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Why it's used

Safezone Injection is used to treat certain types of pneumonia and infections. It is also used to treat sexually transmitted diseases such as gonorrhea and syphilis and respiratory symptoms such as coughing and shortness of breath. This medicine works by weakening the outermost layer of bacteria which leads to the breakdown of the bacterial cells. This medicine helps by killing bacteria in the body. Safezone is also used to prevent infection of the female reproductive organs, to reduce infections before surgery, and for the management of a decreased number of neutrophils and fever due to bacterial infection.
When not to use
Safezone will not work to treat viral infections such as common cold.
Cephalosporin Antibacterials
Safezone is a prescription medicine that belongs to a class of medicines called Cephalosporin Antibacterials. Cephalosporins are antibacterial medicines that kill bacteria by interfering with how bacteria build their cell walls.

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How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Safezone Injection. If you have any questions related to this medicine, ask your doctor or pharmacist. Inject this medicine as recommended by your doctor.

Typical Dosage

The typical dose of Safezone is 1-2 g once a day (not more than 4 g in one day). The maximum adult dose of Safezone is 4 g in a day. This medicine is typically used for a period of at least 10 days for infection caused by Streptococcus pyogenes bacteria, 7-14 days for meningitis, 3 days for middle ear infection, and 10-14 days for syphilis.
This medicine should be used on an as-needed basis. Safezone may be used for a long time to treat complicated infections. You should continue to use this medicine as directed by the doctor even if you feel well.
The injection form of the medicine may be used on the large muscles. Safezone injection is directly injected into muscles (intramuscular) and into veins (intravenous) route.
If you have any kidney disease, a daily dose of Safezone should not be increased by more than 2 g in case of kidney failure. You should consult with your doctor before stopping the use of Safezone.
Older patients may see an increase in the incidence of side-effects with this medicine. As a result, a lower dose may be recommended for older patients.

Use in Children

If you are giving Safezone Injection to a child, be sure to use a product that is meant for children. Before giving this medicine to a child, use the child's weight or age to find the right dose from the product package. You can also read the dosage section of this page to know the correct dose for your child. Else, consult with your doctor and follow their recommendation.

Storage

You should store Safezone Injection at room temperature 25°C (77°F), and away from light. Store the medicine away from the reach of children and pets.
Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Safezone Injection for conditions for which it was not prescribed. Do not give Safezone Injection to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.

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How to take Safezone

Your dose may depend on several personal factors. You should consult with your doctor to find out the dose that is best for you. The dose of Safezone depends on the following factors:
  • patient's age
  • patient's weight
  • patient's health
  • the health of the patient's liver
  • medicines recommended by your doctor
  • any other medicines in use

Safezone Dosage

Dosage for community-acquired pneumonia

Adult (adults and children above 12 years (greater than or equal to 50 kg/110.23 lbs))
  • Recommended: 1000-2000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg/110.23 lbs))
  • Recommended: 50-80 mg/kg (22.68-36.28 mg/lb) once a day
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) once daily
  • Maximum: 50 mg/kg/day (22.68 mg/lb/day)

Dosage for gonorrhea

Adult
  • Recommended: 250 mg as a single intramuscular dose

Dosage for the prevention of infections before surgery

Adult
  • Recommended: 1000 mg as a single dose injected directly into the vein (1/2 to 2 hours before surgery)
Children (neonates, infants and children of 15 days-12 years (less than 50 kg))
  • Recommended: 50-80 mg/kg (22.68-36.28 mg/lb) as a single dose
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) as a single dose

Dosage for middle ear infection (otitis media)

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 1000-2000 mg once daily
Children (neonates, infants and children of age 15 days-12 years (less than 50 kg))
  • Recommended: 50 mg/kg/day (22.68 mg/lb/day)
  • Maximum: 1000 mg/day
Children
  • Initial: 50 mg/kg (22.68 mg/lb) as a single dose
  • Maximum: neonates of age 0-14 days

Dosage for skin infections

Adult (adults and children above 12 years (greater than or equal to 50 kg))
  • Recommended: 2000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg/110.23 lbs))
  • Recommended: 50-100 mg/kg (22.68-45.36 mg/lb) once daily
  • Maximum: 4000 mg once daily
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) once daily
  • Maximum: 50 mg/kg (22.68 mg/lb) once daily

Dosage for urinary tract infections

Adult (adults and children above 12 years (greater than or equal to 50 kg))
  • Recommended: 1000-2000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg/110.23 lbs))
  • Recommended: 50-80 mg/kg (22.68-36.28 mg/lb) once daily
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) once daily
  • Maximum: 50 mg/kg/day (22.68 mg/lb/day)

Dosage for decreased number of neutrophils and fever

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 2000-4000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg))
  • Recommended: 50-100 mg/kg (22.68-45.36 mg/lb) once daily
  • Maximum: 4000 mg once daily
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) once daily
  • Maximum: 50 mg/kg/day (22.68 mg/lb/day)

Dosage for insect bite infection

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 2000 mg once daily for 14-21 days
Children (neonates, infants and children of 15 days-12 years (less than 50 kg/110.23 lbs))
  • Recommended: 50-80 mg/kg (22.68-36.28 mg/lb) once daily for 14-21 days

Dosage for bone and joint infections

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 2000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg))
  • Recommended: 50-100 mg/kg (22.68-45.36 mg/lb) once daily
  • Maximum: 4000 mg once daily
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) once daily
  • Maximum: 50 mg/kg/day (22.68 mg/lb/day)

Dosage for intra-abdominal infections

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 1000-2000 g once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg/110.23 lbs))
  • Recommended: 50-80 mg/kg (22.68-36.28 mg/lb) once daily
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) once daily
  • Maximum: 50 mg/kg/day (22.68 mg/lb/day)

Dosage for brain and spinal cord inflammation

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 2000-4000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg))
  • Recommended: 80-100 mg/kg (36.28-45.36 mg/lb) once daily
  • Maximum: 4000 mg once daily
Children (neonates of age 0-14 days)
  • Recommended: 50 mg/kg (22.68 mg/lb) once daily
  • Maximum: 50 mg/kg/day (22.68 mg/lb/day)

Dosage for hospital-acquired pneumonia

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 2000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg))
  • Recommended: 50-80 mg/kg (22.68-36.28 mg/lb) once daily
Children (neonates of age 0-14 days)
  • Recommended: 20-50 mg/kg (9.07-22.68 mg/lb) once daily
  • Maximum: 50 mg/kg/day (22.68 mg/lb/day)

Dosage for syphilis

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 500 mg-1000 mg once daily and 2000 mg once daily for neurosyphilis for 10-14 days
Children (neonates, infants and children of 15 days-12 years (less than 50 kg))
  • Recommended: 75-100 mg/kg (34.02-45.36 mg/lb) once daily for 10-14 days
  • Maximum: 4000 mg once daily for 10-14 days
Children (neonates of age 0-14 days)
  • Recommended: 50 mg/kg (22.68 mg/lb) once daily for 10-14 days

Dosage for worsening of respiratory symptoms

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 1000-2000 mg once daily

Dosage for infection of the inner part of the heart

Adult (adults and children over 12 years (greater than or equal to 50 kg))
  • Recommended: 2000-4000 mg once daily
Children (neonates, infants and children of 15 days-12 years (less than 50 kg/110.23 lbs))
  • Recommended: 100 mg/kg (45.36 mg/lb) once daily
  • Maximum: 4000 mg once daily
Children (neonates of age 0-14 days)
  • Recommended: 50 mg/kg (22.68 mg/lb) once daily
  • Maximum: 50 mg/kg (22.68 mg/lb) once daily

Dosage calculation for children

To calculate the dosage for children please use the weight based dose calculator to calculate the appropriate dosage as per the weight of your child.

Forms

Powder for Injection
Strength: 1 g, 2g

Special Instructions

Intramuscular/Intravenous injection
The drug products which are injected directly into muscles and veins should be tested visually for the presence of solid particles into the solution for injection.

Missed Dose

If you miss an injection, you should get it as soon as you remember it. And if it is almost the time for your next injection, skip the missed one.

Overdose

What to do if you overdose on Safezone?
No specific antidote is available for an overdose of Safezone. However, the treatment according to the symptoms should be given immediately.
Symptoms of an overdose of Safezone
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
If you think you have overdosed on Safezone Injection, call a poison control center immediately. You can look up the poison control center information from the Poison Center Finder at TabletWise.com.

