Dolfenal United medicine relieves dysmenorrhea, toothache, pain due to trauma (25 blisters x 4 tablets)

Dosage form Film bag tablets
Specifications Box of 25 blisters x 4 tablets
Ingredient Mefenamic Acid

Ingredient

Composition information	Content
Mefenamic Acid	500mg

Uses

Indications

Dolfenal drug indicated for treatment in the following cases:

reduce symptoms of rheumatoid arthritis, osteoarthritis and analgesic including muscle aches, trauma pain, toothache, headache, postoperic and postpartum pain. Learning

dolfenal (Mefenamic acid), derivatives of Anthanilic Acid, is a nonsteroidal anti -inflammatory agent. This substance is similar to sodium meclofenamate in terms of structure and pharmacology.

Dolfenal (Mefenamic Acid) has a cooling effect, analgesic, anti -inflammatory, mainly due to inhibition of prostaglandin synthesis. Like other nonsteroidal anti -inflammatory drugs, Dolfenal (Mefenamic Acid) inhibits the synthesis of prostaglandin in the body tissue by inhibiting cyclooxygenase enzyme, an enzyme that catalyzes the formation of prostaglandin (endoperoxid) from arachidonic acid. Different from other nonsteroidal anti -inflammatory agents, the fenamate group includes dolfenal (Mefenamic acid) competing with prostaglandin to connect with the receptors of prostaglandin, so strongly tame the prostaglandin has been formed.

Anti -inflammatory effect

Anti -inflammatory effects of dotfenal (Mefenamic acid) are obtained due to inhibition of prostaglandin synthesis and release during inflammation.

Analgesic effect

Dolfenal analgesic effect (Mefenamic acid) may be due to the central and peripheral mechanism. Prostaglandin probably senses receptors that receive pain from mechanical stimuli or other chemical mediators (such as Bradykinin, histamine). Dolfenal analgesic effect (Mefenamic acid) is given by inhibiting prostaglandin synthesis as well as preventing the effects of prostaglandin. In addition, the anti -inflammatory effect of dolfenal (Mefenamic acid) also contributes to the pain relief effect of the drug.

Effect of reducing fever

dolfenal (Mefenamic acid) lower the body's body's fever. The antipyretic effect is obtained due to inhibition of prostaglandin synthesis in the central nervous system (possibly hypothalamus).

pharmacokinetic pharmacokinetics

absorption and distribution

Mefenamic acid is absorbed through the gastrointestinal tract. The peak concentration of 10 mg/l is achieved after 2 hours when using a dose of 1g in adults.

Metabolism

Mefenamic acid is metabolized mainly by cytochrom P450 CYP2C9 enzyme in the liver, first is 3-hydroxymethyl derivative (I metabolic I) and then 3 carboxyl derivatives (II metabolites). Both metabolites have undergone secondary conjugate to form glucuronide.

Therefore, in patients who already know or suspect is poor metabolism because CYP2C9 is based on the previous history/result with other CYP2C9 substrates, caution should be cautious about using Mefenamic acid because plasma concentration may be abnormal due to reduction of metabolic clearance.

Elimination

52% of the dose is found in urine, 6% in the form of Mefenamic acid, 25% in the form of metabolites I and 21% in the form of metabolites II. Fertilizer test for 3 days, about 10-20% of the dosage excreted in feces mainly in the form of an inexperienced II metabolic.

Mefenamic acid concentration in plasma is decreasing with a half -hour selling time.

Before taking Dolfenal United medicine relieves dysmenorrhea, toothache, pain due to trauma (25 blisters x 4 tablets)

How to use

oral tablets. Should be taken during or after meals, drink according to the guidance of the doctor.

Dosage

Adults

For children over 12 years old and adults: Dolfenal 500 mg orally 1 capsule/time x 3 times/day.

In case of menstrual period, taking the drug on the first day of menstruation and continuing to use as directed by the doctor.

In case of dysmenorrhea, taking the drug when it starts dysmenorrhea and continues to use as directed by the doctor.

Elderly (over 65 years old)

Dosage as adults.

The elderly increases the risk of serious side effects. If it is necessary to use NSAID, the lowest dose should be used as effective and in the shortest possible time. Patients need to be monitored regularly on gastrointestinal bleeding during NSAID treatment.

Use Dolfenal cautiously in elderly patients who are dehydrated and kidney disease. Non -urinary and ultra -dotted kidney failure - rectal has been reported mainly in elderly patients who continue to use Mefenamic acid despite being diarrhea.

Children

Do not recommend taking drugs for children under 12 years old.

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 using overdose?

Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rare diarrhea, disorientation, irritation, coma, drowsiness, tinnitus, fainting, sometimes convulsions. In case of significant poisoning, may cause acute renal failure and liver damage.

Handling

Patients should be treated with symptoms when needed.

Consider using activated carbon within an hour after taking the dose causing poisoning. In addition, in adults, gastric lavage within an hour after overdose is likely to be life -threatening.

Monitoring the patient's urine and closely monitoring the kidney and liver function.

Need to monitor patients at least four hours after overdose.

Constitutional or prolonged convulsions should be treated with intravenous diazepam.

Other measures may be indicated depending on the patient's clinical condition.

Less valuable hemolytic hemolyticity is because of Mefenamic acid and its metabolites closely associated with plasma proteins.

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

Common side effects of Mefenamic acid related to the digestive tract.

Diarrhea sometimes occurs after using Mefenamic acid. This side effect can occur right at the beginning of treatment, which can also occur after a few months of continuous use. Diarrhea has been recorded in some patients and continues to take this medication despite prolonged diarrhea. These patients were found to have an accompanying - rectal inflammation. If diarrhea lasts for a long time, the drug should be stopped immediately and does not use the drug again.

Unknown side effects:

Blood and lymphatic disorders:

Hemolytic anemia (self -recovery when stopping drugs), anemia, hematocrit, hematocrit, thrombocytopenic hemorrhage, temporary leukopenia with the risk of infection, blood infections and intravascular blood coagulation spread. Seed leukemia, anemia anemia, eosinophilia loves EOSIN, neutral leukocytes, reducing all bloody, platelets.

immune system disorders:

Hypersensitivity reaction has been reported after nsaid treatment. May include Non -specific allergic reactions and anaphylactic shock, respiratory reactions such as asthma, worse asthma, bronchospasm, or shortness of breath, skin disorders including diverse rash, itching, urticaria, hemorrhage, angioed and rarely flaky or water glossy skin (including epidermal necrosis and diverse roses).

Disorders of metabolism and nutrition:

Intentional glucose in patients with diabetes, hypoglycet.

Mental disorders:

Confusion, depression, hallucinations, restlessness.

Nervous system disorders:

Mental inflammation, headache, severe, dizziness, drowsiness, sterile meningitis (especially in patients with autoimmune diseases such as systemic lupus erythematosus, mixed connective tissue) with symptoms such as stiff neck, headache, nausea, vomiting, fever, or disorientation. Blurred vision, convulsions, insomnia.

eye disorders: eye irritation, color blindness can recover, visual disorders.

Disorders of ear and inner ears: Ear pain, tinnitus, dizziness.

Heart/blood vessel disorders: edema, hypertension and heart failure, brushing chest drum, lowering blood pressure. Clinical trials and epidemiological data show that some NSAIDs (especially in high doses and prolonged treatment) may be associated with increased cardiovascular risk (such as myocardial infarction or stroke). The risk of cardiovascular thrombosis (see more caution).

respiratory disorders, chest and mediastinum: asthma, shortness of breath.

Gastrointestinal disorders:

Most of the most common side effects are in the digestive tract. Stomach ulcers, perforation or gastrointestinal bleeding, sometimes fatal, especially can occur in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, black stools, vomiting blood, mouth ulcers, worse colitis and Crohn's disease has been reported after taking the drug. The less common frequency is gastritis.

Elderly or depression patients are likely to withstand gastric ulcer or gastrointestinal bleeding worse than other groups of objects and most spontaneous reports on deaths due to the impact of the drug on the gastrointestinal tract are in this group of objects. Anorexia, colitis, bowelitis, stomach ulcers with or without hemorrhage, pancreatitis, stool.

