Mazith Powder for Suspension
Azithromycin
200mg/5ml
Hallmark Pharmaceuticals Ltd.
| Pack size | 35ml bot |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 130.39 AED |
Available as:
Indications
Mazith Powder for Suspension is used for:
Bacterial infections, bacterial endocarditis, typhoid fever, community-acquired pneumonia, uncomplicated gonorrhea, streptococcal pharyngitis/tonsillitis, COPD, acute bacterial sinusitis, acute otitis media, uncomplicated UTI, Uncomplicated gonorrhea, PID, non-gonococcal urethritis, chancroid, acute salmonellosis, cervicitis, babesiosis, chlamydial infections, pelvic inflammatory disease, PID, traveler's diarrhea,
Adult Dose
Oral
Adult: As tab, cap, or immediate release suspension:
Community-acquired pneumonia (mild severity), Pharyngitis/tonsillitis (second-line therapy), Skin/skin structure (uncomplicated)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5.
Community-acquired pneumonia: As extended-release suspension: 2 g as a single dose.
Acute bacterial exacerbations of chronic bronchitis (mild to moderate)
500 mg as a single dose on Day 1, followed by 250 mg once daily on Days 2 through 5 or 500 mg once daily for 3 days.
Acute bacterial sinusitis
500 mg once daily for 3 days.
As extended-release suspension: 2 g as a single dose.
Genital ulcer disease (chancroid), Non-gonococcal urethritis, Uncomplicated genital infections due to Chlamydia trachomatis and Cervicitis
1 g as a single dose.
Gonococcal urethritis and Cervicitis
2 g as a single dose
Uncomplicated gonorrhoea
Adult: 1 g or 2 g as a single dose, in combination with ceftriaxone.
Prophylaxis of disseminated Mycobacterium avium complex (MAC) infections
Adult: 1.2 g once weekly.
Intravenous
Community-acquired pneumonia
Adult: 500 mg as a single daily dose for at least 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 500 mg daily to complete 7-10 days.
Pelvic inflammatory disease
Adult: 500 mg daily as a single dose for 1 or 2 days, given at a rate of 1 mg/mL over 3 hours or 2 mg/mL over 1 hour, followed by oral dose of 250 mg daily to complete 7 days.
Child Dose
Child
Acute otitis media (6 months of age and older)
30 mg/kg as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on Day 1 followed by 5 mg/kg/day on Days 2 through 5.
Acute bacterial sinusitis (6 months of age and older)
10 mg/kg once daily for 3 days.
Community-acquired pneumonia (6 months of age and older)
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on Days 2 through 5.
or 60 mg/kg once of ER susp
Pharyngitis/tonsillitis (2 years of age and older)
12 mg/kg once daily for 5 days.
CABP: 10 mg/kg for 1 day, then 5 mg/kg/day for 4 days
MAC/PCP prophylaxis: 5 mg/kg/day
Skin and soft tissue infections, Respiratory tract infections: 10 mg/kg daily for 3 days or 10 mg/kg on day 1, followed by 5 mg/kg/day on days 2-5.
IV: 10 mg/kg q24h
>6 mth 10 mg/kg;
15-25 kg: 200 mg;
26-35 kg: 300 mg;
36-45 kg: 400 mg.
All doses to be taken once daily for 3 days.
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Oral Administration
Tablet: Take tablets without regard to food; however, food may enhance tolerability
Oral suspension
Conventional oral suspension (100 mg/5 mL, 200 mg/5 mL) may be stored for 10 days after reconstitution and taken without regard to food
Conventional 1 g package must be taken immediately after reconstitution
Extended-release oral suspension must be taken on empty stomach within 12 hours of reconstitution; given only in single dose; not interchangeable with immediate release formulation
IV Preparation
Dilute 500-mg vial in 4.8 mL of SWI (100 mg/mL)
Dilute further in NS to 1 mg/mL (500 mL) or 2 mg/mL (250 mL)
IV Administration
1 mg/mL solution: Infuse over 3 hours
2 mg/mL solution: Infuse over 1 hour
Contra Indications
Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic. Coadministration w/ pimozide. History of cholestatic jaundice/hepatic dysfunction associated w/ prior use of azithromycin.
Precautions
Serious (including fatal) allergic and skin reactions: Discontinue Azithromycin if a reaction occurs.
Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue Azithromycin immediately if signs and symptoms of hepatitis occur.
Infantile Hypertrophic Pyloric Stenosis (IHPS): Following the use of azithromycin in neonates (treatment up to 42 days of life), IHPS has been reported. Direct parents and caregivers to contact their physician if vomiting or irritability with feeding occurs.
Prolongation of QT interval and cases of torsades de pointes have been reported. This risk which can be fatal should be considered in patients
with certain cardiovascular disorders including known QT prolongation or history torsades de pointes, those with proarrhythmic conditions, and with other drugs that prolong the QT interval.
Cardiovascular Death: Some observational studies have shown an approximately two-fold increased short-term potential risk of acute cardiovascular death in adults exposed to azithromycin relative to other antibacterial drugs, including amoxicillin. Consider balancing this potential risk with treatment benefits when prescribing Azithromycin.
Clostridioides difficile-Associated Diarrhea: Evaluate patients if diarrhea occurs.
Azithromycin may exacerbate muscle weakness in persons with myasthenia gravis.
Monitoring Parameters
Liver function tests, CBC w/ differential.
Pregnancy-Lactation
Pregnancy
Available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data); data do not suggest embryofetal risk (Developmental and Reproductive Toxicology Database [DART]; https://toxnet.nlm.nih.gov/newtoxnet/dart.htm)
Animal data
Developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area; decreased viability and delayed development were observed in offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area
Lactation
Drug is present in human milk; non-serious adverse reactions reported in breastfed infants after maternal administration of therapy; there are no available data on effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and potential adverse effects on breastfed infant from drug or underlying maternal condition; advise women to monitor breastfed infant for diarrhea, vomiting, or rash.
Interactions
Coadministration of nelfinavir at steady-state with a single oral dose of azithromycin resulted in increased azithromycin serum concentrations; closely monitor for adverse reactions of azithromycin
Spontaneous postmarketing reports suggest that coadministration of azithromycin may potentiate the effects of oral anticoagulants (eg, warfarin), although the prothrombin time was not affected in the dedicated drug interaction study with azithromycin and warfarin; carefully monitor prothrombin time while patients are receiving azithromycin and oral anticoagulants concomitantly
Drug interactions with digoxin, colchicine or phenytoin have been observed when combined other macrolide; until further data are developed regarding drug interactions when digoxin, colchicine or phenytoin are used with azithromycin careful monitoring of patients is advised
Increases serum concentrations of digoxin, ciclosporin, terfenadine, hexobarbital and phenytoin.
Decreased rate of absorption w/ antacids containing aluminium and magnesium.
Increased risk of ergot toxicity.
Nelfinavir: Close monitoring for known adverse reactions of azithromycin, such as liver enzyme abnormalities and hearing impairment, is warranted. (7.1)
Warfarin: Use with azithromycin may increase coagulation times; monitor prothrombin time.
Potentially Fatal: Increased risk of cardiotoxicity w/ pimozide.
Contraindicated (1)
pimozide
Adverse Effects
Side effects of Azithromycin :
>10%
High single dose therapy
Diarrhea (52.8%),Nausea (32.6%),Abdominal pain (27%),Loose stool (19.1%)
1-10%
Cramping (2-10%),Vaginitis (2-10%),Dyspepsia (9% with single high dose therapy),Flatulence (9% with single high dose therapy),Vomiting (6.7% with single high dose therapy),Malaise (1.1%)
<1%
Agitation,Allergic reaction,Anemia,Anorexia,Candidiasis,Chest pain,Conjunctivitis,Constipation,Dermatitis (fungal),Dizziness,Eczema,Edema,Enteritis,Facial edema,Fatigue,Gastritis,Headache,Hyperkinesia,Hypotension,Increased cough,Insomnia,Leukopenia,Malaise,Melena,Mucositis,Nervousness,Oral candidiasis,Pain,Palpitations,Pharyngitis,Pleural effusion,Pruritus,Pseudomembranous colitis,Rash,Rhinitis,Seizures,Somnolence,Urticaria,Vertigo
Potentially Fatal: Angioedema and cholestatic jaundice.
Mechanism of Action
Azithromycin is a semisynthetic azalide antibiotic. It blocks transpeptidation by binding to 50s ribosomal subunit of susceptible organisms and disrupting RNA-dependent protein synthesis at the chain elongation step.
Note
Mazith 200mg/5ml Powder for Suspension manufactured by Hallmark Pharmaceuticals Ltd.. Its generic name is Azithromycin. Mazith is availble in Bangladesh.
Farmaco BD drug index information on Mazith Powder for Suspension is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.