Tygin

Tygin

tigecycline

Manufacturer:

Able Medical

Distributor:

Able Medical

Marketer:

Able Medical
Concise Prescribing Info
Contents
Tigecycline
Indications/Uses
Complicated skin & skin structure, intra-abdominal infections & community-acquired bacterial pneumonia (CABP) caused by susceptible bacteria in patients ≥18 yr.
Dosage/Direction for Use
IV Administer over approx 30-60 min every 12 hr. Adult Initially 100 mg, followed by 50 mg every 12 hr. Treatment duration: Complicated skin & skin structure infections or complicated intra-abdominal infections (cIAI) 5-14 days. CABP 7-14 days. Absence of alternative antibacterial drugs in ped patient 12-17 yr 50 mg every 12 hr, 8-11 yr 1.2 mg/kg every 12 hr. Max: 50 mg every 12 hr. Severe hepatic impairment (Child Pugh C) Initially 100 mg followed by reduced maintenance dose of 25 mg every 12 hr.
Contraindications
Hypersensitivity including anaphylactic reaction.
Special Precautions
Anaphylactic reactions. Discontinue ongoing antibiotic use not directed against Clostridium difficile if Clostridium difficile-associated diarrhea (CDAD) is suspected or confirmed. Not for diabetic foot infections. Avoid in patients w/ known hypersensitivity to tetracycline-class antibacterials; as monotherapy in cIAI secondary to clinically apparent intestinal perforation. Consider cessation of treatment in cases suspected of developing pancreatitis. Acute pancreatitis; significant hepatic dysfunction & hepatic failure; hypofibrinogenemia; enamel hypoplasia; CDAD ranging from mild diarrhea to fatal colitis. Photosensitivity, pseudotumor cerebri & anti-anabolic action (leading to increased BUN, azotemia, acidosis & hyperphosphatemia). Monitor for evidence of worsening hepatic function & evaluate for risk/benefit of continuing therapy in patients who develop abnormal LFTs during therapy. Increase in all-cause mortality; risk of development of drug-resistant bacteria when used in absence of proven or strongly suspected bacterial infection; total bilirubin conc, prothrombin time & transaminases. Patients w/ ventilator-associated pneumonia. Obtain baseline blood coagulation parameters, including fibrinogen & continue to monitor regularly during treatment. Reserved for use in situations when alternative treatments are not suitable. May affect ability to drive & use machines. Severe hepatic impairment (Child Pugh C). Advise patients of potential risk to fetus if used during 2nd or 3rd trimester of pregnancy. May cause permanent discoloration of deciduous teeth (yellow-gray-brown) & reversible inhibition of bone growth when administered during 2nd & 3rd trimester of pregnancy, infancy & childhood to 8 yr. Lactation. Avoid use in ped patients. Ped patients w/ hepatic impairment. Decrease in fibula growth rate in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hr.
Adverse Reactions
Abdominal pain, abscess, asthenia, headache, infection; phlebitis; diarrhea, dyspepsia, nausea, vomiting; anemia; bilirubinemia, abnormal healing, hyponatremia, hypoproteinemia, increased alkaline phosphatase, amylase, BUN, SGOT & SGPT; pneumonia; dizziness; rash.
Drug Interactions
Monitor prothrombin time or other suitable anticoagulation test when used concomitantly w/ warfarin. Increased serum trough conc of calcineurin inhibitors eg, tacrolimus. Reduced effectiveness of OCs.
MIMS Class
Tetracyclines
ATC Classification
J01AA12 - tigecycline ; Belongs to the class of tetracyclines. Used in the systemic treatment of infections.
Presentation/Packing
Form
Tygin powd for soln for infusion 50 mg
Packing/Price
1's
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