Renalgan - Instructions For Use, Reviews, Price, Tablets, Solution

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

Renalgan

Renalgan: instructions for use and reviews

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

Latin name: Ranalgan

ATX code: N02BB52

Active ingredient: Metamizole sodium + Pitofenone + Fenpiverinium bromide (Metamizole sodium + Pitofenone + Fenpiverinium bromide)

Manufacturer: Lekhim-Kharkov (Ukraine)

Description and photo update: 2018-24-10

Renalgan is a non-narcotic analgesic with an antispasmodic effect.

Release form and composition

• tablets: white or white with a yellowish tinge, flat-cylindrical surface, there are chamfers and risks (10 pcs. in blisters, in a cardboard box 1-2 packs);
• solution for injection: transparent liquid of light yellow color with a slightly greenish tinge (2 or 5 ml in ampoules, in a carton pack of 5, 10 or 100 ampoules or 5 ampoules in blisters, in a carton pack of 1-2 blisters).

Composition of 1 tablet:

• active substances: metamizole sodium - 500 mg, pitofenone hydrochloride - 5 mg, fenpiverinium bromide - 0.1 mg;
• auxiliary components: calcium stearate, potato starch.

Composition of 1 ml solution:

• active substances: metamizole sodium - 500 mg, pitofenone hydrochloride - 2 mg, fenpiverinium bromide - 0.02 mg;
• auxiliary component: water for injection.

Pharmacological properties

Pharmacodynamics

Renalgan is a combination drug that has analgesic, antispasmodic (papaverine-like), anticholinergic (atropine-like) and some anti-inflammatory effects. Reduces tone and eliminates spasms of smooth muscles of internal organs.

Metamizole sodium is a substance that has a pronounced analgesic and antipyretic, less pronounced anti-inflammatory and antispasmodic effect. Its effect is due to the ability to inhibit the synthesis of prostaglandins and endogenous algogens, to increase the threshold of excitability in the thalamus and to conduct painful extero- and interoceptive impulses in the central nervous system. Also, the agent affects the formation of endogenous pyrogens and the hypothalamus.

Pitofenone hydrochloride has a pronounced myotropic spasmolytic (papaverine-like) effect on vascular and extravascular smooth muscles.

Fenpiverinium bromide has a moderate ganglion-blocking and parasympathetic properties, reduces the tone and motility of smooth muscles of the urinary and biliary tract, intestines and stomach.

In combination, the active substances of the drug mutually potentiate the pharmacological effects of each other.

Pharmacokinetics

After oral administration, metamizole sodium is rapidly and well absorbed in the gastrointestinal tract. It is hydrolyzed in the intestinal wall with the formation of pharmacologically active metabolites; it practically does not enter the blood unchanged. 30 minutes after oral administration, no more than 5% of the maximum serum concentration is detected in the blood serum. The connection with plasma proteins of the active substance is about 50-60%. It is metabolized in the liver, excreted by the kidneys in the urine. No more than 3% of metamizole is released unchanged. When used in therapeutic doses, individual components penetrate into breast milk.

When administered intramuscularly, metamizole sodium is rapidly absorbed. Systemic bioavailability is about 85%. 50-60% bound to plasma proteins. Penetrates the placental and blood-brain barrier. The volume of distribution is about 0.7 l / kg. It undergoes intensive biotransformation in the liver with the formation of pharmacologically active metabolites. The maximum plasma concentration is observed after 30–90 minutes. It is excreted by the kidneys, unchanged - no more than 3%. The half-life is about 10 hours.

Indications for use

Renalgan is used to relieve mild and moderate pain syndrome with muscle spasms of internal organs, including in the following cases: spastic dysmenorrhea, chronic colitis, spasms of the ureter and bladder, intestinal and biliary colic, renal colic in case of kidney stones, inflammatory diseases. urinary tract, accompanied by pain and dysuric disorders, spastic dyskinesia of the biliary tract.

As an aid, Renalgan is used to reduce pain after diagnostic and surgical interventions.

Also, the drug can be used as an analgesic for short-term symptomatic therapy for myalgia, neuralgia, arthralgia, sciatica.

Contraindications

• suspicion of acute surgical pathology;
• megacolon;
• gastrointestinal obstruction;
• hepatic porphyria;
• decompensated liver and kidney function disorders;
• atony of the gall or bladder;
• deficiency of glucose-6-phosphate dehydrogenase with a tendency to urinary retention;
• hypertrophy of the prostate;
• angle-closure glaucoma;
• bronchial asthma;
• collaptoid states;
• diseases of the blood system (anemia, infectious or cytostatic neutropenia);
• changes in the composition of peripheral blood (leukopenia, agranulocytosis);
• decompensated heart failure;
• tachycardia;
• oppression of bone marrow hematopoiesis;
• age up to 5 years - for tablets, up to 15 years - for solution;
• period of pregnancy and lactation;
• hypersensitivity to the components of Renalgan or other non-steroidal anti-inflammatory drugs (NSAIDs).

