Proflaxin Uses

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• Proflaxin indications
• Uses of Proflaxin in details
• Proflaxin description
• Proflaxin dosage
• Proflaxin interactions
• Proflaxin side effects
• Proflaxin contraindications

What is Proflaxin?

Proflaxin is used to treat bacterial infections in many different parts of the body. Proflaxin oral liquid and tablets are also used to treat anthrax infection after inhalational exposure. Proflaxin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Proflaxin extended-release tablets are only used to treat urinary tract infections, including acute uncomplicated pyelonephritis.

Proquin® XR tablets are only used to treat uncomplicated or simple urinary tract infections (acute cystitis).

Proflaxin belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Proflaxin will not work for colds, flu, or other virus infections.

Proflaxin is available only with your doctor's prescription.

Proflaxin indications

Proflaxin Tablets, USP are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.

Urinary Tract Infections

Proflaxin Tablets, USP are indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus faecalis.

Acute Uncomplicated Cystitis

Proflaxin Tablets, USP are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

Chronic Bacterial Prostatitis

Proflaxin Tablets, USP are indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

Lower Respiratory Tract Infections

Proflaxin Tablets, USP are indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Also, Proflaxin Tablets, USP are indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis.

Acute Sinusitis

Proflaxin Tablets, USP are indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Skin and Skin Structure Infections

Proflaxin Tablets, USP are indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin­-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

Bone and Joint Infections

Proflaxin Tablets, USP are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

Complicated Intra-Abdominal Infections

Proflaxin Tablets, USP are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

Infectious Diarrhea

Proflaxin Tablets, USP are indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii†, Shigella dysenteriae, Shigella flexneri or Shigella sonnei† when antibacterial therapy is indicated.

†Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

Typhoid Fever (Enteric Fever)

Proflaxin Tablets, USP are indicated in adult patients for treatment of typhoid fever (enteric fever) caused by Salmonella typhi. The efficacy of Proflaxin in the eradication of the chronic typhoid carrier state has not been demonstrated.

Uncomplicated Cervical and Urethral Gonorrhea

Proflaxin Tablets, USP are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae.

Complicated Urinary Tract Infections and Pyelonephritis

Proflaxin Tablets, USP are indicated in pediatric patients one to 17 years of age for treatment of complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli.

Inhalational Anthrax (post-exposure)

Proflaxin Tablets, USP are indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Proflaxin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication.1 Supportive clinical information for Proflaxin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001.

Plague

Proflaxin Tablets, USP are indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. Efficacy studies ​of Proflaxin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only.

Limitation of Use

Use in Pediatric Patients

Although effective in clinical trials, Proflaxin is not a drug of first choice in the pediatric population due to an increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues. Proflaxin Tablets, USP, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals.

Lower Respiratory Tract Infections

Proflaxin Tablets, USP are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to Streptococcus pneumoniae.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Proflaxin Tablets, USP and other antibacterial drugs, Proflaxin 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.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to Proflaxin. Therapy with Proflaxin Tablets, USP may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Proflaxin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.

How should I use Proflaxin?

Use Proflaxin tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Proflaxin tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Proflaxin tablets refilled.
• Take Proflaxin tablets by mouth with or without food. The preferred dosing time is 2 hours after a meal.
• Swallow Proflaxin tablets whole with a full glass of water. Do not break, crush, or chew before swallowing. If you cannot swallow Proflaxin tablets whole, tell your doctor.
• Drinking extra fluids while you are taking Proflaxin tablets is recommended. Check with your doctor for instructions.
• If you also take any products containing magnesium, aluminum, calcium, iron, or zinc (eg, antacids, quinapril, vitamins/minerals); didanosine; sucralfate; or bismuth subsalicylate, do not take them within 6 hours before or 2 hours after taking Proflaxin tablets. Check with your doctor if you have questions.
• If you also take sevelamer, do not take it within 4 hours before or after taking Proflaxin tablets. Check with your doctor if you have questions.
• Proflaxin tablets works best if it is taken at the same time each day.
• To clear up your infection completely, take Proflaxin tablets for the full course of treatment. Keep taking it even if you feel better in a few days.
• Avoid taking Proflaxin tablets with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Proflaxin tablets as part of a full meal that contains milk or milk products is permitted.
• Do not miss any doses. If you miss a dose of Proflaxin tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Proflaxin tablets.

