DRUGS & SUPPLEMENTS
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Urofar (Phenazopyridine) is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Urofar (Phenazopyridine) HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and Urofar (Phenazopyridine) HCl should be discontinued when symptoms are controlled.
The analgesic action may reduce or eliminate the need for systemic analgesics or narcotics. It is, however, compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with Urofar (Phenazopyridine) HCl should not exceed two days because there is a lack of evidence that the combined administration of Urofar (Phenazopyridine) HCl and an antibacterial provides greater benefit than administration of the antibacterial alone after two days. (See DOSAGE AND ADMINISTRATION section.)
Urofar (Phenazopyridine) HCl should not be used in patients who have previously exhibited sensitivity to it. The use of Urofar (Phenazopyridine) HCl is contraindicated in patients with renal insufficiency.
Headache, rash, pruritus and occasional gastrointestinal disturbance. At anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section).
A yellowish tinge of the skin or sclera may indicate accumulation due to impaired renal excretion and the need to discontinue therapy. The decline in renal function associated with advanced age should be kept in mind.
NOTE: Patients should be informed that Urofar HCl produces a reddish-orange discoloration of the urine and may stain fabric. Staining of contact lenses has been reported.
Laboratory Test Interaction:
Due to its properties as an azo dye, Urofar (Phenazopyridine) HCl may interfere with urinalysis based on spectrometry or color reactions.
Long-term administration of Urofar (Phenazopyridine) HCl has induced neoplasia in rats (large intestine) and mice (liver).
Although no association between Urofar (Phenazopyridine) HCl and human neoplasia has been reported, adequate epidemiological studies along these lines have not been conducted.
Pregnancy Category B:
Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Urofar (Phenazopyridine) HCl. There are, however, 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.
No information is available on the appearance of Urofar (Phenazopyridine) HCl, or its metabolites in human milk.
100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals.
200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals.
When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Urofar (Phenazopyridine) HCl should not exceed 2 days.
Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and “bite cells” (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.
100 mg Tablets: Supplied in bottles of 100 (NDC 60846-501-01) counts.
Appearance: Deep brown to maroon colored, round, film coated tablets debossed "PY" above "1" on one side and plain on the other.
200 mg Tablets: Supplied in bottles of 1-- (NDC 60846-502-01) counts.
Appearance: Deep brown to maroon colored, round, film coated tablets debossed "PY" above "2" on one side and plain on the other.
DISPENSE contents with a child-resistant closure (as required) and in a tight container as defined in the USP.
STORE at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).
Gemini Laboratories, LLC
Bridgewater, NJ 08807
Indication: For the treatment bacterial infections causing bronchitis, prostatitis and urinary tract infections.
Urofar (Sulfamethoxazole) is a sulfonamide drug that inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA) for binding to dihydropteroate synthetase (dihydrofolate synthetase). Urofar (Sulfamethoxazole) is bacteriostatic in nature. Inhibition of dihydrofolic acid synthesis decreases the synthesis of bacterial nucleotides and DNA. Urofar (Sulfamethoxazole) is normally given in combination with Trimethoprim, a dihydrofolate reductase inhibitor, which inhibits the reduction of dihydrofolic acid to tetrahydrofolic acid. Studies have shown that bacterial resistance develops more slowly with the combination of the two drugs than with either Trimethoprim or Urofar (Sulfamethoxazole) alone.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Urofar (Trimethoprim) tablets, USP and other antibacterial drugs, Urofar (Trimethoprim) tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they 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.
For the treatment of initial episodes of uncomplicated urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Enterobacter species, and coagulase-negative Staphylococcus species, including S. saprophyticus.
Cultures and susceptibility tests should be performed to determine the susceptibility of the bacteria to Urofar (Trimethoprim). Therapy may be initiated prior to obtaining the results of these tests.
Urofar (Trimethoprim) is contraindicated in individuals hypersensitive to Urofar (Trimethoprim) and in those with documented megaloblastic anemia due to folate deficiency.
Serious hypersensitivity reactions have been reported rarely in patients on Urofar (Trimethoprim) therapy. Urofar (Trimethoprim) has been reported rarely to interfere with hematopoiesis, especially when administered in large doses and/or for prolonged periods.
The presence of clinical signs such as sore throat, fever, pallor, or purpura may be early indications of serious blood disorders (see OVERDOSAGE, Chronic).
Complete blood counts should be obtained if any of these signs are noted in a patient receiving Urofar (Trimethoprim) and the drug discontinued if a significant reduction in the count of any formed blood element is found.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Urofar (Trimethoprim) tablets, USP, 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 antiobiotic 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.
Prescribing Urofar tablets, USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Urofar (Trimethoprim) should be given with caution to patients with possible folate deficiency. Folates may be administered concomitantly without interfering with the antibacterial action of Urofar (Trimethoprim). Urofar (Trimethoprim) should also be given with caution to patients with impaired renal or hepatic function (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION).
Patients should be counseled that antibacterial drugs including Urofar (Trimethoprim) tablets, USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Urofar (Trimethoprim) tablets, USP are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Urofar (Trimethoprim) tablets, USP or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with and without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Urofar may inhibit the hepatic metabolism of phenytoin. Urofar (Trimethoprim), given at a common clinical dosage, increased the phenytoin half-life by 51% and decreased the phenytoin metabolic clearance rate by 30%. When administering these drugs concurrently, one should be alert for possible excessive phenytoin effect.
Urofar (Trimethoprim) can interfere with a serum methotrexate assay as determined by the Competitive Binding Protein Technique (CBPA) when a bacterial dihydrofolate reductase is used as the binding protein. No interference occurs, however, if methotrexate is measured by a radioimmunoassay (RIA).
The presence of Urofar (Trimethoprim) may also interfere with the Jaffé alkaline picrate reaction assay for creatinine, resulting in overestimations of about 10% in the range of normal values.
Long-term studies in animals to evaluate carcinogenic potential have not been conducted with Urofar.
Urofar (Trimethoprim) was demonstrated to be nonmutagenic in the Ames assay. In studies at two laboratories, no chromosomal damage was detected in cultured Chinese hamster ovary cells at concentrations approximately 500 times human plasma levels; at concentrations approximately 1000 times human plasma levels in these same cells, a low level of chromosomal damage was induced at one of the laboratories. No chromosomal abnormalities were observed in cultured human leukocytes at concentrations of Urofar (Trimethoprim) up to 20 times human steady-state plasma levels. No chromosomal effects were detected in peripheral lymphocytes of human subjects receiving 320 mg of Urofar (Trimethoprim) in combination with up to 1600 mg of sulfamethoxazole per day for as long as 112 weeks.
No adverse effects on fertility or general reproductive performance were observed in rats given Urofar in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females.
Urofar has been shown to be teratogenic in the rat when given in doses 40 times the human dose. In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with doses six times the human therapeutic dose.
While there are no large, well-controlled studies on the use of Urofar (Trimethoprim) in pregnant women, Brumfitt and Pursell,3 in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or Urofar (Trimethoprim) in combination with sulfamethoxazole. The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving Urofar (Trimethoprim) and sulfamethoxazole. There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received Urofar (Trimethoprim) and sulfamethoxazole at the time of conception or shortly thereafter.
Because Urofar (Trimethoprim) may interfere with folic acid metabolism, Urofar (Trimethoprim) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The oral administration of Urofar (Trimethoprim) to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.
Urofar is excreted in human milk. Because Urofar (Trimethoprim) may interfere with folic acid metabolism, caution should be exercised when Urofar (Trimethoprim) is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 2 months have not been established. The effectiveness of Urofar (Trimethoprim) as a single agent has not been established in pediatric patients under 12 years of age.
Clinical studies of Urofar (Trimethoprim) tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience4,5 has not identified differences in response between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Case reports of hyperkalemia in elderly patients receiving trimethoprim-sulfamethoxazole have been published.6 Urofar (Trimethoprim) is known to be 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, and it may be useful to monitor potassium concentrations and to monitor renal function by calculating creatinine clearance.
The adverse effects encountered most often with Urofar were rash and pruritus.
Rash, pruritus, and phototoxic skin eruptions. At the recommended dosage regimens of 100 mg b.i.d. or 200 mg q.d., each for 10 days, the incidence of rash is 2.9% to 6.7%. In clinical studies which employed high doses of Urofar (Trimethoprim), an elevated incidence of rash was noted. These rashes were maculopapular, morbilliform, pruritic, and generally mild to moderate, appearing 7 to 14 days after the initiation of therapy.
Rare reports of exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and anaphylaxis have been received.
Epigastric distress, nausea, vomiting, and glossitis. Elevation of serum transaminase and bilirubin has been noted, but the significance of this finding is unknown. Cholestatic jaundice has been rarely reported.
Thrombocytopenia, leukopenia, neutropenia, megaloblastic anemia, and methemoglobinemia.
Aseptic meningitis has been rarely reported.
Fever, and increases in BUN and serum creatinine levels.
Signs of acute overdosage with Urofar may appear following ingestion of 1 gram or more of the drug and include nausea, vomiting, dizziness, headaches, mental depression, confusion, and bone marrow depression (see Chronic subsection).
Treatment consists of gastric lavage and general supportive measures. Acidification of the urine will increase renal elimination of Urofar (Trimethoprim). Peritoneal dialysis is not effective and hemodialysis is only moderately effective in eliminating the drug.
Use of Urofar (Trimethoprim) at high doses and/or for extended periods of time may cause bone marrow depression manifested as thrombocytopenia, leukopenia, and/or megaloblastic anemia. If signs of bone marrow depression occur, Urofar (Trimethoprim) should be discontinued and the patient should be given leucovorin; 5 to 15 mg leucovorin daily has been recommended by some investigators.
The usual oral adult dosage is 100 mg of Urofar (Trimethoprim) every 12 hours or 200 mg of Urofar (Trimethoprim) every 24 hours, each for 10 days. The use of Urofar (Trimethoprim) in patients with a creatinine clearance of less than 15 mL/min is not recommended. For patients with a creatinine clearance of 15 to 30 mL/min, the dose should be 50 mg every 12 hours.
Urofar (Trimethoprim) tablets, USP, 100 mg: White, round, convex tablet, debossed “9”, scored, “3” on one side and debossed “21 58” on the other, in bottles of 100.
Store at 20° to 25°C (68° to 77°F).
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure (as required).
Manufactured In Canada By:
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
Rev. K 6/2016
Depending on the reaction of the Urofar after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Urofar 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 Urofar 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