Freenos SR

Freenos SR Special Precautions

loratadine + pseudoephedrine

Manufacturer:

PT Ferron

Distributor:

Hind Wing
Full Prescribing Info
Special Precautions
Sympathomimetic agents should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy or bladder neck obstruction, cardiovascular disease, increased intraocular pressure or diabetes mellitus.
Sympathomimetic agents should be used with caution in patients receiving digitalis.
Sympathomimetic agents may cause central nervous system (CNS) stimulation, excitability, convulsions and/or cardiovascular collapse with accompanying hypotension.
Acute generalized exanthematous pustulosis (AGEP), a form of severe skin reaction, may occur with pseudoephedrine containing products in isolated cases. If signs and symptoms such as the sudden occurrence of small (generalized) pustules, erythema, or fever are observed, patients should discontinue using the drug.
Pseudoephedrine, like other CNS stimulants, has been abused. At high doses, patients commonly experience mood elevation, decreased appetite and a sense of increased energy, physical strength, mental capacity and alertness. Anxiety, irritability, and loquacity also have been reported. With continued use, tolerance develops; the user increases the dose and ultimately toxicity occurs. Depression may follow rapid withdrawal.
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine, an initial dose of one tablet daily is recommended.
Dependence liability: there are no data available to indicate that abuse or dependency occurs with loratadine.
Because of the lack of experience with long-term use of this drug, its use should be limited to three months unless recommended by a physician.
Use in elderly: In patients 60 years or older, sympathomimetic agents may cause confusion, hallucinations, convulsions, CNS depression and death. Consequently, caution should be exercised when administering a repeat action formulation to this patient group.
Use in children: Safety and efficacy in children younger than 12 years of age have not yet been established.
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