Megion Uses

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• Megion indications
• Uses of Megion in details
• Megion description
• Megion dosage
• Megion interactions
• Megion side effects
• Megion contraindications

What is Megion?

Megion is used to treat bacterial infections in many different parts of the body. Megion is also given before certain types of surgery to prevent infections.

Megion belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, Megion will not work for colds, flu, or other virus infections.

Megion is available only with your doctor's prescription.

Megion indications

Before instituting treatment with B Braun Megion, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of B Braun Megion and other antibacterial drugs, B Braun Megion should be used only to treat or prevent 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.

B Braun Megion is indicated for the treatment of the following infections when caused by susceptible organisms: Lower respiratory tract infections caused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia. coli, Enterobacter aerogenes, Proteus mirabilis or Serratia marcescens.

Skin and skin structure infections caused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii*, Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis* or Peptostreptococcus spp.

Urinary tract infections (complicated and uncomplicated) caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganii or Klebsiella pneumoniae.

Pelvic inflammatory disease caused by Neisseria gonorrhoeae. Megion, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

Bacterial septicemia caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae or Klebsiella pneumoniae.

Bone and joint infections caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae or Enterobacter spp.

Intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridium spp (Note: Most strains of Clostridium difficile are resistant) or Peptostreptococcus spp.

Meningitis caused by Haemophilus influenzae, Neisseria meningitidis or Streptococcus pneumoniae.

Megion has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis* and Escherichia coli*.

*Efficacy for this organism in this organ system was studied in fewer than 10 infections.

Surgical Prophylaxis: The preoperative administration of a single 1 g dose of B Braun Megion may reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated (eg, vaginal or abdominal hysterectomy or cholecystectomy for chronic calculous cholecystitis in high-risk patients eg, those >70 years of age, with acute cholecystitis not requiring therapeutic antimicrobials, obstructive jaundice or common duct bile stones) and in surgical patients for whom infection at the operative site would present serious risk (eg, during coronary artery bypass surgery). Although Megion has been shown to have been as effective as cefazolin in the prevention of infection following coronary artery bypass surgery, no placebo-controlled trials have been conducted to evaluate any cephalosporin antibiotic in the prevention of infection following coronary artery bypass surgery.

When administered prior to surgical procedures for which it is indicated, a single 1 g dose of B Braun Megion provides protection from most infections due to susceptible organisms throughout the course of the procedure.

How should I use Megion?

Use Megion as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Megion is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Megion at home, a health care provider will teach you how to use it. Be sure you understand how to use Megion. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Megion is light yellow to amber in color. Do not use Megion if it contains particles, is cloudy or discolored, or if the vial or container is cracked or damaged in any way.
• To clear up your infection completely, use Megion for the full course of treatment. Keep using 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 Megion, take 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 take 2 doses at once.

Ask your health care provider any questions you may have about how to use Megion.

Uses of Megion in details

Use: Labeled Indications

Bloodstream infection: Caused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, or Klebsiella pneumoniae.

Bone and joint infections (osteomyelitis and/or discitis, prosthetic joint infection, septic arthritis): Caused by S. aureus, S. pneumoniae, E. coli, Proteus mirabilis, K. pneumoniae, or Enterobacter spp.

Gonococcal infection, uncomplicated (cervical/urethral, rectal, and pharyngeal): Caused by Neisseria gonorrhoeae, including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of N. gonorrhoeae.

Intra-abdominal infection, community-acquired (mild to moderate infection in low-risk patients): Caused by E. coli, K. pneumoniae, Bacteroides fragilis, Clostridium spp. (Note: Most strains of C. difficile are resistant), or Peptostreptococcus spp.

Lower respiratory tract infections (pneumonia, community-acquired): Caused by S. pneumoniae, S. aureus, H. influenzae, Haemophilus parainfluenzae, K. pneumoniae, E. coli, Enterobacter aerogenes, P. mirabilis, or Serratia marcescens.

