Drug Information

Drug Interaction:

Interacting drugs- summary

+ Aztreonam

Probenecid

concomittant administration causes clinically insignificant increases in aztreonam Furosemide levels

Antibiotics

(eg. cefoxitin, imipenem ) induce high levels of Beta- lactamase in vitro in some gram-negative aerobes such as Enterobacter and Psuedomonas species resulting in antagonism to many Beta lactum antibiotics including aztreonam. Beta-lactanase-inducing antibiotics should not be used concomittantly with aztreonam

Indication:

New drugs approved For Marketing by Drug Controller General of India(DCGI )

during the period January 1988 to November 2014

(Ref- IDMA Annual Publication 2015)

Name of Drug Indication Date of Approval

Aztreonam Anti-bacterial 01-11-2002

Urinary tract infections Lower respiratory tract infections Septicemia Skin and skin structure infections Intra-abdominal infections Gynaecologic infections

Adverse Reaction:

Local- phlebitis/thromophlebitis, following Iv administration,discomfort/swelling at the injection site following IM administration.

Hematologic- pancytopenia, neutropenia, thrombocutopenia, anemia, leukocytosis, thrombocytosis

GI- diarrhea, nausea, vomiting, abdominal cramps, GI bleeding Dermtologic- rash, purpura, erythema mutiforme, urticaria, exfoliative dermatisis, petechiae, pruritus, diaphoresis

Cardiovascular - transcient ECG changes, (ventricular bigminy and PVC ) hypotension. Hepatic- hepatitis, jaundice

CNS- seizure, confusion, headache, vertigo, paresthesia, insomnia, diziness.

Special senses- tinnitus, diplopia, mouth ulcer, alterd taste, numb tongue, sneezing, nasal congeston, halitosis

Miscellaneous- vaginal candidiasis, vaginitis, breast tenderness, weakness, muscular aches, fever, malaise, anaphylaxis, flushing, chaest pain, dyspnea.

Lab test abnormalities- Elevation of AST, ALT, and alkaline phosphatase, increase in prothrombin times, eosinophillia, positive Coombs test,and serum creatinine.

Contra-Indications:

Hypersensitivity to Aztreonam

Special precautions-

Superinfection- use ofantibiotics (especially prolonged or repeated therapy) may result in bacterial ( including gram-positive S aureus and S faecalis ) or fungal overgrowth of nonsuceptible organisms. Such overgrowth may lead to a secondaryinfection. Take appropiate measures if superinfection occurs.

Warnings

Hypersentivity

Monitor patients who have had immediate hypersensitivity reactions (eg.anphylactic or urticarial ) to penicillins or cephalosprins. If an allergic raection to aztreonam occurs, doscontinue the drug and institute supportive treatment.

Renal/hepatic function impairment- appropitae monitoring is recommended. If an aminoglycoside is used concurrently with aztreonam ,especially if high doses of the former are used or if therapy is prolonged, monitor renal function because of potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.

Pregnancy- Use during pregnancy only if clearly needed.

Lactation- Consider temporary discontinuation of nursing.

Children- Safey and efficacy for use in children is not established.

Dosages/ Overdosage Etc:

Indication:

Urinary tract infections

Dosage: Give IM or IV. Individualise dosage. 500 mg or 1g 8 or 12 hours

Children- 30mg/kg every 6 to 8 hours has been used in children for various infections

Patient Information:

Azetreonam- Systemic

1.Allergies-

Tell your doctor if you are have ever had any unusual or allergic reaction to

azetreonam. Also tell your healthcare care professional if you are allergic to any other

substances such as foods. preservatives or dyes.

2.Pregnancy-

Studies have not been done in humans. However, azetreonam has not shown to

cause birth defects or other problems in studies in rabbits and rats given up to

15 times the highest human dose.

3. Breast-feeding-

Small amounts of azetronam passes into breast milk. However, this medicine

is not absorbed when taken by mouth, and problems have not been seen in

nursing babies.

4.Children-

This medicine has been tested in a limited number of children up to 12 years of age

and and has not been shown to cause different side effects or problems in children

than it does in adults.

5.Older adults-

Azetreon has been tested in a limited number of patients 65 years of age or

older and has not shown to cause different side effects or problems in older people

than it does in younger adults

6. Other medicines-

Although certain medicines should not be used together at all, in other cases two

different medicines may be used together even if an interaction might occur. In such

cases your doctor may want to change the dose, or other precautions may be necessary.

Tell your doctor if you are taking other prescription or nonprescription ( over-the- counter) (OTC) medicine

7. Other medical problems-

The presence of other medical problems may affect the use of aztreonam. Make sure

you tell your doctor if you have any other medical problems especially-

Cirrhosis ( liver diease) - patients receiving high doses of azetronam for a long time,

who also have severe liver disease , may have an increased chance of side effects.

Kidney disease- patients with kidney disease may have an increased chance of

side effects

Pharmacology/ Pharmacokinetics:

Pharmacology:

Azetreonam,a synthetic bactericidal antibiotic, is the first of a new class of antibiotics identified as monmobactams. The monobactums have a monocyclic Beta-lactum nucleus and are structurally different from Beta-lactums (eg. penicillins, cephalosporins, cephamycin). Aztreonam has a wide range of spectrum of activity against gram-negative aerobic pathogens. The bactericidal action results from the inhibition of bacterial cell wall synthesis due to a high affinity of aztreonam for penicillin binding protein 3 (PBP3).

Pharmacokinetics

Following a single IM injection of 500mfg an 1g maximun serum concentration occur at about 1 hour. The serum half-life averaged 1.7 hrs in subjects with normal renal function, independent of the dose and the route. The average elimination half-life appears slightly longer in healthy males. In patients with impaired renal function,the serum half-life is prolonged.

Pregnancy and lactation:

Pregnancy

Use during pregnancy only if clearly needed.

Lactation

Consider temporary discontinuation of nursing.

Children

Safey and efficacy for uee in children is not established.

Aztreonam- @ - Monobactams-(Nov 2002)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation