Dialrapid

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Dialrapid: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Use in the elderly
14. Drug interactions
15. Analogs
16. Terms and conditions of storage
17. Terms of dispensing from pharmacies
18. Reviews
19. Price in pharmacies

Latin name: Dialrapid

ATX code: M01AB05

Active ingredient: diclofenac potassium (Diclofenac potassium)

Manufacturer: Mipharm S.p. A (Mipharm, SpA) (Italy)

Description and photo update: 2020-09-07

Prices in pharmacies: from 399 rubles.

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Powder for preparation of dialrapid oral solution

Dialrapid is a non-steroidal anti-inflammatory drug (NSAID).

Release form and composition

The drug is produced in the form of a powder for the preparation of a solution for oral administration, a uniform consistency, with a specific odor, from white to light yellow (900 mg each in hermetically sealed sachets, in a cardboard box, instructions for using Dialrapid and 3, 6, 9, 12, 21, 24 or 30 sachets). The solution reconstituted from the powder is a transparent slightly opalescent liquid with a specific mint smell.

The composition of the preparation for 1 sachet:

active substance: diclofenac potassium - 50 mg;
auxiliary components: aspartame, potassium bicarbonate, mannitol, sodium saccharinate, glyceryl dibehenate, mint and anise flavors.

Pharmacological properties

Pharmacodynamics

The active ingredient of Dialrapid is diclofenac potassium - a non-steroidal drug with anti-inflammatory, analgesic and antipyretic effects.

The main mechanism of action of the drug, confirmed by research, is its ability to inhibit the synthesis of prostaglandins, which play a primary role in the pathogenesis of pain, inflammation, and fever.

Under in vitro conditions, diclofenac potassium, used in concentrations equivalent to those achieved in humans, did not inhibit the biosynthesis of proteoglycans in cartilage tissue.

Diclofenac potassium salt is characterized by a rapid onset of action, therefore its use is recommended for the treatment of acute inflammatory conditions, as well as for the relief of moderate and severe pain syndrome. In case of postoperative and post-traumatic inflammatory reactions, Dialrapid rapidly reduces edema and relieves pain, including that arising from movement.

With migraine attacks, diclofenac potassium reduces not only the intensity of the headache, but also nausea with vomiting.

In the course of clinical studies, it was found that Dialrapid reduces pain associated with dysmenorrhea, and also reduces blood loss.

Pharmacokinetics

The main pharmacokinetic characteristics of diclofenac:

absorption: after oral administration, diclofenac potassium is rapidly and fully absorbed. Maximum concentration (C _max) after a single dose of 50 mg (in the form of a solution prepared from powder) is about 5.5 μmol / l and is reached after about 5–20 minutes. With simultaneous intake of food, the onset of absorption of Dialrapid and its rate may decrease slightly, but the degree of absorption does not change. There is a linear dependence of the absorption of the drug on the dose taken. The AUC (area under the concentration-time curve) after oral administration of the drug is approximately half of that due to parenteral administration. After repeated administration of Dialrapid, its pharmacokinetics does not change. With the correct use of the drug according to its recommended dosage regimen, no cumulation in the body of diclofenac is observed;
distribution: diclofenac binds 99.7% to serum proteins, and about 99.4% - to albumin. Its volume of distribution (V _d) ranges from 0.12 to 0.17 l / kg. The substance penetrates into the synovial fluid, here C _max reaches about 2–4 hours later than in the blood plasma. However, after this time, C _max in synovial fluid becomes higher than in plasma, and higher values remain for a period up to 12 hours;
metabolism: diclofenac is biotransformed in the liver, with about half of the dose being metabolized during the initial passage through the liver. Metabolism is carried out advantageously by hydroxylation and methoxylation (single or multiple), in part through glucuronidation of the unchanged molecule. As a result, several phenolic metabolites are formed, most of which are converted to glucuronide conjugates. Only two phenolic metabolites have biological activity, but it is much lower than that of diclofenac. Metabolism occurs with the participation of the isoenzyme CYP2C9;
elimination: the systemic clearance of diclofenac is 263 ± 56 ml / min; the final half-life (T _1/2) is 1–2 hours, from the synovial fluid - 3–6 hours. The T _{1/2 of} most metabolites, including active ones, ranges from 1 to 3 hours, only one inactive metabolite has a longer T _{1 / 2}. Approximately 60% of the oral dose is excreted by the kidneys in the form of glucurone conjugates of unchanged diclofenac, as well as in the form of metabolites, most of which are also glucurone conjugates. The volume of excretion of unchanged diclofenac is no more than 1%. The rest of the drug is excreted in the bile as metabolites.

Pharmacokinetics in special cases:

age: no significant differences in pharmacokinetic parameters were observed in patients of different ages;
compensated cirrhosis of the liver and chronic hepatitis: pharmacokinetics similar to those in patients with normal liver function;
impaired renal function: if the dosage regimen is observed, unchanged diclofenac does not cumulate. In patients with creatinine clearance (CC) <10 ml / min, the calculated equilibrium concentrations of hydroxylated metabolites are approximately 4 times higher than in patients with normal renal function, while the metabolites are excreted only in the bile.

Indications for use

Dialrapid is intended for short-term symptomatic treatment of the following acute conditions:

back pain;
migraine attacks;
post-traumatic or postoperative pain, inflammation and edema, for example, after orthopedic or dental intervention, ligament damage, etc.;
rheumatic diseases of extra-articular soft tissues;
pain and / or inflammation against the background of gynecological diseases, for example, adnexitis, primary dysmenorrhea.

The drug is not intended to reduce the isolated elevated body temperature not caused by the inflammatory process.

Contraindications

Absolute:

uncontrolled arterial hypertension;
cardiac ischemia;
chronic heart failure II – IV functional class in accordance with the NYHA classification;
period of exacerbation of gastric ulcer or duodenal ulcer, inflammatory bowel disease;
ulcerative perforation and bleeding of the stomach or duodenum;
renal failure [glomerular filtration rate (GFR) <15 ml / min / 1.73 m ²];
severe liver dysfunction;
a combination (including incomplete) of bronchial asthma, recurrent polyposis of the nose / paranasal sinuses with intolerance to other NSAIDs, including in the past;
diseases of the peripheral arteries and blood vessels of the brain;
phenylketonuria (since the powder contains aspartame, which is the source of phenylalanine);
III trimester of pregnancy;
lactation period;
age up to 14 years (due to the difficulty of dosing the drug for patients of this age category);
hypersensitivity to any component of Dialrapid or other NSAIDs.

Relative (the drug should be used with extreme caution and under close medical supervision):

symptoms that may indicate a lesion or disease of the gastrointestinal tract (GIT);
history of intestinal or stomach ulcers, perforation or bleeding;
a history of Helicobacter pylori infection;
ulcerative colitis or Crohn's disease;
hepatic porphyria;
a history of severe hepatic dysfunction, mild or moderate abnormalities at the present time;
diabetes;
dyslipidemia / hyperlipidemia;
arterial hypertension;
impaired renal function, including chronic renal failure (GFR 15-60 ml / min / 1.73 m ²);
defects of the hemostatic system;
the risk of developing cardiovascular thrombosis;
a significant decrease in the volume of circulating blood, regardless of etiology, including in the pre- and postoperative period in connection with extensive surgical intervention;
alcohol abuse;
smoking;
I and II trimesters of pregnancy;
old age, especially frail elderly people or those with low body weight;
simultaneous use of the following drugs: diuretics and other drugs that affect renal function, selective serotonin reuptake inhibitors, antiplatelet agents, anticoagulants, systemic glucocorticosteroids.

Dialrapid, instructions for use: method and dosage

A solution prepared from Dialrapid powder should be taken orally, preferably before meals. First, the contents of the sachet must be dissolved in a glass of still water. The solution may be slightly cloudy, but its effectiveness and quality is not affected by this condition.

The doctor always selects the dose of the drug individually. To reduce the risk of side effects, it is recommended, if possible, to carry out treatment with the minimum effective dose for the shortest possible course.

With moderate severity of symptoms, as a rule, a dose of 50–100 mg per day (1–2 sachets) is sufficient for patients. The maximum allowable daily dose of Dialrapid is 150 mg in 3 divided doses of 1 sachet.

In case of primary dysmenorrhea, the dose is selected individually. At the beginning of treatment it is recommended to take 1-2 sachets. During several menstrual cycles, if the effect is insufficient, the daily dose can be increased to 3 sachets. You should start taking Dialrapid immediately after the first symptoms appear. The therapy can take several days.

