Tecline (WOCKHARDT)

Complicated Skin and Skin Structure Infections

Tecline (WOCKHARDT) for injection is indicated in patients 18 years of age and older for the treatment of complicated skin and skin structure infections caused by susceptible isolates of Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae, and Bacteroides fragilis.

Complicated Intra-abdominal Infections

Tecline (WOCKHARDT) for injection is indicated in patients 18 years of age and older for the treatment of complicated intra-abdominal infections caused by susceptible isolates of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

Community-Acquired Bacterial Pneumonia

Tecline (WOCKHARDT) for injection is indicated in patients 18 years of age and older for the treatment of community-acquired bacterial pneumonia caused by susceptible isolates of Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae, and Legionella pneumophila.

Limitations of Use

Tecline (WOCKHARDT) is not indicated for the treatment of diabetic foot infections. A clinical trial failed to demonstrate non-inferiority of Tecline (WOCKHARDT) for treatment of diabetic foot infections.

Tecline (WOCKHARDT) is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia. In a comparative clinical trial, greater mortality and decreased efficacy were reported in Tecline (WOCKHARDT)-treated patients.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tecline (WOCKHARDT) and other antibacterial drugs, Tecline (WOCKHARDT) should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to Tecline (WOCKHARDT). Tecline (WOCKHARDT) may be initiated as empiric monotherapy before results of these tests are known.

Tecline (WOCKHARDT) is an antibiotic that fights bacteria in the body.

Tecline (WOCKHARDT) is used to treat many different bacterial infections of the skin or the digestive system, as well as pneumonia.

Tecline (WOCKHARDT) should be used only for infections that cannot be treated with other medicines.

Tecline (WOCKHARDT) may also be used for purposes not listed in this medication guide.

The recommended dosage regimen for Tecline (WOCKHARDT) is an initial dose of 100 mg, followed by 50 mg every 12 hrs.

Intravenous (IV) infusion of Tecline (WOCKHARDT) should be administered over approximately 30 to 60 min every 12 hrs.

The recommended duration of treatment with Tecline (WOCKHARDT) for cSSSI or for cIAI is 5 to 14 days. The recommended duration of treatment with Tecline (WOCKHARDT) for CAP is 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient’s clinical and bacteriological progress.

Patients with Renal Impairment: No dosage adjustment of Tecline (WOCKHARDT) is necessary in patients with renal impairment or in patients undergoing hemodialysis.

Patients with Hepatic Impairment: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). Based on the pharmacokinetic profile of Tecline (WOCKHARDT) in patients with severe hepatic impairment (Child Pugh C), the dose of Tecline (WOCKHARDT) should be altered to 100 mg followed by 25 mg every 12 hrs.

Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response.

Children: Clinical trials to establish the safety and effectiveness of Tecline (WOCKHARDT) in patients under 18 years have not been conducted. Therefore, use in patients under 18 years is not recommended unless no alternative antibacterial drugs are available.

Under these circumstances, the following doses are suggested.

Pediatric patients 8 to 11 years should receive 1.2 mg/kg of Tecline (WOCKHARDT) every 12 hrs intravenously to a maximum dose of 50 mg of Tecline (WOCKHARDT) every 12 hrs.

Pediatric patients 12 to 17 years should receive 50 mg of Tecline (WOCKHARDT) every 12 hrs.

The proposed pediatric doses of Tecline (WOCKHARDT) were chosen based on exposures observed in pharmacokinetic trials, which included small numbers of pediatric patients.

Elderly: In a pooled analysis of 3900 subjects who received Tecline (WOCKHARDT) in Phase 3 and 4 clinical studies, 1026 were 65 years and over. Of these, 419 were 75 years and over. No unexpected overall differences in safety were observed between these subjects and younger subjects. No dosage adjustment is necessary in elderly patients.

Race and Gender: No dosage adjustment is necessary based on race or gender.

Administration:

Intravenous infusion.

See also:
What is the most important information I should know about Tecline (WOCKHARDT)?

Do not use this medicine if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Tecline (WOCKHARDT) can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using Tecline (WOCKHARDT).

You should not use this medication if you are allergic to Tecline (WOCKHARDT).

