Velosef
INDICATIONS
Velosef (Cephradine) Capsules and Velosef for Oral Suspension are indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms:
Respiratory Tract Infections: (e.g.,tonsillitis, pharyngitis, and lobar pneumonia) caused by group A beta-hemolytic streptococci and S.pneumoniae (formerly D.pneumonia.)
(Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Velosef is generally effective in the eradication of streptococci from the nasopharynx; substantial data establishing the efficacy of Velosef in the subsequent prevention of rheumatic fever are not available at present.)
Otitis Media: caused by group A beta-hemolytic streptococci, S. pneumoniae (formerly D. pneumoniae), H.influenzae, and staphylococci.
Skin and Skin Structure Infections: caused by staphylococci (penicillin-susceptible and penicillin-resistant) and beta-hemolytic streptococci.
Urinary Tract Infections: including prostatitis, caused by E. coli, P mirabilis, Klebsiella species, and enterococci (S.faecalis). The high concentrations of cephradine achievable in the urinary tract will be effective against many strains of enterococci for which disc susceptibility studies indicate relative resistance. It is to be noted that among beta-lactam antibiotics, ampicillin is the drug of choice for enterococcal urinary tract (S.faecalis) infection.
Note - Culture and susceptibility tests should be initiated prior to and during therapy.
Following clinical improvement achieved with parenteral therapy, oral cephradine may be utilized for continuation of treatment of persistent or severe conditions where prolonged therapy is indicated.
DOSAGE AND ADMINISTRATION
Velosef (Cephradine) may be given without regard to meals.
Adults
For respiratory tract infections (other than lobar pneumonia) and skin and skin structure infections, the usual dose is 250 mg every 6 hours or 500 mg every 12 hours.
For lobar pneumonia, the usual dose is 500 mg every 6 hours or 1 g every 12 hours.
For uncomplicated urinary tract infections, the usual dose is 500 mg every 12 hours. In more serious urinary tract infections, including prostatitis, 500 mg every 6 hours or 1 g every 12 hours may be administered.
Larger doses (up to 1 g every 6 hours) may be given for severe or chronic infections.
Children
No adequate information is available on the efficacy of b.i.d. regimens in children under nine months of age. The usual dose in children over nine months of age is 25 to 50 mg/kg/day administered in equally divided doses every 6 or 12 hours. For otitis media due to H.influenzae, doses are from 75 to 100 mg/kg/day administered in equally divided doses every 6 or 12 hours, but should not exceed 4 g per day. Dosage for children should not exceed dosage recommended for adults.
All patients, regardless of age and weight: Larger doses (up to 1 g q.i.d.) may be given for severe or chronic infections.
As with antibiotic therapy in general, treatment should be continued for a minimum of 48 to 72 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. In infections caused by group A beta-hemolytic streptococci, a minimum of 10 days of treatment is recommended to guard against the risk of rheumatic fever or glomerulonephritis. In the treatment of chronic urinary tract infection, frequent bacteriologic and clinical appraisal is necessary during therapy and may be necessary for several months afterwards. Persistent infections may require treatment for several weeks. Prolonged intensive therapy is recommended for prostatitis. Doses smaller than those indicated are not recommended.
Patients With Impaired Renal Function
Not on Dialysis: The following initial dosage schedule is suggested as a guideline based on creatinine clearance. Further modification in the dosage schedule may be required because of individual variations in absorption.
| Creatinine | Dose | Time Interval |
| > 20 mL/min | 500 mg | 6 hours |
| 5-20 mL/min | 250 mg | 6 hours |
| < 5 mL/min | 250 mg | 12 hours |
On Chronic, Intermittent Hemodialysis:
250 mg Start
250 mg at 12 hours
250 mg 36-48 hours (after start)
Children may require dosage modification proportional to their weight and severity of infection.
HOW SUPPLIED
Velosef Capsules (Cephradine Capsules USP)
| Velosef '250' 250 mg/ capsule: | bottles of 24 (NDC 0003-0113-24) and 100 (NDC 0003-0113-50) and 100 Unimatic® unit-dose packs (NDC 0003-0113-52). Capsule identification no. 113. |
| Velosef '500' 500 mg/ capsule: | bottles of 24 (NDC 0003-0114-26) and 100 (NDC 0003-0114-50) and 100 Unimatic unit- dose packs (NDC 0003-0114-52). Capsule identification no. 114. |
Velosef for Oral Suspension (Cephradine for Oral Suspension USP)
| Velosef '125' | When constituted as directed on the container label, a pleasant fruit-flavored suspension containing 125 mg per 5 mL, in bottle sizes for preparation of 100 mL (NDC 0003-1193-50) and 200 mL (NDC 0003-1193-80). |
| Velosef '250' | When constituted as directed on the container label, a pleasant fruit-flavored suspension containing 250 mg per 5 mL, in bottle sizes for preparation of 100 mL (NDC 0003-1194-50) and 200 mL (NDC 0003-1194-80) |
Storage
Velosef Capsules - Keep tightly closed. Do not store above 86° F.
Velosef for Oral Suspension - Prior to constitution, store at room temperature; avoid excessive heat. After constitution, when stored at room temperature, discard unused portion after seven days; when stored in refrigerator, discard unused portion after 14 days. Keep tightly closed.
Rx only
Bulk Container - Not For Household Dispensing
Each capsule contains 500 mg cephradine
Keep tightly closed Do not store above 86° F
Dispense in tight containers
Generic Name: Cephradine
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