Tazar Side effects

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

What are the possible side effects of Tazar?

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

Call your doctor at once if you have:

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

• a seizure (convulsions);

• low white blood cell countsIclusigfever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

• low potassiumIclusigleg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• signs of inflammation in your bodyIclusigswollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, upper stomach pain, jaundice (yellowing of the skin or eyes), chest pain, new or worsening cough with fever, trouble breathing; or

• severe skin reactionIclusigfever, 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 Tazar side effects may include:

• diarrhea, constipation;

• nausea, vomiting, upset stomach;

• fever;

• skin rash or itching;

• itching or white patches in your mouth or throat;

• headache, sleep problems (insomnia); or

• vaginal itching or discharge.

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 Tazar in details

Adverse drug reactions reported with Tazar are similar to those reported with Piperacillin (Tazar) alone and generally are transient and mild to moderate in severity. Adverse events have been reported in about ≤10% of patients receiving parenteral Tazar and have been severe enough to require discontinuance in ≤3% of patients.

The most common frequent adverse effects reported with Tazar are gastrointestinal (GI) effects, headache and hypersensitivity reactions.

Hypersensitivity Reactions: Rash, pruritus and fever have been reported in up to 4% of patients receiving Tazar. Rare reports of bronchospasm have also been reported.

Gastrointestinal Effects: Diarrhea, nausea, constipation have been reported in up to 11% of patients receiving Tazar. Vomiting, dyspepsia, stool changes and abdominal pain can occur in up to 3%, while melena, flatulence, hemorrhage, gastritis, hiccups and ulcerative stomatitis are reported in ≤1% of patients.

Clostridium difficile-associated diarrhea and colitis or antibiotic-associated pseudomembranous colitis have been reported in at least 1 patient receiving Tazar. Colitis may occur during or following discontinuance of anti-infective therapy and may range in severity from mild to life-threatening.

Hematologic Effects: Transient leukopenia, neutropenia and thrombocytopenia have been reported in patients receiving Tazar for a prolonged period of time (eg, after ≥21 days) and generally were reversible, systemic symptoms (eg, fever, rigors and chills) may also occur in some patients. Epistaxis and purpura have been reported in ≤1% patients.

Hepatic Effects: Transient increases in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin can occur.

Renal Effects: Increases in serum concentrations of creatinine and blood urea nitrogen (BUN) may be observed. Urinary retention, dysuria, oliguria, hematuria and incontinence have been reported in ≤1% and proteinuria, pyuria, leukorrhea and vaginitis can also occur.

Effect on the Central Nervous System: Headache and insomnia have been reported in up to 7-8%, while agitation, dizziness and anxiety have been reported in ≤2% patients. Tremors, seizures, vertigo, confusion, hallucination, malaise and depression have been reported in ≤1% of patients receiving Tazar. Neuromuscular excitability or seizures could occur in higher than recommended doses are given IV, especially in patients with kidney failure.

Local Reactions: Adverse reactions at the injection site have been reported in ≤1% of patients. Adverse local reactions include phlebitis, pain, inflammation, thrombophlebitis and edema.

Other Adverse Effects: Hypertension, chest pain, edema, moniliasis, rhinitis, dyspnea, hypotension, ileus, syncope and rigors have been reported in ≤2% of patients. Tachycardia, bradycardia, heart failure and myocardial infarction have been reported in at most 1%.

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

• Tazar may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Tazar with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Tazar may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Tazar. To prevent pregnancy, use an extra form of birth control (eg, condoms).
• Tazar only works against bacteria; it does not treat viral infections (eg, the common cold).
• Be sure to use Tazar 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 Tazar 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.
• Mild diarrhea is common with antibiotic use. However, a more serious and sometimes fatal 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.
• Tell your doctor or dentist that you take Tazar before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients - Tazar may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Diabetes patients - Tazar may cause the results of some tests for urine glucose to be wrong. Ask your doctor before you change your diet or the dose of your diabetes medicine.
• Tazar may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Tazar.
• Lab tests, including complete blood cell counts and blood electrolyte levels, may be performed while you use Tazar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Tazar with caution in the ELDERLY; they may be more sensitive to its effects.
• Tazar should be used with extreme caution in CHILDREN younger than 2 months old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tazar while you are pregnant. Tazar is found in breast milk. If you are or will be breast-feeding while you use Tazar, check with your doctor. Discuss any possible risks to your baby.

Tazar contraindications

Tazar for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors.

References

1. European Chemicals Agency - ECHA. "4-Thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid,6-[[[[(4-ethyl-2,3-dioxo-1-piperazinyl)carbonyl]amino] phenylacetyl]amino]-3,3-dimethyl-7-oxo-,monohydrate, [2S-[2alpha, 5alpha, 6beta(S*)]]: 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).
2. European Chemicals Agency - ECHA. "4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-, 4,4-dioxide, sodium salt (1:1), (2S,3S,5R)-: 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. "Tazobactam: 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