Patient Medication Information: uses, side effects, how to take - Acyclovir (Sanis Health, 200 mg, 800 mg)
ABOUT THIS MEDICATION
What the medication is used for and what it does: ACYCLOVIR (acyclovir) is an antiviral medicine.
Treatment of shingles (herpes zoster)
ACYCLOVIR is used to treat shingles (herpes zoster) infections. Shingles is caused by the varicella-zoster virus. The virus multiplies in and eventually destroys affected skin cells. ACYCLOVIR stops the virus from multiplying and therefore from spreading to neighbouring healthy cells. It cannot replace a cell which has been damaged by the multiplying virus, but it will facilitate the process of healing.
Treatment of chickenpox (varicella)
ACYCLOVIR is used to treat chickenpox (varicella) which is caused by the varicella-zoster virus. See the “Information for Parents” section at the end of this leaflet.
Treatment and suppression of genital herpes
ACYCLOVIR is used to treat initial episodes of genital herpes.
Genital herpes is a sexually transmitted infection caused by the herpes simplex virus (HSV). HSV causes small, fluid-filled blisters in the genital area which break down into ulcers/sores which may be itchy or painful. The fluid in these blisters contains the virus which causes the disease. It is a feature of all herpes viruses that once in the body, they stay there throughout life alternating between active (outbreak) and inactive states.
When taken on a daily basis, ACYCLOVIR can also be used to prevent the HSV infection from coming back. This type of treatment is called suppressive therapy.
When it should not be used:
You should not use ACYCLOVIR if you are allergic to or react badly to acyclovir or any other components of the formulation of ACYCLOVIR (see “What the non-medicinal ingredients are” section). Tell your doctor if you have ever had an allergic reaction to any of these ingredients.
What the medicinal ingredient is:
ACYCLOVIR Tablets contain the active ingredient acyclovir.
What the non-medicinal ingredients are:
ACYCLOVIR 200 mg Tablets contain the non-medicinal ingredients: lactose, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, povidone, and FD&C blue No. 2 aluminum lake.
ACYCLOVIR 400 mg Tablets contain the non-medicinal ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, povidone and Iron Oxide 30.
ACYCLOVIR 800 mg Tablets contain the non-medicinal ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, povidone, and FD&C blue No. 2 aluminum lake.
What dosage forms it comes in:
ACYCLOVIR is available in tablets containing 200 mg, 400 mg or 800 mg of acyclovir.
WARNINGS AND PRECAUTIONS
Before using ACYCLOVIR, tell your doctor if:
- You have kidney problems or if you are 65 years of age or older. Your doctor may give you a lower dose of ACYCLOVIR.
You are pregnant, planning to become pregnant, or breastfeeding.
When using ACYCLOVIR for suppression of genital herpes, your doctor may periodically stop your drug therapy in order to reassess your need for continuous treatment. The effect of long-term use in humans has not been fully assessed. Prudence is therefore suggested when choosing continuous, long term therapy with ACYCLOVIR. Suppression of recurrent genital herpes is therefore, only recommended in those who are severely affected. Some patients experience increased severity of the first episode of genital herpes after stopping treatment.
Genital herpes is passed from one person to another through direct intimate contact. To reduce the risk of transmission, wash your hands immediately if you touch your skin sores, and do not touch other parts of your body until you have done so. Especially avoid intimate contact with others when the disease is visible. Herpes virus particles may also be released when you do not have blisters or sores. For this reason, it is safest to believe that you can spread the infection to your partner even when sores are not present.
Although decreased sperm counts were observed in animals treated with high doses, these effects did not occur in humans.
PROPER USE OF THIS MEDICATION
Medication should not be shared with others. The prescribed dosage should not be exceeded.
Usual dose for shingles:
For the treatment of shingles (herpes zoster), the usual dose of ACYCLOVIR is 800 mg every 4 hours, 5 times daily for 7 to 10 days. ACYCLOVIR must be taken as early as possible within 72 hours of the onset of lesions.
Usual dose for chickenpox:
For the treatment of chickenpox (varicella), the usual dose of ACYCLOVIR is 20 mg/kg (not to exceed 800 mg) 4 times daily for 5 days. ACYCLOVIR must be taken as early as possible within 24 hours of the appearance of rash.
Usual dose for genital herpes:
For the treatment of an initial episode of genital herpes, the usual dose of ACYCLOVIR is 200 mg every 4 hours, 5 times daily (maximum 1 g daily) for 10 days. ACYCLOVIR must be taken as early as possible following onset of signs and symptoms.
For the suppression of genital herpes, the usual dose of ACYCLOVIR is 200 mg 3 to 5 times daily or 400 mg twice daily. You should follow dosing instructions carefully. The objective is to keep enough of the drug in the body at all times to prevent the herpes virus from multiplying. Your doctor will try to prescribe the minimum dose required to do this in your case and may therefore increase or decrease your dose during the first few weeks. Follow your doctor's instruction carefully to ensure that you get the best possible response to treatment.
For the treatment of recurrent episodes of genital herpes, the usual dose of ACYCLOVIR is 200 mg every 4 hours 5 times daily for 5 days. ACYCLOVIR must be taken at the earliest sign or symptom (prodrome) of recurrence.
Overdose:
It is important to follow the dosage instructions on the label of your medicine. In the event of an overdose, you should IMMEDIATELY contact either your doctor, the nearest hospital emergency department or poison control centre.
Missed dose:
If you forget to take a dose, take it as soon as you remember. Then continue with the next dose at the proper time interval. Do not double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with any widely prescribed medication, adverse events in association with the use of ACYCLOVIR are reported from time to time. The common ones are listed below; they have rarely been severe enough to make it necessary to stop taking the drug.
Headache, nausea, diarrhea, skin rash and upset stomach.
If you experience any of the following side effects, contact your doctor as soon as possible:
- Pain in the side (between ribs and hip) or kidney area of your back.
- Unusual bruising or bleeding.
Tell your pharmacist or doctor if you notice other side effects from your medicine which are not mentioned here. A complete listing of adverse events that have been reported is contained in the Product Monograph supplied to your doctor and pharmacist.
HOW TO STORE IT
Store ACYCLOVIR Tablets at room temperature (15° to 25°C). ACYCLOVIR Tablets should be stored in a dry place and protected from light.
Keep your ACYCLOVIR Tablets in a safe place where children cannot reach them.
| CHICKENPOX – INFORMATION FOR PARENTS |
Chickenpox is one of the most common infections in otherwise healthy children. It usually occurs in children before the age of ten, but anyone who has never had chickenpox can become infected - irrespective of age.
Chickenpox is caused by a virus called "varicella zoster" and it is highly contagious. Family members often give the disease to each other. For reasons that are not known, often the second or third child who catches it from a brother or sister will be sicker than the first child. Also, the disease tends to be more severe in teenagers than in younger children.
The disease can be mild with few pox or mild symptoms – alternatively, it could be severe with hundreds of pox. The pox can occur both outside and inside the body. There is no way to predict the severity of chickenpox.
Recognizing the Disease
The early symptoms of chickenpox may be vague and could include fever, itching, headache, aching joints and muscles, sore throat, general malaise: loss of appetite, listlessness and irritability. After that, itchy, small, red spots (the "pox") appear, and become blisters within a few hours. New spots and blisters continue to appear for about five days. The blisters start to dry up and within six or seven days turn into scabs.
Incubation
Not all who are exposed come down with the disease. The incubation period may extend from one to three weeks after exposure. The virus is spread through the air when: (1) a person with chickenpox scratches the blisters, allowing the virus to become airborne; or (2) a person with chickenpox coughs or sneezes within close contact of others. The disease is most contagious shortly before the rash appears, through the early stages of the rash, and until all the blisters have dried. A patient
is not contagious once all the blisters have become scabs.
Early consultation with your doctor
If you think your child has been exposed to chickenpox, be on the lookout for symptoms described above. At the first sign of rash, CALL YOUR DOCTOR. There are more treatment options available when the infection is caught this early. Your doctor may prescribe a medication which could offer the child less discomfort, and possibly a faster recovery.
Tips to bear in mind
It is important to follow the doctor's orders with all medications prescribed - even if the patient seems to feel better. Never use medications containing acetylsalicylic acid (ASA) in children with fever and chickenpox. Acetaminophen may be given to reduce fever.
The rash can be soothed by coating with an anti-itch product such as calamine, or other medications that your doctor recommends. The discomfort of itching can be relieved temporarily by baths and wet compresses. Bathing daily with soap and water can also help prevent infection. Do not use antiseptics on the sores; rather consult your doctor, who might prescribe an antibiotic if necessary. Since infection or scarring can occur at scratch sites, it is important to discourage scratching and spreading of virus particles through the air. Keep the rash clean and dry. If possible keep the nails cut short, cover the hands and feet with cotton gloves, mitts or socks to discourage children scratching at sleep time.
Possible Complications
Complications are rare in the healthy child. The people who are at greatest risk of complications are: pregnant women, newborn babies, or people being treated for cancer, arthritis, asthma, or after organ transplants - where medicine is suppressing their immune systems. If anyone in your family falls within these groups inform your doctor so that the preventive measures can be taken.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- 1. Report online at www.healthcanada.gc.ca/medeffect
- 2. Call toll-free at 1-866-234-2345
- 3.
Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Sanis Health Inc., at: 1-866-236-4076