For migraine attacks, take 1 sachet for the first time. If the pain persists after 2 hours, you can take 1 more sachet. Additional drug intake is possible in the next 4-6 hours. During the day, the dose should not exceed 150 mg (3 sachets), treatment is allowed for no more than 2 days. It is recommended to start taking Dialrapid as soon as possible after the onset of symptoms of an impending attack. The effectiveness of the drug for migraine in children has not been established.

The drug is used with caution in patients with diseases that can cause pathologies of the cardiovascular system. If it is necessary to carry out long-term treatment (lasting more than 4 weeks), a daily dose of 100 mg should not be exceeded.

For adolescents 14-18 years old Dialrapid is prescribed at the rate of 0.5-2 mg / kg. The maximum permissible daily dose is 3 mg / kg; in this amount, the drug can be prescribed for rheumatoid arthritis.

Side effects

To assess the side effects of Dialrapid, the following criteria were used: often - from ≥ 1/100 to <1/10, infrequently - from ≥ 1/1000 to <1/100, rarely - from ≥ 1/10 000 to <1/1000, very rarely - <1/10 000, including isolated cases.

In the course of clinical studies and in practice of using diclofenac, the following undesirable effects have been identified:

from the gastrointestinal tract: often - flatulence, diarrhea, vomiting, nausea, loss of appetite, abdominal pain, dyspepsia; rarely - gastritis, stomach and intestinal ulcers (including perforation / stenosis / bleeding; development of peritonitis is possible); diarrhea mixed with blood, melena, vomiting of blood; very rarely - dysgeusia, glossitis, stomatitis, constipation, pancreatitis, the formation of diaphragmatic strictures in the intestine, damage to the esophagus, exacerbation of Crohn's disease or ulcerative colitis, the occurrence of nonspecific hemorrhagic or ischemic colitis;
from the liver and biliary tract: often - increased activity of hepatic enzymes; rarely - liver dysfunction, jaundice, hepatitis; very rarely - liver failure, liver necrosis, fulminant hepatitis;
from the immune system: rarely - hypersensitivity reactions, anaphylactoid or anaphylactic reactions; very rarely - angioedema;
from the nervous system and psyche: often - dizziness, headache; rarely - drowsiness; very rarely - memory disorders, impaired sensitivity, anxiety, irritability, insomnia, nightmares, depression, disorientation, tremor, aseptic meningitis, acute cerebrovascular accidents, convulsions, mental disorders;
from the respiratory system: rarely - bronchial asthma; very rarely - pneumonitis;
on the part of the kidneys and urinary tract: very rarely - proteinuria, hematuria, nephrotic syndrome, tubulointerstitial nephritis, acute kidney damage, papillary necrosis;
on the part of the blood and lymphatic system: very rarely - anemia (hemolytic or aplastic), leukopenia, thrombocytopenia, agranulocytosis;
from the heart and blood vessels *: infrequently - chest pain, heart palpitations, heart failure, myocardial infarction; very rarely - increased blood pressure, vasculitis;
on the part of the organ of vision and hearing **: often - vertigo; very rarely - diplopia, blurred vision, impaired vision and hearing, tinnitus;
on the part of the skin and subcutaneous tissues ***: often - skin rash; rarely - urticaria; very rarely - itching, exfoliative dermatitis, purpura (including Shenlein-Genoch), photosensitivity reactions, eczema, bullous dermatitis, erythema, purpura, alopecia, Lyell's syndrome, Stevens-Johnson's syndrome, erythema multiforme.

Notes

* According to the data of clinical studies, Dialrapid slightly increases the risk of thrombotic complications (including myocardial infarction), especially with prolonged use of daily doses of diclofenac more than 150 mg.

** Violations of the organ of vision, presumably, are the class effects of drugs in the NSAID group. After stopping treatment, they are reversible. In the event of the development of such disorders, it is recommended to conduct an ophthalmological examination in order to exclude any other causes of the pathology.

*** The greatest risk of developing severe dermatological reactions exists in the first month of using diclofenac. Anaphylactoid / anaphylactic reactions are very rare in people who are not allergic to diclofenac.

Overdose

An overdose of diclofenac can manifest itself as dizziness, tinnitus, diarrhea, gastrointestinal bleeding, vomiting, convulsions. In case of serious intoxication, there is a risk of respiratory depression, lowering blood pressure, liver damage and the development of acute renal failure.

