Quinsair -Levofloxacin uses, dose and side effects

Quinsair is used to treat lung infections caused by Pseudomonas aeruginosa in adults with cystic fibrosis. It is an antibacterial drug that is inhaled (inhaled) straight into the lungs where it kills the bacteria that cause infection. This helps to facilitate breathing in people with cystic fibrosis.

What you need to know before using Quinsair

Do not use Quinsair

if you are allergic to levofloxacin, to other quinolone antibiotics, e.g. moxifloxacin, ciprofloxacin or ofloxacin, or any of the other ingredients of this medicine (listed in section 6)
if you have or have had problems with your tendons ( inflammation of a tendon or a tendon rupture ) during treatment with other quinolone or fluoroquinolone antibiotics
if you have epilepsy
if you are pregnant or breastfeeding.

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone/quinolone medicines, including Quinsair if you have previously had any serious side effects from taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.

When you take this medicine

In rare cases, joint pain and swelling and inflammation or tendon rupture may occur. The risk increases if you are older (over 60 years), have undergone an organ transplant, have kidney problems, or if are being treated with cortisone ( corticosteroids ). Inflammation and tendon rupture can occur within the first 48 hours of treatment but also up to several months after the end of treatment with Quinsair. At the first sign of pain or inflammation in a tendon (for example, in the ankle, wrist, elbow, shoulder, or knee), stop taking Quinsair, consult a doctor and let the painful area rest. Avoid unnecessary effort as it may increase the risk of stretch marks.

Tell your doctor before taking Quinsair

if you have or have had any of the following:

Long-term, disabling, and possibly lasting serious side effectsAntibacterial fluoroquinolone/quinolone drugs, including Quinsair, have been linked to very rare but serious side effects. Some of these have been long-lasting (up to months or years), disabled, or possibly permanent. This includes pain in tendons, muscles, and joints in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), and sensory disorders in the form of impaired vision, taste, and smell and hearing, depression, memory loss, extreme fatigue, and severe sleep disorders. If you get any of these side effects after taking Quinsair, talk to your doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic.
Serious kidney problems
A severe allergic reaction. The symptoms are listed in section 4.
Serious skin reactions
If you are treated with Quinsair, you may experience serious skin reactions such as blisters or injuries. Tell your doctor if you notice any skin reactions after using Quinsair.
Liver problem. The symptoms are listed in section 4.
Abnormal heart rhythm
Quinsair can lead to changes in the heart rhythm, especially if you are taking medicines to treat heart problems or if you have low levels of potassium or magnesium in your blood. Women who take these types of drugs are more likely to be affected. If you experience palpitations or irregular heartbeat while using Quinsair, contact your doctor immediately.
Seizures and seizures
Quinolone antibiotics, including Quinsair, can cause seizures or seizures. If this happens, stop using Quinsair and contact a doctor immediately.
Depression or mental health problems
Nerve
damage In rare cases, you may experience symptoms of nerve damage ( neuropathy ) such as pain, a burning, and stinging sensation, numbness, and/or weakness, especially in the feet and legs or in the hands and arms. If this happens, stop taking Quinsair and contact a doctor immediately to prevent the development of a possible permanent condition.
A disease that leads to muscle weakness and fatigue is called myasthenia gravis.
Inflammation of a tendon that leads to pain, stiffness, and/or swelling in the joints (tendinitis).
If you have had difficulty breathing after taking Quinsair, the symptoms may be mild to severe ( bronchospasm )
Cough or blood-mixed mucus from the respiratory tract
Glucose ‑6 ‑ phosphate
dehydrogenase deficiency Quinolone antibiotics, such as Quinsair, can make patients with glucose ‑6 ‑ dehydrogenase deficiency (a rare hereditary disease) susceptible to blood complications leading to a sudden increase in body temperature, yellowing of the skin, dark skin and mucous membranes, fatigue, heavy and fast breathing and weak, fast pulse. Talk to your doctor if you have any questions about this.
Diabetes
Quinolone antibiotics, including Quinsair, can cause your blood sugar levels to become either too high or too low. If you have diabetes, you should monitor your blood sugar levels closely.
Diarrhea
You may get diarrhea during or after treatment with Quinsair. If it becomes difficult or persistent, or if you notice blood in the stool, stop taking Quinsair immediately and contact a doctor. Do not take any medicine to treat diarrhea without first talking to a doctor.
Antibiotic resistance Bacteria can eventually
become resistant to treatment with antibiotics. This means that Quinsair should not be used to prevent lung infections. It should only be used to treat lung infections caused by Pseudomonas aeruginosa. Talk to your doctor if you are worried or have any questions about this.
Superinfections
Sometimes long-term treatment with antibiotics can mean that you get another infection caused by other bacteria that are not affected by the antibiotic (superinfection). Talk to your doctor if you are worried or have any questions about this and using Quinsair.
Vision problems
If you notice changes in vision or other eye problems while using Quinsair, contact your doctor immediately.
Hypersensitivity of the skin to light
Quinsair may cause your skin to become more sensitive to sunlight. You should not be exposed to sunlight for long periods or too intense sunlight. Do not use tanning beds or other UV lamps while taking Quinsair and for 48 hours after stopping treatment.
False test results
Some tests (eg to confirm tuberculosis or the use of strong painkillers) may give false results during treatment with Quinsair.

