Te Li Xin Uses

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What is Te Li Xin?

Te Li Xin 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).

Te Li Xin belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Te Li Xin will not work for colds, flu, or other virus infections. Te Li Xin injection may be used for other problems as determined by your doctor.

Te Li Xin 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, Te Li Xin is used in certain patients with the following medical condition:

Te Li Xin 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 Te Li Xin Tablets and other antibacterial drugs, Te Li Xin 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.

Te Li Xin 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

Te Li Xin 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

Te Li Xin 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 Te Li Xin?

Use Te Li Xin drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Te Li Xin drops.

Uses of Te Li Xin 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 Te Li Xin 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, Te Li Xin, 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, Te Li Xin) 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 Te Li Xin (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, Te Li Xin is effective and recommended treatment for patients with travelers' diarrhea. Due to increased levels of resistance to fluoroquinolones, Te Li Xin 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.

Te Li Xin description

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Each film-coated tablet contains Azithromycin dihydrate equivalent to Te Li Xin 500 mg.

Te Li Xin is a nitrogen-containing macrolide or azalide with actions and uses similar to those of erythromycin. Te Li Xin is derived from erythromycin. However, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.

Te Li Xin dosage

Tablet: Adults: Usual Dose: 500 mg as a single dose daily for 3 days. Alternatively, an initial dose of 500 mg may be followed by 250 mg daily for a further 4 days.

Uncomplicated Genital Infections Caused by Chlamydia trachomatis and for Chancroid: 1 g given as a single dose.

Uncomplicated Gonorrhoea: A single dose of 2 g has been given.

Treatment of Granuloma Inguinale: Initially, 1 g followed by 500 mg daily may be given or 1 g may be given once a week for at least 3 weeks, until all lesions have completely healed.

Mild or Moderate Typhoid Caused by Multidrug-Resistant Strains: 500 mg once daily may be given for 7 days.

Injection: Treatment of Mild to Moderate CAP in Adults: 500 mg given as a single dose on the 1st day of therapy, followed by 250 mg once daily on days 2-5. Total Cumulative Dose: 1.5 g administered over 5 days.

Treatment of CAP in Adults or Adolescents ≥16 years who Require Initial IV Therapy: 500 mg given IV as a single daily dose for 2 days. IV therapy generally is followed by oral Te Li Xin given as a single, daily 500-mg dose to complete a 7-10 days of therapy. The timing of the change from IV to oral therapy should be individualized by the physician, taking into account the clinical response of the patient.

Treatment of Acute PID in Patients Requiring Initial IV Therapy: 500 mg given IV as a single daily dose for 1-2 days. If anaerobic bacteria are suspected, an anti-infective active against anaerobes should also be used. IV therapy generally is followed by oral Te Li Xin 250 mg once daily to complete a 7-day course of therapy. The timing of the change from IV to oral therapy should be individualized by the physician, taking into account clinical response of the patient.

Administration: Te Li Xin for IV infusion must be reconstituted and be further diluted prior to administration. Te Li Xin powder for injection is for IV use only.

IV solutions containing Te Li Xin in a concentration of 1 mg/mL generally are infused over 3 hrs and solutions containing Te Li Xin 2 mg/mL generally are infused over 1 hr.

Te Li Xin interactions

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What other drugs will affect Te Li Xin?

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Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with Te Li Xin, no effects on overall bioavailability was seen although peak serum concentrations were reduced by up to 30%. In patients receiving both Te Li Xin 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 Te Li Xin.

Cimetidine: A single dose of cimetidine administered 2 hrs before Te Li Xin had no effect on the pharmacokinetics of Te Li Xin.

Cyclosporin: In the absence of conclusive data from pharmacokinetics or clinical studies investigating potential interaction between Te Li Xin 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 Te Li Xin 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, Te Li Xin and ergot derivatives should not be co-administered.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Te Li Xin had no significant effect on the pharmacokinetics of methylprednisolone.

Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between Te Li Xin 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 Te Li Xin and theophylline are co-administered in healthy volunteers.

Coumarin-Type

Oral Anticoagulants:

In a pharmacodynamic interaction study, Te Li Xin 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 Te Li Xin 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 Te Li Xin is used in patients receiving coumarin-type oral anticoagulants.

Zidovudine: Single 1000 mg doses, and multiple 1200 mg or 600 mg doses of Te Li Xin did not affect the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Te Li Xin 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 Te Li Xin 1200 mg with didanosine in 6 subjects did not appear to affect the pharmacokinetics of didanosine as compared with placebo.

Rifabutin: Co-administration of Te Li Xin and rifabutin did not affect the serum concentrations of either drug. Neutropenia was observed in subjects receiving concomitant treatment of Te Li Xin and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Te Li Xin has not been established.

Te Li Xin side effects

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What are the possible side effects of Te Li Xin?

Te Li Xin is well tolerated with a low incidence of side effect. Palpitations and arrhythmias including ventricular tachycardia (as seen with other macrolides) have been reported although a causal relationship to Te Li Xin has not been established.

Dizziness/vertigo, convulsions (as seen with other macrolides), headache, somnolence, paraesthesia and hyperactivity.

Anorexia, nausea, vomiting/diarrhea (rarely resulting in dehydration), loose stools, dyspepsia, abdominal discomfort (pain/cramps), constipation, flatulence, pseudomembranous colitis and rare reports of tongue discolouration.

Asthenia has been reported although a causal relationship has not been established, moniliasis and anaphylaxis (rarely fatal).