If an excessively high dose of Dialrapid is taken orally, to prevent its absorption, it is recommended to rinse the stomach as soon as possible and take activated charcoal. Treatment is symptomatic and supportive. Diclofenac binds well to plasma proteins and is extensively metabolized, therefore hemodialysis, forced diuresis and hemoperfusion are ineffective.

special instructions

If bleeding or gastrointestinal tract symptoms occur during treatment with diclofenac, the drug should be canceled. Like all NSAIDs, Dialrapid can cause severe perforation and bleeding, sometimes even fatal. The consequences can be especially severe in the elderly. Persons who have a predisposition to gastrointestinal complications, as well as patients receiving low doses of acetylsalicylic acid or other drugs that increase the risk of gastrointestinal tract damage, should take gastroprotectors prescribed by a doctor while taking Dialrapid.

Side effects such as seasonal urticaria, Quincke's edema and exacerbation of bronchial asthma most often occur in patients with polyps of the nasal mucosa, seasonal allergic rhinitis, respiratory diseases (especially those manifested by allergic rhinitis-like symptoms), chronic obstructive pulmonary disease and bronchial asthma. All of these groups of patients, as well as those who are allergic to any other drug, should be especially careful during treatment with the drug. If the first signs appear (rash, mucosal lesions, etc.) Dialrapid should be canceled.

All drugs of the NSAID group can increase the activity of liver enzymes, therefore, during long-term therapy, it is necessary to monitor liver function. Dialrapid is discontinued if signs of liver disease occur, liver dysfunction persists or progresses, or other symptoms occur (eg, rash or eosinophilia). It should be borne in mind that diclofenac can cause the development of hepatitis, which is not accompanied by prodromal phenomena.

NSAIDs can cause fluid retention and edema. In this regard, treatment is carried out with caution, under the control of renal function, especially with hypertension, cardiovascular pathologies, impaired renal function, a significant decrease in the volume of circulating blood, the simultaneous use of diuretics or other drugs that affect renal function, as well as old age. After discontinuation of Dialrapid, renal function is usually normalized.

Due to the risk of an increased frequency of side effects, other NSAIDs, including selective COX-2 inhibitors, should not be used concurrently with diclofenac.

With an increase in the duration of treatment and an increase in the dose of the drug, the risk of thrombotic complications increases. For this reason, Dialrapid should be used with extreme caution for the treatment of patients with existing diseases of the cardiovascular system or a high risk of their development (arterial hypertension, diabetes mellitus, hyperlipidemia, smoking). It is recommended to prescribe diclofenac in the minimum dose and to carry out therapy for the shortest possible period. If long-term treatment is planned (more than 4 weeks), such patients should not exceed a daily dose of 100 mg. Periodically it is necessary to assess the appropriateness and effectiveness of the therapy. The doctor should inform patients about the need for immediate medical attention if symptoms such as chest pain, weakness, speech impairment appear,feeling short of breath.

Dialrapid is able to temporarily suppress platelet aggregation. Appropriate laboratory tests are required periodically in patients with impaired hemostasis. It is advisable for such patients to use diclofenac only for a short course. But in the case of justified long-term treatment, it is necessary to regularly check the picture of the peripheral blood.

All drugs from the NSAID group can mask the symptoms of infectious processes, which complicates their diagnosis.

Dialrapid can have a negative effect on female fertility, therefore it is contraindicated during pregnancy planning, as well as for women undergoing examination due to the impossibility of conception.

Influence on the ability to drive vehicles and complex mechanisms

The degree of restrictions is determined individually, depending on the tolerance of diclofenac. Patients who experience drowsiness, dizziness, visual disturbances or other disorders of the central nervous system during the period of taking Dialrapid should refrain from driving and potentially hazardous types of work.

Application during pregnancy and lactation

Dialrapid is contraindicated in the last trimester of pregnancy, since it can disrupt kidney function and cause premature closure of the ductus arteriosus in the fetus, as well as suppress uterine contractility, and cause oligohydramnios (oligohydramnios). There are no data on the safety of diclofenac when used in the first half of pregnancy, and therefore the drug is prescribed only if the benefits of treatment outweigh the potential risks.

