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DRUGS & SUPPLEMENTS
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How old is patient? |
Cephalexin:
Unifex is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria:
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Unifex (Cephalexin) and other antibacterial drugs, Unifex (Cephalexin) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6)
Unifex (Cephalexin) is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcuspyogenes.
Unifex is indicated for the treatment of otitis media caused by susceptible isolates of Streptococcuspneumoniae, Haemophilus infl uenz ae, Staphylococcus aureus, Streptococcuspyogenes, and Mo raxella catarrhalis.
Unifex (Cephalexin) is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus and Streptococcus pyogenes.
Unifex is indicated for the treat ment of bone infections caused by susceptible isolates of Staphylococcusaureus and Proteus mi rabilis.
Unifex (Cephalexin) is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escheric hia c oli, Proteus mirabilis, and Klebsiella pneumonia e.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Unifex (Cephalexin) and other antibacterial drugs, Unifex (Cephalexin) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information is available, this information should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Adults and patients at least 15 years of age | T he usual dose is 250 mg every 6 hours, but a dose of 5 00 mg every 12 hours may be administered |
Pediatric patients (over 1 year of age) |
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The usual dose of oral Unifex (Cephalexin) capsule, USP is 250 mg every 6 hours, but a dose of 500 mg every 12 hours may be administered. Treatment is administered for 7 to 14 days.
For more severe infections larger doses of oral Unifex (Cephalexin) capsules, USP may be needed, up to 4 grams daily in two to four equally divided doses.
The recommended total daily doseof oral Unifex (Cephalexin) capsules, USP for pediatric patients is 25 to 50 mg/kg givenin equally divided doses for 7 to 14 days. In the treatment of β-hemolyticstreptococcal infections, duration of at least 10 days is recommended. Insevere infections, a total daily dose of 50 to 100 mg/kg may be administered inequally divided doses.
For thetreatment of otitis media, the recommended daily dose is 75 to 100 mg/kg givenin equally divided doses.
Administer the following dosing regimens for Unifex (Cephalexin) capsules, USP to patients with impaired renal function [see War nin gsand Precautions (5.4) and Use inSpecific Populations (8.6 ) ].
Table 1. Recommended Dose Regimen for Patients with Renal Impairment
Renal Function | Dose regimen recommendation |
Creatinine cleartance ≥ 60mL/min. | No dose adjustment |
Creatinine clearance 30 to 59 mL / min | No dose adjustment; maximum daily dose should not exceed 1 g |
Creati nine clearance 15 to 29 mL / min | 250 mg, every 8 hours or every 12 hours |
Creati nine clearance 5 to 14 mL / min not yet on dialysis* | 250 mg, every 24 hours |
Creati nine clearance 1 to 4 mL / min not yet on dialysis* | 250 mg, every 48 hours or every 60 hours |
*There is insufficient information to make dose adjustment recommendations in patients on hemodialysis.
250 mg capsules: a white to off white powder filled into size 2 capsules (dark green cap and dark green body) that are imprinted with “220” on the both cap and body in edible black ink.
500 mg capsules: a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink.
333 mg capsules: a white to off white powder filled into size 1 capsules (light green cap and light green body) that are imprinted “CEP” on cap and “333” on body in edible black ink.
750 mg capsules: a white to off white powder filled into size '00 Elongated' capsules (dark green cap and dark green body) that are imprinted “CEP” on cap and “750” on body in edible white ink.
Capsules: 250 m g, 333mg, 500 mg and 750 mg ( 3)
Unifex (Cephalexin) is contraindicated in patients with known hypersensitivity to Unifex (Cephalexin) or other members of the cephalosporin class of antibacterial drugs.
Patients with known hypersensitivity to Unifex (Cephalexin) or other members of the cephalosporin class of antibacterial drugs. ( 4)
Allergic reactions in the form of rash, urticaria, angioedema, anaphylaxis, erythema multiforme, Stevens- Johnson syndrome, or toxic epidermal necrolysis have been reported with the use of Unifex (Cephalexin). Before therapy with Unifex (Cephalexin) is instituted, inquire whether the patient has a history of hypersensitivity reactions to Unifex (Cephalexin), cephalosporins, penicillins, or other drugs. Cross-hypersensitivity among beta-lactam antibacterial drugs may occur in up to 10% of patients with a history of penicillin allergy.
If an allergic reaction to Unifex (Cephalexin) occurs, discontinue the drug and institute appropriate treatment.
Clostridium difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including Unifex (Cephalexin), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B, which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Positive direct Coombs’ tests have been reported during treatment with the cephalosporin antibacterial drugs including Unifex (Cephalexin). Acute intravascular hemolysis induced by Unifex (Cephalexin) therapy has been reported. If anemia develops during or after Unifex (Cephalexin) therapy, perform a diagnostic work-up for drug-induced hemolytic anemia, discontinue Unifex (Cephalexin) and institute appropriate therapy.
Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced. If seizures occur, discontinue Unifex. Anticonvulsant therapy can be given if clinically indicated.
Cephalosporins may be associated with prolonged prothrombin time. Those at risk include patients with renal or hepatic impairment, or poor nutritional state, as well as patients receiving a protracted course of antibacterial therapy, and patients receiving anticoagulant therapy. Monitor prothrombin time in patients at risk and manage as indicated.
Prescribing Unifex (Cephalexin) in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Prolonged use of Unifex (Cephalexin) may result in the overgrowth of nonsusceptible organisms. Careful observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
The following serious events are described in greater detail in the Warning and Precautions section:
The most common adverse reactions associated with Unifex (Cephalexin) include diarrhea, nausea, vomiting, dyspepsia and abdominal pain. ( 6)
To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice
In clinical trials, the most frequent adverse reaction was diarrhea. Nausea and vomiting, dyspepsia, gastritis, and abdominal pain have also occurred. As with penicillins and other cephalosporins, transient hepatitis and cholestatic jaundice have been reported.
Other reactions have included hypersensitivity reactions, genital and anal pruritus, genital candidiasis, vaginitis and vaginal discharge, dizziness, fatigue, headache, agitation, confusion, hallucinations, arthralgia, arthritis, and joint disorder. Reversible interstitial nephritis has been reported. Eosinophilia, neutropenia, thrombocytopenia, hemolytic anemia, and slight elevations in aspartate transaminase (AST) and alanine transaminase (ALT) have been reported.
In addition to the adverse reactions listed above that have been observed in patients treated with Unifex (Cephalexin), the following adverse reactions and other altered laboratory tests have been reported for cephalosporin class antibacterial drugs:
Other Adverse Reactions: Fever, colitis, aplastic anemia, hemorrhage, renal dysfunction, and toxic nephropathy.
Altered Laboratory Tests:Prolonged prothrombin time, increased blood urea nitrogen (BUN), increased creatinine, elevated alkaline phosphatase, elevated bilirubin, elevated lactate dehydrogenase (LDH), pancytopenia, leukopenia, and agranulocytosis.
Administration of Unifex (Cephalexin) with metformin results in increased plasma metformin concentrations and decreased renal clearance of metformin.
Careful patient monitoring and dose adjustment of metformin is recommended in patients concomitantly taking Unifex (Cephalexin) and metformin [ see Clinical Pharmacology (12.2) ].
The renal excretion of Unifex is inhibited by probenecid. Co-administration of probenecid with Unifex (Cephalexin) is not recommended.
A false-positive reaction may occur when testing for the presence of glucose in the urine using Benedict’s solution or Fehling’s solution.
Pregnancy Category B
There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Reproduction studies have been performed on mice and rats using oral doses of Unifex monohydrate 0.6 and 1.5 times the maximum daily human dose (66 mg/kg/day) based upon body surface area basis, and have revealed no evidence of impaired fertility or harm to the fetus.
Unifex (Cephalexin) is excreted in human milk. Caution should be exercised when Unifex (Cephalexin) is administered to a nursing woman.
The safety and effectiveness of Unifex in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see Dosage and Administration ( 2.2 ) ] .
Of the 701 subjects in 3 published clinical studies of Unifex (Cephalexin), 433 (62%) were 65 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients.
This drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [ see Warnings and Precautions ( 5.4 ) ].
Unifex (Cephalexin) should be administered with caution in the presence of impaired renal function (creatinine clearance < 30 mL/min, with or without dialysis). Under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended .
Symptoms of oral overdose may include nausea, vomiting, epigastric distress, diarrhea, and hematuria. In the event of an overdose, institute general supportive measures.
Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of Unifex (Cephalexin).
