an ultra-broad-spec...

an ultra-broad-spectrum injectable antibiotic Doripenem hydrate

an ultra-broad-spectrum injectable antibiotic Doripenem hydrate

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1 Gram

FOB Price: USD 0.1000

  • Min.Order :1 Gram
  • Purity: 99.9%
  • Payment Terms : L/C,D/A,D/P,T/T,

Keywords

Doripenem hydrate Doripenem Doripenem Monohydrate

Quick Details

  • Appearance:White to off white powder
  • Application:Doripenem injection is used to treat serious infections of the urinary tract, kidney, and abdomen that are caused by bacteria. Doripenem injection is not approved by the Food and Drug Administration (
  • PackAge:1 kgs/Tin, 25kgs/Tin
  • ProductionCapacity:1|Metric Ton|Month
  • Storage:0-6℃ storage
  • Transportation:By Air, By Sea or By Courier

Superiority:

Doripenem hydrate(Doripenem Monohydrate/Doripenem)

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GMP,FDA,CEP,COS,ANDA

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Process

  • Doripenem (common name doripenem monohydrate) is an ultra-broad-spectrum injectable antibiotic. It is a beta-lactam and belongs to the subgroup of carbapenems. It is particularly active against Pseudomonas aeruginosa.

  • Doripenem can be used for bacterial infections such as: complex abdominal infections, pneumonia within the setting of a hospital, and complicated infections of the urinary tract including kidney infections with septicemia. Doripenem decreases the process of cell wall growth, which eventually leads to elimination of the infectious cell bacteria altogether.
    It is recommended that those allergic to doripenem or to any type of beta-lactam antibiotics such as cephalosporin or other Carbapenems not receive doripenem.
    Doripenem was approved by the United States Food and Drug Administration on October 12, 2007, to be sold under the tradename Doribax.It is the fourth member of the carbapenem class to be approved in the United States. The greater stability of doripenem in aqueous solution compared to earlier members of the carbapenem class allows it to be administered as an infusion over 4 hours or more, which may be advantageous in the treatment of certain difficult-to-treat infections.It may present a lower risk of inducing seizures than other carbapenems
  • Chemistry and Pharmacology
    Doripenem is a beta-lactam antibiotic agent belonging to the carbapenem group, with a broad spectrum of bacterial sensitivity including both gram-positive and gram-negative bacteria. In vivo, doripenem inhibits the synthesis of cell walls by attaching itself to penicillin-binding proteins, also known as PBPs. However it is not active against MRSA. It is stable against beta-lactamases including those with extended spectrum, but it is susceptible to the action of carbapenemases. Doripenem is also more active against Pseudomonas aeruginosa then other carbapenems.
    Physicochemical Properties
    Doripenem appears as crystalline powder anywhere from a white to somewhat yellowish colour.Doripenem is moderately soluble in water, slightly soluble in methanol, and virtually insoluble in ethanol. Doripenem is also solution in N,N-dimethylformamide. Doripenem's chemical configuration has 6 asymmetrical carbon atoms (6 stereocentres) and is most commonly supplied as one pure isomer. In terms of doripenem for injection, the crystallized powered drug can form a monohydrate when mixed with water. However, Doripenem has not been proven to possess polymorphism.
    Adverse effects
    Seizure risk: carbapenems in general have been reported to cause seizure activity in some people.In addition, those who already have a seizure disorder may be at risk for further seizures if they are using valproic acid to control their seizures; doripenem has been found to decrease serum concentrations of valproic acid.
    Infection related: use of doripenem can lead to clostridium difficile infection.It has also been noted to increase mortality in people who have ventilator-associated bacterial pneumonia, and is no longer recommended as a treatment for this condition.
    Resistance[edit]Potential avenues for the development of resistance to doripenem are: altered PBPs (penicillin-binding protein), reduced activity in the permeability of the outer membrane especially when accepting foreign toxic substances within the cell, and deactivation of the drug by hydrolyzing enzymes from the carbapenem. Beta-lactamases (such as penicillinases) formed by gram-positive and gram-negative bacteria can stabilize doripenem to hydrolysis. However, carbapenem-hydrolyzing beta-lactamases are an exception. Doripenem is the antibiotic specially suitable for children to treat nosocomial pneumonia.
    Pharmacokinetics
    Distribution On average, about 8.1% of plasma proteins attached to doripenem; it is separate from drug concentrations of plasma. Doripenem’s distribution volume is close to that of extracellular fluid volume in humans (18.2 L). When doripenem is essentially stable, the average volume of distribution is approximately 16.8 L. Within the few of the body’s fluids and tissues, Doripenem is filtered successfully as well as reaching concentration levels that are able to restrain from more vulnerable bacteria than what is required.
    Metabolism
    Doripenem is metabolized by the enzyme dehydropeptidase-I into an inactive ring-opened metabolite.
    Excretion
    In young and healthy adults, the elimination half-life of doripenem considering the average plasma terminal is normally around 1 hour. The plasma clearance is about 15.9 L/hour and the average renal clearance is 10.3 L/hour. Research indicates doripenem is filtered by the glomerular capillary bed in Bowman’s capsule and the tubular

     

 

 

Details:

Product Details

Why is this medication prescribed?

Doripenem injection is used to treat serious infections of the urinary tract, kidney, and abdomen that are caused by bacteria. Doripenem injection is not approved by the Food and Drug Administration (FDA) to treat pneumonia that developed in people who were on a ventilator in a hospital. Doripenem injection is in a class of medications called carbapenem antibiotics. It works by killing bacteria. Antibiotics will not work for colds, flu, or other viral infections.

How should this medicine be used?

Doripenem injection comes as a liquid to be injected intravenously (into a vein). It is usually given every 8 hours. The length of your treatment depends on the type of infection being treated. After your condition improves, your doctor may switch you to another antibiotic that you can take by mouth to complete your treatment. You may receive doripenem injection in a hospital or you may administer the medication at home. If you are using doripenem injection at home, use it at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use doripenem injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You should begin to feel better during the first few days of treatment with doripenem injection. If your symptoms do not improve or get worse, call your doctor.

Use doripenem injection until you finish the prescription, even if you feel better. If you stop using doripenem injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before using doripenem injection,

  • tell your doctor and pharmacist if you are allergic to doripenem injection; other carbapenem antibiotics such as imipenem/cilastatin (Primaxin) or meropenem (Merrem); penicillins; cephalosporin antibiotics such as cefaclor, cefadroxil, cefuroxime (Ceftin, Zinacef), or cephalexin (Keflex); aztreonam (Azactam); or any other medications.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the following: probenecid (Probalan, in Col-Probenecid) and valproic acid (Depakene). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have any allergies and if you have or have ever had a stroke, seizures or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using doripenem injection, call your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What side effects can this medication cause?

Doripenem injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • nausea
  • diarrhea
  • redness, pain, or swelling at the injection site

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • hives
  • itching
  • rash
  • blisters on the skin, mouth, nose, and eyes
  • sloughing (shedding) of skin
  • fever
  • difficulty breathing or swallowing
  • seizures
  • watery or bloody stools (up to 2 months after your treatment)
  • excessive tiredness
  • weakness
  • shortness of breath
  • pale skin

Doripenem may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about storage and disposal of this medication?

If you will be injecting doripenem injection at home, your health care provider will tell you where you should store it and how long you may keep it. Follow these directions carefully. Be sure to store doripenem injection in the container it came in and out of reach of children. Throw away any medication that is outdated or no longer needed. Talk to your health care provider about the proper disposal of your medication

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to doripenem injection.

Do not let anyone else take your medication. If you still have symptoms of infection after you finish doripenem injection, talk to your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

 

 

Packaging 

The packaging can be customized, normally, 1kgs/Tin, or 5kgs/Tin or per drums

Company Introduction

Top Pharm Chemical Group is specialized in the New Drug Researching and Developing, and mainly manufacture Chemical Intermediates,  Pharmaceutical APIs and Pilot Production. To meet customers regulatory needs, we can offer products from gram to kilo and tons scale, and we can also support our customers with the DMF and other documents to Complete the registration.  

Our Targets:

"Best Technic; Better Quality; Better Price; Better Service"

Main Products:

Anidulafungin,Micafungin,Caspofungin,Posaconazole etc. (Anti-Infective)

Ixabepilone, Argatroban, Decitabine, Everolimus etc. (Anti-Tumor)

Epothilone B, Tacrolimus, Rapamycin,Temsirolimus etc. (Fermentation)

Bimatoprost, Latanoprost, Travoprost, Cloprostenol etc.(Prostaglandins)

 

 

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