Videx - instructions for use, dose, side effects, contraindications

Didanosine (2 ', 3'-dideoxyinosine or ddI) is a synthetic analogue of the nucleoside of deoxyadenosine, inhibits reverse transcriptase of HIV. It is proved that didanosine suppresses the replication of HIV in cultured human cells and in cell lines in vitro.

After entering the cage didanosine under the action of cellular enzymes is converted into active metabolite dideoxyadenosine-5'-triphosphate (ddATF). During the replication of the nucleic acid of the virus, the incorporation of the 2 ', 3'-dideoxynucleoside leads to an interruption in the growth of the DNA strand and hence stops the replication of the virus. In addition, ddATP suppresses HIV-1 reverse transcriptase activity by competing with deoxyadenosine-5'-triphosphate (dATP) for binding to active regions of the enzyme.By binding to the active site of the enzyme, thereby inhibiting the growth of the strand of proviral DNA.

Pharmacokinetics:

Absorption

After oral administration didanosine quickly absorbed, the maximum concentration in the blood plasma (C_m_Oh) is dose-dependent when administered in the form of capsules with a dosage of up to 400 mg and is noted after 30-90 minutes. Bioavailability is about 42%.

Area under the curve "concentration - time" (AUC) in the equilibrium state averages 2.60 mg h / l for adult patients and children,

Powder should be taken at least 30 minutes before or 2 hours after meals. If the drug is taken earlier than 2 hours after eating, the value of C_m_Oh and AUC decrease by approximately 55%. When the drug is taken with food, the bioavailability of didanosine is reduced by about 50%.

Apparent volume of distribution - an average of about 300 liters for adults and 100 liters - for children.

Binding to plasma proteins - no more than 5%.

Metabolism

The metabolism of didanosine in humans has not been studied. According to animal studies, it is assumed that in humans it occurs along the pathway of endogenous purine metabolism.

Excretion

After oral administration, the half-life of didanosine averages 1.6 hours, in urine approximately 20% of the dose is detected.The clearance is approximately 175 l / h for adults and 90 l / h for children.

Kidney clearance is 50% of the total clearance (800 ml / min), which indicates active tubular secretion when dedating dedanosine through the kidneys, along with glomerular filtration.

Pharmacokinetics in renal dysfunction

After oral administration, the half-life increases on average from 1.4 hours in patients with normal renal function to 4.1 hours in patients with severe renal dysfunction. In peritoneal dialysis fluid didanosine is not found, while during hemodialysis for 3-4 hours of hemodialysis procedure, 0.6-7.4% of the dose administered is excreted.

Absolute bioavailability does not change in patients with severe renal dysfunction, compared with patients with normal renal function, however, the clearance of didanosine decreases in proportion to the creatinine clearance.

Pharmacokinetics for violations of liver function

Mean values of C_m_Oh and AUC in patients with impaired liver function were slightly higher (13% and 19%, respectively) than in healthy patients, however, dose adjustments for this category of patients are not required, since the spread of individual indices in patients with hepatic and non-hepatic function disorders was the same .

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 C_m_Ohand AUC increased in proportion to the dose. The absolute bioavailability of didanosine upon oral administration of the drug was approximately 36% after the first dose and 47% in the equilibrium state.

The half-life period averages about 0.8 hours. After the first oral dose, didanosine concentrations in urine were 18% and 21% in the steady state. Renal clearance about 243 ml / m²/ min, which was 46% of the total clearance from the body. As in adults, children had active tubular secretion. When oral intake of the drug for 26 days cumulation didanosine in children is not observed.

Indications:Treatment of HIV-1 infection (in combination with other antiretroviral drugs).

Contraindications:

- Hypersensitivity to didanosine and / or any of the excipients of the drug,

- The simultaneous use with allopurinol, ribavirin,

- Breastfeeding period.

Carefully:The drug should be used with caution in patients with an increased risk of developing pancreatitis, with pancreatitis in the anamnesis,in patients with risk factors for lactate acidosis (obesity, long-term treatment with nucleotide analogues), with progressive HIV infection, with a history of peripheral neuropathy, in patients taking neurotoxic drugs (increased risk of peripheral neuropathy), in elderly patients, with treatment of patients with impaired renal function (dose adjustment is necessary), in patients with eye diseases (due to the risk of developing neuritis and changes in the retina). With extreme caution should be used in patients with impaired liver function due to the risk of developing severe hepatomegaly with steatosis.

Pregnancy and lactation:

Adequate and controlled studies in pregnant women have not been conducted. Use Videx® during pregnancy should only be in the presence of strict indications and only in those cases where the potential benefit to the mother exceeds the possible risk to the fetus.

During treatment with the drug, breastfeeding should be discontinued.

Dosing and Administration:

Inside, on an empty stomach, at least 30 minutes before or 2 hours after meals, necessarily mixed with antacids, containing aluminum and magnesium hydroxides.

The recommended daily dose depends on the body weight.Powder is taken 1 or 2 times a day (see table). With a two-time dose, the interval between doses should be 12 hours.

Adults

Body mass	Dosing regimen
>60 kg	400 mg once a day or 200 mg 2 times a day
<60 kg	250 mg once a day or 125 mg 2 times a day

Children

Calculation of body surface area - for children immediately after birth:

Newborns and children under 8 months: daily dose - 100 mg / m² twice a day with an interval of 12 hours.

Children older than 8 months: daily dose - 120 mg / m² twice a day at intervals 12 hours.

Before the first appointment, the doctor prepares the drug solution, teaches the patient (or the child's parents) how to prepare the solution, determines the exact dose for the specific patient, depending on the type of antacid, concomitant therapy, etc. A suitable syringe can be used to dispense the prepared drug solution.

Instructions for preparation of the drug solution in mixture with antacids

In the table below, antacid preparations are divided into three groups (A, B and C), depending on the content of active substances in them. The left column of the table indicates the magnesium hydroxide content in mg per 5 ml of the preparation, in the middle column - the amount of aluminum hydroxide that should be contained in the preparation,the right column indicates the group to which the antacid drug belongs.

The content of magnesium hydroxide *, mg / 5 ml.	Aluminum hydroxide content, mg / 5 ml (**).	The ruppa, to which the antacid drug belongs.
400	400 to 900	A
350	425 to 900	A
300	450 to 900	A

250	200 to 450	AT
200	213 to 450	AT
150	225 to 450	AT

125	100 to 225	FROM
100	107 to 225	FROM
75	113 to 225	FROM

Before preparing the solution, you should determine to which group of antacid preparations the drug at your disposal belongs.

* If the magnesium hydroxide content falls between these values, it is possible to apply the drug when the minimum content of aluminum hydroxide compensates for the reduced magnesium hydroxide content.

EXAMPLES:

1. If the preparation contains 325 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide, the preparation belongs to group A. The minimum aluminum hydroxide content is calculated as follows: a decrease in the magnesium hydroxide content by 1 mg requires an increase in the aluminum hydroxide content by at least 0.5 mg. In our example, reducing the magnesium hydroxide content by 75 mg (from 400 mg to 325 mg) requires a minimum increase in the aluminum hydroxide content by 37.5 mg (if rounded off - by 38 mg).Therefore, the content of aluminum hydroxide in the preparation should be at least 438 mg.

2. If the preparation contains 175 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide, the preparation belongs to group B. The minimum aluminum hydroxide content is calculated as follows: a decrease in the magnesium hydroxide content by 1 mg requires an increase in the aluminum hydroxide content by at least 0.25 mg. In our example: a decrease in the magnesium hydroxide content by 75 mg (from 250 mg to 175 mg) requires a minimum increase in the aluminum hydroxide content by 18.75 mg (if rounded by 19 mg). Therefore, the content of aluminum hydroxide in the preparation should be at least 219 mg.

3. If the preparation contains 85 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide, the preparation belongs to group C. The minimum aluminum hydroxide content of aluminum is calculated as follows: a decrease in the magnesium hydroxide content by 1 mg requires an increase in the aluminum hydroxide content by at least 0.25 mg. In our example: reducing the magnesium hydroxide content by 40 mg (from 125 mg to 85 mg) requires a minimum increase in the aluminum hydroxide content by 10 mg.Therefore, the content of aluminum hydroxide in the preparation should be at least 110 mg.

** If the preparation contains aluminum oxide, recalculate its content on aluminum hydroxide: 1 mg of oxide corresponds to 1.53 mg of aluminum hydroxide.

Preparation of solution with preparations of group A.

Add 100 ml of water to the label of 100 ml on the label of the vial, a solution with a concentration of didanosine of 20 mg / ml is formed. Mix well. Add the antacid suspension to the label of 200 ml on the vial label. The concentration of didanosine in the suspension is 10 mg / ml. Mix well.

