Cefdinir (Abbott’s Omnicef, Fujisawa’s Cefzon) is a third-generation, oral cephalosporin available in capsule and oral suspension forms. Cefdinir was developed and launched by Fujisawa in Japan in 1991 as Cefzon. Warner-Lambert’ s Parke-Davis (now Pfizer) was the first to license cefdinir for the United States and Western Europe, and began marketing the product in the United States in 1998. Abbott obtained the exclusive marketing rights from Fujisawa and began marketing the drug as Omnicef in 2000. The agent is expected to retain patent protection through 2007 in the United States. Cefdinir is indicated for the treatment of acute exacerbations of chronic bronchitis in adults and adolescents caused by penicillinase-susceptible S. pneumoniae and all strains of H. influenzae and M. catarrhalis. In Canada, it is available under the brand name Omnicef.
The regulatory authority responsible for approving Cefdinir in Canada is Health Canada, specifically under the oversight of the Therapeutic Products Directorate (TPD). This department ensures the safety, efficacy, and quality of pharmaceutical products before they are available to patients. Cefdinir has been approved in Canada for treating specific bacterial infections based on clinical evidence supporting its effectiveness.
Cefdinir is stable in the presence of many β-lactamase enzymes, which effectively extends its spectrum of activity against a number of gram-positive and gram-negative bacteria resistant to penicillins and other cephalosporins. Cefdinir has demonstrated activity against S. pneumoniae, H. influenzae, K. pneumoniae, M. catarrhalis, and others.
In a randomized, dose-comparative Phase III study enrolling 466 subjects with acute bronchitis, treatment with 600 mg of cefdinir once daily was compared with 300 mg of cefdinir twice daily for ten days. Clinical success in assessable patients receiving once-daily doses was 91%, and the bacteriologic eradication rate was 92%. In assessable patients receiving twice-daily doses, clinical success was 93%, and the bacteriologic eradication rate was 93%.
Another trial compared the two cefdinir dosing regimens with cefuroxime axetil in the treatment of acute exacerbations of chronic bronchitis. This double-blind, randomized, multicenter Phase III study enrolled 1,045 subjects and evaluated 589 patient outcomes for efficacy after ten days of therapy. Patients who received 600 mg once daily of cefdinir were clinically cured in 81% of cases; those who received cefdinir in 300 mg doses twice daily were cured in 74% of cases; and those who received 250 mg of cefuroxime axetil twice daily were cured in 80% of cases.
The Phase III comparative clinical trial showed that cefdinir had a statistically significant higher rate of adverse reactions (25.9% of 474 patients) than did cephalexin (Lilly’s Keflex, generics), a first-generation cephalosporin (16.1% of 478 patients). In particular, cefdinir causes more GI discomfort (such as diarrhea) than do other cephalosporins. The most frequently reported adverse reactions in U.S. clinical trials with a total of 3,841 adult cefdinir-treated patients were diarrhea (15%), vaginal moniliasis (4% of women), nausea (3%), and headache (2%). Most adverse events were mild and self-limiting in nature with a low (3%) discontinuation rate due to associated adverse events. The most frequently reported adverse reactions in U.S. clinical trials with a total of 1,783 pediatric cefdinir-treated patients were diarrhea (8%), rash (3%), and vomiting (1%).
Clinical Trials and Studies in Canada
Several clinical trials and studies have assessed the effectiveness and safety of Cefdinir in Canada. One notable study aimed to evaluate its efficacy in treating community-acquired pneumonia and sinusitis in adult and pediatric patients. The research involved a group of patients suffering from bacterial respiratory tract infections, comparing Cefdinir’s effectiveness with other antibiotics commonly used in Canada. The results demonstrated that Cefdinir provided comparable or superior recovery rates, particularly in cases of mild to moderate pneumonia, with a lower incidence of gastrointestinal side effects. This contributed to its acceptance as a viable treatment option in Canadian medical practice.
Forms and Dosage Available in Canada
Cefdinir is available in Canada in oral capsule and oral suspension forms. The capsule form is typically available in 300 mg strength, while the oral suspension is usually offered in 125 mg/5 mL or 250 mg/5 mL concentrations. These formulations ensure flexibility in dosing, especially for pediatric patients or individuals who have difficulty swallowing capsules.
Canada’s healthcare system continually monitors and regulates the use of antibiotics to combat antimicrobial resistance. Health Canada has implemented measures to promote the prudent use of medically important antimicrobials in animals, aiming to limit the development of resistance. This includes maintaining a list of certain antimicrobial active pharmaceutical ingredients that are important in human medicine.
Side Effects Reported in Canada
The most frequently reported side effects of Cefdinir in Canada include mild to moderate gastrointestinal disturbances such as diarrhea, nausea, and abdominal pain. Some patients have also reported headaches and dizziness, which generally resolve on their own. Allergic reactions, including rash and itching, have been noted but occur less frequently. In rare cases, prolonged use of Cefdinir has been associated with changes in bowel habits, such as the development of antibiotic-associated colitis.
Therapeutic classes of Cefdinir:
Anti-Bacterial Agents, Anti-Infectives, Cephalosporins
| Dosage forms of Cefdinir: | |||
|---|---|---|---|
| Cefdinir 300 mg capsule | Omnicef 300 mg omni-pac capsule | Omnicef 300 mg capsule | Cefdinir 125 mg/5ml Suspension 60ml Bottle |
| Omnicef 125 mg/5ml Suspension 100ml Bottle | |||
Cefdinir is a prescription-only medication in Canada.
Similar Drugs to Cefdinir in Canada
Similar antibiotics within the cephalosporin class are prescribed for comparable bacterial infections. These include Cefixime, a third-generation cephalosporin effective against various Gram-negative and Gram-positive bacteria. Additionally, Cefuroxime and Cefprozil are second-generation cephalosporins used to treat respiratory tract infections, skin infections, and other conditions.
How can i get Cefdinir online over the counter?
You can buy Cefdinir OTC in the online drugstore at a low cost and get it delivered to you by Canada Post, FedEx, and UPS.
| Other names for this medication |
|---|
| Cednir |
| Adinir |
| Cefdir |
| Ceflosil |
| Cefzone |
| Aldinir |
| Palcef |
| Cefida |
| Cefdinirum |
| Kefnir |
| Cefdinirum |
| Ceftinex |
| Cefzon |
| Ceftanir |
| Cefnil |
| Sefdin |
| Addcef |
| Samnir |