Azithromycine Ratiopharm injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent Mycobacterium avium complex (MAC) disease in patients infected with the human immunodeficiency virus (HIV).
Azithromycine Ratiopharm belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Azithromycine Ratiopharm will not work for colds, flu, or other virus infections. Azithromycine Ratiopharm injection may be used for other problems as determined by your doctor.
Azithromycine Ratiopharm 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 these uses are not included in product labeling, Azithromycine Ratiopharm is used in certain patients with the following medical condition:
Trachoma (treatment).
Azithromycine Ratiopharm indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Azithromycine Ratiopharm Tablets and other antibacterial drugs, Azithromycine Ratiopharm Tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Azithromycine Ratiopharm Tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.
Mycobacterial Infections
Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease
Azithromycine Ratiopharm Tablets, taken alone or in combination with rifabutin at its approved dose, are indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection.
Treatment of Disseminated MAC Disease
Azithromycine Ratiopharm Tablets, taken in combination with ethambutol, are indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection.
How should I use Azithromycine Ratiopharm?
Use Azithromycine Ratiopharm drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Azithromycine Ratiopharm drops. Talk to your pharmacist if you have questions about this information.
Azithromycine Ratiopharm drops is for use in the eye only. Do not swallow it.
Wash your hands immediately before you use Azithromycine Ratiopharm drops.
To use Azithromycine Ratiopharm drops, turn the bottle upside down and shake once before each use. Remove the cap while the bottle is still upside down. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Gently squeeze the bottle to drop the medicine into the pouch, then gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eye for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
If a drop does not come out of the bottle when using your dose, repeat these steps.
To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
Do not wear contact lenses while you are using Azithromycine Ratiopharm drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
To clear up your infection completely, use Azithromycine Ratiopharm drops for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Azithromycine Ratiopharm drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Azithromycine Ratiopharm drops.
Uses of Azithromycine Ratiopharm in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications
Oral, IV:
Chancroid: Treatment of genital ulcer disease (in men) due to Haemophilus ducreyi (chancroid)
Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) due to Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae
Mycobacterium avium complex: Prevention of Mycobacterium avium complex (MAC) in patients with advanced HIV infection; treatment of disseminated MAC (in combination with ethambutol) in patients with advanced HIV infection
Otitis media, acute: Treatment of acute otitis media due to H. influenzae, M. catarrhalis, or S. pneumoniae
Pneumonia, community-acquired: Treatment of community-acquired pneumonia (CAP) due to Chlamydophila pneumoniae, H. influenzae, Legionella pneumophila, M. catarrhalis, Mycoplasma pneumoniae, or S. pneumoniae
Skin and skin structure infection, uncomplicated: Treatment of uncomplicated skin and skin structure infections due to Staphylococcus aureus, Streptococcus pyogenes, or Streptococcus agalactiae
Streptococcal pharyngitis (group A): Treatment of pharyngitis/tonsillitis due to S. pyogenes as an alternative to first-line therapy
Urethritis/cervicitis: Treatment of urethritis and cervicitis due to Chlamydia trachomatis or Neisseria gonorrhoeae
Off Label Uses
Acne vulgaris
Data from controlled trials support the use of Azithromycine Ratiopharm in the treatment of acne vulgaris in adults with moderate to severe acne.
Based on the American Academy of Dermatology guidelines of care for the management of acne vulgaris, Azithromycine Ratiopharm, in combination with topical therapy, may be considered as a treatment option for moderate and severe acne and forms of inflammatory acne that are resistant to topical treatments. However, its use should be limited to patients who cannot receive a tetracycline (ie, pregnant women). Concomitant topical therapy with benzoyl peroxide or a retinoid should be administered with systemic antibiotic therapy (eg, Azithromycine Ratiopharm) and continued for maintenance after the antibiotic course is completed.
Babesiosis
Data from a prospective, nonblinded, randomized trial in patients with non-life-threatening babesiosis, support the use of Azithromycine Ratiopharm (in combination with atovaquone) for the treatment of this condition.
Based on the CDC Yellow Book, the ACG guideline for the diagnosis, treatment, and prevention of acute diarrheal infections in adults, and the IDSA practice guidelines for the diagnosis and management of infectious diarrhea, Azithromycine Ratiopharm is effective and recommended treatment for patients with travelers' diarrhea. Due to increased levels of resistance to fluoroquinolones, Azithromycine Ratiopharm may be a recommended first-line treatment, especially in regions with a high prevalence of Campylobacter (eg, Southeast Asia, India) or in geographical areas with suspected fluoroquinolone-resistant pathogens or enterotoxigenic Escherichia coli.
Azithromycine Ratiopharm description
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Each film-coated tablet contains Azithromycin dihydrate equivalent to Azithromycine Ratiopharm 500 mg.
Azithromycine Ratiopharm is a nitrogen-containing macrolide or azalide with actions and uses similar to those of erythromycin. Azithromycine Ratiopharm is derived from erythromycin. However, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
Azithromycine Ratiopharm dosage
Not for pediatric use.
For pediatric patients, please refer to the INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections of the prescribing information for Azithromycine Ratiopharm for oral suspension 100 mg/5 mL and 200 mg/5 mL bottles.
Azithromycine Ratiopharm Tablets may be taken without regard to food. However, increased tolerability has been observed when tablets are taken with food.
Mycobacterial Infections
Prevention of Disseminated MAC Infections
The recommended dose of Azithromycine Ratiopharm Tablets for the prevention of disseminated Mycobacterium avium complex (MAC) disease is: 1200 mg taken once weekly. This dose of Azithromycine Ratiopharm Tablets may be combined with the approved dosage regimen of rifabutin.
Treatment of Disseminated MAC Infections
Azithromycine Ratiopharm Tablets should be taken at a daily dose of 600 mg, in combination with ethambutol at the recommended daily dose of 15 mg/kg. Other antimycobacterial drugs that have shown in vitro activity against MAC may be added to the regimen of Azithromycine Ratiopharm plus ethambutol at the discretion of the physician or health care provider.
Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with Azithromycine Ratiopharm, no effects on overall bioavailability was seen although peak serum concentrations were reduced by up to 30%. In patients receiving both Azithromycine Ratiopharm and antacids, the drug should not be taken simultaneously.
Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite in patients receiving concomitant Azithromycine Ratiopharm.
Cimetidine: A single dose of cimetidine administered 2 hrs before Azithromycine Ratiopharm had no effect on the pharmacokinetics of Azithromycine Ratiopharm.
Cyclosporin: In the absence of conclusive data from pharmacokinetics or clinical studies investigating potential interaction between Azithromycine Ratiopharm and cyclosporin, caution should be exercised before concurrent administration of these drugs. If co-administration of these drugs is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.
Digoxin: Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin (in the gut) in some patients. Therefore, in patients receiving concomitant Azithromycine Ratiopharm and digoxin, the possibility of raised digoxin levels should be bourne in mind, and digoxin levels monitored.
Ergot Derivatives: Because of the theoretical possibility of ergotism, Azithromycine Ratiopharm and ergot derivatives should not be co-administered.
Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Azithromycine Ratiopharm had no significant effect on the pharmacokinetics of methylprednisolone.
Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between Azithromycine Ratiopharm and terfenadine. There have been rare cases reported where the possibility of such an interaction could not be entirely excluded; however, there was no specific evidence that such an interaction had occured.
Theophylline: There is no evidence of any pharmacokinetic interaction when Azithromycine Ratiopharm and theophylline are co-administered in healthy volunteers.
Coumarin-Type
Oral Anticoagulants:
In a pharmacodynamic interaction study, Azithromycine Ratiopharm did not alter the anticoagulant effect of a single dose warfarin 15 mg administered to healthy volunteers. There have been reports received in the post-marketing period of potentiated anticoagulant subsequent to co-administration of Azithromycine Ratiopharm and coumarin-type oral anticoagulants. Although a causal relationship has not been established, consideration should be given to the frequency of monitoring prothrombin time when Azithromycine Ratiopharm is used in patients receiving coumarin-type oral anticoagulants.
Zidovudine: Single 1000 mg doses, and multiple 1200 mg or 600 mg doses of Azithromycine Ratiopharm did not affect the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Azithromycine Ratiopharm increased the concentrations of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of this finding is unclear, but it may be of benefit to patients.
Didanosine: Co-administration of daily doses of Azithromycine Ratiopharm 1200 mg with didanosine in 6 subjects did not appear to affect the pharmacokinetics of didanosine as compared with placebo.
Rifabutin: Co-administration of Azithromycine Ratiopharm and rifabutin did not affect the serum concentrations of either drug. Neutropenia was observed in subjects receiving concomitant treatment of Azithromycine Ratiopharm and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Azithromycine Ratiopharm has not been established.
Applies to Azithromycine Ratiopharm ophthalmic: ophthalmic solution
In addition to its needed effects, some unwanted effects may be caused by Azithromycine Ratiopharm ophthalmic. In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Azithromycine Ratiopharm ophthalmic:
Less common:
Burning, redness, stinging, or other eye irritation
Rare
Blistering, burning, crusting, dryness, or flaking of the skin
blurred vision
cough
decreased vision
discharge from the eye
fever
headache
hives or welts
itching, scaling, severe redness, soreness, or swelling of the skin
pain or tenderness around the eyes and cheekbones
painful irritation of the clear front part of the eye
shortness of breath or troubled breathing
skin rash
stuffy or runny nose
swelling of the face
swelling or puffiness of the eyes
tightness of the chest or wheezing
Minor Side Effects
Some of the side effects that can occur with Azithromycine Ratiopharm ophthalmic may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
Azithromycine Ratiopharm Tablets are contraindicated in patients with known hypersensitivity to Azithromycine Ratiopharm, erythromycin, any macrolide, or ketolide drug.
Hepatic Dysfunction
Azithromycine Ratiopharm Tablets are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of Azithromycine Ratiopharm.
Active ingredient matches for Azithromycine Ratiopharm:
DailyMed. "AZITHROMYCIN: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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