Videx

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

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

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

Release form and composition

capsules 125 mg: hard gelatinous, 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 has yellow-brown overprints: “BMS”, “125 mg” and “6671” (10 pcs. in blisters, 3 blisters in a cardboard box);
capsules 200 mg: hard gelatinous, size 2, volume ~ 0.4 ml; consist of two opaque white parts, filled with white or almost white granules in an enteric coating; the capsule has green overprints: “BMS”, “200 mg” and “6672” (10 pcs. in blisters, in a cardboard box 3 blisters);
capsules 250 mg: hard gelatinous, size No. 1, volume ~ 0.5 ml; consist of two opaque white parts, filled with white or almost white granules in an enteric coating; the capsule is overprinted in blue: "BMS", "250 mg" and "6673" (10 pcs. in blisters, in a cardboard box 3 blisters);
capsules 400 mg: hard gelatinous, 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, in a cardboard box 3 blisters);
powder for the preparation of oral solution for children: white or almost white (2 or 4 g each in colorless glass bottles, 1 bottle in a cardboard box);
chewable tablets / for preparation of suspension for oral administration: flat, round, with beveled edges, from pure white to light yellow, slight superficial marbling is possible; marking on one side - "100", on the other - VIDEX (60 pcs. in polyethylene bottles, child-proof screw caps, 1 bottle in a cardboard box).

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 [1: 1], 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 dyes red and iron oxide yellow / titanium dioxide, indigo carmine, iron dye yellow oxide / indigo carmine / simethicone, ammonium hydroxide, iron dye oxide red.

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

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

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

active substance: 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 HIV from multiplying.

Contraindications

Absolute contraindications for all forms of release:

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

Due to the method of administration, Videx capsules are contraindicated for use in children under 3 years of age.

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

For pregnant women, Videx should be taken exclusively under strict indications and only if the intended benefit to the mother outweighs the potential risk to the fetus. Lactation (breastfeeding) should be interrupted during therapy.

Method of administration and dosage

All dosage forms of 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. The 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.

The recommended dosage regimen depending on body weight:

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

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

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

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

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

To prepare the suspension, the adult dose is dissolved in ~ 30 ml; for children, 1 tablet is dissolved in ~ 15 ml of water. To improve the taste of the suspension, you can add apple juice without pulp: for adults ~ 30 ml, for children ~ 15 ml. After that, the suspension is stirred and drunk, since the finished product is 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 the preparation of a solution for oral administration for children is prepared directly by the attending physician, at the same time 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 powder, depending on the age of the child and body surface area (provided that it is taken 2 times a day with an interval of 12 hours):

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

The recommended dosing regimen of Videx for adult patients with impaired renal function depends on the CC (creatinine clearance) and body weight.

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

CC ≥ 60: (usual dose) capsules - 400 mg once a day; tablets and powder - 400 mg once a day or 200 mg twice a day;
KK 30–59: capsules - 200 mg once a day; tablets and powder - 200 mg once a day or 100 mg twice a day;
KK 10-29: capsules - 125 mg once a day; tablets and powder - 150 mg once a day;
CC <10: capsules - 125 mg 1 time per day; tablets and powder - 100 mg once a day.

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

CC ≥ 60: (usual dose) capsules - 250 mg 1 time per day; tablets and powder - 250 mg once a day or 125 mg twice a day;
KK 30–59: capsules - 125 mg once a day; tablets and powder - 150 mg once a day or 75 mg twice a day;
CC 10-29: capsules - 125 mg 1 time per day; tablets and powder - 100 mg once a day;
CC <10: capsules are replaced with another dosage form; tablets and powder - 75 mg once a day.

Patients on dialysis should take a daily dose of Videx immediately after the procedure, no additional dose is needed.

With renal failure in children, there are no precise 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 choose the dose more carefully, since an age-related decrease in renal function is possible. Monitoring of kidney function and appropriate dose adjustment is required.

Patients with hepatic impairment may need to reduce the dose depending on the level of hepatic enzymes. A clinically significant excess of their level may require interruption of Videx therapy, and in the case of a rapid increase in the level of transaminases, termination or suspension of treatment with any nucleoside analogs.

Side effects

pancreatitis: a severe toxic reaction (of varying severity, up to death) to didanosine, can 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, even in the absence of external symptoms;
lactic acidosis and / or steatosis in severe form with hepatomegaly (up to death): are noted due to the use of nucleoside analogs, including didanosine for monotherapy or in combination with other antiretroviral drugs. They are mainly observed in women, while the risk of these side effects can be aggravated by prolonged use of nucleosides and obesity. In the case 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: usually accompanied by a symmetrical bilateral feeling of numbness of the extremities with tingling and pain in the feet (less pronounced in the hands), in the early stages, the complication is less common; according to observations, the course of the disease can be aggravated by the joint intake of antiretroviral drugs, including didanosine with hydroxycarbamide.

Other adverse reactions from organs and systems:

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

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

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

special instructions

The simultaneous use of Videx and drugs with an established toxic effect on the peripheral nervous system or on the pancreas significantly increases the likelihood of these negative side effects.

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

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

Due to the rapid destruction of didanosine in the acidic environment of gastric juice, antacids are included in the tablets (to reduce acidity). Oral solution for children from powder is also taken only in combination 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 decreases by an average of 50%.

In patients with HIV with severe immunodeficiency during combined antiretroviral treatment, signs of an inflammatory reaction to asymptomatic or residual opportunistic infections may appear. Usually, the syndrome occurs within the first few weeks / months after starting therapy. There is a likelihood 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, stop. 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 hepatic transaminase index slightly exceeds the upper limit of the norm) indicates the need to interrupt treatment with didanosine. If the excess of these indicators is significant, the treatment is stopped.

Recommendations for the use of Videx in special cases:

impaired renal 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 aspartame - 36.5 / 1 tablet (100 mg); phenylalanine is not contained in capsules and powder;
diet with limited salt intake: the presence of sodium in the contents of the capsules should be taken into account - not less than 0.424 / 100 mg; tablets and powder of sodium salts do not contain, but if the powder is used, 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 interactions

stavudine and other drugs with toxicity similar 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 (combined use is contraindicated);
methadone (in patients with opioid dependence on the background of prolonged treatment): when used with Videx in the form of tablets or powder, the AUC (area under the concentration-time curve) of didanosine decreases significantly (up to 57%), which requires an increase in its dose;
tenofovir: decreases the plasma concentration of didanosine (dose adjustment required);
indinavir, delavirdine: the AUC value of indinavir / delavirdine in the presence of Videx significantly increases, so they are taken one hour before taking the drug in the form of tablets or powder; no interaction with capsules has been identified;
ketoconazole, itraconazole (for oral administration): their absorption is affected by the acidity of gastric juice, which is reduced by antacids contained in tablets and Videx powder, which should be taken 2 hours after taking ketoconazole and itraconazole; there is no likelihood 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 in a steady state on average to 111%, reduces the AUC of ganciclovir in a stationary state by 21% (in the case of taking Videx 2 hours before ganciclovir); while the renal clearance of any of the drugs did not change, the relationship between changes in AUC and the safety of Videx or the efficacy of ganciclovir has not been established; there were no data confirming the enhancement of the myelosuppressive effects of ganciclovir under the influence of didanosine;
antibiotics of the tetracycline series, some antibiotics of the fluoroquinolone series (ciprofloxacin): their plasma concentration decreases in the presence of antacids due to the formation of chelate compounds, and therefore tablets and Videx 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 chance of interaction;
ribavirin: able to increase the level of intracellular didanosine triphosphates, 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; such a 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 the data of special studies with repeated use with didanosine, drug interaction was not revealed;
loperamide, metoclopramide, ranitidine, sulfamethoxazole, trimethoprim: according to special studies, with a single use with didanosine, drug interaction was not revealed.

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

Analogs

The analogue of Videx is Didanosine.

Terms and conditions of storage

Keep out of the reach of children. Store at temperature: tablets and powder - 15-30 ° C, capsules - up to 25 ° C.

Shelf life:

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

Terms of dispensing from pharmacies

Dispensed by prescription.

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