Velforo 500
Velforo 500: 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: Velphoro 500
ATX code: V03AE05; B03AB02
Active ingredient: complex "β-iron (III) oxyhydroxide + sucrose + starch" [complex β-ferric (III) oxyhydroxide + sucrose + amylum]
Producers: Vifor AG (Vifor, SA) (Switzerland); Catalent Germany Schorndorf, GmbH (Germany); Vifor (International) Inc. [Vifor (International), Inc.] (Switzerland)
Description and photo update: 2020-25-06
Prices in pharmacies: from 4300 rubles.
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Velforo 500 is a drug for the treatment of hyperkalemia and hyperphosphatemia.
Release form and composition
Dosage form - chewable tablets: flat-cylindrical, round, chamfered, red-brown, engraved on one of the sides PA500; tablets have a characteristic berry odor (in blisters made of aluminum foil, 6 pcs., in a cardboard box 5 blisters; in polyethylene bottles with a capacity of 150 or 400 ml, sealed with foil, which provides control of the first opening, and a polypropylene lid that prevents children from opening, 30 or 90, respectively, each bottle contains a sachet of silica gel and a cotton swab to protect the tablets from physical damage. Each pack also contains instructions for the use of Velforo 500).
Composition for 1 chewable tablet:
- active ingredient: complex "β-iron (III) oxyhydroxide + sucrose + starch" - 2500 mg (equivalent to the content of 500 mg of iron);
- auxiliary components: flavoring "Forest berry" - 40 mg; magnesium stearate - 25 mg; anhydrous colloidal silicon dioxide - 12.49 mg; neohesperidin dihydrochalcone (E959) - 0.01 mg.
Pharmacological properties
Pharmacodynamics
The active ingredient of Velforo 500 is a complex of β-iron (III) oxyhydroxide (pn-FeOOH) with sucrose and starch.
The complex binds to phosphates through ligand exchange between hydroxo groups and / or water with phosphate ions, which occurs in the digestive tract, provided that the pH is within physiological values.
In the blood serum, the phosphorus content, as well as the calcium / phosphorus-containing substance level, decreases due to a decrease in the absorption of phosphate obtained from food.
Pharmacokinetics
Since the clinical effect of Velforo 500 lies in the binding of phosphate in the gastrointestinal tract (GIT), its content in the blood serum does not affect the effectiveness of therapy.
The insolubility and features of the cleavage of the complex make it impossible to determine such pharmacokinetic parameters as volume of distribution, area under the pharmacokinetic curve, average retention time, etc.
Main pharmacokinetic characteristics:
- absorption: Velforo 500 is practically insoluble, therefore, it is not absorbed in the gastrointestinal tract, but its cleavage products, monocyclic iron-containing compounds released from the surface of pn-FeOOH, can be absorbed;
- distribution: insolubility and the characteristics of drug degradation make it impossible to assess its distribution in tissues and organs;
- metabolism: the complex "β-iron (III) oxyhydroxide + sucrose + starch" is not metabolized. But the products of its cleavage (monocyclic iron-containing substances) are able to be released from the surface and absorbed in the digestive tract. In the course of clinical studies, low systemic absorption of iron contained in the preparation was established. The data of in vitro studies suggest that the sucrose and starch that make up the product can break down into glucose and fructose during digestion, and then be absorbed into the blood;
- excretion: in studies conducted on rats and dogs, after ingestion of the 59 Fe- labeled complex "β-iron (III) oxyhydroxide + sucrose + starch", iron isotopes were found only in the feces. The drug is not excreted through the urinary system.
Indications for use
Velforo 500 is used in patients with end-stage chronic renal failure (chronic renal failure) who are on hemo- or peritoneal dialysis to control the phosphorus content in the blood serum.
The drug is used as part of a complex therapy aimed at preventing the development of renal osteodystrophy, simultaneously with calcium preparations, vitamin D 3 (1,25-dihydroxycholecalciferol) or its analogues, or with calcimimetics.
