Voltaren injection 75mg/3ml Novartis treat acute inflammation and rheumatism (1 blister x 5 tubes x 3ml)

Dosage form Box of 1 blister x 5 tubes x 3ml
Specifications Diclofenac sodium

Ingredient

Thành phần cho 3ml

Composition informationContent
Diclofenac sodium75mg

Uses

Indications

Voltaren medicine 75mg/3ml are indicated in the following cases:

intramuscularly

Treatment of drama of rheumatitis and rheumatism: rheumatoid arthritis, spinal inflammation, osteoarthritis, vertebral inflammation, pain syndrome of the spine, dysching outside the joints.

Treatment of acute attacks of gout.

Treatment of kidney pain, bile cramps.

Treatment of pain, inflammation and swelling after trauma and after surgery.

Treatment of serious migraine.

intravenous infusion

Treatment or prevention of pain after surgery in the hospital environment.

Pharmacokology

Mechanism of action

Voltaren contains sodium diclofenac, which is non -steroids with anti -inflammatory, analgesic and antipyretic properties. The inhibition of prostaglandin biosynthesis, proved by experimental, is considered as the basic mechanism of effect of the drug. Prostaglandin plays an important role in inflammation, pain and fever. In vitro, sodium diclofenac does not inhibit proteoglycan biosynthesis in cartilage with concentrations equivalent to humans.

Pharmacokology

In low diseases, Voltaren's anti -inflammatory and analgesic effect evokes a clinical response characteristic by reducing signs and symptoms such as pain when resting, pain when exercising, stiffness in the morning, swelling of joints, and the drug also improves the function of joints.

In post -surgery and postoperative conditions, Voltaren relieves both spontaneous pain and pain when moving, reducing inflammation and edema due to wounds.

Pharmacokinetics

absorption

Maximum concentration in plasma is 2.5 mg/ml (8 mmol/l) reached about 20 minutes after the injection of 75 mg of diclofenac. The concentration of plasma is linearly related to the dose.

Distribution

After the injection, the area below the concentration curve is about double the area recorded after oral or rectal line with the same dose due to the same dose when using these sugars, half the active ingredient must be metabolized when the first time through the liver. 99.7% diclofenac binds to plasma proteins, mainly with albumin (99.4%).

Pharmacokinetics does not change when using repeated doses.

Do not accumulate in plasma after using multiple doses if obeyed the medication distance. Diclofenac goes into the epidemic and has a maximum concentration of 2-4 hours after reaching the maximum concentration in plasma.

Metabolism

Biological metabolism is partly due to the glucuronicization of intact molecules, but mainly due to glucuronicization after hydroxylation one or more times.

Elimination

The active ingredient is eliminated from plasma with the body clearance coefficient of 263 ± 56 ml/min. The final half -life is 1-2 hours.

About 60% of the dose is excreted through the kidneys in the form of metabolic substances, less than 1% is excreted in the form of unprocessed. The rest is eliminated in the form of molasses metabolites in feces.

The semi -cancellation time is 3 - 6 hours. This means that the active ingredient concentration in the epidemic has been higher than the concentration of plasma after 4-6 hours of medication, and they exist for up to 12 hours.

Before taking Voltaren injection 75mg/3ml Novartis treat acute inflammation and rheumatism (1 blister x 5 tubes x 3ml)

How to use

intramuscularly

Must follow the following instructions for intramuscular form to avoid nerve damage or other tissue at the injection site (which can cause muscle weakness, muscle paralysis or decrease in sensory).

In general, the usual daily dose is 1 75 mg tube, intramuscularly into the buttocks, the upper ¼ in addition to using aseptic technique, in serious cases (eg cramping pain) with daily dose may increase to 2 tubes, divided into 2 times a few hours apart (each injection in a butt).

Can be used alternately, 1 75 mg syringe in combination with another form of dosage of voltaren (tablets, bullets) to the maximum daily dose is 150 mg.

In migraine pain, clinical experience is limited to the starting dose of 75 mg as soon as possible, followed by the anal bullet pills to the dose of 100 mg of the same day, if necessary. The total dose should not exceed 75 mg on the first day.

intravenous infusion

Do not be injected directly into the veins of the Voltaren solution.

just before the intravenous infusion, dilute the Voltaren injection solution with 0.9% NaCl solution or 5% glucose, the transmission solution is cushioned with sodium bicarbonate according to the instructions in the "manual, processing and cancellation".