Meningitis, bacterial: Caused by H. influenzae, Neisseria meningitidis, or S. pneumoniae. Megion has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis and E. coli (efficacy for these 2 organisms in this organ system was studied in fewer than 10 infections).

Otitis media, acute: Caused by S. pneumoniae, H. influenzae (including beta-lactamase-producing strains), or Moraxella catarrhalis (including beta-lactamase-producing strains).

Pelvic inflammatory disease (mild to moderate): Caused by N. gonorrhoeae. Megion, like other cephalosporins, has no activity against Chlamydia trachomatis; therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and C. trachomatis is one of the suspected pathogens, appropriate antichlamydial coverage should be added.

Skin and soft tissue infections: Caused by S. aureus, S. epidermidis, Streptococcus pyogenes, viridans group streptococci, E. coli, Enterobacter cloacae, Klebsiella oxytoca, K. pneumoniae, P. mirabilis, Morganella morganii (efficacy for this organism in this organ system was studied in fewer than 10 infections), S. marcescens, Acinetobacter calcoaceticus, B. fragilis (efficacy for this organism in this organ system was studied in fewer than 10 infections), or Peptostreptococcus spp.

Surgical prophylaxis, colorectal: To reduce the incidence of postoperative infections in patients undergoing surgical procedures classified as contaminated or potentially contaminated.

Urinary tract infection, complicated (including pyelonephritis): Caused by E. coli, P. mirabilis, Proteus vulgaris, M. morganii, or K. pneumoniae.

Off Label Uses

Actinomycosis, severe or extensive

Data from a limited number of patients suggest Megion may be beneficial for the treatment of severe or extensive actinomycosis.

Megion description

B Braun Megion is a sterile, nonpyrogenic, single use, packaged combination of Megion and dextrose injection (diluent) in the Duplex sterile container. The Duplex container is a flexible dual chamber container.

The drug chamber is filled with Megion, a sterile, semisynthetic, broad-spectrum cephalosporin antibiotic for IV administration. Megion is (6R,7R)-7-[2-(2-Amino-4-thiazolyl)glyoxylamido]-8-oxo-3-[[(1,2,5,6-tetrahydro-2-methyl-5,6-dioxo-as-triazin-3-yl)thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7²-(Z)-(O-methyloxime), disodium salt, sesquaterhydrate.

Its chemical formula is C₁₈H₁₆N₈Na₂O₇S₃·3.5H₂O. It has a calculated molecular weight of 661.6.

Megion is supplied as a dry powder form equivalent to either 1 or 2 g of Megion. It is a white to yellowish-orange crystalline powder which is readily soluble in water, sparingly soluble in methanol and very slightly soluble in ethanol. The pH of a 1% aqueous solution is approximately 6.7. The color of Megion solutions ranges from light yellow to amber, depending on the length of storage and concentration.

Megion contains approximately 83 mg (3.6 mEq) of sodium per gram of Megion activity.

The diluent chamber contains dextrose injection. The concentration of hydrous dextrose in water for injection USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose USP has been added to adjust osmolality (approximately 1.87 g and 1.11 g to 1 g and 2 g dosages, respectively). Dextrose injection is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents.

The molecular weight of hydrous dextrose USP is 198.17.

After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single IV use. When reconstituted, the approximate osmolality for the reconstituted solution for B Braun Megion is 290 mOsmol/kg.

The Duplex container is latex-free, PVC-free, and DEHP-free.

The Duplex dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.

Megion dosage

Intended for IV administration only.

B Braun Megion and calcium-containing solutions, including continuous calcium-containing infusions eg, parenteral nutrition, should not be mixed or co-administered to any patient irrespective of age, even via different infusion lines at different sites.

Treatment of Skin and Skin Structure Infections: Recommended Total Daily Dose: 50-75 mg/kg given once a day (or in equally divided doses twice a day). The total daily dose should not exceed 2 g.

Treatment of Serious Miscellaneous Infections Other than Meningitis: Recommended Total Daily Dose: 50-75 mg/kg, given in divided doses every 12 hrs. The total daily dose should not exceed 2 g.

