Almiral (diclofenac sodium) ampoules 75 mg/3 ml. N5

Almiral (diclofenac sodium) ampoules 75 mg/3 ml. N5

$12.00

Manufacturer: Cyprus

Non-steroidal anti-inflammatory drugs. Derivatives of acetic acid and related compounds. ATX code M01A B05.

The drug, when administered, is intended for the treatment of:

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

The drug, when administered as an intravenous infusion, is intended for the treatment or prevention of postoperative pain.

Category:

Description

Ingredients

active ingredient: diclofenac;

3 ml solution (1 ampoule) contains diclofenac sodium 75 mg;

excipients: propylene glycol, benzyl alcohol, sodium formaldehyde sulfoxylates, sodium metabisulfite (E 223), sodium hydroxide, water for injection.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drugs. Derivatives of acetic acid and related compounds. ATX code M01A B05.

Pharmacodynamics

Almiral is a non-steroidal drug with pronounced analgesic / anti-inflammatory properties. It is a prostaglandin synthetase (COX) inhibitor. Diclofenac sodium in vitro at concentrations equivalent to those achieved in humans does not inhibit the biosynthesis of proteoglycans in cartilage tissue. If the drug is used simultaneously with opioids to relieve postoperative pain, Almiral significantly reduces the need for opioids.

Indications

The drug, when administered, is intended for the treatment of:

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

The drug, when administered as an intravenous infusion, is intended for the treatment or prevention of postoperative pain.

Contraindications

  • Hypersensitivity to the active substance, sodium metabisulfite or to any other components of the drug;
  • History of bleeding or perforation of the gastrointestinal tract associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
  • Active peptic ulcer/bleeding or history of recurrent peptic ulcer/bleeding (two or more separate episodes of established ulcer or bleeding)
  • III trimester of pregnancy;
  • Like other NSAIDs, 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 disease (such as Crohn’s disease or ulcerative colitis);
  • Liver failure
  • Renal failure (creatinine clearance <15 ml/min/1.73 m2)
  • Congestive heart failure (NYHA II-IV)
  • High risk of postoperative bleeding, blood clotting, hemostasis disorders, hematopoietic disorders or cerebrovascular bleeding;
  • Treatment of perioperative pain in coronary artery bypass grafting (or use of a heart-lung machine)
  • Ischemic heart disease in patients with angina pectoris, myocardial infarction
  • Cerebrovascular disease in patients who have had a stroke or have episodes of transient ischemic attacks.
  • Diseases of the peripheral arteries.
  • In this dosage form, the drug is contraindicated in children.

For intravenous use only.

  • Simultaneous use of NSAIDs or an anticoagulant (including low doses of heparin).
  • History of hemorrhagic diathesis, confirmed or suspected cerebrovascular bleeding in history.
  • Operations associated with a high risk of bleeding.
  • Bronchial asthma in history.
  • Moderate or severe renal impairment (serum creatinine > 160 µmol/l).
  • Hypovolemia or dehydration from any cause.

Dosage and administration

The drug should be used in the most effective doses for a short period of time, taking into account the goals of treatment in each individual patient.

adults

The drug Almiral, solution for injection, do not use for more than 2 days. If necessary, treatment can be continued with diclofenac tablets or suppositories.

Intramuscular injection

In order to prevent damage to nerve or other tissues at the injection site, the following rules must be observed.

The dose is usually 75 mg (1 ampoule) per day, which should be administered by deep injection into the upper external sector of the gluteus maximus muscle. In severe cases (eg, colic), the daily dose can be increased to two injections of 75 mg, between which an interval of several hours should be observed (one injection in each buttock). Alternatively, the 75 mg solution for injection may be combined with other diclofenac dosage forms (eg tablets or suppositories) up to a maximum total daily dose of 150 mg diclofenac sodium.

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

There are no data available on the use of Almiral for the treatment of migraine attacks for more than one day.

Intravenous infusions

Immediately before the start of the infusion, Almiral should be diluted in 100-500 ml of 0.9% sodium chloride solution or 5% glucose solution. Both solutions need buffering with sodium bicarbonate solution (0.5 ml of 8.4% solution or 1 ml of 4.2%). Only clear solutions can be used.

Almiral, solution for injection, should not be administered as a bolus injection.

Recommended alternative dosing regimens for Almiral, solution for injection:

  • for the treatment of moderate and severe postoperative pain, 75 mg should be administered continuously from 30 minutes to 2 hours; if necessary, treatment can be repeated after 4-6 hours, but the dose should not exceed 150 mg per day
  • for the prevention of postoperative pain 15 minutes – 1 hour after surgery, a loading dose of 25-50 mg should be administered, after which a continuous infusion of approximately 5 mg / hour should be used up to a maximum daily dose of 150 mg.

Elderly patients

Although in elderly patients the pharmacokinetics of the drug Almiral does not worsen to any clinically significant extent, NSAIDs should be used with caution in such patients, who, as a rule, are more prone to the development of adverse reactions. In particular, for debilitated elderly patients or patients with low body weight, it is recommended to use the lowest effective doses (see also the section “Peculiarities of use”); also patients should be examined for gastrointestinal bleeding when treated with NSAIDs.

The recommended maximum daily dose of Almiral is 150 mg.

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