Zofran 8 mg/4 ml injection 5 amp

Trade Name:

Zofran 4 mg/2 ml (or 8mg/4 ml) Solution for Injection or Infusion

Composition:

Each 4 ml contains 8 mg ondansetron (as ondansetron hydrochloride dihydrate)

Inactive ingredients:

citric acid monohydrate (E330), sodium citrate (E331), sodium chloride and water for injections.

Properties:

Zofran Solution for Injection or Infusion contains a medicine called ondansetron. This belongs to a group of medicines called anti-emetics. 

Indications:

Zofran injection is used for:

preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer, 

preventing nausea and vomiting after surgery.

Contraindications:

Do not have Zofran injection if:

• if you are taking apomorphine (used to treat Parkinson’s disease)
• if you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Zofran injection

Warnings and precautions:

• Check with your doctor or pharmacist before having Zofran injection if:

-you have ever had heart problems

-you have an uneven heart beat (arrhythmias)

-you are allergic to medicines similar to ondansetron, such as granisetron

• Zofran injection should start to work soon after having the injection. You must talk to a doctor if you do not feel better or if you feel worse.

-Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Zofran can affect the way some medicines work. 

Also some other medicines can affect the way Zofran works.

In particular, tell your doctor, nurse or pharmacist if you are taking any of the following medicines:

carbamazepine or phenytoin,

Rifampicin, antiarrhythmic medicines, beta-blocker medicines, tramadol, cancer medicines.

Zofran injection should not be given in the same syringe or infusion (drip) as any other medication.

Pregnancy and breast-feeding:

It is not known if Zofran is safe during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor, nurse or pharmacist for advice before taking this medicine. 

Do not breast-feed if you have Zofran. This is because small amounts pass into the mother’s milk. 

Driving and using machines:

Zofran is not expected to impair the ability to drive. However,do not drive or 

operate machines if you are feeling unwell.

Dosage and administration:

Zofran injection is normally given by a nurse or doctor. The dose you have been prescribed will depend on the treatment you are having.

• To prevent nausea and vomiting from chemotherapy or radiotherapy

-Adults:

On the day of chemotherapy or radiotherapy:

A single dose should not be more than 16mg. The usual adult dose is 8 mg given by an injection into your vein or muscle over at least 30 seconds, just before your treatment, and possibly another two 8 mg doses given by injection into your vein or muscle two to four hours apart, depending on the strength of your chemotherapy or radiotherapy. After chemotherapy, your medicine will usually be given by mouth as an 8 mg Zofran tablet or 10 ml (8 mg) Zofran syrup.

On the following days:

The usual adult dose is one 8 mg tablet or 10 ml (8 mg) syrup taken twice a day 

this may be given for up to 5 days.

If your chemotherapy or radiotherapy is likely to cause severe nausea and vomiting, you may be given more than the usual dose of Zofran. Your doctor will decide this.

Children and Adolescents (aged 6 months to 17 years): To prevent nausea and 

vomiting from chemotherapy only.

On the day of chemotherapy:

The first dose is given by an injection into the vein (up to 8 mg), just before your child’s treatment. After chemotherapy, 12 hours after the initial injection, your child’s medicine will usually be given by mouth; -in tablet format up to 4mg twice a day or 5 ml (4 mg) Zofran syrup.

On the following days:

Up to one 4 mg tablet or 5 ml (4 mg) syrup every twelve hours 

This can be given for up to five days.

• To prevent nausea and vomiting after an operation

The usual dose for adults is 4 mg given by an injection into your vein or muscle. This will be given just before your operation.

For children aged 2 years and over, the doctor will decide the dose. The maximum dose is 4 mg given as an injection into the vein. This will be given just before the operation.

• To treat nausea and vomiting after an operation

The usual adult dose is 4 mg given by an injection into your vein or muscle.

For children aged 2 years and over, the doctor will decide the dose. The maximum dose is 4 mg given as an injection into the vein.

• Patients with moderate or severe liver problems

The total daily dose should not be more than 8 mg. If you have blood tests to check how your liver is working. This medicine may affect the results.

Side effects:

-Allergic reactions:

These reactions are rare in people taking Zofran. If you have an allergic reaction, tell your 

doctor or a member of the medical staff straight away. 

The signs may include:

sudden wheezing and chest pain or chest tightness, swelling of your eyelids, face, lips, mouth or tongue, skin rash – red spots or lumps under your skin (hives) anywhere on your body, collapse.

Other side effects include:

• Very common: headache.
• Common: a feeling of warmth or flushing

constipation, changes to liver function test results, irritation and redness at the site of injection.

• Uncommon: hiccups, low blood pressure, which can make you feel faint or dizzy, uneven heart beat, slow heart rate, chest pain, fits, unusual body movements or shaking.
• Rare: blurred vision, disturbance in heart rhythm 
• Very rare: poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.

Storage:

Keep out of the reach and sight of children.

Store at a temperature not exceeding 30°C. Store in the original package in order to protect from light.

When Zofran injection is diluted in intravenous fluids:

-it must be stored at 2 – 8°C for not more than 24 hours

-it does not need to be protected from light during infusion.

Package:

Carton box holds a plastic tray with 5 ampoules of 4 ml and paper instructions