Attributes
- Form
- Dosage mg
- Pack
- Description en
- Dosage form: Eye drops. Description: Clear, greenish-yellow solution. Composition: 1 ml of the preparation contains active substances: Moxifloxacin (in the form of moxifloxacin hydrochloride) 5 mg, Dexamethasone phosphate (in the form of dexamethasone sodium phosphate) 1 mg. Excipients: Disodium edetate, boric acid, sodium chloride, sorbitol, poloxamer, hydrochloric acid and/or sodium hydroxide, water for injection. ATC code: S01CA01. Pharmacotherapeutic group: Ophthalmic agents. Combination of corticosteroids and antimicrobials. Dexamethasone and antimicrobials. Pharmacological properties: Pharmacodynamics: Bivoxa-D is a combined preparation whose action is due to the broad-spectrum antibiotic (moxifloxacin) and the potent long-acting synthetic glucocorticoid (dexamethasone) it contains. Moxifloxacin's mechanism of action is related to the inhibition of topoisomerase IV and DNA gyrase, enzymes involved in bacterial DNA replication, transcription, repair, and recombination. Fluoroquinolones primarily act on the DNA gyrase of Gram-negative bacteria, and on topoisomerase IV in Gram-positive bacteria. Moxifloxacin is active against most strains of microorganisms (both in vitro and in vivo): Aerobic Gram-positive microorganisms: Corynebacterium spp.1, Micrococcus luteus1, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group; Aerobic Gram-negative microorganisms: Acinetobacter lwoffii1, Haemophilus influenzae, Haemophilus parainfluenzae. 1 Efficacy for these microorganisms was studied in fewer than 10 infected patients. Corticosteroids have anti-inflammatory effects by inhibiting the release of arachidonic acid, as well as by suppressing the expression of adhesion molecules of vascular endothelial cells and cyclooxygenase. This action leads to a reduction in the release of inflammatory mediators and a weakening of the adhesion of circulating leukocytes to the vascular endothelium, preventing their penetration into inflamed eye tissues. In addition, the decrease in cyclooxygenase expression leads to a reduction in the production of inflammatory prostaglandins, which are known to cause breakdown of the hemato-ophthalmic barrier and leakage of plasma proteins into eye tissues. Pharmacokinetics: Moxifloxacin: Moxifloxacin plasma concentration was measured in healthy adult men and women receiving bilateral ophthalmic doses of 0.5% moxifloxacin eye drops three times daily. The mean maximum plasma concentration of moxifloxacin at steady state (Cmax) is 2.7 ng/ml, and the area under the plasma concentration-time curve (AUC) is 45 ng.h/ml. These values are approximately 1600-fold and 1000-fold lower than the Cmax and AUC after a 400 mg oral therapeutic dose of moxifloxacin. The plasma half-life (t1/2) of moxifloxacin is approximately 13 hours. Dexamethasone: Dexamethasone phosphate is rapidly converted to dexamethasone in the human body. After topical application of a 0.1% dexamethasone solution in patients who underwent cataract surgery, the dexamethasone level in the aqueous humor averaged 31 ± 3.9 ng/ml 90-120 minutes after dosing. Indications: Treatment of bacterial eye infections caused by susceptible microorganisms; Prevention of postoperative inflammatory complications and bacterial infections in ophthalmic surgery. Method of administration and dosage: Bivoxa-D is intended for topical use only. For the prevention of postoperative inflammatory or infectious processes in the eye: one drop in the eye to be operated on 4 times a day, starting one day before surgery and continuing for no more than 15 days after surgery. For the treatment of eye infections caused by susceptible microorganisms: one drop 4 times a day for 7 days or as prescribed by a doctor. It is necessary to follow the dose, treatment regimen, and duration prescribed by the doctor. To avoid microbial contamination of the dropper and solution, care must be taken and the dropper should not touch the eyelids, the area around the eyes, and other surfaces. If a dose is missed, treatment should be continued according to the schedule. Contraindications: Hypersensitivity to the active substances or other drugs of the fluoroquinolone group, or to any of the excipients; Keratitis caused by herpes simplex, variola, varicella, and other viral infections of the cornea or conjunctiva; Fungal or untreated parasitic infections of the eye, as well as eye infections caused by mycobacteria; Children under 2 years of age. Adverse reactions: Frequency categories for adverse reactions are defined as follows: very common (≥ 1/10); common (≥ 1/100 but < 1/10); uncommon (≥ 1/1000 but < 1/100); rare (≥ 1/10000 but < 1/1000); very rare (< 1/10000); unknown frequency (cannot be estimated from available data). Psychiatric disorders: Rare - insomnia. Nervous system disorders: Uncommon - dysgeusia. Eye disorders: Common - eye itching, eye irritation; Uncommon - decreased visual acuity, eyelid pain; Unknown frequency - conjunctival hyperemia. Respiratory, thoracic and mediastinal disorders: Uncommon - pharyngeal pain. Reporting of suspected adverse reactions: Reporting of suspected adverse reactions after the medicinal product has been authorized is important. If you notice any serious or new adverse reactions (not described in this section), please report them according to the national pharmacovigilance system. Special instructions: After instilling eye drops, it is recommended to press the inner corner of the eye with a finger or close the eyes, which reduces systemic absorption and thus systemic adverse reactions. In patients treated with systemic fluoroquinolones, there have been reports of serious and sometimes fatal hypersensitivity (anaphylactic) reactions, sometimes after the first dose. Some reactions were accompanied by cardiovascular failure, syncope, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin develops, the use of the preparation should be discontinued. Serious acute hypersensitivity reactions may require emergency medical attention. If there are clinical indications, oxygen administration and restoration of airway patency are necessary. Prolonged use of topical ophthalmic corticosteroids may cause ocular hypertension and/or glaucoma with optic nerve damage, visual acuity and visual field disturbances, as well as the development of posterior subcapsular cataracts. In patients on long-term corticosteroid therapy, intraocular pressure should be monitored regularly. This is especially important in children, as corticosteroid-induced intraocular hypertension develops faster in them than in adults, and the risk of its development is also higher than in adults. Bivoxa-D eye drops are not indicated for use in children. The risk of developing corticosteroid-induced intraocular pressure and/or cataracts is higher in predisposed patients, such as those with diabetes. Treatment with systemic fluoroquinolones can cause tendon inflammation and damage. At the first signs of tendonitis, treatment with Bivoxa-D should be discontinued. Cushing's syndrome and/or adrenal suppression associated with systemic absorption of topically administered dexamethasone may occur in susceptible patients after intensive or prolonged continuous therapy, including children and patients treated with CYP3A4 inhibitors (e.g., ritonavir or cobicistat). In such cases, treatment should not be discontinued abruptly, but with gradual dose reduction. Corticosteroid treatment may reduce the body's resistance and lead to overgrowth of non-susceptible microorganisms, development of bacterial, fungal, viral or parasitic infections, and masking of clinical manifestations of infection. The possibility of developing fungal infection should be considered in patients with persistent corneal ulcers. If signs of fungal infection appear, corticosteroid treatment should be discontinued. Topical ophthalmic corticosteroids may impair corneal wound healing. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are also known to impair healing. Concurrent use of topical steroids and NSAIDs may have an adverse effect on the corneal healing process. Cases of perforation have been reported with the use of topical corticosteroids in diseases that cause thinning of the cornea or sclera. Prolonged use of antibiotics can lead to overgrowth of non-susceptible microorganisms, including fungi. If superinfection develops, appropriate treatment should be initiated. The possibility of fungal infections of the cornea should be considered after prolonged use. The preparation is contraindicated in children under 2 years of age because it contains boron, which may adversely affect future fertility. Effects on ability to drive and use machines: Temporary blurring of vision or other visual disturbances may affect the ability to drive and operate machinery. If blurred vision occurs after using eye drops, the patient should wait until vision is restored before driving or operating other machinery. Fertility, use during pregnancy and lactation: Fertility: Data on the effect of moxifloxacin and dexamethasone on male and female fertility are limited. Moxifloxacin and dexamethasone do not reduce fertility in rats. Pregnancy: Data on the use of Bivoxa-D by pregnant women are limited or practically non-existent. Prolonged or repeated use of corticosteroids during pregnancy is associated with an increased risk of intrauterine growth retardation. Infants whose mothers received significant doses of corticosteroids during pregnancy