Description

White powder with yellowish colors.

Composition on 1 bottle

Active substances:

Ampicillin sodium 333.5 mg

(in terms of ampicillin)

Oxacillin sodium 166.5 mg

(in terms of oxacillin)

Form release

Powder for preparing a solution for intravenous and intramuscular administration.

Pharmacotherapeutic group

Antibacterial agents For systemic use. Ampicillin, combination.

PBX code: j01s51.

Indications for use

Infectious inflammatory - diseases - caused by sensitive pathogens: sinusitis, tonsillitis, middle Otitis; bronchitis, pneumonia; cholegitis, cholecystitis; Pyelonephritis, pylitis, cystitis, urethritis, gonorrhea, cervicitis, skin infections and soft tissues: Ryg, impetigo, secondaryly infected dermatoses and others.

Prevention postoperative complications for surgical interventions (including on the background of immunodeficiency), infections in newborns (infection of the accumulation fluid; breach of the newborn breathing, requiring the use of resuscitation measures; the risk of aspiration pneumonia).

Septis, endocarditis, meningitis, postpartum infection.

Contraindications

Hypersensitivity infectious mononucleosis, lympholoikosis.

Precautions

Carefully

Children who are born in mothers with hypersensitivity to penicillins. Allergic reactions in history and / or bronchial asthma, renal failure, bleeding in history, enterocolit on the background of the use of antibiotics (a history).

special instructions

In case treatment, it is necessary to monitor the condition of the function of the blood formation organs, liver and kidneys.

With the appearance of signs of anaphylactic, urgent measures should be taken to excrete the patient from this state and the introduction of epinephrine (adrenaline), glucocorticosteroids (hydrocortisone or prednisone) and antihistamine tools, if necessary, perform lung ventilation.

The possibility of the development of superinfection (due to the growth of microflora insensitive) requires an appropriate change in antibacterial therapy. In patients having increased sensitivity to penicillins, crosst allergic reactions with cephalosporin antibiotics. When applied in high doses in patients with renal failure, a toxic effect on the central nervous system.

Interaction with other medicines

Ampicillin. Pharmaceutically incompatible with aminoglycosides.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; Bacteriostatic preparations (macrolides, chloramphenicol, lincoosamides, - tetracycles, sulfonamides) - antagonistic.

Increases efficiency indirect anticoagulantov (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); Reduces the effectiveness of estrogen-containing oral contraceptives, drugs, in the process of metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol (in the latter case, the risk of developing "breakthrough" bleeding).

Diuretics, Allopurinol, Oxyphenbutayon, phenylbutazone, nonsteroidal anti-inflammatory drugs and other drugs - means blocking the channel secretion, increase the concentration of ampicillin in plasma (by reducing the tubular secretion).

Allopurinol increases the risk of skin rash.

Reduces clearance and increases the toxicity of methotrexate.

Oxacillin. Increases the toxicity of methotrexate (competition for the canal secretion); It may be necessary to increase the doses of calcium folinate (antagonist anti-pin folic acid) and longer use.

It is necessary to avoid co-use with other drugs that have a hepatotoxic effect.

Drugs that block the tubular secretion increase the concentration of oxacillin in the blood.

Method of application and dose

Intramuscularly and intravenously (inkjano or drip).

The doses of the drug listed below are the sum of the dosages of ampicillin and oxacillin (sodium salts) in their fixed 2: 1 ratio (i.e., in the following dosages 0.5 g of the drug is equal to the amount of 333.5 mg of ampicillin + 166.5 mg oxacillin ).

Daily dose for adults and children over 14 years old - 3-6 g; for newborn, premature and children before | of the year - 100-200 mg / kg / day; 1-6 years - 100 mg / kg / day; 7-14 years old - 50 mg / kg / day. The daily dose is introduced in 3-4 administration with an interval of 6-8 hours. If necessary, the specified doses can be increased by 1.5-2 times.

The duration of treatment depends on the severity of the disease (from days to 2-3 days

weeks, and in chronic processes - for several months).

Patients with severe disruption of the kidney function (creatinine clearance less than 10 ml / min) requires correction of the dosing mode: the dose of the drug should be reduced or the interval between acceptors is increased. In cases of dialysis, an additional dose of the drug should be administered after the end of the procedure.

For intramuscular administration, the contents of the vial (333.5 mg + 166.5 mg) are dissolved in 5 ml of water for injection.

For intravenous jet administration (for 2-3 minutes), a one-time dose is dissolved in 10-15 ml of water for injection or 0.9% sodium chloride solution.

For intravenous drip administration An adult dose is dissolved in 100-200 ml of 0.9% sodium solution of chloride or 5% declaration solution (glucose) and administered at a speed of 60-80 CAP / min; Children as a solvent use 30- 100 ml of 5-10% declaration solution (glucose). Intravenously introduced 5-7 days, followed by the transition to intramuscular administration.

Solutions are used immediately after cooking.

Pregnancy and lactation period

The use of the drug during pregnancy is possible only when the alleged benefit for the mother exceeds the potential risk to the fetus.

If necessary, prescribe a drug during lactation should be stopped breast-feeding (stands out with breast milk).

Overdose

Symptoms: a toxic manifestation is not a central nervous system (especially in patients with renal failure); Nausea, vomiting, diarrhea, impaired water and electrolyte balance.

Treatment: symptomatic. Exit with hemodialysis.

Sideeffects

Allergic reactions: itching and skin peeling, urticaria, skin hyperemia, rhinitis, conjunctivitis, angioedema edema, rarely - fever, arthralgia, eosinophilic, erythematous and maculopapulous rash, exfoliative dermatitis, multimular erythema (including Stevens-Johnson syndrome), reaction, Similar with serum disease, in single cases anaphylactic shock, non-allergic ampicillin rash can disappear without cancellation of the drug.

From the gastrointestinal tract: Dysbacteriosis, a change in taste, vomiting, nausea, diarrhea, moderate increase in the activity of "liver" transaminases, rarely - pseudomambranous colitis.

From the central nervous system:

Very rarely: when using high intravenous doses of the drug, especially in patients with renal failure, aggressiveness, myoclonic spasms and convulsions may arise as a result of increasing its concentration in spinal fluid. The absence of adjusting the dosing of the drug in renal failure and an increase in its concentration in the liquor in the diseases of the brain contributes to the emergence of cerebral (epileptic) attacks.

Laborateore indicators:leukopenia, neutropenia, anemia, hematuria, proteinuria.

Local reactions: pain in the place of introduction, phlebitis and freebies (with intravenous administration); with intramuscular - in the place of introduction of infiltrate.

Others: interstitial jade, nephropathy, superinfection (especially in patients with chronic diseases or reduced organism resistance), vaginal candidiasis.

Conditions andtimestorage

In the place protected from light at a temperature not higher than 20 ° C.

Do not use after the expiration date.

Store in places inaccessible to children.

Conditions of vacation from pharmacies

On prescription.

Packaging

333.5 mg + 166.5 mg in vials with a capacity of 10 ml, hermetically sealed with rubber corks, fascinated caps aluminum or caps combined aluminum with plastic covers.

10 bottles with a liner is placed in a pack of cardboard.

50 bottles with 5 instructions for use are placed in a box of cardboard for delivery to hospitals.

Manufacturer / Organanimation accepting complaints

OPEN JOINT STOCK COMPANY "Joint-Stock Kurgan Society medical preparations and "Synthesis" products (Synthesis OJSC).

Antibiotic group penicillins wide spectrum Actions resistant to penicillinase

Active substances

Release form, composition and packaging

Powder for the preparation of the solution for in / m administration

Powder for preparing a solution for in / in administration (or porous weight) White with a yellowish tint of color, forming a transparent, almost colorless solution when dissolved.

10 ml bottles (10) - cardboard boxes.
10 ml bottles (50) - cardboard boxes.

pharmachologic effect

Combined antibacterial drug.

Oxacillin is an antibiotic from a group of semi-synthetic penicillins. Suitable bactericity, suppressing the synthesis of the cell wall of bacteria. Resistant to penicillinase. Staphylococcus SPP. (including Penicillinase producing), Streptococcus SPP. (including Streptococcus Pneumoniae), Corynebacterium Diphtheriae, Bacillus Anthracis; gram-negative bacteria: Neisseria Gonorrhoeae, Neisseria Meningitidis; an. aerobic bacteria: Sponge-forming sticks, Actinomyces SPP. To oxacillin sustainable Most gram-negative bacteria, rickettsia, viruses, simplest, mushrooms.

Ampicillin is an antibiotic from a group of semi-synthetic penicillins. Suitable bactericity, suppressing the synthesis of the cell wall of bacteria. Active in terms of gram-positive bacteria: Staphylococcus SPP. (With the exception of penicillinase strains), Streptococcus SPP. (including Enterococcus SPP.), Unfortunately-forming bacteria (including Listeria Monocytogenes); gram-negative aerobic bacteria: Neisseria Gonorrhoeae, Neisseria Meningitidis, Escherichia Coli, Shigella SPP., Salmonella SPP., Bordetella Pertussis, some strains of Haemophilus Influenzae.

Ampicillin is destroyed by penicillinase.

The combination of ampicillin with oxacillin is rational, because The latter, coal activity of penicillinase, thereby reduces the destruction of ampicillin. The range of action with this combination becomes wider.

Pharmacokinetics

Suction

C Max active substances It is achieved after 0.5-1 h after the introduction. When in / in the introduction in the blood, high concentrations are rapidly created, exceeding those at the Introduction.

Distribution and elimination

For repeated administration The active substances are not accumulated in the body, which makes it possible to apply the drug for a long time. Displays with urine.

Indications

• infection respiratory tract (including bronchitis, pneumonia, bronchiectatic disease);
• diseases of biliary tract (including cholangitis, cholecystitis);
• infection urinary tract and kidneys (including pyelitis, pyelonephritis, cystitis);
• skin infections and soft tissues (including infected wounds);
• burn disease;
• angina.

Prevention of postoperative complications in surgical interventions.

Prevention and treatment of infections in newborns.

Contraindications

• increased sensitivity to the components of the drug and other antibiotics from the penicillin group.

Dosage

The drug is introduced in / m or in / in (stove or drip).

One-time dose for adults is 0.5-1 g, daily dose - 2-4 g.

Newborn, premature babies and children under the age of 1 The drug is prescribed in a daily dose of 100-200 mg / kg body weight; 1-7 years old - 100 mg / kg / day; 7-14 years old - 50 mg / kg / day; adolescents older than 14 years Assign a dose for adults.

For severe course infection These doses can be increased 1.5-2 times. The daily dose is introduced in 3-4 receptions with an interval of 6-8 hours. The duration of treatment from 5-7 days to 3 weeks and more.

The drug is introduced within 5-7 days with a subsequent transition (if necessary) on the Introduction.

Rules of preparation and administration of solutions

The solutions for the I / M administration are prepared immediately before administration by adding 2 ml of sterile water for injection to the contents of the vial.

For B / in infusion, the drug (one-time dose) is dissolved in 10-15 ml of water for injection or isotonic solution and are injected slowly for 2-3 minutes.

For in / in drip administration for adults The drug (one-time dose) is dissolved in 100-200 ml of isotonic sodium chloride solution or 5-10% dextrose solution and introduced at a speed of 60-80 drops / min. With drip administration to children as a solvent, a 5-10% dextrose solution is used (30-100 ml, depending on age).

Side effects

Allergic reactions: skin rash, urticaria, swelling of quinque; seldom .

Local reactions: When in / in the introduction, the development of phlebitis and perifelibates is possible; At the I / M of the introduction - pain in the injection site.

Overdose

Currently, the cases of overdose of the drug Oxep-sodium did not communicate.

Medicinal interaction

The synergism of antibacterial action is observed during the combination of the drug with bactericidal antibiotics - aminoglycosides, cephalosporins, vancomycin, rifampicin.

special instructions

In the occurrence of allergic reactions, it is necessary to stop the administration of the drug and carry out desensitizing therapy.

With the development of anaphylactic shock, the introduction of epinephrine, GKS (or prednisone), bronchoditics, histamine block plactors H 1 -receptors; If necessary, conduct IVL.

Use in pediatrics

Caution should be prescribed the drug to children if the mother's history has an indication of increased sensitivity to penicillins. In such cases, if necessary, the appointment of the drug Oxep-sodium in the presence of concomitant diseases (, hay fever and others allergic diseases) The simultaneous use of desensitizing drugs is shown.

Pregnancy and lactation

It is possible to use the drug Oxep-sodium during pregnancy by testimony. It stands out with breast milk at low concentrations.

Conditions of vacation from pharmacies

The drug is released by the prescription.

Terms and Storage Terms

The drug should be stored in a dry place protected from light, at room temperature. Shelf life - 2 years.

Instruction

Oxep is a combined drug. Refers to a large group of penicillins. It is used in the treatment of many infectious diseases of different organs and systems.

Forms of release and composition

This medical preparation is considered combined because it combines 2 active substancesa: ampicillin and oxacillin. Both compounds relate to penicillins, which contributes to the expansion of the bactericidal action of the drug.

The drug is produced in 2 main forms: capsules and powder for the preparation of an injection solution.

Capsules are designed only for intake. Each of them is exactly 125 mg of active substances. They are packed in special blisters for 10 pcs. In each or in polymer cans of 20 pcs.

Oxampa-sodium powder is intended for the preparation of an injection solution. The solution is entered both injectable and infusion method. The powder is placed in special glass bottles, in which there is 0.5 g of the combination of active substances.

This is an antibiotic or not

The drug refers to the antibiotics of the penicillin row. Has an extensive spectrum of action.

pharmachologic effect

The antibiotic combines the action of ampicillin and oxacillin.

Ampicillin is a semi-synthetic Penicillin derivative. Not destroyed under the influence of strong acids and has an excellent bactericidal effect. There is an activity both in relation to gram-positive and gram-negative pathogenic bacteria.

Oxacillin is evaluated not only to acids, but also to penicillinase. Bactericidal action applies to almost all groups of harmful microorganisms.

Pharmacokinetics

Almost the entire dose of the medical preparation after taking inside falls directly into the bloodstream. The largest concentration of active compounds is observed 2 hours after taking medication.

The elimination occurs by renal filtering. Almost all the dose comes out with urine, only a small amount - with bile.

The drug does not accumulate in the body even with long use.

Indications for use

The antibiotic is prescribed mainly for comprehensive treatment infectious diseases inflammatory character. This is especially true of diseases that were caused by pathogenic bacteria, sensitive to the active components of the medication.

Main indications for use:

• skin and soft tissue infections: Ryg, impetigo, dermatosis;
• cholegit and cholecystitis;
• sinusitis, otitis the middle ear, tonsillitis;
• pyelonephritis, cystitis, cervicitis and urethritis;
• gonorrhea;
• bronchitis, pneumonia.

The medicine is often used to prevent the development of secondary infection after the surgical interventions carried out.

Contraindications

There are some prohibitions for the use of a medical process:

• individual intolerance to the components of the medication;
• infectious mononucleosis;
• lympholoicosis;
• children's age up to 3 years;
• the period of tooling the child and breastfeeding.

All these contraindications need to be taken into account before the start of treatment. The patient must be aware of all risks and possible adverse reactions.

OKSAMPA use and dosage method

The tool is adopted both in capsuated form and in the form of injections. Take medicine regardless of food, but it is better that after receiving food until the medication has passed at least 2 hours.

With pyelonephritis

With pyelonephritis, adults are prescribed 2 g of antibiotic. Daily dose must be divided into 4 receptions.

Little children show injections, since the effect of the capsule may not give a positive result. The solution is introduced both intravenously and intramuscularly. Break powder in water for injection. So that the injections were not so painful, novocaine can be added.

With cystitis

When cystitis, the dosage for adults sometimes increase to 4 g. This is necessary for better destruction of pathogenic bacteria. But if there is no positive result, you need to replace the medical process with another.

For urethritis

When uretrite, the maximum daily dose can be up to 8 g. It is divided into 4 receptions. The effect of the use of medication should be achieved in about 5 days. In severe cases, appropriate antibacterial therapywhich enhances the action of Oxampa.

How to give children

Children medication is prescribed mainly in capsuated form. Daily dose for children 7-14 years - 50 mg per kg of body weight; 3-7 years - 100 mg per kg of weight. Daily dose is divided into several techniques. Course treatment - from 5 to 14 days.

Do Oxamp causes side effects

Upon reception, unwanted side effects often arise:

• nausea, vomiting, diarrhea;
• dysbacteriosis, change in taste, enterocolitis;
• leukopenia and anemia;
• rises the risk of internal bleeding;
• urticaria, the development of anaphylactic shock and swelling swelling;
• rhinitis, conjunctivitis, arthralgia;
• superinfection.

All these negative reactions should take place without special medical intervention immediately after the cancellation of the medication. But if this does not happen, you may need disintellation and antiallergic therapy.

Overdose

Overdose drug is not marked. But in some cases, its symptoms can be determined to increase the severity of some side Effects. If the patient's well-being deteriorates, the stomach is washed, sorbents are prescribed. In the presence of any complications, the symptomatic therapy is carried out.

Features of the use of the drug Oxep

Antibacterial treatment should be changed in the case of superinfection.

If the reactions of hypersensitivity to penicillins are observed, the risk of developing cross-allergic reactions increases.

If anaphylactic shock develops, it is necessary to take urgent measures to stop it. Patient introduces epinephrine, antihistamine medical preparations and glucocorticosteroids.

During pregnancy and lactation

Because active substances penetrate the protective barrier of the placenta, the medication cannot be taken during the baby tool. The existing compounds have teratogenic and mutagenic effect on the fruit. The appearance of certain anomalies of the intrauterine development of the fetus.

