Maximus Oral Spray

Maximus Oral Spray is a pharmaceutical product manufactured in Turkey, specifically designed to address various inflammatory conditions affecting the oropharyngeal region. This comprehensive guide explores the composition, therapeutic applications, administration guidelines, and safety considerations associated with this medication. As a non-steroidal anti-inflammatory drug (NSAID) formulation, it plays a crucial role in managing oral pain and inflammation while offering protective benefits following dental procedures.

Composition and Formulation

Maximus Oral Spray contains flurbiprofen as its active pharmaceutical ingredient. Each 30 ml bottle of the oral spray contains 0.075 g of flurbiprofen, a potent member of the propionic acid derivative class of NSAIDs. The medication works primarily through the inhibition of prostaglandin synthesis, conferring analgesic, antipyretic, and anti-inflammatory properties.

The formulation includes several excipients that enhance stability, palatability, and therapeutic delivery:

• Sodium benzoate

• Macrogolglycerol hydroxystearate 40

• Sodium bicarbonate

• Glycerol

• Saccharin sodium

• Sorbitol liquid non-crystallized (70%)

• Ecocool MP

• Peppermint

• Patent V blue

• Propylene glycol

• Purified water

The spray is packaged in 30 ml white HDPE bottles with specialized spray applicators, all contained within protective carton boxes.

Therapeutic Indications

Primary Applications

Maximus Oral Spray is primarily indicated for the symptomatic treatment of pain associated with inflammation in the oropharyngeal region. Its therapeutic applications include:

1. Anti-inflammatory treatment for conditions affecting the oral and pharyngeal mucosa

2. Pain management in cases of gingival inflammation (gingivitis)

3. Symptomatic relief for oral inflammation of various etiologies

4. Treatment of pharyngeal inflammation and associated discomfort

5. Post-dental treatment protection to facilitate healing and reduce discomfort following dental procedures

The spray formulation allows direct application to affected areas, providing targeted relief where it is most needed.

Mechanism of Action

Flurbiprofen, the active component in Maximus Oral Spray, belongs to the NSAID family. Its therapeutic effects stem from its ability to inhibit cyclooxygenase enzymes, thereby reducing the synthesis of prostaglandins-key mediators of inflammation, pain, and fever.

When applied topically to the oropharyngeal mucosa, flurbiprofen provides localized anti-inflammatory effects while minimizing systemic absorption compared to oral tablet formulations. This targeted approach can effectively reduce pain and inflammation while potentially limiting systemic side effects commonly associated with NSAIDs.

Clinical Evidence

Research supports the efficacy of topical flurbiprofen in managing oropharyngeal pain. A prospective, double-blind, randomized, placebo-controlled study demonstrated that topical flurbiprofen spray significantly reduced post-tonsillectomy pain compared to placebo. Patients receiving flurbiprofen spray reported lower pain scores and required less analgesic medication during the study period. Importantly, the study found no evidence of additional complications associated with topical flurbiprofen use.

Dosage and Administration

Standard Dosage

The recommended dosage regimen for Maximus Oral Spray is three direct sprays to the affected area three times daily. Each spray delivers approximately 0.13 ml of solution containing 0.325 mg of flurbiprofen.

Administration Method

The medication should be administered by spraying directly onto the affected area in the oral cavity. The spray format allows precise application to target specific sites of inflammation or pain.

Special Population Considerations

• Pediatric Use: Maximus Oral Spray is contraindicated in children younger than 12 years of age.

• Geriatric Use: While specific data for the elderly population is limited, caution is advised due to the potential for increased sensitivity to NSAIDs in older patients.

• Renal Impairment: The medication should be used with caution in patients with renal insufficiency, as NSAIDs may affect renal function.

• Hepatic Impairment: Patients with liver impairment should use the product cautiously, as hepatic metabolism plays a role in flurbiprofen clearance.

Contraindications

Maximus Oral Spray is contraindicated in the following circumstances:

1. Hypersensitivity to flurbiprofen or any of the excipients in the formulation

2. Known hypersensitivity to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs

3. History of bronchospasm (breathing difficulty related to bronchial narrowing) associated with NSAID use

4. Active peptic ulceration or history of recurrent peptic ulceration/hemorrhage

5. Severe heart failure, as NSAIDs may worsen cardiac function

Warnings and Precautions

Cardiovascular Risks

NSAIDs like flurbiprofen may increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke. This risk may increase with duration of use and pre-existing cardiovascular disease. Although topical application may reduce systemic exposure compared to oral administration, caution is still warranted in patients with:

• Heart disease

• History of hypertension

• Risk factors for cardiovascular disease

Gastrointestinal Risks

Even with topical application, some systemic absorption may occur, potentially increasing the risk of gastrointestinal adverse effects, including:

• Peptic ulcers

• Gastrointestinal bleeding

• Perforation of the stomach or intestines

These risks are higher in elderly patients, those with a history of peptic ulcer disease, and patients taking certain medications concomitantly.

Renal Effects

NSAIDs may cause dose-dependent reduction in prostaglandin formation, potentially leading to renal insufficiency. Patients with impaired renal function, dehydration, or heart failure may be at greater risk for renal toxicity.

Drug Interactions

While topical application generally results in lower systemic exposure compared to oral administration, potential interactions should still be considered:

1. Diuretics: Flurbiprofen may rarely decrease the diuretic activity of furosemide

2. Anticoagulants: Increased risk of bleeding when combined with anticoagulant therapy

3. Other NSAIDs: Concomitant use with other NSAIDs may increase the frequency of gastrointestinal ulcers and bleeding

4. Corticosteroids: May enhance the risk of gastrointestinal ulceration or bleeding

5. Anti-hypertensives: NSAIDs may diminish the anti-hypertensive effect of ACE inhibitors, angiotensin receptor blockers, and beta-blockers

The medication has reportedly shown no interactions with digoxin, tolbutamide, or antacids.

Side Effects

Common Side Effects

The most commonly observed adverse events associated with flurbiprofen are gastrointestinal in nature, although the topical spray formulation may reduce the incidence compared to systemic administration. These may include:

• Nausea and vomiting

• Dyspepsia

• Abdominal discomfort

• Diarrhea or constipation

Serious Adverse Effects

Though less common with topical application, serious adverse effects may include:

1. Cardiovascular events: Including hypertension, myocardial infarction, and stroke

2. Gastrointestinal complications: Peptic ulcers, gastrointestinal bleeding, and perforation

3. Hypersensitivity reactions: Ranging from rash to severe anaphylactic reactions

4. Respiratory reactions: Including asthma exacerbation, bronchospasm, and dyspnea in susceptible individuals

5. Hepatic effects: Elevated liver enzymes and rarely, more severe hepatic reactions

6. Renal effects: Including interstitial nephritis, nephrotic syndrome, and renal failure

Product Specifications and Storage

Maximus Oral Spray is available in 30 ml white HDPE bottles with spray applicators. The current retail price in Turkey (as of 2023) is approximately 110.71 Turkish Lira.

The product should be stored according to the manufacturer’s instructions, typically at room temperature away from direct light and moisture. Keep out of reach of children.

Information Table

Conclusion

Maximus Oral Spray represents a targeted therapeutic approach for managing pain and inflammation in the oropharyngeal region. Its active ingredient, flurbiprofen, provides effective relief through local anti-inflammatory action while potentially minimizing systemic exposure associated with oral NSAID formulations. Clinical evidence supports its efficacy in reducing pain, particularly following procedures such as tonsillectomy.

As with all medications, Maximus Oral Spray should be used according to prescribed guidelines, with attention to potential contraindications and precautions. While the topical application generally offers a favorable safety profile compared to systemic administration, healthcare providers should consider patient-specific factors including age, comorbidities, and concomitant medications when recommending this therapy.

For optimal therapeutic outcomes, patients should follow the recommended dosage regimen and consult healthcare professionals if symptoms persist or worsen despite treatment.