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What is Ciprofloxacin Alphapharm?
Ciprofloxacin Alphapharm is used to treat bacterial infections in many different parts of the body. Ciprofloxacin Alphapharm oral liquid and tablets are also used to treat anthrax infection after inhalational exposure. Ciprofloxacin Alphapharm may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.
Ciprofloxacin Alphapharm 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).
Ciprofloxacin Alphapharm belongs to the class of drugs known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Ciprofloxacin Alphapharm will not work for colds, flu, or other virus infections.
Ciprofloxacin Alphapharm is available only with your doctor's prescription.
Ciprofloxacin Alphapharm indications
Ciprofloxacin Alphapharm is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below.
Uncomplicated Urinary Tract Infections (Acute Cystitis)
Ciprofloxacin Alphapharm is indicated for the treatment of uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis, Enterococcus faecalis, or Staphylococcus saprophyticus.
Because fluoroquinolones, including Ciprofloxacin Alphapharm, have been associated with serious adverse reactions and for some patients uncomplicated UTI (acute cystitis) is self-limiting, reserve Ciprofloxacin Alphapharm for treatment of uncomplicated UTIs (acute cystitis) in patients who have no alternative treatment options.
Complicated Urinary Tract Infections, And Acute Uncomplicated Pyelonephritis
Ciprofloxacin Alphapharm is indicated for the treatment of complicated urinary tract infections (cUTI) caused by Escherichia coli, Klebsiella pneumoniae, Enterococcus faecalis, Proteus mirabilis, or Pseudomonas aeruginosa and acute uncomplicated pyelonephritis (AUP) caused by Escherichia coli.
Limitations Of Use
- The safety and efficacy of Ciprofloxacin Alphapharm in treating infections other than urinary tract infections has not been demonstrated.
- Ciprofloxacin Alphapharm is not indicated for pediatric patients.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Alphapharm and other antibacterial drugs, Ciprofloxacin Alphapharm should be used only to treat 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.
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 Ciprofloxacin Alphapharm. Therapy with Ciprofloxacin Alphapharm 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 Ciprofloxacin Alphapharm. 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 Ciprofloxacin Alphapharm?
Use Ciprofloxacin Alphapharm suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Ciprofloxacin Alphapharm suspension comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ciprofloxacin Alphapharm suspension refilled.
- An extra patient leaflet may be available with Ciprofloxacin Alphapharm suspension. Talk to your pharmacist if you have questions about this information.
- Take Ciprofloxacin Alphapharm suspension by mouth with or without food. The preferred dosing time is 2 hours after a meal.
- Shake well before each use.
- Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
- Take Ciprofloxacin Alphapharm suspension with a full glass of water (8 oz [240 mL]).
- Drinking extra fluids while you are taking Ciprofloxacin Alphapharm suspension 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 Ciprofloxacin Alphapharm suspension. Check with your doctor if you have questions.
- If you also take sevelamer, do not take it within 4 hours before or after taking Ciprofloxacin Alphapharm suspension. Check with your doctor if you have questions.
- Ciprofloxacin Alphapharm suspension works best if it is taken at the same time each day.
- To clear up your infection completely, take Ciprofloxacin Alphapharm suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
- Avoid taking Ciprofloxacin Alphapharm suspension with milk or milk products (eg, calcium-enriched juice, yogurt) by themselves. However, taking Ciprofloxacin Alphapharm suspension 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 Ciprofloxacin Alphapharm suspension, 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 Ciprofloxacin Alphapharm suspension.
Uses of Ciprofloxacin Alphapharm in details
Ciprofloxacin Alphapharm is used to treat wide range of bacterial infections including lung or respiratory tract infections, eye infection, bladder and kidney infections, reproductive tract infections, skin and soft tissue infections and bone and joint infections.
Ciprofloxacin Alphapharm description
Ciprofloxacin Alphapharm: 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.
Ciprofloxacin Alphapharm 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.
Ciprofloxacin Alphapharm XR: Each 500 mg tablet contains Ciprofloxacin HCl monohydrate 334.8 mg and Ciprofloxacin Alphapharm hydrous 253 mg, corresponding to Ciprofloxacin Alphapharm 500 mg. Each 1 g tablet contains Ciprofloxacin HCl monohydrate 669.4 mg and Ciprofloxacin Alphapharm hydrate 506 mg, corresponding to Ciprofloxacin Alphapharm 1000 mg.
Ciprofloxacin Alphapharm XR also contains the following excipients: Crospovidone, magnesium stearate, anhydrous colloidal silica, succinic acid, hypromellose, macrogol 3350, titanium dioxide and purified water in bulk.
Ciprofloxacin Alphapharm dosage
Dosage and Important Administration Instructions
- Ciprofloxacin Alphapharm is for intratympanic administration only.
- Ciprofloxacin Alphapharm is intended for single-patient use, discard unused portion.
- Administer Ciprofloxacin Alphapharm as a single intratympanic administration of one 0.1 mL (6 mg) dose into each affected ear, following suctioning of middle ear effusion.
Preparation of Ciprofloxacin Alphapharm
Directions for Ciprofloxacin Alphapharm dose preparation and handling is illustrated in Figure 1 below.
Figure 1: Directions for Ciprofloxacin Alphapharm Dose Preparation
|STEP 1 Preparation |
1 vial of Ciprofloxacin Alphapharm (enough for 2 doses); Two 1mL luer lock syringers;
Two 18G-21G preparation needles; Two 20-24G, 2-3 inch blunt, flexible administration needles; Alcohol pads; Optional: ice pack and drape to keep Ciprofloxacin Alphapharm vial cold
Keep product cold during preparation. If Ciprofloxacin Alphapharm thickens during
preparation, place the vial back in refrigeration.
|STEP 2 Ciprofloxacin Alphapharm Mixing |
To keep the vial cold during shaking, hold the Ciprofloxacin Alphapharm vial by the
aluminium seal to prevent gelation. Shake the vial for 5 to 8 seconds to
mix well until a visually homogenous suspension is obtained.
Always hold the vial by the aluminium seal to prevent gelation.
|STEP 3 Ciprofloxacin Alphapharm Removal |
Using an 18-21G needle, withdraw 0.3 mL of the suspension into the 1 mL
|STEP 4 Replace with the Aldministration Needle |
Replace the needle with a 20-24G, 2-3 inch blunt, flexible needle to be used for administration.
|STEP 5 Priming the Syringe |
Prime the needle leaving a dose of 0.1 ml (0.1 cc).
|STEP 6 Preparing Second Dose for Bilateral Administartion Only |
Repeat Steps 3, 4, and 5 using the same vial to prepare a second syringe
for the other ear and dispose of the vial.
Use a different syringe for each ear.
After preparation, syringes can be kept at room temperature or in the
refrigerator prior to administration.
Keep syringes on their side.
Discard syringes if not administered in 3 hours.
Ciprofloxacin Alphapharm interactions
As with some other quinolones, concurrent administration of Ciprofloxacin Alphapharm with theophylline may lead to elevated serum concentrations of theophylline, which may result in an increased risk of a patient developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, serum concentrations of theophylline should be monitored and dosage adjustments made as appropriate.
Antacids and Other Products Containing Multivalent Cations
Concurrent administration of quinolones, including Ciprofloxacin Alphapharm, with multivalent cation-containing products such as magnesium or aluminum antacids, sucralfate, VIDEX® chewable/buffered tablets or pediatric powder, or products containing calcium, iron, or zinc may substantially decrease the absorption of Ciprofloxacin Alphapharm. Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) should be given either 2 hours after or at least 4 hours before these products. This time window is different than for other oral formulations of Ciprofloxacin Alphapharm, which are usually administered 2 hours before or 6 hours after antacids.
Concomitant administration of Ciprofloxacin Alphapharm with milk products or calcium-fortified juices alone should be avoided since decreased absorption of Ciprofloxacin Alphapharm is possible.
Quinolones, including Ciprofloxacin Alphapharm, have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be monitored if Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) is administered concomitantly with warfarin or other oral anticoagulants. Patients should also be monitored for evidence of bleeding.
Some quinolones, including Ciprofloxacin Alphapharm, have been associated with transient elevations in serum creatinine in patients receiving cyclosporine concomitantly. Cyclosporine whole blood trough concentrations should be monitored when given concomitantly with Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl).
Renal tubular transport of methotrexate may be inhibited by concomitant administration of Ciprofloxacin Alphapharm, potentially leading to increased plasma concentrations of methotrexate. This might increase the risk of methotrexate toxic reactions. Therefore, patients under methotrexate therapy should be carefully monitored when concomitant Ciprofloxacin Alphapharm therapy is indicated.
Altered serum concentrations of phenytoin (increased and decreased) have been reported in patients receiving concomitant Ciprofloxacin Alphapharm. Phenytoin serum concentrations should be monitored when given concomitantly with Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl).
The concomitant administration of Ciprofloxacin Alphapharm with the sulfonylurea glyburide has, on rare occasions, resulted in severe hypoglycemia.
Non-steroidal Anti-inflammatory Drugs (NSAIDs), but not Aspirin
NSAIDs in combination with very high doses of quinolones have been shown to provoke convulsions in nonclinical studies [see Nonclinical Toxicology.
Some quinolones, including Ciprofloxacin Alphapharm, have been shown to interfere with the metabolism of caffeine. This may lead to reduced clearance of caffeine and prolongation of the serum half-life of caffeine.
Probenecid interferes with renal tubular secretion of Ciprofloxacin Alphapharm and produces increased concentrations of Ciprofloxacin Alphapharm in serum.
Ciprofloxacin Alphapharm side effects
Serious and Otherwise Important Adverse Reactions
The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:
- Tendon Effects
- Hypersensitivity Reactions
- Other Serious and Sometimes Fatal Reactions
- Central Nervous System Effects
- Clostridium difficile-Associated Diarrhea
- Peripheral Neuropathy
- Development of Drug Resistant Bacteria
Crystalluria and cylindruria have been reported with quinolones, including Ciprofloxacin Alphapharm. Therefore, adequate hydration of patients receiving Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) should be maintained to prevent the formation of highly concentrated urine.
Clinical Trial Experience
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.
The data described below reflect exposure to Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) in 524 patients in one clinical trial. The population studied had a mean age of 39 years (approximately 93.4% of the population were < 65 years of age), 100% were female, 77% were Caucasian and 7.4% were Black. Patients received Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) 500 mg once daily for 3 days. Patients were followed for approximately 5 weeks after the end of study drug dosing.
Discontinuation of Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) occurred in 1.4% of patients. Each of the discontinuations were for a different adverse reactions. Refer to Table 1.
The most common adverse reactions ( ≥ 2%) were fungal infection, nasopharyngitis, headache, and micturition urgency.
Table 1: Adverse reactions (regardless of relationship to study drug) occurring in ≥ 1% of Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) -treated patients (500 mg once daily for 3 days) during the entire study period compared to Ciprofloxacin Alphapharm-immediate release tablets (250 mg twice daily for 3 days)
|Adverse Reaction||Ciprofloxacin Alphapharm||Ciprofloxacin Alphapharm-immediate release tablets|
|Urinary tract infection||10.8||9.8|
|Upper respiratory tract infection||1.4||2.9|
The incidence of adverse events (regardless of relationship to study drug) reported for at least 1% of patients treated with Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) during study drug treatment and up to 3 days after study drug was headache (1.5%).
Less common reactions, occurring at any time during the study in less than 1% of Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl) -treated patients were:
- Cardiac Disorders: ventricular bigeminy.
- Immune System Disorders: hypersensitivity.
- Gastrointestinal Disorders: abdominal pain, nausea, diarrhea, dyspepsia, aggravated irritable bowel syndrome, lower abdominal pain, vomiting.
- General Disorders: suprapubic pain, fatigue, pain, rigors, tenderness.
- Infections and Infestations: urinary tract infection, fungal vaginosis, bacterial vaginitis, vaginal candidiasis, vaginal infection, vaginitis.
- Investigations: blood bilirubin increased, alanine aminotransferase increased, abdominal aortic bruit, aspartate aminotransferase increased, body temperature increased.
- Musculoskeletal and Connective Tissue Disorders: joint swelling, muscle spasms, night cramps.
- Nervous System Disorders: headache, dizziness, disturbance in attention, paresthesia.
- Renal and Urinary Disorders: micturition urgency, dysuria, urinary frequency, abnormal urine odor, hematuria.
- Reproductive System and Breast Disorders: female genital pruritus.
- Respiratory, Thoracic, and Mediastinal Disorders: dyspnea.
- Skin/Subcutaneous Tissue Disorders: rash, photosensitivity/ phototoxicity reaction, pruritus, urticaria.
Adverse Reactions Reported with Other Systemic Formulations of Ciprofloxacin Alphapharm
In addition, to the adverse reactions reported with Ciprofloxacin Alphapharm (Ciprofloxacin Alphapharm hcl), the following adverse reactions have been reported during clinical trials and from worldwide post-marketing experience with other systemic formulations of Ciprofloxacin Alphapharm (includes all dosages and indications).
Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or a causal relationship to drug exposure. Abnormal gait, achiness, acidosis, agitation, agranulocytosis, allergic reactions (ranging from urticaria to anaphylactic reactions), amylase increase, anemia, angina pectoris, angioedema, anosmia, anxiety, arrhythmia, arthralgia, ataxia, atrial flutter, bleeding diathesis, blurred vision, bronchospasm, C. difficile associated diarrhea, candidiasis (cutaneous, oral), candiduria, cardiac murmur, cardiopulmonary arrest, cardiovascular collapse, cerebral thrombosis, chills, cholestatic jaundice, chromatopsia, confusion, convulsion, delirium, depression, diplopia, drowsiness, dysphagia, dyspnea, edema (conjunctivae, face, hands, laryngeal, lips, lower extremities, neck, pulmonary), epistaxis, erythema multiforme, erythema nodosum, exfoliative dermatitis, fever, fixed eruptions, flushing, gastrointestinal bleeding, gout (flare up), grand mal convulsion, gynecomastia, hallucinations, hearing loss, hematuria, hemolytic anemia, hemoptysis, hemorrhagic cystitis, hepatic failure (including fatal cases), hepatic necrosis, hepatitis, hiccup, hyperesthesia, hyperpigmentation, hypertension, hypertonia, hypoesthesia, hypotension, ileus, insomnia, interstitial nephritis, intestinal perforation, jaundice, joint stiffness, lethargy, lightheadedness, lipase increase, lymphadenopathy, malaise, manic reaction, marrow depression, migraine, moniliasis (oral, gastrointestinal, vaginal), mouth dryness, myalgia, myasthenia, myasthenia gravis (possible exacerbation), myocardial infarction, myoclonus, nephritis, nightmares, nystagmus, oral ulceration, pain (arm, back, breast, chest, epigastric, eye, extremities, foot, jaw, neck, oral mucosa), palpitation, pancreatitis, pancytopenia, paranoia, paresthesia, peripheral neuropathy, perspiration (increased), petechia, phlebitis, phobia, photosensitivity/phototoxicity reaction pleural effusion, polyuria, postural hypotension, prothrombin time prolongation, pseudomembranous colitis (the onset of symptoms may occur during or after antimicrobial treatment), pulmonary embolism, purpura, renal calculi, renal failure, respiratory arrest, respiratory distress, restlessness, serum sickness-like reaction, Stevens-Johnson syndrome, sweating, syncope, tachycardia, taste loss, tendonitis, tendon rupture, tinnitus, torsade de pointes, toxic epidermal necrolysis, toxic psychosis, tremor, twitching, unresponsiveness, urethral bleeding, urinary retention, urination (frequent), vaginal pruritus, vasculitis, ventricular ectopy, vesicles, visual acuity (decreased), visual disturbances (flashing lights, change in color perception, overbrightness of lights), weakness.
The following adverse laboratory changes, in alphabetical order, regardless of incidence or relationship to drug, have been reported in patients given Ciprofloxacin Alphapharm (includes all formulations, all dosages, all drug-therapy durations, and all indications):
Decreases in blood glucose, BUN, hematocrit, hemoglobin, leukocyte counts, platelet counts, prothrombin time, serum albumin, serum potassium, total serum protein, uric acid.
Increases in alkaline phosphatase, ALT (SGPT), AST (SGOT), atypical lymphocyte counts, blood glucose, blood monocytes, BUN, cholesterol, eosinophils counts, LDH, platelet counts, prothrombin time, sedimentation rate, serum amylase, serum bilirubin, serum calcium, serum cholesterol, serum creatinine phosphokinase, serum creatinine, serum gamma-glutamyl transpeptidase (GGT), serum potassium, serum theophylline (in patients receiving theophylline concomitantly), serum triglycerides, uric acid.
Others: albuminuria, change in serum phenytoin, crystalluria, cylindruria, immature WBCs, leukocytosis, methemaglobinemia, pancytopenia.
Ciprofloxacin Alphapharm contraindications
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 Ciprofloxacin Alphapharm or similar antibiotics such as gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.
Before taking Ciprofloxacin Alphapharm, 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 Ciprofloxacin Alphapharm 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 Ciprofloxacin Alphapharm.
Ciprofloxacin Alphapharm 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 Ciprofloxacin Alphapharm 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 Ciprofloxacin Alphapharm:
Ciprofloxacin in Australia.
- 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).
- PubChem. "ciprofloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ciprofloxacin". http://www.drugbank.ca/drugs/DB00537 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology