Each tablet contains active substance – didanosine 100 mg. Excipients: ., Calcium carbonate, magnesium hydroxide, aspartame, sorbitol, microcrystalline cellulose, crospovidone, flavoring mandarin orange, magnesium stearate Capsules Each capsule contains active substance – didanosine 125 mg, 200 mg, 250 mg or 400 mg.   Anadrol pills shellac, propylene glycol, potassium hydroxide, titanium dioxide, iron oxide red dye and yellow iron oxide colorant,Anadrol pills – shellac, propylene glycol, indigo carmine, titanium dioxide, iron oxide yellow dye; Capsules 250 mg – shellac, propylene glycol, indigo carmine; Capsules 400 mg -. shellac, propylene glycol, simethicone, iron oxide red dye, ammonia water Powder for oral solution for children Each vial contains the active substance – Didanosine 2 g Excipients absent.

Description

Tablets anadrol pills for chewing, or suspension for oral
round, flat tablets with bevelled edges on the white or almost white to light yellow color labeled “100” on one side of the tablet and «VIDEX» another. Slight “marbling” the surface of the tablets. Capsules Hard gelatin capsules consisting of two parts, an opaque white color. The contents of capsules: white or almost white granules enteric coated. Capsules 125 mg: №3 size. Inscriptions “the BMS”, “125 mg” and “6671” marked yellow-brown color. Capsules 200 mg: Size №2. Inscriptions “the BMS”, “200 mg” and “6672” marked in green. Capsules 250 mg: Size №1. Inscriptions “the BMS”, “250 mg” and “6673” marked in blue. Capsules 400 mg: Size №0. Inscriptions “the BMS”, “400 mg” and “6674” marked in red. Powder for solution for oral administration for children powder white or nearly white.

Pharmacotherapeutic group:

Antiviral (HIV) agent [J05AF02].

Contraindications:

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

Precautions
The drug should be used with caution in patients with an increased risk of pancreatitis, with a history of pancreatitis, with advanced HIV infection in elderly patients, in patients with impaired renal function unadjusted doses of the drug. With extreme caution should be used in patients with impaired liver function.

Pregnancy and lactation

Adequate and well-controlled studies have not been conducted in pregnant women. Apply Videx during pregnancy should only be in the presence of strict indications and only in those cases where the anadrol pills potential benefit to the mother outweighs the potential risk to the fetus. At the time of treatment should stop breastfeeding.

Dosage and administration:

Inside.

Capsules. The recommended daily dose depends on the body weight (see. Table).

 

Body mass dosage capsules
≥60kg 400 mg 1 time per day
<60kg 250 mg 1 time per day

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

Chewable tablets or suspension for oral administration and powder for oral solution. The recommended daily dose depends on body weight. Tablets or powder take 1 or 2 times per day (see. Table). When the drug twice a day reception interval between doses should be 12 hours.

 

Body mass The dosage tablets
≥60kg 400 mg 1 time per day, or 200 mg two times a day
<60 kg 250 mg 1 time per day, or 125 mg two times a day

Choose the appropriate dose may be a combination of tablets of different dosages, avoiding the possibility of overdose antacids or phenylalanine contained in the tablets. Each dose should consist of at least two of the tablets, but not more than 4 tablets in an amount not exceeding the recommended dose. Children under 1 year should receive one tablet at the reception, which would provide a sufficient amount of antacid for this age group.
Reception of tablets children up to 3 years is recommended only in the form of a suspension. Tablets are taken at least 30 minutes before or 2 hours after eating. The tablet should be thoroughly chewed or dissolved in at least 30 ml of water and mixed thoroughly until a homogeneous suspension. Babies recommended dose of 1 tablet dissolved in 15 ml of water. For the correction of taste, you can add about 30 ml (for adults) or 15 mL (for children) of apple juice without pulp.
After cooking, the resulting suspension should be mixed with a drink in its entirety. The resulting suspension is stable for 1 hour at room temperature storage (17-23 ° C).
Infants and children up to 8 months of daily dose depends on the body surface area, and is 100 mg / m2 day twice a day with 12-hour interval .
children over 8 months, the daily dose is 120 mg / m 2 twice daily with an interval of 12 hours.
powder for solution for oral administration to children should be taken at least 30 minutes before anadrol pills or 2 hours after eating only in a mixture antacids that contain aluminum and magnesium hydroxides (oxides).Antacids we propose to split into three groups (A, B and C), depending on the content of those active substances. The first column indicates the content hydroxide (oxide) of magnesium in 5 mg per ml of the preparation, in the second – the amount of aluminum hydroxide to be contained in the formulation, the third – the group to which the preparation is.