Uses of Proflaxin in details

Use: Labeled Indications

Children and Adolescents: Treatment of complicated urinary tract infections and pyelonephritis due to E. coli. Note: Although effective, Proflaxin is not the drug of first choice in children.

Infants, Children, Adolescents, and Adults: Prophylaxis to reduce incidence or progression of disease following inhalation exposure to Bacillus anthracis; prophylaxis and treatment of plague (Yersinia pestis).

Adults: Treatment of the following infections when caused by susceptible bacteria: Urinary tract infections; acute uncomplicated cystitis in females, chronic bacterial prostatitis, bone and joint infections, complicated intra-abdominal infections (in combination with metronidazole), infectious diarrhea, typhoid fever (Salmonella typhi), hospital-acquired (nosocomial) pneumonia.

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve Proflaxin for use in patients who have no alternative treatment options for acute uncomplicated cystitis.

Off Label Uses

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) expert panel meetings on prevention and treatment of anthrax, Proflaxin is an effective and recommended agent for treatment of cutaneous or systemic anthrax.

Bite wound infection (animal and human bites)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTIs), Proflaxin, in combination with an appropriate agent for anaerobes, is an effective and recommended alternative option for prophylaxis and treatment of human or animal bite wounds, particularly in patients who are hypersensitive to beta-lactams.

Cat scratch disease, lymphadenitis (nondisseminated)

Data from a limited number of patients suggest that Proflaxin may be beneficial for the treatment of cat scratch disease ).

Tularemia

Data from retrospective studies and case reports/series demonstrate varied results with the use of Proflaxin in the management of tularemia. Guidelines created by the Infectious Diseases Society of America, Working Group on Civilian Biodefense, and the European Commission's Task Force on Biological and Chemical Agent Threats (BICHAT) recommend Proflaxin as an alternative in the management of mild tularemia infection. In scenarios of mass casualty management and postexposure prophylaxis, the Working Group on Civilian Biodefense considers oral Proflaxin and doxycycline as drugs of choice.

Proflaxin description

Proflaxin: Each 250- and 500-mg tablet contains Ciprofloxacin HCl 250 mg and 500 mg, respectively.

Each 50-, 100- and 200-mL vial of infusion solution contains Ciprofloxacin lactate 100 mg, 200 mg and 400 mg, respectively.

Proflaxin tablet also contains microcrystalline cellulose, maize starch, crospovidone, anhydrous colloidal silica, magnesium stearate, hypromellose, macrogol 4000 and titanium dioxide (E171) while the infusion solution also contains lactic acid, sodium chloride, concentrated hydrochloric acid and water for injections.

Proflaxin XR: Each 500 mg tablet contains Ciprofloxacin HCl monohydrate 334.8 mg and Proflaxin hydrous 253 mg, corresponding to Proflaxin 500 mg. Each 1 g tablet contains Ciprofloxacin HCl monohydrate 669.4 mg and Proflaxin hydrate 506 mg, corresponding to Proflaxin 1000 mg.

Proflaxin XR also contains the following excipients: Crospovidone, magnesium stearate, anhydrous colloidal silica, succinic acid, hypromellose, macrogol 3350, titanium dioxide and purified water in bulk.

Proflaxin dosage

Proflaxin (Proflaxin hcl) 500 mg tablets should be administered orally once daily for 3 days with a main meal of the day, preferably the evening meal.

Proflaxin (Proflaxin hcl) tablets should be taken whole and never split, crushed, or chewed.

Proflaxin (Proflaxin hcl) should be administered at least 4 hours before or 2 hours after antacids containing magnesium or aluminum, sucralfate, VIDEX® (didanosine) chewable/buffered tablets or pediatric powder, metal cations such as iron, and multivitamin preparations containing zinc.

Concomitant administration of Proflaxin with milk products or calcium-fortified juices alone should be avoided since decreased absorption is possible.

Adequate hydration of patients receiving Proflaxin (Proflaxin hcl) should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria has been reported with quinolones.

How supplied

Dosage Forms And Strengths

Extended release tablets: 500 mg* of Proflaxin

*present as 582 mg of Proflaxin hydrochloride monohydrate

Storage And Handling

Proflaxin (Proflaxin hcl) is available as blue film-coated tablets containing 500 mg Proflaxin. The tablet is debossed with “500” on one side and “DMI” on the other side.

Store Proflaxin (Proflaxin hcl) at 25°C (77 °F); excursions permitted to 15-30 °C (59-86 °F).

Revised February 2011. Depomed, Inc. 1360 O'Brien Drive, Menlo Park, CA 94025-1436. 1-866-458-6389

Proflaxin interactions

See also:
What other drugs will affect Proflaxin?

Proflaxin may interfere with the clearance of drugs metabolized by the liver eg, theophylline and caffeine on account of the ability of Proflaxin to inhibit hepatic metabolism. In 1 study, seizures had developed after concomitant use of Proflaxin with theophylline.

Proflaxin is not recommended to be administered orally within 4 hrs of taking magnesium, aluminum or iron and zinc salts-containing antacids to prevent the reduction of absorption of Proflaxin as well as other fluoroquinolones. Sucralfate, which releases aluminum ions in the stomach, may reduce absorption of Proflaxin and other quinolones.

The possibility of interfering with the absorption of fluoroquinolones may be present in dairy products having high calcium content.

Although histamine H₂ antagonist affect the pharmacokinetics of Proflaxin, clinical effect is found insignificant.

Naproxen and chloroquine were found to cause adverse neurological effect with the addition of Proflaxin. Effect was reduced when the antirheumatic drugs were discontinued.

In surgical infection prophylaxis, concomitant administration of Proflaxin with opioid analgesics is not recommended as the peak serum concentration of Proflaxin is reduced significantly.

Cytotoxic chemotherapy was reported to reduce the absorption of Proflaxin. Enhanced nephrotoxicity was developed after concomitant use of the Proflaxin with cyclosporine.

Plasma concentration of midazolam increases when administered with Proflaxin.

Probenecid was found to reduce the urinary excretion of Proflaxin without increasing plasma concentration of the latter.

Interference with Laboratory Results: In elderly patients treated with Proflaxin for urinary tract infections, a false-positive reaction for urinary glucose (pseudoglycosuria) has been reported.

Proflaxin side effects

See also:
What are the possible side effects of Proflaxin?

Among the usual adverse effects of Proflaxin are gastrointestinal disturbances, CNS toxicity and hypersensitivity reactions.

Nausea, vomiting, diarrhea, abdominal pain and dyspepsia are experienced as common gastrointestinal disturbances. Reports of pseudomembranous colitis are seldom received. Headache, anorexia, flatulence, bilirubinemia, dizziness and restlessness are the most common CNS effects. Other CNS toxicity associated with the use of Proflaxin are tremor, drowsiness, insomnia, agitation, confusion, unpleasant dreams, visual disturbances and other sensory disturbances, hallucinations, depression and convulsions, eosinophilic meningitis, acute psychoses, peripheral neuropathy, dysesthesia, catatonia, hemisparesis and tinnitus.

Patients taking Proflaxin may also experience hypersensitivity reactions eg, rash, pruritus, photosensitivity, vasculitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, laryngeal edema and anaphylaxis (may be fatal). Reversible arthralgia and joint erosions were seen in animals. A case of tendon damage was also reported.

Reports of transient elevation of serum creatinine, blood urea nitrogen and liver enzyme values, acute renal failure secondary to interstitial nephritis, crystalluria, jaundice, moniliasis, asthenia, hepatitis, eosinophilia, leukopenia, thrombocytopenia, pancytopenia, hemolytic anemia or agranulocytosis, myalgia and gynecomastia were received. Tachycardia, edema syncope, hot flushes and sweating are among the cardiovascular effects of the use of Proflaxin.

Pseudomembranous colitis and superinfection with Candida, C. difficile and S. pneumoniae associated with the use of Proflaxin were reported. The risk of methicillin-resistant S. aureus and vancomycin-resistant enterococci colonization are high in patients taking Proflaxin.

Proflaxin contraindications

See also:
What is the most important information I should know about Proflaxin?

You should not use this medication if you are taking tizanidine (Zanaflex), if you have a history of myasthenia gravis, or if you are allergic to Proflaxin or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

Before taking Proflaxin, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, diabetes, muscle weakness or trouble breathing, a condition called pseudotumor cerebri, a history of seizures, a history of head injury or brain tumor, low levels of potassium in your blood, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.

Do not take Proflaxin with dairy products such as milk or yogurt, or with calcium-fortified juice.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 6 hours before or 2 hours after you take Proflaxin.

Proflaxin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. Stop taking Proflaxin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Active ingredient matches for Proflaxin:

Ciprofloxacin in Costa Rica, Dominican Republic, Nicaragua.

References

1. DailyMed. "CIPROFLOXACIN; DEXAMETHASONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "ciprofloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "ciprofloxacin". http://www.drugbank.ca/drugs/DB00537 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology