Cipro A Powder for Suspension

Cipro A Powder for Suspension is used for: Skin and Skin Structure Infections, Bone and Joint Infections, Complicated Intra-Abdominal Infections, Infectious Diarrhea, Typhoid Fever (Enteric Fever), Nosocomial Pneumonia, Empirical Therapy for Febrile Neutropenic Patients, Uncomplicated Cervical and Urethral Gonorrhea, Inhalational Anthrax, Plague, Chronic Bacterial Prostatitis, Lower Respiratory Tract Infections, Acute Exacerbation of Chronic Bronchitis, Urinary Tract Infections, Acute Uncomplicated Cystitis, Complicated UTI, Acute Pyelonephritis, Acute Sinusitis, Diabetic foot infection, Fistulating Crohn’s disease, Acute diverticulitis, Acute prostatitis, Meningococcal meningitis, Superficial ophthalmic infections, Otitis externa, Surgical prophylaxis

Oral Adult Dose: For oral dosage & suspension: Urinary Tract infection: Acute uncomplicated: 250 mg twice daily for 3 days; Mild/Moderate: 250 mg twice daily for 7 to 14 days; Severe/Complicated: 500 mg twice daily for 7 to 14 days; Chronic Bacterial Prostatitis: 500 mg twice daily for 28 days; Lower Respiratory Tract Infection: Mild/Moderate: 500 mg twice daily for 7 to 14 days, Severe/Complicated: 750 mg twice daily for 7 to 14 days; Acute Sinusitis : 500 mg twice daily for 10 days; Skin and Skin Structure Infection: Mild/Moderate: 500 mg twice daily for 7 to 14 days, Severe/Complicated: 750 mg twice daily for 7 to 14 days, Bone and joint infection: Mild/Moderate 500 mg twice daily for 4 to 8 weeks, Severe/Complicated: 750 mg twice daily for 4 to 8 weeks, Intra-Abdominal Infection: 500 mg twice daily for 7 to 14 days, Infectious Diarrhea: Mild/Moderate/Severe: 500 mg twice daily for 5 to 7 days, Typhoid Fever: 500 mg twice daily for 10 days, Urethral & Cervical Gonococcal Infections: Uncomplicated: 250 mg Single dose. Anthrax Infection Postexposure therapy Inhalation (prophylaxis/postexposure): 500 mg twice daily for 60 days Cutaneous: 500 mg twice daily for 60 days Plague Indications for treatment and prophylaxis of plague due to Yersinia pestis 500-750 mg twice daily for 14 days Ciprofloxacin extended release: PO Adults 500–1,000 mg once daily. For IV infusion: Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days; Lower Respiratory Tract Infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days; Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days; Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days; Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6 weeks; Intra-abdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days; Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days: Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days. Anthrax Infection Postexposure therapy Inhalation (prophylaxis/postexposure): 400 mg IV twice daily for 60 days Cutaneous: 400 mg IV twice daily for 60 days Plague Indications for treatment and prophylaxis of plague due to Yersinia pestis 400 mg IV 8-12 hourly for 14 days

Child Dose: Oral 20–40 mg/kg/day, max 1.5 g/day twice daily. Complicated UTI and Pyelonephritis (1 to 17 years of age) 10–20 mg/kg (maximum 750 mg per dose) twice daily, 10–21 days Inhalational Anthrax (Post-Exposure) 15 mg/kg (maximum 500 mg per dose) twice daily, 60 days Plague 15 mg/kg (maximum 500 mg per dose) every 8 to 12 hours for 14 days For IV infusion: 20–30 mg/kg/day, max 1.2 g/day twice daily. Children and adolescents: RTI & GI infections: Neonate-15mg/kg twice daily, Child (1 month - 18 years)-20mg/kg (max 750 mg) twice daily; UTI: Neonate-10 mg/kg twice daily, Child (1 month - 18 years)-10mg/kg (max 750 mg) twice daily; Pseudomonal lower respiratory tract infection in cystic fibrosis: Child (1 month - 18 years) - 20mg/kg (max 750 mg) twice daily; Anthrax (treatment & post-exposure prophylaxis): Child (1 month - 18 years) - 20mg/kg (max 750 mg) twice daily. Oral Suspension: 250 mg ciprofloxacin per 5 mL after reconstitution Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) and Plague 9 kg to 12 kg: ½ teaspoonfuls (2.5 mL) 125 mg 13 kg to 18 kg: 1 teaspoonful (5 mL) 250 mg 19 kg to 24 kg: 1 to 1 ½ teaspoonful(s) (5 mL to 7.5 mL) 250 mg to 375 mg 25 kg to 31 kg: 1 ½ to 2 teaspoonfuls (7.5 mL to 10 mL) 375 mg to 500 mg 32 kg to 37 kg: 1 ½ to 2 ½ teaspoonful’s (7.5 mL to 12.5 mL) 375 mg to 625 mg 38 kg or more: 2 to 3 teaspoonful’s (10 mL to 15 mL) 500 mg to 750 mg

Renal impairment CrCl >50 mL/min Dose adjustment not necessary CrCl 30-50 mL/min Immediate-release: 250-500 mg PO q12hr Extended-release: 1 g PO q24hr Intravenous: 400 mg IV q8-12hr CrCl 5-29 mL/min Immediate-release: 250-500 mg PO q18hr Extended-release: 500 mg PO q24hr Intravenous: 200-400 mg IV q12-24hr Hemodialysis or peritoneal dialysis Administer after dialysis Immediate-release: 250-500 mg PO q24hr Extended-release: 500 mg PO q24hr Intravenous: 200-400 mg IV q24hr

May be taken with or without food. May be taken w/ meals to minimise GI discomfort. Do not take w/ antacids, Fe or dairy products. IV Administration Infuse 1-2 mg/mL (diluted in D5W or NS) into large vein over 60 minutes

Hypersensitivity. Not to be used concurrently with tizanidine. Avoid exposure to strong sunlight or sun lamps during treatment.

