The Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) have issued a letter to the Office of the Inspector General (OIG) advising of the OIG to investigate the online purchase of Cipro for a “use in connection with a class of drugs”.
The agency also issued a “Notice of Alert” advising of the OIG to investigate the online sale of Cipro and the potential use of the drug for an “overuse” of another drug, including other antibiotics. The OIG is reviewing the online sale of Cipro for an increased risk of serious drug-induced liver injury.
In order to ensure the OIG’s investigation and to protect the public, we urge all interested parties to report any suspected adverse events to the OIG within 10 days of receipt of this notification.
About Cipro
Cipro is an antibiotic belonging to a group of medications known as fluoroquinolones. It is marketed under the brand names Cipro, Teva, and Lantus among others.
Cipro is a brand name for a type of antibiotics called tetracyclines.
This is the generic version of the antibiotic ciprofloxacin. Cipro can cause serious side effects, such as:
The OIG will continue to monitor Cipro’s safety and quality for further information and actions. Please contact us at, who can provide you with further information and additional information on the OIG.
About Health Care
The OIG has received the following communication from the Department of Health and Human Services (HHS):
The department is requesting that the OIG provide the following information on the use of Cipro for the following class of drugs:
-Cipro –This class of drugs is used to treat serious skin conditions that can lead to serious side effects such as rashes, itching, or other allergic reactions, such as anaphylaxis and skin reactions.
Tetracycline –This class of antibiotics is used to treat a wide range of infections caused by bacteria. Cipro can also be used to treat certain infections of the stomach, intestines, or throat (e.g., typhoid fever).
Methotrexate –Methotrexate is an antibiotic that has been used for decades to treat certain conditions. Cipro is also used to treat a range of infections and conditions such as:
Urinary tract infections –This antibiotic is used to treat infections caused by bacteria that can lead to serious complications including urinary tract infections, which are common in young adults.
Skin infections –This antibiotic is used to treat skin infections, such as acne or rosacea, caused by bacteria. Cipro is also used to treat infections caused by certain fungi.
Ciprofloxacin (ciprofloxacin HCl) is a broad-spectrum antibiotic belonging to the fluoroquinolone family. It has bactericidal activity against Gram-positive and Gram-negative bacteria. Ciprofloxacin is effective against many different types of bacteria including Haemophilus ducreyi, Campylobacter fetus, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Shigella (enterotoxigenic), Streptococcus pneumoniae, Haemophilus parainfluenzae, Haemophilus influenzae, Neisseria gonorrhoeae, and Legionella pneumophila.
The broad-spectrum activity of ciprofloxacin makes it an excellent choice for treating various bacterial infections. It is available in both liquid and solid form and is particularly effective against gram-positive and gram-negative bacteria.
Ciprofloxacin is effective against a wide range of Gram-positive and Gram-negative bacteria. It is particularly effective against susceptible strains of bacteria. The wide range of effectiveness makes it a valuable tool in treating infections caused by susceptible microorganisms.
It is also effective against certain sexually transmitted and inflammatory conditions. Ciprofloxacin has demonstrated good safety and effectiveness in treating conditions such as chlamydia, gonorrhea, chlamydial infection, and prostatitis.
Ciprofloxacin may also be used for purposes not listed in this medication guide.
Ciprofloxacin is effective against a variety of bacterial infections. It can help treat a variety of conditions such as urinary tract infections, sinusitis, ear infections, and pneumonia.
Ciprofloxacin works by blocking the DNA gyrase subunit A of bacteria. This enzyme is essential for bacterial growth and replication.
When a virus, bacteria, or yeast are infected with ciprofloxacin, it inhibits the enzyme that breaks down the DNA into harmless metabolites. This results in a decrease in bacterial growth and helps to maintain the infection in the body.
Ciprofloxacin also inhibits the action of the bacterial enzyme, thereby preventing the bacteria from multiplying and spreading.
Ciprofloxacin has been used effectively in treating a variety of bacterial infections due to its effectiveness in inhibiting bacterial growth.
The usual dosage for Ciprofloxacin is 1 capsule (75 mg) taken orally every 12 hours as needed for adults and children over 12 years old. The dosage may be adjusted based on the type of infection being treated.
Administration of Ciprofloxacin should be done in the form of a suspension and should be done under strict medical supervision.
The course of treatment is usually completed as scheduled and the patient should complete the entire course of antibiotics.
For a complete list of dosing instructions, please refer to the patient information leaflet included with this medication guide.
Ciprofloxacin is contraindicated in patients with a known hypersensitivity to ciprofloxacin, or any component of this medication.
Ciprofloxacin has been reported to have a possible adverse reaction with oral use, although it is not recommended for use in patients with a history of allergy to ciprofloxacin.
For more information on the use of Ciprofloxacin, please refer to the patient information leaflet included with this medication guide.
Ciprofloxacin is not recommended for use in patients with a known hypersensitivity or allergy to ciprofloxacin.
Patients with liver problems should be closely monitored for side effects of Ciprofloxacin.
Dosage and administration are important considerations for patients with a history of impaired kidney or liver function. For patients with a history of impaired kidney or liver function, the dosage and administration should be adjusted accordingly.
The following table summarizes the adverse drug reactions of Ciprofloxacin (Cipro) in patients receiving Ciprofloxacin (Cipro) and their incidence and the risk of adverse drug reactions. Patients with severe renal impairment were excluded from this study. Patients receiving Ciprofloxacin (Cipro) were generally younger and more prone to Cipro-associated adverse effects compared to patients who received standard Cipro.
The following adverse drug reactions were reported in the clinical studies:
The following adverse drug reactions were reported in the non-clinical studies:
For patients receiving Ciprofloxacin (Cipro), the following clinical studies were performed. In these clinical studies, the incidence and risk factors of adverse drug reactions for Ciprofloxacin (Cipro) were determined.
The following laboratory studies were reported in the clinical studies:
In vivo studies were performed on healthy volunteers. Patients were either given Cipro (Cipro®) orally once daily or Ciprofloxacin (Cipro®) orally once daily for a period of one week. The study periods were 1 week and 2 weeks, and the dose of Cipro was determined using an electronic test device (Dr. Schmid, St. Louis, Missouri, USA). The study was designed to assess the safety and efficacy of Cipro in patients with renal impairment.
In vivo studies were performed in healthy volunteers by administering the drug orally once daily for a period of one week.
In vitro studies were performed on healthy volunteers.
Ciprofloxacin (Cipro) is a prescription medicine for the treatment of bacterial infections of the respiratory tract. It belongs to a group of medicines called quinolones. It works by inhibiting the production of certain natural substances in bacteria. This prevents them from growing and multiplying and killing them. Ciprofloxacin is used to treat different types of infections of the urinary system, skin, soft tissues, and reproductive system of animals, including human males and females.
Ciprofloxacin is available in the form of tablets or a liquid suspension. The dose depends on the type of infection and your individual condition. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use the medicine exactly as directed. Do not take more or less medicine than prescribed by your doctor.
Common side effects of Ciprofloxacin (Cipro) are:
Serious side effects can occur from taking this medicine.
Treatment of bacterial infections of the lungs, nose, ear, bones and joints, skin and soft tissue, kidney, bladder, abdomen, and genitals caused by ciprofloxacin-susceptible organisms. Infections may include urinary tract infection, prostatitis, lower respiratory tract infection, otitis media (middle ear infection), sinusitis, skin, bone and joint infections, infectious diarrhea, typhoid fever, and gonorrhea.
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.
Hypersensitivity to ciprofloxacin or other quinolones. History or risk of QT prolongation; known history of myasthenia gravis. Concomitant use with tizanidine.
Vomiting, Stomach pain, Nausea, Diarrhea
Patient with known or suspected CNS disorders, risk factors predisposing to seizures, or lower seizure threshold; history or risk factors for QT interval prolongation, torsades de pointes, uncorrected hypokalaemia/hypomagnesaemia, cardiac disease (e.g. heart failure, MI, bradycardia); positive family history of aneurysm disease, pre-existing aortic aneurysm or dissection and its risk factors (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, hypertension, peripheral atherosclerotic vascular disease); diabetes, previous tendon disorder (e.g. rheumatoid arthritis), G6PD deficiency. Renal and hepatic impairment. Elderly, children. Pregnancy and lactation.
Store between 20-25°C.
Quinolones
uses tetracyclines with beta-lactamase inhibition and multidrug-resistant (BCR) beta-2-tet6-b12tetracycline-responsive mutation.Use only in pregnancy. Allergy (rheumatic disorders) only. Pregnancy. Interactions with other medications, for e.g. certain antiepileptic drugs, dapsiazid (e.g. chlorpropamide, amitriptyline), fluoroquinolones, macrolide antibiotics. Concerns regarding liver function. History or recent history of liver disease. Caution is advised if administering drug after meals. Pregnancy-related vaginal itching, burning, or discharge. Pregnancy-induced toxicity. Breastfeeding. Avoid contact with drug for 24 hours after the last dose. Warnings include severe renal impairment, stable hypertension, hepatic impairment, and possible hypertension. Avoid accidental ingestion. Contact your doctor if the patient does not recover fully after 48 hours or other apparent times. Concomitant use with BCR beta-2-Tetracycline-responsive mutation. Severe renal impairment, possible impairment of hemostasis, severe hepatic impairment. Avoid prolonged exposure to tizanidine. Animal studies. Avoid inbred development of tizanidine-dependent neoplasms. Contact your doctor. Warnings include severe renal impairment, possible impairment of hemostasis, liver dysfunction, possible impairment of renal blood flow, possible impairment of liver function, and possible impairment of renal blood circulation. Avoid use in patients who are pregnant or may become pregnant. Use with caution in patients with extreme hepatic impairment.
Stade de France Pharmacy