There are 2 alternating doses of Voltaren injection solution recommended:

Surgical pain dose for pain from medium to severe pain, 75 mg is needed for a period of 30 minutes to 2 hours. When necessary, it can repeat the above treatment after a few hours, but the dose should not exceed 150 mg.

Instructions for use, processing and cancellation

The following instructions for intramuscular injection must be followed to avoid damaging the nerve or other tissues in the injection site.

Deep intramuscular injection on the upper buttocks using aseptic technique, or by intravenously by transmitting slowly after dilution according to the following instructions. Each tube is only used once. The solution should be injected immediately after opening. The rest must be left.

Depending on the time you want to transmit, mix from 100 - 150 ml of isothermic salt solution (0.9% NaCl solution) or 5% glucose solution with drugs in 1 voltaren tube. Both solutions are cushioned with sodium bicarbonate salt for injection (0.5 ml of the 8.4% or 1 ml solution of 4.2% solution or the corresponding volume of other concentrations) removed from the newly opened bottle. Only use transparent solutions. When a crystal or precipitate is noticed, it is not allowed to use that solution to transmit.

Dosage

as recommended, the dose should be adjusted to each individual. In order to minimize the risk of adverse incidents, Voltaen is required at the lowest daily doses in the shortest possible time as possible.

General patient group

Adults

Voltaren injection should not be used for more than 2 days; When needed, you can continue treatment with the form of tablets or Voltaren bullets.

Special patient group

Pediatric patients (under 18 years old)

Due to the content of the drug, the Voltaren solution is not suitable for children and teenagers.

Elderly patients (from 65 years of age)

Although Voltaren's pharmacokinetics are not impaired to clinical -related levels in elderly patients, it is especially cautious when taking nonsteroidal anti -inflammatory drugs in this group of patients who are often prone to adverse reactions. Especially recommended the lowest use of effective doses in older patients or mild weights and patients should be monitored with stomach bleeding - intestines when treated with NSAID.

SECRETING HEALTH (AD -FACILITY FUNCTION OF THE HEART FILL ADMINISTRATION ADMINISTRATION OF THE NEW York Heart Association - NYHA) or important cardiovascular risk factors

generally do not recommend the treatment of Voltaren in patients with congestive heart failure (degree I according to the function of the heart failure according to the New York - NYHA heart) or uncontrolled hypertension. If necessary, patients with congestive heart failure (according to the function of the heart failure according to the New York - NYHA heart failure), uncontrolled hypertension or have important cardiovascular risk factors that should only be treated with Voltaren after careful consideration and only at the dose of ≤100 mg per day if treatment for more than 4 weeks.

kidney failure

Voltaren is contraindicated in patients with severe renal failure (GFR

There is no separate research conducted on patients with impaired renal function, so it is not recommended to adjust specific dose adjustments on this patient object. Caution should be used when using Voltaren for patients with impaired renal function.

Hepatic failure

Coltaren is contraindicated in patients with severe liver failure.

There is no separate research conducted in patients with impaired liver function, so it is not recommended to adjust specific dose adjustments on this patient object. Be careful when using Voltaren for patients with mild to moderate liver function.

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?

Symptoms

There is no typical clinical disease due to the overdose of Diclofenac. Overdose can cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions. In the case of severe poisoning, acute renal failure and liver damage.

Treatment measures

Advancid poisoning management with NSAID, including Diclofenac, including basic measures to support and treat symptoms. Symptomatic support and treatment measures should be applied to complications such as hypotension, kidney failure, convulsions, gastrointestinal disorders and respiratory failure. Specific measures such as diuretic, juris or blood transfusion are probably not to help eliminate NSAIDs, including Diclofenac, because NSAID has a strong combination rate with protein-mutual and strong transformation. Activated carbon can be used after an overdose that is likely to be toxic, and to detoxify the stomach (such as causing vomiting, gastric lavage) after overdose that is likely to be life -threatening.

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. Do not use double the prescribed dose.

Side Effects

When using Voltaren 75mg/3ml, you may experience unwanted effects (ADR).

Common, ADR> 1/100

Neurology: headache, dizziness.

ears and vestibular: dizziness.

Digestive: Nausea, vomiting, diarrhea, indigestion, abdominal pain, flatulence, anorexia.

Liver: Increase transaminase.

Skin and subcutaneous tissue: rash.

Uncommon, 1/1000

Heart: myocardial infarction, heart failure, chest drum, chest pain.

Rare, 1/10,000

The immune system: hypersensitivity, anaphylactic reactions and anaphylaxis (including hypotension and shock).

Neuroscope: Sleep.

Respiratory: Hen (including shortness of breath).

Gastrointestinal: gastritis, gastrointestinal bleeding, vomiting blood, hemorrhagic diarrhea, black stool, stomach ulcers (with or without bleeding or perforation).

Hepatitis: hepatitis, jaundice, liver disorders.

Skin and subcutaneous tissue: urticaria.

general: edema

Very rare, ADR

Blood and lymphatic system: platelet decreased, leukemia, anemia (including hemolytic anemia and hydrophobic anemia), granulocytosis.

The immune system: Evana (including face edema).

Mental: loss of direction, depression, insomnia, nightmares, irritability, mental disorders.

Neurological: Perception, memory loss, convulsions, anxiety, tremor, sterile meningitis, taste disorders, stroke.

Eyes: visual disorders, blurred vision, marketing.

ears and vestibular: tinnitus, hearing loss.

vascular: hypertension, vasculitis.

Respiratory: pneumonia.

Digestive: colitis (including bleeding colitis and increases the severity of colitis or Crohn's disease), constipation, stomatitis, tongue, esophagus disorders, narrowing of the intestinal membrane due to the horizontal membrane of the intestines, pancreatitis.

Liver: Violence, liver necrosis, liver failure.

Skin and subcutaneous tissue: Water dermatitis, eczema, erythema, polymorphic erythema, Stevens-Johnson syndrome, poisoned epidermal necrosis (lyell syndrome), flaking dermatitis, hair loss, photosensitive reaction, Schonlein bleeding, itching.

Kidney - Urinary urinary: Acute renal failure, urinary blood, proteinuria, kidney syndrome, renal tubular inflammation - interstitial tissue, kidney necrosis.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

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

Contraindicated

Voltaren medicine 75mg/3ml Contraindicated in the following cases:

  • Hypersensitivity to the active ingredient, with sodium metabisulphit or with any other component of excipients. (From Grade II to ivism according to the functional degree of heart failure according to the New York Heart Association - NYHA), ischemic heart disease, peripheral artery disease, cerebrovascular disease. grant.

    Caution when using

    influence on the gastrointestinal tract

    Bleeding ulcers or gastrointestinal perforation, can lead to death, and may occur at any time during treatment, with or without warning symptoms or previous history of stomach - intestinal events seriously. These cases have more serious consequences in the elderly. If bleeding or stomach ulcers - intestines in patients are taking Voltaren, it is necessary to stop taking the drug.

    Must closely monitor medical and need special caution when prescribing Voltaren for patients with symptoms of gastrointestinal disorders or a history of suggestive ulcer, bleeding or gastric or intestinal perforation. The risk of stomach - intestinal baseball is higher when increasing the dose of NSAID and in patients with a history of ulcer, especially if there is complication of bleeding or perforation in the elderly. To reduce the risk of toxicity for the stomach - intestines in patients with a history of ulcer, especially if there are complications of hemorrhage or perforation, and in the elderly patients, the starting and maintenance treatment is effective at the lowest doses. Treatment should be considered for combinations of protective drugs (such as proton or Misoproton pump inhibitors) for these patients, and for patients who are in need of simultaneous use of acetylsalicylic acid (Asa) low -dose or other drugs that can increase the risk of the stomach - bowel.

    Patients with a history of stomach -intestinal toxicity, especially the elderly, should report any abdominal abdominal symptoms (especially stomach bleeding). Be cautious in patients who are taking simultaneously drugs that may increase the risk of ulcers or bleeding such as corticosteroids using systemic sugar, anticoagulant drugs, anti -platelets or selective Serotonin recovery inhibitors.

    Heart effect

    Treatment with NSAID drugs including Diclofenac, especially in high and long -term doses, can be associated with a small risk of increased cardiovascular thrombosis (including myocardial and stroke infarction).

    In general, it is not recommended to use Voltaren for patients with cardiovascular disease (congestive heart failure, heart anemia, peripheral artery disease) or uncontrolled hypertension. If necessary, patients with cardiovascular disease, uncontrolled hypertension or important cardiovascular risk factors (such as hypertension, hyperlipidemia, diabetes and smoking) should only be treated with Voltaren after careful consideration and at the dose of ≤ 100mg a day at continuous treatment for more than 4 weeks.

    Because Diclofenac's cardiovascular risks may increase at doses and contact time, the lowest daily dose is effective, so it is used in the shortest possible time. It is advisable to re -evaluate the need for patients in response and symptomatic treatment, especially when treated continuously for more than 4 weeks. Patients should be alert with signs and symptoms of arterial thrombosis (such as chest pain, short breath (shortness of breath), weakness, difficulty speaking) may appear beyond warning. In such cases, patients should be directed to see a doctor immediately.

    Hematological effects

    When using long -term voltaren, as well as other NSAIDs, blood recipe must be monitored.

    As with other NSAIDs, Voltaren can temporarily inhibit platelets. Need to carefully monitor patients with hemostatic disorders.

    The effect on respiratory (asthma before)

    In patients with asthma, seasonal allergic rhinitis, swelling of the nasal lining (such as nasal polyps), chronic obstructive pulmonary disease or chronic respiratory infections (especially if it is related to symptoms such as allergic rhinitis), NSAIDs reacts such as asthma attacks (called intolerance with pain relievers/analgesic medications, more often than other patients. Therefore, it is necessary to be particularly cautious with such patients (prepared for emergency media). Special attention must be paid to patients who have been allergic to other substances, such as skin reactions, itching or urticaria.

    Particularly cautious when using Voltaren injected in bronchial asthma patients because symptoms may be worse.

    Effects on bile liver system

    Strict medical monitoring requirements when prescribing Voltaren for patients with impaired liver function because their condition may worsen.

    Like other NSAIDs, including diclofenac, the value of one or more liver enzymes can increase. During prolonged treatment with Voltaren (as with the form of tablets or drugs), regular monitoring of liver function is indicated as a preventive measure. If the abnormal or worse liver function tests are taken, if there are clinical signs or symptoms associated with liver disease, or if other manifestations appear (such as eosin leukemia, rash) should stop using Voltaren. Hepatitis may occur when using diclofenac without prior symptoms. Be cautious when using Voltaren for patients with dyslyline metabolic disorders of the liver because it can cause acute porphyrin attacks.

    Skin reaction

    Serious skin reactions, some deaths, including scaled dermatitis, Stevens-Johnson syndrome and poisoned epidermal necrosis were recorded in very rare cases with NSAID use, including Voltaren. Patients with the highest risk of these reactions early in the treatment process, onset the reaction occurs in most cases in the first month of treatment. Voltaren must be stopped when the first manifestation of skin rash, mucosal damage or any other hypersensitivity signs.

    Like other NSAIDs, allergic reactions, including anaphylactic/anaphylactic reactions, can occur in rare cases with diclofenac without previous exposure to the drug.

    Effects on the kidneys

    Treatment with NSAIDs including Diclofenac often causes fluid and edema, so special attention should be paid to patients with heart or kidney damage, a history of hypertension, elderly people, patients treated simultaneously with diuretic drugs or drugs that affect kidney function, and patients with non -cellular loss patients due to any causes, for example, for example, indicating indicators (see indefinite induction). Monitoring of kidney function is an early preventive measure when using Voltaren in such cases. Stop treatment often restores the state before treatment.

    Elderly patients

    It is necessary to be cautious for the elderly who are having basic medical diseases. Especially recommend the lowest doses effectively in old patients or lightweight people.

    Interaction with NSAIDs

    Do not use the voltaren simultaneously with NSAIDs using systemic sugar including cyclooxygenase-2 inhibitors to avoid unwanted effects.

    Special excipients

    Sodium metabisulphites in the injection solution can lead to severe severe hypersensitivity reactions and bronchospasm.

    Covering the signs of infection

    Like other NSAIDs, voltaren can cover the signs and symptoms of infections due to its pharmacological properties.

    Reproduction

    The use of Voltaren can reduce fertility in women and do not recommend in women who are trying to get pregnant. In women who are difficult to conceive or those who are being checked in infertility, should consider stopping voltaren.

    The ability to drive and operate machinery

    Patients with visual disorders, dizziness, dizziness, chicken sleep or other central nervous system disorders when using Voltaren should not drive and operate machinery.

    Pregnancy

    There is no adequate data on the use of diclofenac in pregnant women. Therefore, Voltaren should not be used in the first 3 months and the middle 3 months of pregnancy unless the expected benefits for mothers are higher than the risk that may have for the fetus. Like other NSAIDs, contraindicated use of diclofenac for the last 3 months of pregnancy due to the possibility of uterine and/or early closed artery.

    The period of breastfeeding

    as well as other NSAIDs, Diclofenac goes into breast milk in small amounts. Therefore, Voltaren should not be used while breastfeeding to avoid unwanted effects for children.

    Drug interaction

    The following drug interactions include the cases that have been observed when using Voltaren and/or other forms of Diclofenac.

    Interactions should be considered

    strong inhibitors CYP2C9:

    Caution is recommended when used simultaneously diclofenac with strong CYP2C9 inhibitors (such as sulfinPyrazone and Voriconazole), this can significantly increase the peak concentration in plasma and DiClofenac exposure due to the inhibition of Diclofenac's metabolism.

    lithium:

    If used simultaneously, Diclofenac may increase the plasma concentration of lithium. Control of lithium concentration in serum is recommended.

    digoxin:

    If used simultaneously, Diclofenac can increase the plasma concentration of Digoxin. Control of Digoxin concentration in serum is recommended.

    Diuretics and anti -hypertension drugs:

    Like other NSAIDs, simultaneously using Diclofenac with diuretics or anti -hypertension drugs (for example, beta blockers, angiotensin transferring enzymes (ACE) can reduce the anti -hypertension effect of these drugs. Therefore, the combination needs to be cautious and in these patients, especially the elderly, so the patient should be tested for the patient. The kidneys after starting to use and check periodically later, especially for diuretics and ACE inhibitors because they can increase the risk of kidney toxicity.

    ciclosporin and tacrolimus:

    diclofenac, like other NSAIDs, can increase the toxicity of Ciclosporin's kidneys due to the effect on prostaglandin in the kidney. Therefore, in this case, the diclofenac dose must be used lower than the dose commonly used in patients who do not use ciclosporin or tacrolimus.

    Hemorrhage -causing medicine:

    Concentrated with diuretics holding potassium, ciclosporin, tacrolimus or trimethoprim may increase the concentration of potassium in serum, so it should be monitored regularly in serum potassium concentration.

    Quinolone antibacterial drugs:

    There have been individual reports on convulsions due to simultaneous use of Quinolone and NSAID.

    Expected interactions are considered

    Other NSAIDs and corticosteroids:

    Simultaneous use of diclofenac and other systemic nsaids or corticosteroids may increase the frequency of side effects on the stomach.

    anticoagulants and platelets:

    Be cautious because when used simultaneously can increase the risk of bleeding (see the warning and caution). Although clinical studies do not show that Diclofenac affects the activity of anticoagulants, there are sporadic reports on increased risk of bleeding in patients with simultaneous use of Diclofenac and anticoagulant drugs. Therefore, closely monitoring these patients is recommended.

    Selective Serotonin reabsorption inhibitors (SSRI):

    Simultaneous use of systemic nsaids, including dicloífenac, and SSRI may increase the risk of stomach-intestinal bleeding.

    anti -diabetic drugs:

    Clinical studies show that Diclofenac can be used with oral anti -diabetic drugs without affecting their clinical effectiveness, but there are sporadic reports on increased effects and hypoglycemia requires the dose changes of anti -diabetes when treated with Diclofenac. For this reason, the control of blood sugar levels is recommended as a preventive measure when treated simultaneously.

    phenytoin:

    When using simultaneously phenytoin with diclofenac, the control of phenytoin concentration in plasma is recommended by an increase in predictions of exposure to phenytoin.

    methotrexate:

    Be careful when NSAID, including Diclofenac prescribed less than 24 hours before or after treatment with methotrexate, due to increased blood methotrexate levels and toxicity of this substance may increase.

    • Storage

    Store in closed packaging, avoid light, in a dry place, temperature below 30 ° C.

    Avoid frozen storage.

    Other drugs

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

    The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

    count views

    Popular Keywords