Videx - description of the drug, instructions for use, reviews. Videx instructions for use, contraindications, side effects, reviews Videx side effects

05.03.2020 -

Instructions for medical use drug

Description of the pharmacological action

Antiviral drug active against HIV. Didanosine (2",3"-dideoxyinosine or ddI), a synthetic analog of the nucleoside dioxyadenosine, inhibits HIV replication in cultured human cells and cell lines in vitro.

After entering the cell, didanosine is converted by cellular enzymes to the active metabolite dideoxyadenosine triphosphate (ddATP). When replicating nucleic acid Incorporation of 2",3"-dideoxynucleoside into the virus prevents chain growth and thus suppresses viral replication. In addition, ddATP inhibits the activity of HIV reverse transcriptase by competing with dioxyadenosine 5-triphosphate (dATP) for binding to active sites of the enzyme, preventing the synthesis of proviral DNA.

Indications for use

Treatment of HIV infection (in combination with other antiretroviral drugs).

Release form

capsules 125 mg; blister 10, cardboard pack 3;

Capsules 200 mg; blister 10, cardboard pack 3;

Capsules 250 mg; blister 10, cardboard pack 3;

Capsules 400 mg; blister 10, cardboard pack 3;

Capsules, soluble in the intestine 125 mg; blister 10, cardboard pack 3;

Capsules, soluble in the intestine 250 mg; blister 10, cardboard pack 3;

Capsules, soluble in the intestine 400 mg; blister 10, cardboard pack 3;

Pharmacodynamics

After entering the cell, it is enzymatically converted into an active metabolite - 2,3-dideoxyadenosine-5 "-triphosphate (ddATP), which inhibits HIV-1 DNA polymerase (reverse transcriptase). In addition, the absence of 3"-hydroxyl makes it impossible to replicate nucleic acids, because it is an acceptor for the 5"-monophosphate group, the addition of which causes further growth of DNA and RNA chains; the incorporation of ddATP into the viral DNA chain thus leads to chain termination.

Pharmacokinetics

Suction

AUC of didanosine in blood plasma and Cmax in blood plasma when taking capsules and tablets are equal. Compared with tablets, the absorption rate of the drug from capsules is lower, the Cmax value when taking capsules is 60% of the Cmax value when taking tablets. Tmax is approximately 2 hours for capsules and 0.67 hours for tablets.

Tablets and powder for oral solution for children should be taken at least 30 minutes before or 2 hours after a meal. If the drug is taken earlier than 2 hours after a meal, the Cmax and AUC values decrease by approximately 55%. When taking the drug during meals, the bioavailability of didanosine is reduced by approximately 50%.

Capsules should be taken on an empty stomach, at least 1.5 hours before or 2 hours after meals. When using capsules with fatty foods, Cmax and AUC values are reduced by 46% and 19%, respectively.

Metabolism

The metabolism of didanosine in humans has not been studied. Animal studies suggest that in humans it occurs via the endogenous purine pathway.

breeding

After oral administration, T1 / 2 of the drug averages 1.6 hours, approximately 20% of the dose taken is found in the urine. Renal clearance is 50% of the total clearance (800 ml/min), indicating active tubular secretion during renal excretion of didanosine along with glomerular filtration.

Pharmacokinetics in special clinical situations

After oral administration, T1 / 2 increases on average from 1.4 hours in patients with normal function kidneys up to 4.1 hours in patients with severely impaired renal function. In the peritoneal dialysis fluid, didanosine is not detected, while during hemodialysis, after 3-4 hours, didanosine concentrations are 0.6-7.4% of the administered dose. The absolute bioavailability does not change in patients with severely impaired renal function, compared with patients with normal renal function, however, didanosine clearance decreases in proportion to creatinine clearance.

The metabolism of didanosine depends on the degree of liver dysfunction.

During the study of pharmacokinetics in children aged 1 to 17 years, the absorption of didanosine varied over a wide range. Despite this, the values of Cmax and AUC increased in proportion to the dose. The absolute oral bioavailability of didanosine was approximately 36% after the first dose and 47% at steady state.

T1 / 2 averages about 0.8 hours. After the first oral dose urinary didanosine concentrations were 18% and 21% at steady state. Renal clearance is about 243 ml / m2 / min, which is 46% of the total clearance from the body. As in adults, active tubular secretion was observed in children. When taking the drug orally for 26 days, cumulation of didanosine in children is not observed.

Use during pregnancy

There are no adequate and well-controlled studies in pregnant women. Videx should be used during pregnancy only if there are strict indications and only in cases where the potential benefit to the mother outweighs possible risk for the fetus.

During drug treatment breast-feeding should be stopped.

Contraindications for use

Children's age up to 3 years (for capsules, contraindication due to the method of application);
- phenylketonuria;
- lactation period;
- Hypersensitivity to didanosine and/or any of the excipients drug.

The drug should be used with caution in patients with an increased risk of developing pancreatitis, with a history of pancreatitis, with progressive HIV infection, in elderly patients, in the treatment of patients with impaired renal function with uncorrected doses of the drug.

With extreme caution should be used in patients with impaired liver function.

Side effects

Pancreatitis is a severe toxic effect of the drug. pancreatitis varying degrees severity, often fatal, may develop in a patient on different stages treatment and does not depend on whether the drug is used as monotherapy or in combination with other drugs, or on the degree of immunosuppression. Pancreatitis is a dose-dependent complication. When using a suspension, it is necessary to take into account data on an increase in the level of pancreatitis markers to clinically significant level even in the absence of symptoms.

Lactic acidosis / Severe form of steatosis with hepatomegaly, incl. fatal cases have been reported with nucleoside analogues alone or in combination with other antiviral agents, including didanosine. Basically, this side effect was observed in women. Obesity and long-term use nucleosides may be risk factors for this side effect. Treatment with the drug should be discontinued if patients develop clinical or laboratory signs lactic acidosis or hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of obvious signs increase in transaminase activity).

Peripheral neuropathy is usually accompanied by bilateral symmetrical numbness of the extremities: tingling and pain in the soles of the feet (and, to a lesser extent, in the hands). On the early stages diseases, these phenomena are less frequent. There is information that the course of peripheral neuropathy may be aggravated by the co-administration of antiretroviral drugs, including didanosine, and hydroxyurea.

From the digestive system: dry mouth, anorexia, nausea, vomiting, abdominal pain, diarrhea and increased gas formation, hepatitis, pancreatitis, increased activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, parotid hypertrophy salivary gland.

From the nervous system: paresthesia, pain in the hands and feet, headache.

On the part of the organ of vision: dry eyes, neuritis optic nerve, retinal depigmentation.

From the side musculoskeletal system: myalgia, arthralgia, myopathy, sialadenitis, rhabdomyolysis.

On the part of the hematopoietic organs: anemia, granulocytopenia, leukopenia, thrombocytopenia.

Laboratory indicators: hypo- and hyperkalemia, hyperuremia, increased concentrations of amylase and lipase, hypo- and hyperglycemia.

Other: alopecia, anaphylactoid / allergic reactions, asthenia, chills, itching, skin rash, lipodystrophy, lipoatrophy.

Side effects of the drug in children and adult patients are similar. The development of pancreatitis in children is observed in 3% of cases when taken in doses not exceeding the recommended ones, and in 13% when treated with the drug in higher doses. Visual disturbances are observed in children in rare cases and are characterized by changes in the retina and optic neuritis.

Dosage and administration

Capsules should be swallowed whole, without chewing, on an empty stomach.

≥60 kg. - 400 mg once a day

Overdose

There is no antidote for an overdose of didanosine.

Symptoms: pancreatitis, peripheral neuropathy, hyperuricemia, liver dysfunction.

Treatment: Didanosine is not removed from the body by peritoneal dialysis and very little by hemodialysis. During hemodialysis sessions lasting 3-4 hours, approximately 25-30% of didanosine is removed from the total concentration of didanosine circulating in the blood at the beginning of hemodialysis.

Interactions with other drugs

When using the drug Videx in combination with other drugs with similar toxicity (for example, with stavudine), the risk of developing the described side effects increases significantly.

When using the drug Videx in the form of tablets or powder for oral solution for children in patients with opioid dependence on the background of long-term treatment with methadone, a decrease in the AUC value of didanosine (by 57%) is observed. With the simultaneous use of drugs, the dose of Videx should be increased.

When used together with tenofovir, a decrease in the concentration of didanosine in the blood plasma is observed, so the dose of the drug must be adjusted.