Unifex (Cephalexin) capsules, USP is a semisynthetic cephalosporin antibacterial drug intended for oral administration. It is 7-(D-α-Amino-α-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate. Unifex (Cephalexin) has the molecular formula C 16 H 17 N 3O 4S-H 2Oand the molecular weight is 365.41.
Unifex (Cephalexin) has the following structural formula:
Each capsule contains Unifex (Cephalexin) monohydrate equivalent to 250 mg, 333 mg, 500 mg, or 750 mg of Unifex (Cephalexin). The 250 mg, 333 mg, 500 mg and 750 mg capsules contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, FD & C Blue No. 1, D & C Yellow No. 10, gelatin, sodium lauryl sulphate, titanium dioxide. In addition, the 250 mg capsule contains FD & C Red No. 40; 333 mg and 750 mg Capsules contains FD & C Yellow No. 6. The imprinting ink contains; shellac, propylene glycol, strong ammonia solution and potassium hydroxide. Also black Iron oxide is used in 250mg, 333mg and 500mg and titanium dioxide is used in 750mg.
Unifex is a cephalosporin antibacterial drug [seeMicrobiology ( 12.4 ) ] .
Absorption:
Unifex (Cephalexin) is acid stable and may be given without regard to meals. Following doses of 250 mg, 500 mg, and 1 g, average peak serum levels of approximately 9, 18, and 32 mcg/mL, respectively, were obtained at 1 hour. Serum levels were detectable 6 hours after administration (at a level of detection of 0.2 mcg/mL).
Distribution:
Unifex (Cephalexin) is approximately 10% to 15% bound to plasma proteins.
Excretion:
Unifex (Cephalexin) is excreted in the urine by glomerular filtration and tubular secretion. Studies showed that over 90% of the drug was excreted unchanged in the urine within 8 hours. During this period, peak urine concentrations following the 250 mg, 500 mg, and 1 g doses were approximately 1000, 2200, and 5000 mcg/mL respectively.
Drug Interactions
In healthy subjects given single 500 mg doses of Unifex (Cephalexin) and metformin, plasma metformin mean Cmax and AUC increased by an average of 34% and 24%, respectively, and metformin mean renal clearance decreased by 14%. No information is available about the interaction of Unifex (Cephalexin) and metformin following multiple doses of either drug.
Mechanism of Action
Unifex (Cephalexin) is a bactericidal agent that acts by the inhibition of bacterial cell-wall synthesis.
Resistance
Methicillin-resistant staphylococci and most isolates of enterococci are resistant to Unifex (Cephalexin). Unifex (Cephalexin) is not active against most isolates of Enterobacter spp., Morganella morganii, and Proteus vulgaris. Unifex (Cephalexin) has no activity against Pseudomonas spp., or Acinetobacter calcoaceticus. Penicillin-resistant Streptococcus pneumoniae is usually cross-resistant to beta-lactam antibacterial drugs.
Antimicrobial Activity
Unifex (Cephalexin) has been shown to be active against most isolates of the following bacteria both in vitro and in clinical infections [ see Indications and Usage (1) ].
Gram-positive bacteria
Staphylococcus aureus (methicillin-susceptible isolates only)
Streptococcus pneumoniae (penicillin-susceptible isolates)
Streptococcus pyogenes
Gram-negative bacteria
Escheric h ia coli
Haemophilusinfl uenzae
Klebsiellapneumoniae
Moraxella catarrhalis
Proteusmi rabilis
Susceptibility Tests Methods
When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.
In cases of uncomplicated urinary tract infection only, susceptibility of E. coli, K. pneumoniae, and P. mirabilis to Unifex (Cephalexin) may be inferred by testing cefazolin2.
Dilution Techniques
Quantitative methods are used to determine antimicrobial minimal inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs should be determined using a standardized test methods (broth or agar)1,2.
Diffusion Techniques
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method2,3.
A report of Susceptible (S) indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of Intermediate (I) indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of the drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant (R) indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentrations usually achievable at the infection site; other therapy should be selected.
Qualit y Co n t r ol
Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test 1 ,2,3,.
Lifetime studies in animals have not been performed to evaluate the carcinogenic potential of Unifex (Cephalexin). Tests to determine the mutagenic potential of Unifex (Cephalexin) have not been performed. In male and female rats, fertility and reproductive peLifetime studies in animals have not been performed to evaluate the carcinogenic potential of Unifex (Cephalexin). Tests to determine the mutagenic potential of Unifex (Cephalexin) have not been performed. In male and female rats, fertility and reproductive performance were not affected by Unifex (Cephalexin) oral doses up to 1.5 times the highest recommended human dose based upon body surface area.rformance were not affected by Unifex (Cephalexin) oral doses up to 1.5 times the highest recommended human dose based upon mg/m2.
1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobials Susceptibility Tests; Twenty-Fifth Informational Supplement. CLSI document M100-S25, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard - Twelfth Edition. CLSI document M02-A12, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
Unifex (Cephalexin) capsules, USP, are supplied as follows:
The 500 mg capsules are a white to off white powder filled into size 0 capsules (light green cap and light green body) that are imprinted with “219” on the both cap and body in edible black ink. They are available as follows:
Bottles of 4, 6, 8, 9, 10, 14, 20, 21, 24, 28, 30, 40 and 56 capsules.
Store at 20°C to 25°C (68°F to77°F); excursions permitted to 15 to 30°C (59 to 86°F).
Manufactured by:
Alkem Laboratories ltd.
Mumbai - 400 013, India
Distributed by:
Ascend Laboratories, LLC
Parsippany, NJ 07054
Revised: July 2016
PT 1199-08
Probenecid:
Unifex (Probenecid) is a uricosuric and renal tubular transport blocking agent.
The chemical name for Unifex (Probenecid) is 4-[(dipropylamino) sulfonyl] benzoic acid (molecular weight 285.37). It has the following structural formula:
C13H19NO4S
Unifex (Probenecid), USP is a white or nearly white, fine, crystalline powder. Unifex (Probenecid) is soluble in dilute alkali, in alcohol, in chloroform, and in acetone; it is practically insoluble in water and in dilute acids.
Each tablet for oral administration contains 500 mg of Unifex (Probenecid) and the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium carbonate, sodium lauryl sulfate, sodium starch glycolate, cornstarch, titanium dioxide, triacetin, FD&C Yellow #6, D&C Yellow #10, and FD&C Blue #2.
Unifex (Probenecid) is a uricosuric and renal tubular blocking agent. It inhibits the tubular reabsorption of urate, thus increasing the urinary excretion of uric acid and decreasing serum urate levels. Effective uricosuria reduces the miscible urate pool, retards urate deposition, and promotes resorption of urate deposits.
Unifex (Probenecid) inhibits the tubular secretion of penicillin and usually increases penicillin plasma levels by any route the antibiotic is given. A 2-fold to 4-fold elevation has been demonstrated for various penicillins.
Unifex (Probenecid) also has been reported to inhibit the renal transport of many other compounds including aminohippuric acid (PAH), aminosalicylic acid (PAS), indomethacin, sodium iodomethamate and related iodinated organic acids, 17-ketosteroids, pantothenic acid, phenolsulfonphthalein (PSP), sulfonamides, and sulfonylureas. See also Drug Interactions.
Unifex (Probenecid) decreases both hepatic and renal excretion of sulfobromophthalein (BSP). The tubular reabsorption of phosphorus is inhibited in hypoparathyroid but not in euparathyroid individuals.
Unifex (Probenecid) does not influence plasma concentrations of salicylates, nor the excretion of streptomycin, chloramphenicol, chlortetracycline, oxytetracycline, or neomycin.
Unifex (Probenecid) tablets are indicated for the treatment of the hyperuricemia associated with gout and gouty arthritis.
As an adjuvant to therapy with penicillin or with ampicillin, methicillin, oxacillin, cloxacillin, or nafcillin, for elevation and prolongation of plasma levels by whatever route the antibiotic is given.
Hypersensitivity to Unifex (Probenecid).
Children under 2 years of age.
Not recommended in persons with known blood dyscrasias or uric acid kidney stones.
Therapy with Unifex (Probenecid) should not be started until an acute gouty attack has subsided.
Exacerbation of gout following therapy with Unifex may occur; in such cases colchicine or other appropriate therapy is advisable.
Unifex (Probenecid) increases plasma concentrations of methotrexate in both animals and humans. In animal studies, increased methotrexate toxicity has been reported. If Unifex (Probenecid) is given with methotrexate, the dosage of methotrexate should be reduced and serum levels may need to be monitored.
In patients on Unifex (Probenecid) the use of salicylates in either small or large doses is contraindicated because it antagonizes the uricosuric action of Unifex (Probenecid). The biphasic action of salicylates in the renal tubules accounts for the so-called "paradoxical effect" of uricosuric agents. In patients on Unifex (Probenecid) who require a mild analgesic agent the use of acetaminophen rather than small doses of salicylates would be preferred.
Rarely, severe allergic reactions and anaphylaxis have been reported with the use of Unifex (Probenecid). Most of these have been reported to occur within several hours after readministration following prior usage of the drug.
The appearance of hypersensitivity reactions requires cessation of therapy with Unifex (Probenecid).
Unifex (Probenecid) crosses the placental barrier and appears in cord blood. The use of any drug in women of childbearing potential requires that the anticipated benefit be weighed against possible hazards.
Hematuria, renal colic, costovertebral pain, and formation of uric acid stones associated with the use of Unifex in gouty patients may be prevented by alkalization of the urine and a liberal fluid intake. In these cases when alkali is administered, the acid-base balance of the patient should be watched.
Use with caution in patients with a history of peptic ulcer.
Unifex (Probenecid) has been used in patients with some renal impairment, but dosage requirements may be increased. Unifex (Probenecid) may not be effective in chronic renal insufficiency particularly when the glomerular filtration rate is 30 mL/minute or less. Because of its mechanism of action, Unifex (Probenecid) is not recommended in conjunction with a penicillin in the presence of known renal impairment.
A reducing substance may appear in the urine of patients receiving Unifex (Probenecid). This disappears with discontinuance of therapy. Suspected glycosuria should be confirmed by using a test specific for glucose.
When Unifex (Probenecid) is used to elevate plasma concentrations of penicillin or other beta-lactams, or when such drugs are given to patients taking Unifex (Probenecid) therapeutically, high plasma concentrations of the other drug may increase the incidence of adverse reactions associated with that drug. In the case of penicillin or other beta-lactams, psychic disturbances have been reported.
The use of salicylates antagonizes the uricosuric action of Unifex (Probenecid). The uricosuric action of Unifex (Probenecid) is also antagonized by pyrazinamide.
Unifex (Probenecid) produces an insignificant increase in free sulfonamide plasma concentrations, but a significant increase in total sulfonamide plasma levels. Since Unifex (Probenecid) decreases the renal excretion of conjugated sulfonamides, plasma concentrations of the latter should be determined from time to time when a sulfonamide and Unifex (Probenecid) are coadministered for prolonged periods. Unifex (Probenecid) may prolong or enhance the action of oral sulfonylureas and thereby increase the risk of hypoglycemia.
It has been reported that patients receiving Unifex (Probenecid) require significantly less thiopental for induction of anesthesia. In addition, ketamine and thiopental anesthesia were significantly prolonged in rats receiving Unifex (Probenecid).
The concomitant administration of Unifex (Probenecid) increases the mean plasma elimination half-life of a number of drugs which can lead to increased plasma concentrations. These include agents such as indomethacin, acetaminophen, naproxen, ketoprofen, meclofenamate, lorazepam, and rifampin. Although the clinical significance of this observation has not been established, a lower dosage of the drug may be required to produce a therapeutic effect, and increases in dosage of the drug in question should be made cautiously and in small increments when Unifex (Probenecid) is being coadministrated. Although specific instances of toxicity due to this potential interaction have not been observed to date, physicians should be alert to this possibility.
Unifex (Probenecid) given concomitantly with sulindac had only a slight effect on plasma sulfide levels, while plasma levels of sulindac and sulfone were increased. Sulindac was shown to produce a modest reduction in the uricosuric action of Unifex (Probenecid), which probably is not significant under most circumstances.
In animals and in humans, Unifex (Probenecid) has been reported to increase plasma concentrations of methotrexate.
Falsely high readings for theophylline have been reported in an in vitro study, using the Schack and Waxler technique, when therapeutic concentrations of theophylline and Unifex (Probenecid) were added to human plasma.
The following adverse reactions have been observed and within each category are listed in order of decreasing severity.
Central Nervous System: headache, dizziness.
Metabolic: precipitation of acute gouty arthritis.
Gastrointestinal: hepatic necrosis, vomiting, nausea, anorexia, sore gums.
Genitourinary: nephrotic syndrome, uric acid stones with or without hematuria, renal colic, costovertebral pain, urinary frequency.
Hypersensitivity: anaphylaxis, fever, urticaria, pruritus.
