Butirol Fort Syrup

Description

Butirol Fort Syrup is a non-narcotic antitussive (cough suppressant) medication containing butamirate citrate as its active pharmaceutical ingredient. This medication, primarily manufactured in Turkey by Drogsan Pharmaceuticals, is used for the symptomatic treatment of non-productive cough from various etiologies. Unlike opioid-based cough suppressants, Butirol Fort offers effective relief without causing sedation, constipation, or dependency concerns, making it a preferred option for many healthcare providers treating cough-related conditions.

Composition and Formulation

Butirol Fort Syrup contains butamirate citrate as its active ingredient, with each 5 ml of the syrup containing 22.5 mg of butamirate citrate. The formulation includes several excipients that contribute to its stability, palatability, and therapeutic efficacy. These include sorbitol (70% non-crystallizing liquid), sodium benzoate, raspberry flavor, glycerol, sucralose, fructose, citric acid monohydrate, sodium citrate dihydrate, tutti frutti flavor, azorubin (carmoisine), and purified water. The medication is presented as a light pink, clear solution with a fruity aroma in a 100 ml amber glass bottle, accompanied by a 5 ml measuring spoon for accurate dosing.

Mechanism of Action

Butamirate citrate functions primarily as a centrally acting cough suppressant. It works directly on the cough center in the brainstem to reduce the tussigenic reflex, thereby suppressing the urge to cough. While the exact mechanism is not fully understood, research indicates that it diminishes the cough reflex by acting on specific receptors in the medullary center of the brain.

Additionally, butamirate demonstrates peripheral activity through non-specific anticholinergic and bronchospasmolytic effects that facilitate respiratory function. This dual-action mechanism provides effective cough suppression without the disadvantages associated with narcotic antitussives. The medication also has mild anti-inflammatory properties that contribute to its efficacy in treating cough associated with respiratory tract inflammation.

Pharmacokinetic Properties

Butamirate is rapidly and completely absorbed after oral administration. The peak plasma level of the principal metabolite, 2-phenylbutyric acid, is reached in approximately 1.5 hours. The apparent elimination half-life is approximately 6 hours, with no accumulation observed following repeated administration.

The hydrolysis of butamirate, principally into 2-phenylbutyric acid and diethylaminoethoxyethanol, begins in the plasma. These two metabolites also have antitussive action and are extensively bound to plasma proteins (approximately 95%), accounting for the long plasma half-life. The metabolites are mainly eliminated renally, with the acid metabolites being extensively linked to glucuronic acid.

Therapeutic Indications

Butirol Fort Syrup is indicated for the symptomatic treatment of various cough conditions, including:

• Dry, non-productive cough of various etiologies

• Acute cough due to viral respiratory tract infections

• Cough associated with bronchitis, tracheitis, and laryngitis

• Pre- and post-operative cough management

• Cough suppression before or after bronchoscopy

• Whooping cough and other acute lower respiratory tract infections

Dosage and Administration

Adults

The recommended dosage for adults is 5 ml (22.5 mg) four times daily, which can be taken before or after meals or with food.

Adolescents (Over 12 Years)

For adolescents over 12 years of age, the recommended dosage is 5 ml (22.5 mg) three times daily.

Children

The dosage for children varies according to age:

• Children 6-12 years: 5 ml (22.5 mg) twice daily

• Children under 6 years: Not recommended

• Children under 3 years: Contraindicated

The syrup should be taken orally using the provided 5 ml measuring spoon, which should be washed and dried after each use. Unless otherwise prescribed by a physician, the maximum treatment duration should not exceed 7 days. The lowest effective dose should be used for the shortest duration necessary to control symptoms.

Contraindications

Butirol Fort Syrup is contraindicated in:

• Patients with known hypersensitivity to butamirate citrate or any of the excipients in the formulation

• Children under 3 years of age

Special Warnings and Precautions

Several important considerations should be taken into account when using Butirol Fort:

• Concomitant use with expectorants should be avoided as butamirate inhibits the cough reflex, which could lead to mucus accumulation in the respiratory tract, increasing the risk of bronchospasm and respiratory infections

• The medication is not recommended for use in children under 6 years of age

• If cough worsens or persists for more than 7 days, and/or is accompanied by fever or persistent headache, patients should consult a healthcare professional to evaluate underlying causes

• The product contains sorbitol, making it unsuitable for patients with hereditary fructose intolerance

• Butamirate may cause drowsiness and dizziness, potentially affecting the ability to drive or operate machinery

Interactions with Other Medications

No specific drug interactions have been definitively established with butamirate citrate. However, as a precautionary measure:

• Butamirate should not be used together with strong enzyme inhibitors due to the possible risk of increased exposure

• Medications with a narrow therapeutic index should not be used concurrently with butamirate due to the possible risk of altered exposure to these drugs

• Concomitant use with expectorants must be avoided

Use in Special Populations

Pregnancy

No adequate studies have been conducted in pregnant women. Butamirate should not be used during the first trimester of pregnancy. During the second and third trimesters, it should be administered with caution and only if absolutely necessary, taking into consideration the benefit for the mother and the potential risk for the fetus.

Breastfeeding

There are no data available on the excretion of butamirate or its metabolites in breast milk. Therefore, the use of Butirol Fort during breastfeeding is not recommended.

Elderly

No specific studies have been conducted on the use of Butirol Fort in elderly patients.

Renal/Hepatic Impairment

Butirol Fort has not been specifically studied in patients with renal or hepatic impairment. Patients with kidney and/or liver disease may be at greater risk of adverse effects from butamirate due to potential drug and metabolite accumulation.

Side Effects

Butirol Fort is generally well-tolerated. However, some adverse reactions may occur rarely (≥1/10,000, <1/1,000):

• Nervous System Disorders: Drowsiness, dizziness

• Gastrointestinal Disorders: Nausea, diarrhea

• Skin and Subcutaneous Tissue Disorders: Urticaria (hives), rash

• Immune System Disorders: Hypersensitivity reactions

If serious side effects such as skin rash occur, patients should consult their healthcare provider immediately.

Overdose

Symptoms of butamirate overdose may include drowsiness, nausea, vomiting, diarrhea, dizziness, and hypotension.

In case of overdose, standard treatment measures are recommended, including gastric lavage, administration of activated charcoal, and if necessary, monitoring and treatment of vital signs. There is no known specific antidote for butamirate.

Storage Conditions

Butirol Fort Syrup should be stored in its original packaging at room temperature, protected from light. The shelf life is typically 36 months from the date of manufacture.

Key Information

Conclusion

Butirol Fort Syrup containing butamirate citrate 22.5 mg/5 ml is an effective non-narcotic antitussive medication for the symptomatic treatment of dry, non-productive cough. Its dual mechanism of action, both central and peripheral, provides efficient cough suppression without the risks associated with opioid-based cough suppressants. While generally well-tolerated, healthcare provider guidance should be sought for prolonged or worsening symptoms, particularly in special populations such as pregnant women, breastfeeding mothers, and patients with renal or hepatic impairment.

The medication’s efficacy in reducing the cough reflex while also providing bronchodilatory effects makes it a valuable option in the management of cough, especially when sedation or dependency is a concern. As with all medications, patients should strictly follow the prescribed dosage and consult healthcare professionals if symptoms persist or worsen despite treatment.