Megion Side effects

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• Side effects of Megion in details
• Megion contraindications
• Megion reviews

What are the possible side effects of Megion?

Get emergency medical help if you have signs of an allergic reaction to Megion: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a seizure (convulsions);

• severe stomach pain, diarrhea that is watery or bloody;

• sudden weakness or ill feeling, fever, chills, cold or flu symptoms, mouth sores;

• pale or yellowed skin, dark colored urine;

• severe pain in your upper stomach that comes and goes or spreads to your back;

• a blood cell disorder--skin rash or tight feeling, severe tingling or numbness, pain, muscle weakness;

• kidney or bladder problems--pain in your side or lower back spreading to your groin, blood in your urine, painful or difficult urination, little or no urine; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common Megion side effects may include:

• mild diarrhea;

• warmth, tight feeling, or a hard lump where the injection was given;

• vaginal itching or discharge;

• rash; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Megion in details

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.

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

• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
• Megion only works against bacteria; it does not treat viral infections (eg, the common cold).
• A severe and sometimes fatal type of anemia (hemolytic anemia) has been reported in patients using cephalosporin antibiotics, including Megion. Discuss any questions or concerns with your doctor. Contact your doctor right away if you experience unusual tiredness or weakness, unusually pale skin, dizziness, fever or chills, severe back or stomach pain, or yellowing of the eyes or skin.
• Be sure to use Megion for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Megion may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• Megion may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Megion.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Megion while you are pregnant. Megion is found in breast milk. If you are or will be breast-feeding while you use Megion, check with your doctor. Discuss any possible risks to your baby.

Megion contraindications

Hypersensitivity: Hypersensitivity to Megion, any of excipients of Megion or to any other cephalosporin. Patients with previous hypersensitivity reactions to penicillin and other β-lactam agents may be at greater risk of hypersensitivity to Megion.

Lidocaine: It must be excluded before IM injection of Megion when lidocaine solution is used as a solvent. Megion solutions containing lidocaine should never be administered IV.

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

Hyperbilirubinemic Newborns: Should not be treated with Megion. In vitro studies have shown that Megion can displace bilirubin from its binding to serum albumin, leading to a possible risk of bilirubin encephalopathy in these patients.

Neonates and 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 eg, parenteral nutrition because of the risk of precipitation of Megion-calcium.

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 IV infusion line was used for both Megion and calcium-containing fluids and in some a precipitate was observed in the IV infusion line. At least 1 fatality has been reported in a neonate in whom Megion and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.

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. European Chemicals Agency - ECHA. "(6R,7R)-7-[[(2E)-2-(2-amino-1,3-thiazol-4-yl)-2-methoxyiminoacetyl]amino]-3-[(2-methyl-5,6-dioxo-1H-1,2,4-triazin-3-yl)sulfanylmethyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. NCIt. "Ceftriaxone: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology