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Saturday, June 14, 2014

moxifloxacin (Avelox)

DRUG DESCRIPTION

AVELOX (moxifloxacin) hydrochloride is a synthetic broad spectrum antibacterial agent for oral and intravenous administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow crystalline substance with a molecular weight of 437.9. Its empirical formula is C21H24FN3O4*HCl and its chemical structure is as follows:
AVELOX (moxifloxacin) Structural Formula Illustration

AVELOX Tablets

  • AVELOX Tablets are available as film-coated tablets containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).
  • The inactive ingredients are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and ferric oxide.

AVELOX IV

  • AVELOX IV is available in ready-to-use 250 mL latex-free flexibags as a sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from 4.1 to 4.6.
  • The appearance of the intravenous solution is yellow. The color does not affect, nor is it indicative of, product stability.
  • The inactive ingredients are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric acid and/or sodium hydroxide for pH adjustment.
  • AVELOX IV contains approximately 34.2 mEq (787 mg) of sodium in 250 mL.

What are the possible side effects of moxifloxacin (Avelox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using moxifloxacin and call your doctor at once if you have a serious side effect such as:
  • severe dizziness, fainting, fast or pounding heartbeats;
  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, insomnia or nightmares, unusual...

What are the precautions when taking moxifloxacin hcl (Avelox)?

See also Warning section.
Before taking moxifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, levofloxacin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart problems (such as recent heart attack), joint/tendon problems (such as tendonitis, bursitis), liver disease, myasthenia gravis, nerve problems (such as peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (such as brain/head injury, brain tumors, cerebral...

Levofloxacin

Levofloxacin is used to treat certain infections such as pneumonia, chronic bronchitis and sinus, urinary tract, kidney, prostate (a male reproductive gland), and skin infections. Levofloxacin is also used to prevent anthrax (a serious infection that may be spread on purpose as part of a bioterror attack) in people who may have been exposed to anthrax germs in the air. Levofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics will not work for colds, flu, or other viral infections.

How should this medicine be used?

Levofloxacin comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day. The length of your treatment depends on the type of infection you have. Your doctor will tell you how long to take levofloxacin. The tablet may be taken with or without food. The solution should be taken 1 hour before or 2 hours after eating. Take levofloxacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take levofloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
You should begin to feel better during the first few days of treatment with levofloxacin. If your symptoms do not improve or if they get worse, call your doctor.
Take levofloxacin until you finish the prescription, even if you feel better. Do not stop taking levofloxacin without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING or SIDE EFFECTS sections. If you stop taking levofloxacin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Other uses for this medicine


Levofloxacin is also sometimes used to treat endocarditis (infection of the heart lining and valves), certain sexually transmitted diseases, and tuberculosis (TB). Levofloxacin is also sometimes used to prevent or treat traveler's diarrhea and plague (a serious infection that may be spread on purpose as part of a bioterror attack). Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?


Before taking levofloxacin,

  • tell your doctor and pharmacist if you are allergic or have had a severe reaction to levofloxacin; any other quinolone or fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the U.S.), gemifloxacin (Factive), lomefloxacin (Maxaquin) (not available in the U.S.), moxifloxacin (Avelox), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), and sparfloxacin (Zagam) (not available in the U.S.): or any other medications, or if you are allergic to any of the ingredients in levofloxacin tablets or solution. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); certain antidepressants; antipsychotics (medications to treat mental illness); cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills'); insulin; oral medications for diabetes such as glyburide (DiaBeta, in Glucovance, Micronase, others); certain medications for irregular heartbeat such as amiodarone (Cordarone), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin, others) and naproxen (Aleve, Naprosyn, others); tacrolimus (Prograf); or theophylline (Elixophyllin, Theo-24, Uniphyl, others). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • if you are taking antacids containing aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, Tums, others), didanosine (Videx), sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc, take these medications 2 hours before or after you take levofloxacin.
  • tell your doctor if you or anyone in your family has or has ever had a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death) or an irregular heartbeat, and if you have or have ever had nerve problems; a low level of potassium in your blood; a slow heartbeat; cerebral arteriosclerosis (narrowing of blood vessels in or near the brain that can lead to stroke or mini-stroke); seizures; chest pain; or liver disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking levofloxacin, call your doctor.
  • you should know that levofloxacin may cause confusion, dizziness, lightheadedness, and tiredness. Do not drive a car, operate machinery, or participate in activities requiring alertness or coordination until you know how this medication affects you.
  • plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing, sunglasses, and sunscreen. Levofloxacin may make your skin sensitive to sunlight or ultraviolet light. If your skin becomes reddened, swollen, or blistered, like a bad sunburn, call your doctor.

What special dietary instructions should I follow?


Make sure you drink plenty of water or other fluids every day while you are taking levofloxacin.

What should I do if I forget a dose?


Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?


Levofloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • diarrhea
  • stomach pain
  • constipation
  • heartburn
  • headache
  • vaginal itching and/or discharge

Some side effects can be serious. If you experience any of these symptoms call your doctor immediately, but do not stop taking levofloxacin without talking to your doctor:

  • severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
  • dizziness
  • confusion
  • nervousness
  • restlessness
  • anxiety
  • not trusting others or feeling that others want to hurt you
  • difficulty falling asleep or staying asleep
  • nightmares or abnormal dreams
  • hallucinations (seeing things or hearing voices that do not exist)
  • depression
  • thoughts about dying or killing yourself
  • uncontrollable shaking of a part of the body

If you experience any of the following symptoms, or the symptoms of tendinitis or tendon rupture described in the IMPORTANT WARNING section, stop taking levofloxacin and call your doctor immediately or get emergency medical help:

  • rash
  • hives
  • itching
  • peeling or blistering of the skin
  • fever
  • swelling of the eyes, face, mouth. lips, tongue, throat, hands, feet, ankles or lower legs
  • hoarseness
  • difficulty breathing or swallowing
  • fast heartbeat
  • fainting
  • loss of consciousness
  • yellowing of the skin or eyes
  • dark urine
  • decreased urination
  • seizures
  • unusual bruising or bleeding
  • joint or muscle pain
Levofloxacin may cause problems with bones, joints, and tissues around joints in children. Levofloxacin should not normally be given to children younger than 18 years of age unless they have been exposed to anthrax in the air. If your doctor prescribes levofloxacin for your child, be sure to tell the doctor if your child has or has ever had joint-related problems. Call your doctor if your child develops joint problems, such as pain or swelling, while taking levofloxacin or after treatment with levofloxacin.
Levofloxacin may cause nerve damage that may not go away even after you stop taking levofloxacin. This damage may occur soon after you begin taking levofloxacin. If you experience any of the following symptoms, call your doctor immediately: numbness, tingling, pain, or burning in the arms or legs; or a change in your ability to feel light touch, pain, heat, or cold. If you experience these symptoms, do not take any more levofloxacin until you talk to your doctor. Your doctor may prescribe a different antibiotic for you to take instead of levofloxacin.
Talk to your doctor about the risks of taking levofloxacin or giving levofloxacin to your child.
Levofloxacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online

What should I know about storage and disposal of this medication?


Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose


In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?


Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to levofloxacin.
Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking levofloxacin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish taking levofloxacin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names

       Leflox
      
  • Levaquin®

Klaricid (clarithromycin)

What is it used for?

  • Bacterial infections of the lungs (chest or lower respiratory tract infections), eg bronchitis, pneumonia.
  • Bacterial infections of the nasal passages, sinuses or throat (upper respiratory tract infections) eg sinusitis, pharyngitis.
  • Bacterial infections of the skin or soft tissue, eg cellulitis, folliculitis or erysipelas.
  • Bacterial infections of the middle ear (otitis media).
  • Lyme disease.
  • Eradicating Helicobacter pylori bacteria from the gut in people with peptic ulcers.

How do I take it?

  • The dose of this medicine and how long it needs to be taken for depends on the type of infection you have and your age. Follow the instructions given by your doctor. These will be printed on the dispensing label that your pharmacist has put on the packet of medicine.
  • Clarithromycin is usually taken twice a day (every 12 hours). It can be taken either with or without food.
  • Klaricid adult sachets contain granules that should be mixed with a small amount of water before taking.
  • Bottles of Klaricid paediatric suspension should be shaken before measuring out a dose. Only use the measuring spoon provided with the suspension. You should not use a regular teaspoon or tablespoon to take the medicine, as this will not give an accurate dose.
  • Unless your doctor tells you otherwise, it is important that you finish the prescribed course of this antibiotic medicine, even if you feel better or it seems the infection has cleared up. Stopping the course early increases the chance that the infection will come back and that the bacteria will grow resistant to the antibiotic.

Warning!

  • Broad-spectrum antibiotics can sometimes cause inflammation of the bowel (colitis). For this reason, if you get diarrhoea that becomes severe or persistent or contains blood or mucus, either during or after taking this medicine, you should consult your doctor immediately.
  • All antibiotics can sometimes result in overgrowth of organisms that are not susceptible to the antibiotic, in particular fungi. You should let your doctor know if you think you have developed any other infections while you are taking this medicine, so that they can be treated appropriately.
  • Klaricid paediatric suspension can be stored at room temperature (below 30°C). Any suspension remaining after 14 days should be disposed of, preferably by returning it to your pharmacist.

Use with caution in

  • Decreased kidney function.
  • Decreased liver function.
  • People with an abnormal heart rhythm seen on a heart monitoring trace (ECG) as a 'prolonged QT interval', or people at risk of this (your doctor will know).

