CEFOZONE® (SULBACTAM & CEFOPERAZONE FOR INJECTION 1G)

Read the entire leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What is Cefoperazone Sodium?

Cefoperazone Sodium Injection is used for Respiratory tract infections, Bacterial infections and other conditions. Cefoperazone Sodium Injection may also be used for purposes not listed in this medication guide.

Cefoperazone Sodium Injection contains Cefoperazone Sodium as an active ingredient.

Cefoperazone Sodium Injection works by inhibiting the bacterial cell wall synthesis.

Taj Pharma manufactures Cefoperazone Sodium Injection.

Detailed information related to Cefoperazone Sodium Injection’s uses, composition, dosage, side effects and reviews is listed below.

Sulbactam Sodium

About Sulbactam SodiumAn irreversible ?-lactamase inhibitor, To increase the antibacterial activity of penicillins and cephalosporins against ?-lactamase?producing organisms.Mechanism of Action of Sulbactam SodiumSulbactam has no significant antimicrobial activity, despite sharing the ?-lactam ring that is characteristic of beta-lactam antibiotics. This similarity in chemical structure helps the Sulbactam to act as a competitive inhibitor of beta-lactamase enzyme secreted by certain bacteria that are resistant to beta-lactam antibiotics. This inhibition restores the antibacterial activity of beta-lactam antibiotics against ?-lactamase-secreting resistant bacteria.It is usually given in combination with Amoxycillin.

It is used to increase the antibacterial spectrum of penicillin and cephalosporin against penicillinase-producing and beta-lactamase-producing organisms such as Staphylococcus aureus, H. flu, Moraxella catarrhalis that are resistant to Ampicillin alone.

Side Effects of Sulbactam Sodium

1. Injection site reactions

2. Anaphylaxis

3. Diarrhoea

4. Rash

5. Blood dyscrasias

6. Elevated liver enzymes

Contra-indications of Sulbactam SodiumHypersensitivity to SulbactamSpecial Precautions while taking Sulbactam SodiumPatient hypersensitive to CephalosporinPregnancy Related InformationUse with cautionOld Age Related InformationUse with cautionBreast Feeding Related InformationUse with cautionChildren Related InformationN/AIndications for Sulbactam

Sodium

1. Skin infections

2. Intra abdominal infectionS

3. Gynecologic infections

Cefoperazone Sulbactam Injection Uses

Cefoperazone Sulbactam Injection is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms:

• Intra abdominal infections

• Bacterial infections

• Urinary tract infection

• Skin and soft tissue infection

• Infections of the respiratory tract

• Endometritis

• Surgical infections

• Bacterial infection

• Peritonitis

• Intra-abdominal infections

• Pelvic inflammatory disease

• Septicemia

• Respiratory tract infections

• Intraabdominal infections

• Gynecological infections

• Skin or soft tissue infections

• Cefoperazone Sulbactam Injection may also be used for purposes not listed here.

Cefoperazone Sulbactam Injection - Composition and Active Ingredients

Cefoperazone Sulbactam Injection is composed of the following active ingredients (salts)

• Cefoperazone - 1 GM

• Sulbactam - 1 GM

Please note that this medicine may be available in various strengths for each active ingredient listed above.

Cefoperazone Sulbactam Injection - Side-effects

The following is a list of possible side-effects that may occur from all constituting ingredients of Cefoperazone Sulbactam Injection. This is not a comprehensive list. These side-effects are possible, but do not always occur. Some of the side-effects may be rare but serious. Consult your doctor if you observe any of the following side-effects, especially if they do not go away.

• Vomiting

• Creatinine levels in blood

• Allergic reactions

• Neutropenia

• Diarrhea

• Nausea

• Pain at site of injection

• Rash

• Inflammation of a vein caused by a blood clots

• Cefoperazone Sulbactam Injection may also cause side-effects not listed here.

If you notice other side-effects not listed above, contact your doctor for medical advice. You may also report side-effects to your local food and drug administration authority.

Cefoperazone Sulbactam Injection Working, Mechanism of Action and Pharmacology

Cefoperazone Sulbactam Injection improves the patient's condition by performing the following functions:

• Inhibiting bacterial cell wall synthesis.

• Preventing destruction antibiotics, from chemicals released from bacteria.

Cefoperazone Sulbactam Injection - Precautions & How to Use

Before using Cefoperazone Sulbactam Injection, inform your doctor about your current list of medications, over the counter products (e.g. vitamins, herbal supplements, etc.), allergies, pre-existing diseases, and current health conditions (e.g. pregnancy, upcoming surgery, etc.). Some health conditions may make you more susceptible to the side-effects of the drug. Take as directed by your doctor or follow the direction printed on the product insert. Dosage is based on your condition. Tell your doctor if your condition persists or worsens. Important counseling points are listed below.

• Avoid alcohol while taking this medication

• History of gastrointestinal disease

• If you develop bloody or watery diarrhea contact your doctor immedately

• Inform your doctor if you have had allergic reactions to penicillins or other cephalosporins in the past

• It is important that you finish the entire course as prescribed

• Kidney problems

• Liver problems

• Pregnant, planning to get pregnant or breastfeeding

• Regularly check your urine for sugar level

• Risk of bleeding

Cefoperazone Sulbactam Injection - Drug Interactions

If you use other drugs or over the counter products at the same time, the effects of Cefoperazone Sulbactam Injection may change. This may increase your risk for side-effects or cause your drug not to work properly. Tell your doctor about all the drugs, vitamins, and herbal supplements you are using, so that you doctor can help you prevent or manage drug interactions. Cefoperazone Sulbactam Injection may interact with the following drugs and products:

• Alcohol

• Allopurinol

• Amikacin

• Aminoglycoside antibiotics

• Gentamicin

• Probenecid

• Tetracyclines

• Tobramycin

Cefoperazone Sulbactam Injection - Contraindications

Hypersensitivity to Cefoperazone Sulbactam Injection is a contraindication. In addition, Cefoperazone Sulbactam Injection should not be used if you have the following conditions:

• Asthma

• Clostridium difficile infection

• Diabetes

• Hypersensitivity

• Hypersensitivity to cephalosporins

• Kidney or gastrointestinal disease

• Pseudomembranous colitis

• Runny nose due to allergy

Other important Information on Cefoperazone Sulbactam Injection

Missing a dose

In case you miss a dose, use it as soon as you notice. If it is close to the time of your next dose, skip the missed dose and resume your dosing schedule. Do not use extra dose to make up for a missed dose. If you are regularly missing doses, consider setting an alarm or asking a family member to remind you. Please consult your doctor to discuss changes in your dosing schedule or a new schedule to make up for missed doses, if you have missed too many doses recently.

Overdosage of Cefoperazone Sulbactam Injection

• Do not use more than prescribed dose. Taking more medication will not improve your symptoms; rather they may cause poisoning or serious side-effects. If you suspect that you or anyone else who may have overdosed of Cefoperazone Sulbactam Injection, please go to the emergency department of the closest hospital or nursing home. Bring a medicine box, container, or label with you to help doctors with necessary information.

• Do not give your medicines to other people even if you know that they have the same condition or it seems that they may have similar conditions. This may lead to overdosage.

• Please consult your physician or pharmacist or product package for more information.

Storage of Cefoperazone Sulbactam Injection

• Store medicines at room temperature, away from heat and direct light. Do not freeze medicines unless required by package insert. Keep medicines away from children and pets.

• Do not flush medications down the toilet or pour them into drainage unless instructed to do so. Medication discarded in this manner may contaminate the environment. Please consult your pharmacist or doctor for more details on how to safely discard Cefoperazone Sulbactam Injection.

Expired Cefoperazone Sulbactam Injection

• Taking a single dose of expired Cefoperazone Sulbactam Injection is unlikely to produce an adverse event. However, please discuss with your primary health provider or pharmacist for proper advice or if you feel unwell or sick. Expired drug may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use expired drug. If you have a chronic illness that requires taking medicine constantly such as heart condition, seizures, and life-threatening allergies, you are much safer keeping in touch with your primary health care provider so that you can have a fresh supply of unexpired medications.

Dosage Information

Please consult your physician or pharmacist or refer to product package.

Cefoperazone Sulbactam Injection - Packages and Strengths

Cefoperazone Sulbactam Injection is available in the following packages and strengths

Cefoperazone Sulbactam Injection - Packages: 1 Vial

Cefoperazone Sulbactam Injection - Strengths: 500MG+500MG, 1GM+1GM