Delavirdine or indinavir should be taken 1 hour before taking Videx in the form of tablets or powder for oral solution for children. In the presence of Videx, the AUC value of delavirdine or indinavir increases significantly. No drug interactions have been identified between indinavir and Videx capsules.

In special studies of multiple doses of Videx simultaneously with nevirapine, rifabutin, foscarnet, ritonavir, stavudine and zidovudine and a single dose of Videx simultaneously with loperamide, metoclopramide, ranitidine, sulfamethoxazole, trimethoprim drug interaction not found.

Ketoconazole or itraconazole whose oral absorption is affected by acidity gastric juice, should be taken 2 hours before taking the drug Videx in the form of tablets or powder for the preparation of an oral solution for children. Videx capsules do not contain antacids, so there is no risk of interaction between these drugs.

When taking the drug Videx in the form of tablets or powder for oral solution for children 2 hours before taking ganciclovir or simultaneously with it, the steady-state AUC of didanosine increases to an average of 111%. A slight decrease in AUC at steady state (by 21%) of ganciclovir was observed in cases where patients took Videx 2 hours before ganciclovir. No changes in renal clearance were observed for either of these two drugs. It is not known whether these changes are associated with changes in the safety of Videx or the effectiveness of ganciclovir. There is no evidence that didanosine enhances the myelosuppressive effects of ganciclovir.

Plasma concentrations of tetracycline antibiotics and some fluoroquinolone antibiotics (eg, ciprofloxacin) decrease in the presence of antacids, as form chelates. Therefore, Videx tablets containing antacids, or powder for oral solution for children dissolved in antacid suspension, should be taken at least 6 hours before or 2 hours after taking ciprofloxacin. Videx capsules do not contain antacids, so there is no risk of interaction with tetracycline and fluoroquinolone antibiotics.

Ribavirin may increase intracellular didanosine triphosphate levels and potentially increase the risk of side effects. Cases have been reported when didanosine was co-administered with ribavirin, with or without stavudine. liver failure with a fatal outcome, as well as cases of pancreatitis, peripheral neuropathy and systemic hyperlactatemia / lactic acidosis. The combined use of didanosine and ribavirin should be avoided unless the potential benefit outweighs the risk of side effects.

Less than 5% of didanosine is bound to plasma proteins, indicating a low likelihood of drug interactions involving displacement from binding sites.

Precautions for use

Fluoroquinolones, tetracyclines, dapsone, ketoconazole, itraconazole are administered 2 hours before or 2 hours after didanosine.

Special instructions for admission

Chewable tablets or for the preparation of a suspension for oral administration in children under 3 years of age are recommended to be used only in the form of a suspension.

With the simultaneous use of the drug Videx with drugs with a known toxic effect to the peripheral nervous system or pancreas, the risk of these toxic effects is greatly increased.

With the simultaneous administration of intravenous pentamidine or drugs that increase the activity of didanosine (hydroxycarbamide, allopurinol), it is recommended to use Videx in the form of a suspension.

Periodic vision checks should be made and any visual disturbances noted, such as altered color perception or blurry vision of objects.

Children should have a retinal examination every 6 months or whenever there is any change in vision.

Didanosine is rapidly destroyed in the acidic contents of gastric juice. Therefore, to reduce acidity, antacids are included in the composition of the tablets. Powder for oral solution for children should only be taken in combination with antacids. In capsules, didanosine is contained in the form of granules coated with an enteric coating, as a result of which the absorption of the drug in the intestine increases.

In HIV-infected patients with severe immunodeficiency during combined antiretroviral therapy symptoms may appear inflammatory response for asymptomatic or residual opportunistic infections. This syndrome was observed during the first few weeks or months after the start of antiretroviral therapy. There may be signs of cytomegalovirus retinitis, generalized or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci.

If symptoms of pancreatitis appear, treatment with the drug should be suspended, and when the diagnosis is confirmed, treatment should be stopped. With a clinically significant excess of the level of biochemical parameters, even in the absence of symptoms of pancreatitis, the drug should be prescribed in the form of a suspension.

If clinically confirmed symptoms of hepatotoxicity or lactic acidosis appear (even if hepatic transaminases are slightly above the upper limit of normal), treatment with the drug should be suspended. With a significant excess of the norm of these indicators, treatment should be discontinued.

Absorption of didanosine regardless of dosage form in the presence of food is reduced by an average of 50%. Tablets and powder for oral solution for children should be taken 30 minutes before or 2 hours after a meal, capsules should be taken on an empty stomach.

When prescribing the drug to patients with impaired renal function, it should be borne in mind that each tablet contains 8.6 meq of magnesium.

When prescribing the drug to patients with phenylketonuria, it should be borne in mind that each 100 mg tablet contains 36.5 mg of phenylalanine as part of aspartame. Capsules and powder for oral solution for children do not contain phenylalanine.

When prescribing the drug to patients on a salt-restricted diet, it should be borne in mind that 100 mg of the contents of the capsules contain at least 0.424 mg of sodium. Tablets do not contain sodium salts.

Powder for oral solution for children does not contain sodium salts. However, the sodium content should be taken into account when selecting and calculating the amount of antacids.

Dosage forms do not contain sucrose, therefore, restrictions on the use of the drug in patients diabetes no.

Storage conditions

At a temperature not higher than 25 °C.

Best before date

Belonging to ATX-classification:

** The Medication Guide is for informational purposes only. For more complete information please refer to the manufacturer's instructions. Do not self-medicate; Before you start using Videx, you should consult a doctor. EUROLAB is not responsible for the consequences caused by the use of the information posted on the portal. Any information on the site does not replace the advice of a doctor and cannot serve as a guarantee of the positive effect of the drug.

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Active substance

Didanosine (didanosine)

Release form, composition and packaging

Tablets for chewing or suspension for oral administration from white or almost white to light yellow, round, flat, with bevelled edges, marked "100" on one side and "VIDEX" on the other; slight marbling of the surface of the tablets is allowed.

The composition of the granules:

The composition of the capsule shell:
Ink Composition: shellac, propylene glycol, potassium hydroxide, titanium dioxide, iron dye red oxide, iron dye yellow oxide.

Capsules hard gelatin, size No. 2, consisting of two parts of an opaque white color with the inscriptions "BMS", "200 mg" and "6672" applied in green; the contents of the capsules are white or almost white granules coated with an enteric coating.

	1 caps.
didanosine	200 mg

The composition of the granules: sodium carboxymethyl starch, sodium carmellose.
The composition of the suspension for the shell of the granules: copolymer of methacrylic acid and ethacrylate, diethyl phthalate, water, talc.
The composition of the capsule shell: sodium lauryl sulfate, titanium dioxide, colloidal silicon dioxide, gelatin.
Ink Composition: shellac, propylene glycol, titanium dioxide, iron oxide yellow.

10 pieces. - blisters (3) - packs of cardboard.

Capsules hard gelatin, size No. 1, consisting of two parts of an opaque white color with the inscriptions "BMS", "250 mg" and "6673" printed in blue; the contents of the capsules are white or almost white granules coated with an enteric coating.

	1 caps.
didanosine	250 mg

10 pieces. - blisters (3) - packs of cardboard.

Capsules hard gelatin, size No. 0, consisting of two parts of an opaque white color with the inscriptions "BMS", "400 mg" and "6674" printed in red; the contents of the capsules are white or almost white granules coated with an enteric coating.

	1 caps.
didanosine	400 mg

10 pieces. - blisters (3) - packs of cardboard.

pharmachologic effect

An antiviral drug active against HIV. Didanosine (2",3"-dideoxyinosine or ddI), a synthetic analog of the nucleoside dioxyadenosine, inhibits HIV replication in cultured human cells and cell lines in vitro.

After entering the cell, didanosine is converted by cellular enzymes to the active metabolite dideoxyadenosine triphosphate (ddATP). During viral nucleic acid replication, the incorporation of 2",3"-dideoxynucleoside interferes with chain growth and thus suppresses viral replication. In addition, ddATP inhibits the activity of HIV reverse transcriptase by competing with dioxyadenosine 5-triphosphate (dATP) for binding to active sites of the enzyme, preventing the synthesis of proviral DNA.

Pharmacokinetics

Suction

From the digestive system: dry mouth, anorexia, nausea, vomiting, abdominal pain, diarrhea and increased gas formation, hepatitis, liver failure, portal hypertension not associated with liver cirrhosis, pancreatitis, increased activity of hepatic transaminases and alkaline phosphatase, increased concentrations of amylase and lipase, hyperbilirubinemia, hypertrophy parotid salivary gland, sialadenitis.