Liver - bile disorders: Increase on the limit of one or more tests of liver function, jaundice. Mild liver poisoning, hepatitis, liver syndrome.

Skin and subcutaneous disorders: angioedema, laryngeal edema, diverse roses, face edema, water ball reaction include Lyell syndrome (poisoned epidermal necrosis) and Stevens - Johnson syndrome, sweat, rash, light sensitive reaction, itching and urticaria.

Kidney and urinary disorders: allergic glomerulonephritis, acute interstitial nephritis, difficulty urination, blood urination, nephrotic syndrome, nephrotic failure (especially in dehydration), proteinuria, kidney failure including kidney necrosis.

Systemic disorders: fatigue, discomfort, multi -organ failure, fever.

Testing: The positive reaction in the tests of molasses in urine in patients using Mefenamic acid has been shown to be due to the presence of drugs and its metabolites, not due to the presence of bile.

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

Contraindicated

Contraindications Dolfenal in the following cases:

Hypersensitivity to mefenamic acid or any ingredients of the drug. Aspirin, ibuprofen or other nonsteroidal anti -inflammatory drugs, must not simultaneously use Mefenamic acid with these drugs for patients with previous hypersensitivity reactions (e.g. asthma, bronchial spasm, rhinitis, angioedema or jute).

The last three months of pregnancy.

Caution when using

Unwanted effects can be minimized by using the lowest doses that are most effective in the shortest time needed to control symptoms.

Patients with long -term treatment should be monitored regularly, paying special attention to liver dysfunction, skin rash, hematuria or diarrhea. Any symptoms such as appearing should stop treatment immediately.

Simultaneous use NSAID with specific inhibitors Cycloxygenase 2.

For extension of any painkillers in the treatment of headaches can make this condition worse.

If there is a occurrence or suspicion, need medical advice and should stop treatment.

Caution should be cautious in patients with dehydration and kidney disease, especially the elderly.

Elderly: Elderly people increase the frequency of adverse reactions due to NSAID especially bleeding and puncture of the gastrointestinal tract can be fatal.

Respiratory disorders: Caution should be cautious in patients who are infected or have a history of asthma.

Heart failure, kidney failure and liver failure: The use of NSAIDs can cause decreased dose of prostaglandin and cause kidney failure. Patients with the highest risk are those who have impaired renal function, heart failure, liver dysfunction, diuretic users and the elderly. Need to monitor kidney function in these patients.

Cardiovascular disease and cerebrovascular disease: It is necessary to monitor and advise appropriately for patients with a history of hypertension and/or congestion from mild to moderate congestion due to fluid fluid and edema that have been reported due to NSAID use.

Risk of cardiovascular thrombosis:

Non -steroid anti -inflammatory drugs (NSAIDs), not aspirin, use systemic sugar, can increase the risk of cardiovascular thrombosis, including myocardial infarction and stroke, which can lead to death. This risk can appear early in the first few weeks of taking the drug and can increase over time. The risk of cardiovascular thrombosis is recorded mainly at high doses. Patients should be warned of the symptoms of serious cardiovascular events and need to visit the doctor as soon as they appear. Mefenamic acid should be treated after careful consideration. It is necessary to consider before starting long -term treatment for patients with risk factors for cardiovascular disease (such as hypertension, hyperlipidemia, diabetes, smoking). At any time in treatment, there are or no warning symptoms or a serious digestive events. Smoking and drinking alcohol are risk factors. Combined therapy with protective drugs (such as Misoprostol or Proton pump inhibitors) should be considered for patients at risk of gastrointestinal bleeding such as elderly people and patients who need low -dose aspirin, or other drugs that can increase risks on the digestive tract. Be careful in patients who are taking simultaneous medications that may increase the risk of poisoning or gastrointestinal bleeding such as corticosteroids, anticoagulant drugs such as warfarin, selective Serotonin reabsorption inhibitors or platelet anti -platelets such as aspirin. (SLE) and mixed connective tissue, can increase the risk of aseptic meningitis. Discontinue mefenamic acid when a skin rash appears, mucosal damage or any other hypersensitivity signs. In women who are difficult to conceive or are treating infertility, it is advisable to consider stopping mefenamic acid. CYP2C9 is different, caution should be used to use Mefenamic acid because plasma concentrations may be abnormal due to reduced metabolic clearance.