The active components of the medicine penetrate and breast milk. Therefore, for the period of treatment it is better to abandon breastfeeding.

In childhood

In treating bacterial infections The means is forbidden to give children up to 3 years. After a three-year-old, treatment is carried out strictly according to the instructions with clear observance of the dosage.

With violations of the kidney function

In the case of a history of renal failure, an increase in the toxic effects of the drug on the central nervous system is possible.

When violations of the liver function

With a long-term course of treatment, it is necessary to monitor the liver function. With the deterioration of hepatic samples, the dosage is reduced to the minimum efficient or completely cancel the reception of the drug.

Influence on the concentration of attention

The antibiotic affects the speed of psychomotor reactions and the concentration of attention. Therefore, it is better to avoid self-control vehicle Or work with complex mechanisms.

Medicinal interaction

In the treatment of infectious diseases, a whole range of medicines is often used. Some combinations contribute to the fastest recovery. Others are considered to be antagonists each other.

With other drugs

Glucosamine, aminoglycosides and some laxatives reduce the absorption of the medical process. Cephalosporins and rifampicin improve the effect of the antibiotic. Tetracycles, macrolides and sulfonamides are antagonists of Oxampa. When combined, the activity of indirect anticoagulants increases, the activity of intestinal microflora and the synthesis of vitamin K. is suppressed

Ascorbic acid helps to increase absorption drug. The effectiveness of many oral contraceptives is reduced. Diuretics and nonsteroidal anti-inflammatory drugs increase the concentration of Oxampa in the blood.

Compatible with alcohol

You can not apply with alcohol. The action on the CNS increases, the symptoms of intoxication becomes more pronounced. In this case, the effectiveness of the antibiotic itself is greatly reduced.

Terms and Storage Terms

Keep the medicine is needed at room temperature in a dry place. Protect maximally from direct sunlight and children.

Shelf life - 2 years from the date of manufacture, which must be defined on the original packaging.

Conditions of vacation from pharmacies

Medication can be bought at the prescription pharmacy.

Whether they sell without a recipe

The drug can be purchased only by a special recipe issued by the attending physician.

How much is

The cost of the capsules does not exceed 100 rubles. for packaging. Powder bottles are about 150 rubles.

Manufacturer

OJSC Synthesis (Russia).

Analogs

There are several analogs of the drug:

They all differ in price; They have different manufacturers. In its composition, these medicines are similar, have almost the same therapeutic effect on the body

Oxep: instructions for use and reviews

Latin name: Oxamp.

ATX code: j01cr50

Active substance: Ampicillin + oxacillin (ampicillin + oxacillin)

Manufacturer: OJSC Synthesis (Russia)

Actualization of the description and photo: 12.08.2019

Oxep - Combined antibiotic preparation (semi-synthetic penicillins).

Release form and composition

Oxepa is released in the form of capsules (10 pcs. In contour cellular packs, 1 or 2 packages in a cardboard pack; 20 pcs. In banks, 1 bank in a cardboard pack).

The composition of 1 capsule includes active substances:

• Ampicillin - 125 mg (as an ampicillin trihydrate);
• Oxacillin - 125 mg (in the form of oxacillin sodium).

Auxiliary components: Potato starch, sugar powder (sucrose).

The composition of the gelatin capsule: propyl aprichedroxibenzoate, gelatin, titanium dioxide, methyl apoxideroxybenzoate, acetic acid.

Pharmacological properties

Pharmacodynamics

Oxep is a combined antibiotic combining the spectrum of action of oxacillin and ampicillin.

Ampicillin refers to semi-synthetic penicillins resistant to acid action and with a bactericidal action. It exhibits activity against gram-negative (Haemophilus influenzae, Neisseria meningitidis, Neisseria gonorrhoeae, Proteus mirabilis, Escherichia coli, Shigella spp., Salmonella spp.) And gram-positive, not participating in the formation of penicillinase (Streptococcus pneumoniae, Streptococcus spp., Staphylococcus spp. ) Microorganisms.

Oxacillin is a semi-synthetic antibiotic related to the category of penicillins and resistant to acids and penicillinase. It is characterized by a bactericidal action against Gram-negative cocci (Neisseria meningitidis, Neisseria gonorrhoeae), gram-positive microorganisms (anaerobic spore-forming bacillus, including Clostridium spp., Staphylococcus spp., Corynebacterium diphtheria, Streptococcus spp., Including Streptococcus pneumoniae, Bacillus anthracis, Actinomyces SPP.), Treponema SPP., Escherichia Coli, Actinomyces SPP., Proteus Mirabilis, Klebsiella Pneumoniae, Haemophilus Influenzae.

Morganella Morganii, Pseudomonas Aeruginosa, and other gram-negative bacteria of the non-enzyme type, Providencia RetTgeri, are resistant to Oxampa, Providencia Rettgeri, most Proteus vulgaris strains.

Pharmacokinetics

For oral reception Almost all the adopted dose of Oxamba penetrates blood. The maximum concentrations of the active components of the drug are found in the blood 1.5-2 hours after intake. Both antibiotics are removed mainly with urine, partly with bile. The re-administration of the drug does not lead to the cumulation of its actors in the body.

Indications for use

Oxep antibiotic is prescribed for the treatment of infectious inflammatory diseases caused by sensitivity to the action of active substances by microorganisms:

• Infections of soft tissues and skin, including impetigo, rye, secondally infected dermatoses;
• Cholecystitis, cholangitis;
• Tonsillitis, sinusitis, middle otitis;
• Gonorrhea, pyelonephritis, cystitis, pyelit, urethritis, cervicitis;
• Bronchitis, pneumonia.

Contraindications

• Lympholoicosis;
• Infectious mononucleosis;
• Hypersensitivity to the components of the drug.

Children Oxep are not prescribed under the age of 3 years.

Pregnant women preparation apply only after the benefit ratio with mother and child health. During the lactation in cases of the need to receive the drug, breastfeeding is recommended to be interrupted.

OXAMPA instructions: Method and dosage

• Adults and children from 14 years old: one-time dose - 0.5-1 g, daily - 2-4 g;
• Children 7-14 years old: daily dose - 0.05 g / kg (in 4-6 receptions);
• Children 3-7 years: daily dose - 0.1 g / kg (in 4-6 receptions).

The duration of the healing course may vary from 5-7 to 14 days.

Side effects

• Hooping system: neutropenia, leukopenia, anemia;
• Digestive system: change in taste, dysbacteriosis, vomiting, diarrhea, nausea; rarely - pseudommbranous enterocolitis;
• Allergic reactions: Skin hyperemia, urticaria, rhinitis, angioedema edema, conjunctivitis, arthralgia, fever, eosinophilia; rarely - anaphylactic shock;
• Others: superinfection.

Overdose

It is possible to determine the overdose of Oxampa to enhance the severity of side effects. With a deterioration of well-being, it is recommended to rinse the stomach, take activated carbon and conduct symptomatic therapy.

special instructions

In patients with renal failure, when conducting therapy with high doses of Oxampa, a toxic effect on the central nervous system is possible.

When conducting a long course of therapy should be monitored functional state Blood formations, kidney and liver organs.

With probabilities of the development of superinfection (due to the growth of the microflora insensitive to it), the appropriate change in antibacterial treatment is required.

In the presence of hypersensitivity to penicillins, cross-allergic reactions with antibiotics of a group of cephalosporins are possible.

If symptoms of anaphylactic shock appear during the drug, urgent measures should be taken to remove the patient from this state, including the introduction of epinephrine, antihistamine preparations and glucocorticosteroids, if necessary, artificial ventilation should be carried out.

Childcare

According to the instructions, Oxep, children can be applied according to the testimony. The drug must be applied with caution in children whose mothers have increased sensitivity to penicillins.

With violations of the kidney function

When taking Oxampa in high doses, patients with renal failure can have a toxic effect on the CNS. When the course of treatment is passing, constant monitoring of the kidney function is necessary.

When violations of the liver function

Currency treatment requires the implementation of continuous control of the functioning of the liver.

Medicinal interaction

With the joint use of an antibiotic Oxep with some drugs, the following effects may occur:

• Glucosamine, antacids, laxatives, food, aminoglycosides (enteral administration): slowdown and reducing Oxampa absorption;
• Bactericidal antibiotics (including rifampicin, cephalosporins, aminoglycosides, vancomycin): action potentiation;
• Bacteriostatic preparations (tetracycles, chloramphenicol, macrolides, lincoosamides, sulfonamides): antagonistic effect;
• Indirect anticoagulants: an increase in their effectiveness, as well as the suppression of intestinal microflora, a decrease in the synthesis of vitamin K and the prothrombin index;
• Ascorbic acid: increasing Oxampa absorption;
• Oral contraceptives, ethinyl estradiol, drugs, in the process of metabolism of which para-aminobenzoic acid is formed: reducing their effectiveness;

Recommended by recipe.

Instruction

by medical application

drug

Oxep ® -Natriya

Tradename

Oxep ® -Natriya

International non-proprietary title

Dosage form

Powder for the preparation of the injection solution 0.5 g

Composition for one bottle

active substances -ampicillin sodium (in terms of ampicillin) - 0.3335 g,

oxacillin sodium (in terms of oxacillin) - 0.1665 g

Description

White powder with yellowish colors

Pharmacotherapeutic group

Antibacterial drugs for system use. Beta-lactam antibacterial drugs. Penicillins in combination with beta lactamase inhibitors. Combination of penicillins.

Code ATX J01Cr50

Pharmacological properties

Pharmacokinetics

The time to achieve maximum concentration (TC MAX) after intramuscular administration of both antibiotics in the blood - 0.5-1 hours. The half-life period is 1-2 hours. The drug penetrates well into different organs and fabrics. In the intravenous administration in the blood, the concentrations of the drug are created, exceeding those with intramuscular administration, are created in the blood (after 5-10 minutes). Both antibiotics are removed by the kidneys, partly with bile. With repeated administrations do not cumulative.

Pharmacodynamics

Oxep ® -Tatry - a combined antibiotic, which combines ampicillin and oxacillin action spectrum.

Ampicillin is a semi-synthetic penicillin, a bactericidal, acid resistant. Active against gram-positive neobrazuyuschih penicillinase (Staphylococcus spp., Streptococcus spp., Streptococcus pneumoniae) and Gram (Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Salmonella spp., Shigella spp., Proteus mirabilis, Haemophilus influenzae) microorganisms. Oxacillin is a penicillinase-resistant semi-synthetic antibiotic from a group of penicillins, acid resistant; has a bactericidal action against Gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., including Streptococcus pneumoniae, Bacillus anthracis, Corynebacterium diphtheriae, anaerobic spore-forming rods, including Clostridium), Gram negative cocci (Neisseria gonorrhoeae, Neisseria meningitidis ), Escherichia coli, Proteus Mirabilis, Haemophilus Influenzae, Klebsiella Pneumoniae, Actinomyces SPP., Treponema SPP.

To the action of the drug is resistant Pseudomonas Aeruginosa, and others. Nefering gram-negative bacteria Most strains of Proteus Vulgaris, Providencia Rettgeri, Morganella Morganii.

Indications for use

Bacterial infections caused by sensitive pathogens: sinusitis, tonsillitis, middle otitis, bronchitis, pneumonia; Halgitis, cholecystitis, pyelonephritis, pyelitis, cystitis, urethritis, gonorrhea, cervicitis, dog, impetigo, secondary infected dermatoses and others

Prevention of postoperative complications in surgical interventions (including on the background of immunodeficiency), infections in newborns (infection of the ammunition fluid; disruption of the newborn breathing, requiring the use of resuscitation measures; the risk of aspiration pneumonia)

Sepsis, endocarditis, meningitis, postpartum infection

Mode of application and dose

Intramuscularly and intravenously (inkjano or drip).

The doses of the drug referred to below are the sum of the dosages of ampicillin and oxacillin (sodium salts) in their fixed ratio 2: 1 (i.e., in the following dosages 0.5 g of the drug is equal to the amount of 333.5 mg of ampicillin + 166.5 mg oxacillin ).

Daily dose for adults and children over 14 years old - 3-6 g; For newborns, premature and children up to 1 year - 100-200 mg / kg / day; 1-6 years - 100 mg / kg / day; 7-14 years old - 50 mg / kg / day. The daily dose is introduced in 3-4 receptions with an interval of 6-8 hours. If necessary, the specified doses can be increased by 1.5-2 times. Maximum daily dose for adults - 8 g.

The duration of treatment depends on the severity of the disease (from 5-7 days to 10 days, and in chronic processes within a few months).

For intramuscular administration, the contents of the vial of 333,5 mg + 166.5 mg are dissolved in 5 ml of water for injection.

For intravenous jet administration (for 2-3 minutes), a one-time dose is dissolved in 10-15 ml of water for injection or 0.9% sodium chloride solution.

For intravenous drip administration, an adult dose is dissolved in 100-200 ml of 0.9% solution of sodium chloride or a 5% dextrose solution (glucose) and introduced at a speed of 60-80 CAP / min; Children as a solvent use 30-100 ml of 5-10% declaration solution (glucose). Intravenously introduced 5-7 days, followed by the transition to intramuscular administration.

The solution is used immediately after cooking.