Hematologic: aplastic anemia, leukopenia, hemolytic anemia which in some patients could be related to genetic deficiency of glucose-6-phosphate dehydrogenase in red blood cells, anemia.
Integumentary: dermatitis, alopecia, flushing.
Therapy with Unifex should not be started until an acute gouty attack has subsided. However, if an acute attack is precipitated during therapy, Unifex (Probenecid) may be continued without changing the dosage, and full therapeutic dosage of colchicine, or other appropriate therapy, should be given to control the acute attack.
The recommended adult dosage is 250 mg (1/2 Unifex (Probenecid) tablet), twice a day for one week, followed by 500 mg (1 tablet) twice a day thereafter.
Some degree of renal impairment may be present in patients with gout. A daily dosage of 1000 mg may be adequate. However, if necessary, the daily dosage may be increased by 500 mg increments every 4 weeks within tolerance (and usually not above 2000 mg per day) if symptoms of gouty arthritis are not controlled or the 24 hour uric acid excretion is not above 700 mg. As noted, Unifex (Probenecid) may not be effective in chronic renal insufficiency particularly when the glomerular filtration rate is 30 mL/minute or less.
Gastric intolerance may be indicative of overdosage, and may be corrected by decreasing the dosage.
As uric acid tends to crystallize out of an acid urine, a liberal fluid intake is recommended, as well as sufficient sodium bicarbonate (3 to 7.5 g daily), or potassium citrate (7.5 g daily) to maintain an alkaline urine.
Alkalization of the urine is recommended until the serum urate level returns to normal limits and tophaceous deposits disappear, i.e., during the period when urinary excretion of uric acid is at a high level. Thereafter, alkalization of the urine and the usual restriction of purine-producing foods may be somewhat relaxed.
Unifex (Probenecid) should be continued at the dosage that will maintain normal serum urate levels. When acute attacks have been absent for 6 months or more and serum urate levels remain within normal limits, the daily dosage may be decreased by 500 mg every 6 months. The maintenance dosage should not be reduced to the point where serum urate levels tend to rise.
The recommended dosage is 2000 mg ) daily in divided doses. This dosage should be reduced in older patients in whom renal impairment may be present.
2–14 years of age:
Initial dose: 25 mg/kg body weight (or 0.7 g/square meter body surface).
Maintenance Dose: 40 mg/kg body weight (or 1.2 g/square meter body surface) per day, divided into 4 doses.
For children weighing more than 50 kg (110 lb) the adult dosage is recommended.
Unifex (Probenecid) is contraindicated in children under 2 years of age.
The PSP excretion test may be used to determine the effectiveness of Unifex (Probenecid) in retarding penicillin excretion and maintaining therapeutic levels. The renal clearance of PSP is reduced to about one-fifth the normal rate when dosage of Unifex (Probenecid) is adequate.
In uncomplicated gonococcal infections in men and women (urethral, cervical, rectal), 1 g of Unifex (Probenecid) should be given orally with 4.8 million units of aqueous procaine penicillin G
For further guidance, see CDC recommendations for definition of regimens of choice, alternative regimens, treatment of hypersensitive patients, and other aspects of therapy.
*Recommended by the Center for Disease Control, U.S. Department of Health and Human Services, Public Health Service (Morbidity and Mortality Weekly Report Supplement, Volume 34, Number 4S, October 18, 1985).
Unifex (Probenecid) Tablets, USP are available containing 500 mg of Unifex (Probenecid), USP.
The tablets are capsule shaped, film-coated yellow, debossed with MYLAN 156 on one side, 500 on the other side. They are available as follows:
NDC 0378-0156-01
bottles of 100 tablets
Store at 20° to 25°C (68° to 77°F).
Protect from light.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505
REVISED MARCH 2006
PROB:R4AQ
PRINCIPAL DISPLAY PANEL - 500 mg
NDC 0378-0156-01
Unifex (Probenecid)
Tablets, USP
500 mg
Rx only 100 Tablets
Each film-coated tablet contains:
Unifex (Probenecid), USP 500 mg
Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.
Keep container tightly closed.
Keep this and all medication
out of the reach of children.
Store at 20° to 25°C (68° to 77°F).
[See USP for Controlled Room
Temperature.]
Protect from light.
Usual Adult
Dosage: See accom-
panying prescribing information.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Mylan.com
RM0156A11
Depending on the reaction of the Unifex after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Unifex not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Unifex addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology