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Novapime® Injection

Novapime® Injection

Novapime® Injection is indicated for patients who suffer from bacterial infections such as moderate to severe pneumonia, pyelonephritis, infections of skin and skin structure, intra-abdominal infections (alongside metronidazole) etc. Novapime® Injection is not used to treat common viral conditions like flu or cold or mycoses (fungal infections).  Show full description

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Description

Novapime® Injection is manufactured by Lupin. Novapime® Injection’s active constituent is Cefepime, a 4th generation Cephalosporin antibiotic with an extended spectrum activity against gram-positive and gram-negative bacteria.

Indications:

- lower respiratory tract infections (moderate to severe pneumonia);

- empiric therapy for febrile neutropenic patients;

- uncomplicated and complicated urinary tract infections (pyelonephritis);

- uncomplicated skin and skin structure infections;

- complicated intra-abdominal infections (used in conjunction with metronidazole).

MOA (mechanism of action):

Cefepime is a beta-lactam-based antibiotic with a strong bactericidal action. It interferes with the last step of bacterial cell wall synthesis, resulting in exposure of osmotically less stable membrane. In other words, Cefepime kills bacteria by destroying their cell walls. Cefepime is active against gram-negative bacteria, including Enterobacter, Pseudomonas aeruginosa, Klebsiella pneumoniae, Serratia, Citrobacter, Proteus mirabilis and less active against Bacillus fragillis; gram-positive cocci: Staphylococcus aureus (methicillin-susceptible strains only), Streptococcus pneumoniae, Streptococcus pyogenes.

Dosage

For intravenous (IV) and intramuscular (IM) use only.

Do not use Novapime® Injection in neonates and infants under 2 months old.

Adults

For moderate to severe pneumonia: 1 to 2 g IV every 12 hours (during 10 days).

For empiric therapy for febrile neutropenic patients: 2 g IV every 8 hours (during 7 days, or until resolution neutropenia).

For mild to moderate uncomplicated and complicated urinary tract infections (pyelonephritis): 500 mg to 1 g IV or IM every 12 hours (7-10 days).

For severe uncomplicated and complicated urinary tract infections (pyelonephritis): 2 g IV every 12 hours (during 10 days).

For moderate to severe uncomplicated skin and skin structure infections: 2 g IV every 12 hours (during 10 days).

For complicated intra-abdominal infections (used in combination with metronidazole): 2 g IV every 12 hours (7-10 days).

Children between 2 months - 16 years

The usual recommended dosage in children up to 40 kg in weight for uncomplicated and complicated urinary tract infections (pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg per kg per dose, administered every 12 hours (50 mg per kg per dose, every 8 hours for febrile neutropenic patients), for durations as given above in Adults Dosage.

Administration

For IV and IM administration, reconstitute Novapime® Injection powder with 10 ml of sterile water.

Novapime® Injection may be given intravenously or by deep intramuscular injection into a large muscle mass (such as the upper outer quadrant of the gluteus maximus).

Intramuscular (IM) administration is indicated only for mild to moderate, uncomplicated or complicated UTIs due to E. coli.

The solution must be used fresh, immediately after reconstitution (within 30 minutes after preparation).

Product is for single use in one patient only.

Where to give intramuscular (IM) injection

Wash your hands and sanitize the patch of skin over the muscle where the injection will take place with an alcohol swab prior to performing the injection.

1. Thigh. Divide your thigh into 3 equal parts. A third in the middle will be right for injection. This area is good for kids under 3 years of age.

2. Hip. Place the palm of your hand on the upper, outer part of the thigh, where the buttocks meet. Point your thumb at the groin and fingers toward the patient's head. Make a V with fingers, whilst separating the first finger from the other three. With the tips of little and ring fingers, you will feel the edge of a bone. The area to give the injection is in the middle of the V. The hip best suits for adults and children older than 7 months.

3. Upper arm muscle. The upper arm should be completely exposed. The injection is given in the middle of an upside down triangle. The bone going across the top of the upper arm is a part of the scapula, called acromion process. The bottom of it forms the base of the triangle. The point of the triangle is below the center of the base nearly the armpit. The suitable area to give an injection is in the middle of the triangle, 2,5 to 5,1 cm below the acromion process. The hip should not be used if the person is very thin or the muscle is too small.

4. Buttocks. Expose one side of the buttocks. Draw a line from the top of the crack between the buttocks to the side of the body with an alcohol wipe. Find the middle of that line and go up 7,6 cm. From this point, draw another line down and across the first line, ending about halfway down the buttock. You should have drawn a cross. There will be a curved bone in the upper outer square. The injection will be given into the upper outer square below the curved bone. Do not use this area for injections in infants or children under 3 years of age.

How to give intramuscular (IM) injection

1. Place the syringe between your thumb and first finger. Let the syringe lean on your second finger.

2. With your free hand, gently press on and pull the skin so that it is tight a little bit.

3. Hold the syringe tightly and use your wrist to inject the needle into the skin and into the muscle at an angle 90 degrees.

4. Stop holding the skin with your other hand. Keep the syringe pointed straight in. Aspirate a little to make sure you did not hit a blood vessel. If blood comes, remove the needle immediately. Do not inject the medication. Dispose of both the syringe and the medicine. Get more medication in a new syringe. When you give the second injection, give it on the other side.

5. Insert the medication by pushing on the plunger. Inject the medication slowly to reduce the pain.

6. Remove needle swiftly. Press sterile cotton wool onto the opening. Secure with adhesive tape.

7. Dispose of syringe safely; wash your hands.

How to give intravenous (IV)

Material for injection: syringe with the drug (without air), needle (long and medium thickness; on syringe), liquid disinfectant, cotton wool, adhesive tape, tourniquet.

1. Wash your hands and expose the arm completely.

2. Apply tourniquet and look for a suitable vein.

3. Wait for the vein to swell.

4. Sanitize skin with an alcohol cotton wool (using liquid disinfectant).

5. Stabilize the vein by pulling the skin taut in the longitudinal direction of the vein. Do this with the hand you are not going to use for injecting.

6. Insert the needle at an angle of about 35 degrees.

7. Penetrate into the skin and push the needle slightly into the vein (3-5 mm).

8. Hold the syringe and needle firmly.

9. Aspirate. If blood appears hold the syringe steady, you are in the vein. If blood doesn't come, try again.

10. If you are in the vein, loosen tourniquet and inject very slowly.

12. Remove needle swiftly. Press sterile cotton wool onto the opening. Secure with adhesive tape.

13. Dispose of syringe safely; wash your hands.

Missing a dose

If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule. Do not take a double dose of Novapime® Injection to compensate the missed dose.

Overdose

If an overdose occurs and you are not feeling well, stop taking the medication immediately. You should seek emergency medical attention or contact your healthcare provider immediately.

Storage

Store at a cool temperature, away from excess moisture and heat. Avoid freezing of the reconstituted solution. Throw away any unused medicine after the expiration date. Keep out of the reach of children.

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Side effects

The most common side effects associated with Novapime® Injection are:

  • antibiotic-associated diarrhea
  • allergic reactions
  • nausea
  • vomiting
  • swelling of the lips, cheeks, tongue and eyelids
  • skin rash, itching
  • yellowing of the whites of the eyes and skin
  • discomfort in passing urine
  • blood in the urine
  • lower back pain

Side effects occurrence does not only depend on the medication you are taking, but also on your overall health and other factors.

Contraindications

Do not use Novapime® Injection if you are allergic to Cefepime, Cephalosporins or other beta-lactam antibiotics.

Do not use Novapime® Injection if you are allergic to Penicillins.

Do not use Novapime® Injection if you are allergic to any ingredient comprised in Novapime® Injection.

Do not use Novapime® Injection if you have a history of severe allergic reactions associated with using antibiotics.

Consult your doctor prior using Novapime® Injection if you have kidney disease (or if you are on dialysis), liver disease, diabetes.

Do not use Novapime® Injection if you are malnourished.

Do not use Novapime® Injection if you have a history of clostridium difficile associated diarrhea (CDAD).

Do not use Novapime® Injection if you have a history gastrointestinal disease (e.g. colitis).

Do not use Novapime® Injection if you are pregnant, plan to have a baby or are breastfeeding.

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Frequently asked questions

Q: What is Novapime® Injection used for?

A: Novapime® Injection is indicated for patients who suffer from bacterial infections such as moderate to severe pneumonia, pyelonephritis, infections of skin and skin structure, intra-abdominal infections (alongside metronidazole) etc.

Q: Can I use Novapime® Injection if I have diarrhea?

A: Do not use Novapime® Injection if you have diarrhea or if you have a history of clostridium difficile associated diarrhea (CDAD).

Q: Can I use Novapime® Injection for a cold?

A: Novapime® Injection cannot be used to treat viral infections like flu or cold.

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