Acyclovir (as sodium) 500mg

Acyclovir®

Acyclovir

Powder for injection 250mg, 500mg

 

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

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

 

Acyclovir® is an anti-viral medicine. It is used:

• to treat severe genital herpes
• to prevent or treat Herpes simplex infections (may appear as cold sores around the lips or as blisters on any part of the skin including the genitals) in patients whose immune system is not working properly
• to treat Herpes simplex infections in very young babies or in infants up to 3 months of age
• to treat Varicella zoster viral infections (e.g. chicken pox and shingles)
• to treat herpes encephalitis (inflammation of the brain following infection with herpes)

Before use this drug, ask your doctor:

• if you are allergic to acyclovir or valacyclovir or any of the other ingredients of this medicine
• if you have kidney problems
• if you are over 65 years of age
• if you are taking any of the following medicines:
• probenecid, used to treat gout
• cimetidine, used to treat stomach ulcers
• tacrolimus, ciclosporin or mycophenolate mofetil, used to stop your body rejecting transplanted organs
• theophylline (a medicine used to treat some breathing disorders)
• lithium (a medicine used for manic-depressive disorder)

 

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 pharmacist for advice before using this medicine.

 

Warnings and precautions

Talk to your doctor or pharmacist or nurse before using Aciclovir for Infusion if you:

• have kidney problems as the dose may need to be modified according to how your kidneys are working.
• have a low resistance to disease (are immune compromised)
• are elderly
• are dehydrated (extremely thirsty)
• are on a low sodium diet (see ‘Important information for patients on a controlled sodium diet’ section below). The sodium content of each gram of Acyclovir is approximately 4.2 mEq Sodium ion. You should tell your doctor or pharmacist if you are on a controlled sodium diet.

 

Driving and using machines

Acyclovir for Infusion can cause confusion, hallucinations (seeing or hearing things that are not there), agitation, tremor and drowsiness which may affect your ability to drive or use machines. If you are affected, do not drive or operate machinery.

 

Medical Tests

Interactions with laboratory tests have not been established.

 

Method of administration

• For i.v. infusion

Reconstitute 250mg or 500mg vial with 10ml of water for injection or 0.9% Sodium Chloride. Dilute doses up to 500mg in 100ml of 0.9% Sodium Chloride or 5% Glucose and 250mg in 50ml of 0.9% Sodium Chloride or 5% Glucose. The infusion should be given over at least 60 minutes.

 

The recommended dose

The dose of medicine given to you and how often you are given it will be determined by your doctor and will depend on your medical condition, age, size and how well your kidneys are working.

Treatment with acyclovir usually lasts 5 days depending on how quickly you get better. However, treatment for herpes encephalitis usually lasts for at least 10 days. For very young babies treatment for herpes typically lasts 14 days for skin/eye/mouth infections and for 21 days for infections affecting the whole body.

If acyclovir is being given to prevent a viral infection, it will be given for the period your doctor thinks you are at risk of getting an infection.

It is important to drink plenty of water after you have been given acyclovir infusion.

For the treatment of herpes infections, chickenpox or ‘shingles’ in adults:

• The recommended adult dose of Acyclovir for Infusion is 5mg per kg bodyweight every eight hours for five days.
• This dose is doubled to 10mg per kg every eight hours for:

– patients with low resistance to disease who have chicken pox or shingles

– patients with herpes inflammation of the brain (these patients may need ten days treatment).

For the treatment of herpes infections in newborn and babies up to 3 months old

• In the newborn and babies up to three months old, the dose is 20mg per kg of bodyweight every eight hours, usually for 14 days for skin, eye and mouth infections, or 21 days if the disease is widely spread or has affected the central nervous system.

For the treatment of chickenpox or herpes infections in children aged 3 months to 12 years

• For children aged 3 months to 12 years, the dose is 250mg per m² of body surface area, every eight hours, usually for five days.

 

People with liver and kidney problems

If you have kidney problems, it is important to drink plenty of water while you are being treated with Acyclovir.

 

If you are given more Acyclovir for injection than you should

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call a poison control center right away. Symptoms of overdose may include: change in the amount of urine, extreme tiredness, agitation, loss of consciousness, seizures.

 

If you forget to use Acyclovir for injection

A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or

nurse.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.

 

If you stop using Acyclovir for injection

Do not stop taking Acyclovir for injection unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

 

Adverse reactions

Like all medicines Acyclovir Sterile Concentrate can cause side effects, although not everybody gets them.

If any of the following happen, tell your doctor immediately:

 

• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint
• changes in your blood cells e.g. anaemia and/or reduced white blood cells and/or lowered platelet levels (leading to unexplained bruising). Your doctor may take blood samples to monitor for these
• yellowing of the skin and whites of the eyes (jaundice)
• pain or swelling at the injection site during or immediately after the injection
• convulsions or fits
• confusion or unusual and disordered thoughts (psychosis)
• hallucinations
• agitation
• trembling or shaking
• coma
• difficulty breathing, shortness of breath
• difficulty in controlling movements
• problems with your speech
• kidney problems or failure, including blood in urine
• a severe form of rash with itchy pink-red blotches (erythema multiforme), which may blister
• in patients who have a compromised immune system:

– a rare disorder of the blood clotting system called thrombotic thrombocytopenic purpura, which may give you bruising, headaches, hallucinations and also blood clots in the kidneys

– a severe form of anaemia called haemolytic uraemic syndrome, which may make you look pale and feel tired due to anaemia, and give you bruising and kidney problems

These side effects are very rare.

 

Common (may affect up to 1 in 10 people)

• inflammation (soreness, redness and swelling) along the vein used for the infusion
• feeling or being sick
• rash, hives or sensitivity of the skin to light
• changes in your liver and kidney function (Your doctor may take blood samples to monitor for these)
• nausea
• vomiting

 

Uncommon (may affect up to 1 in 100 people)

• reduced numbers of red blood cells (anaemia)
• reduced numbers of white blood cells (leukopenia)
• reduced numbers of blood platelets (thrombocytopenia)

 

Very rare side effects (may affect up to 1 in 10,000 people)

• sweating or fever
• headache
• abdominal pain
• diarrhoea
• dizziness
• tiredness
• feeling unusually sleepy
• problem of the brain (encephalopathy)
• pain in your lower back, the kidney area of your back or pain when passing urine (renal pain)

 

Frequency unknown (frequency cannot be estimated from the available data)

• thirst
• ow blood pressure (you may feel dizzy when you stand up)
• rupture of red blood cells (haemolysis)
• problems with small blood vessels (leukocytoclastic vasculitis)
• tingling or numbness

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

 

Special precautions for storage

• Keep out of the reach and sight of children.
• This medicine must not be used after the expiry date which is stated on the vial label and carton after ‘EXP’. Where only a month and year is stated, the expiry date refers to the last day of that month.
• Do not store above 25ºC. Do not refrigerate.
• The vials should be kept in their outer carton, in order to protect from light.
• Once the powder has been made into a solution the product should be used immediately. If this is not possible it would generally not be stored for more than 24 hours at 2-8°C.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

 

Acyclovir®

Each vial contains:

Acyclovir (as sodium) 250mg, 500mg

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.