Ondansetron Solution for injection  4 mg/2 ml or 8mg/4 ml USP in Prefilled Syringe Taj Pharma

Ondansetron (as hydrochloride dihydrate)

Qualitative and Quantitative Composition

Ondansetron Solution for Injection in Prefilled Syringes:

2ml glass prefilled syringes each containing
4 mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intramuscular or intravenous administration.

4ml glass prefilled syringes each containing
8 mg ondansetron (as hydrochloride dihydrate) in aqueous solution for intravenous or intramuscular administration.

Pharmaceutical Form  

Solution for injection in Prefilled Syringes Clear, colourless solution

Posology and Method of Administration  

Ondansetron is also available for oral use to allow the route of administration and dosing to be flexible.

Chemotherapy and Radiotherapy induced nausea and vomiting (CINV and RINV) Adults

The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge.

The dose range of Ondansetron Solution for Injection in Prefilled Syringes is 8 to 32 mg a day and selected as shown below.

Emetogenic chemotherapy and radiotherapy: The recommended intravenous or intramuscular dose of Ondansetron is 8 mg administered as a slow injection in not less than 30 seconds immediately before treatment.

Oral treatment is recommended to protect against delayed or prolonged emesis after the first 24 hours. The recommended oral dose is 8 mg to be taken twice daily.

Highly emetogenic chemotherapy: For patients receiving highly emetogenic chemotherapy, e.g. high-dose cisplatin, Ondansetron may be administered as a single 8 mg intravenous or intramuscular dose immediately before chemotherapy. Doses of greater than 8 mg and up to 16 mg of Ondansetron may only be given by intravenous infusion diluted in 50-100 ml of saline or other compatible infusion fluid (See Instructions for Use/Handling) and infused over not less than 15 minutes .A single dose greater than 16mg should not be given due to dose dependent increase of QT-prolongation risk (see sections 4.4, 4.8 and 5.1 of the SPC). For management of highly emetogenic chemotherapy, a dose of 8 mg of Ondansetron may be administered by slow intravenous injection in not less than 30 seconds, or intramuscular injection   immediately   before   chemotherapy,   followed   by   two   further   intravenous or intramuscular doses of 8 mg two to four hours apart, or by a constant infusion of 1mg/hour for up to 24 hours.

The selection of dose regimen should be determined by the severity of the emetogenic challenge.

The efficacy of Ondansetron in highly emetogenic chemotherapy may be enhanced by the addition of a single intravenous dose of dexamethasone sodium phosphate, 20 mg administered prior to chemotherapy.

Oral treatment is recommended to protect against delayed or prolonged emesis after the first 24 hours.

Paediatric population

CINV in Children and Adolescents (aged 6 months to 17 years)

The dose of CINV can be calculated based on body surface area (BSA) or weight. Weight- based dosing results in higher total daily doses compared to BSA-based dosing (section 4.4 and 5.1 of the prescribing information).

There are no data from controlled clinical trials on the use of Ondansetron in the prevention of chemotherapy-induced delayed or prolonged nausea and vomiting. There are no data from controlled clinical trials on the use of Ondansetron for radiotherapy-induced nausea and vomiting in children.

In paediatric clinical studies, ondansetron was given by IV infusion diluted in 25 to 50 ml of saline or other compatible infusion fluid (see Instructions for Use and Handling) and infused over not less than 15 minutes.

Dosing by Body Surface Area (BSA)

Ondansetron should be administered immediately before chemotherapy as a single IV dose of 5 mg/m2. The IV dose must not exceed 8 mg. Oral dosing can commence twelve hours later and may be continued for up to 5 days (Table 1). The total daily dose must not exceed adult dose of 32 mg.

Table 1. BSA-based dosing for CINV (aged 6 months to 17 years)

BSA Day 1(a,b) Days 2-6(b)
< 0.6 m2 5 mg/m2 IV plus 2 mg syrup after 12 h 2 mg syrup

every 12 h

> 0.6 m2 5 mg/m2 IV plus 4 mg syrup

or tablet after 12 h

4 mg syrup or tablet

every 12 h

The intravenous dose must not exceed 8 mg

the total daily dose must not exceed adult dose of 32 mg Dosing by bodyweight

Weight-based dosing results in higher total daily doses compared to BSA-based dosing (see section 4.4 and 5.1 of the prescribing information).

Ondansetron should be administered immediately before chemotherapy as a single IV dose of 0.15 mg/kg. The IV dose must not exceed 8 mg.

On Day 1, two further IV doses may be given in 4-hourly intervals. Oral dosing can commence twelve hours later and may be continued for up to 5 days (Table 2). The total daily dose must not exceed adult dose of 32 mg.

