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Quinox
Ciprofloxacin Tablets
Composition:
Quinox 250: Each film coated tablet contains Ciprofloxacin
Hydrochloride equivalent to Ciprofloxacin 250 mg.
Quinox 500: Each film coated tablet contains Ciprofloxacin
Hydrochloride equivalent to Ciprofloxacin 500 mg.
Excipients: Microcrystalline cellulose, starch, crospovidone,
silicon dioxide, magnesium stearate, hydroxypropyl
methylcellulose, polyethylene glycol and titanium dioxide
(E171).
Quinox 750: Each film coated tablet contains Ciprofloxacin
Hydrochloride equivalent to Ciprofloxacin 750 mg.
Excipients:
Croscarmellose
sodium,
povidone,
microcrystalline cellulose, colloidal silicon dioxide,
magnesium stearate, hydroxypropyl methylcellulose,
polyethylene glycol, simethicone and titanium dioxide
(E171).
Properties:
Quinox is a trade name of Ciprofloxacin tablet which is an
active substance from the group of quinolones. It has broad
spectrum of
anti-bacterial activity against many
gram-negative and gram-positive bacteria. Ciprofloxacin
acts intracellularly by inhibiting DNA gyrase which is needed
for the synthesis of bacterial DNA.
Ciprofloxacin is also effective against bacteria which is
resistant to other antibiotics like aminoglycosides, penicillins,
cephalosporins and tetracyclines.
Absorption: Oral: Rapid (~50% to 85%).
Distribution: Vd: 2.1-2.7 L/Kg; tissue concentrations often
exceed serum concentrations especially in kidneys, gall
bladder, liver, lungs, gynecological tissue, and prostatic
tissues; CSF concentrations: 10% of serum concentrations
(noninflamed meninges), 14% to 37% (inflamed meninges);
crosses placenta; enters breast milk. Protein binding: 20%
to 40%.
Metabolism: Partially hepatic; forms 4 metabolites (limited
activity).
Half life elimination: Children: 2.5 hours; Adults: Normal
renal function: 3-5 hours. Time to peak: Oral: 0.5-2 hours.
Excretion: Urine (30% to 50% as unchanged drug); feces
(15% to 40%).
Indications:
Quinox is used for the treatment of infections caused by
susceptible organisms causing:
- Lower respiratory tract infections (not for pneumococcal
pneumonia).
- Infection of skin and skin structure.
- Bone and joint infection.
- Urinary tract infection.
- Gonorrhea.
- Infectious diarrhea.
- Infections of gastrointestinal system (including typhoid
fever).
Contraindications:
Quinox is contraindicated in patients with known history of
hypersensitivity to Ciprofloxacin or to any of its components.
If an allergic reaction occurs (itching, urticaria, dyspnea,
facial edema, loss of consciousness) discontinue drug
immediately.
Precautions:
Quinox should be used cautiously in patients with history of
convulsions, psychosis, increased intracranial pressure and
renal diseases. Also caution should be taken in elderly
patients.
Fluroquinolone (Quinox) should be used with caution in
patients with myasthenia gravis.
Tell your doctor if you:
- Have ever had kidney problems because your treatment
may need to be adjusted.
- Suffer from epilepsy or other neurological conditions.
- Have a history of tendon problems during previous
treatment with antibiotics such as ciprofloxacin.
- Have myasthenia gravis (a type of muscle weakness).
- Have a history of abnormal heart rhythms (arrythmias).
Interactions with other drugs:
Concomitant administration of Ciprofloxacin with aluminium,
magnesium or calcium containing antacids, zinc salts,
iron-containing preparations, sucralfate and dairy products
can interfere with its oral absorption, resulting in decreased
serum levels.
Metabolism of beta blockers might be reduced when
combined with Ciprofloxacin. An increase in serum
concentration of phenytoin might occur when it is combined
with Ciprofloxacin.
Ciprofloxacin might prolong prothrombin time and increase
the risk of bleeding when combined with warfarin.
Ciprofloxacin increases plasma theophylline concentration.
The risk of convulsions is increased when combined with
NSAID and Foscarnet.
The risk of nephrotoxicity is increased when combined with
cyclosporin.
Probenecid decreases renal excretion of Ciprofloxacin.
Tell your doctor if you are taking:
- Oral anti-coagulant (other than warfarin).
- Methotrexate (for certain types of cancer, psoriasis,
rheumatoid arthritis).
- Clozapine (an antipsychotic).
- Ropinirole (for Parkinson’s disease).
Do not take ciprofloxacin together with tizanidine,
because this may cause side effects such as low blood
pressure and sleepiness.
Any calcium you take as part of a meal will not seriously
affect uptake. However, do not take ciprofloxacin tablets with
dairy products such as milk or yoghurt or with fortified fruit
juices (e.g. calcium-fortified orange juice).
Ciprofloxacin may increase the levels of the following
medicines in your blood:
- Pentoxifylline (for circulatory disorders).
- Caffeine.
Overdosage:
In case of overdosage stomach should be emptied by
inducing emesis or by gastric lavage. General supportive
treatment with maintenance of adequate hydration is
indicated. Peritoneal dialysis or hemodialysis may be
helpful, particularly if patient's renal function is
compromised.
Side Effects:
Like all medicines, Quinox can cause side effects, although
not everybody gets them.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, tell your doctor or
pharmacist.
Common side effects (between 1 and 10 in every 100
people are likely to get these):
- Nausea, diarrhea.
- Joint pains in children.
Uncommon side effects (between 1 and 10 in every
1,000 people are likely to get these):
- Fungal superinfections.
- A high concentration of eosinophils, a type of white blood
cell.
- Loss of appetite (anorexia).
- Hyperactivity or agitation.
- Headache, dizziness, sleeping problems, or taste
disorders.
- Vomiting, abdominal pain, digestive problems such as
stomach upset (indigestion/heartburn), or wind.
- Increased amounts of certain substances in the blood
(transaminases and/or bilirubin).
- Rash, itching, or hives.
- Joint pain in adults.
- Poor kidney function.
- Pains in your muscles and bones, feeling unwell
(asthenia), or fever.
- Increase in blood alkaline phosphatase (a certain
substance in the blood).
Rare side effects (between 1 and 10 in every 10,000
people are likely to get these):
- Inflammation of the bowel (colitis) linked to antibiotic use
(can be fatal in very rare cases).
- Changes to the blood count (leukopenia, leukocytosis,
neutropenia, anaemia), increased or decreased amounts of
a blood clotting factor (thrombocytes).
- Allergic reaction, swelling (edema), or rapid swelling of the
skin and mucous membranes (angio-edema).
- Increased blood sugar (hyperglycaemia).
- Confusion, disorientation, anxiety reactions, strange
dreams, depression, or hallucinations.
- Pins and needles, unusual sensitivity to stimuli of the
senses, decreased skin sensitivity, tremors, seizures, or
giddiness.
- Eyesight problems.
- Tinnitus, loss of hearing, impaired hearing.
- Rapid heartbeat (tachycardia).
- Expansion of blood vessels (vasodilation), low blood
pressure, or fainting.
- Shortness of breath, including asthmatic symptoms.
- Liver disorders, jaundice (cholestatic icterus), or hepatitis.
- Sensitivity to light.
- Muscle pain, inflammation of the joints, increased muscle
tone, or cramp.
- Kidney failure, blood or crystals in the urine, urinary tract
inflammation.
- Fluid retention or excessive sweating.
- Abnormal levels of a clotting factor (prothrombin) or
increased levels of the enzyme amylase.
Very rare side effects (less than 1 in every 10,000 people
are likely to get these):
- A special type of reduced red blood cell count (haemolytic
anaemia); a dangerous drop in a type of white blood cells
(agranulocytosis ); a drop in the number of red and white
blood cells and platelets (pancytopenia), which may be
fatal; and bone marrow depression, which may also be
fatal.
- Severe allergic reactions (anaphylactic reaction or
anaphylactic shock, which can be fatal - serum sickness).
- Mental disturbances (psychotic reactions).
- Migraine, disturbed coordination, unsteady walk (gait
disturbance), disorder of sense of smell (olfactory
disorders), pressure on the brain (intracranial pressure).
- Visual colour distortions .
- Inflammation of the wall of the blood vessels (vasculitis).
- Pancreatitis.
- Death of liver cells (liver necrosis) very rarely leading to
life-threatening liver failure.
- Small, pin-point bleeding under the skin (petechiae);
various skin eruptions or rashes (for example, the
potentially fatal Stevens-Johnson syndrome or toxic
epidermal necrolysis).
- Muscle weakness, tendon inflammation, tendon rupture –
especially of the large tendon at the back of the ankle
(Achilles tendon); exacerbation of symptoms of myasthenia
gravis.
Frequency not known (cannot be estimated from the
available data)
- Troubles associated with the nervous system such as pain,
burning, tingling, numbness and/or weakness in
extremities.
- Severe cardiac rhythm abnormalities, irregular heart beat
(Torsades de Pointes).
Pharmaceutical Precautions:
Store below 30ºC.
Do not use beyond the expiry date or if the product shows
any sign of deterioration.
Presentations:
Quinox 250: Pack of 10 Film Coated Tablets.
Quinox 500: Pack of 10 Film Coated Tablets.
Quinox 750: Pack of 10 Film Coated Tablets.
Hospital packs are available.
Warnings:
Dosage and Administration:
Respiratory-tract infections: 250-750 mg twice daily.
Urinary-tract infections: 250-500 mg twice daily.
Gonorrhea: 250-500 mg as a single dose.
Most other infections: 500-750 mg twice daily.
Surgical prophylaxis: 750 mg 60-90 minutes before
procedure.
is a trademark.
THIS IS A MEDICAMENT
- Medicament is a product which affects your health and its
consumption contrary to instructions is dangerous for you.
- Strictly follow the doctor’s prescription, the method of use and the
instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits
and risks.
- Do not by yourself interrupt the period of treatment prescribed for
you.
- Do not repeat the same prescription without consulting your doctor.
Keep medicament out of reach of children.
Council of Arab Health Ministers & Union of Arab Pharmacists.
May 2012
44000/R10
CNS stimulation may occur (tremor, restlessness, confusion,
and very rare hallucinations or seizures). Use with caution in
patients with known or suspected CNS disorders. Prolonged
use may result in superinfection. Tendon inflammation
and/or rupture have been reported with Ciprofloxacin and
other quinolone antibiotics, Risk may be increased with
concurrent corticosteroids, particularly in the elderly.
Discontinue at first sign of tendon inflammation or pain.
Adverse effects, including those related to joints and/or
surrounding tissues, are increased in pediatric patients.
Rare cases of peripheral neuropathy may occur.
Pregnancy risk C: not recommended unless benefits
outweighs risk only for short duration.
Lactation: not recommended.
Driving and using machines: Ciprofloxacin may make you
feel less alert. Some neurological adverse events can occur.
Therefore, make sure you know how you react to
ciprofloxacin before driving a vehicle or operating
machinery. If in doubt, talk to your doctor.
Fluroquinolone (Quinox) should be used with caution in
patients with myasthenia gravis.
Manufactured by:
TABUK PHARMACEUTICAL MANUFACTURING COMPANY,
P.O. Box 3633, TABUK-SAUDI ARABIA.