Azactum IM/IV Injection
Aztreonam
1gm/5ml
Drug International Ltd.
| Pack size | 1 gm vial |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 400.00 AED |
Indications
Azactum IM/IV Injection is used for:
Bone and joint infections, Intra-abdominal infections, Lower respiratory tract infections, Meningitis, Septicaemia, Skin and soft tissue infections, Pelvic infections, Gonorrhoea, Cystitis, Urinary tract infections, Cystic fibrosis
Adult Dose
Adult:
IV/IM
Systemic Infections
Moderately severe: 1-2 g IV/IM q8-12hr; not to exceed 8 g/day
Severe or life-threatening: 2 g IV/IM q6-8hr; not to exceed 8 g/day
Pseudomonal Infections
2 g IV/IM q6-8hr; not to exceed 8 g/day
Urinary Tract Infections
0.5-1 g IV/IM q8-12hr; not to exceed 8 g/day
Cystic fibrosis
75 mg via nebulizer q8hr for 28 days; at least 4 hr apart; not to be repeated for another 28 days after completion; pretreatment with broncdilator recommended
IM Cystitis; Gonorrhoea 1 g as a single dose.
Child Dose
Child: IV, IM 90–120 mg/kg/day q6–8hr
Infants >1 wk: 30 mg/kg every 6 or 8 hr
Mild-to-Moderate Infections
<9 months: Safety and efficacy not established
>9 month: 30 mg/kg IV q8hr; not to exceed 120 mg/kg/day
Moderate-to-Severe Infections
<9 months: Safety and efficacy not established
>9 month: 30 mg/kg IV q6-8hr; not to exceed 120 mg/kg/day
Cystic Fibrosis
<9 months: Safety and efficacy not established
>9 month: 50 mg/kg IV q6-8hr; not to exceed 200 mg/kg/day; not to exceed 8 g/day
>7 years: 75 mg via nebulizer three times daily, at least 4 hr apart, for 28days; not to be repeated for another 28 days
Renal Dose
Renal impairment
CrCl 10-30 mL/min: 1-2 g loading dose, then 50% of usual dosage
CrCl <10 mL/min: 1-2 g loading dose, then 25% of usual dosage
Administration
IV Preparation
Reconstituted solutions are colorless to light straw-yellow; may turn pink upon standing, without affecting potency
Use reconstituted solutions and IV solutions (in NS or D5W) within 48 hours if kept at room temperature or within 7 days if kept in refrigerator
IV/IM Administration
IM: Inject deep into large muscle mass
IV: Preferred for doses >1 g or in patients with severe life-threatening infections; administer drug by IV push over 3-5 minutes or by intermittent infusion over 20-60 minutes at final concentration not to exceed 20 mg/mL
Contra Indications
Hypersensitivity to aztreonam.
Precautions
In patients with impaired hepatic or renal function, appropriate monitoring is recommended during therapy
If aminoglycoside is used concurrently, especially if high dosages of former are used or if therapy is prolonged, renal function should be monitored because of potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics
Use of antibiotics may promote overgrowth of nonsusceptible organisms, including Gram-positive organisms (Staphylococcus aureus and Streptococcus faecalis) and fungi; take appropriate measures if superinfection occur during therapy
Rare cases of toxic epidermal necrolysis reported in association with therapy in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis
Clostridium difficile–associated diarrhea (CDAD)
Reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
Monitoring Parameters
Monitor for signs of anaphylaxis during 1st dose; periodic LFT.
Monitor infusion/injection sites carefully; administer around-the-clock to minimize variations in peak and trough serum levels
Pregnancy-Lactation
Pregnancy category: B
Lactation: Drug is excreted in milk in low concentrations; use not recommended (American Academy of Pediatrics committee states that drug is compatible with nursing)
Interactions
Concurrent use w/ oral anticoagulants may increase prothrombin time.
Contraindicated (0)
Serious - Use Alternative (4)
BCG vaccine live
cholera vaccine
microbiota oral
typhoid vaccine live
Adverse Effects
Side effects of Aztreonam :
>10%
Injection
Pain at injection site (12%; children); (2%; adults)
Increase in serum transaminases (4-6%)
Neutropenia (3-11%, children); (<1%, adults)
1-10%
Rash (4%),Thrombocytopenia (4%, children); (<1% adults),Diarrhea (1%),Nausea (1%),Vomiting (1%),Fever (<1%)
< 1%
Abnormal taste,Anaphylaxis,Anemia,Angioedema,Aphthous ulcer,Breast tenderness,Bronchospasm,Clostridium difficile-associated diarrhea (CDAD),Confusion,Diplopia,Dizziness,Dsypnea,Electrocardiographic changes (transient),Erythema multiforme,Eosinophilia,Fever,Flushing,Halitosis,Headache,Hepatitis,Hypotension,Insomnia,Jaundice,Leukocytosis,Neutropenia,Pancytopenia,Seizures,Thrombocytopenia,Tinnitus,Tongue numbness,Toxic epidermal necrolysis,Urticaria,Vaginitis,Vertigo,Weakness,Wheezing
Potentially Fatal: Clostridium difficile-associated diarrhoea from mild diarrhoea to fatal colitis.
Mechanism of Action
Aztreonam inhibits bacterial cell wall synthesis due to its high affinity for penicillin-binding protein 3 (PBP-3) of gm-ve bacteria. It is highly resistant to hydrolysis by many narrow-spectrum β-lactamases. It is also active against most Enterobacteriaceae (including E. coli, Citrobacter, Enterobacter, Klebsiella, Proteus, Providencia, Salmonella, Serratia, Shigella, Yersinia spp. and Morganella morganii).
Note
Azactum 1gm/5ml IM/IV Injection manufactured by Drug International Ltd.. Its generic name is Aztreonam. Azactum is availble in Bangladesh.
Farmaco BD drug index information on Azactum IM/IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.