Not to be used in

  • People allergic to other macrolide-type antibiotics, eg erythromycin, azithromycin.
  • People taking astemizole, cisapride, pimozide, terfenadine or ergot derivatives, eg ergotamine, dihydroergotamine.
  • Klaricid tablets and adult sachets are not suitable for children under 12 years of age.
  • Klaricid adult sachets and Klaricid paediatric suspensions contain sucrose and are not suitable for people with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
  • The safety of this medicine during pregnancy has not been established. It should not be used in pregnant women unless the expected benefit to the mother is greater than any possible risk to the developing baby. Seek medical advice from your doctor.
  • This medicine passes into breast milk, but the effect on the nursing infant is unknown. It should not be used in breastfeeding women unless the expected benefit to the mother is greater than any possible risk to the nursing infant. Seek medical advice from your doctor.

Label warnings

  • Take at regular intervals. Complete the prescribed course unless otherwise directed.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
  • Disturbances of the gut such as diarrhoea, nausea, vomiting, indigestion, abdominal pain.
  • Sore mouth or tongue.
  • Tongue or tooth discolouration.
  • Oral thrush (see warning section above).
  • Pins and needles sensations.
  • Headache.
  • Pain in the muscles or joints.
  • Disturbance of taste or smell.
  • Allergic skin reactions.
  • Dizziness.
  • Spinning sensation (vertigo).
  • Difficulty sleeping or bad dreams.
  • Confusion.
  • Reversible loss of hearing.
  • Inflammation of the large intestine (colitis) - see warning section above.
  • Low blood sugar (hypoglycaemia).
  • Liver or kidney disorders.
  • Abnormal heart beats (arrhythmias).
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
Clarithromycin should not be taken by people who are taking any of the following medicines, because clarithromycin can raise the blood levels of these medicines, resulting in an increased risk of serious side effects:
  • astemizole
  • cisapride
  • dronedarone
  • eletriptan
  • eplerenone
  • ergot derivatives, eg ergotamine, dihydroergotamine or methysergide (used to treat migraine)
  • everolimus
  • ivabradine
  • mizolastine
  • pimozide
  • ranolazine
  • saquinavir
  • simvastatin
  • terfenadine.
Clarithromycin may reduce the breakdown of the medicines listed below. If the blood levels of these medicines are raised as a result, it may lead to an increased risk of their side effects. If you are taking one of these medicines and are prescribed clarithromycin you should let your doctor or pharmacist know if you experience any new or increased side effects:
  • alprazolam
  • aprepitant
  • bromocriptine
  • cabergoline
  • carbamazepine
  • ciclosporin
  • cilostazol
  • colchicine
  • digoxin
  • disopyramide
  • droperidol
  • etravirine
  • fesoterodine
  • itraconazole
  • maraviroc
  • methylprednisolone and possibly other corticosteroids
  • midazolam
  • nilotinib
  • pazopanib
  • phenytoin
  • quetiapine
  • reboxetine
  • repaglinide
  • rifabutin (increased risk of uveitis)
  • sildenafil
  • sirolimus
  • tacrolimus
  • tadalafil
  • theophylline
  • tolterodine
  • triazolam
  • vardenafil
  • verapamil
  • zopiclone.
Clarithromycin may also increase the blood levels and hence anti-blood-clotting effects of the anticoagulants nicoumalone and warfarin. As this may increase the risk of bleeding, people taking these combinations, particularly elderly people, may need more frequent monitoring of their blood clotting time (INR) so the dose of anticoagulant can be adjusted if necessary.
Clarithromycin may also increase the blood levels of cholesterol-lowering medicines called statins, eg atorvastatin and simvastatin. This may increase the risk of side effects on the muscles (myopathy) from these medicines. Combined use of simvastatin and clarithromycin should be avoided.
Clarithromycin may decrease the absorption of zidovudine from the gut. If you are taking both these medicines the clarithromycin should be taken at least two hours before or after the zidovudine to avoid the interaction. Ask your pharmacist for further advice.
There may be an increased risk of abnormal heart beats if clarithromycin is taken in combination with any of the following medicines:
  • anti-arrhythmic medicines (for an irregular heartbeat), eg amiodarone, disopyramide, quinidine
  • certain antimalarials, eg chloroquine, quinine, mefloquine, halofantrine
  • certain antipsychotics, eg chlorpromazine, thioridazine, fluphenazine, haloperidol.
Oral typhoid vaccine (Vivotif) should not be taken until at least three days after you have finished a course of this antibiotic, because the antibiotic could make this vaccine less effective.
In the past, women using hormonal contraception such as the pill or patch would be advised to use an extra method of contraception (eg condoms) while taking an antibiotic like this one and for seven days after finishing the course. However, this advice has now changed. You no longer need to use an extra method of contraception with the pill, patch or vaginal ring while you take a course of antibiotics. This change in advice comes because to date there is no evidence to prove that antibiotics (other than rifampicin or rifabutin) affect these contraceptives. This is the latest guidance from the Faculty of Sexual & Reproductive Healthcare.
However, if you are taking the contraceptive pill and experience vomiting or diarrhoea as a result of taking this antibiotic, you should follow the instructions for vomiting and diarrhoea described in the leaflet provided with your pills.
Ritonavir may increase the blood level of clarithromycin. This is not normally a problem, but if you have kidney problems and are taking ritonavir your doctor may prescribe you a lower than normal dose of clarithromycin.