The ability to drive and operate machinery

Unwanted effects such as dizziness, drowsiness, fatigue and visual disorders may have sometimes take steroid anti -inflammatory drugs. If affected, patients should not drive or operate machinery.

Pregnancy

There is a congenital deformity report when using NSAID in humans; However, it occurs at low frequency and
does not occur with any clear individual. The known NSAID side effects on the fetal cardiovascular system (the risk of early ductus arteriosclerotic), contraindicated to use the drug in the last three months of pregnancy. Labor may be slow and prolonged with the trend of increasing bleeding in both mother and child.

Do not use NSAIDs in the first 6 months of pregnancy or labor unless the benefits are greater than the potential risk to the fetus.

Breastfeeding period

Small amount of Mefenamic acid can appear in breast milk and through breastfeeding. Therefore, mefenamic acid should not be used in nursing women.

Medicinal interaction

Simultaneous treatment with other plasma proteins mound drugs may need to adjust the dosage.

anticoagulants:

NSAID can increase the effects of anticoagulants, like warfarin. Concomitance mefenamic acid with oral anticoagulants need to monitor prothrombin time.

Use NSAID in combination with warfarin or heparin is considered unsafe unless under direct medical monitoring.

lithium:

Reduce lithium clearance through the kidneys and increase lithium concentration in plasma. Patients need
to carefully monitor the signs of lithium poisoning.

The following drug interactions have been reported to NSAID:

Other painkillers include selective inhibitors of COX - 2: Avoid using simultaneously two or more NSAIDs (including aspirin) because of increased risk of side effects.

Antidepressant drugs: Selective Serotonin Rehabilitation Inhibitors (SSRIs), increasing the risk of gastrointestinal bleeding.

Treatment of hypertension and diuretic: Reduce the effect of lowering blood pressure and diuretic. Diuretics can increase the toxicity on the kidneys of NSAID.

Angiotensin - II transferring enzyme inhibitors and receptor anti -receptor drugs: reduce the effect of lowering blood pressure and increase the risk of special kidney failure in elderly patients. Patients need to be sufficient water and kidney function assessment from the beginning and during simultaneous treatment.

Aminoglycosides: Reduce kidney function in sensitive people, reduce aminoglycoside and increase plasma concentrations.

Anti -plateletic drugs: Increased risk of ulcerative or gastrointestinal bleeding.

Acetylsalicylic acid: Experimental data shows that Mefenamic acid affects the anti -platelet aggregation effect of low -dose Aspirin when used simultaneously, and therefore can affect Aspirin's disease prevention treatment. However, limited and uncertain data on peripheral data with clinical situations, shows that it is impossible to make a certain conclusion about the use of regular Mefenamic acid.

Heart support glycosides: NSAIDs can worsen heart failure, reduce glomerular filtration and increase glycoside concentration in plasma.

ciclosporin: may increase the risk of kidney toxicity of ciclosporin.

corticosteroid: Increased risk of ulcerative or gastrointestinal bleeding.

Oral hypoglycemic drugs: Inhibit the metabolism of Sulfonylurea drugs, prolong the half -life and increase the risk of hypoglycemia.

methotrexate: may reduce the elimination of drugs, leading to increased plasma concentrations.

Mifepristone: Do not use NSAID for 8-12 days after using Mifepristone, NSAID can reduce the effect of Mifepristone.

Probenecid: Reduce metabolism and eliminate NSAID and metabolites.

Antibiotics Quinolone: Animal data shows that NSAID may increase the risk of convulsions related to Quinolone antibiotics.

tacrolimus: The risk of kidney poisoning may be increased when using NSAIDs with tacrolimus.

Ziovudine: Increased risk of hematology when using NSAID with zidovudine.

Storage

Store at temperatures not exceeding 30 ° C.

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