Buy Omnicef Online

The description

Blue-beige capsules with the Pharmacar logo on the lid and the body of the capsule.

Pharmacotherapeutic group

Antibacterial agents for systemic use. Third generation cephalosporins.

Pharmacological properties

Pharmacodynamics

The active substance in Omnicef is cefdinir - a third generation broad spectrum semi-synthetic cephalosporin antibiotic for oral administration. Like other antibiotics in the cephalosporin group, cefdinir exerts a bactericidal effect against sensitive microorganisms due to the inhibition of peptidoglycan synthesis in the bacterial cell wall by disrupting the final stage of transamination, necessary for crosslinking. Cefdinir is resistant to many, but not all, β-lactamases produced by gram-positive and gram-negative bacteria. For this reason, many microorganisms resistant to penicillins and certain cephalosporins are sensitive to cefdinir.

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

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

Pharmacokinetics

Oral bioavailability - absorption

The time required to reach the maximum plasma concentration of cefdinir when administered orally in the form of capsules or suspensions is 2 to 4 hours after administration. The plasma concentration of cefdinir increases with increasing dose, but the increase becomes less proportional in the dose range of 300 mg (7 mg / kg) to 600 mg (14 mg / kg). The bioavailability of cefdinir was 21% after administration of a 300 mg capsule and 16% after administration of 600 mg capsules.

Food effect

When taking cefdinir in capsule form with fat-rich foods, the maximum plasma concentrations (Cmax) and the area under the concentration curve over time (AUC) decrease by 16% and 10% respectively. This decrease is considered to be clinically insignificant. Therefore, cefdinir can be taken regardless of the meal.

The plasma concentrations and pharmacokinetic parameters of cefdinir in the form of capsules after oral administration of single doses of 300 and 600 mg to adult subjects are presented in the following table:

Multiple reception

Cefdinir does not accumulate in plasma with one or two doses per day in patients with normal renal function.

Distribution

The mean volume of distribution (Vdarea) of cefdinir in adult patients is 0.35 L / kg (± 0.29); in pediatric patients (aged 6 months to 12 years), (Vdarea) is 0.67 L / kg (± 0.38). The degree of binding of cefdinir to plasma proteins is 60% to 70% in adults and pediatric patients; the degree of binding does not depend on the concentration of cefdinir. The drug is well distributed in the fluid from skin blisters, in the tissue of the tonsils, sinuses, middle ear and lungs. There are no data on the penetration of cefdinir into the cerebrospinal fluid.

Metabolism and excretion

Cefdinir does not undergo significant metabolism. Cefdinir is eliminated mainly by the kidneys, the mean plasma half-life (t1 / 2) is 1.7 (± 0.6) hours. In healthy volunteers with intact renal function, renal clearance is 2.0 (± 1.0) ml / min / kg, apparent oral clearance is 11.6 (± 6.0) and 15.5 (± 5.4) ml / min / kg after administration of 300 and 600 mg, respectively. The average percentage of the accepted dose, excreted unchanged in the urine when taking 300 and 600 mg, is 18.4% (± 6.4) and 11.6% (± 4.6), respectively. The clearance of cefdinir is reduced in patients with renal impairment (see Dosage and Administration - patients with renal impairment). Since renal excretion is the main route of elimination, the dosage of the drug should be reduced accordingly in patients with severe renal impairment or in hemodialysis patients (see Dosage and Administration).

Patients with renal insufficiency

In patients with a creatinine clearance (CLcr) of 30 to 60 ml / min, the Cmax and t1 / 2 were greater than approximately 2 times and the AUC approximately 3 times. In subjects with CLcr <30 ml / min, Cmax increased approximately 2 times, t1 / 2 - approximately 5 times and AUC approximately 6 times. Patients with severe renal impairment (creatinine clearance <30 ml / min) are recommended to change the dosing schedule (see Dosage and / Administration).

Hemodialysis

During dialysis (lasting 4 hours), 63% of cefdinir is eliminated from the body and the half-life t1 / 2 decreases from 16 (± 3.5) to 3.2 (± 1.2) hours. Modification of the dosing schedule is recommended in this category of patients (see. Method of administration and dosage).

Liver disease

Since cefdinir is mainly excreted by the kidneys and does not undergo significant metabolism, no studies have been conducted in patients with hepatic impairment. The need to modify the dosing regimen in this patient category is not expected.

Elderly patients

The effect of age on the pharmacokinetics of cefdinir after taking a single dose of 300 mg was evaluated in 32 volunteers aged 19 to 91 years. The systemic effect of cefdinir is significantly increased in elderly volunteers (N = 16), Cmax by 44%, AUC by 86%. This increase is due to a decrease in the clearance of cefdinir. The apparent volume of distribution also decreases, so there is no significant change in the average apparent half-life (t1 / 2) (elderly people: 2.2 ± 0.6 hours compared to young people: 1.8 ± 0.4 hours).

Since the clearance of cefdinir is mainly related to a change in renal function and not to age, elderly patients do not need to change the dosage regimen, except in cases of proven renal impairment (clearance of creatinine 30 ml / min).

Directions for use

Cefdinir is indicated for the treatment of mild to moderate infections caused by susceptible microorganisms.

Adults:

Community-acquired pneumonia, caused by Haemophilus influenza (including strains producing β-lactamase), Haemophilus parainfluenzae (including strains producing β-lactamase), Streptococcus pneumonia (strains sensitive to penicillin only) and Moraxella catarrhalis (including strains producing β-lactamase).

Exacerbation of chronic bronchitis, caused by Haemophilus influenza (including strains producing β-lactamase), Haemophilus parainfluenzae (including strains producing β-lactamase), Streptococcus pneumonia (strains sensitive to penicillin only) and Moraxella catarrhalis (including strains producing β-lactamase).

Acute sinusitis, caused by Haemophilus influenza (including strains producing β-lactamase), Streptococcus pneumonia (only strains sensitive to penicillin) and Moraxella catarrhalis (including strains producing β-lactamase).

Pharyngitis / tonsillitis, caused by Streptococcus pyogenes.

Simple infections of the skin and skin structures, caused by Staphylococcus aureus (including strains producing β-lactamase) and Streptococcus pyogenes.

Dosage and administration

The dosage regimen is defined individually based on the patient's age, body weight, kidney function, and the severity of the infection. For adults, the daily dose for all infectious diseases is 600 mg in a single dose or in two divided doses.

Dosing the medicine once a day for 10 days is as effective as taking it twice a day. The once-daily capsule dosage has not been studied for pneumonia and skin infections; therefore, in these cases, the drug should be taken twice a day.

Omnicef can be taken regardless of the meal. The duration of the course is 5 to 10 days.

Children (6 months to 12 years old inclusive) are recommended to take cefdinir as a suspension.

Adults:

1. Community-acquired pneumonia: 10 days, 300 mg every 12 hours;
2. Exacerbation of chronic bronchitis: 5 to 10 days 10 mg 300 mg every 12 hours or 600 mg every 24 hours;
3. Acute sinusitis: 10 days, 300 mg every 12 hours or 600 mg every 24 hours;
4. Pharyngitis / tonsillitis: 5 to 10 days 10 mg 300 mg every 12 hours or 600 mg every 24 hours
5. Uncomplicated skin and soft tissue infections: 10 days, 300 mg every 12 hours.

Patients with renal insufficiency

For patients with creatinine clearance 30 ml / min, cefdinir should be prescribed at a dose of 300 mg once a day.

Hemodialysis patients

Hemodialysis helps remove cefdinir from the body. For patients undergoing permanent hemodialysis, the recommended starting dose is 300 mg or 7 mg / kg for each following day. At the end of each hemodialysis session, 300 mg (or 7 mg / kg) of cefdinir is prescribed. The next doses (300 mg or 7 mg / kg) are then prescribed for each following day.

Patients with hepatic impairment

Since cefdinir is not significantly metabolized and is eliminated mainly by the kidneys, no studies have been conducted in patients with hepatic impairment. No dose adjustment is expected in this group of patients.

Elderly patients

The effect of age on the pharmacokinetics of cefdinir after taking a single dose of 300 mg was evaluated in 32 volunteers aged 19 to 91 years. The systemic effect of cefdinir increased significantly in elderly volunteers (N = 16), Cmax by 44%, the area under the concentration curve over time (AUC) by 86%. This increase is due to a decrease in the clearance of cefdinir. The volume of distribution also decreased, so there was no significant change in the average half-life (t1 / 2) (elderly: 2.2 ± 0.6 hours compared to young: 1.8 ± 0.4 hours). Due to the fact that the clearance of cefdinir is mainly related to a change in renal function and not to age, elderly patients do not need to change the dosage regimen.

If you miss the next dose, take it as soon as you remember. If this dose is missed when taking the next dose, skip the dose and skip the previous dosing schedule, do not double the dose.

Safety precautions

Before starting treatment with Omnicef, it is necessary to exclude the presence of a history of hypersensitivity reactions to penicillins and cephalosporins or other medicines.

If cefdinir is to be prescribed to a patient with existing hypersensitivity to penicillins, extreme caution should be exercised, as the presence of cross-hypersensitivity between beta-lactam antibiotics has been proven, reaching 10% in patients with a history allergic reactions to penicillin. If an allergic reaction develops during administration of cefdinir, administration should be stopped immediately. In the event of a severe hypersensitivity reaction, administration of epinephrine and other urgent measures may be necessary, including oxygen supply, administration of intravenous fluids, intravenous antihistamines, corticosteroids, amines pressure and airway management when clinically necessary.

Administration of Omnicef in the absence of a proven or suspected bacterial infection, or for a justified reason for prophylactic purposes, is of questionable benefit to the patient and increases the risk of developing bacteria resistant to antibiotics.

When using almost all antibacterial agents, including cefdinir, cases of diarrhea associated with Clostridium difficile have been identified, the severity of which ranges from mild diarrhea to fatal colitis. Treatment with antibacterial agents changes the normal microflora of the large intestine, resulting in excessive growth of C. difficile.

If suspected or confirmed development of diarrhea associated with Clostridium difficile, prescribed antibiotic therapy should be discontinued if it does not affect Clostridium difficile. Based on the clinical condition, the patient can be shown a reconstitution of fluids, the introduction of electrolyte and amino acid solutions, antibiotic therapy with Clostridium difficile and surgery.

Omnicef, like other broad-spectrum antimicrobials (antibiotics), should be prescribed with caution to patients with a history of colitis.

In patients with short-term or persistent renal impairment, the daily dose of Omnicef should be reduced, since administration at the recommended doses may lead to a significant increase in plasma concentrations and half-life of cefdinir (see Instructions for Use).

Administration of cephalosporins can sometimes lead to a positive Coombs test.

Interaction with other drugs

Co-administration of cefdinir and antacid resulted in an approximately 40% decrease in the rate (Cmax) and degree (AUC) of absorption of cefdinir. If you have to take antacids while taking Omnicef, you should take Omnicef at least 2 hours before or two hours after taking the antacid. As with other β-lactam antibiotics, the probenicide disrupts the renal excretion of cefdinir when given concomitantly, resulting in an approximately two-fold increase in AUC, an increase in the maximum plasma concentration of cefdinir by 54% and an extended half-life of t1 / 2 by 50%. Co-administration of cefdinir with iron-containing medicines containing 60 mg of elemental iron (as FeSO4), or vitamin preparations containing 10 mg of iron, reduces the absorption of cefdinir by 80% and 31%, respectively. If the patient needs to take iron preparations during treatment with cefdinir, Omnicef should be taken at least 2 hours before or 2 hours after taking iron-containing medicines.

Reddish stools have been reported in patients taking cefdinir. In many cases, these patients have taken iron-fortified foods simultaneously. The reddish color may be associated with the formation in the gastrointestinal tract of the non-absorbable complex of cefdinir or its decomposition products and iron.

A false positive reaction to ketones in the urine is possible in tests using nitroprusside, but not with nitroferricyanide. Taking cefdinir may lead to false positive results from a blood glucose test using Clinitest®, Benedict's solution, the Feling reagent. The use of enzyme tests for glucose is recommended. Administration of cephalosporins can lead to a positive Coombs test.

Pregnancy and childbirth

In preclinical studies, no teratogenic effects of cefdinir were administered orally to rats at doses up to 1000 mg / kg / day (70 times the maximum recommended therapeutic dose based on the calculation of mg / kg / day, 11 times based on the calculation of mg / m2 / day) or in rabbits at doses up to 10 mg / kg / day (0.7 times the maximum recommended therapeutic dose based on the calculation mg / kg / day, 0.23 times based on the calculation of mg / m2 / day). Cefdinir did not affect the reproductive parameters of females, the survival rates of the offspring, as well as the parameters of its development, behavior and reproductive function.

However, data from clinical trials on the use of cefdinir in pregnant women are not available. Since studies on the evaluation of the effect on reproductive function in animals do not always predict effects on the human body, cefdinir can only be prescribed during pregnancy if there is a need reasonable clinic.

The effect of administration of cefdinir on childbirth has not been studied. Breastfeeding: when prescribing cefdinir at a dose of 600 mg, it has not been detected in breast milk in nursing mothers.

Influence on ability to drive and work with mechanisms

Side effect

The safety of cefdinir has been studied in clinical trials involving 5093 adults and adolescents at a dose of 600 mg / day. Cefdinir was characterized by good tolerance, the undesirable effects detected were mild in the nature of their manifestation and spontaneously passed after withdrawal. In 3% of adult patients, withdrawal of cefdinir due to the development of an adverse effect has been assessed as having a reliable, probable or possible relationship with the administration of cefdinir. Most withdrawal cases were associated with disorders of the gastrointestinal tract, manifestedprimarily by diarrhea or nausea. In 0.4% of adult patients, drug withdrawal was due to the development of a rash with cefdinir.

Very often: diarrhea, vaginal candidiasis, nausea, headache, vaginitis, abdominal pain.

Often: rash, dyspepsia, flatulence, nausea, stool disorder, anorexia, constipation, dizziness, dry mouth, asthenia, insomnia, leukorrhea, candidiasis, skin candidiasis, itching, drowsiness, hyperkinesia, increased AST, maculopapular rash, abdominal pain, leukopenia.

Characteristic side effects of cephalosporins

The following side effects and changes in laboratory parameters have been reported with the appointment of antibiotics from the cephalosporin group as a whole:

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

The use of certain cephalosporins has been accompanied by the development of convulsions, in particular in patients with renal impairment, who have not recounted the dose. If seizures develop during treatment, you should stop taking the antibiotic. If clinically necessary, anticonvulsant therapy may be prescribed.

Post-registration period

The following adverse reactions and changes in laboratory parameters, regardless of their relationship to cefdinir, were reported in a comprehensive post-registration study that began in Japan in 1991: Allergic reactions, shock, anaphylaxis (in rare cases with fatal outcome), swelling of the ligament space and face, suffocation, whey syndrome, conjunctivitis, stomatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema polymorphic, nodular erythema hepatitis, cholestatic syndrome, fulminant hepatitis, liver failure, jaundice, high amylase level, acute enterocolitis, hemorrhagic diarrhea, hemorrhagic colitis, melena, pseudomembranosis colitis, pancytopenia, agranulocytosis, leukopenia, thrombocytopenia, thrombocytopenia, thrombocytopenia, thrombocytopenia, thrombocytopenia hemolytic, acute respiratory failure, asthma attack, drug-induced pneumonia, eosinophilic pneumonia, idiopathic interstitial pneumonia, fever, acute nephropathy, acute neuropathy generalized thrombohemorrhagic syndrome, bleeding from upper gastrointestinal tract, peptic ulcer, obstructed ction at shechnika, loss of consciousness, hypersensitivity vasculitis, cefdinir-diclofenac interoperability, heart failure, chest pain, myocardial infarction, involuntary movements, rhabdomyolysis, hypertension.

Adverse reaction reporting

If you experience any side effects, consult your doctor. This recommendation applies to all possible side effects, including those not listed in the instructions. You can also report side effects to the Adverse Drug Reaction Information Database, including reports of drug ineffectiveness. By reporting side effects, you can help get more information about the safety of the drug.

Overdose

There is no evidence of an overdose of cefdinir in humans. In acute rodent toxicity studies, single oral administration of cefdinir at a dose of 5600 mg / kg did not lead to the development of adverse effects. During hemodialysis, cefdinir is eliminated from the body, which can be useful in case of serious toxic reactions caused by overdose, especially in patients with renal insufficiency.

The toxic signs and symptoms seen after an overdose of other β-lactam antibiotics included nausea, vomiting, epigastric distress, diarrhea and seizures.