Azithromycin 250mg (Azithromycin )

DESCRIPTION

Azithral 250mg belongs to antibacterial drugs and which is aprescription medicine approved by the U.S. FDAfor prevention of certain bacterial infections, such as:

• different bacterial respiratory diseases, involves pneumonia, acute sinus and ear infections, and acute worsening of chronic bronchitis.
• Pelvic inflammatory disease.
• Genital ulcer disease.
• Infections of the urethra, cervix, throat, tonsils, and skin.

Certain bacterial respiratory diseases for which azithromycin treatment is FDA-approved are opportunistic infections (OIs) of HIV. An OI is an infection which occurs more frequently or is more serious in people with low immune systems—such as people with HIV—than in people with healthy immune systems.

INDICATION

Azithral 250mg is indicated for the treatment of certain bacterial infections such as bronchitis, Pneumonia, Sexually transmitted disease (STD) Azithral500mg is also indicated to prohibit the disseminated Mycobacterium avium complex (MAC) infection Infection of the ears, lungs, sinuses, throat and reproductive organs.

MECHANISM OF ACTION

Azithral 250mg belongs to semisynthetic azalide antibiotic and works by linking to the 23S rRNA of the 50S ribosomal subunit of susceptible microorganisms preventing synthesis of bacterial protein and impeding the assembly of the 50S ribosomal subunit.

PHARMACOKINETICS

Absorption

absorbed rapidly from the GI tract. Reduced by food (capsule formulation). bioavailability: Approx 34-52%. Duration of maximumserum concentration: Oral tab: 2-3 hr;

Distribution

Volume of distribution: 31-33 L/kg. The Azithral 250mg tablet based on concentration has Plasma protein binding about 7-51% (oral and IV).

Metabolism

Metabolism occur in Hepatic through demethylation.

Elimination

Through bile (as unchanged drug and inactive metabolites); urine (approx 6% of oral dose). Terminal elimination half-life: 68 hr.

DOSAGE MANAGEMENT

For oral dosage form
In adults for bacterial infections

500 to 2000mg once daily, administer as single dose, this may continue with 250 to 500mg dose once daily for several days

For pharyngitis or tonsillitis

500mg on day 1 taken as single dose followed by 500mg on 2nd day through 5th day

In children for infections (6months age – older)

based on body weight is dose and must be determined by your doctor. 10 to 30mg/kg of body weight once daily, taken as a single dose. Depends on the type of infection, continue with doses of 5 to 10 mg/kg of body weight once daily for several days. Infants < 6 months: discuss with doctor

For pharyngitis or tonsillitis

based on body weight: 12mg/kg of body weight once daily for 5 days < 2yrs children’s: discuss with doctor for dose.

OVERDOSAGE

If dose administer higher than prescribed dose will cause nausea, diarrhea, vomiting. If it occurs, then provide general symptomatic and supportive measures are indicated as needed

SIDE EFFECTS

Some serious side effects is caused by Azithral 250mg

• Watery or bloody diarrhae
• Pain in head associated with chest discomfort and severe vertigo, fainting, fast heartbeats
• Hepatic problems – upper stomach pain, decreased appetite, dark urine, clay-colored stools, jaundice
• Serious dermatological reaction – fever, pharyngtitis, blisters in face or tongue, burning of eyes, red or purple skin rashes.

Common side effects of Azithral 250mg as follows

• Diarrhae
• Nausea, vomiting, stomach pain
• Pain in head

If these symptoms occurs call doctor immediately

DRUG INTERACTIONS

Interaction of Azithral 250mg with Nelfinavir will increases azithromycin serum concentrations. Azithral 250mg combination with Warfarin causes Prothrombin times should be carefully monitored while patients gettingcontinues azithromycin and oral anticoagulants Concomitant use with Macrolides leads to Serum concentration of macrolides may increase when combined with Azithromycin

CONTRAINDICATIONS

The patients using Azithral 250mg is contraindicated with hypersensitivity to azithromycin and its components. history of liver discomfort analog to before use of azithromycin

WARNING & PRECAUTIONS

While use of antibacterial agents will cause mild diarrhea to fatal colitis and it alters the normal colon flora results overgrowth of C.difficile. These will produce toxin A and Toxin B leads to development of CDAD and hence increases morbidity and mortality. Before using Azithral 250mg inform the doctor. If an allergic reaction occurs including angioedema, anaphylaxis and dermatologic reactions, the drug should be discontinuing, and convenient treatment must carried out. Consult with doctor for the symptoms arise. If symptoms of abnormal liver function, cholestatic jaundice, liver necrosis have occurred then stop the azithromycin and inform the doctor.

PREGNANCY

Category B: There are no analyzed determined for fetal harm in animal reproduction and no controlled studies have been shown in pregnant women or animal reproduction in 1st trimester and later trimester there is no evidence of a harm of fetal.

LACTATION

Some amount of Azithral 250mg is excreted in breast milk. The usage of drug during breast feeding the mother should use with caution. Please consult the doctor for further details.

STORAGE

Stored below 30°C Keep away from the children Don’t store outdated medicine Discuss with pharmacist for the disposal of unused drugs

MISSED DOSE

Take the missed dose as soon as possible before next dose reaches or leave the missed dose and continue the routine schedule. Do not have extra dose. Please consult with the doctor.