Carefully:

• tendency to arterial hypotension;
• disturbances in the rhythm of cardiac activity;
• chronic congestive heart failure;
• ischemic heart disease (especially acute myocardial infarction);
• hyperthyroidism;
• moderate impairment of kidney / liver function;
• stomach diseases (gastroesophageal reflux, achalasia, stenosis of the pyloric stomach);
• tendency to arterial hypotension and orthostatic reactions;
• chronic bronchitis, bronchospasm;
• hives or coryza caused by taking acetylsalicylic acid or other NSAIDs;
• hypersensitivity to non-narcotic analgesics.

Instructions for the use of Renalgan: method and dosage

Pills

Renalgan tablets should be taken orally after meals, swallowing the tablets whole and drinking water.

Adults and adolescents from 15 years old are prescribed 1-2 tablets up to 3 times a day, but no more than 6 tablets a day.

The duration of therapy is up to 5 days. An increase in the duration of administration and / or the dose of the drug is possible only as directed by a doctor and under his control.

Single doses of Renalgan for children (taking the drug is possible only as prescribed by a doctor):

• 5-7 years old - ½ tab.;
• 8–12 years old - ¾ tab.;
• 13-15 years old - 1 tab.

Frequency rate of admission - up to 3 times a day. Increasing the dose is possible only on the recommendation of a doctor.

Injection

In the form of a solution, Renalgan is administered intramuscularly.

Single dose - 2-5 ml. If necessary, another dose is administered after 6–8 hours.

The maximum daily dose is 10 ml of solution. Duration of application is 2-3 days. If it is necessary to continue treatment, the patient is transferred to the oral form of the drug.

Side effects

In therapeutic doses, Renalgan is usually well tolerated.

In some cases, the following side effects are noted:

• allergic reactions: urticaria (including on the conjunctiva and mucous membranes of the nasopharynx), skin rash, itching; rarely - anaphylactic shock, Quincke's edema; in isolated cases - hemorrhages, Stevens-Johnson syndrome, toxic epidermal necrolysis;
• from the digestive system: dry mouth, burning sensation in the epigastric region, discomfort, constipation, exacerbation of gastric ulcer and gastritis;
• on the part of the cardiovascular system: arterial hypotension, cardiac arrhythmias, tachycardia;
• from the central nervous system: dizziness, headache;
• on the part of the blood system: granulocytopenia, anemia, thrombocytopenia, leukopenia, agranulocytosis (may manifest with the following symptoms: sore throat, chills, stomatitis, unmotivated increase in body temperature, development of proctitis / vaginitis);
• from the respiratory system: bronchospasm;
• on the part of the urinary system: anuria, oliguria, urinary retention, proteinuria, impaired renal function, urine staining red, difficulty urinating, interstitial nephritis, polyuria, development of acute renal failure;
• on the part of the visual organs: violation of accommodation, visual impairment;
• others: reduced sweating;
• local reactions with intramuscular administration of the drug: infiltrates at the injection site.

Overdose

In case of an overdose, symptoms of intoxication with metamizole sodium prevail in combination with anticholinergic effects: gastrointestinal disorders, a feeling of dry mouth, pain in the epigastric region, nausea, vomiting, symptoms of impaired hematopoietic functions, toxic-allergic syndrome, impaired accommodation, confusion, drowsiness, arterial hypotension, decreased sweating, impaired renal / liver function, convulsions; in severe cases, symptoms of brain damage.

If you suspect an overdose, Renalgan should be canceled immediately. There is no specific antidote. In case of taking a high dose of the drug in tablets, vomiting should be induced, gastric lavage should be performed, and urine excretion should be increased. For the fastest elimination of the Renalgan solution from the body, forced diuresis is used, water-salt solutions are injected. If necessary, it is possible to carry out hemodialysis, peritoneal dialysis. Further treatment is symptomatic.

special instructions

Renalgan should not be used for acute abdominal pain until the exact cause is established.

With long-term treatment (more than 7 days), it is necessary to monitor the state of the liver and peripheral blood function.

If symptoms appear, which may indicate the development of agranulocytosis or thrombocytopenia, the drug should be canceled. The development of agranulocytosis is independent of dose and cannot be predicted. It can occur both after the first intake of Renalgan, and after its repeated use. Patients with hemolytic diseases, including a history, should be prescribed the drug only after assessing the balance of benefits and risks, during treatment, the hematological status should be monitored.

During treatment, urine may turn red; this phenomenon has no clinical significance.

For the period of taking Renalgan, you should refrain from drinking alcohol.

When treating with the drug, there is a risk of developing anaphylactic reactions. When the first signs of hypersensitivity appear, the administration of the solution should be stopped immediately and measures should be taken urgently to relieve the condition (administration of adrenaline, antihistamines, glucocorticoids). The risk of developing hypersensitivity reactions is increased in patients with atopic diseases (hay fever, bronchial asthma), drug or food allergies.

For patients with kidney and liver diseases, the dose of the drug should be selected individually, since there is a risk of side effects and lengthening the half-life of metamizole sodium metabolites in the presence of hepatocyte dysfunction.

Renalgan should be used with caution in obstructive diseases of the digestive tract (achalasia, pyloroduodenal stenosis). With repeated use of the drug in such patients, delayed gastrointestinal contents and intoxication are possible. Special care and medical supervision is required for paralytic ileus, gastroesophageal reflux disease, intestinal atony, myasthenia gravis, glaucoma, heart disease (arrhythmias, coronary heart disease, congestive heart failure).

Renalgan should be used with caution when treating patients with systolic blood pressure below 100 mm Hg. Art. Special precautions are required when administering a solution of the drug in a dose of more than 2 ml, since there is a risk of a sharp decrease in blood pressure.

Influence on the ability to drive vehicles and complex mechanisms

Renalgan can cause side effects on the part of the nervous system (disturbance of accommodation, dizziness), therefore, vehicle drivers and people employed in potentially hazardous industries requiring attention and speed of reactions are advised to refrain from these activities during the period of treatment with the drug in the form of a solution. When using tablets, care should be taken when driving vehicles and working with complex mechanisms.

Application during pregnancy and lactation

According to the instructions, Renalgan is contraindicated during pregnancy. If necessary, use during lactation, breastfeeding should be discontinued.

Pediatric use

Renalgan tablets are contraindicated for children under 5 years old, injection solution - up to 15 years old. For children aged 5 to 15 years, tablets can only be taken as directed by a doctor.

With impaired renal function

In case of renal failure, the drug should be used with caution.

Renalgan is contraindicated in decompensated renal dysfunction.

For violations of liver function

In hepatic impairment, the drug should be used with caution. In the case of long-term treatment (more than 7 days), it is necessary to monitor the functional state of the liver.

Renalgan is contraindicated in decompensated liver function disorders.

Drug interactions

Metamizole is an enzyme inducer, so it should be used with caution in combination with other drugs.

Enzyme inducers (including phenylbutazone, barbiturates and glutethimide) reduce the effect of sodium metamizole. Tranquilizers, sedatives, antagonists of H ₂ -receptors of histamine, codeine, propranolol - enhance its effects.

With the simultaneous use of phenothiazine derivatives (for example, chlorpromazine), severe hypothermia may develop.

Quinine may enhance the anticholinergic effect of Renalgan.

Cytostatics and thiamazole increase the risk of developing leukopenia.

Renalgan reduces the concentration of cyclosporine in the blood.

Due to the content of metamizole sodium in the composition of the drug, penicillin, colloidal blood substitutes and X-ray contrast agents should not be used during treatment.

Metamizole sodium can increase the severity of the action of glucocorticoids, oral hypoglycemic agents, indirect anticoagulants and indomethacin.

The M-anticholinergic action of Renalgan can be enhanced by tricyclic antidepressants, H ₂ histamine blockers, butyrophenones, phenothiazines, amantadine, quinidine.

With the simultaneous use of non-narcotic analgesics, side effects may mutually increase.

Metamizole sodium enhances the hypoglycemic effect of oral antidiabetic agents, reduces the activity of coumarin anticoagulants.

With the combined use of mercazolil or sarcolysin, the risk of developing leukopenia increases.

Allopurinol, oral contraceptives, tricyclic antidepressants can slow down the metabolism of metamizole sodium and increase its toxicity.

Renalgan can affect the psychophysical abilities of a person in the case of drinking alcohol or taking drugs that depress the central nervous system.

With the simultaneous use of chloramphenicol or other myelotoxic drugs, there is a risk of bone marrow suppression.

Metamizole significantly increases the maximum plasma concentrations of chloroquine.

In the case of the combined use of other analgesics or NSAIDs, the likelihood of developing hypersensitivity reactions and other side effects increases.

Renalgan solution should not be administered in the same syringe with other medicines.

The drug, if necessary, can be combined with glibenclamide, furosemide, hyoscinebutyl bromide.

Analogs

Renalgan's analogues are: Baralgetas, Revalgin, Geomag, Spazmalgon, Bralangin, Spazmaton, Renalgan, Plenalgin, Bral, Spazmoblok, Spazmalin, Spazgan, Maksigan, Trinalgin.

Terms and conditions of storage

Shelf life - 2 years from the date of production.

Recommended storage conditions: dry, dark place, temperature - no more than 25 ° С.

Terms of dispensing from pharmacies

The tablets are dispensed without a prescription, and the injection is prescription.

Reviews about Renalgan

According to reviews, Renalgan is an effective drug that quickly relieves pain and eliminates spasm of smooth muscles of internal organs. Many attribute the low price to an additional advantage of the tablets, which is an order of magnitude lower than many other similar analgesics.

Price for Renalgan in pharmacies

The price of Renalgan in tablets is 30–70 rubles per pack of 10 pcs., In the form of a solution for injections - 135–275 rubles per pack of 5 ampoules of 5 ml.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!