 

The content of hydroxide,
magnesium * mg / 5 ml.
The content of hydroxide
aluminum mg / 5 mL (**).
The group to which the
antacid preparation.
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 C
100 107 to 225 C
75 113 to 225 C

Before preparing the solution, determine which group of antacids include yours.
* If the content of magnesium hydroxide falls between these values, use the drug is possible in the case where the minimum content of aluminum hydroxide compensates for reduced content of magnesium hydroxide.
– For example, the preparation contains 325 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide, the drug refers to the group A. the minimum content of aluminum hydroxide was calculated as follows: reduction of magnesium hydroxide per 1 mg of aluminum hydroxide requires increasing the content of at least 0.5 mg. In our example reduction of magnesium hydroxide, 75 mg (400 mg to 325 mg) requires a minimal increase in the content of aluminum hydroxide, 37.5 mg (if round – 38 mg). . Therefore, the content of aluminum hydroxide in the formulation should be at least 438 mg
– For example, the preparation contains 175 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide formulation refers to the group B. The minimum content of aluminum hydroxide was calculated as follows: reduction of magnesium hydroxide per one requires mg increasing the content of aluminum hydroxide is at least 0.25 mg. In our example reduction of magnesium hydroxide, 75 mg (250 mg to 175 mg) requires a minimal increase in the content of aluminum hydroxide 18.75 mg (if round – 19 mg). Therefore, the content of aluminum hydroxide in the formulation should be at least 219 mg.
– For example, if the preparation contains 85 mg of magnesium hydroxide and a sufficient amount of aluminum hydroxide formulation refers to the group C. The minimum content of aluminum hydroxide was calculated as follows: reduction of magnesium hydroxide per 1 mg requires an increase in the content of aluminum hydroxide is at least 0.25 mg. In our example reduction of magnesium hydroxide, 40 mg (125 mg and 85 mg) requires a minimal increase in the content of aluminum hydroxide at 10 mg. Therefore, the content of aluminum hydroxide in the formulation should be at least 110 mg.
** If the product contains aluminum oxide, restates its content on aluminum hydroxide 1 mg oxide corresponds to 1.53 mg of aluminum hydroxide.

Preparation of solution preparations group A.
Add 100 ml water to 100 ml mark contained on the label, formed solution with a concentration of 20 mg didanosine / ml. Mix anadrol pills well. Antacid suspension add up to the mark of 200 mL, contained in the vial.Didanosine concentration in the suspension is 10 mg / ml. Mix well. Preparation of solution formulations with a group B. Add 100 ml of the suspension of antacid up to the mark of 100 mL, contained in the vial, a suspension with a concentration of 20 mg didanosine / ml. Mix well. Antacid suspension add up to the mark of 200 mL, contained in the vial. Didanosine concentration in the suspension is 10 mg / ml.Mix well. Preparation of the solution to the drug group C. Add 100 ml of antacid suspension to the mark with 100 ml contained in the vial label. Mix well. Antacid suspension add up to the mark of 200 mL, contained in the vial. Mix well. Transfer the resulting suspension to a glass or plastic vial and add appropriate size to it an additional 200 ml of antacid suspensions. The concentration in the resulting suspension didanosine – 5 mg / ml, the resulting suspension is enough for half of days less than using antacids groups A and B.

The obtained mixture was stored in a sealed bottle in a refrigerator (2 to 8 ° C) for 30 days. Before applying stir. Unused medication after 30 days of storage discarded.

For adults with impaired renal function is recommended to decrease the dose and / or increase the interval between doses, depending on creatinine clearance:

Creatinine clearance
(ml / min / 1.73 m²)
Capsules Tablets and also for powder
solution for
oral administration to children
Body weight> 60 kg
≥60 (usual dose) 400 mg 1 time per day 400 mg 1 time per day, or 200 mg two times a day
30-59 200 mg 1 time per day 200 mg 1 time per day, or 100 mg two times a day
10-29 125 mg 1 time per day 150 mg 1 time per day
<10 125 mg 1 time per day 100 mg 1 time per day
Body weight <60 kg
≥60 (usual dose) 250 mg 1 time per day 250 mg 1 time per day
or 125 mg twice a day
30-59 125 mg 1 time per day 150 mg 1 time per day
or 75 mg twice a day
10-29 125 mg 1 time per day 100 mg 1 time a day
<10 b 75 mg 1 time per day

and Each dose should consist of at least two of the tablets, but not more than 4 tablets in an amount not exceeding the recommended dose. Choose dose combination tablets can be different dosages. BPatients with body weight <60 kg and creatinine clearance <10 mL / min should appoint another dosage form.

