FLABU 40 MG/ML (IBUPROFEN) – 15 ML ORAL DROPS

Active Ingredient: Ibuprofen 40 mg/mL
Dosage Form: Oral drops
Pack Size: 15 mL
Therapeutic Category: Non-Steroidal Anti-Inflammatory Drug (NSAID) / Analgesic / Antipyretic.

Product Overview

Flabu 40 mg/mL Oral Drops contain ibuprofen, a non-steroidal anti-inflammatory drug (NSAID) used to relieve mild to moderate pain, reduce fever, and alleviate inflammation in children.

Ibuprofen works by inhibiting cyclooxygenase (COX) enzymes, reducing the production of prostaglandins responsible for pain, inflammation, and elevated body temperature.

With its concentrated oral-drop formulation, Flabu provides a convenient option for administering weight-based doses in children when an appropriate dose has been prescribed.

Concentration: Each 1 mL contains 40 mg of ibuprofen.

Active Ingredient and Mechanism of Action

Ibuprofen 40 mg/mL

Ibuprofen is a non-selective cyclooxygenase (COX-1 and COX-2) inhibitor.

Its pharmacological actions include:

• Antipyretic Action: Helps reduce elevated body temperature by decreasing prostaglandin production involved in fever regulation.
• Analgesic Action: Relieves mild to moderate pain, including pain associated with teething, headaches, earaches, and musculoskeletal discomfort.
• Anti-inflammatory Action: Reduces inflammation, swelling, and associated discomfort.
• Prostaglandin Inhibition: Blocks COX enzymes, reducing the synthesis of prostaglandins that contribute to pain, fever, and inflammation.

Indications and Benefits

Flabu 40 mg/mL Oral Drops are used for the symptomatic relief of fever and mild to moderate pain in children.

Main therapeutic benefits include:

1. Fever Reduction: Helps lower elevated body temperature associated with common childhood illnesses.

2. Teething Pain Relief: Helps relieve discomfort associated with teething.

3. Earache Relief: Helps reduce pain associated with ear infections and other causes of ear discomfort.

4. Headache Relief: Provides symptomatic relief from mild to moderate headaches.

5. Sore Throat Relief: Helps alleviate pain and discomfort associated with throat inflammation.

6. Musculoskeletal Pain Relief: Helps reduce pain associated with minor injuries, muscle aches, and inflammation.

7. Anti-inflammatory Support: Helps reduce inflammatory symptoms accompanying painful conditions.

Important: Ibuprofen provides symptomatic relief but does not treat the underlying cause of an infection.

Dosage and Administration

Important: Pediatric ibuprofen dosing should be calculated according to the child's body weight, age, and clinical condition.

Usual Pediatric Dose:

• Dose: 5–10 mg/kg per dose.

• Frequency: Every 6–8 hours when needed.

• Maximum daily dose: 40 mg/kg/day.

• Use the lowest effective dose for the shortest possible duration.

Flabu Concentration Conversion:

Each 1 mL contains 40 mg of ibuprofen.

Example: For a child weighing 10 kg:

• A 5 mg/kg dose = 50 mg = 1.25 mL.
• A 10 mg/kg dose = 100 mg = 2.5 mL.

These are calculation examples, not individualized prescriptions.

Method of Administration:

• Administer orally using the supplied calibrated dropper or an appropriate oral measuring syringe.
• Measure the dose carefully; do not estimate using household teaspoons.
• Shake the bottle if instructed on the product leaflet.
• Administration with or after food may help reduce stomach discomfort.
• Do not exceed the recommended daily dose.
• Maintain adequate fluid intake during treatment.

Age Restrictions:

Ibuprofen is generally used in children from 3–6 months of age or older, depending on the product's approved labeling and the child's weight. For younger infants, medical assessment is essential before administration.

Important: Do not administer Flabu 40 mg/mL using dosing volumes intended for 20 mg/mL or other lower-concentration ibuprofen preparations. The concentration is twice that of a 20 mg/mL suspension, so dosing errors can result in overdose.

Possible Side Effects

Flabu is generally well tolerated when administered at the recommended dose and duration. However, some adverse effects may occur.

Common or relatively frequent side effects:

• Nausea.
• Vomiting.
• Abdominal pain.
• Indigestion.
• Diarrhea.
• Headache.
• Dizziness.

Less Common but Serious Side Effects:

• Gastrointestinal bleeding or stomach ulcers.
• Allergic reactions, including skin rash, itching, and swelling.
• Bronchospasm or worsening asthma symptoms in susceptible patients.
• Kidney impairment, particularly in dehydrated children.
• Fluid retention.
• Severe skin reactions.

Ibuprofen may increase the risk of kidney injury in children who are dehydrated due to vomiting, diarrhea, fever, or inadequate fluid intake.

Discontinue administration and seek immediate medical attention if the child develops breathing difficulties, facial swelling, severe abdominal pain, bloody vomiting, black stools, or a severe skin reaction.

Warnings and Precautions

• Dehydration: Avoid ibuprofen in children with significant dehydration, especially due to vomiting or diarrhea, because of the increased risk of kidney injury.
• Asthma: Use cautiously in children with asthma, particularly those with previous sensitivity to aspirin or other NSAIDs.
• Chickenpox: Avoid ibuprofen in children with chickenpox unless specifically recommended by a physician.
• Gastrointestinal Disorders: Use caution in patients with a history of stomach ulcers, gastrointestinal bleeding, or inflammatory bowel disease.
• Renal Impairment: Avoid or use only under medical supervision in patients with impaired kidney function.
• Hepatic Impairment: Children with significant liver disease require medical assessment before treatment.
• Cardiovascular Conditions: Use caution in patients with cardiovascular disease or fluid-retention disorders.
• Long-Term Use: Prolonged or repeated administration should be medically supervised.
• Pregnancy: Although this is a pediatric formulation, ibuprofen use during pregnancy requires specific medical consideration.

Contraindications

Flabu (ibuprofen) should not be administered to patients with:

• Known hypersensitivity to ibuprofen or any formulation ingredient.
• Previous allergic reactions, asthma attacks, or urticaria triggered by aspirin or other NSAIDs.
• Active peptic ulceration or gastrointestinal bleeding.
• History of gastrointestinal perforation or bleeding associated with NSAID treatment.
• Severe renal, hepatic, or cardiac impairment.
• Severe dehydration.
• Concomitant use with another NSAID when duplication increases toxicity risk.

Drug Interactions

Ibuprofen may interact with several medications, potentially increasing the risk of adverse effects.

Important interactions include:

• Other NSAIDs: Such as diclofenac, naproxen, and aspirin. Concomitant use increases the risk of gastrointestinal bleeding and kidney-related adverse effects.
• Anticoagulants: Such as warfarin, may increase the risk of bleeding.
• Corticosteroids: Such as prednisolone, may increase the risk of gastrointestinal ulceration and bleeding.
• Diuretics: May increase the risk of kidney impairment, particularly in dehydrated patients.
• Antihypertensive Medicines: May reduce the effectiveness of certain blood-pressure-lowering medications.
• Methotrexate: Ibuprofen may increase methotrexate exposure and toxicity.
• Lithium: May increase lithium concentrations.

Parents and caregivers should inform the physician or pharmacist about all medications the child is receiving before administering Flabu.

Storage Conditions

• Store according to the conditions stated on the original packaging.
• Protect from excessive heat and direct sunlight.
• Keep the bottle tightly closed.
• Keep out of reach of children.
• Do not use after the expiry date.
• Follow the manufacturer's instructions regarding storage after opening.

References

1. U.S. National Library of Medicine (NIH) – DailyMed. Ibuprofen Oral Suspension: Official prescribing information, pediatric dosing, pharmacological action, contraindications, and safety precautions. DailyMed – Ibuprofen prescribing information.

2. National Health Service (NHS), UK. Ibuprofen for Children: Dosage, administration, precautions, and adverse effects. NHS – Ibuprofen for children.

3. American Academy of Pediatrics (AAP). Ibuprofen Dosing Table for Fever and Pain: Weight-based pediatric dosing and administration recommendations. AAP – Pediatric ibuprofen dosing.

4. Therapeutic Goods Administration (TGA), Australia. OTC Medicine Monograph: Ibuprofen for Oral Use. Includes dosing recommendations for 40 mg/mL pediatric formulations. TGA – Ibuprofen oral-use monograph.

5. World Health Organization (WHO). Guidelines for the Pharmacological and Radiotherapeutic Management of Cancer Pain in Adults and Adolescents, with pediatric medication information including ibuprofen. WHO – Ibuprofen medication guidance.

6. IWK Health Centre, Canada. Pediatric Drug Dosing Guidelines: Ibuprofen. Includes weight-based dosing, maximum daily doses, and precautions. Pediatric ibuprofen dosing guidelines.

Patient Disclaimer

This product description is intended for educational and informational purposes only. Flabu 40 mg/mL (ibuprofen) is a medication intended for symptomatic relief of fever, pain, and inflammation. Pediatric dosing must be calculated according to the child's weight and age, using the correct product concentration. Avoid administration in dehydrated children or without appropriate medical advice in patients with underlying medical conditions. Always follow the package instructions and consult a qualified healthcare professional before use. This product is not intended to diagnose, treat, cure, or prevent any disease.