Contraindications
Absolute:
- hemochromatosis, other disorders of the accumulation of iron in the body;
- genetically determined glucose-galactose malabsorption, fructose intolerance, sucrase-isomaltase deficiency;
- period of breastfeeding;
- children and adolescents up to 18 years old;
- increased individual sensitivity to any of the components of the complex or excipients.
With caution, after a comprehensive assessment of the ratio of the benefits of therapy with the risk of developing negative reactions, Velforo 500 tablets are used for peritonitis against the background of peritoneal dialysis, severe disorders of the digestive system, after extensive surgical interventions on the digestive tract and during pregnancy.
Velforo 500, instructions for use: method and dosage
Velforo 500 chewable tablets are intended for oral administration. They should be chewed at the same time with food intake; it is not recommended to swallow the tablets whole.
The maximum absorption of phosphate from food during the day is ensured by dividing the prescribed daily dose between meals. You do not need to drink a lot of liquid in comparison with the usual drinking diet. If necessary, tablets can be crushed before use.
If 1 dose or more is missed at the next meal, Velforo 500 is taken in the usual dose.
The recommended initial daily dose for adult patients, including the elderly over 65 years of age, is 3 tablets (1500 mg per day).
The selection of the dosage regimen and the determination of the maintenance dose are carried out by monitoring the level of phosphorus in the blood serum. If necessary, the dose is increased or decreased by 1 tablet (500 mg) per day, once every 2-4 weeks, until an acceptable concentration of phosphorus in the blood plasma is reached. In the future, regular monitoring of this indicator is required.
Therapy in clinical practice is based on monitoring serum phosphorus levels. The standard maintenance dose that ensures the optimal therapeutic effect is 3-4 tablets (1500-2000 mg).
The maximum daily dose is 6 tablets (3000 mg).
Side effects
The incidence of adverse reactions listed below is established by the ratio of the number of registered cases to the number of patients taking the drug: very often - at least 1/10; often - not less than 1/100, but less than 1/10; infrequently - not less than 1/1000, but less than 1/100.
Side effects from systems and organs:
- digestive system: very often - diarrhea, discoloration of stool - meets the expectations from oral use of preparations containing iron; often - constipation, nausea, vomiting, abdominal pain, dyspepsia, flatulence, discoloration of tooth enamel and / or tongue (several episodes of discoloration of tooth enamel and tongue are known, all of them are transient); infrequently - gastritis, bloating, abdominal discomfort, gastroesophageal reflux disease, dysphagia;
- metabolism: infrequently - hypocalcemia, hypercalcemia;
- central and peripheral nervous system: infrequently - headache;
- respiratory system: infrequently - shortness of breath;
- skin and subcutaneous tissues: infrequently - rash, itching;
- general disorders: often - dysgeusia (distortion of the taste of the food taken); infrequently - fatigue;
- laboratory test results: no significant deviations from the norm of these laboratory safety tests were observed. No clinically significant changes in the accumulation of iron in the body, such as saturation of transferrin and ferritin, as well as fat-soluble vitamins A, D, E and K, were detected during the intake of Velforo 500.
Overdose
Overdose cases of Velforo 500 are unknown. Due to the weak absorption of the iron contained in the preparation, the likelihood of developing systemic intoxication is insignificant.
Treatment of any consequences of an overdose, for example, hypophosphatemia, is carried out in accordance with standard clinical practice.
special instructions
The iron contained in Velforo 500 can lead to staining of feces in black and help to visually mask gastrointestinal bleeding. However, the drug does not affect the results when performing tests for occult blood (Weber test with guaiac resin or immunological methods iColo Rectal and Hexagon OBTI).
Because chewable tablets contain sucrose, the drug can contribute to the destruction of tooth enamel and the formation of caries.
Velforo 500 contains carbohydrates (starch). For patients with gluten hypersensitivity, with celiac disease or diabetes mellitus, it is important to take into account that one chewable tablet contains about 1.4 g of carbohydrates, which is equivalent to 0.116 XE (bread unit).
