Sumamed 125 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).
Sumamed 125 belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, Sumamed 125 will not work for colds, flu, or other virus infections. Sumamed 125 injection may be used for other problems as determined by your doctor.
Sumamed 125 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, Sumamed 125 is used in certain patients with the following medical condition:
Trachoma (treatment).
Sumamed 125 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 Sumamed 125 Tablets and other antibacterial drugs, Sumamed 125 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.
Sumamed 125 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
Sumamed 125 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
Sumamed 125 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 Sumamed 125?
Use Sumamed 125 drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Sumamed 125 drops. Talk to your pharmacist if you have questions about this information.
Sumamed 125 drops is for use in the eye only. Do not swallow it.
Wash your hands immediately before you use Sumamed 125 drops.
To use Sumamed 125 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 Sumamed 125 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 Sumamed 125 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 Sumamed 125 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 Sumamed 125 drops.
Uses of Sumamed 125 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 Sumamed 125 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, Sumamed 125, 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, Sumamed 125) 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 Sumamed 125 (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, Sumamed 125 is effective and recommended treatment for patients with travelers' diarrhea. Due to increased levels of resistance to fluoroquinolones, Sumamed 125 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.
Sumamed 125 description
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Each film-coated tablet contains Azithromycin dihydrate equivalent to Sumamed 125 500 mg.
Sumamed 125 is a nitrogen-containing macrolide or azalide with actions and uses similar to those of erythromycin. Sumamed 125 is derived from erythromycin. However, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring.
Sumamed 125 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 byChlamydia trachomatisand 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 Sumamed 125 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 Sumamed 125 250 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: Sumamed 125 for IV infusion must be reconstituted and be further diluted prior to administration. Sumamed 125 powder for injection is for IV use only.
IV solutions containing Sumamed 125 in a concentration of 1 mg/mL generally are infused over 3 hrs and solutions containing Sumamed 125 2 mg/mL generally are infused over 1 hr.
Antacids: In a pharmacokinetic study investigating the effects of simultaneous administration of antacid with Sumamed 125, no effects on overall bioavailability was seen although peak serum concentrations were reduced by up to 30%. In patients receiving both Sumamed 125 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 Sumamed 125.
Cimetidine: A single dose of cimetidine administered 2 hrs before Sumamed 125 had no effect on the pharmacokinetics of Sumamed 125.
Cyclosporin: In the absence of conclusive data from pharmacokinetics or clinical studies investigating potential interaction between Sumamed 125 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 Sumamed 125 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, Sumamed 125 and ergot derivatives should not be co-administered.
Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, Sumamed 125 had no significant effect on the pharmacokinetics of methylprednisolone.
Terfenadine: Pharmacokinetic studies have reported no evidence of an interaction between Sumamed 125 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 Sumamed 125 and theophylline are co-administered in healthy volunteers.
Coumarin-Type
Oral Anticoagulants:
In a pharmacodynamic interaction study, Sumamed 125 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 Sumamed 125 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 Sumamed 125 is used in patients receiving coumarin-type oral anticoagulants.
Zidovudine: Single 1000 mg doses, and multiple 1200 mg or 600 mg doses of Sumamed 125 did not affect the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, administration of Sumamed 125 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 Sumamed 125 1200 mg with didanosine in 6 subjects did not appear to affect the pharmacokinetics of didanosine as compared with placebo.
Rifabutin: Co-administration of Sumamed 125 and rifabutin did not affect the serum concentrations of either drug. Neutropenia was observed in subjects receiving concomitant treatment of Sumamed 125 and rifabutin. Although neutropenia has been associated with the use of rifabutin, a causal relationship to combination with Sumamed 125 has not been established.
Sumamed 125 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 Sumamed 125 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 Sumamed 125. 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 Sumamed 125 has not been established.
Sumamed 125 Tablets are contraindicated in patients with known hypersensitivity to Sumamed 125, erythromycin, any macrolide, or ketolide drug.
Hepatic Dysfunction
Sumamed 125 Tablets are contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of Sumamed 125.
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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