Brontox – Sinus

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Brontox-Sinus contains Desloratadine, a long-acting, non-sedating histamine antagonist with potent selective antagonist activity on peripheral H1 receptors. Desloratadine has demonstrated antiallergic, antihistamine and anti-inflammatory activity. It also contains Pseudoephedrine Hydrochloride, an oral vasoconstrictor that causes a sustained gradual decongestant effect; together with acetaminophen, an antipyretic analgesic that inhibits cyclooxygenase and consequently the synthesis of prostaglandins.

Therapeutic indications

Brontox-Sinus is indicated to treat flu symptoms (stuffy nose, runny nose, itchy nose, tearing, fever and muscle aches).


Clinical pharmacology

Pharmacodynamic properties

Desloratadine: After oral administration, desloratadine selectively blocks peripheral histamine H1 receptors, because the agent is effectively excluded from entry into the central nervous system (CNS). In addition to antihistamine activity, desloratadine has shown antiallergic and anti-inflammatory activity in numerous studies.

Pseudoephedrine: It acts on the alpha-adrenergic receptors of the mucosa of the respiratory tract, producing vasoconstriction. It reduces tissue hyperemia, edema, and nasal congestion, and increases the permeability of the nasal airways.

Pharmacokinetic properties

Desloratadine: Desloratadine plasma concentrations can be detected within 30 minutes of administration. The agent is well absorbed, achieving maximum concentrations after approximately 3 hours; the terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine corresponds to its half-life (approximately 27 hours) and the frequency of administration once a day. The bioavailability of desloratadine is proportional to the dose between the limits of 5 and 20 mg. Desloratadine is moderately conjugated (83% to 87%) with plasma proteins.

Pseudoephedrine: It is incompletely metabolized in the liver, it begins its action from 15 to 30 minutes; and lasts from 3 to 4 hours and in a long-acting capsule its effect is from 8 to 12 hours. About 55 to 75% of a dose is excreted unchanged. The excretion rate increases in acidic urine.

Acetaminophen: Absorbed rapidly and almost completely orally; it reaches its maximum plasma concentration in 30 minutes on average, with a range of 10 to 60 minutes after oral administration; distributes quickly and uniformly in most tissues; about 25% of acetaminophen circulates in blood bound to plasma proteins for 1.25 hours to 3 hours; the main route of elimination (85%) is the urinary one and it is excreted almost totally within 24 hours after its ingestion.

Pharmacological interactions

No clinically relevant drug interactions with desloratadine have been observed in clinical studies. Desloratadine taken concomitantly with alcohol does not potentiate performance impairment effects due to alcohol. Pseudoephedrine: Mao, Methyldopa, Reserpine inhibitors. Antacids increase the absorption rate of pseudoephedrine and kaolin decreases it. Acetaminophen can increase the activity of coumarin anticoagulants.

Composition

Each coated caplet contains:

Acetaminophen     325 mg

Pseudoephedrine HCL     30 mg

Desloratadine     2.5 mg

C.S.P. excipients     1 coated caplet


Administration route

Oral


Presentation

Box containing 25 blisters with 2 coated caps each.

Box containing 1 blister with 10 coated caps each.


Storage Recommendations

Store below 30 °C. Protect from light and moisture.

 


Cautions

The efficacy and safety of desloratadine in children younger than 1 year of age have not been established.

No effects on the ability to guide vehicles and use machinery have been observed.

Pseudoephedrine should be used with caution in patients with glaucoma, cardiovascular disease, prostatic hypertrophy, diabetes mellitus.

Pregnancy and lactation

The safety in the use of Brontox-Sinus during pregnancy and lactation has not been established, therefore the use in these conditions should be avoided.


Posology

Adults and adolescents (over 12 years of age): Two caplets twice a day.