarin. Monitor the Inr more often, adjust the dose carefully until the INR desired, and shorten the treatment time may be useful for patients at high risk of bleeding. The patient should be instructed to minimize the risk of bleeding and immediately notify the doctor the signs and symptoms of bleeding.
Check the INR and reduce or skip the dose depending on the INR is essential, consulting and anticoagulant care later if necessary. If the INR is too high, reduce the dose or stop warfarin; Sometimes this is necessary to reverse anticoagulant effects. Inr should be checked for 2-3 days to ensure the value is decreasing.
Precautions when using combination with any anti -plateletic drugs due to increased risk of bleeding.
Bleeding:
Stroke:
Surgery:
Dental surgery:
Progressive stomach ulcer:
Interactive:
Any change in treatment, including self -use drugs, requires Inr monitoring. The patient should be instructed to notify the doctor before starting to use any additional drugs including non -prescribing drugs, medicinal herbs or vitamins.
Calcium vascular and skin necrosis (calciumlaxis):
Cases of vascular and skin necrosis have been recorded in both patients using Warfarin without kidney disease. In the event of this syndrome, patients need to be properly treated and consider stopping using warfarin.
thyroid disorders:
The following conditions can also increase the effects of warfarin, and need to reduce the dose:
The following conditions can reduce the effects of warfarin, and need to increase the dose:
Other caution:
Genetic information:
Obery of the patient:
Elderly:
Patients with renal failure:
Warning related to excipients:
used for drivers and operating machinery
warfarin does not affect the ability to drive and operate machinery.
Use drugs for pregnant or nursing women
Pregnant women:
breastfeeding women:
Drug interaction
warfarin has a narrow treatment range and needs to be cautious when using combined. Information on all new treatment coordinates should be advised for specific instructions on the adjustment of Warfarin dose and monitoring treatment. If there is no information, the possibility of drug interactions should be considered. Should consider increasing monitoring when starting any new treatment if there is doubt about the ability to interact.
pharmacokinetic interaction
contraindications
Combining drugs used in treatment and prevention of thrombosis, or other drugs with unwanted effects on hemostasis can increase Warfarin's pharmacological effects and increase the risk of bleeding.
Contraindicated fibrin resolved drugs such as streptokinase and alteplase in patients taking warfarin.
Drugs should be avoided if possible
Should avoid the following medications or use carefully and enhance clinical and subclinical monitoring:
clopidogrel.
NSAID (including aspirin and selective inhibitors COX-2).
sulfinPyrazon.
Thrombin inhibitors such as bivalirudin, dabigatran.
dipyridamol.
Heparin is not segmented and derivative, low molecular heparin.
fondaparinux, rivaroxaban.
Glycoprotein Ilb/ IIIA receptor antagonists such as Eptifibatid, Tirofiban and Abciximab.
prostacyclin.
SSRI and SNRI antidepressants.
Other drugs have the effect of inhibiting hemostasis, coagulation or platelet effects.
low -dose aspirin in combination with warfarin may be beneficial in some patients but the risk of gastrointestinal bleeding will increase, warfarin can be used with heparin at the beginning of treatment in thrombotic patients, until the INR is in the appropriate range.
Metabolic interaction
Warfarin is a mixture of optical contracts metabolized by different cytochrom P450s. R-Warfarin is metabolized mainly by CYP1A2 and CYP3A4. S-Warfarin is metabolized mainly by CYP2C9. The effect of warfarin is mainly affected when the metabolism of s-warfarin is changed.
Competitive drugs in the form of substrates of these cytochrom or inhibiting their activity may increase plasma and INR concentration, which can increase the risk of bleeding.
When used with these drugs, it may be necessary to reduce the dose of warfarin and increase the level of monitoring.
In contrast, these metabolic paths can reduce plasma and Inr concentrations, which can lead to effective reduction. When used with these drugs, it may need to increase the dose of warfarin and increase the level of monitoring.
There is a small group of drugs that interact with Warfarin, but clinical effects on Inr are diverse, in these cases, it should be intensified to monitor at the beginning and stop treatment.
should also be cautious when stopping or reducing the dose of induction drugs or inhibiting metabolic inhibits, once the patient has stabilized when using this combination (offset effect).
Medicines with significant interaction with clinical warfarin
Medications that increase the effects of warfarin:
alopurinol, capecitabin, erlotinib, disulfiram, antifungal drugs azol (ketoconazole, fluconazol, ...), omeprazol, paracetamol (regularly used, prolonged), propafenon, amopdaron, tamoxifen, methylphenidate, zafirlukast, fibrats, fibrats, statin, states. Pravastatin, mainly interact with fluvastatin), erythromycin, sulfamethoxazol, Metronidazol.
Warfarin -acting antagonists:
barbiturat, primidon, carbamazepin, griseofulvin, oral contraceptive pills, rifampicin, azathioprin, phenytoin.
Drugs have a variable effect:
corticosteroids, nevirapin, ritonavir.
Other drug interactions
Broad -spectrum antibiotics can increase the effects of warfarin due to reducing the same gastrointestinal bacteria producing vitamin K, orlistat can reduce the absorption of vitamin K. Cholestyramin and Sucralfate can reduce Warfarin absorption.
There have been an increase in Inr when sharing glucosamine and warfarin. Do not recommend this combination.
Interaction with pharmaceutical preparations
Do not use pharmaceutical preparations containing St John (Hypericum Perforatum) while taking warfarin due to the risk of reducing plasma concentrations and reducing clinical effects of warfarin.
Many other medicinal preparations have theoretical influence on Warfarin, however, most of these interactions have not been proven. In general, avoid using medicines or functional foods containing medicinal herbs while taking warfarin, and should guide the patient to notify the doctor if you are taking any medicinal preparations, as you may need to monitor more often.
alcohol
Using large amounts of alcohol at the same time can inhibit the metabolism of warfarin and increase Inr.
In contrast, using a lot of alcohol for a long time can touch the metabolism of warfarin.
may allow a moderate amount of alcohol.
Interaction with food and functional foods
Single reports show that there may be interaction between warfarin and cranberry juice, in most cases leading to increased Inr or bleeding complications. It is recommended that patients avoid using products with blueberries. Inrinent supervision and monitoring should be considered in any patient who is using warfarin and using cranberry juice regularly.
There is little evidence that grapefruit juice can cause Inr slightly increased in some patients using warfarin.
Some foods such as liver, broccoli, brush cabbage and green leafy vegetables contain large amounts of vitamin K. Sudden changes in diet can affect anti -freeze control.
Should guide patients to ask the doctor's advice before making any major changes in the diet.
Many other functional foods have theoretical influence on Warfarin, but most of these interactions have not been proven. In general, patients should avoid using any functional foods while taking warfarin, and the patient should notify the doctor if they are taking any functional foods, because they may need to monitor more often.
Testing
heparin and danaparoids can extend prothrombin time, so it takes a reasonable time from after taking the drug before the test.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
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