Zilacomb - Instructions For The Use Of Tablets, Price, Reviews, Analogues

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Zilacomb - Instructions For The Use Of Tablets, Price, Reviews, Analogues
Zilacomb - Instructions For The Use Of Tablets, Price, Reviews, Analogues

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Zilacomb

Zilacomb: instructions for use and reviews

  1. 1. Release form and composition
  2. 2. Pharmacological properties
  3. 3. Indications for use
  4. 4. Contraindications
  5. 5. Method of application and dosage
  6. 6. Side effects
  7. 7. Overdose
  8. 8. Special instructions
  9. 9. Application during pregnancy and lactation
  10. 10. Use in childhood
  11. 11. In case of impaired renal function
  12. 12. For violations of liver function
  13. 13. Use in the elderly
  14. 14. Drug interactions
  15. 15. Analogs
  16. 16. Terms and conditions of storage
  17. 17. Terms of dispensing from pharmacies
  18. 18. Reviews
  19. 19. Price in pharmacies irreversible

Latin name: Zilacomb

ATX code: J05AR01

Active ingredient: zidovudine (Zidovudine) + lamivudine (Lamivudine)

Manufacturer: JSC Pharmstandard-Tomskkhimfarm (Russia); Biocad CJSC (Russia); Jiangsu Tasli Dii Pharmaceutical Co., Ltd. (Jiangsu Tasly Diyi Pharmaceutical, Co., Ltd.) (China); Shijiazhuang Yiling Pharmaceutical, Co., Ltd (China)

Description and photo update: 2019-10-07

Film-coated tablets, Zilacomb
Film-coated tablets, Zilacomb

Zilakomb is a combined drug for the treatment of HIV infection.

Release form and composition

The drug is produced in the form of film-coated tablets: almost white or white, biconvex, capsule-shaped, on a cross section of almost white or white (10 pcs. In a blister strip made of aluminum foil and PVC film, in a cardboard box 6 packs and instructions for the use of Zilakomb).

1 tablet contains:

  • active ingredients: lamivudine - 150 mg, zidovudine - 300 mg;
  • additional components: colloidal silicon dioxide, microcrystalline cellulose, sodium carboxymethyl starch, hypromellose-2910, magnesium stearate;
  • film shell: titanium dioxide (E171), hypromellose-2910, polysorbate-80, macrogol.

Pharmacological properties

Pharmacodynamics

Zilacomb is a drug for the treatment of infection caused by the human immunodeficiency virus (HIV). The active ingredients of Zilacomb are zidovudine and lamivudine, which are highly effective selective inhibitors of HIV-1 and HIV-2 reverse transcriptase. Lamivudine is a synergist with zidovudine for inhibition of HIV replication in cell culture. Both active substances are sequentially metabolized with the participation of intracellular kinases to obtain 5'-triphosphate (TF). Lamivudine TF and zidovudine TF are substrates for HIV reverse transcriptase, and are also among its competitive inhibitors. Nevertheless, the antiviral activity of the active substances is mainly associated with the inclusion of their monophosphate form in the DNA chain of the virus, which ensures the break of this chain. The triphosphates of zidovudine and lamivudine are characterized by a significantly lower affinity for DNA polymerases of human cells.

In vitro studies have established low cytotoxicity of lamivudine in relation to lymphocytic and monocytic-macrophage colonies and to some precursor cells of the red bone marrow. Therefore, lamivudine has a broad therapeutic index.

The resistance of HIV-1 to the action of lamivudine is caused by a mutation in the M184V codon located near the active center of HIV reverse transcriptase. This strain is isolated in vitro and in HIV-1-infected patients undergoing treatment with antiretroviral drugs, including lamivudine. In the presence of M184V mutations in viral strains, they are characterized by a significant decrease in sensitivity to lamivudine and demonstrate a lower replicative activity in vitro. In vitro studies have shown that zidovudine-resistant virus isolates may develop sensitivity to zidovudine if they acquire lamivudine resistance. The clinical significance of this phenomenon has not been determined.