Patients who are on dialysis, have to take the daily dose after dialysis. The need for additional doses of the drug do not. Children with impaired renal function. Precise recommendations for adjustments to the dose of the drug in children are absent. Perhaps the reduction in the dose and / or increase the interval between doses of the drug. For elderly patients requires careful titration in mind a possible reduction in kidney function. It is necessary to carry out monitoring of renal function and adjustment of the dose, respectively. For patients with impaired liver function may require a reduction in dose. Precise recommendations on changing the dose of the drug in impaired liver function no. During treatment it is necessary to investigate the level of liver enzymes. If clinically significant liver enzyme level is exceeded it is necessary to suspend the treatment of the drug. With rapidly rising standard of aminotransferases may require the termination or suspension of any treatment with nucleoside analogues.

 

Side effect:

Pancreatitis is a severe toxic effect of the drug. Pancreatitis varying severity often fatal, the patient can develop at different stages of treatment and does not depend on whether the drug is used alone or in combination with other drugs, or the degree of immunosuppression. Pancreatitis is a dose-dependent complication. In the application of the suspension must be observed to increase the level of pancreatitis markers to a clinically significant level, even in the absence of symptoms. Lactic Acidosis / Severe steatosis with hepatomegaly , including fatalities, observed with the use of nucleoside analogues as monotherapy or in combination with other antiviral drugs including didanosine. Basically, this side effect has been observed in women. Obesity and prolonged use of nucleoside can serve as risk factors for the occurrence of this side effect. Drug treatment should be discontinued in the development of patient clinical or laboratory signs of lactic acidosis or hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of clear signs of increased activity of transaminases). Peripheral neuropathy is usually accompanied by bilateral symmetrical sense of limb numbness: tingling and pain in the soles of the feet and, less in the hands. In the early stages of the disease, these phenomena are less frequent. There is information that for peripheral neuropathy may be burdened with a joint reception of antiretroviral drugs, including didanosine and hydroxyurea. From the digestive system: anorexia, nausea, vomiting, abdominal pain, diarrhea and flatulence, hepatitis, pancreatitis, hypertrophy of the parotid gland, lipodystrophy, lipoatrophy. From the nervous system: paresthesia, pain in the hands and feet, headache. From the senses: dry mouth, dry eyes. From the musculoskeletal system: myalgia, arthralgia, and myopathy, sialadenitis. From the of blood: anemia, granulocytopenia, leukopenia, thrombocytopenia. From the side of view: optic neuritis, retinal depigmentation. Laboratory findings: hypo- and hyperkalemia, giperurekimiya, increasing the concentration of amylase and lipase, increased activity of “liver” transaminases and alkaline phosphatase, hyperbilirubinemia , hypo- and hyperglycemia. Other: . alopecia, anaphylactoid / allergic reaction, asthenia, chills, itching, rhabdomyolysis, skin rash . children Side effects of the drug in children and adults alike. Development of pancreatitis in children is observed in 3% of cases when taken in doses that do not exceed recommended and 13% – in the treatment of elevated doses of the drug. Impairment observed in children and in rare cases are characterized by changes in the retina and optic neuritis.

 

Overdose:

Antidote for didanosine overdosage not.
The main manifestations of an overdose of the drug:. Pancreatitis, peripheral neuropathy, hyperuricemia, impaired liver function
Didanosine is not removed from the body with peritoneal dialysis and hemodialysis are very few. During sessions lasting 3-4 hours gemodiliza removed approximately 25-30% of the total concentration of didanosine didanosine, circulating in the blood to the beginning of hemodialysis.

Interaction with other drugs and other forms of interaction

In applying the drug Videx in combination with other drugs with similar toxicities (e.g., stavudine) described the risk of side effects is increased significantly.
Allopurinol is not recommended to use simultaneously with the drug Videx. The risk of pancreatitis is increased in proportion to the concentration of the drug Videx.
Methadone. When using powder or Videx tablets in patients with opioid dependence on the background of long-term methadone treatment a decrease in the AUC of didanosine at 57%. With simultaneous application of drugs Videx dose of the drug should be increased.
Tenofovir. In a joint application is observed reduction of Videx, so the dose must be adjusted.
Delavirdine or indinavir should be taken 1 hour before receiving Videx tablets or powder. In the presence of the drug Videx the AUC of indinavir or delavirdine increases significantly. Drug interaction between indinavir and drug Videx capsules have been identified.
In special studies reusable dose simultaneously with the drugs nevirapine, rifabutin, foscarnet, ritonavir, stavudine and zidovudine and single-use doses of the drug at the same time with drugs loperamide, metoclopramide, ranitidine, sulfamethoxazole, trimethoprim drug interactions not revealed.
ketoconazole or itraconazole on absorbability after oral administration which affect gastric acidity, should be taken for 2 hours before taking Videx tablets or powder. Videx capsules contain antacids, and the risk of drug interaction is absent.
When receiving Videx preparation (tablet or powder) for 2 hours before receiving ganciclovir or simultaneously with the AUC at steady state rate didanosine increases to an average of 111%. A slight decrease in the steady state AUC (21%) of ganciclovir was noted in those cases where patients received Videx for 2 hours prior to ganciclovir. Changes in renal clearance for either of these two drugs was observed. It is not known whether these changes are associated with changes in the safety of the drug Videx or the efficacy of ganciclovir. There is no evidence enhancement didanosine myelosuppressive effects of ganciclovir.
The concentrations of tetracycline antibiotics, and some antibiotics fluoroquinolones (such as ciprofloxacin), in blood plasma are reduced in the presence of antacids as to form chelate compound.
Therefore, Videx tablets containing antacids, or powder dissolved slurry antacids should be taken at least for 6 hours before or after 2 hours after administration of ciprofloxacin.
Capsules Videx not contain an antacid, therefore the risk of interaction with the antibiotics tetracycline and fluoroquinolone series no.
Ribavirin may increase the level of intracellular triphosphate didanosine and potentially increase the risk of side effects. When combined with ribavirin didanosine in anadrol pills combination with stavudine or without reported cases of hepatic 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 the use of side effects.
Less than 5% of didanosine is in bound to plasma proteins, indicating a low probability of drug-drug interactions involving the displacement mechanism of the binding sites.

special instructions

The relationship between sensitivity to didanosine HIV in vitro and clinical response to treatment is not established. Results of in vitro susceptibility vary over a wide range. The positive correlation between in vivo between the measurements of viral activity (eg, methods for determining the polymerase chain reaction RNA) and clinical progression of the disease.
The appointment of tablets chewable or suspension for oral administration, for children up to 3 years is recommended only in the form of a suspension.
With simultaneous use of Videx formulation with drugs with known toxic effects on the peripheral nervous system or the pancreas is a risk that these toxic effects increases considerably.
When concomitant administration of pentamidine by intravenous or drugs that increase the activity of didanosine (hydroxycarbamide, allopurinol) recommended Videx in suspension.
It is necessary to check periodically eyesight and note any visual impairment, such as changes in color perception or blurred vision of objects.
Children should be retinal examination every 6 months or when any change of view.
Didanosine is rapidly degraded in the acidic gastric contents. Therefore, to reduce the acidity of the tablets include antacids. The solution of the powder should be taken only in a mixture with antacids. In didanosine anadrol pills capsules contained in the form of granules, enteric-coated, whereby the absorption of the drug in the intestine is increased.
In HIV-infected patients with severe immune deficiency at the time of combination antiretroviral therapy may experience symptoms of an inflammatory reaction to asymptomatic or residual opportunistic infections. This syndrome was observed within the first few weeks or months after initiation of antiretroviral therapy. You may experience signs of CMV retinitis, generalized or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci.
If symptoms of pancreatitis drug treatment should be suspended, and the treatment should be discontinued if the diagnosis is confirmed. When the level exceeds clinically significant biochemical parameters even in the absence of symptoms of pancreatitis, the drug should be assigned as a suspension.
When clinically confirmed hepatotoxicity or symptoms of lactic acidosis (even if slightly liver transaminases over the upper limit), drug treatment should be stopped. At these rates significantly exceeded indicators treatment should cease.
Absorbability didanosine regardless of the dosage form in the presence of food decreased by an average of 50%. Tablets and powder should be taken 30 minutes before or 2 hours after a meal, the capsules should be taken on an empty stomach.
In appointing the drug to patients with impaired renal function should be taken into account that each tablet contains 8.6 mEq magnesium.
In appointing the drug to patients with phenylketonuria should take into account that: each tablet of 100 mg contains 36.5 mg of phenylalanine in aspartame composition.
The capsules and powder for solution for oral administration for children do not contain phenylalanine.
in appointing the drug to patients who are on a diet with restriction of salt intake, it should be borne in mind that 100 mg capsules contain content not less than 0.424 mg of sodium.
The 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 in the selection and calculation of the amount of antacid.
Dosage forms do not contain sucrose, so the restrictions for use in patients with diabetes is not diabetes drug.

issuance

Tablets for chewing, or suspension for oral administration 100 mg. 60 tablets in high density polyethylene bottle with a screw cap made of polypropylene, inaccessible to children opening. 1 vial together with instructions for use placed in a cardboard box.
Capsules 125 mg, 200 mg, 250 mg and 400 mg. 10 capsules in blister PVC / aluminum foil. 3 blisters with instruction for use in a cardboard box.
Powder for oral solution for children 2 years to 2 g round glass vials of a clear, colorless glass with a tight polypropylene screw cap for child. On the cover of the two arrows and inscriptions «Close tightly» and «While pushing down turn», the cover is provided with a seal foil and cellulose coated with polyvinylidene chloride film. 1 bottle with instruction on use are placed in a stack of cardboard.

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