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Bedoral Injection

API: Ketorolac Tromethamine | Company: Ranbaxy Pharmaceuticals

Clinical Summary

Quick overview from the medicine insert

Indication

Management of moderate to severe pain, particularly post-operative pain.

Dosage (summary)

Administer 30 mg as a single intramuscular or intravenous injection. Maximum duration of treatment is 5 days.

Onset of Action / Duration

Onset of analgesia typically occurs within 30 minutes, with a duration of action lasting up to 6 hours.

Special Populations

Elderly patients
Patients with renal impairment
Patients with hepatic impairment

Pregnancy & Breastfeeding

Use during pregnancy is not recommended, especially in the third trimester. Caution is advised during lactation as it is excreted in breast milk.

Key Drug Interactions

Increased risk of gastrointestinal bleeding when used with anticoagulants or other NSAIDs.
May enhance the effects of diuretics and antihypertensive medications.

Contraindications

Hypersensitivity to ketorolac or any component of the formulation.
Active or history of peptic ulcer disease.
Severe renal impairment.
Concurrent use with other NSAIDs.

Common side effects

Gastrointestinal discomfort
Nausea
Dizziness
Headache
Increased risk of bleeding

Counselling Points

Advise patients to report any signs of gastrointestinal bleeding, such as black stools or vomiting blood.
Instruct patients to avoid alcohol to reduce the risk of gastrointestinal side effects.
Inform patients about the potential for drowsiness and advise caution when driving or operating machinery.

Important Disclaimer

The Bedoral Injection professional information leaflet below is the property of Ranbaxy Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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Clinical Particulars

Section 4 of the official insert — extracted exactly as issued, no alterations

4. POSSIBLE SIDE EFFECTS

BEDORAL u00ae 30 can have side effects. Not all side effects reported for BEDORAL u00ae 30 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BEDORAL u00ae 30, please consult your doctor, pharmacist or other healthcare professional for advice. If any of the following happens, stop taking BEDORAL u00ae 30 and tell your doctor immediately or go to the casualty department at your nearest hospital:

Small purple coloured spots caused by bleeding into the skin.
Convulsions.
Yellowing of skin and eyes, also called jaundice.
Allergic skin reaction and itching.
Injection site reaction.
A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells). These are very serious side effects. If you have them, you may have had a serious allergic reaction to BEDORAL u00ae 30. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
Chest pains.
Abnormally slow pulse rate.
Rapid irregular action of the heart.
Unhealthy pale appearance.
Rapid reddening of the skin.
Difficulty in breathing.
Less urine than is normal for you.

These are serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

Headache.
Dizziness.
High pressure.
Nausea.
Heartburn.
Stomach cramps and discomfort.
Vomiting.
Increased or decreased frequency of stools.
Excessive thirst.
Discomfort to stomach.

Less frequent side effects:

Nose bleeds.
Feeling depressed and having false perceptions.
Hearing difficulties.
Low blood pressure.
Bleeding of duodenal ulcers.

Frequency unknown side effects:

Difficulty sleeping.
Dry mouth.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the u201c6.04 Adverse Drug Reaction Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effect you can help provide more information on the safety of BEDORAL u00ae 30.