Universal reference book for medicines
Product name: RAPTEN RAPID (RAPTEN RAPID)

Active substance: diclofenac potassium

Type: NSAIDs

Manufacturer: HEMOFARM (Serbia)
Composition, form of production and packaging
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The tablets covered with a sugar shell of red color, with small impregnations of more light color, round, biconcave.
1 tab.

diclofenac potassium 12.5 mg

[PRING] calcium hydrophosphate, corn starch, sodium carboxymethyl starch (type A), silicon dioxide colloidal anhydrous, povidone 30, magnesium stearate.

The composition of the sugar shell: sucrose, talc, dye Ponso (E124), acacia gum, povidone 25, titanium dioxide (E171), macrogol 6000.

10 pieces.
- blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

NSAIDs.
Has a pronounced anti-inflammatory, analgesic and antipyretic effect, which is due to inhibition of prostaglandin synthesis by inhibiting the activity of COX-1 and COX-2.
Given that potassium diclofenac is absorbed very quickly from the digestive tract, Rapent Rapid is most effective in treating acute pain and inflammatory conditions, in which a rapid initial effect is most important.

The analgesic and antipyretic effect of Rapent Rapid manifests itself within the first 30 minutes after administration, and the effect lasts for 4-6 hours.

PHARMACOKINETICS

Suction

After ingestion, the drug is quickly and completely absorbed.
Absorption of diclofenac decreases when taken with food. Absorption begins in the stomach, C max ofdiclofenac in the blood plasma is reached approximately 40 minutes after administration. The concentration in the plasma is linear in the dose of the drug administered. Cmax in the blood plasma after taking the 50 mg tablet is 1.3 μg / ml.
Distribution

Binding to blood plasma proteins (mainly with albumins) is high - up to 99%.
Rapidly distributed into tissues and body fluids. Penetrates into the synovial fluid. In this case, C max of potassium diclofenac in the synovial fluid is noted 2-4 hours later than in plasma. T 1/2 diclofenac potassium from the synovial fluid is 3-6 hours, and its concentration in the synovial fluid 4-6 hours after taking the drug remains higher than in the plasma for another 12 hours.
When observing the recommended interval between meals, cumulation of the drug does not occur.

Metabolism

Diclofenac is metabolized in the liver.
50% of the active substance is metabolized during the "first pass" through the liver. Metabolism occurs by multiple or single hydroxylation and conjugation. The isozyme CYP2C9 is involved in the metabolism. The pharmacological activity of metabolites is lower than that of diclofenac potassium.
Excretion

T 1/2 from the blood plasma is 1-2 hours. It is excreted mainly by the kidneys: about 60% - in the form of metabolites, less than 1% - in unchanged form.
The rest of the drug is excreted with bile in the form of metabolites.
Systemic clearance is 260 ml / min.

Pharmacokinetics in special clinical cases

Pharmacokinetics of the drug does not change depending on the age of the patient.

In patients with severe renal dysfunction (CC <10 ml / min), the time for excretion of metabolites with bile is increased.
At the same time, there is no increase in their concentration in the blood.
In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac are the same as in patients who do not have liver disease.

Changes in the pharmacokinetics of diclofenac against the background of repeated administration do not occur.

INDICATIONS

For short-term treatment (up to 7 days) of pain syndrome accompanying the following conditions:

- inflammatory diseases of the musculoskeletal system (including tendovaginitis, bursitis, myalgia);

- Post-traumatic pain syndromes accompanied by inflammation;

- Postoperative pain;

- Lumbago;

- sciatica;

- neuralgia;

- toothache;

- Migraine;

- inflammatory diseases of the pelvic organs;

- primary algodismenorea;

- proctitis;

- renal colic;

- biliary colic;

- Infectious and inflammatory diseases of ENT organs with severe pain syndrome, incl.
pharyngitis, tonsillitis, otitis (as part of complex therapy);
- fever.

DOSING MODE

The dose of the drug is set individually, taking into account the severity of the disease.

Adults drug prescribed in a daily dose of 100-150 mg, divided into 2-3 admission.

The maximum dose is 200 mg / day.

To adolescents over 15 years of age, the drug is prescribed in a daily dose of 100 mg divided into 2 divided doses.

Older patients, especially the depleted and weakened patients, should be prescribed the drug in the lowest effective dose.

Tablets should be taken orally, with water.
To achieve maximum therapeutic effect, the drug should be taken before meals.
SIDE EFFECT

Determination of the frequency of side effects: often (> 1/100);
sometimes (<1/100, but> 1/1000); rarely (<1/1000, but> 1/10 000); very rarely (<1/10 000).
On the part of the digestive system: often - NSAIDs-gastropathy (gastralgia and discomfort in the epigastric region, nausea, sensation of stomach overflow, belching, heartburn, diarrhea, abdominal pain, flatulence), erosive and ulcerative lesions of the digestive tract, intestinal wall perforation, gastrointestinal bleeding , dry mouth, constipation, pancreatitis, toxic hepatitis;
sometimes - vomiting, decreased appetite, anorexia, stomatitis, glossitis.
From the side of the central nervous system and peripheral nervous system: often - headache, dizziness;
sometimes cramps, aseptic meningitis, memory loss, depression, psychotic reactions, peripheral polyneuropathy (hypesthesia, tremor, pain or weakness in the muscles of the arms and legs), drowsiness, irritability and nervousness, fear, insomnia, weakness and fatigue.
From the senses: sometimes - toxic damage to the optic nerve, reduced visual acuity, diplopia, scotoma, hearing loss, ringing and tinnitus.

From the cardiovascular system: often - increased blood pressure;
sometimes - arrhythmias, cardialgia, decreased blood pressure; rarely - pain behind the breastbone, aggravation of congestive heart failure.
From the urinary system: often - fluid retention;
sometimes - hematuria, cystitis, pollakiuria, proteinuria, interstitial nephritis, nephrotic syndrome, oliguria, anuria, acute renal failure, peripheral edema.
On the part of the reproductive system: sometimes - dysmenorrhea.

On the part of the organs of hematopoiesis: sometimes - agranulocytosis, hemolytic anemia, aplastic anemia, anemia, associated with internal bleeding, leukopenia, neutropenia, thrombocytopenia with or without purpura.

From the respiratory system: sometimes - shortness of breath.

Dermatological reactions: often - skin itching, skin rash (mainly erythematous and urticaria), ecchymosis, skin hyperemia;
sometimes - photodermatitis.
Allergic reactions: sometimes - multi-form exudative erythema, incl.
Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis); rarely - anaphylaxis and anaphylactoid reactions, anaphylactic shock (usually develops rapidly), bronchospastic allergic reactions.
CONTRAINDICATIONS

- "aspirin" asthma;

- erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation);

bleeding from the gastrointestinal tract;

- disorders of hematopoiesis;

- Various violations of hemostasis (including hemophilia);

- Pregnancy;

- the period of lactation (breastfeeding);

- children and adolescence (up to 15 years);

- Hypersensitivity to NSAIDs (including to acetylsalicylic acid).

With caution, use Rapent Rapid in patients with severe impairment of liver and kidney function in history, with CC <60 ml / min, liver porphyria, anemia, bronchial asthma, arterial hypertension, ischemic heart disease, congestive heart failure, edematous syndrome, erosive ulcerative lesions Gastrointestinal tract without exacerbation, diverticulitis, dyslipidemia or hyperlipidemia, diabetes mellitus, severe somatic diseases, in patients receiving long-term NSAIDs in elderly patients and patients in postoperative period
de, chronic alcoholism, smoking.
PREGNANCY AND LACTATION

The use during pregnancy and lactation (breastfeeding) is contraindicated.

Diclofenac can have a negative effect on female fertility, therefore it is not recommended to prescribe Rapent Rapid to women planning a pregnancy.

APPLICATION FOR FUNCTIONS OF THE LIVER

Caution is prescribed Rapent Rapid for violations of kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution appoint Rapten Rapid for violations of the liver.

APPLICATION FOR CHILDREN

Contraindication: children and adolescence (up to 15 years).

APPLICATION IN ELDERLY PATIENTS

With caution apply Rapent Rapid in elderly people



SPECIAL INSTRUCTIONS

When using NSAIDs, there is a possibility of developing gastrointestinal bleeding, as well as gastrointestinal ulcers, sometimes complicated by perforation, without previous symptoms or the presence of such attacks in the patient's anamnesis.
These complications can have serious consequences especially for elderly patients. If these symptoms occur, the drug should be immediately discontinued.
The risk of developing gastrointestinal bleeding increases with increasing doses of NSAIDs in patients with a history of peptic ulcer, especially if the disease is complicated by bleeding and perforation, as well as in elderly patients.
To reduce the risk of complications, therapy should be initiated and maintained at the lowest effective dose level, taking into account the possibility of using combination therapy and the use of protective agents (for example, proton pump inhibitors or misoprostol). When prescribing diclofenac to patients with an existing pathology of the gastrointestinal tract (ulcer, bleeding, perforation) in a history, it is necessary to conduct therapy with careful medical supervision and observance of special care. Caution should be observed when concomitant administration with medications that may increase the risk of erosive ulcerative lesions or bleeding from the gastrointestinal tract (such as systemic corticosteroids, anticoagulants, platelet aggregation inhibitors or selective serotonin reuptake inhibitors).
Patients suffering from ulcerative colitis or Crohn's disease should be treated under close medical supervision.
as a result of diclofenac, there may be an exacerbation of these diseases.
The use of diclofenac should be discontinued at the first signs of skin rash, mucous membranes and other signs of hypersensitivity to the components of the drug.

During treatment, in rare cases, allergies may occur, including anaphylactic / anaphylactoid reactions, incl.
in patients who did not previously use diclofenac.
It should be remembered that in connection with its pharmacological properties, diclofenac can mask the symptoms characteristic of infectious diseases.

The simultaneous use of diclofenac with systemic NSAIDs (including selective inhibitors of COX-2) should be avoided, since there is no evidence of a beneficial effect as a result of synergy, and there are no data on possible side effects.

Care should be taken when prescribing the drug to elderly patients.
We recommend that patients who are elderly and elderly patients with low body weight be prescribed at the lowest effective dose.
In patients with bronchial asthma, seasonal allergic rhinitis, edema of the nasal mucosa (polyps of the nasal mucosa), COPD or chronic infection of the respiratory tract (especially associated with allergic rhinitis-like symptoms), reactions to drugs from the NSAID group in the form of asthma attacks, Quincke's edema or urticaria develop more often than usual.
When appointing the drug to such patients, it is recommended that special care be taken (readiness for immediate medical measures).
When diclofenac is prescribed, patients with impaired liver function should be closely monitored, as the condition of such patients may worsen.
During the application of Raptin Rapid, the activity of one or more hepatic enzymes may increase. If, during treatment, complaints or symptoms that indicate liver disease develop, and if other side effects occur (for example, eosinophilia, rash, etc.), the drug should be discontinued. It should be borne in mind that hepatitis against diclofenac may occur without prodromal phenomena. Care should be taken when prescribing the drug to patients with hepatic porphyria, as taking diclofenac can provoke an attack.
Since there are reports that, with the use of NSAIDs, fluid retention and the appearance of edema may occur, it is recommended that special care be taken when prescribing Rapent Rapid to patients with impaired renal and cardiac function, history of arterial hypertension, elderly patients, concomitant diuretics or drugs that have a significant effect on kidney function, as well as patients who have a significant reduction in BCC of any etiology, for example, in the period before or after a large
surgical interventions. In such cases, when using diclofenac as a precautionary measure, monitoring of renal function is recommended. After discontinuing therapy, the baseline parameters are usually restored.
Rapent Rapid may temporarily inhibit platelet aggregation.
Therefore, patients with hemostasis disorders need careful monitoring of relevant laboratory parameters.
During the use of Rapent Rapid, alcohol should be avoided.

Impact on the ability to drive vehicles and manage mechanisms

During the period of treatment, a slight decrease in the rate of psychomotor reactions is possible.
In this regard, patients taking the drug should refrain from activities that require increased attention and rapid psychomotor reactions.
OVERDOSE

Symptoms: disorders of the digestive system, arterial hypotension, nephrotoxicity (up to acute renal failure), dizziness, headache, hyperventilation of the lungs, clouding of consciousness;
in children - myoclonic cramps, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function.
Treatment: gastric lavage with subsequent administration of activated charcoal, symptomatic and maintenance therapy.
Forced diuresis, hemodialysis are ineffective.
DRUG INTERACTION

With simultaneous use of diclofenac can increase the concentration of lithium and digoxin in the blood plasma.

With simultaneous administration with diuretic or antihypertensive agents (eg, beta-blockers, ACE inhibitors), diclofenac may reduce the severity of antihypertensive action.

Simultaneous use of potassium-sparing diuretics can lead to an increase in serum potassium levels.

The simultaneous use of diclofenac and other systemic NSAIDs or corticosteroids may increase the incidence of adverse events from the gastrointestinal tract.

Special care is required when co-administered with anticoagulants or platelet aggregation inhibitors, since the risk of bleeding increases with simultaneous administration of diclofenac with these drugs.

In clinical studies, it has been established that simultaneous use of diclofenac and oral hypoglycemic drugs is possible and the efficacy of the latter is not changed.However, some cases of development, both hypoglycemia and hyperglycemia, are known, which required a change in the dose of hypoglycemic drugs during the application of diclofenac.

Caution is required when administering NSAIDs less than 24 hours before or after taking methotrexate,
in such cases, the concentration of methotrexate in the blood may increase and its toxic effect may be increased.
The effect of NSAIDs on the synthesis of prostaglandins in the kidneys can enhance the nephrotoxicity of cyclosporine.

There are separate reports on the development of seizures in patients who received antibiotic drugs simultaneously, derivatives of quinolone and NSAIDs.

Antacids, such as aluminum hydroxide and magnesium hydroxide, can slow the absorption of diclofenac, but do not affect the total amount of absorbed drug.

With concomitant therapy, selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline) may increase the risk of developing gastrointestinal bleeding.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of 15 ° to 25 ° C.
Shelf life - 3 years.
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