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and central nervous system (CNS) effects Discontinue treatment immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of Ciprofloxacin. Discontinue Ciprofloxacin at the first sign of skin rash, jaundice or any sign of hypersensitivity. Clostridioides difficile-associated diarrhea: Evaluate if colitis occurs. QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval.

Pregnancy Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes Oral administration during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations; these doses were up to 0.3, 0.6, and 0.4 times the maximum recommended clinical oral dose in mice, rats, and rabbits, respectively, based on body surface area Lactation Published literature reports that ciprofloxacin is present in human milk following intravenous and oral administration; there is no information regarding effects on milk production or breastfed infant; because of potential risk of serious adverse reactions in breastfed infants, including arthropathy shown in juvenile animal studies For most indications a lactating woman may consider pumping and discarding breast milk during treatment and an additional two days (five half-lives) after last dose; alternatively, advise a woman that breastfeeding is not recommended during treatment and for an additional two days (five half-lives) after last dose However, for inhalation anthrax (post-exposure), during an incident resulting in exposure to anthrax, the risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on Ciprofloxacin may be acceptable The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition Ciprofloxacin may cause intestinal flora alteration of breastfeeding infant; advise a woman to monitor breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash)

May increase plasma concentrations of CYP1A2 substrates (e.g. clozapine, ropinirole, theophylline). Enhances effect of oral anticoagulants (e.g. warfarin) and glibenclamide. Increased toxicity of methotrexate. Plasma concentrations may be increased by probenecid. Reduced absorption w/ oral multivitamins and mineral supplements containing divalent or trivalent cations (e.g. Fe, Zn, Ca) and antacids containing Al, Ca or Mg. Concomitant use w/ class IA antiarrhythmics (e.g. quinidine, procainamide), class III antiarrhythmics (e.g. amiodarone, sotalol), TCAs, macrolides and antipsychotics may result in additive effects on QT interval prolongation. Concurrent use w/ corticosteroids may increase risk of severe tendon disorders. Increased risk of CNS stimulation w/ NSAIDs. Altered serum concentrations of phenytoin. Potentially Fatal: Marked elevation in serum levels of tizanidine which is associated w/ potentiated hypotensive and sedative effect. Contraindicated (2) fezolinetant flibanserin

Side effects of Ciprofloxacin : >10% Pediatric Gastrointestinal (15%) 1-10% Adults Nausea (2.5%) Diarrhea (1.6%) Liver function tests abnormal (1.3%) Vomiting (1%) Rash (1%) Pediatric Diarrhea (4.8%) Vomiting (4.8%) Abdominal pain (3.3%) Neurologic (ie, dizziness, nervousness, insomnia, somnolence) (3%) Dyspepsia (2.7%) Nausea (2.7%) Fever (2.1%) Asthma (1.8%) Rash (1.8%) <1% Body as a whole Headache Abdominal pain/discomfort Pain Cardiovascular Syncope Angina pectoris Myocardial infarction Cardiopulmonary arrest Tachycardia Hypotension Central nervous system Restlessness Dizziness Insomnia Nightmares Hallucinations Paranoia Psychosis (toxic) Manic reaction Irritability Tremor Ataxia Seizures (including status epilepticus) Malaise Anorexia Phobia Depersonalization Depression (potentially culminating in self-injurious behavior [eg, suicidal ideations/thoughts and attempted or completed suicide]) Paresthesia Abnormal gait Migraine Gastrointestinal Intestinal perforation Gastrointestinal bleeding Cholestatic jaundice Hepatitis Pancreatitis Hemic/lymphatic Petechia Metabolic/nutritional Hyperglycemia Hypoglycemia Musculoskeletal Arthralgia Joint Stiffness Muscle Weakness Renal/urogenital Interstitial nephritis Renal failure Respiratory Dyspnea Laryngeal edema Hemoptysis Bronchospasm Skin/hypersensitivity Anaphylactic Reactions including life-threatening anaphylactic shock Erythema multiforme/Stevens-Johnson Syndrome Exfoliative dermatitis Toxic epidermal necrolysis Pruritus Urticaria Photosensitivity/phototoxicity reaction Flushing Fever Angioedema Erythema nodosum Sweating Special senses Blurred vision Disturbed vision (chromatopsia and photopsia) Decreased visual acuity Diplopia Tinnitus Hearing loss Bad taste Potentially Fatal: Anaphylactoid reaction; cardiopulmonary arrest.

Ciprofloxacin promotes breakage of double-stranded DNA in susceptible organisms and inhibits DNA gyrase, which is essential in reproduction of bacterial DNA.

Cipro A 250mg/5ml Powder for Suspension manufactured by Acme Laboratories Ltd.. Its generic name is Ciprofloxacin. Cipro A is availble in Bangladesh. Farmaco BD drug index information on Cipro A Powder for Suspension is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.