Side effects

Often

Pain in the place of administration

Itching and skin peeling

Sometimes

Dysbacteriosis, change in taste, vomiting, nausea, diarrhea, moderate increase in the activity of "liver" transaminase

Headache

Harridge, conjunctivitis, rhinitis, skin hyperemia, angioedema edema

Seldom

Pseudommbranous enterocolit

Leukopenia, neutropenia, anemia, hematuria, proteinuria

Fever, arthralgia, eosinophilia, erythematous and maculopapulous rash, exfoliative dermatitis, multiform exudative erythema (incl. Stevens-Johnson syndrome), reactions similar to serum disease

Rarely

Anaphylactic shock

Flebit and perifelbitis (with intravenous administration), with intramuscular - at the injection site infiltrate

Causes

- others: seldom - Interstitial nephritis, nephropathy, superinfection (especially in patients with chronic diseases or reduced organism resistance), vaginal candidiasis

Contraindications

Hypersensitivity to preparations of the penicillin group and other beta-lactam antibiotics

Infectious mononucleosis, lymphole

Heavy liver disorders

Pregnancy and lactation period

Diseases of the gastrointestinal tract in history (colitis due to the use of antibiotics)

Medicinal interactions

Ampicillin. Pharmaceutically incompatible with aminoglycosides.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; Bacteriostatic preparations (macrolides, chloramphenicol, lincoosamides, tetracycles, sulfonamides) - antagonistic effect.

Increases the efficiency of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index); Reduces the effectiveness of estrogen-containing oral contraceptives, drugs, in the process of metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol (in the latter case, the risk of developing bleeding "breakthrough" increases).

Diuretics, Allopurinol, Oxyphenbutayon, Phenylbutazone, Nonteroidal anti-inflammatory drugs and other drugs that block the channel secretion increase the concentration of ampicillin in the plasma (by reducing the channel secretion).

Allopurin increases the risk of skin rash.

Reduces clearance and increases the toxicity of methotrexate.

Oxacillin. Increases the toxicity of methotrexate (competition for the canal secretion); It may be necessary to increase the doses of folinate calcium (antagonist antagonists antagonists) and its longer use.

It is necessary to avoid co-use with other drugs that have a hepatotoxic effect.

It is not recommended to be prescribed simultaneously with bacteriostatic antibiotics (reducing efficiency).

Drugs that block the tubular secretion increase the concentration of oxacillin in the blood.

special instructions

Carefully:children who are born in mothers with hypersensitivity to penicillins. Allergic reactions in history and / or bronchial asthma, renal failure, a history of anamnesis, enterocolit on the background of the use of antibiotics (a history).

In case treatment, it is necessary to monitor the condition of the function of the blood formation organs, liver and kidneys.

When signs of anaphylactic shock appear, urgent measures should be taken to remove the patient from this state: the introduction of epinephrine (adrenaline), glucocorticosteroids (hydrocortisone or prednisone) and antihistamine, if necessary, performed artificial ventilation of the lungs.

The possibility of the development of superinfection (due to the growth of microflora insensitive) requires an appropriate change in antibacterial therapy.

In patients having increased sensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

When applied in high doses in patients with renal failure, a toxic effect on the central nervous system is possible.

Features of the influence of the medicinal product on the ability to control the vehicle or potentially hazardous mechanisms

Oxep ® -Tatry does not affect the ability to control the vehicle and potentially hazardous mechanisms.

Overdose

Symptomsmanifestations of toxic action to the central nervous system (especially in patients with renal failure); Nausea, vomiting, diarrhea, impaired water and electrolyte balance.

Treatment -symptomatic. Exit with hemodialysis.

Release form and packaging

0.5 g of powder in vials with a capacity of 10 ml, hermetically sealed with rubber plugs, compressed caps aluminum or cap combined aluminum caps with plastic lids.

A trademark of the enterprise is applied on the plastic lid, made by casting under pressure.

50 bottles with 5 medical instructions in public and Russian are placed in a box of cardboard.

Storage conditions

Store in a dry, protected from light, at a temperature not higher than 20 ºС

Keep out of the reach of children!

Storage term

Do not use after the expiration date.

Conditions of vacation from pharmacies

On prescription

Manufacturer

OJSC Synthesis.

Russia, 640008, Kurgan, Constitution Avenue, 7

Owner of the registration certificate

OJSC "Synthesis", Russian Federation

Address of the organization hosting in the Republic of Kazakhstan Claims from consumers for product quality

STOFARM LLP, 000100, Republic of Kazakhstan,

Kostanay region, Kostanay, ul. Ural, 14.

tel. 714 228 01 79

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