From the nervous system: paresthesia, headache.

From the side of the organ of vision: dry eyes, optic neuritis, retinal depigmentation.

From the musculoskeletal system: myalgia, arthralgia, myopathy, pain in the hands and feet, rhabdomyolysis.

From the side of the hematopoietic organs: anemia, granulocytopenia, leukopenia, thrombocytopenia.

Laboratory indicators: hypo- and hyperkalemia, hyperuricemia, hypo- and hyperglycemia.

Dermatological reactions: alopecia, itching, skin rash.

Others: anaphylactoid / allergic reactions, asthenia, chills, lipodystrophy, lipoatrophy.

Children

Overdose

There is no antidote for an overdose of didanosine.

Symptoms: pancreatitis, peripheral neuropathy, hyperuricemia, liver dysfunction.

Treatment: didanosine is not removed from the body by peritoneal dialysis and very little by hemodialysis. During hemodialysis sessions lasting 3-4 hours, approximately 25-30% of didanosine is removed from the total concentration of didanosine circulating in the blood at the beginning of hemodialysis.

drug interaction

When using the drug in combination with other drugs with similar toxicity (for example, with stavudine), the risk of developing the described side effects increases significantly.

When using the drug Videx in the form of tablets in patients with opioid dependence on the background of long-term treatment with methadone, a decrease in the AUC value of didanosine (by 57%) is observed. With the simultaneous use of drugs, the dose of Videx should be increased.

When used together with tenofovir, a decrease in the concentration of didanosine in the blood plasma is observed, so the dose of the drug must be adjusted.

Delavirdine or indinavir should be taken 1 hour before taking Videx tablets. In the presence of Videx, the AUC value of delavirdine or indinavir increases significantly. No drug interactions have been identified between indinavir and Videx capsules.

In special studies of the use of the drug Videx in multiple doses simultaneously with nevirapine, rifabutin, foscarnet, ritonavir, stavudine and zidovudine and the use of the drug Videx in a single dose simultaneously with loperamide, metoclopramide, ranitidine, sulfamethoxazole, trimethoprim drug interactions have not been identified.

Ketoconazole or itraconazole, the absorption of which, when taken orally, is affected by the acidity of gastric juice, should be taken 2 hours before taking the drug Videx in the form of tablets. Videx capsules do not contain antacids, so there is no risk of interaction between these drugs.

When taking the drug Videx in the form of tablets 2 hours before taking ganciclovir or simultaneously with it, the steady-state AUC of didanosine increases to an average of 111%. A slight decrease in the AUC of ganciclovir at steady state (by 21%) was noted in cases where patients took Videx 2 hours before ganciclovir. No changes in renal clearance were observed for either of these two drugs. It is not known whether these changes are associated with changes in the safety of Videx or the effectiveness of ganciclovir. There is no evidence that didanosine enhances the myelosuppressive effects of ganciclovir.

Plasma concentrations of tetracycline antibiotics and some fluoroquinolone antibiotics (eg, ciprofloxacin) decrease in the presence of antacids, as form chelates. Therefore, Videx tablets containing antacids should be taken at least 6 hours before or 2 hours after taking ciprofloxacin. Videx capsules do not contain antacids, so there is no risk of interaction with tetracycline and fluoroquinolone antibiotics.

Ribavirin may increase intracellular didanosine triphosphate levels and potentially increase the risk of side effects. Cases of fatal liver failure, as well as cases of pancreatitis, peripheral neuropathy, and systemic hyperlactatemia/lactic acidosis have been reported when didanosine was co-administered with ribavirin, with or without stavudine. The combined use of didanosine and ribavirin should be avoided unless the potential benefit outweighs the risk of side effects.

Less than 5% of didanosine is bound to plasma proteins, indicating a low likelihood of drug interaction involving displacement from binding sites.

special instructions

Chewable tablets or for the preparation of a suspension for oral administration in children under 3 years of age are recommended to be used only in the form of a suspension.

With the simultaneous use of the drug Videx with drugs with a known toxic effect on the peripheral nervous system or pancreas, the risk of these toxic effects increases significantly.

Periodic vision checks should be made and any visual disturbances noted, such as altered color perception or blurry vision of objects.

Children should have a retinal examination every 6 months or whenever there is any change in vision.

Didanosine is rapidly destroyed in the acidic contents of gastric juice. Therefore, to reduce acidity, antacids are included in the composition of the tablets. In capsules, didanosine is contained in the form of enteric-coated granules, as a result of which the absorption of the drug in the intestine increases.

In HIV-infected patients with severe immunodeficiency during combination antiretroviral therapy, signs of an inflammatory response to asymptomatic or residual opportunistic infections may occur. This syndrome was observed during the first few weeks or months after the start of antiretroviral therapy. There may be signs of cytomegalovirus retinitis, generalized or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci.

With the appearance of clinically confirmed symptoms of hepatotoxicity or lactic acidosis (even if hepatic transaminases slightly exceed ULN), treatment with the drug should be suspended. With a significant excess of the norm of these indicators, treatment should be discontinued.

There have been cases in post-marketing studies portal hypertension not associated with cirrhosis of the liver, including cases leading to liver transplantation, as well as to deaths. Didanosine-induced portal hypertension not associated with cirrhosis was confirmed by liver biopsy results in patients with
unconfirmed viral hepatitis. General signs development of portal hypertension included: increased activity of liver enzymes, varicose veins veins of the esophagus, hematemesis, ascites, splenomegaly.

Patients taking Videx should be regularly examined for the presence of early signs portal hypertension (eg, thrombocytopenia and splenomegaly) during routine visits to the doctor. Relevant laboratory
studies, including the study of the activity of liver enzymes, the level of bilirubin, serum albumin, a complete blood count, INR and ultrasonography, should be prescribed to such patients. Videx should be discontinued if the patient develops signs of portal hypertension not associated with liver cirrhosis.

The absorption of didanosine, regardless of dosage form, in the presence of food is reduced by an average of 50%. Tablets should be taken 30 minutes before or 2 hours after a meal, capsules should be taken on an empty stomach.

When prescribing the drug to patients with impaired renal function, it should be borne in mind that each tablet contains 8.6 mEq of magnesium.

When prescribing the drug to patients with phenylketonuria, it should be borne in mind that each 100 mg tablet contains 36.5 mg of phenylalanine as part of aspartame. The capsules do not contain phenylalanine.

Tablets and capsules do not contain sucrose, so there are no restrictions on the use of the drug in patients with diabetes mellitus.

Pregnancy and lactation

During treatment with the drug, breastfeeding should be discontinued.

Application in childhood

The use of capsules in children under the age of 3 years is contraindicated due to the method of application.

For impaired renal function

FROM caution the drug should be used in the treatment of patients with impaired renal function with uncorrected doses of the drug.

The drug should be stored out of the reach of children.

Videx refers to an antiviral drug, the drug is active against HIV. I will consider the instructions for using this tool in more detail.

What is the composition and form of release of Videx?

The drug is available in different dosage forms, one of them is a white powder, from which it is necessary to prepare a solution for oral administration. Its active ingredient is didanosine. The product is placed in colorless glass bottles and packed in cardboard packs.

The next dosage form is chewable tablets, slight marbling is allowed on their surface, their edges are beveled, there are markings in the form of "100" and "VIDEX". The active compound is didanosine in an amount of 100 mg.

Excipients of Videx tablets: calcium carbonate, crospovidone, magnesium hydroxide, magnesium stearate, aspartame, sorbitol, microcrystalline cellulose is present, there is a tangerine flavor. The medicine was placed in polyethylene bottles of 60 pieces.

Another form of medication is hard gelatin capsules, their size is No. 3, they white color, they have an inscription in the form of "BMS", "125 mg" and "6671", there are granules inside them. The active substance is didanosine in the amount of 125 mg.

The composition of the capsule shell: sodium lauryl sulfate, gelatin, titanium dioxide, in addition there is colloidal silicon dioxide. Medicine in blisters on ten pieces is placed in cardboard packs.

There are other green capsules, they are also gelatin in size No. 2, the amount of didanosine is 200 mg.

In addition, there are gelatin capsules size No. 1, white, printed with blue ink, the amount of didanosine is 250 mg. Inside the dosage form, granules are contained, they consist of sodium carboxymethyl starch, as well as sodium carmellose.

Another gelatin capsules, their size is No. 0, the number active ingredient equal to 400 mg. In addition, on the surface of the drug there is an inscription "6674", "BMS", "400 mg". Videx can only be purchased with a prescription. You can store the drug at a temperature of 15 degrees to 30, observing the expiration date of the medication marked on the package.

What is the action of Videx?

The antiviral drug Videx is described in the instructions for use as active against HIV, inhibits its replication in cultured cells. Didanosine, under the influence of cellular enzymes, is converted to the metabolite dideoxyadenosine triphosphate.

What are Videx's indications for use?

The drug is intended for the treatment of HIV infection in conjunction with other necessary medications.

What are the contraindications for Videx?

I will list in which situations Videx is not used, the contraindications are as follows:

Do not prescribe the drug to children under three years of age, this applies to the dosage form presented by capsules;
Contraindication is lactation;
In the presence of phenylketonuria;
At hypersensitivity to the didanosine component or to another substance of this medicine.

With caution, the drug is used at an increased risk of pancreatitis, in old age, with progressive HIV infection, with pathology of the kidneys and liver.

What is the use and dosage of Videx?

Videx is taken orally. Capsules are usually prescribed in a dosage of 250 to 400 mg once a day. They need to be swallowed whole on an empty stomach. Tablets and powder are consumed up to two times a day in the same dose.

Overdose Videx

In case of an overdose, some symptoms may occur in the form of peripheral neuropathy, pancreatitis may develop, hyperuricemia is not excluded. In this case, the patient is treated, due to hemodialysis, up to 30% of didanosine can be removed from the body. There is no antidote.

What are the side effects of Videx?

The most severe side effect of this drug is the development of pancreatitis, often fatal, it refers to a dose-dependent complication. The so-called lactic acidosis, which can also lead the patient to death, is not excluded.

Peripheral neuropathy is usually accompanied by bilateral numbness of the extremities, tingling and pain in the feet. In addition, there are side effects in digestive system, in particular, dry mouth, diarrhea, anorexia, nausea, there may be vomiting, hepatitis, abdominal pain, excessive gas formation, increased transaminases, and hyperbilirubinemia.

In addition to these manifestations, a headache develops, dryness in the eye area is noted, optic neuritis joins, retinal depigmentation is possible, myalgia, arthralgia occurs. In addition, myopathy, sialadenitis, anemia, rhabdomyolysis, as well as thrombocytopenia, granulocytopenia, leukopenia, hyperkalemia, hyperuremia, hypokalemia, increases the concentration of lipase and amylase.

Among other manifestations, alopecia, lipodystrophy are not excluded, a skin rash joins, there may be chills and, in addition, allergic reactions develop, itching on the skin joins.

What are Videx analogues?

Didanosine refers to analogues.

Conclusion

We talked about how and how HIV infection is treated - Videx treatment. The use of the drug is carried out after its appointment by the attending doctor, and after a series of relevant laboratory tests.

Be healthy!

Instructions for use:

Videx is an antiviral drug that is active against the human immunodeficiency virus (HIV).

Release form and composition

capsules 125 mg: hard gelatin, size No. 3, volume ~ 0.3 ml; consist of two opaque white parts filled with white or almost white granules in an enteric coating; the capsule is overprinted in yellow-brown color: “BMS”, “125 mg” and “6671” (10 pcs in blisters, 3 blisters in a carton box);
capsules 200 mg: hard gelatin, size No. 2, volume ~ 0.4 ml; consist of two opaque white parts filled with white or almost white granules in an enteric coating; the capsule is overprinted in green: “BMS”, “200 mg” and “6672” (10 pcs in blisters, 3 blisters in a carton box);
capsules 250 mg: hard gelatin, size No. 1, volume ~ 0.5 ml; consist of two opaque white parts filled with white or almost white granules in an enteric coating; Capsule is overprinted of blue color: "BMS", "250 mg" and "6673" (10 pcs in blisters, 3 blisters in a carton box);
capsules 400 mg: hard gelatin, size No. 0, volume ~ 0.68 ml; consist of two opaque white parts filled with white or almost white granules in an enteric coating; the capsule is overprinted in red: "BMS", "400 mg" and "6674" (10 pcs in blisters, 3 blisters in a carton box);
powder for oral solution for children: white or almost white (2 or 4 g in colorless glass bottles, 1 bottle in a cardboard box);
chewable/oral suspension tablets: flat, round, bevelled, pure white to light yellow, slight surface marbling possible; marking on one side - "100", on the other - VIDEX (60 pcs. in polyethylene bottles, screw caps, protected from opening by children, in cardboard box 1 vial).

Composition of 1 capsule:

active substance: didanosine - 125, 200, 250 or 400 mg;
granules: sodium carmellose, sodium carboxymethyl starch;
enteric coating of granules: methacrylic acid and ethacrylate copolymer, diethyl phthalate, talc, purified water;
capsule shell: colloidal silicon dioxide, sodium lauryl sulfate, titanium dioxide, gelatin;
ink: shellac, propylene glycol, capsules 125/200/250/400 mg - titanium dioxide, potassium hydroxide, iron oxide red and iron oxide yellow / titanium dioxide, indigo carmine, iron oxide yellow / indigo carmine / simethicone, ammonium hydroxide, iron dye red oxide.

The composition of the powder for oral solution for children (1 vial):

active ingredient: didanosine - 2000 or 4000 mg;
auxiliary components: none.

Composition of 1 chewable tablet / for suspension for oral administration:

active ingredient: didanosine - 100 mg;
auxiliary components: aspartame, magnesium hydroxide, calcium carbonate, sorbitol, crospovidone, microcrystalline cellulose, magnesium stearate, tangerine orange flavor.

Indications for use

Videx is used as part of highly active antiretroviral therapy in combination with other drugs that prevent the reproduction of HIV.

Contraindications

Absolute contraindications for all forms of release:

phenylketonuria;
the period of breastfeeding (lactation);
individual hypersensitivity to didanosine or auxiliary components medicinal product.

Capsules Videx in connection with the method of application is contraindicated for children under 3 years of age.

With caution, due to the increased likelihood of side effects, the drug is recommended to prescribe with a tendency to develop pancreatitis or a history of pancreatitis, progressive HIV infection, impaired renal / liver function, and in old age.

Pregnant women should take Videx only under strict indications and only if the expected benefit to the mother outweighs potential risk for the fetus. Lactation (breastfeeding) at the time of therapy should be interrupted.

Method of application and dosage

All dosage forms of the drug Videx are intended for oral administration.

Capsules are swallowed on an empty stomach, without chewing, whole; tablets and powder are taken at least half an hour before or two hours after meals. Tablets are thoroughly chewed or dissolved in water, stirring until a homogeneous suspension is obtained; antacids containing aluminum and magnesium hydroxides must be added to the powder.

patient weight 60 kg or more: capsules - 400 mg 1 time per day; tablets and powder - 400 mg 1 time per day or 200 mg twice a day;
patient weight up to 60 kg: capsules - 250 mg 1 time per day; tablets and powder - 250 mg 1 time per day or 125 mg twice a day.

If daily dose divided into two doses, the interval between them should be 12 hours.

The required dose is selected by combining tablets different dosages(to avoid possible overdose of the antacids and/or phenylalanine contained in them), it should include 2 to 4 tablets totaling the recommended dose.

Children under one year old receive 1 tablet per dose, at a dose that provides the prescribed amount of antacids.

Children under 3 years of age take tablets in the form of a suspension prepared from them for oral administration.

To prepare a suspension adult dose dissolved in ~ 30 ml; for children, 1 tablet is dissolved in ~ 15 ml of water. To improve the taste of the suspension, apple juice without pulp can be added: for adults ~ 30 ml, for children ~ 15 ml. After that, the suspension is stirred and drunk, because. finished product stable at room temperature from 17 to 23 °C for no more than 1 hour.

For the first time, a preparation from a powder for preparing an oral solution for children is prepared directly by the attending physician, while simultaneously teaching the patient (or his parents). The exact dose is determined individually depending on the type of antacid, concomitant treatment and other factors. Dosing of the finished solution can be carried out using a syringe of the appropriate volume.

Calculation of the daily dose of the powder depending on the age of the child and the surface area of the body (provided that it is taken 2 times a day with an interval of 12 hours):

from birth to 8 months: 100 mg / m 2;
from 8 months and older: 120 mg / m 2.

Patient weight 60 kg or more, QC (ml / min / 1.73 m 2):

CC ≥ 60: (usual dose) capsules - 400 mg 1 time per day; tablets and powder - 400 mg 1 time per day or 200 mg twice a day;
KK 30-59: capsules - 200 mg 1 time per day; tablets and powder - 200 mg 1 time per day or 100 mg twice a day;
KK 10-29: capsules - 125 mg 1 time per day; tablets and powder - 150 mg 1 time per day;
QC< 10: капсулы – 125 мг 1 раз в сутки; таблетки и порошок – 100 мг 1 раз в сутки.

Patient weight less than 60 kg, QC (ml / min / 1.73 m 2):

CC ≥ 60: (usual dose) capsules - 250 mg 1 time per day; tablets and powder - 250 mg 1 time per day or 125 mg twice a day;
KK 30-59: capsules - 125 mg 1 time per day; tablets and powder - 150 mg 1 time per day or 75 mg twice a day;
KK 10-29: capsules - 125 mg 1 time per day; tablets and powder - 100 mg 1 time per day;
QC< 10: капсулы заменяют другой лекарственной формой; таблетки и порошок – 75 мг 1 раз в сутки.

Patients on dialysis should take the daily dose of Videx immediately after the procedure, an additional dose of the drug is not needed.

At kidney failure in children there are no exact recommendations for dose adjustment, it may be necessary to increase the interval between doses or reduce the dose of the drug.

Elderly patients need to select a dose more carefully, since an age-related decrease in kidney function is possible. Requires monitoring of kidney function and appropriate dose adjustment.

Patients with hepatic insufficiency may require a dose reduction depending on the level of liver enzymes. A clinically significant excess of their level may require interruption of therapy with Videx, and in the case of a rapid increase in the level of transaminases, termination or suspension of treatment with any nucleoside analogues.

Side effects

pancreatitis: a severe toxic reaction (of varying severity, up to death) to didanosine may develop in patients at different stages of treatment, regardless of the degree of immunosuppression and whether Videx is used in combination with other drugs or for monotherapy; pancreatitis is a dose-dependent complication. In the case of using a suspension, it is important to take into account the availability of data on the increase in the level of pancreatitis markers to clinically significant ones, even in the absence of external symptoms;
lactic acidosis and / or severe steatosis with hepatomegaly (up to death): noted due to the use of nucleoside analogues, including didanosine for monotherapy or in combination with other antiretroviral drugs. Mostly observed in women, while exacerbating the risk of data side effects may long-term use of nucleosides and obesity. In the event of the development of clinical or laboratory indicators of lactic acidosis and / or hepatotoxicity (such as hepatomegaly and steatosis, even without obvious signs of an increase in aminotransferase activity), the drug should be discontinued;
peripheral neuropathy: accompanied by usually symmetrical bilateral numbness of the extremities with tingling and pain in the soles of the feet (less pronounced in the hands), on early stages complication is less common; according to observations, the course of the disease can be aggravated by the combined use of antiretroviral drugs, including didanosine with hydroxyurea.

Other adverse reactions from organs and systems:

digestive system: nausea / vomiting, dry mouth, abdominal pain, diarrhea with increased gas formation, anorexia, pancreatitis, hepatitis, hyperbilirubinemia, increased activity of hepatic aminotransferases and alkaline phosphatase, hypertrophy of the parotid salivary glands;
nervous system: paresthesia, headache, pain in the hands and feet;
organ of vision: dry eyes, retinal depigmentation, optic neuritis;
musculoskeletal system: arthralgia, myalgia, myopathy, rhabdomyolysis, sialadenitis;
hematopoietic organs: anemia, leukopenia, granulocytopenia, thrombocytopenia;
laboratory indicators: hyperuricemia, hypo- and hyperglycemia, hypo- and hyperkalemia, increased concentrations of lipase and amylase;
other reactions: alopecia, asthenia, chills, anaphylactoid / allergic reactions, itching, skin rash, lipoatrophy, lipodystrophy.

In children, side effects are similar to complications in adult patients. Pancreatitis in children when taking Videx in doses not exceeding the recommended ones is observed in 3% of cases, at higher doses - in 13%. Rarely, children also have visual disturbances characterized by optic neuritis and changes in the retina.

Symptoms of an overdose of didanosine are: peripheral neuropathy, pancreatitis, hyperuricemia, liver failure. There is no specific antidote, the drug is not excreted by peritoneal dialysis, in insignificant degree excreted by hemodialysis (only about 25-30% of didanosine of the total concentration at the beginning of hemodialysis in 3-4 hours).

special instructions

Simultaneous use of Videx and medicines established toxic effects on the peripheral nervous system or on the pancreas significantly increases the likelihood of these negative side effects.

Videx simultaneously with pentamidine for intravenous use or drugs that increase the activity of didanosine (allopurinol, hydroxyurea), it is recommended to use in the form of a suspension.

It is required to periodically check vision and note any violations, including changes in color perception, blurry vision of objects, etc. childhood it is required to examine the retina every six months and with the appearance of any changes in the organ of vision.

Due to the rapid destruction of didanosine in the acidic environment of gastric juice, antacids are included in the tablets (to reduce acidity). The oral solution for children from the powder is also taken only in a mixture with antacids. Didanosine in capsules is contained in the form of enteric-coated granules, which significantly increases the absorption of the drug in the intestine. Regardless of the dosage form of Videx, in the presence of food, the absorption of didanosine is reduced by an average of 50%.

Signs of an inflammatory response to asymptomatic or residual opportunistic infections may appear in patients with HIV with severe immunodeficiency during combined antiretroviral treatment. Usually the syndrome is observed during the first few weeks / months after the start of therapy. There is a possibility of signs in the form of generalized or focal mycobacterial infections, pneumocystis pneumonia, cytomegalovirus retinitis.

At the first symptoms of pancreatitis, drug therapy must be suspended, and if the diagnosis is confirmed, discontinued. A clinically significant excess of the level of biochemical parameters, even if there are no symptoms of pancreatitis, requires the appointment of Videx in the form of a suspension.

The appearance of clinically confirmed symptoms of hepatotoxicity / lactic acidosis (even if the liver transaminases are slightly higher than upper bound norm) indicates the need to interrupt treatment with didanosine. If the excess of the norm in these indicators is significant, the treatment is stopped.

impaired kidney function: it is required to take into account the magnesium content - 8.6 meq / 1 tablet;
phenylketonuria: it is required to take into account the content of phenylalanine in the composition of aspartame - 36.5 / 1 tablet (100 mg); capsules and powder do not contain phenylalanine;
salt-restricted diet: the presence of sodium in the contents of the capsules should be taken into account - at least 0.424 / 100 mg; tablets and powder do not contain sodium salts, but in the case of using a powder, the sodium content should be taken into account when selecting and calculating the dose of antacids;
diabetes mellitus: Videx does not contain sucrose in any form of release, so patients can take the drug without restrictions.

drug interaction

stavudine and other drugs with similar toxicity to didanosine: the likelihood of side effects increases significantly;
allopurinol: the risk of developing pancreatitis increases in proportion to the increase in the dose of didanosine ( joint application contraindicated);
methadone (in patients with opioid dependence on the background of long-term treatment): when used with Videx in the form of tablets or powder, the AUC value (area under the concentration-time curve) of didanosine decreases significantly (up to 57%), which requires an increase in its dose;
tenofovir: reduces the plasma concentration of didanosine (dose adjustment is necessary);
indinavir, delavirdine: the AUC value of indinavir / delavirdine in the presence of Videx increases significantly, so they are taken one hour before taking the drug in the form of tablets or powder; interaction with capsules was not revealed;
ketoconazole, itraconazole (for oral administration): their absorption is affected by the acidity of gastric juice, reduced by antacids contained in Videx tablets and powder, which should be taken 2 hours after taking ketoconazole and itraconazole; there is no possibility of interaction with capsules;
ganciclovir: taking Videx in the form of tablets or powder 2 hours before ganciclovir or simultaneously with it increases the AUC of didanosine at steady state by an average of 111%, reduces the AUC of ganciclovir at steady state by 21% (in the case of taking Videx 2 hours before ganciclovir ); at the same time, the renal clearance of none of the drugs did not change, the relationship of changes in AUC with the safety of using Videx or the effectiveness of ganciclovir has not been established; data confirming an increase in the myelosuppressive effects of ganciclovir under the action of didanosine have been reported;
tetracycline antibiotics, some fluoroquinolone antibiotics (ciprofloxacin): their plasma concentration decreases in the presence of antacids due to the formation of chelate compounds, and therefore Videx tablets and powder are taken at least 6 hours before or 2 hours after taking ciprofloxacin and other tetracycline antibiotics /fluoroquinolone series; Videx capsules do not contain antacids, so there is no possibility of interaction;
ribavirin: able to increase the level of intracellular didanosine triphosphate, increasing the risk of side effects; the combined use of didanosine with ribavirin (in combination with stavudine or without) can cause liver failure up to death, as well as pancreatitis, systemic hyperlactatemia / lactic acidosis, peripheral neuropathy; this combination should be avoided unless the potential benefit of therapy outweighs the risk of side effects;
nevirapine, rifabutin, foscarnet, ritonavir, stavudine and zidovudine: according to special studies with repeated use with didanosine, drug interactions have not been identified;
loperamide, metoclopramide, ranitidine, sulfamethoxazole, trimethoprim: according to special studies, no drug interactions have been identified with single use with didanosine.