if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel).
if you have had an aortic dissection (a rupture of the aortic wall).
if you have been diagnosed with leaky heart valves.
if someone in your family has or has had an aortic aneurysm, aortic dissection or congenital heart valve disease, or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome (an inflammatory autoimmune disease) or vascular diseases such as Takayasu’s arteritis, giant cell arteritis, Behçet’s disease, high blood pressure or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (an infection of the heart)).
If you experience sudden, severe pain in the abdomen, chest, or back, visit an emergency room immediately as this may be a symptom of aortic aneurysm and aortic dissection. The risk of developing this may be increased if you are being treated with systemic corticosteroids (“cortisone”).
if you experience sudden shortness of breath, especially when you lie down in bed, notice swelling in your ankles, feet, or stomach, or have a new heartbeat (feeling of rapid or irregular heartbeat), contact a doctor immediately.

Children and young people

Quinsair should not be given to children and adolescents under 18 years of age as there is insufficient information on use in this age group.

Other drugs and Quinsair

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. These medicines may affect the way Quinsair works.

Tell your doctor if you are taking any of the following medicines:

Vitamin K inhibitors such as warfarin (used to prevent blood clots). Taking these medicines with Quinsair may lead to an increased bleeding time. Your doctor may need to take blood samples regularly to check how well your blood is clotting.
Theophylline (used to treat respiratory problems) or non-steroidal anti-inflammatory drugs ( NSAIDs ) such as fenbufen, acetylsalicylic acid (a substance found in many medicines used to relieve pain and lower fever and prevent blood clots), or ibuprofen. Taking Quinsair while you are taking these medicines may increase the risk of having a seizure.
Medicines such as probenecid (used to prevent gout ) or cimetidine (used to treat stomach ulcers ). Taking Quinsair while you are taking these medicines may affect your kidneys’ way of handling medicines, which is especially important if you have kidney problems.
Ciclosporin (used after organ transplantation) or medicines that affect the heartbeat (such as antiarrhythmics , tricyclic antidepressants , macrolide antibiotics or antipsychotics). Quinsair may affect the effect of these medicines. The doctor can tell you more.

Pregnancy and breastfeeding

Quinsair must not be used during pregnancy or breast-feeding. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Quinsair may make you feel dizzy, tired, weak, or cause vision problems. If this happens to you, do not drive or use any tools or machines.

How to use Quinsair

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

How much should I use?

Inhale the contents of one ampoule (240 mg) twice daily with the Zirela nebulizer system. It takes about 5 minutes to inhale the medicine with the nebulizer.

When should I use it?

If you inhale Quinsair at the same time each day, it will be easier to remember when to take the medicine. Inhale the medicine as follows:

1 ampoule in the morning with Zirela nebulizer
1 ampoule in the evening with Zirela nebulizer

It should be as close to 12 hours between doses as possible.

How long should I use it?

You should use Quinsair every day for 28 days and then take a break of 28 days as you should not inhale Quinsair. Then you start with a new treatment regimen.

It is important that you continue to use the medicine twice every day for the 28 days of treatment and that you continue the treatment cycle with 28 days of treatment followed by a 28-day treatment break as long as your doctor tells you to.

Illustration of Quinsair's treatment cycle

If you experience breathing problems while using Quinsair, what additional medicines can your doctor prescribe?

If you experience difficulty breathing after using Quinsair, your doctor may prescribe an inhaler that contains a bronchodilator (dilates the trachea) (eg salbutamol ). Inhale this medicine for at least 15 minutes or up to 4 hours before the next dose of Quinsair.

What should I do if I use the different inhalers and other treatments for cystic fibrosis?

If you are using several different inhalation treatments and other treatments for cystic fibrosis, you should use the medicines in the following order:

Tracheal dilators
Dornan alfa
Techniques that keep the airways open
Quinsair
Inhalation cortisone

How to use it

Quinsair should be taken by inhalation with a Zirela hand nebulizer (including a Zirela aerosol head). This should be connected to either an ease controller or an eFlow rapid controller.

Important information before starting treatment

One ampoule is for single use only . Once an ampoule has been opened, the contents should be used immediately.
Do not use Quinsair if you notice that the sealed foil sachet or ampoules have been tampered with.
Do not use Quinsair if it is cloudy or if the solution contains particles.
Do not mix Quinsair with other medicines in the Zirela hand nebulizer.
No medicines other than Quinsair may be used in the Zirela hand nebulizer.
Do not try to inhale Quinsair with any other type of nebulizer .
Before starting treatment, check that the Zirela nebulizer system is working properly.
You must not swallow the liquid in ampoule one.

Carefully read the instructions for use that come with the Zirela hand nebulizer.

How do I prepare the nebuliser system for inhalation of the drug?

Keep the Zirela Instructions for Use in a safe place as they contain complete information on fitting the nebulizer.

1) Place the Zirela hand nebulizer on a flat and stable surface.

2) Squeeze all the contents of an ampoule into the medicine container on the Zirela hand nebulizer (Figure 1). Make sure you have emptied the entire ampoule one. If necessary, tap it gently against the medicine container.

3) Close the medicine container by aligning the tabs on the medicine lid with the grooves on the medicine container (a). Press down and turn the cover clockwise as far as it will go (Figure 2).

How do I use the Zirela nebulizer system?

1) When you start treatment, sit in a relaxed, upright position.

2) Hold the handset flat , press and hold the on / off button on the control unit for a few seconds. You will hear a “beep” and the status light will illuminate green.

3) After a few seconds, an aerosol vapor will start flowing to the aerosol chamber of the Zirela hand nebulizer. If the aerosol vapor does not start to flow, see the Zirela Instructions for Use.

4) Hold the handset flat, place the nozzle in your mouth and close your lips around it (Figure 3).

5) Breathe normally (in and out) through the mouthpiece. Do not breathe through the nose. Continue to inhale and exhale comfortably until the treatment is completed. It takes about 5 minutes to inhale the medicine with the nebulizer.

6) When all the medicine has been inhaled , two beeps are heard to indicate that the treatment has ended.

7) Open the lid of the medicine container when the treatment is over to check that you have used all the medicine. There may be a few drops in the bottom of the container when the treatment is completed. It is okay. If there are more than a few drops, replace the cap and repeat the treatment, from step 1.

8) When the treatment is completed , disconnect the control unit and disassemble the Zirela hand nebulizer for cleaning and disinfection. The user manual contains complete information on cleaning and disinfection.

What happens if I have to finish treatment before I finish?

If for any reason you have to end the treatment before you are finished, press and hold the on / off button on the control unit for one second. After it is completely turned off and when you are ready to start treatment again, press and hold the on / off button again for a second. The treatment starts again. You should inhale and exhale through the mouthpiece as before,

How and when do I replace the Zirela hand nebulizer?

A nebulizer is intended for use during a 28-day treatment regimen. See instructions for use for information on cleaning and storage.

If you use more Quinsair than you should

If you have used too much Quinsair, contact your doctor as soon as possible. You may experience symptoms such as irregular heartbeat, which must be examined by a doctor. If you swallow the contents of an ampoule , do not worry but consult a doctor as soon as possible.

If you forget to take Quinsair

If you miss a dose , take it as soon as you remember as long as there are 8 hours left before you take the next dose . However, if it is almost time for your next dose, skip the missed dose .

Do not inhale the contents of more than one ampoule to make up for a forgotten dose .

If you stop using Quinsair

Do not stop using Quinsair without talking to your doctor first as your lung infection may get worse.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious.

Seek emergency care immediately if you experience a severe allergic reaction after inhaling Quinsair. Symptoms include:

General itching and feeling of heat, which mainly affects the scalp, mouth, pharynx, palms and soles of the feet
Severe wheezing or wheezing or difficulty breathing
Severe hives
Swelling of the lips, face, throat, or tongue
Pale or grayish skin color
Fast heartbeat
Fainting

Stop using Quinsair and contact a doctor immediately:

if you experience pain, stiffness, and / or joint swelling
if you have liver problems. Symptoms include:
- Reduced appetite
- Yellow skin and eyes (jaundice)
- Dark-colored urine
- Itching
- Tenderness (pain) around the abdomen (abdomen)

Other side effects may include:

Very common: may affect more than 1 user in 10

Cough
Changed sense of taste
Fatigue, weakness, and low exertion tolerance
Reduced appetite
Shortness of breath
Changes in the amount and thickness of mucus
Bloody vomiting
Reduced amount of air that can be inhaled and exhaled in one second (decreased FEV ₁ ‑ test)

Common, may affect up to 1 in 10 users

Fungal infection around the vagina
Sleep problems or sleep problems
Headache
Dizziness
Ringing in the ears ( tinnitus )
Changes in the voice
Nausea and vomiting
Abdominal pain
Diarrhea
Constipation
Rash
Joint or muscle pain
Fever
Abnormal blood test results (increased levels of certain liver enzymes or bilirubin in the blood and impaired renal function on testing)
Impaired lung function during testing
Increase or decrease in the amount of sugar ( glucose ) in the blood
Deviating breathing sounds

Uncommon, may affect up to 1 in 100 people

Fungal infection in the oral cavity
The low number of red blood cells ( anemia ) or blood cells that help the blood clot ( platelets )
Low or high white blood cell count
Anxiety, restlessness, agitation, and/or depression
Decreased sense of smell
Somnolence
Altered vision
Hearing loss
Faster heartbeat
Difficulty breathing
Hulking
Indigestion
Gas formation
Hives and itching
Pain in the chest wall
Kidney failure
Altered heart rhythm
Pain, a burning sensation, tingling, numbness, and / or weakness in the arms and legs ( neuropathy )

The following side effects have also been reported after taking tablets or following an intravenous infusion containing levofloxacin, so they may occur after using Quinsair:

Uncommon: may affect up to 1 in 100 people

Feeling confused or nervous
Shaking
Dizziness, tingling sensation, or feeling of falling ( vertigo )
Heavy sweating

Rare: may affect up to 1 in 1,000 users

Hallucinations and/or paranoid feelings
Feeling anxious
Unusual dreams or nightmares
Seizures
Knitting and / or numbness
Palpitation
Low blood pressure
Muscle weakness
Syndrome linked to decreased water excretion and low sodium levels (SIADH)
Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities ( eosinophilia ), enlarged lymph nodes and effects on other body organs (drug reaction with eosinophilia and systemic symptoms)
Clearly demarcated, reddened spots with or without blisters

Has been reported (occurs in an unknown number of users)

Low number of all types of blood cells
Diabetic coma
Serious mental problems (which in rare cases can lead to self-harm)
Pain, a burning sensation, tingling, numbness, and / or weakness in the arms and legs ( neuropathy )
Involuntary muscle movements, twitches, or spasms
Fainting
Severe throbbing headache with vision loss
Temporary vision loss
Fast or abnormal heartbeat
Pneumonia
Severe skin reactions such as painful blistering or possible sores in the mouth, nose, or vagina
Increased sensitivity of the skin to sunlight or UV light (solarium or UV lamps)
Inflammation of blood vessels
Inflammation of the mouth or lips
Rapid breakdown of muscles
Inflammation of a tendon or an injured tendon
Pain including pain in the back, chest, arms and legs.

Very rare cases of long-term (up to several months or years) or lasting side effects, such as tendinitis, tendonitis, joint pain, pain in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, a burning sensation, depression, Fatigue, sleep disturbances, impaired memory and impaired hearing, vision, taste and smell have been linked to treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of enlargement and weakening of an aortic wall or rupture of an aortic wall ( aneurysms and dissections), which can rupture and be life-threatening, as well as cases of leaking heart valves, have been reported in patients receiving fluoroquinolones. See also section 2.

How to store Quinsair

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the ampoule , foil sachet and cartons after EXP. The expiration date is the last day of the specified month.

One ampoule is for single use only. Once an ampoule has been opened, the contents should be used immediately. All unused products must be discarded. Put all unused, unopened ampoules back from the card in the sachet to protect it from light.

Store in the original package. Sensitive to light. No special temperature instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the package and other information

Content declaration

The active substance is levofloxacin. One ampoule contains levofloxacin hemihydrate equivalent to 240 mg levofloxacin.
The other ingredients are magnesium chloride hexahydrate and water for injections.

What the medicine looks like and the contents of the pack

Quinsair is a clear, light yellow nebulizer solution .

The drug is supplied in small ampoules of 3 ml. Four ampoules are sealed in a foil sachet bag. Quinsair is supplied as a 28-day pack (containing a carton of 56 (14 sachets with 4) ampoules ) or as a 4-day pack (containing 8 (2 sachets with 4) ampoules ) and a carton with a Zirela hand nebulizer and manufacturer’s instructions.

Not all pack sizes may be marketed.

Ampoule one is only marked in English. The information on ampoule one is:

On the front of the “ampoule tail”

Quinsair 240 mg

Solution for nebulizer

levofloxacin

For inhalation 2.4 ml

Embossing on the “shrink part” on both sides of the “ampoule tail”

Lot

EXP

Marketing Authorisation Holder

Chiesi Farmaceutici SpA

Via Palermo, 26 / A

43122 Parma

Italy

Manufacturer

Adare Pharmaceuticals Srl

Via Martin Luther King, 13

20060 Pessano con Bornago (MI)