Influence on the ability to drive vehicles and complex mechanisms
No studies have been conducted on the effects of Velforo 500 on human cognitive function.
Application during pregnancy and lactation
There is no information on the use of Velforo 500 during pregnancy in humans.
In animal studies, no toxic effects on intrauterine development of the fetus and reproductive function have been identified. The drug had no effect on the formation and growth of the embryo / fetus, the course of pregnancy, labor, postnatal growth and development of the calf.
Velforo 500 should be administered to pregnant women with caution, under the supervision of a specialist.
There is no information on the use of the drug during breastfeeding in humans. Despite the fact that the absorption of the iron contained in Velforo 500 is minimal, and its release during lactation is unlikely, if therapy is necessary, a decision should be made whether to continue breastfeeding or start a course of treatment, taking into account the benefits of breastfeeding for the child and the need to take the drug for the mother.
Pediatric use
Since the safety and efficacy of using Velforo by 500 patients under 18 years of age has not been established, it is not used in pediatric practice.
With impaired renal function
Velforo 500 is prescribed to control the concentration of phosphorus in the blood of patients with end-stage chronic renal failure who are on hemo- or peritoneal dialysis.
There is no information on the use of the drug in renal failure in the early stages.
For violations of liver function
In clinical studies of the complex "β-iron (III) oxyhydroxide + sucrose + starch" there was no development of liver responses or significant changes in the activity of liver enzymes.
Use in the elderly
In patients over 65 years of age, there is no need to adjust the dosage regimen of Velforo 500.
Drug interactions
The drug-drug interaction of the complex in dialysis patients has not been studied.
Drug interactions with digoxin, warfarin, losartan, furosemide, and omeprazole have been studied in healthy male and female volunteers. Taking into account the data on the area under the concentration-time pharmacokinetic curve (AUC), it was found that the combined use with Velforo 500 does not affect the bioavailability of these drugs.
Drug-drug interactions established in in vitro studies (adsorption effect of the complex), when used together with Velforo 500:
- doxercalciferol, paricalcitol: no effect of Velforo 500 on the effectiveness of oral analogs of vitamin D associated with a decrease in the level of intact parathyroid hormone was found. The content of vitamin D and 1,25-dihydroxyvitamin D in blood serum remained stable;
- alendronate, doxycycline, cephalexin, levothyroxine: there are no data from clinical studies of their interaction with Velforo 500;
- atorvastatin, simvastatin, other inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase: data from clinical studies indicate no effect of Velforo 500 on their lipid-lowering effect, also the levels of vitamin D and its 1 remained unchanged, 25-dihydroxymetabolite;
- hydrochlorothiazide, metformin, clopidogrel, nifedipine, cinacalcet, ciprofloxacin, enalapril, metoprolol, simvastatin, pioglitazone, quinidine: the absence of their drug interaction with Velforo 500 was established.
If it is necessary to use any medication that interacts with iron, it should be taken no later than 1 hour before or 2 hours after Velforo 500.
Analogs
The analogues of Velforo 500 are OsvaRen, Renagel, Renwella, Selamerex, Fosrenol, etc.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children. The pill bottle must be tightly closed to protect it from moisture penetration.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Velforo 500
There are no patient reviews about Velforo 500.
Experts say the drug is responsive to patient needs, providing a simple, convenient dosing regimen that improves patient adherence to therapy. The advantages of the drug are called a high phosphate-binding effect immediately after taking the pill, which provides control over blood phosphates, and the absence of calcium in the composition.
Price for Velforo 500 in pharmacies
Price Velforo 500, chewable tablets, 500 mg, for 90 pcs. in the package varies widely, from 4300 to 11 250 rubles.
Velforo 500: prices in online pharmacies
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Drug name Price Pharmacy |
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Velforo 500 500 mg chewable tablets 90 pcs. 4300 RUB Buy |
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!
