Luhan Pharmachem Co., Ltd.

Luhan pharmachem Co., Ltd. supplies Tigecycline bulk active pharmaceutical ingredient (API) to the pharmaceutical industry. Our Tigecycline is manufactured by cGMP compliant facility. Welcome to contact us for further details including current DMF status for the product and up to date regulatory status of the manufacturing facility. We look forward to assisting you with your research and development projects.

What is Tigecycline?

Tigecycline is an injection that is usually given by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose. If you feel that the medicine is making you feel unwell or you think it is not working, you should talk to someone who is involved in your care.

Tigecycline is used to treat certain types of bacterial infections. It works by killing certain types of bacteria.

How does Tigecycline work?

This antibiotic is the first clinically-available drug in a new class of antibiotics called the glycylcyclines. It is structurally similar to the tetracyclines in that it contains a central four-ring carbocyclic skeleton and is actually a derivative of minocycline. Tigecycline has a substitution at the D-9 position which is believed to confer broad spectrum activity. The drug inhibits the bacterial 30S ribosome and is bacteriostatic.

Who should not use Tigecycline?

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

• are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine or to medicines similar to Tigecycline such as tetracyclines
• have biliary problems
• have liver problems

Furthermore the prescriber may only prescribe Tigecycline with special care or may not prescribe it at all for someone under 18 years of age.

How should I use Tigecycline?

Posology

The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.

The duration of therapy should be guided by the severity, site of the infection, and the patient’s clinical response.

Hepatic insufficiency

No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).

In patients with severe hepatic impairment (Child Pugh C), the dose of Tigecycline should be reduced to 25 mg every 12 hours following the 100 mg loading dose. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response.

Renal insufficiency

No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.

What happens if I overdose?

In the case of Tigecycline, the person who is responsible for giving you your medicine will make sure that you are given the correct dose.

What should I avoid while using Tigecycline?

Anaphylaxis/anaphylactoid reactions, potentially life-threatening, have been reported with tigecycline.

Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics. Tigecycline may have adverse reactions similar to tetracycline class antibiotics. Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia.

Acute pancreatitis, which can be serious, has occurred (frequency: uncommon) in association with tigecycline treatment. The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis. Most of the reported cases developed after at least one week of treatment. Cases have been reported in patients without known risk factors for pancreatitis. Patients usually improve after tigecycline discontinuation. Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis.

Experience in the use of tigecycline for treatment of infections in patients with severe underlying diseases is limited.

Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock.

The effect of cholestasis in the pharmacokinetics of tigecycline has not been properly established. Biliary excretion accounts for approximately 50 % of the total tigecycline excretion. Therefore, patients presenting with cholestasis should be closely monitored.

Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants.

Tigecycline should not be used in children under 8 years of age because of teeth discoloration, and is not recommended in adolescents below 18 years due to the lack of data on safety and efficacy.

What are the possible side effects of Tigecycline?

Very common: More than 10% of people who take Tigecycline

• diarrhea – seek medical advice if you get diarrhea
• nausea
• vomiting

Common: Between 1% and 10% of people who take Tigecycline

• abnormal laboratory test results
• abscess
• changes in blood clotting time
• death
• dizziness
• headaches
• indigestion
• infections
• itching
• loss of appetite
• phlebitis
• skin rash or rashes
• stomach pain

Uncommon: Between 0.1% and 1% of people who take Tigecycline

• injection site problems such as pain, inflammation or edema
• jaundice
• liver problems
• metabolic problems
• pancreatitis
• sepsis
• septic shock
• thrombophlebitis

What other drugs will affect Tigecycline?

The following medicines may interact with Tigecycline:

• warfarin

The following types of medicine may interact with Tigecycline:

• anticoagulants
• oral contraceptives

Where can I get more information?

If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Storage

Store Tigecycline at or below 25 degrees C.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.