Tigecycline

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Generic Name: Tigecycline Brand Name(s): Generics only. No brands available.

Uses

What is Tigecycline used for?

Tigecycline is used to treat certain serious bacterial infections when other antibiotics may not work. It is related to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria.

This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How should I take Tigecycline?

This medication is given by injection into a vein over 30 to 60 minutes by a healthcare professional. It is given as directed by your doctor, usually every 12 hours. The dosage is based on your medical condition and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Swirl the medication gently to mix. Do not shake. The mixed medication should be yellow to orange in color. Before using, check this product visually for particles or green/black discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same times every day.

Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

How do I store Tigecycline?

Store unmixed powder at room temperature away from moisture and heat.

Mixed medicine in an IV bag may be kept at cool room temperature. But you must use the medicine within 24 hours (up to 6 hours in the vial and the other 18 hours in the IV bag).

Tigecycline mixed in an IV bag with 0.9% sodium chloride or 5% dextrose solution may be stored in a refrigerator and used within 48 hours.

There may be different brands of Tigecycline that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Tigecycline down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Tigecycline?

Before using tigecycline, tell your doctor or pharmacist if you are allergic to it; or to tetracyclines (such as doxycycline, minocycline, tetracycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

This drug may make you dizzy. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Tigecycline may cause live bacterial vaccines (such as typhoid vaccine) to not work as well. Do not have any immunizations/vaccinations while using this medication unless your doctor tells you to.

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children younger than 8 years may be more sensitive to the side effects of tigecycline, especially tooth discoloration. Tooth discoloration has also occurred in older children and in young adults. Discuss the risks and benefits of this medication with the doctor.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tigecycline. Tigecycline may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of possible risk to the infant, consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Tigecycline during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Tigecycline. Tigecycline is pregnancy risk category D according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Tigecycline?

Nausea, vomiting, headache, dizziness, or pain/swelling at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), unusual fatigue, severe stomach/abdominal pain, hearing changes (such as ringing in the ears, decreased hearing), irregular heartbeat, easy bleeding/bruising, yellowing of the eyes or skin, dark urine.

Tetracycline drugs such as tigecycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after tigecycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: headaches that are severe or don’t go away, nausea/vomiting that doesn’t stop, vision changes (such as blurred/double vision, decreased vision, sudden blindness).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn’t stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Tigecycline?

Some products that may interact with this drug are: retinoid medications taken by mouth (such as acitretin, isotretinoin).

Although most antibiotics are unlikely to affect hormonal birth control such as pills, patch, or ring, a few antibiotics (such as rifampin, rifabutin) can decrease their effectiveness. This could result in pregnancy. If you use hormonal birth control, ask your doctor or pharmacist for more details.

Tigecycline may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Tigecycline?

Tigecycline may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Tigecycline?

Tigecycline may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Tigecycline.

What is the dose of Tigecycline for an adult?

Usual Adult Dose for Intraabdominal Infection

100 mg IV initial dose, followed by 50 mg IV every 12 hours

Duration of therapy: 5 to 14 days

Use: For the treatment of complicated intraabdominal infections due to susceptible isolates of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, K pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus group (includes S anginosus, S intermedius, and S constellatus), Bacteroides fragilis, B thetaiotaomicron, B uniformis, B vulgatus, Clostridium perfringens, and Peptostreptococcus micros

Usual Adult Dose for Skin or Soft Tissue Infection

100 mg IV initial dose, followed by 50 mg IV every 12 hours

Duration of therapy: 5 to 14 days

Comments:

-This drug is not indicated for the treatment of diabetic foot infections; a clinical trial failed to show its non-inferiority.

Use: For the treatment of complicated skin and skin structure infections due to susceptible isolates of E coli, E faecalis (vancomycin-susceptible isolates), S aureus (methicillin-susceptible and -resistant isolates), S agalactiae, S anginosus group (includes S anginosus, S intermedius, and S constellatus), S pyogenes, E cloacae, K pneumoniae, and B fragilis

Usual Adult Dose for Skin and Structure Infection

100 mg IV initial dose, followed by 50 mg IV every 12 hours

Duration of therapy: 5 to 14 days

Comments:

-This drug is not indicated for the treatment of diabetic foot infections; a clinical trial failed to show its non-inferiority.

Use: For the treatment of complicated skin and skin structure infections due to susceptible isolates of E coli, E faecalis (vancomycin-susceptible isolates), S aureus (methicillin-susceptible and -resistant isolates), S agalactiae, S anginosus group (includes S anginosus, S intermedius, and S constellatus), S pyogenes, E cloacae, K pneumoniae, and B fragilis

Usual Adult Dose for Pneumonia

100 mg IV initial dose, followed by 50 mg IV every 12 hours

Duration of therapy: 7 to 14 days

Comments:

-This drug is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia; greater mortality and decreased efficacy reported in comparative clinical trial.

Use: For the treatment of community-acquired bacterial pneumonia due to susceptible isolates of S pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae, and Legionella pneumophila

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Adult patients:

-Mild to moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended.

-Severe liver dysfunction (Child-Pugh C): 100 mg IV initial dose, followed by 25 mg IV every 12 hours

Comments:

-Caution recommended in patients with severe liver dysfunction; such patients should be monitored for treatment response.

Dialysis

Hemodialysis: No adjustment recommended.

Other Comments

Administration advice:

-Reserve this drug for situations when alternative therapies are not suitable.

-Administer IV infusions over about 30 to 60 minutes; administer through a dedicated line or through a Y-site.

-If the same IV line is used for sequential infusion of several drugs, flush the line before and after infusion of this drug with an infusion solution compatible to all drugs; the manufacturer product information should be consulted.

-Duration of therapy should be guided by severity and site of infection and clinical and bacteriological progress of the patient.

Storage requirements:

-Prior to reconstitution: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F)

-After reconstitution: May store at room temperature (not to exceed 25C [77F]) for up to 24 hours (up to 6 hours in the vial and the remaining time in the IV bag); if storage conditions exceed 25C (77F), use immediately. Alternatively, if mixed with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP, may store refrigerated at 2C to 8C (36F to 46F) for up to 48 hours after immediate transfer of reconstituted solution into the IV bag

Reconstitution/preparation techniques:

-This drug must be reconstituted and then further diluted; the manufacturer product information should be consulted.

IV compatibility:

-Compatible IV solutions: 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; Lactated Ringer’s Injection, USP

-Compatible drugs/diluents for administration through a Y-site (when used with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP): Amikacin, dobutamine, dopamine hydrochloride (HCl), gentamicin, Lactated Ringer’s, lidocaine HCl, metoclopramide, morphine, norepinephrine, potassium chloride, propofol, ranitidine HCl, theophylline, tobramycin

-Incompatible drugs: Amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, omeprazole

-The manufacturer product information should be consulted regarding compatibility of haloperidol and piperacillin-tazobactam (ethylenediaminetetraacetic acid [EDTA] formulation).

General:

-To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria.

-Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

-Appropriate specimens should be obtained for bacteriological examination to isolate and identify causative organisms and determine susceptibility to this drug; may start this drug as empiric monotherapy before test results are known

-Some products may contain 100 mg lactose monohydrate or maltose monohydrate per vial; if the formulation containing maltose is substituted for another formulation, glucose testing methods that do not react with maltose should be used.

Monitoring:

-General: For treatment response in patients with severe liver dysfunction

-Hepatic: For worsening hepatic function in patients who develop abnormal liver function tests (during therapy)

Patient advice:

-Avoid missing doses and complete the entire course of therapy.

-Consult healthcare provider if severe watery or bloody diarrhea develops.

What is the dose of Tigecycline for a child?

Usual Pediatric Dose for Intraabdominal Infection

Proposed for complicated infections:

8 to 11 years: 1.2 mg/kg IV every 12 hours

Maximum dose: 50 mg/dose

12 to 17 years: 50 mg IV every 12 hours

Comments:

-Use of this drug should be avoided unless no alternative antibacterial agents are available.

-Safety and efficacy of proposed dosing regimens have not been evaluated due to observed increase in mortality associated with this drug in adult patients.

-Proposed doses based on exposures seen in pharmacokinetic trials (small numbers of pediatric patients included).

Usual Pediatric Dose for Skin and Structure Infection

Proposed for complicated infections:

8 to 11 years: 1.2 mg/kg IV every 12 hours

Maximum dose: 50 mg/dose

12 to 17 years: 50 mg IV every 12 hours

Comments:

-Use of this drug should be avoided unless no alternative antibacterial agents are available.

-Safety and efficacy of proposed dosing regimens have not been evaluated due to observed increase in mortality associated with this drug in adult patients.

-Proposed doses based on exposures seen in pharmacokinetic trials (small numbers of pediatric patients included).

Usual Pediatric Dose for Pneumonia

Proposed for community-acquired bacterial pneumonia:

8 to 11 years: 1.2 mg/kg IV every 12 hours

Maximum dose: 50 mg/dose

12 to 17 years: 50 mg IV every 12 hours

Comments:

-Use of this drug should be avoided unless no alternative antibacterial agents are available.

-Safety and efficacy of proposed dosing regimens have not been evaluated due to observed increase in mortality associated with this drug in adult patients.

-Proposed doses based on exposures seen in pharmacokinetic trials (small numbers of pediatric patients included).

Precautions

Safety and efficacy have not been established in patients younger than 18 years; this drug is not recommended for use in these patients.

-If no alternative antibacterial agents are available: Pediatric regimens have been suggested; this drug is not recommended for use in children younger than 8 years (due to effects on tooth development).

How is Tigecycline available?

Tigecycline is available in the following dosage forms and strengths:

  • Intravenous powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Tigecycline, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: May 10, 2018 | Last Modified: May 10, 2018

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