The likelihood of drug interactions occurring due to the displacement of didanosine from binding sites is negligible, since it binds to plasma proteins in less than 5%.

Analogues

An analogue of Videx is Didanosine.

Terms and conditions of storage

Keep away from children. Store at a temperature: tablets and powder - 15-30 ° C, capsules - up to 25 ° C.

Best before date:

capsules and tablets, chewable or for the preparation of a suspension for oral administration - 2 years;
powder for oral solution for children - 3 years.

Registration number:

P N013843/01-070508

Tradename : Videx®

International non-proprietary name:

didanosine

chemical name : 2",3"-dideoxyinosine

Dosage form:

chewable tablets or for the preparation of a suspension for oral administration; capsules, powder for oral solution for children.

Composition:

Each tablet contains active substance- didanosine 100 mg.
Excipients: calcium carbonate, magnesium hydroxide, aspartame, sorbitol, microcrystalline cellulose, crospovidone, tangerine orange flavor, magnesium stearate.
Capsules
Each capsule contains active substance- didanosine 125 mg, 200 mg, 250 mg or 400 mg.
Excipients:

Composition:

granules: sodium carboxymethyl starch, sodium carmellose.

Composition:

suspensions for shell granules: methacrylic acid and ethacrylate copolymer, diethyl phthalate, water, talc.

Composition:

capsule shells: sodium lauryl sulfate, titanium dioxide, colloidal silicon dioxide, gelatin.

Composition:

ink: capsules 125 mg - shellac, propylene glycol, potassium hydroxide, titanium dioxide, iron dye red oxide and iron dye yellow oxide;
capsules 200 mg - shellac, propylene glycol, indigo carmine, titanium dioxide, iron dye yellow oxide; capsules 250 mg - shellac, propylene glycol, indigo carmine; capsules 400 mg - shellac, propylene glycol, simethicone, iron dye red oxide, aqueous ammonia.
Each bottle contains the active substance - didanosine 2 g. There are no excipients.

Description

Tablets for chewing or suspension for oral administration
Round, flat tablets with bevelled edges from white or almost white to light yellow, marked "100" on one side of the tablet and "VIDEX" on the other. Slight "marbling" of the surface of the tablets is allowed.
Capsules
Hard gelatin capsules, consisting of two parts of an opaque white color. Contents of capsules: white or almost white granules, enteric-coated.
Capsules 125 mg: Size #3. The inscriptions "BMS", "125 mg" and "6671" are applied in yellow-brown.
Capsules 200 mg: Size #2. The inscriptions "BMS", "200 mg" and "6672" are printed in green.
Capsules 250 mg: Size #1. The inscriptions "BMS", "250 mg" and "6673" are printed in blue.
Capsules 400 mg: Size #0. The inscriptions "BMS", "400 mg" and "6674" are printed in red.
Powder for oral solution for children
Powder of white or almost white color.

Pharmacotherapeutic group:

Antiviral (HIV) agent.

Pharmacological properties:

Pharmacodynamics
Didanosine (2",3"-dideoxyinosine or ddl) is a synthetic analog of the nucleoside dioxyadenosine that inhibits HIV replication in cultured human cells and in cell lines in vitro.
After entering the cell, didanosine is converted by cellular enzymes to the active metabolite dideoxyadenosine triphosphate (ddATO). During viral nucleic acid replication, the incorporation of 2",3"-dideoxynucleoside interferes with chain growth and thus suppresses viral replication.
In addition, ddATO inhibits HIV reverse transcriptase activity by competing with dioxyadenosine 5-triphosphate (dATO) for binding to active sites of the enzyme, preventing proviral DNA synthesis.

Pharmacokinetics
Absorption
The area under the concentration-time curve (AUC) of didanosine in blood plasma and the maximum plasma concentration (Cmax) when taking capsules and tablets are equal. Compared with tablets, the absorption rate of the drug from capsules is lower, the Cmax value of capsules is 60% of the Cmax value of tablets. The time to reach Cmax is approximately 2 hours for Videx capsules and 0.67 hours for Videx tablets.
Tablets and powder should be taken at least 30 minutes before or 2 hours after a meal. If the drug is taken earlier than 2 hours after a meal, the Cmax and AUC values decrease by approximately 55%. When taking the drug during meals, the bioavailability of didanosine is reduced by approximately 50%.
Capsules should be taken on an empty stomach, at least 1.5 hours before or 2 hours after meals. When using capsules with fatty foods, the Cmax and AUC values are reduced by 46% and 19%), respectively.
Metabolism
The metabolism of didanosine in humans has not been studied. Animal studies suggest that in humans it occurs via the endogenous purine pathway.
breeding
After oral administration, the half-life of the drug is on average 1.6 hours, approximately 20% of the dose taken is found in the urine.
Renal clearance is 50% of the total clearance (800 ml/min), indicating active tubular secretion during renal excretion of didanosine along with glomerular filtration.
Pharmacokinetics in renal dysfunction
After oral administration, the elimination half-life increases on average from 1.4 hours in patients with normal renal function to 4.1 hours in patients with severely impaired renal function. In the peritoneal dialysis fluid, didanosine is not detected, while during hemodialysis after 3-4 hours, didanosine concentrations are 0.6-7.4% of the administered dose. The absolute bioavailability does not change in patients with severely impaired renal function, compared with patients with normal renal function, however, didanosine clearance decreases in proportion to creatinine clearance.
Pharmacokinetics in violation of liver function
The metabolism of didanosine depends on the degree of liver dysfunction.
Pharmacokinetics in children and adolescents.
During the study of pharmacokinetics in children aged 1 to 17 years, the absorption of didanosine varied over a wide range. Despite this, the values of Cmax and AUC increased in proportion to the dose. The absolute oral bioavailability of didanosine was approximately 36% after the first dose and 47% at steady state.
The elimination half-life averages about 0.8 hours. After the first oral dose, urinary concentrations of didanosine were 18% and 21% at steady state. Renal clearance is about 243 ml / m / min, which accounted for 46% of the total clearance from the body. As in adults, active tubular secretion was observed in children. With oral administration of the drug for 26 days, cumulation of didanosine in children is not observed.

Indications for use:

Treatment HIV infection(in combination with other antiretroviral drugs).

Contraindications:

Hypersensitivity to didanosine and / or any of the excipients of the drug, phenylketonuria, lactation.
Capsules are contraindicated for children under 3 years of age (contraindication due to the method of application).

Carefully
The drug should be used with caution in patients with an increased risk of developing pancreatitis, with a history of pancreatitis, with progressive HIV infection, in elderly patients, in the treatment of patients with impaired renal function with uncorrected doses of the drug. With particular caution should be used in patients with impaired liver function.

Pregnancy and lactation

Dosage and administration:

inside.

Capsules should be swallowed whole, without chewing, on an empty stomach.

Tablets for oral suspension or chewing and powder for oral solution. The recommended daily dose depends on body weight. Tablets or powder are taken 1 or 2 times a day (see table). When taking the drug twice a day, the interval between doses should be 12 hours.

You can choose the required dose by a combination of tablets of different dosages, avoiding possible overdose antacids or phenylalanine contained in tablets. Each dose of the drug should consist of at least 2 tablets, but not more than 4 tablets, in total not exceeding the recommended dose. Children under 1 year of age should receive one tablet per dose, which would provide enough antacids for this age group.
Taking tablets by children under 3 years of age is recommended only in the form of a suspension. Tablets are taken at least 30 minutes before or 2 hours after a meal. The tablet should be thoroughly chewed or dissolved in at least 30 ml of water, mixing thoroughly until a homogeneous suspension is obtained. For children, the recommended dose of 1 tablet is dissolved in 15 ml of water. To correct the taste, you can add about 30 ml (for adults) or 15 ml (for children) apple juice without pulp.
After preparation, the resulting suspension should be mixed and drunk whole. The resulting suspension is stable for 1 hour when stored at room temperature (17-23°C).
For newborns and children under 8 months of age, the daily dose is calculated depending on the surface area of the body and is 100 mg / m2 per day twice a day with an interval of 12 hours.
For children older than 8 months, the daily dose is 120 mg / m2 twice a day with an interval of 12 hours.
Powder for the preparation of an oral solution for children should be taken at least 30 minutes before or 2 hours after a meal only mixed with antacids containing aluminum and magnesium hydroxides (oxides). We propose to divide antacids into three groups (A, B and C), depending on the content of these active substances. The first column indicates the content of magnesium hydroxide (oxide) in mg per 5 ml of the preparation, the second - the amount of aluminum hydroxide that should be contained in the preparation, the third - the group to which the preparation belongs.

Hydroxide content magnesium*, mg/5 ml.	Hydroxide content aluminum, mg/5 ml (**).	The group to which it belongs antacid drug.
400	400 to 900	BUT
350	425 to 900	BUT
300	450 to 900	BUT
250	200 to 450	IN
200	213 to 450	IN
150	225 to 450	IN
125	100 to 225	C
100	107 to 225	C
75	113 to 225	C

Before preparing the solution, determine which group antacids yours applies.
* If the content of magnesium hydroxide falls between the indicated values, it is possible to use the drug in the case when the minimum content of aluminum hydroxide compensates for the reduced content of magnesium hydroxide.
– For example, a preparation contains 325 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide, then the preparation belongs to group A. The minimum content of aluminum hydroxide is calculated as follows: a decrease in the content of magnesium hydroxide by 1 mg requires an increase in the content of aluminum hydroxide by at least 0.5 mg. In our example: a reduction in magnesium hydroxide by 75 mg (from 400 mg to 325 mg) requires a minimum increase in aluminum hydroxide by 37.5 mg (rounded up by 38 mg). Therefore, the content of aluminum hydroxide in the preparation should be at least 438 mg.
– For example, a preparation contains 175 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide, the preparation belongs to group B. The minimum content of aluminum hydroxide is calculated as follows: a decrease in the content of magnesium hydroxide by 1 mg requires an increase in the content of aluminum hydroxide by at least 0.25 mg. In our example: a reduction in magnesium hydroxide by 75 mg (from 250 mg to 175 mg) requires a minimum increase in aluminum hydroxide by 18.75 mg (rounded up by 19 mg). Therefore, the content of aluminum hydroxide in the preparation should be at least 219 mg.
– For example, if a preparation contains 85 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide, the preparation belongs to group C. The minimum content of aluminum hydroxide is calculated as follows: a decrease in the content of magnesium hydroxide by 1 mg requires an increase in the content of aluminum hydroxide by at least 0.25 mg. In our example: a 40 mg decrease in magnesium hydroxide (from 125 mg to 85 mg) requires a minimum increase in aluminum hydroxide by 10 mg. Therefore, the content of aluminum hydroxide in the preparation should be at least 110 mg.
** If the preparation contains aluminum oxide, its content is converted to aluminum hydroxide: 1 mg of oxide corresponds to 1.53 mg of aluminum hydroxide.

Preparation of a solution with preparations of group A.
Add 100 ml of water up to the 100 ml mark on the vial label to form a solution with a concentration of didanosine of 20 mg/ml. Mix well. Add the antacid suspension up to the 200 ml mark on the vial label. The concentration of didanosine in the suspension is 10 mg/ml. Mix well.
Preparation of a solution with drugs of group B.
Add 100 ml of antacid suspension up to the 100 ml mark on the vial label to form a suspension with a concentration of didanosine of 20 mg/ml. Mix well. Add the antacid suspension up to the 200 ml mark on the vial label. The concentration of didanosine in the suspension is 10 mg/ml. Mix well.
Preparation of a solution with drugs of group C.
Add 100 ml of antacid suspension up to the 100 ml mark on the vial label. Mix well. Add the antacid suspension up to the 200 ml mark on the vial label. Mix well. Transfer the resulting suspension to a glass or plastic bottle of a suitable size and add another 200 ml of the antacid suspension to it. The concentration of didanosine in the resulting suspension is 5 mg / ml, the resulting suspension is enough for half a day less than when using antacids of groups A and B.

Store the prepared mixture in a tightly closed bottle in the refrigerator (from 2 to 8°C) for no more than 30 days. Shake before use. Unused drug after 30 days of storage is thrown away.

Creatinine clearance (ml/min/1.73 m²)	Capsules	Tablets a and powder for preparing a solution for ingestion for children
Body weight > 60 kg
≥60 (usual dose)	400 mg once a day	400 mg once daily or 200 mg twice daily
30-59	200 mg once a day	200 mg once daily or 100 mg twice daily
10-29	125 mg once a day	150 mg once a day
<10	125 mg once a day	100 mg once a day
Body mass< 60 кг
≥60 (usual dose)	250 mg once a day	250 mg once a day or 125 mg twice a day
30-59	125 mg once a day	150 mg once a day or 75 mg twice a day
10-29	125 mg once a day	100 mg once a day
<10	- b	75 mg once a day

a Each dose of the drug must consist of at least 2 tablets, but not more than 4 tablets, in total not exceeding the recommended dose. You can choose the dose by a combination of tablets of different dosages.
b Patients with body weight Patients on dialysis should take the daily dose of the drug after dialysis. There is no need for an additional dose of the drug.
Children with impaired renal function. There are no precise recommendations for adjusting the dose of the drug in children. It is possible to reduce the dose and / or increase the interval between doses of the drug.
For elderly patients careful selection of the dose is necessary in view of the possible decrease in renal function. It is necessary to monitor renal function and, accordingly, adjust the dose of the drug.
For patients with impaired liver function dose reduction may be required. There are no exact recommendations for changing the dose of the drug in patients with impaired liver function. During treatment with the drug, it is necessary to examine the level of liver enzymes. With a clinically significant excess of the level of liver enzymes, it is necessary to suspend treatment with the drug. With a rapidly increasing level of aminotransferases, it may be necessary to stop or suspend treatment with any nucleoside analogs.

Side effect:

pancreatitis is a severe toxic effect of the drug. Pancreatitis of varying severity, often fatal, may develop in a patient at different stages of treatment and does not depend on whether the drug is used as monotherapy or in combination with other drugs, or on the degree of immunosuppression. Pancreatitis is a dose-dependent complication. When using a suspension, it is necessary to take into account data on an increase in the level of pancreatitis markers to a clinically significant level, even in the absence of symptoms.
Lactic acidosis/Severe steatosis with hepatomegaly, including fatal cases, have been observed with the use of nucleoside analogs alone or in combination with other antiviral drugs, including didanosine. Basically, this side effect was observed in women. Obesity and long-term use of nucleosides may be risk factors for this side effect. Treatment with the drug should be discontinued if patients develop clinical or laboratory signs of lactic acidosis or hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of obvious signs of an increase in transaminase activity).
Peripheral neuropathy usually accompanied by bilateral symmetrical numbness of the extremities: tingling and pain in the soles of the feet and, to a lesser extent, in the hands. In the early stages of the disease, these phenomena are less frequent. There is information that the course of peripheral neuropathy may be aggravated by the co-administration of antiretroviral drugs, including didanosine, and hydroxyurea.
From the digestive system: anorexia, nausea, vomiting, abdominal pain, diarrhea and increased gas formation, hepatitis, pancreatitis, parotid salivary gland hypertrophy, lipodystrophy, lipoatrophy.
From the nervous system: paresthesia, pain in the hands and feet, headache.
From the sense organs: dry mouth, dry eyes.
From the musculoskeletal system: myalgia, arthralgia and myopathy, sialadenitis.
From the side of the hematopoietic organs: anemia, granulocytopenia, leukopenia, thrombocytopenia.
From the side of the organs of vision: optic neuritis, retinal depigmentation.
Laboratory indicators: hypo- and hyperkalemia, hyperuricemia, increased concentrations of amylase and lipase, increased activity of "liver" transaminases and alkaline phosphatase, hyperbilirubinemia, hypo- and hyperglycemia.
Others: alopecia, anaphylactoid / allergic reactions, asthenia, chills, pruritus, rhabdomyolysis, skin rash.
Children. Side effects of the drug in children and adult patients are similar. The development of pancreatitis in children is observed in 3% of cases when taken in doses not exceeding the recommended ones and in 13% when treated with increased doses of the drug. Visual disturbances are observed in children in rare cases and are characterized by changes in the retina and optic neuritis.

Overdose:

There is no antidote for an overdose of didanosine.
The main manifestations of an overdose of the drug: pancreatitis, peripheral neuropathy, hyperuricemia, abnormal liver function.
Didanosine is not removed from the body by peritoneal dialysis and very little by hemodialysis. During hemodialysis sessions lasting 3-4 hours, approximately 25-30% of didanosine is removed from the total concentration of didanosine circulating in the blood at the beginning of hemodialysis.

Interaction with other medicinal products and other forms of interaction

When using the drug Videx in combination with other drugs with similar toxicity (for example, with stavudine), the risk of developing the described side effects increases significantly.
Allopurinol is not recommended to be used simultaneously with Videx. The risk of developing pancreatitis increases in proportion to the increase in the concentration of the drug Videx.
Methadone. When using Videx tablets or powder in patients with opioid dependence on the background of long-term treatment with methadone, a decrease in the AUC value of didanosine by 57% is observed. With the simultaneous use of drugs, the dose of Videx should be increased.
Tenofovir. When used together, a decrease in the level of Videx is observed, so the dose of the drug must be adjusted.
Delavirdine or indinavir should be taken 1 hour before Videx tablets or powder. In the presence of Videx, the AUC value of delavirdine or indinavir increases significantly. No drug interactions have been identified between indinavir and Videx capsules.
In special studies of multiple doses of the drug simultaneously with nevirapine, rifabutin, foscarnet, ritonavir, stavudine and zidovudine and a single dose of the drug simultaneously with loperamide, metoclopramide, ranitidine, sulfamethoxazole, trimethoprim, no drug interactions were identified.
Ketoconazole or itraconazole, the absorption of which, when taken orally, is affected by the acidity of gastric juice, should be taken 2 hours before taking Videx tablets or powder. Videx capsules do not contain antacids, so there is no risk of interaction between these drugs.
When taking the drug Videx (tablets or powder) 2 hours before taking ganciclovir or simultaneously with it, the steady-state AUC of didanosine increases to an average of 111%. A slight decrease in AUC at steady state (by 21%) of ganciclovir was observed in cases where patients took Videx 2 hours before ganciclovir. No changes in renal clearance were observed for either of these two drugs. It is not known whether these changes are associated with changes in the safety of Videx or the effectiveness of ganciclovir. There is no evidence that didanosine enhances the myelosuppressive effects of ganciclovir.
Concentrations of tetracycline antibiotics and some fluoroquinolone antibiotics (eg, ciprofloxacin) in blood plasma decrease in the presence of antacids, as they form chelate compounds.
Therefore, Videx tablets containing antacids, or a powder dissolved in an antacid suspension, should be taken at least 6 hours before or 2 hours after taking ciprofloxacin.
Videx capsules do not contain antacids, so there is no risk of interaction with tetracycline and fluoroquinolone antibiotics.
Ribavirin may increase intracellular didanosine triphosphate levels and potentially increase the risk of side effects. Cases of fatal liver failure, as well as cases of pancreatitis, peripheral neuropathy, and systemic hyperlactatemia/lactic acidosis have been reported when didanosine was co-administered with ribavirin, with or without stavudine. The combined use of didanosine and ribavirin should be avoided unless the potential benefit outweighs the risk of side effects.
Less than 5% of didanosine is bound to plasma proteins, indicating a low likelihood of drug interactions involving displacement from binding sites.

special instructions

An association between in vitro susceptibility of HIV to didanosine and clinical response to treatment has not been established. In vitro susceptibility results vary widely. A positive in vivo correlation has been established between viral activity measurements (eg, RNA polymerase chain reaction assays) and clinical disease progression.
The appointment of chewable tablets or for the preparation of a suspension for oral administration to children under 3 years of age is recommended only in the form of a suspension.
With the simultaneous use of the drug Videx with drugs with a known toxic effect on the peripheral nervous system or pancreas, the risk of these toxic effects increases significantly.
With the simultaneous administration of pentamidine intravenously or drugs that increase the activity of didanosine (hydroxyurea, allopurinol), it is recommended to use Videx in the form of a suspension.
Periodic vision checks should be made and any visual disturbances noted, such as altered color perception or blurry vision of objects.
Children should have a retinal examination every 6 months or whenever there is any change in vision.
Didanosine is rapidly destroyed in the acidic contents of gastric juice. Therefore, to reduce acidity, antacids are included in the composition of the tablets. The powder solution should only be taken in combination with antacids. In capsules, didanosine is contained in the form of granules coated with an enteric coating, as a result of which the absorption of the drug in the intestine increases.
In HIV-infected patients with severe immunodeficiency during combination antiretroviral therapy, signs of an inflammatory response to asymptomatic or residual opportunistic infections may occur. This syndrome was observed during the first few weeks or months after the start of antiretroviral therapy. There may be signs of cytomegalovirus retinitis, generalized or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci.
If symptoms of pancreatitis appear, treatment with the drug should be suspended, and when the diagnosis is confirmed, treatment should be stopped. With a clinically significant excess of the level of biochemical parameters, even in the absence of symptoms of pancreatitis, the drug should be prescribed in the form of a suspension.
If clinically confirmed symptoms of hepatotoxicity or lactic acidosis appear (even if hepatic transaminases are slightly above the upper limit), treatment with the drug should be suspended. With a significant excess of the norm of these indicators, treatment should be discontinued.
The absorption of didanosine, regardless of dosage form, in the presence of food is reduced by an average of 50%. Tablets and powder should be taken 30 minutes before or 2 hours after a meal, capsules should be taken on an empty stomach.
When prescribing the drug to patients with impaired renal function, it should be borne in mind that each tablet contains 8.6 mEq of magnesium.
When prescribing the drug to patients with phenylketonuria, it should be borne in mind that: each 100 mg tablet contains 36.5 mg of phenylalanine as part of aspartame.
Capsules and powder for oral solution for children do not contain phenylalanine.
When prescribing the drug to patients on a salt-restricted diet, it should be borne in mind that 100 mg of the contents of the capsules contain at least 0.424 mg of sodium.
Tablets do not contain sodium salts.
Powder for oral solution for children does not contain sodium salts. However, the sodium content should be taken into account when selecting and calculating the amount of antacids.
Dosage forms do not contain sucrose, so there are no restrictions on the use of the drug in patients with diabetes mellitus.

Release form

Tablets for oral administration or chewing 100 mg. 60 tablets in a high-density polyethylene bottle with a child-resistant polypropylene screw cap. 1 bottle together with instructions for use is placed in a cardboard box.
Capsules 125 mg, 200 mg, 250 mg and 400 mg. 10 capsules in a PVC / aluminum foil blister. 3 blisters with instructions for use in a cardboard box.
Powder for solution for oral administration for children 2 g. 2 g in round glass bottles of transparent colorless glass with a tightly screwed polypropylene cap, inaccessible to children. Two arrows and the inscriptions "Close tightly" and "While pushing down turn" are applied to the lid, the lid is equipped with a gasket made of foil and cellulose, covered with a PVC film. 1 bottle together with instructions for use is placed in a cardboard box.

Storage conditions:

Chewable tablets or tablets for oral suspension should be stored at a temperature of 15-30 °C.
Store capsules at a temperature not exceeding 25 ° C.
Powder for the preparation of oral solution for children should be stored at a temperature of 15 to 30 ° C.
Keep out of the reach of children.

Best before date:

Tablets for chewing or for oral suspension and capsules. 2 years.
Powder for oral solution for children. 3 years.
Do not take the drug after the expiration date indicated on the package.

Conditions for dispensing from pharmacies:

On prescription.

Manufacturer:

Tablets are chewable or for the preparation of a suspension for oral administration; capsules - Bristol-Myers Squibb, France.
Bristol-Myers Squibb, La-Goualle - 19250 MEYMAC, France.
Bristol-Myers Squibb, La Gouale - 19250 MEIMAK, France.
Powder for oral solution for children - Bristol-Myers Squibb Company, USA.
Bristol-Myers Squibb Company, 2400 Lloyd Expressway, Evansville, Indiana 47721-0001, USA
Bristol-Myers Squibb Company, 2400 West Lloyd Expressway, Evansville, Indiana, 47721-0001, USA

Consumer claims are accepted at the address of the representative office:
123001, Moscow, Trekhprudny per., 9, building 1B.

Videx - description of the drug, instructions for use, reviews. Videx instructions for use, contraindications, side effects, reviews Videx side effects

Description of the pharmacological action

Indications for use

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Pharmacodynamics

Pharmacokinetics

Use during pregnancy

Contraindications for use

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Belonging to ATX-classification:

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