Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects.
Discontinue the drug 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.
Serious adverse effects and limitations-of-use
- Both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system
- These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
- 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
- For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option
This medication contains Ciprolone. Do not take Cipro, Cipro XR, or ProQuin XR if you are allergic to Ciprolone or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Before taking this medicine
You should not use Ciprolone if you are allergic to it, or if:
you also take tizanidine; or
You also take theophylline
Ciprolone 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. This can happen during treatment or up to several months after you stop taking this medicine. Tendon problems may be more likely in certain people (children and older adults, or people who use steroid medicine or have had an organ transplant).
To make sure this medicine is safe for you, tell your doctor if you have ever had:
tendon problems, bone problems, arthritis, or other joint problems (especially in children);
blood circulation problems, aneurysm, narrowing or hardening of the arteries;
heart problems, high blood pressure;
a genetic disease such as Marfan syndrome or Ehler's-Danlos syndrome;
a muscle or nerve disorder, such as myasthenia gravis;
long QT syndrome (in you or a family member); or
low levels of potassium in your blood (hypokalemia).
Do not give this medicine to a child without medical advice.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.
You should not breast-feed while using this medicine.
Ciprolone side effects
Get emergency medical help if you have signs of an allergic reaction to Ciprolone (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).
Ciprolone can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).
Stop taking this medicine and call your doctor at once if you have:
low blood sugar - headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
nerve symptoms in your hands, arms, legs, or feet - numbness, weakness, tingling, burning pain;
serious mood or behavior changes - nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
signs of tendon rupture - sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).
In rare cases, Ciprolone may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.
Also, stop using this medicine and call your doctor at once if you have:
severe stomach pain, diarrhea that is watery or bloody;
fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
the first sign of any skin rash, no matter how mild;
muscle weakness, breathing problems;
little or no urination;
jaundice (yellowing of the skin or eyes); or
increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.
Common Ciprolone side effects may include:
nausea, vomiting, diarrhea, stomach pain;
vaginal itching or discharge;
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What special dietary instructions should I follow?
Do not drink or eat a lot of caffeine-containing products such as coffee, tea, energy drinks, cola, or chocolate. Ciprolone may increase nervousness, sleeplessness, heart pounding, and anxiety caused by caffeine.
Make sure you drink plenty of water or other fluids every day while you are taking Ciprolone.
How should I take Ciprolone?
Take Ciprolone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
You may take Ciprolone with or without food, at the same time each day.
Shake the oral suspension (liquid) for 15 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon). Do not give Ciprolone oral suspension through a feeding tube.
Swallow the extended-release tablet whole and do not crush, chew, or break it.
Use Ciprolone for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. This medicine will not treat a viral infection such as the flu or a common cold.
Do not share Ciprolone with another person.
Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze. Throw away any unused liquid after 14 days.
¿Cuál es la información más importante que debo saber sobre Ciprolone?
Usted no debe usar Ciprolone si usted también está tomando tizanidine.
Es posible que no pueda usar Ciprolone si usted tiene un trastorno muscular. Dígale a su médico si usted tiene un historial de miastenia grave.
Ciprolone puede causar hinchazón o ruptura de un tendón (la fibra que conecta un hueso con un músculo en el cuerpo), en particular el tendón de Aquiles en el talón del pie. Este efecto puede ocurrir con mayor probabilidad si usted es mayor de 60, si usted usa medicamento esteroide, o si ha tenido un trasplante de riñón, corazón, o pulmón.
Llame de inmediato a su médico su usted tiene dolor súbito, hinchazón, moretones, sensibilidad, rigidez, o problemas para mover cualquiera de sus articulaciones. Descanse la articulación hasta que reciba cuidado médico o instrucciones.
What should I avoid while giving Ciprolone to my pet?
Do not administer Ciprolone to pregnant pets, as it has detrimental effects on growing joints and bones. Do not give Ciprolone to pets younger than 1 year of age. It may also have a detrimental effect on growing large breed dogs as old as 2 years. Use with extreme caution on cats, especially those with pre-existing kidney failure. Use with caution in all pets with kidney disease, liver disease, central nervous system disorders, or epilepsy.