Children should not use Tecline (WOCKHARDT). Tecline (WOCKHARDT) can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Before using Tecline (WOCKHARDT), tell your doctor if you are allergic to a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap). Also tell your doctor if you have liver disease or if you are using a blood thinner such as warfarin (Coumadin, Jantoven).

You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection, and how to properly mix and store the medication.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Avoid exposure to sunlight or tanning beds. Tecline (WOCKHARDT) can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Use Tecline (WOCKHARDT) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tecline (WOCKHARDT) is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Tecline (WOCKHARDT) at home, carefully follow the injection procedures taught to you by your health care provider.
• Tecline (WOCKHARDT) should be yellow to orange in color. If it contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• To clear up your infection completely, take Tecline (WOCKHARDT) for the full course of treatment. Keep taking it even if you feel better in a few days.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If you miss a dose of Tecline (WOCKHARDT), use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tecline (WOCKHARDT).

Tecline (WOCKHARDT) is used to treat various types of infections such as complicated skin and skin structure infections, complicated intra-abdominal infections and community-acquired bacterial pneumonia.

See also:
What other drugs will affect Tecline (WOCKHARDT)?

Tecline (WOCKHARDT) (100 mg followed by 50 mg every 12 hours) and digoxin (0.5 mg followed by 0.25 mg every 24 hours) were co-administered to healthy subjects in a drug interaction study. Tecline (WOCKHARDT) slightly decreased the C_max of digoxin by 13%, but did not affect the AUC or clearance of digoxin. This small change in C_max did not affect the steady-state pharmacodynamic effects of digoxin as measured by changes in ECG intervals. In addition, digoxin did not affect the pharmacokinetic profile of Tecline (WOCKHARDT). Therefore, no dosage adjustment is necessary when Tecline (WOCKHARDT) is administered with digoxin.

Concomitant administration of Tecline (WOCKHARDT) (100 mg followed by 50 mg every 12 hours) and warfarin (25 mg single dose) to healthy subjects resulted in a decrease in clearance of R-warfarin and S-warfarin by 40% and 23%, and an increase in AUC by 68% and 29%, respectively. Tecline (WOCKHARDT) did not significantly alter the effects of warfarin on increased international normalized ratio (INR). In addition, warfarin did not affect the pharmacokinetic profile of Tecline (WOCKHARDT). However, prothrombin time or other suitable anticoagulation tests should be monitored if Tecline (WOCKHARDT) is administered with warfarin.

In vitro studies in human liver microsomes indicate that Tecline (WOCKHARDT) does not inhibit metabolism mediated by any of the following 6 cytochrome CYP450 isoforms: 1A2, 2C8, 2C9, 2C19, 2D6, and 3A4. Therefore, Tecline (WOCKHARDT) is not expected to alter the metabolism of drugs metabolized by these enzymes. In addition, because Tecline (WOCKHARDT) is not extensively metabolized, clearance of Tecline (WOCKHARDT) is not expected to be affected by drugs that inhibit or induce the activity of these CYP450 isoforms.

In vitro studies using Caco-2 cells indicate that Tecline (WOCKHARDT) does not inhibit digoxin flux, suggesting that Tecline (WOCKHARDT) is not a P-glycoprotein (P-gp) inhibitor. This in vitro information is consistent with the lack of effect of Tecline (WOCKHARDT) on digoxin clearance noted in the in vivo drug interaction study described above.

Tecline (WOCKHARDT) is a substrate of P-gp based on an in vitro study using a cell line overexpressing P-gp. The potential contribution of P-gp-mediated transport to the in vivo disposition of Tecline (WOCKHARDT) is not known. Co-administration of P-gp inhibitors (e.g., ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of Tecline (WOCKHARDT).

Concurrent use of antibiotics with oral contraceptives may render oral contraceptives less effective.

Interference with Laboratory and Other Diagnostic Tests: There are no reported drug-laboratory test interactions.

See also:
What are the possible side effects of Tecline (WOCKHARDT)?

Clinical Trials Experience: Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 2514 patients were treated with Tecline (WOCKHARDT). Tecline (WOCKHARDT) was discontinued due to adverse reactions in 7% of patients compared to 6% for all comparators. Table 11 shows the incidence of treatment-emergent adverse reactions through test of cure reported in ≥2% of patients in these trials.

In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of patients receiving Tecline (WOCKHARDT) and 3.0% (110/3646) of patients receiving comparator drugs. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk difference of all-cause mortality was 0.6% (95% CI -0.1, 1.2) between Tecline (WOCKHARDT) and comparator treated patients. The cause of the imbalance has not been established. Generally, deaths were the result of worsening infection, complications of infection or underlying co-morbidities.

An analysis of mortality in all trials conducted for approved indications, cSSSI, cIAI and CABP, including post-market trials (315, 400, 900, respectively), showed an adjusted mortality rate of 2.5% (66/2640) for Tecline (WOCKHARDT) and 1.8% (48/2628) for comparator, respectively. The adjusted risk difference of mortality stratified by trial weight was 0.6% (95% CI 0.0, 1.2).

In comparative clinical studies, infection-related serious adverse events were more frequently reported for subjects treated with Tecline (WOCKHARDT) (7%) versus comparators (6%). Serious adverse events of sepsis/septic shock were more frequently reported for subjects treated with Tecline (WOCKHARDT) (2%) versus comparators (1%). Due to baseline differences between treatment groups in this subset of patients, the relationship of this outcome to treatment cannot be established.

The most common treatment-emergent adverse reactions were nausea and vomiting which generally occurred during the first 1-2 days of therapy. The majority of cases of nausea and vomiting associated with Tecline (WOCKHARDT) and comparators were either mild or moderate in severity. In patients treated with Tecline (WOCKHARDT), nausea incidence was 26% (17% mild, 8% moderate, 1% severe) and vomiting incidence was 18% (11% mild, 6% moderate, 1% severe).

In patients treated for complicated skin and skin structure infections (cSSSI), nausea incidence was 35% for Tecline (WOCKHARDT) and 9% for vancomycin/aztreonam; vomiting incidence was 20% for Tecline (WOCKHARDT) and 4% for vancomycin/aztreonam. In patients treated for complicated intra-abdominal infections (cIAI), nausea incidence was 25% for Tecline (WOCKHARDT) and 21% for imipenem/cilastatin; vomiting incidence was 20% for Tecline (WOCKHARDT) and 15% for imipenem/cilastatin. In patients treated for community-acquired bacterial pneumonia (CABP), nausea incidence was 24% for Tecline (WOCKHARDT) and 8% for levofloxacin; vomiting incidence was 16% for Tecline (WOCKHARDT) and 6% for levofloxacin.

Discontinuation from Tecline (WOCKHARDT) was most frequently associated with nausea (1%) and vomiting (1%). For comparators, discontinuation was most frequently associated with nausea (<1%).

The following adverse reactions were reported infrequently (<2%) in patients receiving Tecline (WOCKHARDT) in clinical studies: Body as a Whole: Injection site inflammation, pain, reaction, edema and phlebitis; septic shock; allergic reaction; chills.

Cardiovascular System: Thrombophlebitis.

Digestive System: Anorexia, jaundice, abnormal stools.

Metabolic/Nutritional System: Increased creatinine, hypocalcemia, hypoglycemia.

Special Senses: Taste perversion.

Hemic and Lymphatic System: Activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia.

Skin and Appendages: Pruritus.

Urogenital System: Vaginal moniliasis, vaginitis, leukorrhea.

Post-marketing Experience: The following adverse reactions have been identified during post-approval use of Tecline (WOCKHARDT). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish causal relationship to drug exposure: Anaphylaxis/anaphylactoid reactions; acute pancreatitis; hepatic cholestasis and jaundice; severe skin reactions, including Stevens-Johnson syndrome; symptomatic hypoglycemia in patients with and without diabetes mellitus.

Each vial of Tecline (WOCKHARDT) contains Tigecycline lyophilized powder 50 mg and lactose monohydrate 100 mg.

The pH is adjusted with hydrochloric acid, and if necessary sodium hydroxide. Tecline (WOCKHARDT) does not contain preservatives.

Tecline (WOCKHARDT) is a glycylcycline antibacterial for IV infusion. Tecline (WOCKHARDT) is (4S,4aS,5aR,12aS)-9-[2-(tert-butylamino)acetamido]-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide. The molecular formula is C₂₉H₃₉N₅O₈ and molecular weight is 585.65.

Tecline (WOCKHARDT) is an orange lyophilized powder or cake.