VANCOJECT®

 

Vancomycin Powder for injection 500mg, 1 g

 

Vancomycin Hydrochloride 500 mg and 1 g Powder for Concentrate for Infusion

Read all of this leaflet carefully before you starts taking this medicine because it contains important information for you.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• If you have any further questions, ask your doctor or pharmacist

Warnings and precautions

Talk to your doctor or hospital pharmacist or nurse before using Vancomycin if:

• If you are allergic to vancomycin or any of the other ingredients of this medicine
• You suffered a previous allergic reaction to teicoplanin because this could mean you are also allergic to vancomycin.
• You have a hearing disorder; especially if you are elderly (you may need hearing tests during treatment).
• You have kidney disorder (you will need to have your blood and kidneys tested during treatment).
• You are receiving vancomycin by infusion for the treatment of the diarrhoea associated to Clostridium difficile infection instead of orally.

Talk to your doctor or hospital pharmacist or nurse during treatment with Vancomycin if:

• You are receiving vancomycin for a long time (you may need to have your blood, hepatic and kidneys tested during treatment).
• You develop any skin reaction during the treatment.
• You develop severe or prolonged diarrhoea during or after using vancomycin, consult your doctor immediately. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
• Special care will also be taken if you are elderly or you are due to have a general anaesthetic.
• Special care is needed if you are taking/using other medicines as some could interact with vancomycin, for example: other antibiotics that can affect your kidneys e.g. streptomycin, neomycin, gentamicin, kanamycin, amikacin, tobramycin, polymyxin B and colistin, water tablets e.g. ethacrynic acid and frusemide, cholestyramine (a medicine used to treat high levels of fat in the blood or diarrhoea in inflammatory diseases of the gut)

Children

• Vancomycin will be used with particular care in premature infants and young infants, because their kidneys are not fully developed and they may accumulare vancomycin in the blood. This age group may need blood tests for controlling vancomycin levels in blood.
• Concomitant administration of vancomycin and anaesthetic agents has been associated with skin redness (erythema) and allergic reactions in children.
• Similarly, concomitant use with other medicines such as aminoglycoside antibiotics, nonsteroidal anti-inflammatory agents (NSAIDs, e.g., ibuprofen) or amphotericin B (medicine for fungal infection) can increase the risk of kidney damage and therefore more frequent blood and renal test may be necessary.

Take special care with Vancomycin Hydrochloride Powder for Concentrate for Infusion

• If you have kidney problems
• If you have hearing difficulties

Pregnancy and breast-feeding

Tell your doctor if you are pregnant, trying to become pregnant or breastfeeding. Your doctor will decide if you should receive this medicine.

Driving and using machines

Do not drive or use machines if you experience any side effect (e.g. dizziness) which may lessen your ability to do so.

How to use Vancomycin Hydrochloride Powder for Concentrate for Infusion

You will be given Vancomycin by medical staff while you are in hospital. Your doctor will decide how much of this medicine you should receive each day and how long the treatment will last.

Dosage

Intravenous administration

Adults and adolescents (from 12 years and older)

The recommended dose is 7.5 mg/kg of body weight or 500 mg every 6 hr., or 15 mg per kg of body weight or 1 g every 12 hr.

In very severe infections, 3 to 4 g a day has been used intravenously for short periods.

Infants and children aged from one month to less than 12 years of age:

The recommended dose is 10 mg/kg body weight every 6 hours or 20 mg per kg of body weight every 12 hours.

Preterm and term newborn infants (from 7 to 27 days)

The recommended dose is 15 mg/kg body weight initialy, followed by 10 mg per kg of body weight every 8 hours.

Preterm and term newborn infants (from 0 to 7 days)

The recommended dose is 15 mg/kg body weight initialy, followed by 10 mg per kg of body weight every 12 hours

Preparation of Solution:

For single use.

At the time of use, add 10 ml of sterile Water for Injections BP to a 500 mg vial of Vancomycin Hydrochloride 500 mg Powder for Concentrate for Infusion. Similarly, add 20 ml of sterile Water for Injections BP to a 1 g vial of Vancomycin Hydrochloride 1 g Powder for Concentrate for Infusion. Vials reconstituted in this manner will give a solution of 50 mg/ml. Further dilution is required depending on method of administration:

Intermittent infusion (the preferred method of administration):

Reconstituted solutions containing 500 mg vancomycin must be diluted with at least 100 ml diluent. Reconstituted solutions containing 1 g vancomycin must be diluted with at least 200 ml diluent.

Sodium Chloride Intravenous Infusion B.P. or 5% Dextrose Intravenous Infusion B.P. are suitable diluents. The desired dose should be administered by intravenous infusion over a period of at least 60 minutes. If administered over a shorter period of time or in higher concentrations, there is a possibility of inducing marked hypotension in addition to thrombophlebitis. Rapid administration may also produce flushing and a transient rash over the neck and shoulders.

Continuous infusion (should only be used when intermittent infusion not feasible):

1 g or 2 g of vancomycin may be added to a sufficiently large volume of Sodium Chloride Intravenous Infusion B.P. or 5% Dextrose Intravenous Infusion B.P. to permit the desired dose to be infused over twenty-four hours.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

>10%

Bitter taste (PO)

Erythematous rash on face and upper body (IV; red neck or red man syndrome; related to infusion rate)

Hypotension accompanied by flushing (IV)

Nausea and vomiting (PO)

1-10%

Chills (IV)

Drug fever (IV)

Eosinophilia (IV)

Rash (IV)

Fatique (PO)

Peripheral edema (PO)

Urinary tract infection (PO)

Back pain (PO)

Headache (PO)

Reversible neutropenia (IV)

Phlebitis (IV)

<1%

Nephrotoxicity

Ototoxicity (especially with large doses)

Stevens-Johnson syndrome

Thrombocytopenia

Vasculitis

Postmarketing Reports

Ototoxicity: Hearing loss associated IV administration (most cases had coexisting renal impairment or pre-existing hearing loss, or were coadministered an ototoxic drug), vertigo, dizziness, and tinnitus

Hematopoietic: Reversible neutropenia, thrombocytopenia

Miscellaneous: Anaphylaxis, drug fever, chills, nausea, eosinophilia, rashes, Stevens-Johnson syndrome, toxic epidermal necrolysis, and vasculitis

How to store Vancomycin Hydrochloride Powder for Concentrate for Infusion

Keep this medicine out of the sight and reach of children

Keep the vial in the outer carton, in order to protect from light, and store at or below 25°C.

The reconstituted solution should be used immediately, however, if this is not possible it can be stored for up to 4 days in a refrigerator, provided it has been prepared in a way to exclude microbial contamination.

 

VANCOJECT®

Each vial contains:

Vancomycin (as HCl) 500mg, 1g

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.