Diclofenac solution for injections of 25 mg/ml in ampoules of 3 ml, 5 pcs — Made in Ukraine — Free Delivery

Brand: Lekhim
Product Code: Diclofenac
Availability: In Stock

$17.59

Description

Indication

When administered intramuscularly, the drug is intended for the treatment of:

inflammatory and degenerative forms of rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, vertebral pain syndrome, extra-articular rheumatism;
acute attacks of gout;
renal and hepatic colic;
pain and swelling after injuries and operations;
severe migraine attacks.

When administered in the form of intravenous infusions, the drug is intended for the treatment or prevention of postoperative pain.

Contraindication

Hypersensitivity to the active substance, sodium metabisulfite or other components of the drug is known.

History of bleeding or perforation of the gastrointestinal tract associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs).

Active peptic ulcer disease/bleeding or history of recurrent peptic ulcer disease/bleeding (two or more separate episodes of established ulceration or bleeding).

III trimester of pregnancy.

Like other non-steroidal anti-inflammatory drugs, diclofenac is also contraindicated in patients in whom the use of ibuprofen, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs provokes attacks of bronchial asthma, angioedema, urticaria or acute rhinitis.

Inflammatory bowel diseases (for example, Crohn's disease or ulcerative colitis).

Liver failure.

Renal failure (creatinine clearance 2).

Congestive heart failure (NYHA II-IV).

There is a high risk of developing postoperative bleeding, blood clotting disorders, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding.

Treatment of perioperative pain during aorto-coronary bypass surgery (or the use of an artificial blood circulation device).

Ischemic heart disease in patients with angina pectoris and myocardial infarction.

Cerebrovascular diseases in patients who have suffered a stroke or have episodes of transient ischemic attacks.

Diseases of peripheral arteries.

In this dosage form, the drug is contraindicated for children.

For intravenous use only.

Simultaneous use of NSAIDs or anticoagulant (including low-dose heparin).

History of hemorrhagic diathesis, confirmed or suspected history of cerebrovascular bleeding.

Operations associated with a high risk of bleeding.

History of bronchial asthma.

Moderate or severe impairment of kidney function (serum creatinine 160 μmol/l).

Hypovolemia or dehydration from any cause.

Composition

Active substance: diclofenac sodium;

1 ml of solution contains diclofenac sodium 25 mg;

excipients: mannitol (E 421), sodium metabisulfite (E 223), benzyl alcohol, propylene glycol, sodium hydroxide, water for injections.

The ability to influence the speed of reaction when driving vehicles or other mechanisms

Patients who experience visual disturbances, dizziness, vertigo, drowsiness or other central nervous system disturbances during treatment with diclofenac sodium should refrain from driving vehicles and working with other mechanisms.

Method of application and dosage

The drug should be used in the smallest effective doses for the shortest period of time, taking into account the task of treatment in each individual patient.

Adults

Diclofenac sodium, solution for injection, should not be used for more than two days. If necessary, the treatment can be continued with Diclofenac sodium tablets or suppositories.

Intramuscular injection.

In order to prevent damage to nerves or other tissues at the site of intramuscular injection, the following rules should be followed. Such damage can lead to muscle weakness, muscle paralysis and paresthesia.

The dose is usually 75 mg (1 ampoule), the content of which is administered by deep injection into the upper outer sector of the gluteus maximus muscle using aseptic technique. In severe cases (for example, colic), the daily dose can be increased to two injections of 75 mg, between which an interval of several hours is observed (one injection in each buttock). As an alternative, 75 mg of the solution for injection can be combined with other medicinal forms of the drug Diclofenac sodium (for example, tablets, suppositories) up to a total maximum daily dose of 150 mg of diclofenac sodium.

In the conditions of a migraine attack, clinical experience is limited to cases with the initial use of 1 ampoule of 75 mg, the dose should be administered as soon as possible after using suppositories of 100 mg on the same day (if necessary). The total daily dose should not exceed 175 mg on the first day.

No data are available on the use of diclofenac sodium for the treatment of migraine attacks for more than one day.

Intravenous infusions.

Diclofenac sodium should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution immediately before the infusion. Both solutions must be buffered with sodium bicarbonate solution (0.5 ml of 8.4% solution or 1 ml of 4.2%). Only clear solutions can be used.

Diclofenac sodium, solution for injection, should not be administered as an intravenous bolus injection.

Recommended alternative dosing regimens of the drug Diclofenac sodium, solution for injection:

for the treatment of moderate and severe postoperative pain, 75 mg must be administered continuously from 30 minutes to 2 hours; if necessary, the treatment can be repeated after 4-6 hours, but the dose should not exceed 150 mg per day;

for the prevention of postoperative pain, a loading dose of 25-50 mg should be administered 15 minutes - 1 hour after surgery, after which a continuous infusion of approximately 5 mg / h should be used up to a maximum daily dose of 150 mg.

Elderly patients (from 65 years old).

Although the pharmacokinetics of diclofenac sodium are not impaired to any clinically significant degree in elderly patients, nonsteroidal anti-inflammatory drugs should be used with particular caution in such patients, who are generally more prone to adverse reactions. In particular, for debilitated elderly patients or patients with a low body weight, it is recommended to use the lowest effective doses (see also the section "Peculiarities of use"); patients should also be examined for the presence of gastrointestinal bleeding during treatment with NSAIDs.

The recommended maximum daily dose of Diclofenac sodium is 150 mg.

Children

Children (up to 18 years old). diclofenac sodium in medicinal form, solution for injection is contraindicated for use in children.

Overdose

Symptoms there is no typical clinical picture of the consequences of diclofenac overdose. overdose may cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, diarrhea, dizziness, disorientation, agitation, coma, drowsiness, ringing in the ears, loss of consciousness, or convulsions. in the case of severe poisoning, acute kidney failure and liver damage are possible.

Treatment. Within 1 hour after administration of a potentially toxic amount of the drug orally, the possibility of using activated charcoal should be considered. In addition, in adults, gastric lavage should be considered for 1 hour after administration of a potentially toxic amount of the drug. Diazepam should be administered intravenously in case of frequent or prolonged convulsions. Taking into account the clinical condition of the patient, other measures may be indicated. Treatment is symptomatic.

Adverse reactions

The following side effects include those associated with the administration of the drug Diclofenac sodium in conditions of short-term and long-term use.

From the blood and lymphatic system: very rarely - thrombocytopenia, leukopenia, anemia (including hemolytic and aplastic anemia), agranulocytosis.

From the side of the immune system: rarely - hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension); very rarely - angioedema (including facial edema).

Mental disorders: very rarely - disorientation, depression, insomnia, nightmares, irritability, and other mental disorders.

From the side of the nervous system: often - headache, dizziness; rarely - drowsiness, fatigue; very rarely - paresthesia, memory impairment, convulsions, anxiety, tremor, aseptic meningitis, taste disorder, stroke, frequency unknown - confusion, hallucinations, sensitivity disorders, general malaise.

On the part of the organs of vision: very rarely - visual impairment, blurred vision, diplopia; frequency unknown - optic neuritis.

On the part of the organs of hearing and the labyrinth: often - vertigo; very rarely - tinnitus, hearing impairment.

From the side of the heart: very rarely - palpitations, chest pain, heart failure, myocardial infarction.

From the side of the vascular system: very rarely - arterial hypertension, arterial hypotension, vasculitis.

Respiratory, thoracic and mediastinal disorders: rarely - asthma (including dyspnea), bronchospasm; very rarely - pneumonitis.

From the digestive system: often - nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, anorexia; rarely - gastritis, gastrointestinal bleeding, vomiting with blood impurities, hemorrhagic diarrhea, melena, stomach or intestinal ulcer with bleeding, gastrointestinal stenosis with perforation (sometimes with a fatal outcome, especially in elderly patients); very rarely - colitis (including hemorrhagic colitis, ischemic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, disorders of the esophagus, intestinal membrane strictures, pancreatitis.

Hepatobiliary disorders: often - an increase in the level of transaminases, rarely - hepatitis, jaundice, liver function disorders; very rarely - instantaneous hepatitis, hepatonecrosis, liver failure.

From the side of the skin and subcutaneous tissues: often - a rash; rarely - urticaria; very rarely - bullous rashes, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, allergic purpura, itching.

From the side of the kidneys and urinary tract: very rarely - acute kidney damage (acute renal failure), hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

General disorders and disorders at the injection site: often - a reaction at the injection site, pain, tightness; rarely - edema, necrosis at the injection site, very rarely - abscess at the injection site.

From the reproductive system and mammary glands: very rarely - impotence.

Data from clinical studies and epidemiological data indicate an increased risk of thrombotic complications (for example, myocardial infarction or stroke) associated with the use of diclofenac, in particular at high therapeutic doses (150 mg per day) and with long-term use.

Visual disturbances.

Visual disturbances such as blurred vision, visual impairment, and diplopia are side effects of the NSAID class and are usually reversible after discontinuation of the drug. The most likely mechanism of visual disturbances is suppression of the synthesis of prostaglandins and other related compounds, which, by disrupting the regulation of retinal blood flow, contribute to the development of visual disturbances. If such symptoms occur during treatment with diclofenac, an ophthalmological examination should be performed to rule out other possible causes.

Storage conditions

Store in the original packaging at a temperature not higher than 25°C.

Keep out of the reach of children.

Packaging

For 3 ml in ampoules. 5 ampoules in a pack with partitions or 5 ampoules in a one-sided blister, 1 blister in a pack; or 100 ampoules in a box with partitions.

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