Diclofenac sodium 1% 30 g ointment in tube
INSTRUCTIONS for the use of the drug for specialists Diclofenac sodium (Diclofenac natrium) Trade name Diclofenac sodium Diclofenac natrium International nonproprietary name Diclofenac Dosage form Ointment 1% Composition 100 g of ointment contain the active substance - diclofenac sodium - 1 g, excipients: dimexide, polyethylene oxide-1500, polyethylene oxide-400, propylene glycol. Description White or almost white ointment, with a slight specific odor. Pharmacological group Preparations for external use for pain syndrome in diseases of the musculoskeletal system. Non-steroidal anti-inflammatory drugs for external use. ATC code M02AA15 Pharmacological properties Pharmacokinetics After application to the skin, it is absorbed and determined in the subcutaneous tissues within 5 minutes. The amount of diclofenac that is absorbed through the skin is proportional to the time of contact of the ointment with the skin and the area of application, depending on the total dose of the ointment and the degree of skin hydration. The analgesic effect occurs 30-60 minutes after application of the ointment and persists for 2.5-5 hours. The maximum effect is observed 1-2 hours after application. Excreted by the kidneys. In patients with polyarthritis who receive local therapy (in the area of the inflamed joint), the concentration in the synovial fluid is higher than the concentration in plasma. Pharmacodynamics The ointment has a pronounced anti-inflammatory and analgesic effect. By inhibiting the synthesis of prostaglandins, the drug reduces pain caused by inflammation, swelling and tissue hyperemia. When applied topically, it causes a weakening or disappearance of pain at the site of application of the ointment, including pain in the joints at rest and during movement, reduces morning stiffness and swelling of the joints. Indications for use - inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, ankylosing spondylitis and others) - degenerative diseases of the musculoskeletal system (osteoarthrosis, osteochondrosis) - post-traumatic inflammation of tendons, ligaments, muscles and joints (sprains, sports injuries, overload, bruises ) - inflammatory diseases of extra-articular tissues (tenosynovitis, bursitis, periarthritis) - myositis Method of administration and dosage: Apply a thin layer of ointment 2-4 g to the skin over the site of inflammation and lightly rub in 2-3 times a day. The maximum daily dose is 8 g. The duration of treatment should not exceed 14 days without consulting a doctor. Side effects - skin rash, burning, redness of the skin at the site of application - loss of appetite, nausea, flatulence, pain in the epigastric region - headache, dizziness, drowsiness - bronchospasm, systemic anaphylactic reactions, including shock - photosensitivity Contraindications - hypersensitivity to the components of the drug ( including other non-steroidal anti-inflammatory drugs) - bronchial asthma, urticaria or rhinitis, provoked by the use of acetylsalicylic acid (salicylates) - peptic ulcer of the stomach and duodenum - pregnancy and lactation - children under 6 years of age - violation of the integrity of the skin Drugs interactions Due to low systemic absorption, the ointment does not interact with other drugs and does not change the effect of drugs affecting the central nervous system, anticoagulants and antiplatelet agents. When used simultaneously with nonsteroidal anti-inflammatory drugs for systemic use, it enhances their effect without significantly increasing toxicity. Menthol, capsaicin preparations, essential oils, when applied simultaneously with ointment, enhance its analgesic effect. Special instructions The ointment is intended for external use only. It is recommended to apply the drug only to undamaged skin, avoiding contact of the ointment with damaged areas and open wounds. The drug should not come into contact with mucous membranes (mouth, eyes, etc.). The duration of treatment should not exceed 14 days without consulting a doctor. In case of severe impairment of liver and kidney function, chronic heart failure and old age, the use of the drug is indicated only after consulting a doctor. The use of the drug may provoke an exacerbation of hepatic porphyria, so its use in this group of patients should be carried out with caution. After application, do not apply an occlusive dressing. When applied to large surface areas of the skin for a long time, the risk of developing systemic side effects increases. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms The drug does not affect the control of a vehicle or potentially dangerous mechanisms. Overdose An overdose of diclofenac when used in ointment form is unlikely, which is due to its low systemic absorption. The likelihood of an overdose increases with accidental or intentional use of the ointment orally. Symptoms: dizziness, headache, hyperventilation, clouding of consciousness, myoclonic convulsions, nausea, vomiting, abdominal pain, bleeding, liver and kidney dysfunction. Treatment: gastric lavage, administration of activated carbon, symptomatic therapy aimed at eliminating increased blood pressure, impaired renal function, convulsions, irritation of the gastrointestinal tract, respiratory depression. Forced diuresis and hemodialysis are ineffective. Release form Ointment 30 g in aluminum tubes. 1 tube in a cardboard box with instructions for use. Storage conditions Store in a place protected from light, at a temperature not exceeding +25 ºС. Keep out of the reach of children! Shelf life: 2 years Do not use after the expiration date indicated on the package. Conditions for dispensing from pharmacies Without a prescription, Republic of Belarus, Minsk region, Borisov, st. Chapaeva, 64/27, tel/fax 732425.
Diclofenac sodium ointment for external use. approx. 10 mg/g 30 g tube No. 1
Trade name: Diclofenac sodium. International nonproprietary name: Diclofenac/Diclofenac. Dosage form: ointment for external use 10 mg/g. Composition: one tube (30 g of ointment) contains the active ingredient - diclofenac sodium 0.3 g, excipients: dimethyl sulfoxide, propylene glycol, macrogol 1500, macrogol 400.
Description: ointment of white or almost white color, with a weak specific odor.
Pharmacotherapeutic group: Nonsteroidal anti-inflammatory and antirheumatic drugs. Derivatives of acetic acid and related compounds.
Indications for use Traumatically caused inflammation of tendons, ligaments, muscles and joints (due to sprains, stress and bruises). Localized forms of soft tissue rheumatism, such as shoulder-hand syndrome, tendovaginitis, bursitis, periarthropathy. Localized rheumatic diseases, for example, arthrosis of the joints.
Contraindications Hypersensitivity to Diclofenac sodium or other components of the drug, acetylsalicylic acid or other NSAIDs, aspirin asthma, pregnancy (III trimester), lactation period, children (up to 12 years), violation of the integrity of the skin.
With caution Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe dysfunction of the liver and kidneys, chronic heart failure, bronchial asthma, old age, pregnancy I and II trimester.
Method of administration and dosage Externally, 2 - 4 g of ointment (which is comparable in volume to the size of a cherry or walnut and is sufficient to treat a body surface area of 400-800 cm2) is applied in a thin layer, lightly rubbing into the skin over the inflammation, 2-3 once a day. After applying the ointment, hands must be washed if they are not the area of treatment (for arthrosis of the fingers). The maximum daily dose is 8 g. The duration of treatment depends on the indications and the observed effect (to enhance the effect, the ointment can be used together with other dosage forms of diclofenac). It is necessary to consult a doctor after 2 weeks of using the drug.
Side effects On the skin: eczema, photosensitivity, contact dermatitis (itching, hyperemia, swelling of the treated skin area, papular vesicular rashes, peeling). Allergic reactions: (itching and burning of the skin, erythematous skin rash, urticaria, angioedema, systemic anaphylactic reactions (including shock).
Special instructions: Apply only to intact areas of the skin; after application, do not apply an occlusive dressing. With long-term use and/or application to large areas of the skin, the risk of developing systemic side effects increases, incl. Increased activity of liver enzymes may be observed. To minimize the possible risk of adverse reactions from the liver, Diclofenac sodium should be used in the minimum effective dose for the shortest possible period. Avoid contact of the ointment with the eyes, mucous membranes or open wounds.
Use during pregnancy There are no controlled clinical studies in pregnant women, therefore Diclofenac sodium should not be used during pregnancy. Use is especially dangerous in the third trimester of pregnancy due to the possible premature closure of the ductus botallus and the likelihood of suppression of labor contractions. Use during breastfeeding There is no data on the penetration of Diclofenac sodium, applied topically, into breast milk. Therefore, the drug should not be used in nursing women. If there are compelling reasons for prescribing, the drug should not be applied to the chest area; it should not be used to treat large areas of the surface or use it for a long time.
Overdose Due to low systemic absorption when applying the ointment, overdose is unlikely.
Interaction with other drugs May enhance the effect of drugs that cause photosensitivity. Use with caution with other drugs known to have hepatoxicity, for example, antibiotics, antiepileptic drugs. Clinically significant interactions with other drugs are unlikely due to negligible systemic absorption.
Packaging: 30 g in tubes in package No. 1. Storage conditions: at a temperature not exceeding 25C. Keep out of the reach of children. Shelf life: 2 years. Do not use after expiration date. Conditions for dispensing from pharmacies: without a prescription.
Diclofenac is no less dangerous for heart patients than Vioxx
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The well-known painkiller diclofenac increases the risk of heart attacks in the same way as the drug Vioxx, banned in 2004, Australian researchers believe. In their opinion, diclofenac cannot be recommended for patients suffering from cardiovascular diseases.
The study, conducted by researchers at the University of Newcastle in Australia, used the results of 23 previously published studies, taking into account data on more than 1.2 million patients taking analgesics from the group of non-steroidal anti-inflammatory drugs.
Heart pain is one of the most common reasons people seek emergency care.
In patients predisposed to cardiovascular diseases, scientists recorded a 40% increase in the likelihood of heart attacks with long-term use of the drug diclofenac. This widely used pain reliever, also known under the trade names Cataflam and Voltaren, is available without a prescription in most countries, including Russia.
The increased risk with long-term use of diclofenac is roughly equivalent to the risk associated with Vioxx, which was withdrawn from global markets by its manufacturer Merck in 2004, the researchers noted.
The risk of cardiovascular disease will increase by 33% when using Vioxx in doses of 25 mg per day, with higher dosages of the drug increasing the risk of the widow.
In this regard, people taking diclofenac may need to be advised to switch to a safer drug, scientists say.
However, according to research project coordinator Professor David Henry, patients should not stop taking medications without consulting their doctor. "There's no point in panicking as nothing will likely happen to you in the coming days and weeks, but in the long term it might be a good idea to switch to a different drug that doesn't increase your risk of heart disease," Henry added.
In general, in a study conducted by Australian scientists, the properties of 9 analgesics from the group of non-steroidal anti-inflammatory drugs were examined. The two drugs studied in this group - Celebrex and Vioxx - belong to the newest subgroup of selective cyclooxygenase-2 inhibitors, and, unlike their predecessors, do not cause ulcers and bleeding in the stomach.
These drugs were very popular and brought huge profits to manufacturing companies until 2004, when the Vioxx scandal broke. To date, former Vioxx users have filed thousands of personal injury claims against Merck, totaling several billion dollars.
According to Australian researchers, the closest analogue of Vioxx Celebrex is safer for heart patients in recommended doses (up to 200 mg per day). At the same time, scientists do not rule out that with increased dosages of Celebrex (up to 400 mg per day), the risk of cardiovascular diseases may still increase.
A slight increase in the likelihood of exacerbation of cardiovascular diseases was also recorded with long-term use of non-steroidal anti-inflammatory drugs such as ibuprofen, piroxicam, meloxicam and indomethacin. However, the findings were either statistically insignificant or based on a small number of studies, the scientists said.
According to the results of the study, naproxen can be considered the safest non-steroidal anti-inflammatory drug for heart patients: according to the collected data, taking this medication is not associated with an increased risk of cardiovascular diseases, scientists say.
The study report was published in the Journal of the American Medical Association.
Commenting on the researchers' findings regarding diclofenac, the US Food and Drug Administration (FDA) said that while the findings were consistent with some previous studies, they were not yet conclusive. In the United States, diclofenac is available only with a doctor's prescription.
