Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections.

Vancomycin powder is made into a solution for infusion or oral solution.

Vancomycin is used in all age groups by infusion for the treatment of the following serious infections:

-        Infections of the skin and tissues below the skin.

-        Infections of bone and joints.

-        An infection of the lungs called "pneumonia".

-        Infection of the inside lining of the heart (endocarditis) and to prevent endocarditis in patients at risk when undergoing major surgical procedures.

-        Infection in the blood linked to the infections listed above.

Vancomycin can be given orally in adults and children for the treatment of infection of the mucosa of the small and the large intestines with damage to the mucosae (pseudomembranous colitis), caused by the Clostridium difficile bacterium preventing severe diarrhea with blood in the stools.

Do not use Vancomycin

• If you are allergic to vancomycin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Serious side effects that may lead to loss of vision have been reported following the injection of vancomycin in the eyes. Vancomycin is not authorised for use in the eyes.

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

-        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.

Serious skin reactions including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) and linear IgA bullous dermatosis (LABD) have been reported in association with vancomycin treatment. Stop using vancomycin and seek medical attention immediately if you notice any of the symptoms described in section 4.

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.

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.

Other medicines and Vancomycin

Tell your doctor or hospital pharmacist if you are taking or have recently taken or might take any other medicines.

Special care is needed if you are taking/using other medicines as some could interact with vancomycin.

The following medicine may interact with Vancomycin:

·       Anaesthetic agents

·       Medicine for muscle relaxation

·       Other antibiotics that can affect your kidneys (e.g. streptomycin, neomycin, gentamicin, kanamycin, amikacin, tobramycin, polymixin B, piperacillin/tazobactam, colistin and bacitracin)

·       Medicine for fungal infection (amphotericin B)

·       Medicine for tuberculosis (viomycin)

·       Medicine for cancer (cisplatin)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or hospital pharmacist for advice before taking this medicine. Vancomycin should be given during pregnancy and breast-feeding only if clearly needed. The doctor may decide that you should stop breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Not applicable

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

The dose given to you will depend on:

-        your age,

-        your weight,

-        the infection you have,

-        how well your kidneys are working,

-        your hearing ability,

-        any other medicines you may be taking.

Intravenous administration

Adults and adolescents

The usual daily intravenous dose is 2 g divided either as 500 mg every 6 hours or 1 g every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer.

Use in children

Children aged from one month to less than 12 years of age

The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

Preterm and term newborn infants (from 0 up to 1 month)

In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

Oral administration

Oral vancomycin is used in treating antibiotic-associated pseudomembranous colitis caused by C. difficile and for staphylococcal enterocolitis. Vancomycin is not effective by the oral route for other types of infections. The usual adult total daily dosage is 500 mg to 2 g given in 3 or 4 divided doses for 7 to 10 days. The total daily dose in children is 40 mg/kg of body weight in 3 or 4 divided doses for 7 to 10 days. The total daily dosage should not exceed 2 g. The appropriate dose may be diluted in 1 oz of water and given to the patients to drink. Common flavoring syrups may be added to the solution to improve the taste for oral administration. The diluted solution may be administered via a nasogastric tube.

Method of administration

Intravenous infusion means that the medicinal product flows from an infusion bottle or bag through a tube to one of your blood vessels and into your body. Your doctor, or nurse, will always give vancomycin into your blood and not in the muscle.

Vancomycin will be given into your vein for at least 60 minutes.

If given for treatment of gastric disorders (so called Pseudomembranous colitis), the medicinal product must be administrated as a solution for oral use (you will take the medicine by mouth).

Duration of treatment

The length of treatment depends on the infection you have and may last a number of weeks.

The duration of the therapy may be different depending on the individual response to treatment for every patient.

During the treatment, you might have blood tests, be asked to provide urine samples and possibly have hearing tests to look for signs of possible side effects.

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

Infusion-Related Events

During or soon after rapid infusion of vancomycin hydrochloride for injection, patients may develop anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, or pruritus. Rapid infusion may also cause flushing of the upper body (“red neck”) or pain and muscle spasm of the chest and back. These reactions usually resolve within 20 minutes but may persist for several hours. Such events are infrequent if vancomycin hydrochloride for injection is given by a slow infusion over 60 minutes. In studies of normal volunteers, infusion-related events did not occur when vancomycin hydrochloride for injection was administered at a rate of 10 mg/min or less.

Nephrotoxicity

Systemic vancomycin exposure may result in acute kidney injury (AKI). The risk of AKI increases as systemic exposure/serum levels increase. Additional risk factors for AKI in patients receiving vancomycin include receipt of concomitant drugs known to be nephrotoxic, in patients with pre-existing renal impairment, or with co-morbidities that predispose to renal impairment. Interstitial nephritis has also been reported in patients receiving vancomycin.

Gastrointestinal

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.

Ototoxicity

A few dozen cases of hearing loss associated with vancomycin have been reported. Most of these patients had kidney dysfunction or a preexisting hearing loss or were receiving concomitant treatment with an ototoxic drug. Vertigo, dizziness, and tinnitus have been reported rarely.

Hematopoietic

Reversible neutropenia, usually starting 1 week or more after onset of therapy with vancomycin or after a total dosage of more than 25 g, has been reported for several dozen patients.

Neutropenia appears to be promptly reversible when vancomycin is discontinued. Thrombocytopenia has rarely been reported. Although a causal relationship has not been established, reversible agranulocytosis (granulocytes <500/mm³) has been reported rarely.

Phlebitis

Inflammation at the injection site has been reported.

Miscellaneous

Patients have been reported to have had anaphylaxis, drug fever, nausea, chills, eosinophilia, rashes including exfoliative dermatitis, Stevens-Johnson syndrome, (see section 4.4), and vasculitis in association with the administration of vancomycin.

Chemical peritonitis has been reported following intraperitoneal administration.

Post Marketing Reports

The following adverse reactions have been identified during post-approval use of vancomycin. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and Subcutaneous Tissue Disorders

Severe dermatologic reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), and linear IgA bullous dermatosis (LABD).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via national reporting system.

By reporting side effects you can help provide more information on the safety of this medicine.

·       Saudi Arabia

·       Other GCC states

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and vial as EXP. The expiry date refers to the last day of that month.

Powder as packaged for sale:

Store below 25 °C.

Keep the vial in the outer carton in order to protect from light.

Reconstituted concentrate:

The reconstituted concentrate may be stored in a refrigerator for 14 days without significant loss of potency.

Diluted product:

Solutions that are diluted with 5% Dextrose Injection or 0.9% Sodium Chloride Injection may be stored in a refrigerator for 14 days without significant loss of potency.

Solutions that are diluted with the following infusion fluids may be stored in a refrigerator for 96 hours:

5% Dextrose Injection and 0.9% Sodium Chloride Injection USP

Lactated Ringer’s Injection USP

Lactated Ringer’s and 5% Dextrose Injection USP