Table 2. Weight-based dosing for CINV (aged 6 months to 17 years)

Body Weight Day 1(a,b) Days 2-6(b)
≤ 10 kg Up to 3 doses of 0.15 mg/kg every 4 h 2 mg syrup

every 12 h

> 10 kg Up to 3 doses of 0.15 mg/kg

every 4 h

4 mg syrup or tablet

every 12 h

The intravenous dose must not exceed 8 mg the total daily dose must not exceed adult dose of 32 mg

Elderly

Ondansetron is well tolerated by patients over 65 years and no alteration of dosage, dosing frequency or route of administration are required.

Post-Operative Nausea and Vomiting

(PONV) Adults

For the prevention of PONV the recommended dose of Ondansetron Solution for Injection or

Infusion is a single dose of 4 mg by intramuscular or slow intravenous injection administered at the induction of anesthesia.

For treatment of established PONV a single dose of 4 mg given by intramuscular or slow intravenous injection is recommended.

Paediatric population – Children and Adolescents (aged 1 month to 17 years)

For prevention of PONV in paediatric patients having surgery performed under general anaesthesia, a single dose of Ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4 mg either prior to, at or after induction of anaesthesia.

For the treatment of PONV after surgery in paediatric patients having surgery performed under general anaesthesia, a single dose of Ondansetron may be administered by slow intravenous injection (not less than 30 seconds) at a dose of 0.1mg/kg up to a maximum of 4 mg.

There are no data on the use of Ondansetron for the treatment of PONV in children under 2 years of age.

Elderly

There is limited experience in the use of Ondansetron in the prevention and treatment of PONV in the elderly, however Ondansetron is well tolerated in patients over 65 years receiving chemotherapy.

Patients with renal impairment

No alteration of daily dosage or frequency of dosing, or route of administration are required.

Patients with hepatic impairment

Clearance of Ondansetron (ondansetron) is significantly reduced and serum half-life significantly prolonged in subjects with moderate or severe impairment of hepatic function. In such patients a total daily dose of 8 mg IV or oral should not be exceeded.

Patients with poor sparteine/debrisoquine metabolism

The elimination half-life of Ondansetron (ondansetron) is not altered in subjects classified as poor metabolizers of sparteine and debrisoquine. Consequently, in such patients repeat dosing will give drug exposure levels no different from those of the general population. No alteration of daily dosage or frequency of dosing are required.

Overdose

Symptoms and Signs

There is limited experience of Ondansetron overdose. In the majority of cases symptoms were similar to those already reported in patients receiving recommended doses (see section 4.8 of the prescribing information). Manifestations that have been reported include visual disturbances, severe constipation, hypotension and a vasovagal episode with transient second-degree AV block.

Ondansetron prolongs QT interval in a dose-dependent fashion. ECG monitoring is recommended in cases of overdose.

Treatment

There is no specific antidote for Ondansetron, therefore in cases of suspected overdose, symptomatic and supportive therapy should be given as appropriate.

The use of ipecacuanha to treat overdose with Ondansetron is not recommended, as patients are unlikely to respond due to the anti-emetic action of Ondansetron itself.

Reconstitution and dilution of Ondansetron Solution for Injection in Prefilled Syringes Compatibility with intravenous fluids

Ondansetron Solution for injection in Prefilled Syringes should only be mixed with those infusion solutions which are recommended:

Sodium Chloride Intravenous Infusion BP 0.9%w/v Glucose Intravenous Infusion BP 5%w/v

Mannitol Intravenous Infusion BP 10%w/v Ringers Intravenous

 

Infusion

Potassium Chloride 0.3%w/v and Sodium Chloride 0.9%w/v Intravenous Infusion BP Potassium Chloride 0.3%w/v and Glucose 5%w/v Intravenous Infusion BP

In keeping with good pharmaceutical practice dilutions of Ondansetron injection in intravenous fluids should be prepared at the time of infusion or stored at 2-8oC for no more than 24 hours before the start of administration.

Compatibility studies have been undertaken in polyvinyl chloride infusion bags and polyvinyl chloride administration sets. It is considered that adequate stability would also be conferred by the use of polyethylene infusion bags or Type 1 glass bottles.

Dilutions of Ondansetron in sodium chloride 0.9%w/v or in glucose 5%w/v have been demonstrated to be stable in polypropylene syringes. It is considered that Ondansetron injection in Prefilled Syringes diluted with other compatible infusion fluids would be stable in polypropylene syringes.

Compatibility with other drugs

Ondansetron Solution for injection in Prefilled Syringes may be administered by intravenous infusion at 1mg/hour, e.g. from an infusion bag or syringe pump. The following drugs may be administered via the Y-site of the ondansetron giving set for ondansetron concentrations of 16 to 160 micrograms/ml (e.g. 8 mg/500 ml and 8 mg/50 ml respectively);

Cisplatin: Concentrations up to 0.48 mg/ml (e.g. 240 mg in 500 ml) administered over one to eight hours.

5-Fluorouracil: Concentrations up to 0.8 mg/ml (e.g. 2.4 g in 3 litres or 400 mg in 500 ml) administered at a rate of at least 20 ml per hour (500 ml per 24 hours). Higher concentrations of 5-fluorouracil may cause precipitation of ondansetron. The 5-fluorouracil infusion may contain up to 0.045% w/v magnesium chloride in addition to other excipients shown to be compatible.

Carboplatin: Concentrations in the range 0.18 mg/ml to 9.9 mg/ml (e.g. 90 mg in 500 ml to 990 mg in 100 ml), administered over ten minutes to one hour.

Etoposide: Concentrations in the range 0.144 mg/ml to 0.25 mg/ml (e.g. 72 mg in 500 ml to 250 mg in 1 litre), administered over thirty minutes to one hour.

Ceftazidime: Doses in the range 250 mg to 2000 mg reconstituted with Water for Injections BP as recommended by the manufacturer (e.g. 2.5 ml for 250 mg and 10 ml for 2g ceftazidime) and given as an intravenous bolus injection over approximately five minutes.

Cyclophosphamide: Doses in the range 100 mg to 1 g, reconstituted with Water for Injections BP, 5 ml per 100 mg cyclophosphamide, as recommended by the manufacturer and given as an intravenous bolus injection over approximately five minutes.

Doxorubicin: Doses in the range 10-100 mg reconstituted with Water for Injections BP, 5 ml per 10 mg doxorubicin, as recommended by the manufacturer and given as an intravenous bolus injection over approximately 5 minutes.

Dexamethasone: Dexamethasone sodium phosphate 20mg may be administered as a slow intravenous injection over 2-5 minutes via the Y-site of an infusion set delivering 8 or 16 mg of ondansetron diluted in 50-100 ml of the following infusion fluids:

Sodium Chloride Intravenous Infusion BP 0.9% w/v Glucose Intravenous Infusion BP 5% w/v

Sodium Chloride Intravenous Infusion 0.9% w/v and Glucose Intravenous Infusion BP 5% w/v over approximately 15 minutes

Compatibility between dexamethasone sodium phosphate and ondansetron has been demonstrated supporting administration of these drugs through the same giving set resulting in concentrations in line of 32 microgram – 2.5 mg/ml for dexamethasone sodium phosphate and 8 microgram – 1mg/ml for ondansetron.

Shelf Life      

36 months (unopened)

24 hours (dilutions stored 2 – 8ºC)

Special Precautions for Storage     

Store in the original container to protect from light Store below 30ºC

Dilutions of Ondansetron injection in compatible intravenous infusion fluids are stable under normal room lighting conditions or daylight for at least 24 hours, thus no protection from light is necessary while infusion takes place.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

 

Ondansetron Solution for injection
4 mg/2 ml or 8mg/4 ml USP in Prefilled Syringe Taj Pharma

Ondansetron (as hydrochloride dihydrate)

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 about your illness or your medicine, ask your doctor, nurse or pharmacist.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1 What Ondansetron Solution for Injection in Prefilled Syringes is and what it is used for

2 What you need to know before you have Ondansetron Solution for Injection in Prefilled Syringes

3 How to have Ondansetron Solution for Injection in Prefilled Syringes

4 Possible side effects

5 How to store Ondansetron Solution for Injection in Prefilled Syringes

6 Contents of the pack and other information

1 What Ondansetron Solution for Injection in Prefilled Syringes is and what it is used for

Ondansetron Solution for Injection in Prefilled Syringes (called ‘Ondansetron injection’ in this leaflet) contains a

medicine called ondansetron (as hydrochloride dihydrate). This belongs to a group of medicines called anti-emetics.

Ondansetron injection is used for:

preventing nausea and vomiting caused by chemotherapy or radiotherapy for cancer preventing nausea and vomiting after surgery.

Ask your doctor, nurse or pharmacist if you would like any further explanation about these uses.

Ondansetron 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.

2 What you need to know before you have Ondansetron Solution for Injection in Prefilled Syringes

Do not have Ondansetron injection if:

if you are taking apomorphine (used to treat Parkinson’s disease)

you are allergic (hypersensitive) to ondansetron or any of the other ingredients in Ondansetron

injection (listed in Section 6).

If you are not sure, talk to your doctor, nurse or pharmacist before having Ondansetron injection.

 

Warnings and precautions

Check with your doctor or pharmacist before having Ondansetron 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 (known as
  • ‘Kytril’)
  • you have liver problems
  • you have a blockage in your gut
  • you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.

The container of this medicinal product contains latex rubber. May cause severe allergic reactions.

If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Ondansetron injection.

Other Medicines and Ondansetron

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 Ondansetron can affect the way some medicines work. Also, some other medicines can affect the way Ondansetron works.

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

  • carbamazepine or phenytoin, used to treat epilepsy, as these medicines may reduce the effect of Ondansetron
  • Rifampicin, used to treat infections such as tuberculosis (TB), as this medicine may
  • reduce the effect of Ondansetron
  • anti-arrhythmic medicines used to treat an uneven heartbeat, as these medicines may
  • interact with Ondansetron & effect the rhythm of the heart
  • beta-blocker medicines used to treat certain heart or eye problems, anxiety or prevent
  • migraines, as these medicines may interact with Ondansetron and effect the rhythm of the heart
  • tramadol, a pain killer, as Ondansetron may reduce the effect of tramadol

Medicines that affect the heart

Cancer medicines (especially anthracyclines), as these may interact with Ondansetron to cause heart arrhythmias

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before having Ondansetron injection.

Ondansetron injection should not be given in the same syringe in Prefilled Syringes(drip) as any other medication.

Pregnancy and breast-feeding

It is not known if Ondansetron 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 Ondansetron. This is because small amounts pass into the mother’s milk. Ask your doctor or midwife for advice.

Driving and using machines

Ondansetron is not expected to impair the ability to drive. However, if any of the side effects (listed

section 4) affect you (e.g. dizziness, blurred vision) caution is advisable. Do not drive or operate machines if you are feeling unwell.

Ondansetron Solution for Injection in Prefilled Syringescontains sodium citrate and sodium chloride.

This means that Ondansetron injection contains 7 mg of sodium per 4 mg dose. If you are on a low sodium diet, speak to your doctor, nurse or pharmacist before you have Ondansetron injection.

3 How to have Ondansetron Solution for Injection in Prefilled Syringes

Ondansetron 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 Ondansetron tablet or 10 ml (8 mg) Ondansetron 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 Ondansetron. Your doctor will decide this.

Children and Adolescents (aged 6 months to 17 years): To prevent nausea and vomiting from chemotherapy only

The doctor will decide the dose. Look at the label for more information

On the day of chemotherapy, the first dose is given by an injection into the vein (up to 8mg), 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) Ondansetron 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.

If you have more Ondansetron injection than you should

Your doctor or nurse will give you Ondansetron injection so it is unlikely that you will receive too much. If you think you have been given too much or have missed a dose, tell your doctor or nurse.

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

4 Possible side effects

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

Conditions you need to look out for

Allergic reactions

These reactions are rare in people taking Ondansetron. 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

Other side effects include:

Very common (affects more than 1 in 10 people)

  • haedache

Common (affects less than 1 in 10 people)

  • a feeling of warmth or flushing
  • constipation
  • changes to liver function test results (if you have Ondansetron injection with a medicine called
  • cisplatin, otherwise this side effect is uncommon)
  • irritation and redness at the site of injection.

Uncommon (affects less than 1 in 100 people)

  • 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 (affects less than 1 in 1,000 people)
  • feeling dizzy or light headed during IV administration
  • blurred vision
  • Disturbance in heart rhythm (sometimes causing a sudden loss of consciousness).

Very rare (affects less than 1 in 10,000 people)

  • poor vision or temporary loss of eyesight, which usually comes back within 20 minutes.

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.

5 How to store Ondansetron Solution for Injection in Prefilled Syringes

Keep out of the reach and sight of children.

Do not use Ondansetron injection after the expiry date which is stated on the pack after ‘Exp’.

The expiry date refers to the last day of that month.

Do not store Ondansetron injection above 30°C. Store in the original package in order to protect from light.

Ondansetron injection is a clear colourless solution, do not use if it has any other appearance, e.g. appears cloudy

When Ondansetron 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.

6 Contents of the pack and other information

What Ondansetron injection contains

The active ingredient is ondansetron (as hydrochloride dihydrate) in a solution for injection in Prefilled Syringes which has a concentration of 2 mg in each ml. Each 2 ml Ondansetron injection ampoule contains ondansetron 4 mg. Each 4 ml Ondansetron injection ampoule contains ondansetron 8 mg.

The other ingredients are citric acid monohydrate (E330), sodium citrate (E331), sodium chloride and Water for Injections.

What Ondansetron injection looks like and contents of the pack

Ondansetron Solution for Injection in Prefilled Syringes is a clear, colourless liquid. Ondansetron injection is

available in 2 ml (4 mg) and 4 ml (8 mg) ampoules. Packed in plastic ampoule like trays in cardboard boxes of 5 ampoules per box.

Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at: Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com