Diclofenac passes into the milk of a nursing mother in small quantities. However, it is contraindicated during lactation, since there is a risk of side effects in a nursing baby. If treatment with Dialrapid is clinically justified, the woman should transfer the baby to artificial feeding.

Pediatric use

Dialrapid is not used to treat children under 14 years of age.

With impaired renal function

Safety studies of Dialrapid in patients with impaired renal function have not been conducted, therefore there is no information on the need for dose adjustment of the drug. However, treatment should be carried out under medical supervision.

Dialrapid powder is contraindicated in renal failure (GFR <15 ml / min / 1.73 m ²).

For violations of liver function

With hepatic porphyria, mild and moderate impairment of hepatic function, it is not necessary to adjust the dose of the drug, but treatment should be carried out with caution.

It is contraindicated to prescribe Dialrapid in severe liver dysfunction.

Use in the elderly

Elderly people (over 65 years of age) do not need to adjust the dose of Dialrapid, however, it is recommended to be careful during treatment, especially if the patient is weak or has a low body weight.

Drug interactions

The interactions described below were observed in patients who received Dialrapid and / or Diclofenac in other dosage forms.

Confirmed interactions:

digoxin, lithium: diclofenac increases their plasma concentrations, therefore, when they are used together, this indicator should be monitored;
inhibitors of the isoenzyme CYP2C9: can increase the content of diclofenac in blood plasma; this combination requires special care;
tacrolimus, cyclosporine: diclofenac affects the activity of prostaglandins in the kidneys, which may increase the nephrotoxicity of these drugs. In this regard, the dose of Dialrapid should be reduced;
quinolone derivatives: in rare cases, this combination can cause seizures;
potassium-sparing diuretics, trimethoprim, tacrolimus, cyclosporine: an increase in plasma potassium levels is possible, so this indicator should be monitored;
antihypertensive and diuretic drugs: their effect may be reduced, and therefore patients receiving these drugs in conjunction with Dialrapid, especially in the elderly, should periodically measure blood pressure, monitor the degree of hydration and kidney function.

Intended interactions:

selective serotonin reuptake inhibitors (eg paroxetine, fluoxetine, citalopram, sertraline): the risk of gastrointestinal bleeding increases, caution is required;
antiplatelet agents (including acetylsalicylic acid and clopidogrel), anticoagulants (including warfarin): there are isolated reports of an increased risk of gastrointestinal bleeding, therefore, the combination should be used with caution;
glucocorticosteroids and other NSAIDs: the incidence of side effects increases;
methotrexate: its concentration in the blood increases and the toxic effect increases if less than 24 hours pass between doses of drugs; special care should be taken;
phenytoin: its systemic effect may increase, which requires monitoring the concentration of the drug in the blood;
oral hypoglycemic drugs: in clinical trials, diclofenac did not affect the effectiveness of antidiabetic drugs. However, there are separate reports that with the simultaneous use of diclofenac, an increase or decrease in their effectiveness was noted. In this regard, when taking Dialrapid, you should control the blood sugar level and, if necessary, control the dose of the hypoglycemic drug;
inducers of the isoenzyme CYP2C9 (for example, rifampicin): a significant decrease in the plasma concentration of diclofenac is possible, care must be taken;
metformin: there are isolated reports of the development of metabolic acidosis, especially with concomitant impairment of renal function.

Analogs

Dialrapid analogs are Argett Rapid, Arguette Duo, Voltaren, Diklak, Diclogen, Diclofenac, Diclofenac Sandoz, Naklofen, Ortofen, Ortofer, Rapten Duo, Rapten Rapid, Tabuk-Di, etc.

Terms and conditions of storage

Keep out of the reach of children, in a dry place at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Dialrapid

Feedback on Dialrapid is positive. Patients note that the drug quickly and effectively relieves pain. It is well tolerated and suitable for course use. The taste of the finished solution is specific, so not everyone likes it.

The disadvantages of the remedy include a large list of contraindications. Some patients consider it to be somewhat overpriced.

Price in pharmacies

The price of Dialrapid in the form of a powder for preparation of a solution for oral administration is from 490 rubles. per pack containing 9 sachets.

Dialrapid: prices in online pharmacies

Drug name

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Pharmacy

Dialrapid 50 mg powder for oral solution 9 pcs.

399 RUB

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Dialrapid powder for prig solution for internal approx. 50mg (sachet) 900mg 9 pcs.

RUB 536

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!