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What is cefdinir 300 mg: Cefdinir: MedlinePlus Drug Information

Uses of Cefdinir 300mg | Vinmec

This is an automatically translated article.

Cefdinir 300mg contains the active ingredient Cefdinir – a 3rd generation cephalosporin antibiotic, indicated in the treatment of mild to moderate infections caused by susceptible groups of bacteria. Let’s learn about the dosage and notes when using Cefdinir 300mg through the article below.

1. Uses of Cefdinir 300mg

Cefdinir 300mg is indicated in the following cases:
Adults and adolescents:
Pneumonia caused by Haemophilus Parainfluenzae, Haemophilus influenzae, Streptococcus Pneumoniae; Chronic bronchitis caused by Haemophilus Parainfluenzae, Haemophilus Enzae, Moraxella Catarrhalis, Streptococcus Pneumoniae; Tonsillitis , pharyngitis caused by Streptococcus Pyogenes; Uncomplicated skin structure infections caused by Streptococcus Pyogenes, Staphylococcus. Children:
Acute otitis media caused by Streptococcus Pneumoniae, Haemophilus Enzae; Tonsillitis, pharyngitis caused by Streptococcus Pyogenes; Skin structure infections caused by Streptococcus Pyogenes, Staphylococcus Aureus. It is indicated for the treatment of infections caused by bacteria and has no effect on infections caused by viruses (flu or common cold).

2. Dosage and how to use Cefdinir 300mg

2.1. Cefdinir dosage belongs to the group of prescription drugs, so the use of the drug in treatment needs to be prescribed by the treating doctor. All information about the recommended dosage below is for reference only, patients absolutely do not use the drug without a doctor’s prescription. The recommended dosage of Cefdinir 300 is as follows:
Pneumonia: Adults and children 13 years of age and older take 300 mg every 12 hours, the duration of drug therapy is about 5 – 10 days (or 600 mg every 24 hours). hours in 10 days).
Acute sinusitis:
Adults: Take 300mg of Cefdinir every 12 hours or 600mg every 24 hours for a period of 10 days; Children 6 months – 12 years: Oral 7mg/kg every 12 hours or 14mg/kg every 24 hours for 10 days (maximum dose 600mg/day) Uncomplicated skin structure infections:
Adults: Take 300mg of the drug every 12 hours for a period of 10 days; Children from 6 months to 12 years old: Take 7mg/kg every 12 hours for 10 days (maximum dose 600mg/day). Tonsillitis, pharyngitis:
Adults: Take 300mg of medicine every 12 hours for 5-10 days or 600mg of medicine every 24 hours for 10 days; Children 6 months – 12 years old: Take 7mg/kg drug every 12 hours for 5-10 days or 14mg/kg drug every 24 hours for 10 days (Maximum dose is about 600mg/day). Acute otitis media:
Children from 6 months to 12 years of age: Take 7mg/kg of drug every 12 hours for 5 to 10 days or 14mg/kg of medicine every 24 hours for 10 days (Maximum dose is 600mg/day). Chronic bronchitis: Adults and children over 3 years of age take 300mg every 12 hours for 5 to 10 days or 600mg every 24 hours for 10 days.
Dosage needs to be adjusted in patients with renal impairment: Specifically, adults with renal failure with creatinine clearance less than 30mL/min should take a dose not exceeding 300mg/day, children with renal failure have small creatinine clearance. more than 30mL/min at a dose of 7mg/kg every 24 hours.
2.2. How to take Cefdinir is taken orally, with or without food (the dose can be taken once or in 2 divided doses every 12 hours).
The dose used is based on the patient’s medical condition and response, the recommended dose is 600mg/day in adults.
The effectiveness of the drug is highest when the concentration is maintained at a stable level. Therefore, patients should take Cefdinir at certain intervals. Continue using the medicine until the end of the course of treatment prescribed by your doctor, even if the symptoms disappear after a few days of treatment. Stopping medication too soon can cause bacteria to continue to grow, leading to a recurrence of the infection and an increased risk of drug resistance.

3. Side effects of Cefdinir 300mg

Cefdinir 300mg may cause some side effects as follows:
Common: Skin rash, Candida skin infections, diarrhea, yeast infections in the vagina and vulva, headache, nausea , inflammation or infection of the vagina, stomach cramps, vomiting; Uncommon: Indigestion, bloating; Rare: Anaphylaxis, Stevens-Johnsons syndrome, serum sickness reactions, acquired hemolytic anemia, leukopenia, drug-induced aplastic anemia, erythema multiforme, convulsions, hearing disturbances , vaginal discharge, constipation, dizziness, itching, dry mouth, trouble sleeping.

4. Notes when using Cefdinir 300mg

4.1. Contraindications Contraindicated to use Cefdinir 300mg in the following cases:
Patients with hypersensitivity to any component of Cefdinir; Patients with diarrhea caused by Clostridium difficile infection; Patients with severe renal failure; People who are allergic to beta-lactams, cephalosporins. 4.2. Precautions for use Cefdinir should be used with caution in the following patients:
Patients with a history of hypersensitivity to penicillin group antibiotics; Patients with a predisposition to allergic reactions or family members with allergic reactions such as urticaria, rash or bronchial asthma; Patients with kidney disorders; Persons who are malnourished by oral route or needing parenteral nutrition, have a weak physical condition; Elderly: Treatment with Cefdinir in the elderly requires adjustment of the dose and dosing interval, based on the patient’s condition and careful clinical judgment. Similar to other broad-spectrum antibiotics, long-term treatment with Cefdinir can lead to the development of multiple antibacterial strains. Patients should be carefully monitored if necessary. Intoxication occurring during treatment with Cefdinir requires appropriate supportive therapy.
Effects on the ability to drive and use machines: The drug does not affect the ability to drive or use machines.
Pregnant women, lactating women: There are no studies to determine the safety of the drug in pregnant and lactating women. Therefore, caution should be exercised when using Cefdinir in these subjects.

5. Drug interactions

The excretion of Cefdinir may be reduced when used with the following drugs: Aspartame, pravastatin, cefotiam, baclofen, liothyronine, doxycycline, indomethacin, digoxin, aminohippuric acid…
Above is important drug information. Cefdinir . Before using you should consult your doctor and read carefully before use to help the use of the drug bring good results.

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Cefdinir Oral Capsule 300 mg – Health Information Library

For treating bacterial infection.

Generic Name: Cefdinir

Instructions

This medicine may be taken with or without food.

Keep the medicine at room temperature. Avoid heat and direct light.

Do not take this medicine with antacids.

Do not take any antacid or vitamins with magnesium, calcium, aluminum, or iron for 2 hours before and 2 hours after taking this medicine.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Tell your doctor and pharmacist about all your medicines. Include prescription and over-the-counter medicines, vitamins, and herbal medicines.

Keep using this medicine for the full number of days that it is prescribed. Do not stop the medicine even if you start to feel better.

If you have diabetes and use urine glucose tests, this medicine may cause incorrect results. Please check with your doctor before making any changes to your diabetes treatment plan.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Do not use the medication any more than instructed.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Speak with your health care provider before receiving any vaccinations.

Please tell your doctor if you have moderate to severe diarrhea while on this medicine. Do not treat the diarrhea with over-the-counter diarrhea medicine.

Tell the doctor or pharmacist if you are pregnant, planning to be pregnant, or breastfeeding.

Do not start or stop any other medicines without first speaking to your doctor or pharmacist.

Do not share this medicine with anyone who has not been prescribed this medicine.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • diarrhea
  • changes in the color of the urine or stool
  • headaches
  • nausea and vomiting
  • stomach upset or abdominal pain
  • yeast infection of mouth
  • vaginal itching or yeast infection

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • confusion
  • severe, watery or bloody diarrhea
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • red, burning, or itchy skin
  • increased urinary frequency
  • urinating less often

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

IMPORTANT NOTE: This document tells you briefly how to take your medicine, but it does not tell you all there is to know about it. Your doctor or pharmacist may give you other documents about your medicine. Please talk to them if you have any questions. Always follow their advice.

There is a more complete description of this medicine available in English. Scan this code on your smartphone or tablet or use the web address below. You can also ask your pharmacist for a printout. If you have any questions, please ask your pharmacist.