Preparation of solution with preparations of group B.

Add 100 ml of the antacid suspension to the 100 ml label on the vial label, a suspension with a didanosine concentration of 20 mg / ml is formed. Mix well. Add the antacid suspension to the label of 200 ml on the vial label. The concentration of didanosine in the suspension is 10 mg / ml. Mix well.

Preparation of solution with preparations of group C.

Add 100 ml of the antacid suspension to the 100 ml label on the vial label. Mix well. Add the antacid suspension to the label of 200 ml on the vial label. Mix well. Transfer the resulting suspension to a glass or plastic bottle of a suitable size and add to it another 200 ml of the antacid suspension.The concentration of Didanosine in the resulting suspension is 5 mg / ml, the resulting suspension is enough for half a day less than with the use of Group A and B antacids.

The prepared mixture should be stored in a tightly closed bottle in the refrigerator (2 to 8 ° C) for no more than 30 days. Shake before use. The unused medication after 30 days of storage is discarded.

Use in special patient groups

Adults with impaired renal function: it is recommended to reduce the dose and / or increase the intervals between doses due to the slowing down of didanosine excretion rate:

Creatinine clearance (ml / min / 1.73 m²)	Dosing regimen
Body mass ≥ 60 kg
≥ 60 (usual dose)	400 mg 1 once a day
	or 200 mg twice daily
30-59	200 mg once a day or 100 mg 2 times a day
10-29	150 mg once a day
< 10	100 mg once a day
Body weight <60 kg
> 60 (usual dose)	250 mg once a day or 125 mg twice daily
30-59	150 mg once a day or 75 mg twice daily
10-29	100 mg once a day
< 10	75 mg once a day

Patients on peritoneal dialysis or hemodialysis should take a daily dose of the drug after dialysis, following recommendations for patients with creatinine clearance <10 mL / min. There is no need for an additional dose of the drug after a hemodialysis session.

Children with impaired renal function. Didanosine is excreted mainly in the urine, so its clearance may vary in children with impaired renal function. Precise recommendations for correcting the dose of the drug in children are absent. Correction of the dosing regimen (dose reduction and / or increase in the interval between doses of the drug) should be performed depending on the creatinine clearance using a principle similar to that recommended for adult patients with impaired renal function.

For elderly patients the usual dosing regimen for adult patients is recommended. However, in view of a possible reduction in kidney function, it is necessary to monitor their performance and, accordingly, adjust the dose of the drug according to the recommendations for adult patients with impaired renal function.

For patients with impaired liver function no dose reduction is required. During treatment with the drug, it is necessary to examine the level of liver enzymes. With a clinically significant excess of the activity of liver enzymes, it is necessary to suspend treatment with the drug. With the rapidly increasing activity of aminotransferases, it may be necessary to stop or stop treatment with nucleoside analogues.

Dosing regimen with simultaneous use with tenofovir

For patients who take both Videx® and tenofovir, a reduction in the daily dose of Videx® is required:

for adults with a body weight of at least 60 kg and a creatinine clearance of at least 60 ml / min - 250 mg once a day on an empty stomach together with tenofovir (alternatively, if tenofovir taken with food, then Videx® powder on an empty stomach - 30 minutes before or 2 hours after eating);

for adults weighing less than 60 kg and creatinine clearance of at least 60 ml / min - 200 mg once a day on an empty stomach along with tenofovir (alternatively, if tenofovir taken with food, then Videx® powder on an empty stomach - 30 minutes before or 2 hours after eating).

Side effects:

From the digestive system and liver: anorexia, dyspepsia, nausea, vomiting, abdominal pain, diarrhea and increased gas production, hepatitis, hepatic insufficiency, portal hypertension, not associated with cirrhosis of the liver, pancreatitis, symptomatic hyperlactatemia (lactate acidosis) / severe steatosis with hepatomegaly, parotid hypertrophy, sialadenitis, dry mouth, fat metabolism redistribution / accumulation (lipodystrophy / lipoatrophy),including obesity of the central type, increasing the amount of fatty tissue in the area dorsotservikalnoy ( "buffalo hump"), reducing the amount of fat limbs and face, breast augmentation, "Kushingoid face."

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

From the sense organs: dry eye, optic neuritis, depigmentation of the retina.

From the side of the locomotive and propulsion system: myalgia (with or without increased creatine kinase activity), arthralgia, myopathy, rhabdomyolysis.

From the hematopoiesis: Anemia, granulocytopenia, leukopenia, thrombocytopenia.

Side effects with combined therapy: with the simultaneous use of didanosine and drugs with a similar toxicity profile (stavudine and / or hydroxycarbamide), side effects such as pancreatitis, hepatotoxicity (including fatal), and severe peripheral neuropathy are more frequent than in the absence of such treatment regimens.

Laboratory indicators: hypo- and hyperkalemia, hyperuricamia, increased activity of amylase and lipase, increased activity of "hepatic" transaminases and alkaline phosphatase, hyperbilirubinemia, hypo- and hyperglycemia.

Other: diabetes mellitus, alopecia, anaphylactoid / allergic reactions, asthenia,

fatigue, chills / fever, itching, skin rash.

Children.

The side effects of the drug in children and adult patients are similar. The development of pancreatitis in children is observed in 3% of cases with admission in doses not exceeding recommended, and in 13% - in the treatment with increased doses of the drug. Also, the children observed changes in the retina and optic neuritis, but the frequency of these side effects is not established.

Overdose:

Antidote for an overdose of didanosine.

With long-term administration of the drug in doses significantly exceeding the recommended (10 times), the following phenomena were observed: pancreatitis, peripheral neuropathy, hyperuricemia, and liver dysfunction.

Treatment: symptomatic, control over vital vital functions is necessary.

Didanosine is not removed from the body by peritoneal dialysis and in a very weak degree by hemodialysis. During the 3-4-hour hemodialysis sessions, approximately 25-30% of didanosine is removed from the total concentration of didanosine circulating in the blood at the onset of hemodialysis.

Interaction:

When using Videke® in combination with other drugs with similar toxicity (for example, with stavudine), the risk of developing these side effects is significantly increased.

With the simultaneous use of Videx® with drugs with toxic effects on the peripheral nervous system or pancreatic iron, as well as in patients with peripheral neuropathy in history, the risk of developing peripheral neuropathy or pancreatitis is significantly increased.

The risk of developing pancreatitis may increase in proportion to the increase in didanosine concentration caused by the joint use of Videx® and allopurinol. In this regard, the combined use of allopurinol and Videx® is contraindicated.

Methadone. When Videx® powder is used in patients with opioid dependence, long-term methadone treatment results in a decrease in the value AUC didanosine by 57%. With simultaneous use of drugs, the dose of Videx® should be increased.

Tenofovir. When combined, there is an increase in the concentration of didanosine in plasma,therefore the dose of the drug must be adjusted: for adults with a body weight of at least 60 kg and creatinine clearance of at least 60 ml / min - 250 mg once a day on an empty stomach together with tenofovir (alternatively, if tenofovir taken with food, then Videx® powder on an empty stomach - 30 minutes before or 2 hours after eating);

Delavirdine or indinavir should be taken 1 hour before taking Videx® powder. In the presence of Videx®, the value AUC delavirdine or indinavir is significantly increased.

Nelfinavir should be taken 1 hour after taking Videx® while they are administered simultaneously. There were no clinically significant changes in pharmacokinetic parameters nelfinavir when taken together with light food after 1 hour after didanosine in the form of a powder.

In special studies of repeated use of the drug simultaneously with the drugs dapsone, nevirapine, rifabutin, foscarnet, ritonavir, stavudine and zidovudine and single application simultaneously with drugs loperamide, metoclopramide, ranitidine, sulfamethoxazole, trimethoprim no drug interactions were detected.

Ketoconazole or itraconazole, the absorption of which, when administered orally, is affected by the acidity of the gastric juice, should be taken 2 hours before taking Videx® powder.

When taking Videx® powder powder 2 hours prior to admission ganciclovir or at the same time the indicator AUC in a steady state didanosine increases on average to 111%. Slight decrease AUC in a steady state (by 21%) ganciclovir was noted in cases when 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 related to changes in the safety of Videx® or the effectiveness of ganciclovir. There is no evidence to confirm the increased didanosine myelosuppressive effects of ganciclovir. Concentrations antibiotics of tetracycline and some fluoroquinolone antibiotics (eg, ciprofloxacin), in the blood plasma are reduced in the presence of antacids, since chelate compounds are formed. In this regard, Videx® powder, dissolved in antacid suspension, should be taken at least 6 hours before or 2 hours after taking ciprofloxacin.

Ribavirin can increase the level of intracellular didanosine triphosphates and potentially increase the risk of side effects. With the combined use of didanosine with ribavirin in combination with stavudine or without it, cases of hepatic insufficiency with a lethal outcome, as well as cases of pancreatitis, peripheral neuropathy and symptomatic hyperlactatemia / lactic acidosis, have been reported. In this regard, the combined use of didanosine and ribavirin is contraindicated.

Drugs that have a neurotoxic effect. When combined with didanosine, care should be taken in view of the increased risk of developing neuropathy.

Less than 5% didanosine is in a bound state with blood plasma proteins, indicating a low probability of drug interactions involving the mechanism of displacement from the binding sites.

Special instructions:

The relationship between HIV sensitivity to didanosine in vitro and no clinical response to treatment has been established. The results of determining the sensitivity in vitro vary over a wide range. Positive correlation is established in vivo between the results of measurements of viral activity (for example, determination by the method of polymerase chain reaction of HIV RNA) and clinical progression of the disease. The administration of the drug to children under 3 years is recommended only in the form of a suspension. With the simultaneous use of Videx® with drugs with toxic effects on the peripheral nervous system or pancreas The risk of these toxic effects increases significantly. With the simultaneous use of pentamidine intravenously or drugs that increase the activity of didanosine (hydroxycarbamide, allopurinol), therapy with Videx® is recommended to be suspended.

Visual disturbances

It is necessary to periodically check the vision and note any visual impairment, such as altered perception of color or a vague vision of objects. Children should conduct a retina scan every 6 months or if there is any change in vision.

The decision to change therapy can be made on the basis of the patient's examination and the evaluation of the benefit / risk relationship. Зliver abortion

Hepatotoxicity and hepatic insufficiency were fatal in post-marketing studies in HIV-infected patients during combined antiretroviral therapy with hydroxycarbamide. Cases of liver dysfunction with a fatal outcome were observed in such patients with the combination hydroxycarbamide, didanosine and stavudine, in connection with which the joint use of these drugs should be avoided.

The efficacy and safety of Videx® in patients with severe hepatic impairment have not been established in history. During combined antiretroviral therapy in such patients, including patients with active chronic hepatitis, the frequency of liver function abnormalities, including severe and potentially life-threatening, increases. Observation of the condition of such patients should be carried out in accordance with standard practice. In case of worsening of the condition of such patients,as well as with an increase in the activity of "hepatic" enzymes above a clinically significant level, therapy with Videx® should be suspended or canceled.

Immunodeficiency Syndrome

In HIV-infected patients with severe immunodeficiency during combined antiretroviral therapy, there may be signs of an inflammatory response to asymptomatic or residual opportunistic infections. This syndrome was observed during the first few weeks or months after initiation of antiretroviral therapy. There may be signs of cytomegalovirus retinitis, generalized or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci. If necessary, appropriate therapy is prescribed. There were cases of autoimmune diseases (for example, Graves' disease) that occurred with the restoration of immunity, but the timing of the onset of such diseases varied in different patients and could occur many months after initiation of therapy.

Pancreatitis

Pancreatitis is a severe toxic effect of the drug.Pancreatitis of varying severity, often fatal, can develop in the patient at different stages of treatment and does not depend on whether the drug is administered as monotherapy or in combination with other drugs, or on the degree of immunosuppression. Pancreatitis is a dose-related complication. Patients taking Videx® in combination with stavudine, hydroxycarbamide, are at a higher risk of developing this side effect. The risk of developing pancreatitis increases in elderly patients, in patients with pancreatitis in the anamnesis, with renal dysfunction in the absence of appropriate dose adjustment, as well as in patients with progressive HIV infection.

In patients with risk factors for pancreatitis, Videx® should be used with caution.

When symptoms of pancreatitis appear, treatment with the drug should be stopped, and when the diagnosis is confirmed, treatment should be discontinued. With clinically significant excess of biochemical markers, even in the absence of symptoms of pancreatitis, treatment should also be stopped.

Lactate acidosis / Severe form of steatosis with hepatomegaly

Lactate acidosis / Severe form of steatosis with hepatomegaly, including fatal cases, are observed with the use of nucleoside reverse transcriptase inhibitors in monotherapy or in combination with other antiretroviral drugs, including didanosine. In general, this side effect was observed in women. Obesity and long-term administration of nucleoside reverse transcriptase inhibitors may be a risk factor for this side effect. In pregnant women, the risk of developing lactic acidosis with a fatal outcome increases with the intake of didanosine in combination with stavudine or other antiretroviral drugs. In this regard, the combination of these drugs in pregnant women can be used with extreme caution. When clinically confirmed symptoms of hepatotoxicity or lactic acidosis (which may include hepatomegaly and steatosis, even if there are no obvious signs of an increase in the activity of "liver" transaminases), treatment with the drug should be stopped. At a significant excess of the activity of "liver enzymes" and bilirubin (an increase of 3-4 degrees: 5 times higher than normal for "liver" transaminases and alkaline phosphatase;times higher than normal for lipase; in 2,6 times higher than the norm for bilirubin) treatment should be discontinued.

Portal hypertension, unrelated to cirrhosis of the liver

In postmarketing studies, cases of portal hypertension unrelated to cirrhosis of the liver, including cases leading to liver transplantation, as well as to fatal outcomes, were noted. Unrelated to cirrhosis of the portal portal hypertension caused by didanosine was confirmed in patients with unconfirmed viral hepatitis. The first signs and symptoms of portal hypertension appeared in the period from several months to several years after initiation of didanosine therapy. Common signs of development of portal hypertension included: increased activity of liver enzymes, varicose veins of the esophagus, bloody vomiting, ascites, splenomegaly. Patients receiving didanosine, should be regularly monitored for early signs of portal hypertension (eg, thrombocytopenia and splenomegaly) during scheduled visits to the doctor. Appropriate laboratory studies, including a study of the activity of liver enzymes, concentrations of bilirubin, albumin in the serum,an expanded blood test, an international standardized ratio (MHO) and ultrasonography, should be prescribed to such patients.

The use of Videx® should be discontinued when the patient develops symptoms of portal hypertension, not associated with cirrhosis of the liver.

Peripheral Neuropathy

Peripheral neuropathy is usually accompanied by a bilateral symmetrical sense of numbness of the limbs: tingling and pain in the feet and, less often, in the hands. In the early stages of the disease, these phenomena are less common. There is information that the course of peripheral neuropathy can be aggravated by the joint administration of antiretroviral drugs, including didanosine, stavudine, and hydroxycarbamide. When the appearance of the phenomena of peripheral neuropathy should be suspended therapy with didanosine until they are eliminated. After eliminating these symptoms, the patient may take a reduced dose of the drug.

Redistribution / accumulation of fatty tissue (lipodystrophy / lipoatrophy)

In patients receiving antiretroviral therapy, there were cases of redistribution / accumulation of fatty tissue (lipodystrophy / lipoatrophy), which manifested itself as obese by the central type,an increase in the amount of fat in the dorso-cervical zone ("buffalo hump"), a decrease in the amount of fatty tissue in the limbs and face, breast augmentation, "cushingoid face." The mechanism and long-term consequences, as well as the causes of the occurrence of these phenomena are not known.

Didanosine is rapidly destroyed in the acidic content of gastric juice. The powder solution should be taken only in admixture with antacids.

Absorption of Didanosine regardless of the dosage form in food decreases by an average of 50%. Powder should be taken 30 minutes before or 2 hours after eating.

Powder for the preparation of 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.

Does not contain sucrose, so the restrictions for the use of the drug patients with diabetes mellitus no.

Effect on the ability to drive transp. cf. and fur:Special studies that study the effect of Videx® on the ability to drive vehicles and mechanisms have not been carried out.

Form release / dosage:Powder for solution for oral administration 2 g.

Packaging:To 2 g in round glass bottles of transparent colorless glass with a tightly screwed polypropylene lid, not accessible to children. The cover has two arrows and the inscriptions "Close tightly" and "While pushing down turn", the lid is provided with a foil and cellulose gasket covered with polyvinylidene chloride film. 1 bottle together with the instruction for use is placed in a pack of cardboard.

Storage conditions:

At a temperature of 15 to 30 ° C.

KEEP OUT OF THE REACH OF CHILDREN.

Shelf life:

3 years.

Do not take it after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013843 / 01

Date of registration:07.05.2008 / 20.09.2016

Expiration Date:Unlimited

The owner of the registration certificate:Bristol-Myers Squibb CompanyBristol-Myers Squibb Company USA

Manufacturer: & nbsp

ASTRAZENECA Pharmaceuticals LP USA

Representation: & nbspBRISTOL-Majers SKVIBB, LLCBRISTOL-Majers SKVIBB, LLCRussia

Information update date: & nbsp11.01.2017

Illustrated instructions

Instructions

Videx® (Videx®)