Precautions while using Safezone

Before you use Safezone, tell your doctor of your medical and health history including the following:
  • abnormal functioning of the liver
  • gastrointestinal disease (such as colitis)
  • kidney disease
Before you use Safezone, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Discuss with your doctor if you are allergic to beta-lactam antibacterial agent (penicillins, carbapenems, and monobactams).
The use of Safezone Injection may change blood clotting time. In such patients, alterations in blood clotting time may occur.

Use when Pregnant

Safezone should be used only when required in patients who are pregnant or planning to become pregnant.

If Breastfeeding

Safezone may pass into the breast milk in low amount.

If trying to Conceive

Consult with your doctor on the use of Safezone, if you are trying to conceive.

Seizures

Safezone can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Safezone can worsen the sleepiness. Safezone may cause seizures in some people. Hence, you should discuss with your doctor before performing any activities where a loss of consciousness may cause harm to you or others.

Safezone Side-effects

The following side-effects may commonly occur when using Safezone Injection. If any of these side-effects worsen or last for a long time, you should consult with your doctor:
  • diarrhea
  • increase in the level of liver enzymes
  • increased number of white blood cells
  • low levels of platelets in the blood
  • skin rash
  • the decrease in the number of white blood cells
Rarely, the use of Safezone Injection may cause the following side-effects:
The following severe side-effects may also occur when using Safezone Injection:
  • Clostridium difficile associated diarrhea
    Symptoms: watery and bloody stools, stomach cramps fever
    If these symptoms happen, patients should contact their doctor as soon as possible.
  • increase in the number of white blood cells (leukocytosis)
  • the decrease in the number of white blood cells (leukopenia)
  • low levels of thrombocytes
  • severe skin reactions (Stevens-Johnson syndrome or Lyell's syndrome)
  • calcium salt precipitation in kidneys and lungs in newborn babies (possibly fatal)
  • blood loss due to a ruptured blood vessel (hemorrhage)
  • reoccurrence of a new infection while using an antibiotic (superinfection)
  • life-threatening allergic reactions (anaphylaxis)
Your doctor has prescribed this medicine because they judge that the benefit is greater than the risk posed by side-effects. Many people using this medicine do not have serious cases of side-effects. This page does not contain a complete list of all possible side-effects.
If you experience side-effects or 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. You can look up the drug authority contact information from the Drug Authority Finder at TabletWise.com.

Warnings

Interaction with Calcium-Containing Solution

Patients, who use calcium-containing solution to prepare the injection are at high risk. When the injection of this medicine is prepared with calcium-containing solutions, then it may lead to an increased risk of formation of solid calcium particles. Do not use calcium-containing solutions (such as Ringer’s solution or Hartmann’s solution) for preparing the injection.

Hemolytic Anemia

Patients receiving cephalosporins are at an increased risk of abnormal breakdown of red blood cells (hemolytic anemia). Such patients may see an increased risk of fatal conditions both in adults and children. If this happens, stop using this medicine until its cause is determined.

Use of Antibacterial Medicines

Patients who use antibacterial medicines including Safezone are at increased risk. In such patients, severe diarrhea may occur which is caused by Clostridium difficile bacteria. If this happens, stop using this medicine and take protein supplements or maintain the balance of body fluid and electrolyte (example sodium, chloride, potassium, and bicarbonate).

Long-Term Treatment with Safezone

Patients on long-term treatment with cephalosporins are at an increased risk when using this medicine. In such patients, complete blood count should be checked regularly.

Use of Safezone Sodium

Patients, who use Safezone sodium are at increased risk. Such patients should follow a controlled sodium diet.

Treatment With Safezone

Patients treated with this medicine are at an increased risk of inflammation of the pancreas (pancreatitis).

Kidney Problems

Patients with a history of kidney stone and excessive urinary calcium excretion are at an increased risk when using this medicine. In such patients, the kidney stone may occur upon discontinuation of Safezone.

Abnormal Functioning of the Liver and Kidneys

Such patients are at an increased risk when using this medicine. Careful clinical monitoring of safety and efficacy data is advisable for Safezone.

Allergy to Safezone

Patients who are allergic to Safezone are at an increased risk. Such patients may see an increased risk of life-threatening allergic reactions such as Stevens-Johnson syndrome or Lyell's syndrome. These patients should discontinue the use of this medicine.

Interference with Serological Testing

Use of Safezone may lead to false positive results for the determination of glucose in urine. An alternative testing method should be followed to avoid false positive results.

Interactions with Safezone

When two or more medicines are taken together, it can change how the medicines work and increase the risk of side-effects. In medical terms, this is called as a Drug Interaction.
This page does not contain all the possible interactions of Safezone Injection. Share a list of all medicines that you use with your doctor and pharmacist. Do not start, stop, or change the dose of any medicines without the approval of your doctor.

Galactose Interference in the Urine

Safezone Injection interacts with interference with glucose determination in urine. When using a non-enzymatic method for the determination of glucose in urine, a false-positive result may occur. For this reason, when using this medicine glucose level in urine should be determined according to enzyme activity.

Galactose Interference in the Blood

There may be an interaction of Safezone with interference with galactose determination in blood. A false positive result of the galactosemia can occur when using this medicine.

Coombs' Test

Safezone Injection may interact with Coombs' test, which is used to check blood for antibodies that attack red blood cells. A false positive result of the Coombs test can occur when using this medicine. An alternative testing method should be followed to avoid false positive results.

Anticoagulants

Your doctor's guidelines may need to be followed while taking this medicine along with anticoagulants, which are used to prevent blood clotting. Such patients may have an increased risk of bleeding. Proper monitoring of blood clotting time and dose adjustment is required in patients undergoing therapy with both anticoagulants and Safezone.

Calcium-Containing Solution

Special instructions need to be followed while taking this medicine along with a calcium-containing solution for preparing the injection. When the injection of this medicine is prepared with calcium-containing solutions, then it may lead to an increased risk of formation of solid calcium particles. Do not use calcium-containing solutions (such as Ringer’s solution or Hartmann’s solution) for preparing an injection of Safezone.

Chloramphenicol

There may be an interaction of Safezone with chloramphenicol, which is used to treat bacterial infections. Both the medicines oppose (antagonize) the working of each other.

Aminoglycosides

Safezone Injection may interact with aminoglycosides, which are used to treat bacterial infections. When aminoglycosides are taken with cephalosporins, it may lead to an increased risk of kidney damage. In such cases, carefully monitor the levels of aminoglycosides in the blood.

Traveling With Medication

  • Ensure that you carry enough doses of each of your prescription medicines to last the entire trip. The best place to store your medicines is in the carry on baggage. However, while flying, if carrying liquid medicines, make sure you do not go over the limits imposed for carry-on liquids.
  • While traveling overseas, make sure that you can carry each of your prescription medicines legally to your destination country. One way to ensure this is by checking with your destination country's embassy or website.
  • Make sure that you carry each of your medicines in their original packaging, which should typically include your name and address, and the details of the prescribing doctor.
  • If your travel involves crossing time zones, and you are required to take your medicine as per a fixed schedule, make sure that you adjust for the change in time.

Expired Medication

Taking a single dose of expired Safezone is unlikely to cause a side-effect. However, please discuss with your doctor or pharmacist, if you feel unwell or sick. An expired medicine may become ineffective in treating your prescribed conditions. To be on the safe side, it is important not to use an expired drug. You are much safer by always keeping a fresh supply of unexpired medicines.

Safe Disposal of Medication

  • If there are disposal instructions on the package, please follow the instructions.
  • If there are medicine take-back programs in your country, you should contact the respective authority to arrange for the disposal of the medicine. For example, in the USA, the Drug Enforcement Administration regularly hosts National Prescription Drug Take-Back events.
  • If there are no take-back programs, mix the medicine with dirt and place them in a sealed plastic bag. Throw the plastic bag in your household trash. Separately, remove all personal information including the prescription label from the medicine packaging and then dispose off the container.
  • If specifically indicated on the medicine package that it needs to be flushed down the toilet when no longer needed, perform the required step.
This page provides information for Safezone Injection .
Bacterial Infections
Pneumonia
Skin Infections
Urinary Tract Infections

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