The display and use of this drug information is subject to Terms of Use.

https://api.meducation.com/V2.0/fdbpem/4269

Copyright(c) 2023 First Databank, Inc.

Selected from data included with permission and copyright by First DataBank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

Conditions of Use: The information in this database is intended to supplement, not substitute for the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. The display and use of this drug information is subject to express Terms of Use.

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Health Information Library

Rodinir 300 mg №10 caps

Trade name

Rodinir

International non-proprietary name

Cefdinir

Dosage form

Capsules 300 mg

Composition

One capsule contains

the active substance is cefdinir (form A) 300 mg,

excipients: carmellose calcium 50 mg, polyoxyl 40 stearate 5. 4 mg, colloidal anhydrous silicon dioxide 1.0 mg, magnesium stearate 3.6 mg,

composition of the capsule, in percent: iron (III) oxide black (E172), titanium dioxide (E171), gelatin.

Description

Hard gelatin capsules, size #1, gray body, black cap.

The contents of the capsules are an almost white to white powder.

Pharmacotherapeutic group

Antimicrobials for systemic use. Other beta-lactam antibacterials. Third generation cephalosporins. Cefdinir

ATC code J01DD15

Pharmacological properties

Pharmacokinetics

Absorption: Peak plasma concentrations of cefdinir are reached 2-4 hours after ingestion. Bioavailability at a single dose of 300 mg is 21%, at a dose of 600 mg – 16%. The maximum concentration (Cmax) and AUC are reduced by 16% and 10%, respectively, when eating fatty foods.

Distribution: The mean volume of distribution of cefdinir in adults is 0.35 L/kg and in children (aged 6 months to 12 years) 0. 67 L/kg. The drug is distributed into the fluid of the skin bladder, fluid of the middle ear, tonsils, sinus sinuses, bronchial mucosa, lung tissue at a concentration of 15-48% of the plasma level. Cefdinir is 60-70% bound to plasma proteins, the binding does not depend on the concentration of the drug.

Metabolism and elimination: cefdinir is not significantly metabolized, being excreted primarily by the kidneys. The mean plasma half-life is 1.7-1.8 hours. Renal clearance – 2.0 ml / min / kg. Clearance after oral doses of 300 mg and 600 mg is 11.6 ml/min/kg and 15.5 ml/min/kg, respectively; 18.4% and 11.6%, respectively, are excreted unchanged in the urine.

Pharmacodynamics

Cefdinir is a semi-synthetic β-lactam antibiotic that exhibits a bactericidal effect by inhibiting the synthesis of the bacterial cell wall. The drug acts on many microorganisms that produce β-lactamases and are resistant to penicillins and other cephalosporins, but can be hydrolyzed by certain broad-spectrum plasmid-mediated β-lactamases.

Cefdinir is active against most strains of the following microorganisms, both in vitro and in clinical practice:

– aerobic gram-positive microorganisms: Staphylococcus aureus (including strains producing β-lactamase), Streptococcus pneumoniae (penicillin-susceptible strains only) , Streptococcus pyogenes;

– aerobic Gram-negative microorganisms: Haemophilus influenzae (including β-lactamase producing strains), Haemophilus parainfluenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains).

Cefdinir is inactive against Pseudomonas aeruginosa, Enterobacter spp., Enterococcus spp. and methicillin-resistant Staphylococcus spp.

Indications for use

Infectious and inflammatory diseases from mild to moderate severity caused by microorganisms sensitive to the drug:

– infections of the upper respiratory tract: acute sinusitis, acute otitis media, pharyngitis, tonsillitis

– infections of the lower respiratory tract: exacerbation of chronic bronchitis, community-acquired pneumonia

Uncomplicated skin and soft tissue infections.

Dosage and administration

Rodinir capsules are taken orally 1-2 times a day, regardless of food intake.

Doses are determined by the nature and severity of the infection and the susceptibility of the suspected pathogen.

For adults and children over 13 years of age, the following dosing regimen is recommended for treatment:

– pharyngitis, tonsillitis, exacerbation of chronic bronchitis: 300 mg every 12 hours for 5-10 days or 600 mg once a day for 10 days ;

– acute sinusitis: 300 mg every 12 hours or 600 mg once a day for 10 days;

– community-acquired pneumonia, uncomplicated skin and soft tissue infections: 300 mg every 12 hours for 10 days.

For children from 6 to 12 years old, the drug is prescribed in the following doses:

– acute otitis media, pharyngitis, tonsillitis: 7 mg / kg every 12 hours for 5-10 days or 14 mg / kg once a day for 10 days;

– acute sinusitis: 7 mg/kg every 12 hours or 14 mg/kg once a day for 10 days;

Uncomplicated skin and soft tissue infections: 7 mg/kg every 12 hours for 10 days.

For children, it is preferable to administer the drug in the form of a suspension.

Dosage in renal insufficiency (creatinine clearance less than 30 ml/min):

Adults: 300 mg once a day.

Children 6 to 12 years: 7 mg/kg once daily (up to 300 mg/day).

For hemodialysis, the recommended starting dose is 300 mg (or 7 mg/kg for children 6 months to 12 years of age) every 48 hours. At the end of each hemodialysis session, 300 mg (or 7 mg/kg for children 6 to 12 years of age) should be taken. Subsequent doses of 300 mg (or 7 mg/kg for children 6 to 12 years of age) are taken every 48 hours.

Side effects

The following classification is used to describe the frequency of adverse reactions: very common (≥1/10), frequent (≥1/100 and <1/10), infrequent (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000) and very rare (<1/10000), including isolated cases.

Often (more than 1%)

– nausea, abdominal pain, diarrhea

– headache

Sometimes

– nausea, diarrhea

– headache

– urticaria, erythema multiforme exudative (including Stephen-Johnson), angioedema, pruritus, toxic epidermal necrolysis (Lyell’s syndrome), anaphylactic shock

– anaphylaxis, bronchospasm, dyspnea, skin rash hemolytic anemia and internal bleeding, positive direct Coombs test

– impaired renal function, toxic nephropathy, acute renal failure, interstitial nephritis, glucosuria, ketonuria

– superinfection

Rarely

– dyspepsia, gastritis, vomiting, abdominal pain, increased activity of AST, ALT and LDH

– dizziness

Very rarely

– convulsions

Contraindications 900 03

– hypersensitivity to the components of the drug or to other antibiotics class of cephalosporins.

– individual intolerance to antibiotics of the cephalosporin group

– non-specific ulcerative colitis

– children under 6 years of age (in children under 6 years of age, it is recommended to use the drug in the form of a suspension).

Drug interactions

The action of Rodinir is significantly reduced when used simultaneously with magnesium- or aluminum-containing antacids, as well as with iron-containing drugs. Rodinir should be taken 2 hours before or 2 hours after taking antacids or iron supplements.

As with other β-lactam antibiotics, probenecid inhibits the renal excretion of cefdinir, resulting in an increase in peak plasma concentrations of cefdinir.

Precautions

Patients should be carefully evaluated for hypersensitivity to cefpodoxime, other cephalosporins, penicillins or other medicinal products before initiating therapy with Rodinir.

Special care must be taken when prescribing the drug to patients with hypersensitivity to penicillin antibiotics, due to the development of an allergic cross reaction between beta-lactam antibiotics.

If an allergic reaction occurs, stop taking the drug. Serious hypersensitivity reactions to the drug may require epinephrine therapy and other emergency measures, including oxygenation, intravenous fluids, antihistamines, and ventilatory therapy as clinically indicated.

With prolonged use of the drug, a violation of the normal intestinal microflora is possible, which can lead to excessive reproduction of Clostridium difficile and the development of pseudomembranous colitis. With the appearance of mild forms of antibiotic-associated diarrhea, as a rule, it is enough to stop taking the drug. In severe forms, corrective treatment is recommended (eg, oral vancomycin 250 mg 4 times a day).

The possibility of developing pseudomembranous colitis should be considered when taking any broad-spectrum antibacterial agent.

False-positive direct Coombs test has been reported during treatment with cephalosporin antibiotics; in this regard, it should be noted that a positive Coombs test result may be due to the use of this drug.

As with other cephalosporins, an increase in prothrombin time has been observed in some patients. Therefore, caution should be exercised in patients receiving anticoagulant therapy.

As with other broad-spectrum antibiotics, long-term treatment may cause the emergence and overgrowth of resistant organisms. If a fungal or bacterial superinfection develops during treatment, an appropriate alternative treatment is prescribed.

Cephalosporins in rare cases can reduce prothrombin activity, which leads to an increase in prothrombin time.

Pediatric use

In children under 6 years of age, it is recommended to use Rodinir in the form of a suspension.

Pregnancy and lactation

The use of the drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If necessary, the use of the drug Rodinir during lactation, breastfeeding should be temporarily discontinued.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

No information on cefdinir overdose.

Symptoms: nausea, vomiting, epigastric pain, diarrhea and convulsions.

Treatment: carry out symptomatic therapy. In the event of a serious toxic reaction resulting from an overdose of the drug, elimination of cefdinir from the body is usually carried out using hemodialysis or peritoneal dialysis, especially in cases where the renal system is at risk.

Presentation and packaging

10 capsules in a blister pack made of PVC film and aluminum foil.

1 or 2 blister packs together with instructions for medical use in the state and Russian languages ​​are put into a cardboard pack.

Storage conditions

Store below 25°C.

Keep out of reach of children!

Shelf life

3 years

Do not use after the expiration date.

Pharmacy dispensing conditions

Prescription

Rinicef ​​300mg/ Rinicef ​​300mg

Trade name: Rinicef

International Nonproprietary Name: Cefdinir/Cefdinir

Presentation: capsules 300 mg.

Description: hard gelatin capsules, black opaque cap and gray opaque base.

Composition:

1 capsule contains:

active substance : cefdinir – 300.00 mg;

Pharmacotherapeutic group

Antibacterial agents for systemic use. Third generation cephalosporins. ATX code: J01DD15

Pharmacological properties.

Pharmacodynamics

The active substance cefdinir is a semi-synthetic broad-spectrum cephalosporin antibiotic of the third generation for oral administration. Like other antibiotics of the cephalosporin group, cefdinir has a bactericidal effect against susceptible microorganisms due to the inhibition of the synthesis of peptidoglycan of the bacterial cell wall by disrupting the final stage of transamination necessary for the formation of cross-links. Cefdinir is resistant to many, but not all, beta-lactamases produced by Gram-positive and Gram-negative bacteria. Due to this, many microorganisms resistant to penicillins and some cephalosporins are sensitive to cefdinir. The spectrum of action of cefdinir includes:

Aerobic Gram-positive microorganisms

Staphylococcus aureus (including beta-lactamase producing strains)

Staphylococcus pneumoniae
(only strains sensitive to penicillin)

Staphylococcus pyogenes

Aerobic gram-negative microorganisms

Haemophilus influenzae (including beta-lactamase producing strains)

Haemophilus parainfluenzae
(including beta-lactamase producing strains)

Moraxella catarrhalis (including beta-lactamase producing strains)

The following data was obtained in vitro , but their clinical significance is unknown.

Minimum inhibitory concentration (MIC) of cefdinir in in vitro
is 1 μg / ml or less in relation to (≥ 90%) strains of the following microorganisms; however, the safety and efficacy of cefdinir in the treatment of infections caused by the following microorganisms has not been demonstrated in clinical studies.

Aerobic gram-positive microorganisms

Staphylococcus epidermidis

Streptococcus agalactiae

Streptococcus viridans group

Aerobic Gram-negative microorganisms

Citrobacter diversus

Escherichia coli

Klebsiela pneumoniae

Proteus mirabilis

Cefdinir is inactive against strains Pseudomonas, Enterobacter, Enterococcus and methicillin-resistant strains of staphylococci.

Method of administration and dosage

Recommended dosages and duration of treatment for infections in adults and adolescents are described in the table below. The total daily dose for the treatment of all infections is 600 mg. Dosing the drug once a day for 10 days is as effective as taking it twice a day. Once-daily dosing has not been studied for the treatment of pneumonia and skin infections, so Rinicef ​​should be taken twice daily in these cases. The capsules can be taken with or without food.

For the treatment of children (6 months – 12 years), cefdinir is used in the form of a suspension.

Adults and adolescents (ages 13 and over)

Type of infection

Dosage

Duration

community-acquired pneumonia

300 mg every 12 hours

10 days

Type of infection

Dosage

Duration

Exacerbation of chronic bronchitis

300 mg every 12 hours or

600 mg every 24 hours

5 to 10 days

10 days

Acute sinusitis

300 mg every 12 hours or

600 mg every 24 hours

10 days

10 days

Pharyngitis/tonsillitis

300 mg every 12 hours or

600 mg every 24 hours

5 to 10 days

10 days

Uncomplicated skin and soft tissue infections

300 mg every 12 hours

10 days

Elderly patients: does not require a change in dosing regimen, if there is no significant impairment of renal function (CC < 30 ml / min). If CC < 30 ml / min, the drug should be taken at a dose of 300 mg once a day.

Patients with renal insufficiency

For patients with CC < 30 ml/min, cefdinir should be given at a dose of 300 mg once daily.

Hemodialysis patients

Hemodialysis promotes the elimination of cefdinir from the body. For patients on permanent hemodialysis, the recommended starting dose is 300 mg or 7 mg/kg every other day. At the end of each hemodialysis session, 300 mg (or 7 mg/kg) of cefdinir is given. Subsequent doses (300 mg or 7 mg/kg) are then given every other day.

If you miss the next dose of the drug, you should take it as soon as you remember. If this missed dose occurs at the time of the next dose, skip the missed dose and follow the previous dosing regimen, do not double the dose.

Side effects

Cefdinir is well tolerated, the identified adverse reactions were mild in nature and resolved spontaneously after discontinuation. Most withdrawals were associated with gastrointestinal disturbances, mainly manifested by diarrhea or nausea. In rare cases, the withdrawal of the drug was due to the development of a rash while taking cefdinir.

Adverse reactions are classified according to the frequency of occurrence: very often (≥ 1/10), often (from ≥ 1/100 to < 1/10), infrequently (from ≥ 1/1,000 to < 1/100), rarely (≥ 1/100). 10,000, <1/1000), very rare (<1/10,000), and the frequency is unknown (frequency cannot be established from the available data).

Very common: diarrhea, rash, nausea.

Often: skin candidiasis, abdominal pain, leukopenia, candidal vaginitis, vaginitis, stool changes, dyspepsia, hyperkinesis, macolopapular rash, nausea, increased AST.

Adverse reactions specific to cephalosporins

Allergic reactions, anaphylaxis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, renal dysfunction, toxic nephropathy, liver dysfunction including cholestasis, aplastic anemia, hemolytic anemia, hemorrhagic disorders, false positive urine glucose test, neutropenia, pancytopenia and agranulocytosis. Pseudomembranous colitis can develop both during and after the end of the antibiotic prescription.

The use of some cephalosporins was accompanied by the development of seizures, especially in patients with impaired renal function, who were not dose recalculated. If convulsions develop during therapy, the antibiotic should be discontinued. If clinically necessary, anticonvulsant therapy may be prescribed.

According to the results of post-registration experience of use, the following adverse reactions were identified: shock, anaphylaxis (in rare cases with a fatal outcome), edema of the subglottic space and face, feeling of suffocation, serum-like syndrome, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme, erythema nodosum, acute hepatitis, cholestatic syndrome, fulminant hepatitis, liver failure, jaundice, increased amylase, acute enterocolitis, hemorrhagic diarrhea, hemorrhagic colitis, melena, pseudomembranous colitis, pancytopenia, granulocytopenia, leukopenia, thrombocytopenia, idiopathic thrombocytopenic purpura, hemolytic anemia, acute respiratory failure, asthma attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute renal failure, nephropathy, bleeding tendency, bleeding disorder, generalized thrombohemorrhagic syndrome, upper gastrointestinal bleeding, peptic ulcer, intestinal obstruction, loss of consciousness, allergic vasculitis, possible cefdinir-diclofenac interaction, heart failure, chest pain, myocardial infarction, rhabdomyolysis, involuntary movements, hypertension.

In the event of the listed adverse reactions, as well as a reaction not indicated in the instructions for use, you should consult a doctor.

Contraindications

Rinicef ​​is contraindicated in patients with a history of allergy to the cephalosporin class of antibiotics and hypersensitivity to excipients in the composition of the drug.

Overdose

Data on cefdinir overdose in humans are not available.

In acute toxicity studies in rodents, a single oral dose of cefdinir at a dose of 5600 mg/kg did not lead to the development of adverse reactions. The following signs and symptoms of overdose have been observed with other beta-lactam antibiotics: nausea, vomiting, stomach discomfort, diarrhea, and convulsions.

During hemodialysis, cefdinir is removed from the body, which can be useful in case of serious toxic reactions caused by overdose, especially if the patient has impaired renal function.

Precautions

Before starting therapy with Rinicef, it is necessary to exclude the presence of a history of hypersensitivity reactions to penicillins, cephalosporins or other drugs.

In case of suspicion or confirmation of the development of Clostridium difficile -associated diarrhea, antibiotic therapy should be discontinued if it does not work on Clostridium difficile . Based on the clinical condition, the patient may be indicated for fluid replacement, electrolyte and amino acid solutions, antibiotic therapy Clostridium difficile , surgery.

Rinicef, like other broad-spectrum antimicrobials (antibiotics), should be used with caution in patients with a history of colitis.

In patients with transient or persistent renal insufficiency (CC <30 ml/min), the daily dose of Rinicef ​​should be reduced, since administration at the recommended doses can lead to a significant increase in plasma concentrations and the half-life of cefdinir.

The administration of cephalosporins can sometimes lead to a positive Coombs test result.

Use during pregnancy and lactation.

Pregnancy and childbirth

Experimental reproduction studies have shown the absence of any teratogenic effect.

Data on the results of the use of cefdinir in pregnant women are not available. Cefdinir should only be used during pregnancy if there is a justified clinical need.

Data on the effect of the appointment of cefdinir on childbirth are not available.

Lactation

When prescribing cefdinir at a dose of 600 mg, it is not detected in breast milk in nursing mothers. Cefdinir is prescribed during lactation only after a careful assessment of the benefit / risk ratio for mother and child.

Influence on the ability to drive vehicles and work with mechanisms.

Rincef does not affect the ability to drive vehicles and work with mechanisms.

Interaction with other drugs

Co-administration of cefdinir and an antacid results in a decrease in the rate (C max ) and degree (AUC) of cefdinir absorption by approximately 40%. If antacids are required during treatment with Rinicef, Rinicef ​​should be taken at least 2 hours before or 2 hours after taking the antacid.

As with other beta-lactam antibiotics, probenicide interferes with renal excretion of cefdinir when administered concomitantly, resulting in an approximately two-fold increase in AUC, a 54% increase in maximum cefdinir plasma concentration, and a prolongation of the half-life t 1/2 by 50%.

The simultaneous administration of cefdinir with iron-containing drugs containing 60 mg of elemental iron (as FeSO 4 ), or vitamin drugs containing 10 mg of iron, reduces the absorption of cefdinir by 80% and 31%, respectively. If a patient requires iron medications during cefdinir therapy, Rinicef ​​should be taken at least 2 hours before or after taking iron medications.

There have been reports of reddish-colored stools in patients taking cefdinir. In many cases, iron-fortified foods were taken concomitantly by these patients. The reddish color may be due to the formation in the gastrointestinal tract of a non-absorbable complex of cefdinir or its degradation products and iron.

During treatment with cefdinir, false-positive results for urinary ketones may occur with nitroprusside, but not with nitroferricyanide. False-positive results may also be noted when determining glucose in the urine using Benedict’s solution or Fehling’s reagent (it is recommended to determine glycosuria only by the enzyme method). The use of cephalosporins can sometimes lead to a positive Coombs test result.

Storage conditions and shelf life

At a temperature not higher than 25°C.

Keep out of the reach of children!

Shelf life 3 years. Do not use after the expiry date stated on the package.