Carbapenems API’s for Antibiotic Resistance

A new publication is out called “May 19, 2016 – Tackling Drug-Resistant Infections Globally: final report and recommendations” and it highlights the antibiotic-resistant infections which are being seen for the 1st time in the U.S.

The review says “superbugs” could kill 10 million people each year and cost the world $100 trillion in lost economic output by 2050.

For the first time, a 49-year-old woman in Pennsylvania was infected with an E. coli which carried a gene for resistance against the drug colistin. She was successfully treated with an antibiotic. But, the Centers for Disease Control and Prevention, says “Antibiotic resistance is exploding in numbers as well as severity and the trends are alarming”. Read Article

Amoxicillin Effective When Timed Optimally Before Surgery

Prophylactic Antibiotics Effective When Timed Optimally Before Surgery

Antibiotics, such as Amoxicillin, are extremely effectual when used appropriately prior to surgical procedures. The expiration of the potent antimicrobial drug Moxatag, also known as Amoxicillin, on October 13, 2020, paves the way for additional development of this generic powerhouse. Study results recently released in Infection Control and Hospital Epidemiology reveal that timing is crucial for the proper use of prophylactic antibiotic treatment. Patients who receive antibiotic prophylaxis approximately two hours before a surgical procedure have a significantly reduced risk of surgical site infections. This data, released by the Rambam Medical Center in Israel on January 15, 2014 indicates that post-surgical patients can absolutely benefit from antibiotic prophylaxis if timed perfectly. Patients who receive antibiotic doses either before the optimal two hour timeframe, or once incisions are made have proven to have notably diminished benefits for infection control.

The aforementioned ten year study in Israel involved 2,537 patients who were in need of preoperative antibiotic prophylaxis, specifically prior to cardiac surgery. Patients involved were given antibiotics at different times, including three hours before surgery, two hours prior to their procedure, one hour before surgery and after surgery was concluded. Data gleaned from this large and randomized study revealed that surgical site infections were least common among the patients who were given antibiotics approximately two hours prior to their surgery. Exactly 8.3 percent of the patient group that received preoperative antibiotic treatment exactly two hours before surgery developed a surgical site infection. This small number of patients is compared with 13.9 percent of patients who developed a surgical site infection, which included patients dosed with prophylactic antibiotics at different times, and not during two hour window prior to surgery. Antibiotics, specifically Amoxicillin are regularly dispensed to patients with heart conditions, such as a heart murmur, prior to both simple and complicated surgical procedures.

LGM Pharma is an Amoxicillin API supplier/distributor for research and development purposes, as well as the sole supplier/distributor of Amoxicillin TEVA API for compounding in the U.S.. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk

FDA Approves Dalbavancin for the Treatment of Acute Skin Infections

FDA Approved Dalbavancin CAS 171500-79-1 Acute Skin InfectionsExciting news was announced at the end of May 2014 from Durata Therapeutics with the FDA approval of Dalbavancin, their novel antibiotic treatment. Known as the brand name Dalvance, the FDA nod for Dalbavancin meets a current need for new, safe and efficacious antibiotics. Dalbavancin is officially approved to treat skin structure and bacterial skin infections in adults caused by gram-positive bacteria, which includes methicillin-resistant Staphylococcus aureus. As an effectual lipoglycopeptide, Dalbavancin works by interfering with cell wall synthesis, and is administered via an intravenous infusion. The IV infusion takes roughly thirty minutes to dispense, with the initial dose being 1000 milligrams. A follow up dose of 500 milligrams of Dalbavancin is administered one week after the first 1000 milligram dose.

Clinical trials showed Dalbavancin to be just as effective as Vancomycin for healing acute skin structure and bacterial skin infections. Adverse effects from Dalbavancin were uncommon, with the majority of complaints being diarrhea, nausea and headache. A rapid infusion of Dalbavancin should be avoided, however, due to a rare but possible risk of a reaction resembling red man syndrome. Dalbavancin will be available for clinicians as 500 milligram single use vials which need to be reconstituted with 25 milliliters of sterile water.

Studies of Dalbavancin have proven to be successful. One such study explored the treatment of acute bacterial skin and skin structure infections in older patients. These elderly patients suffered from cellulitis and had large lesions. The administration of Dalbavancin in these patients quickly elicited a substantial decrease in lesion size and abscesses proliferation. Additionally, patients with various subtypes of cellulitis showed similar positive outcomes after being administered with Dalbavancin. The option of outpatient dosing of Dalbavancin for patients offers a decrease in inpatient hospital stays, thus reducing overall risk of additional infections and also reducing the staggering cost of hospital care.

LGM Pharma is a provider of the API Dalbavancin, CAS# 171500-79-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

Weak Sales and a Recall of Daptomycin Reported

Daptomycin, recognized as the brand name antibiotic Cubicin, has a patent expiration of September 24, 2019. Cubist Pharmaceutical markets Cubicin and they recently released a report revealing surprisingly weak sales. Initially Cubist reported strong sales of Daptomycin for the first quarter of 2013, with an overall rise in their revenues due to this potent antibiotic. However, just a year later the story is quite different. While net sales of Daptomycin increased 9.4% to $202 million in the first quarter of 2013, sales of Cubicin {Daptomycin} fell 14.7 percent in the first quarter of 2014. Coupled with a recall for Lot # 280453F of Cubicin on April 18, 2014 due to suspected glass particulates, Cubist Pharmaceuticals is now looking to turn their situation around.

Daptomycin CAS 103060-53-3

Daptomycin is approved in the United States as well as in several other countries to treat serious bacterial, blood and skin or underlying tissue infections. This powerful antibiotic should not be given to patients who have severe kidney disease or are on dialysis. Patients who take certain drugs, specifically warfarin (Coumadin), atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev, Advicor), pravastatin (Pravachol), rosuvastatin (Crestor), simvastatin (Zocor, Simcor, Vytorin) and tobramycin (Nebcin) should not be administered Daptomycin without vigorous monitoring for severe adverse effects. Daptomycin is dispensed as an Intravenous Infusion and is typically administered every 24 hours. The time frame for dosing ranges from seven to ten days, depending on the type and severity of infection. Many patients are in a hospital setting or outpatient environment when they receive their dosing of Daptomycin. Side effects may include headache, nausea, back pain, vomiting and increased sweating.

LGM Pharma supplies Daptomycin, CAS number 103060-53-3, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

 

 

 

 

 

 

 

Metronidazole 1.3% Gel Approved by the FDA for BV

Metronidazole 1.3% Gel Approved by the FDA as an Antibiotic Treatment for Bacterial Vaginosis On March 25, 2014 Actavis and Valeant Pharmaceuticals announced the FDA approval of Metronidazole 1.3% gel for the antibiotic treatment of Bacterial Vaginosis. Bacterial Vaginosis, or BV, is an extremely common vaginal infection which commonly affects women between the ages of 15 and 44. An imbalance of normal bacteria in the vagina is the leading cause of BV. The approval of Metronidazole 1.3% gel is a financial boon for Actavis and Valeant Pharmaceuticals, as the Bacterial Vaginosis treatment market is valued at $140 million annually.

Metronidazole 1.3% gel is now available to women as an easy to use pre-filled disposable applicator. The convenience, as well as efficacy and tolerability of Metronidazole 1.3% gel makes this newly approved treatment for BV significant for the pharmaceutical industry. The safety profile of Metronidazole 1.3% gel was apparent, with very few patients experiencing negative side effects during trials. Common complaints included minor vulvovaginal candidiasis, nausea and headache. Untreated Bacterial Vaginosis can lead to fertility issues, a heightened risk for sexually transmitted diseases and a serious pelvic infection or pelvic inflammatory disease. Antibiotic medications, such as an efficacious gel like Metronidazole, will help ensure that women affected with this regularly diagnosed condition will have proper and timely treatment.

The approval of the 1.3% gel was based on the successful results from a Phase III double-blind, placebo-controlled, randomized and multicenter trial. The higher dosage of Metronidazole proved to be well tolerated and a more effective option for some cases of BV when compared to MetroGel-Vaginal, also known as Metronidazole 0.75% gel. Certain cases of Bacterial Vaginosis require a higher strength treatment with Metronidazole, and the 1.3% gel offers this option.

LGM Pharma provides the API Metronidazole CAS# 443-48-1 for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.