Products

CLARITHROMYCIN 500

Uses For clarithromycin

Clarithromycin is used to treat bacterial infections in many different parts of the body. It works by killing bacteria or preventing their growth. It is also used to treat and prevent Mycobacterium avium complex (MAC) infection, and to treat duodenal ulcers caused by Helicobacter pylori. However, clarithromycin will not work for colds, flu, or other virus infections. Clarithromycin also may be used for other problems as determined by your doctor.

Clarithromycin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, clarithromycin is used in certain patients with the following medical condition:

Legionnaires' disease

Before Using clarithromycin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For clarithromycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to clarithromycin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on clarithromycin have not been done in children up to 6 months of age. In effective doses, the medicine has not been shown to cause different side effects or problems in children over the age of 6 months than it does in adults.

Geriatric

clarithromycin has been tested in a limited number of elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using clarithromycin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Astemizole
Bepridil
Cisapride
Conivaptan
Dihydroergotamine
Dronedarone
Eplerenone
Ergoloid Mesylates
Ergonovine
Ergotamine
Levomethadyl
Mesoridazine
Methylergonovine
Methysergide
Pimozide
Ranolazine
Silodosin
Terfenadine
Thioridazine
Tolvaptan
Ziprasidone

Using clarithromycin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide
Ajmaline
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Aprepitant
Aprindine
Arsenic Trioxide
Atazanavir
Atorvastatin
Azimilide
Bretylium
Chloral Hydrate
Chloroquine
Chlorpromazine
Colchicine
Dasatinib
Desipramine
Dibenzepin
Digoxin
Disopyramide
Dofetilide
Dolasetron
Doxepin
Droperidol
Enflurane
Erythromycin
Etravirine
Everolimus
Fentanyl
Flecainide
Fluconazole
Fluoxetine
Fluticasone
Foscarnet
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydroquinidine
Ibutilide
Iloperidone
Imipramine
Isoflurane
Isradipine
Ixabepilone
Lapatinib
Lidoflazine
Lorcainide
Lovastatin
Mefloquine
Nifedipine
Nilotinib
Nortriptyline
Octreotide
Pazopanib
Pentamidine
Pirmenol
Prajmaline
Probucol
Procainamide
Prochlorperazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Rifabutin
Risperidone
Romidepsin
Salmeterol
Sematilide
Sertindole
Simvastatin
Sirolimus
Sotalol
Spiramycin
Sulfamethoxazole
Sultopride
Sunitinib
Tadalafil
Tamsulosin
Tedisamil
Telithromycin
Temsirolimus
Trifluoperazine
Trimethoprim
Trimipramine
Vasopressin
Venlafaxine
Vinorelbine
Voriconazole
Zolmitriptan
Zotepine

Using clarithromycin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol
Alfentanil
Alprazolam
Bromocriptine
Carbamazepine
Cilostazol
Conjugated Estrogens
Cyclosporine
Darunavir
Delavirdine
Diazepam
Efavirenz
Esterified Estrogens
Estradiol
Estriol
Estrone
Estropipate
Fesoterodine
Glipizide
Glyburide
Hexobarbital
Indinavir
Itraconazole
Lopinavir
Methylprednisolone
Midazolam
Nevirapine
Paroxetine
Phenytoin
Prednisone
Repaglinide
Rifapentine
Ritonavir
Saquinavir
Tacrolimus
Tipranavir
Tolterodine
Trazodone
Triazolam
Verapamil
Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of clarithromycin

Clarithromycin may be taken with meals or milk or on an empty stomach, extended release tablets should be taken with food.

If you are taking clarithromycin and zidovudine, these medicines should be taken at least 4 hours apart.

To help clear up your infection completely, keep taking clarithromycin for the full time of treatment, even if you begin to feel better after a few days. If you stop taking clarithromycin too soon, your symptoms may return.

If you are using clarithromycin oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of clarithromycin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of clarithromycin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage forms (suspension and tablets):
- For bacterial infections:
  - Adults and teenagers—250 to 500 milligrams (mg) every twelve hours for seven to fourteen days.
  - Children 6 months of age and older—7.5 mg per kilogram (kg) (3.4 mg per pound) of body weight every twelve hours for ten days.
  - Infants up to 6 months of age—Use and dose must be determined by your doctor.
  - For community-acquired pneumonia:
    - Adults and teenagers—250 to 500 milligrams (mg) every twelve hours for seven to fourteen days.
    - Children 6 months of age and older—7.5 mg per kilogram (kg) (3.4 mg per pound) of body weight every twelve hours for ten days.
  - For prevention or treatment of Mycobacterium avium complex (MAC) infection:
    - Adults and teenagers—500 mg two times a day.
    - Children 6 months of age and older—7.5 mg per kg (3.4 mg per pound) of body weight, up to 500 mg, two times a day.
    - Infants up to 6 months of age—Use and dose must be determined by your doctor.
  - For treatment of ulcers associated with Helicobacter pylori:
    - Adults and teenagers—500 mg three times a day for fourteen days, in combination with omeprazole or ranitidine bismuth sulfate; or 500 mg every twelve hours in combination with amoxicillin and lansoprazole for fourteen days.
    - Infants and children—Use and dose must be determined by your doctor.
- For long-acting oral dosage form (extended release tablets)
  - For bacterial infections:
    - Adults and teenagers— 1000 milligrams (mg) once a day for seven to fourteen days.
  - For community-acquired pneumonia:
    - Adults and teenagers—1000 milligrams (mg) once a day for seven days

Missed Dose

If you miss a dose of clarithromycin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Do not store suspension in the refrigerator.

Precautions While Using clarithromycin

Clarithromycin should not be taken with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or terfenadine. Doing so may increase the risk of serious side effects affecting the heart.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Clarithromycin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Incidence less frequent

Cough
fever or chills
hoarseness
lower back or side pain
painful or difficult urination

Rare

Abdominal tenderness
fever with or without chills
nausea and vomiting
severe abdominal or stomach cramps and pain
shortness of breath
skin rash and itching
unusual bleeding or bruising
watery and severe diarrhea, which may also be bloody
yellow eyes or skin

Incidence not known

Abdominal pain
anxiety
black, tarry stools
blistering, peeling, loosening of skin
blurred vision
chest pain or discomfort
chills
clay-colored stools
confusion about identity, place, and time
cool pale skin
dark urine
depression
difficulty swallowing
dizziness
fainting
fast, pounding, or irregular heartbeat or pulse
feeling of unreality
feeling that others are watching you or controlling your behavior
feeling that others can hear your thoughts
feeling, seeing, or hearing things that are not there
hives
increased hunger
irregular heartbeat
joint or muscle pain
light-colored stools
loss of appetite
nervousness
nightmares
palpitations
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
recurrent fainting
red irritated eyes
red skin lesions, often with a purple center
redness, swelling, or soreness of tongue
seeing, hearing, or feeling things that are not there
seizures
sense of detachment from self or body
severe mood or mental changes
shakiness
slow heartbeat
slurred speech
sore throat
sores, ulcers, or white spots in mouth or on lips
sudden death
swollen glands
tightness in chest
unpleasant breath odor
unusual behavior
unusual tiredness or weakness
vomiting of blood
wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Acid or sour stomach
belching
bloated, full feeling
change in sensation of taste
diarrhea (mild)
excess air or gas in stomach or intestines
headache
heartburn
indigestion
passing gas
stomach discomfort, upset, or pain