(Cefixime & Azithromycin Tablet)

Composition
Each film coated tablet contains
Cefixime trihydrate
Eq.to Cefixime ………………200mg
Azithromycin …………………250mg
Colour: Titanium dioxide IP

Product Description:
Carton : It is regular proficare design, box opens from the top.
Strip : Strip of 6 tablets and 10 strips in a box
Type of Tablet : Fim coated white oblong, slightly convex surfaces and scored on one side
tablet

Cefixime Trihydrate is an orally active antibiotic with similar antibacterial spectrum and resistance
to βlactamase as third generation cephalosporins. It inhibits an enzyme transpeptidase which is
responsible for bacterial cell walls synthesis.

Azithromycin (AZT) is macrolide antibiotics, it is is an Azalide. It inhibits protein synthesis by

binding 50S ribosomal subunit of the bacteria.
Indications:
Cefixime Trihydrate:
● Lower Respiratory Tract Infections
● Pharyngitis and tonsilitis
● Acute sinusitis
● Gnorrhea and associated infections
● Acute Urinary Tract Infections
● Acute Otitis Media
● Helicobacter pylori infection
● Lyme disease
● Salmonlella and shigella infections.

Azithromycin:
● Otitis media
● Respiratory tract infection
● Cystic fibrosis
● Antiinflammatory in COPD Patient
● In P. Falciparum Malaria with other Antimalarial drugs
● Typhoid fever
● Neissaria gonorrhoeae.

Rationale of Combination:
Product Description: A new combination of cefixime and azithromycin is used for the treatment of
upper and lower respiratory tract infection.Cefixime, an antibiotic, is a thirdgeneration
cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-
lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins
due to the presence of betalactamases, may be susceptible to cefixime. Whereas Azithromycin due
to it's long half life, which enables once daily dosing and shorter administration durations, is a
property distinct from other macrolides.

Pharmacology:
Cefixime Trihydrate:
Absorption: About 40% to 50% is absorbed. C maxfollowing 200 and 400 mg doses of oral
suspension are 3 and 4.6 mcg/mL, respectively. T max occurs between 2 and 6 h following
administration of 400 mg and between 2 and 5 h after a 200 mg dose.
Distribution: Protein binding is about 65%.
Elimination: About 50% of absorbed dose is excreted unchanged in the urine in 24 h. Serum t
½averages 3 to 4 h, but may be as long as 9 h in some healthy subjects.

Azithromycin:
Absorption: Following oral administration, azithromycin is rapidly absorbed and widely distributed
throughout the body. Bioavailability is 37% following oral
administration. Absorption is not affected by food.

Distribution: Azithromycin is extensively distributed in tissues with tissue concentrations reaching

up to 50 times greater than plasma concentrations. Drug becomes concentrated within
macrophages and polymorphonucleocytes giving it good activity against Chlamydia trachomatis.

Elimination: Biliary excretion of azithromycin, predominantly as unchanged drug, is a major route

of elimination. The Half life being 68 hours.

Mechanism of Action: Like all betalactam antibiotics, cefixime binds to specific penicillinbinding
proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last
stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic
enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor. On
the other hand, like other macrolide antibiotics, azithromycin inhibits bacterial protein synthesis by
binding to the 50S ribosomal subunit of the bacterial 70S ribosome. Binding inhibits peptidyl
transferase activity and interferes with amino acid translocation during the process of translation.
Its effects may be bacteriostatic or bactericidal depending of the organism and the drug
concentration.

Adverse Effects:
● Diarrhea that is watery or bloody.
● Chest pain, uneven heartbeats.
● Nausea, stomach pain, low fever, loss of appetite, dark urine, claycolored stools, jaundice
(yellowing of the skin or eyes).
● Severe skin reaction fever, sore throat, swelling in your face or tongue, burning in your
eyes, skin. Contraindications: Known hypersensitivity to cefixime or other
 cephalosporins. Contraindicated in patients with a history of liver disease, kidney disease
and also muscle disease.

Drug Interactions:
●Carbamazepine: Elevated carbamazepine levels have been reported in postmarketing experience
when cefixime is administered concomitantly. Drug monitoring may be of assistance in detecting
alterations in carbamazepine plasma concentrations.

●Warfarin and Anticoagulants: Increased prothrombin time, with or without clinical bleeding, has
been reported when cefixime is administered concomitantly. Although most antibiotics probably do
not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their
effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or
rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control
methodswhile using this antibiotic. The risk of QT prolongation may be increased if you have
certain medical conditions or are taking other drugs that may cause QT prolongation. Before using
azithromycin, tell your doctor or pharmacist of all the drugs you take and if you have any of the
following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the
EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Precautions: ● Because azithromycin is principally eliminated via the liver, caution should be
exercised when azithromycin is administered to patients with impaired hepatic function. ● Take this
medication by mouth, with or without food. You may take this medication with food if stomach
upset occurs. ● During pregnancy, this medication should be used only when clearly needed.