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Country of origin : Colombia

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aztreonam

Vials, injection 1 g

Dossier type
CTD
Dossier status
Ready to file
Country of origin
Colombia
GMP approvals
INVIMA
Manufacturer #18604
The company has more than 40 years of experience. in the development and commercialization of sterile drugs, with a presence in 22 Latin American countries, Asia and Africa. The mission of the company is to preserve health by supplying sterile drugs and pharmaceutical services that generate value for the community and its shareholders.

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Aztreonam

Aztreonam is an antibiotic. It is prescribed primarily in the treatment of infections caused by gram-negative bacteria such as Pseudomonas aeruginosa which include bone infections, endometritis, intra-abdominal infections, urinary tract infections, pneumonia, and sepsis. Aztreonam is a manufactured version of a chemical from the bacterium Chromobacterium violaceum. Aztreonam’s nebulized forms are treat infections resulting from complications of cystic fibrosis in Europe and the US and used off-label to treat non-CF bronchiectasis, ventilator- associated pneumonia, COPD, mycobacterial disease, infections resulting from lung transplants. Aztreonam is sold under the brand names Azactam, and Cayston among others. The first patent was assigned to E. R. SQUIBB & SONS, INC in 1981 and later approved for sales in the United States in 1986. The World Health Organization calls it critically important for human medicine is now sold as a generic medication. It was removed from the WHO’s List of Essential Medicines in 2019.

Dosage Forms & Strengths

Aztreonam is recommended as an intravenous or intramuscular injection or inhaled through an ultrasonic nebulizer in the United States, after receiving approval from the FDA approved 2010, for the suppression of P. aeruginosa infections in patients with cystic fibrosis. It also got conditional approval in Canada and the EU in 2009 and has been fully approved in Australia. It is sold as a solution for inhalation in 75mg units and as a powder for injection in 1g and 2g units. In the treatment of Moderately severe systemic Infections, the dose is 1-2 g every 8 to 12hr with a max does cap at 8 g per day and for Severe or life-threatening, this dose is doubled at 2g given every 6 to 8 hours. For treating Pseudomonal Infections, the dose is 2 g every 6 to 8 hours, and for treating Urinary Tract Infections, it is 0.5 to 1 g every 8 to 12 hours. For treating Cystic fibrosis, the patient is given a 75 mg dose via nebulizer, every 8 hours for 28 days. The does should be at least 4 hr apart and should not exceed 28 days.

The Cost for Aztreonam

The in the USA, the consumers have to pay a cost of around $239 for a supply of 10 powder for injections of 1 g. The same 1g supply can be bought for less than USD 10 in India.

How does Aztreonam work?

Aztreonam actions are similar to penicillin as it inhibits synthesis of the bacterial cell wall. It does this by blocking peptidoglycan crosslinking. It has a mild affinity for penicillin-binding protein-1a and a high affinity for penicillin-binding protein-3. Its actions bind the penicillin- binding proteins of Gram-positive and anaerobic bacteria so it is not effective against other bacteria. Aztreonam is less bactericidal than some other cephalosporins. It has strong activity against susceptible Gram-negative bacteria, including Pseudomonas aeruginosa. It is resistant to some beta-lactamases and is inactivated by extended-spectrum beta- lactamases.

Finding Aztreonam Manufacturers and Suppliers:

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