Due to the cross-sensitivity associated with the M184V mutation in HIV reverse transcriptase, the use of all drugs from the class of nucleoside reverse transcriptase inhibitors (NRTIs) is limited. In relation to lamivudine-resistant strains of HIV-1, the antiretroviral activity exhibited by zidovudine and stavudine remains. Abacavir demonstrates antiretroviral effects against lamivudine-resistant HIV-1, the immunity of which is associated only with the M184V mutation. The sensitivity to zalcitabine and didanosine in M184V mutant strains is reduced by 4 times; the clinical significance of this fact has not yet been fully established.

Resistance to zidovudine and other thymidine analogs is commensurate with a stepwise accumulation, including almost all 6 specific HIV reverse transcriptase mutations located at codons 41, 67, 70, 210, 215, and 219. Phenotypic resistance to thymidine analogs is acquired by viruses by combining mutations in codons 41 and 215 or accumulation, at least four out of six mutations.

There were revealed 2 types of the appearance of mutations leading to multi-resistance, type I - mutations of the viral reverse transcriptase in codons 62, 77, 75, 116 and 151; Type II - T69S mutations with the inclusion of 6 base pairs in this position, which leads to the emergence of phenotypic resistance to NRTIs, including zidovudine. Treatment options are significantly limited by any of these types of mutations that cause the development of multidrug resistance.

It was found that the use of a combination of lamivudine and zidovudine provided a decrease in HIV-1 load and an increase in the number of CD4 + cells. According to clinical data, lamivudine in combination with zidovudine or with other regimens containing zidovudine significantly reduces the risk of disease progression and mortality. Monotherapy with lamivudine or zidovudine has led to the development of HIV isolates with reduced sensitivity to these agents in vitro. In patients who had not previously received antiretroviral therapy (APT), combination therapy with lamivudine and zidovudine slowed down the development of zidovudine-resistant strains. Combination ART regimens that include lamivudine have shown good results in the treatment of patients who have not previously received antiretroviral drugs and in patients who have identified HIV strains with the M184V mutation.

Pharmacokinetics

Both active substances of Zilacomb are quickly and completely absorbed from the intestines. After oral administration in adult patients, the bioavailability of zidovudine is 60–70%, and that of lamivudine is 80–85%. Bioequivalence studies have shown that lamivudine + zidovudine fixed combination is equivalent to simultaneous oral fasting of lamivudine 150 mg and zidovudine 300 mg separately. After taking Zilacomb, the maximum concentrations (C max) of lamivudine and zidovudine were observed after 0.75 (0.5-2) and 0.5 (0.25-2) hours and amounted to 1.5 (1.3-1.8) and 1.8 (1.5-2.2) mg / ml, respectively. After ingestion with food, the degree of absorption of both active substances, based on the area under the pharmacokinetic curve (AUC), and the half-life (T 1/2) were similar to those after fasting intake, but the rate of absorption was slightly slowed down.

The use of tablets in crushed form together with a small amount of liquid or semi-solid food does not affect the pharmacological properties of the drug and, as a result, the clinical effect. This conclusion is based on the pharmacokinetic and physicochemical characteristics of the active components of Zilacomb, provided that the patient immediately uses 100% of the crushed tablet contained in the prepared mixture.

For lamivudine and zidovudine, the mean apparent volume of distribution (V d) is 1.3 and 1.6 l / kg, respectively. When used in therapeutic doses, lamivudine has a linear pharmacokinetics, this substance in a small amount binds to plasma albumin (in vitro less than 36% of serum albumin). Plasma protein binding of zidovudine can be 34–36%. Due to the above, the interaction of both active substances with other drugs by changing the binding sites with proteins is unlikely.

Lamivudine and zidovudine, based on the data obtained, can penetrate into the cerebrospinal fluid and the central nervous system. 2–4 hours after oral administration, the relationship between serum and cerebrospinal fluid levels of lamivudine and zidovudine is approximately 0.5 and 0.12, respectively.

Lamivudine is excreted mainly unchanged by the kidneys. Due to the insignificant degree of metabolism in the liver (5-10%) and the low connection with the serum proteins of the blood of this substance, its metabolic interactions are unlikely. Approximately 50–80% of the dose of zidovudine taken is eliminated by renal excretion, the main metabolite found in both urine and plasma is zidovudine 5'-glucuronide. After intravenous (IV) administration, 3'-amino-3'deoxythymidine is determined in the urine.

T 1/2 of lamivudine is 5-7 hours, systemic clearance is on average 0.32 l / h / kg, while the renal clearance of the substance reaches more than 70% with the participation of organic cations of the transport system. With intravenous administration, the average T 1/2 of zidovudine was 1.1 hours, the average systemic clearance was 1.6 l / h / kg. The renal clearance of zidovudine is carried out by glomerular filtration and active secretion in the renal tubules, and is equal to 0.34 l / h / kg.

Indications for use

Zilacomb is recommended for the treatment of HIV infection in adults and children with a body weight of at least 30 kg.

Contraindications

Zilakomb therapy is contraindicated in the following diseases / conditions:

  • severe anemia (hemoglobin below 75 g / l or 4.65 mmol / l) or neutropenia (neutrophil count less than 0.75 × 10 9 / l);
  • hypersensitivity to any of the constituents of the drug.

Zilacomb, instructions for use: method and dosage

Zilacomb tablets are taken orally, regardless of the time of the meal.

Drug therapy should be carried out by doctors who have experience in treating HIV infection.

In order to maintain the accuracy of dosing, the tablet should be swallowed whole. When treating patients who have difficulty swallowing a whole tablet, it can be crushed and immediately taken orally, added to a small amount of semi-solid food or liquid. You must use all the prepared mixture.

For adolescents with a body weight of at least 30 kg and adults, it is recommended to take Zilacomb 2 times a day, 1 tablet. Children weighing less than 30 kg should use separate zidovudine and lamivudine preparations.

If severe anemia (hemoglobin level below 90 g / l or 5.59 mmol / l) or neutropenia (neutrophil count less than 1.0 × 10 9 / l) appears during therapy, it may be necessary to change the dose of zidovudine. Due to the fact that during the treatment with Zilacomb it is impossible to make an individual selection of doses of its active ingredients, it is recommended to use separate preparations of lamivudine and zidovudine.

If you need to reduce the dose of Zilacomb, reduce the dose or cancel one of its active components, the patient can be switched to taking separate preparations of lamivudine and zidovudine in dosage forms such as oral solution, tablets or capsules.

Side effects

Since Zilacomb tablets contain two active components, it can cause the development of side reactions characteristic of each of these substances. There is currently no evidence that the combined use of zidovudine and lamivudine has additive toxicity.

Disorders reported in monotherapy with lamivudine:

  • respiratory system, chest and mediastinal organs: often - nasal symptoms (nasal congestion, rhinorrhea, headaches, bleeding, impaired nasal breathing), cough;
  • immune system: rarely - angioedema;
  • nervous system: often - insomnia, headache; extremely rare - paresthesia; peripheral neuropathy (the relationship of this complication with lamivudine treatment has not been clarified);
  • blood and lymphatic system: infrequently - thrombocytopenia, anemia, neutropenia; extremely rare - true erythrocyte aplasia;
  • metabolism and nutrition: often - hyperlactatemia; rarely - lactic acidosis; redistribution / accumulation of adipose tissue *;
  • liver and biliary tract: infrequently - a transient increase in the activity of the liver enzymes aspartate aminotransferase (ACT) and alanine aminotransferase (ALT); rarely - hepatitis;
  • gastrointestinal tract (GIT): often - epigastric pain, nausea, vomiting, diarrhea; rarely - pancreatitis, the symptoms of which may be nausea / vomiting, abdominal pain, increased biochemical markers (the connection with the use of lamivudine has not been established); increased activity of serum amylase;
  • musculoskeletal system and connective tissue: often - muscle disorders, arthralgia; rarely - rhabdomyolysis;
  • skin and subcutaneous tissue: often - rash, alopecia;
  • general disorders: often - general malaise, fatigue, fever.

Disorders recorded during treatment with zidovudine in monotherapy regimen:

  • nervous system: very often - headache; often - dizziness; rarely - drowsiness / insomnia, paresthesia, convulsions, decreased mental activity;
  • mental disorders: rarely - anxiety and depression;
  • metabolism and nutrition: often - hyperlactatemia; rarely - anorexia, lactic acidosis, redistribution / accumulation of adipose tissue *;
  • cardiovascular system: rarely - cardiomyopathy;
  • blood and lymphatic system: often - anemia (blood transfusion may be prescribed), leukopenia and neutropenia; infrequently - thrombocytopenia and pancytopenia, with bone marrow hypoplasia; rarely - true erythrocytic aplasia; extremely rare - aplastic anemia;
  • organ of hearing and labyrinthine disorders: vertigo, hearing loss;
  • organ of vision: with an unknown frequency - amblyopia, photophobia, macular edema;
  • respiratory system, organs of the chest and mediastinum: infrequently - shortness of breath; rarely - cough;
  • hepatobiliary system: often - an increase in the activity of liver enzymes and an increase in the level of bilirubin; rarely - liver damage, including severe hepatomegaly with steatosis;
  • Gastrointestinal tract: very often - nausea; often - diarrhea, abdominal pain, vomiting; infrequently - flatulence; rarely - dysgeusia and dyspepsia, pigmentation of the oral mucosa, pancreatitis;
  • skin and subcutaneous tissues: infrequently - rash, itching; rarely - hyperhidrosis, pigmentation of nails and skin, urticaria;
  • reproductive system and mammary glands: rarely - gynecomastia;
  • kidneys and urinary tract: rarely - frequent urination;
  • musculoskeletal system and connective tissue: often - myalgia; infrequently - myopathy;
  • general disorders: often - general malaise; infrequently - fever, asthenia and generalized pain syndrome; rarely - chest pain, chills, flu-like syndrome.

* - The frequency of this reaction depends on many factors, including the specific combination of antiretroviral drugs.

Overdose

There is no information on Zilacomb overdose cases. However, there is limited information on the consequences of acute overdose of zidovudine and lamivudine. In this case, lethal outcomes were not recorded, and disorders caused by overdose were removed in all patients. No specific signs or symptoms of active substance intoxication have been described.

If an overdose is suspected, the patient's condition should be monitored in order to timely detect signs of intoxication, if necessary, standard supportive treatment can be prescribed. Since lamivudine is excreted by dialysis, continuous hemodialysis is allowed against the background of an overdose, but there is no relevant clinical experience to date. It is assumed that peritoneal dialysis and hemodialysis have a limited effect on the elimination of zidovudine, but they lead to an acceleration of the excretion of glucuronide (its metabolite).

special instructions

If it is necessary to titrate the dose of the active components of Zilacomb on an individual basis, it is recommended to carry out therapy with separate preparations of lamivudine and zidovudine.

Even during treatment with Zilacomb or any other antiretroviral drug, opportunistic infections and other complications characteristic of HIV are possible. As a result, patients must be constantly monitored by experienced doctors with experience in HIV therapy.

Patients should be informed that the use of antiretroviral drugs, including Zilacomb, is not able to prevent the risk of HIV transmission to others in the event of infected blood transfusion or unprotected sex.

Patients should also be aware of the possible interaction of Zilacomb with other drugs when used concomitantly.

In patients receiving zidovudine, especially in high daily doses (1200–1500 mg), the likelihood of developing hematological disorders, such as neutropenia, anemia, and leukopenia, increases. Most often, these disorders occur in the late stages of the development of HIV infection, in most cases with a reduced bone marrow reserve before the start of the course of therapy, mainly in patients with a CD4 + cell count below 100 / μl. As a result, in patients taking Zilacomb, careful monitoring of blood biochemical parameters should be carried out. The above-described hematological changes, as a rule, are observed no earlier than 4-6 weeks after the start of the course of therapy. Therefore, in patients with a late stage of HIV infection, during the first 3 months of the course, blood tests should be performed at least once every 2 weeks, and in the future - at least once a month. Since in the early stages of HIV infection, such hematological disorders are rare, blood tests can be done once every one to three months, taking into account the general condition of the patient.

With the development of a severe form of anemia or myelosuppression during therapy, as well as in patients with previous bone marrow suppression, in particular with a neutrophil count of less than 1.0 × 10 9 / L or a hemoglobin level of 90 g / L (5.59 mmol / L) Zidovudine dose adjustment may be required. In this case, it is recommended to switch to taking the separate drugs lamivudine and zidovudine.

Rare cases of lactic acidosis and severe hepatomegaly with fatty liver have been reported in patients who received nucleoside analogs in monotherapy or in combination treatment, including lamivudine and zidovudine. These complications were observed in most cases in women.

Clinical symptoms of lactic acidosis may include the following disorders: loss of appetite, general weakness, sudden and unexplained weight loss, vomiting, nausea, abdominal pain, rapid breathing, shortness of breath, muscle weakness, and other neurological symptoms. In all patients (especially in obese women) with hepatitis, hepatomegaly, or other risk factors for liver damage and fatty liver infiltration (including alcohol and some drugs), nucleoside analogs should be used with extreme caution. Patients with hepatitis C coinfection receiving interferon alfa and ribavirin are at increased risk. In the event of clinical / laboratory signs of hepatotoxicity or lactic acidosis, including hepatomegaly and steatosis, even in the absence of a pronounced increase in the activity of aminotransferases,you should stop taking nucleoside analogues.

During the period of combined ART, some patients experience a phenomenon of redistribution / accumulation of adipose tissue, including central obesity, weight loss of the face and limbs, dorsovisceral fat deposition (buffalo hump), increased blood glucose and serum lipids, and breast enlargement. These symptoms can occur both individually and collectively. The long-term consequences of these violations are currently unknown.

The risk of one or more of the above complications associated with a general syndrome, attributed in most cases to lipodystrophy, exists against the background of treatment with all drugs belonging to NRTIs and protease inhibitors. However, there are data that indicate a number of differences between individual representatives of these classes of drugs in relation to the ability to provoke the appearance of these adverse reactions. It is also required to take into account that the appearance of lipodystrophy syndrome depends on many important concomitant factors, which include old age, the stage of HIV infection, and the duration of ART. During the clinical examination, it is necessary to assess the physical signs of redistribution of adipose tissue, to determine the serum lipid level and the concentration of blood glucose. Therapy of lipid metabolism disorders should be carried out taking into account their clinical manifestations.

Influence on the ability to drive vehicles and complex mechanisms

Special studies on the effect of Zilakomb on the ability to drive vehicles and other potentially dangerous and complex equipment have not been conducted. Given the pharmacological characteristics of lamivudine and zidovudine, there is no evidence to suggest such adverse effects. It is necessary in each individual case to adequately assess the possible side effects of treatment and the clinical status of the patient.

Application during pregnancy and lactation

Pregnancy has no effect on the pharmacokinetics of lamivudine and zidovudine. Both active substances are detected at the birth of a child in serum at concentrations equal to those in the umbilical cord blood during childbirth and the mother's serum, which indicates the passive penetration of these agents through the hematoplacental barrier.

It has been established that therapy with zidovudine in pregnant women and further administration of this drug to newborns reduces the frequency of HIV transmission from mother to fetus. However, no such data are available for lamivudine. It is not recommended to use Zilacomb in the first trimester of pregnancy, unless the intended benefit of treatment for the mother outweighs the possible threat to the fetus.

HIV-infected women are advised not to breastfeed their babies to avoid HIV transmission. In newborns and infants whose mothers received treatment with drugs from the NRTI class during pregnancy or during childbirth, a slight temporary increase in blood lactate was recorded. There are also isolated reports of developmental delay and seizures in a child. In general, for these children, the benefits of reducing the threat of HIV infection seem to outweigh the risks posed by the side effects of NRTIs.

Pediatric use

  • zidovudine: the main indicators of pharmacokinetics in children older than 5-6 months are similar to those in adults. In all studied doses in children and adults, zidovudine is well absorbed from the intestine after administration, and its bioavailability averages 65%. In equilibrium, the maximum concentration (C ss max) is 4.45 μmol (1.19 μg / ml) after using zidovudine in the form of a solution at a dose of 120 mg / m2 or 7.7 μmol (2.06 μg / ml) after administration at a dose of 180 mg / m². A dose of 180 mg / m2 4 times a day provides the same systemic exposure in children (AUC 24 - 10.7 h × μg / ml) as in adults, taking a dose of 200 mg / m2 6 times a day (AUC 24 - 10, 9 h × μg / ml);
  • Lamivudine: Pharmacokinetics in children are generally similar to those in adults, however, absolute bioavailability was reduced in patients under 12 years of age (approximately 55–65%). In children, systemic clearance is higher than in adults, and gradually decreases as they grow older, reaching the same values as in adults by the age of 12. Given these differences, in patients aged 3 months to 12 years with a body weight of 6 to 40 kg, the recommended daily dose of lamivudine is 8 mg / kg. AUC 0-12 after taking this dose reaches 3800-5300 ng × h / ml. According to the latest data, the exposure in children 2–6 years old can be reduced by 30% in comparison with other age groups.

Zilakomb is contraindicated for children weighing less than 30 kg.

With impaired renal function

In the presence of renal failure, the excretion of lamivudine is impaired as a result of reduced renal clearance. Since the plasma level of zidovudine also increases against the background of severe renal failure, patients with creatinine clearance (CC) below 50 ml / min require a decrease in the dose of lamivudine and zidovudine, and therefore it is recommended to use them as separate drugs.

For violations of liver function

A decrease in the glucuronidation process as a result of liver cirrhosis can cause the accumulation of zidovudine. Patients with severe hepatic impairment are advised to use zidovudine and lamivudine as separate drugs because of the possible need for individual dose adjustment of zidovudine.

Zilacomb should be used with caution in patients suffering from decompensated cirrhosis of the liver associated with chronic hepatitis B, because in some cases there is a risk of exacerbation of hepatitis due to the withdrawal of lamivudine. It is recommended to monitor liver activity and hepatitis B virus replication markers for four months after stopping the drug.

Use in the elderly

In persons over the age of 65, the pharmacokinetics of the active substances of the drug have not been studied.

When treating Zilacomb in elderly patients, special care should be taken, due to the possible presence of age-related pathologies, in particular, functional renal disorders and changes in hematological parameters.

Drug interactions

Due to the fact that Zilacomb includes lamivudine and zidovudine, it can enter into any forms of interaction that are characteristic of each of these components separately.

Interaction reactions that are possible when lamivudine is combined with other drugs / agents:

  • drugs excreted by organic cations of the transport system: interactions can be observed due to the same elimination pathway with lamivudine;
  • trimethoprim (one of the components of co-trimoxazole): there is an increase in the plasma concentration of lamivudine by 40% when using this drug in therapeutic doses; in patients with normal renal function, no dose adjustment of lamivudine is required; the pharmacokinetics of trimethoprim or sulfamethoxazole are not influenced by lamivudine; in the presence of renal failure, caution is required, the combination of lamivudine and co-trimoxazole in high doses for the treatment of toxoplasmosis and Pneumocystis pneumonia has not been studied, so it should be avoided;
  • emtricitabine: this combination is not recommended for the treatment of HIV infection due to the similarities between lamivudine and emtricitabine;
  • cladribine, zalcitabine: the process of intracellular phosphorylation of these substances can be suppressed, leading to the risk of reducing their effectiveness; a combination from the deprecated category;
  • ranitidine: no clinically significant interaction is expected, since this substance is only slightly excreted by the renal organic cation transport system; individual selection of doses is not required;
  • fluconazole, phenobarbital, didanosine, valproic acid: the interaction of these drugs with Zilacomb has not been studied.

Interaction reactions possible with the simultaneous use of zidovudine with other drugs / agents:

  • lamivudine: there is an increase in the period of exposure to zidovudine by 13% and an increase in its C max in plasma by 28%, while the AUC of zidovudine does not change significantly; zidovudine does not affect the pharmacokinetics of lamivudine;
  • clarithromycin: when combined with this drug in tablet form, there is a decrease in the absorption of zidovudine, the interval between the use of these substances should be at least 2 hours;
  • atovachone: no effect of zidovudine on the pharmacokinetics of atovachone was recorded, at the same time, the latter reduces the metabolic rate of zidovudine to its glucuronide (AUC of zidovudine in the equilibrium state increases by 33%, plasma C max of glucuronide decreases by 19%); with a combination of zidovudine in daily doses of more than 500-600 mg and concomitant therapy with atovachone for acute pneumocystis pneumonia, an increase in the frequency of undesirable effects due to an increase in the plasma level of zidovudine is unlikely;
  • probenecid: the average T 1/2 and AUC of zidovudine increases due to the suppression of glucuronide synthesis; in the presence of probenecid, renal excretion of glucuronide and, presumably, zidovudine decreases;
  • phenytoin: a decrease in the level of phenytoin in the blood was recorded, and in one case, its increase; it is necessary to control the concentration of phenytoin;
  • rifampicin: there is a 48 ± 34% decrease in zidovudine AUC, the clinical significance of this condition is unknown;
  • doxorubicin: a decrease in the activity of each of these agents in vitro is recorded, simultaneous use is not recommended;
  • ribavirin (nucleoside analogs that disrupt DNA replication): there is an increase in the risk of anemia, possibly in vitro a decrease in the antiviral activity of zidovudine; simultaneous use is not recommended;
  • stavudine: inhibition of intracellular phosphorylation of this substance is noted, the combination is not recommended;
  • didanosine: interaction has not been studied, but dose changes are not required;
  • emtricitabine: no clinically significant interaction was recorded;
  • phenobarbital: the interaction has not been studied, a slight decrease in the plasma level of zidovudine is possible due to the induction of UDP-glucuronosyltransferase (UDP-HT);
  • fluconazole: there is a 74% increase in zidovudine AUC as a result of inhibition of UDP HT; clinical significance has not been established, monitoring of toxic reactions of zidovudine is necessary;
  • ranitidine: the interaction of this substance with zidovudine has not been studied;
  • valproic acid: due to inhibition of UDP HT, an increase in zidovudine AUC by 80% is recorded, it is required to control the toxic effects of zidovudine;
  • pentamidine, co-trimoxazole, pyrimethamine, dapsone, flucytosine, interferon, amphotericin B, ganciclovir, vinblastine, vincristine, doxorubicin (with systemic administration) and other potentially nephrotoxic / myelosuppressive drugs: the threat of development of undesirable effects of zidovudine increases, especially in the treatment of acute conditions; in combination therapy, it is required to carefully monitor hematological parameters and renal activity, and, if necessary, reduce the dose of one or both drugs;
  • morphine, codeine, acetylsalicylic acid, ketoprofen, inosine pranobex, indomethacin, naproxen, clofibrate, lorazepam, oxazepam, cimetidine, dapsone: inhibition of zidovudine metabolism under the action of microsomal liver enzymes or changes in its metabolism due to competitive suppression is possible; before combination therapy with Zilacomb, potential drug interactions should be assessed;
  • aerosolized pentamidine, co-trimoxazole, acyclovir, pyrimethamine (agents used to prevent opportunistic infections): there is no significant increase in the frequency of adverse reactions of zidovudine.

Analogs

Zilakomb's analogues are Zidovudine + Lamivudine, Virokomb, Disaverox, Zidovudine + Lamivudine-Vial, Zidolam, Combivir, Lazevun, Emlazid, Lamy-Zidox.

Terms and conditions of storage

Store in a place protected from light, in its original packaging at a temperature not exceeding 30 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Zilakomb

Reviews of Zilakomb in the HIV ART forums are rather mixed. Many patients believe that the inclusion of Zilacomb in ART, as the classic representative of combined NRTIs, gives good results, since the fixed combination of lamivudine and zidovudine leads to a decrease in the HIV load and provides an increase in CD4 + cells. Therapy, according to the majority of those infected, helps to significantly reduce the risk of disease progression.

However, many patients believe that Zilacomb is already outdated, and it can be used only in the initial treatment regimen for no more than one year, since sometimes it can lead to the development of severe side effects.

The price of Zilacomb in pharmacies irreversible

The price of Zilacomb, film-coated tablets, averages 2500 rubles. per package containing 60 pcs.

Anna Kozlova
Anna Kozlova

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

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

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