Interstitial nephritis and acute failure.

Thrombocytopenia.

Abnormal liver function including hepatitis and cholestatic jaundice have been reported, as well as rare cases of hepatic necrosis and hepatic failure, which have rarely resulted in death.

However, a causal relationship has not been established.

Arthralgia.

Aggressive reaction, nervousness, agitation and anxiety.

Vaginitis.

Allergic reactions including pruritus, rash, photosensitivity, oedema, urticaria and angioedema. Rarely, serious skin reactions including erythema multiforme, Stevens-Johnsons syndrome and toxic epidermal necrolysis have occured.

Hearing impairment has been reported with macrolide antibiotics. There have been reports of hearing impairment, including hearing loss, deafness and/or tinnitus in some patients receiving Te Li Xin. Many of these have been associated with prolonged use of high doses in investigational studies. In those cases where follow-up information was available, the majority of theses events were reversible.

There have been reports of taste perversion. Transient episodes of mild neutropenia have occasionally been observed in clinical trials, although a causal relationship to Te Li Xin has not been established.

Te Li Xin contraindications

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What is the most important information I should know about Te Li Xin?

Hypersensitivity

Te Li Xin Tablets are contraindicated in patients with known hypersensitivity to Te Li Xin, erythromycin, any macrolide, or ketolide drug.

Hepatic Dysfunction

Te Li Xin Tablets are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of Te Li Xin.

Active ingredient matches for Te Li Xin:

Azithromycin in China.


List of Te Li Xin substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Tazix 500mg Tablet (Sun Pharmaceutical Industries Ltd)$ 0.33
TECAZI 500MG TABLET 1 strip / 3 tablets each (United Biotech Pvt Ltd)$ 0.98
Teozi 250mg TAB / 6 (Swaraj)$ 1.14
Teozi 500mg TAB / 3 (Swaraj)$ 0.86
Teozi 100mg x 5mL SUSP / 15ml (Swaraj)$ 0.46
TEOZI tab 250 mg x 6's (Swaraj)$ 1.14
TEOZI tab 500 mg x 3's (Swaraj)$ 0.86
TEOZI oral susp 100 mg x 5 mL x 15ml (Swaraj)$ 0.46
Tetris 100's$ 67.58
Tablet, Film-Coated; Oral; Azithromycin Dihydrate 500 mg (Atlantis)
Tablets, Film-Coated; Oral; Azithromycin Dihydrate 500 mg (Atlantis)
Thraz 250mg TAB / 60 (Acme Skin Care Pvt Ltd)$ 13.17
Thraz 500mg TAB / 30 (Acme Skin Care Pvt Ltd)$ 12.86
Thraz 100mg x 5mL SUSP / 15ml (Acme Skin Care Pvt Ltd)$ 0.40
Thraz 200mg x 5mL SUSP / 15ml (Acme Skin Care Pvt Ltd)$ 0.68
250 mg x 60's (Acme Skin Care Pvt Ltd)$ 13.17
500 mg x 30's (Acme Skin Care Pvt Ltd)$ 12.86
100 mg x 5 mL x 15ml (Acme Skin Care Pvt Ltd)$ 0.40
200 mg x 5 mL x 15ml (Acme Skin Care Pvt Ltd)$ 0.68
Thraz 250 mg Tablet (Acme Skin Care Pvt Ltd)$ 0.10
THRAZ 250MG TABLET 1 strip / 6 tablets each (Acme Skin Care Pvt Ltd)$ 1.40
THRAZ 500MG TABLET 1 strip / 3 tablets each (Acme Skin Care Pvt Ltd)$ 1.30
THRAZ tab 250 mg x 10's (Acme Skin Care Pvt Ltd)$ 2.19
THRAZ tab 500 mg x 10's (Acme Skin Care Pvt Ltd)$ 4.29
THRAZ oral susp 100 mg x 5 mL x 15ml (Acme Skin Care Pvt Ltd)$ 0.40
THRAZ oral susp 200 mg x 5 mL x 15ml (Acme Skin Care Pvt Ltd)$ 0.68
Thraz 250mg Tablet (Acme Skin Care Pvt Ltd)$ 0.23
Thraz 500mg Tablet (Acme Skin Care Pvt Ltd)$ 0.43
THREEOMYCIN 250MG TABLET 1 strip / 6 tablets each (Southshourne Corporation India)$ 0.87
THREEOMYCIN 500MG TABLET 1 strip / 3 tablets each (Southshourne Corporation India)$ 0.91
Threeomycin 500mg Tablet (Southshourne Corporation India)$ 0.30
THREEOMYCIN KID 100MG TABLET 1 strip / 3 tablets each (Southshourne Corporation India)$ 0.25
Thro 250mg TAB / 3 (Olcare (Olski))$ 0.62
Thro 500mg TAB / 3 (Olcare (Olski))$ 1.19
THRO tab 250 mg x 3's (Olcare (Olski))$ 0.62
THRO tab 500 mg x 3's (Olcare (Olski))$ 1.19
Throazi 250mg TAB / 100t (Sanative Remedies (Sanify Healthcare Pvt. Ltd.))$ 19.84
Throazi 500mg TAB / 30 (Sanative Remedies (Sanify Healthcare Pvt. Ltd.))$ 10.24

References

  1. 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).
  2. PubChem. "azithromycin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "azithromycin". http://www.drugbank.ca/drugs/DB00207 (accessed September 17, 2018).

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