require examination for signs of hypoadrenalism. In animal studies, moxifloxacin did not cause adverse reactions directly related to reproductive toxicity. However, reproductive toxicity of dexamethasone (when used systemically) has been observed in animal studies. Topical ophthalmic use of 0.1% dexamethasone also caused fetal abnormalities in rabbits. The use of Bivoxa-D during pregnancy is not recommended. Lactation: It is unknown whether moxifloxacin and dexamethasone are excreted in breast milk. Animal studies have shown that moxifloxacin is excreted in breast milk at low concentrations when taken orally. It is unlikely that significant amounts of moxifloxacin and dexamethasone will be found in breast milk and cause a clinical effect in the newborn with topical use of this preparation by a nursing mother. Since the risk to a breastfed infant cannot be excluded, a decision should be made whether to discontinue breastfeeding or treatment/abstain, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman. Interactions with other medicinal products: Concurrent topical administration of steroids and NSAIDs may impair and adversely affect corneal healing processes. CYP3A4 inhibitors, including ritonavir and cobicistat, may increase the systemic effects of corticosteroids, increasing the risk of adrenal suppression and Cushing's syndrome. This combination should be avoided unless the benefit of treatment outweighs the risk of developing systemic adverse reactions to corticosteroids. Patients using this combination require constant monitoring. Overdose: Due to the dosage form of the preparation, toxic effects are not expected either with overdose of the ophthalmic dose or with accidental ingestion of the contents of the bottle. In case of accidental ingestion of the preparation, consult a doctor. Dosage form: 5 ml eye drops in a plastic bottle with a dropper tip and a screw-on protective cap with a tamper-evident ring. 1 bottle with instructions for medical use in a cardboard box. Storage conditions: Store at a temperature not exceeding 25°C. Keep out of reach of children! After opening the bottle, use the preparation within 28 days. Shelf life: 3 years from the date of manufacture. Do not use after the expiry date. Conditions of dispensing from pharmacies: Pharmaceutical product group III, available without a prescription.
- Active
- moxifloxacin+dexamethasone
What is it?
Dosage form: Eye drops. Description: Clear, greenish-yellow solution. Composition: 1 ml of the preparation contains active substances: Moxifloxacin (in the form of moxifloxacin hydrochloride) 5 mg, Dexamethasone phosphate (in the form of dexamethasone sodium phosphate) 1 mg. Excipients: Disodium edetate, boric acid, sodium chloride, sorbitol, poloxamer, hydrochloric acid and/or sodium hydroxide, water for injection. ATC code: S01CA01. Pharmacotherapeutic group: Ophthalmic agents. Combination of corticosteroids and antimicrobials. Dexamethasone and antimicrobials. Pharmacological properties: Pharmacodynamics: Bivoxa-D is a combined preparation whose action is due to the broad-spectrum antibiotic (moxifloxacin) and the potent long-acting synthetic glucocorticoid (dexamethasone) it contains. Moxifloxacin's mechanism of action is related to the inhibition of topoisomerase IV and DNA gyrase, enzymes involved in bacterial DNA replication, transcription, repair, and recombination. Fluoroquinolones primarily act on the DNA gyrase of Gram-negative bacteria, and on topoisomerase IV in Gram-positive bacteria. Moxifloxacin is active against most strains of microorganisms (both in vitro and in vivo): Aerobic Gram-positive microorganisms: Corynebacterium spp.1, Micrococcus luteus1, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group; Aerobic Gram-negative microorganisms: Acinetobacter lwoffii1, Haemophilus influenzae, Haemophilus parainfluenzae. 1 Efficacy for these microorganisms was studied in fewer than 10 infected patients. Corticosteroids have anti-inflammatory effects by inhibiting the release of arachidonic acid, as well as by suppressing the expression of adhesion molecules of vascular endothelial cells and cyclooxygenase. This action leads to a reduction in the release of inflammatory mediators and a weakening of the adhesion of circulating leukocytes to the vascular endothelium, preventing their penetration into inflamed eye tissues. In addition, the decrease in cyclooxygenase expression leads to a reduction in the production of inflammatory prostaglandins, which are known to cause breakdown of the hemato-ophthalmic barrier and leakage of plasma proteins into eye tissues. Pharmacokinetics: Moxifloxacin: Moxifloxacin plasma concentration was measured in healthy adult men and women receiving bilateral ophthalmic doses of 0.5% moxifloxacin eye drops three times daily. The mean maximum plasma concentration of moxifloxacin at steady state (Cmax) is 2.7 ng/ml, and the area under the plasma concentration-time curve (AUC) is 45 ng.h/ml. These values are approximately 1600-fold and 1000-fold lower than the Cmax and AUC after a 400 mg oral therapeutic dose of moxifloxacin. The plasma half-life (t1/2) of moxifloxacin is approximately 13 hours. Dexamethasone: Dexamethasone phosphate is rapidly converted to dexamethasone in the human body. After topical application of a 0.1% dexamethasone solution in patients who underwent cataract surgery, the dexamethasone level in the aqueous humor averaged 31 ± 3.9 ng/ml 90-120 minutes after dosing. Indications: Treatment of bacterial eye infections caused by susceptible microorganisms; Prevention of postoperative inflammatory complications and bacterial infections in ophthalmic surgery. Method of administration and dosage: Bivoxa-D is intended for topical use only. For the prevention of postoperative inflammatory or infectious processes in the eye: one drop in the eye to be operated on 4 times a day, starting one day before surgery and continuing for no more than 15 days after surgery. For the treatment of eye infections caused by susceptible microorganisms: one drop 4 times a day for 7 days or as prescribed by a doctor. It is necessary to follow the dose, treatment regimen, and duration prescribed by the doctor. To avoid microbial contamination of the dropper and solution, care must be taken and the dropper should not touch the eyelids, the area around the eyes, and other surfaces. If a dose is missed, treatment should be continued according to the schedule. Contraindications: Hypersensitivity to the active substances or other drugs of the fluoroquinolone group, or to any of the excipients; Keratitis caused by herpes simplex, variola, varicella, and other viral infections of the cornea or conjunctiva; Fungal or untreated parasitic infections of the eye, as well as eye infections caused by mycobacteria; Children under 2 years of age. Adverse reactions: Frequency categories for adverse reactions are defined as follows: very common (≥ 1/10); common (≥ 1/100 but < 1/10); uncommon (≥ 1/1000 but < 1/100); rare (≥ 1/10000 but < 1/1000); very rare (< 1/10000); unknown frequency (cannot be estimated from available data). Psychiatric disorders: Rare - insomnia. Nervous system disorders: Uncommon - dysgeusia. Eye disorders: Common - eye itching, eye irritation; Uncommon - decreased visual acuity, eyelid pain; Unknown frequency - conjunctival hyperemia. Respiratory, thoracic and mediastinal disorders: Uncommon - pharyngeal pain. Reporting of suspected adverse reactions: Reporting of suspected adverse reactions after the medicinal product has been authorized is important. If you notice any serious or new adverse reactions (not described in this section), please report them according to the national pharmacovigilance system. Special instructions: After instilling eye drops, it is recommended to press the inner corner of the eye with a finger or close the eyes, which reduces systemic absorption and thus systemic adverse reactions. In patients treated with systemic fluoroquinolones, there have been reports of serious and sometimes fatal hypersensitivity (anaphylactic) reactions, sometimes after the first dose. Some reactions were accompanied by cardiovascular failure, syncope, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. If an allergic reaction to moxifloxacin develops, the use of the preparation should be discontinued. Serious acute hypersensitivity reactions may require emergency medical attention. If there are clinical indications, oxygen administration and restoration of airway patency are necessary. Prolonged use of topical ophthalmic corticosteroids may cause ocular hypertension and/or glaucoma with optic nerve damage, visual acuity and visual field disturbances, as well as the development of posterior subcapsular cataracts. In patients on long-term corticosteroid therapy, intraocular pressure should be monitored regularly. This is especially important in children, as corticosteroid-induced intraocular hypertension develops faster in them than in adults, and the risk of its development is also higher than in adults. Bivoxa-D eye drops are not indicated for use in children. The risk of developing corticosteroid-induced intraocular pressure and/or cataracts is higher in predisposed patients, such as those with diabetes. Treatment with systemic fluoroquinolones can cause tendon inflammation and damage. At the first signs of tendonitis, treatment with Bivoxa-D should be discontinued. Cushing's syndrome and/or adrenal suppression associated with systemic absorption of topically administered dexamethasone may occur in susceptible patients after intensive or prolonged continuous therapy, including children and patients treated with CYP3A4 inhibitors (e.g., ritonavir or cobicistat). In such cases, treatment should not be discontinued abruptly, but with gradual dose reduction. Corticosteroid treatment may reduce the body's resistance and lead to overgrowth of non-susceptible microorganisms, development of bacterial, fungal, viral or parasitic infections, and masking of clinical manifestations of infection. The possibility of developing fungal infection should be considered in patients with persistent corneal ulcers. If signs of fungal infection appear, corticosteroid treatment should be discontinued. Topical ophthalmic corticosteroids may impair corneal wound healing. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are also known to impair healing. Concurrent use of topical steroids and NSAIDs may have an adverse effect on the corneal healing process. Cases of perforation have been reported with the use of topical corticosteroids in diseases that cause thinning of the cornea or sclera. Prolonged use of antibiotics can lead to overgrowth of non-susceptible microorganisms, including fungi. If superinfection develops, appropriate treatment should be initiated. The possibility of fungal infections of the cornea should be considered after prolonged use. The preparation is contraindicated in children under 2 years of age because it contains boron, which may adversely affect future fertility. Effects on ability to drive and use machines: Temporary blurring of vision or other visual disturbances may affect the ability to drive and operate machinery. If blurred vision occurs after using eye drops, the patient should wait until vision is restored before driving or operating other machinery. Fertility, use during pregnancy and lactation: Fertility: Data on the effect of moxifloxacin and dexamethasone on male and female fertility are limited. Moxifloxacin and dexamethasone do not reduce fertility in rats. Pregnancy: Data on the use of Bivoxa-D by pregnant women are limited or practically non-existent. Prolonged or repeated use of corticosteroids during pregnancy is associated with an increased risk of intrauterine growth retardation. Infants whose mothers received significant doses of corticosteroids during pregnancy require examination for signs of hypoadrenalism. In animal studies, moxifloxacin did not cause adverse reactions directly related to reproductive toxicity. However, reproductive toxicity of dexamethasone (when used systemically) has been observed in animal studies. Topical ophthalmic use of 0.1% dexamethasone also caused fetal abnormalities in rabbits. The use of Bivoxa-D during pregnancy is not recommended. Lactation: It is unknown whether moxifloxacin and dexamethasone are excreted in breast milk. Animal studies have shown that moxifloxacin is excreted in breast milk at low concentrations when taken orally. It is unlikely that significant amounts of moxifloxacin and dexamethasone will be found in breast milk and cause a clinical effect in the newborn with topical use of this preparation by a nursing mother. Since the risk to a breastfed infant cannot be excluded, a decision should be made whether to discontinue breastfeeding or treatment/abstain, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the woman. Interactions with other medicinal products: Concurrent topical administration of steroids and NSAIDs may impair and adversely affect corneal healing processes. CYP3A4 inhibitors, including ritonavir and cobicistat, may increase the systemic effects of corticosteroids, increasing the risk of adrenal suppression and Cushing's syndrome. This combination should be avoided unless the benefit of treatment outweighs the risk of developing systemic adverse reactions to corticosteroids. Patients using this combination require constant monitoring. Overdose: Due to the dosage form of the preparation, toxic effects are not expected either with overdose of the ophthalmic dose or with accidental ingestion of the contents of the bottle. In case of accidental ingestion of the preparation, consult a doctor. Dosage form: 5 ml eye drops in a plastic bottle with a dropper tip and a screw-on protective cap with a tamper-evident ring. 1 bottle with instructions for medical use in a cardboard box. Storage conditions: Store at a temperature not exceeding 25°C. Keep out of reach of children! After opening the bottle, use the preparation within 28 days. Shelf life: 3 years from the date of manufacture. Do not use after the expiry date. Conditions of dispensing from pharmacies: Pharmaceutical product group III, available without a prescription.