Treatment of Meningitis: Recommended Initial Therapeutic Dose: 100 mg/kg (not to exceed 4 g). Thereafter, a total daily dose of 100 mg/kg/day (not to exceed 4 g daily) is recommended. The daily dose may be administered once a day (or in equally divided doses every 12 hrs). The usual duration of therapy is 7-14 days.

Adults: Usual Daily Dose: 1-2 g given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. The total daily dose should not exceed 4 g.

If Chlamydia trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because Megion has no activity against this organism.

For preoperative use (surgical prophylaxis), a single dose of 1 g administered IV ½-2 hrs before surgery is recommended.

Generally, B Braun Megion therapy should be continued for at least 2 days after the signs and symptoms of infection have disappeared. The usual duration of therapy is 4-14 days; in complicated infections, longer therapy may be required.

When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.

Children: B Braun Megion in the Duplex container is designed to deliver a 1 or 2 g dose of Megion. To prevent unintentional overdose, B Braun Megion should not be used in pediatric patients who require less than the full adult dose of Megion.

Neonates: Hyperbilirubinemic neonates, especially prematures, should not be treated with B Braun Megion.

Hepatic and Renal Impairment: No dosage adjustment is necessary for patients with impairment of renal or hepatic function; however, blood levels should be monitored in patients with severe renal impairment (eg, dialysis patients) and in patients with both renal and hepatic dysfunctions.

Administration: Directions for Use: B Braun Megion should be administered IV by infusion over a period of 30 min.

Vancomycin, amsacrine, aminoglycosides and fluconazole are physically incompatible with Megion in admixtures. When any of these drugs are to be administered concomitantly with Megion by intermittent IV infusion, it is recommended that they be given sequentially, with thorough flushing of the IV lines (with one of the compatible fluids) between the administrations.

B Braun Megion should not be physically mixed with or piggybacked into solutions containing other antimicrobial drugs due to possible incompatibility.

After the indicated stability time periods, unused portions of solutions should be discarded.

Megion interactions

See also:
What other drugs will affect Megion?

No impairment of renal function after simultaneous administration of Megion with diuretics.

No interference with the action or increase in nephrotoxicity of aminoglycosides during simultaneous administration with Megion. The Megion molecule does not contain the N-methylthio-tetrazole substituent which has been associated with a disulfiram-like effect when alcohol is taken during therapy with certain cephalosporins.

In vitro, chloramphenicol has been shown to be antagonistic with respect to Megion and other cephalosporins.

Caution is advised if concurrent administration of Megion with chloramphenicol is proposed.

In patients treated with Megion, the Coombs' test may rarely become false-positive. Megion eg, other antibiotics, may result in false-positive test for galactosemia. Likewise, non-enzymatic methods for glucose determination in urine may give false-positive results. For this reason, urine glucose determination during therapy with Megion should be done enzymatically.

Megion may adversely affect the efficacy of oral hormonal contraceptives. Consequently, it is advisable to use supplementary (nonhormonal) contraceptive measures during treatment and in the month following treatment.

Incompatibilities: Solutions containing Megion should not be mixed with or added to solutions containing other agents. In particular, Megion is not compatible with calcium-containing solutions eg, Hartmann's solution and Ringer's solution. Megion is not compatible with amsacrine, vancomycin, fluconazole, aminoglycosides and labetalol.

Megion side effects

See also:
What are the possible side effects of Megion?

Post-Marketing: During the use of Megion, the following side effects, which were reversible either spontaneously or after withdrawal of the drug, have been observed: Systemic Side Effects: Gastrointestinal complaints (about 2% of the cases): loose stools or diarrhea, nausea, vomiting, stomatitis and glossitis.

Hematological changes (about 2%): eosinophilia, leukopenia, granulocytopenia, hemolytic anemia, thrombocytopenia. Isolated cases of agranulocytosis (<500/mm³) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more.

Skin reactions (about 1%): exanthema, allergic dermatitis, pruritus, urticaria, edema. Isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens Johnson syndrome or Lyell's Syndrome/toxic epidermal necrolysis) have been reported.

Other, Rare Side Effects: Headache and dizziness, symptomatic precipitation of Megion calcium salt in the gallbladder, increase in liver enzymes, oliguria, increase in serum creatinine, genital mycosis, fever, shivering and anaphylactic or anaphylactoid reactions.

Interaction with Calcium: Two in vitro studies, one using adult plasma and the other neonatal plasma from umbilical cord blood have been carried out to assess interaction of Megion and calcium. Megion concentrations up to 1 mM (in excess of concentrations achieved in vivo following administration of 2 grams Megion infused over 30 minutes) were used in combination with calcium concentrations up to 12 mM (48 mg/dL). Recovery of Megion from plasma was reduced with calcium concentrations of 6 mM (24 mg/dL) or higher in adult plasma or 4 mM (16 mg/dL) or higher in neonatal plasma. This may be reflective of Megion-calcium precipitation.

A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Megion and calcium containing fluids. In some of these cases, the same intravenous infusion line was used for both Megion and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Megion and calcium-containing fluids were administered at different autopsy in this neonate. There have been no similar reports in patients other than neonates.

Pseudomembranous enterocolitis and coagulation disorders have been reported as very rare side effects.

Very rare cases of renal precipitation have been reported, mostly in children older than 3 years and who have been treated with either high daily doses (e.g. ≥80 mg/kg/day) or total doses exceeding 10 grams and presenting other risk factors (e.g. fluid restrictions, confinement to bed, etc.). This event may be symptomatic or asymptomatic, may lead to renal insufficiency, and is reversible upon discontinuation of Megion.

Local Side Effects: In rare cases, phlebitis reactions occurred after i.v. administration. These may be minimized by slow (2-4 minutes) injection.

Intramuscular injection without lidocaine solution is painful.

Laboratory Abnormalities: Influence on Diagnostic Tests: In patients treated with Megion the Coombs' test may rarely become false-positive.

Megion, like other antibiotics, may result in false-positive tests for galactosemia.

Likewise, nonenzymatic methods for the glucose determination in urine may give false positive results. For this reason, urine-glucose determination during therapy with Megion should be done enzymatically.

Megion contraindications

See also:
What is the most important information I should know about Megion?

Hypersensitivity

Megion is contraindicated in patients with known hypersensitivity to Megion, any of its excipients or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other beta lactam antibacterial agents may be at greater risk of hypersensitivity to Megion.

Neonates

Premature Neonates

Megion is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).

Hyperbilirubinemic Neonates

Hyperbilirubinemic neonates should not be treated with Megion. Megion can displace bilirubin from its binding to serum albumin, leading to a risk of bilirubin encephalopathy in these patients.

Neonates Requiring Calcium Containing IV Solutions

Megion is contraindicated in neonates ( ≤ 28 days) if they require (or are expected to require) treatment with calcium-containing IV solutions, including continuous calcium-containing infusions such as parenteral nutrition because of the risk of precipitation of Megion-calcium.

Cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Megion and calcium-containing fluids.

In some of these cases, the same intravenous infusion line was used for both Megion and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. There have been no similar reports in patients other than neonates.

Lidocaine

Intravenous administration of Megion solutions containing lidocaine is contraindicated. When lidocaine solution is used as a solvent with Megion for intramuscular injection, exclude all contraindications to lidocaine. Refer to the prescribing information of lidocaine.

Active ingredient matches for Megion:

Ceftriaxone in Bangladesh, Costa Rica, Croatia (Hrvatska), El Salvador, Guatemala, Honduras, Hungary, Mexico, Nicaragua, Oman, Panama, Serbia.

Ceftriaxone Na in Philippines.

Ceftriaxone sodium in Hungary, Philippines, Venezuela, Mexico.

References

1. DailyMed. "CEFTRIAXONE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. PubChem. "ceftriaxone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
3. DrugBank. "ceftriaxone". http://www.drugbank.ca/drugs/DB01212 (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology