- RESPIRATORY TRACT DRUGS
- Pharmaceutical Form : S.R. Capsules
- Composition : Pseudoephedrine HCl 120 mg + Loratadine 5 mg / S.R.Cap
- Active Substance : Pseudoephedrine HCl+ Loratadine
Loratadine is an antihistamine works by competitively antagonizes histamine at the H 1 receptor, which helps reduce symptoms such as watery eyes and sneezing. Pseudoephedrine is a decongestant that causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha adrenergic stimulation, promoting nasal drainage.
Loratadine: After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism; approximately 40% of the dose is excreted in the urine and 42% in the feces over a 10 day period and that mainly in the form of conjugated metabolites.
Pseudoephedrine: After oral administration of pseudoephedrine HCl 60 mg, as tablets or oral solution, nasal decongestion occurs within 30 min and persists for 46 hrs, Pseudoephedrine and its metabolite are excreted in urine; 55-75% of a dose is excreted unchanged.
- Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing, watery eyes, rhinorrhea, pruritus (of the nose, throat or eyes) and lacrimation.
- Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies: reduces swelling of nasal passages, temporarily relieves sinus congestion and pressure, and temporarily restores freer breathing through the nose.
- Hypersensitivity to any ingredient of product or if the patient have ever had an allergic reaction to this product or any of its ingredients
- Hypersensitivity or Idiosyncratic reactions to adrenergic agents.
- Therapy with monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or for 2 weeks after stopping the MAOI drug.
- Glaucoma, Narrow-angle glaucoma, severe hypertension, severe coronary artery disease, or severe difficulty urinating (urinary retention), hyperthyroidism.
- If the patient is taking droxidopa or have taken furazolidone within the last 14 days.
- If the patient had experienced serious side effects such as irregular heart rhythms with decongestants (eg, pseudoephedrine, phenylephrine)
- The doctor should be consulted before use if the patient has: heart disease, thyroid disease, and diabetes, liver or kidney disease (renal impairment, hepatic impairment) or trouble sleeping, increased intraocular pressure or prostatic hypertrophy.
- The patient should stop use and consult the doctor if an allergic reaction to this product occurs, symptoms do not improve within 5 days or are accompanied by a fever, nervousness, dizziness or sleeplessness.
- Sympathomimetics should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction or bladder neck obstruction.
- Sympathomimetics may cause central nervous system (CNS) stimulation, excitability, convulsions and/or cardiovascular collapse with accompanying hypotension.
- Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine, an initial dose of ½ the usual dose is recommended.
- Pseudoephedrine, like other CNS stimulants, has been abused. With continued use, tolerance develops, the user increases the dose and toxicity occurs. Depression may follow rapid withdrawal.
- Esophageal obstruction and perforation has been reported with this product; Therefore, should not be used by patients with history of difficulty in swallowing tablets or who have known upper GI narrowing or abnormal esophageal peristalsis.
- If patient is to have allergy skin testing, advise patient not to take the medication for at least 6 days before the skin testing.
- It may cause dizziness therefore it should be Used with caution while driving or performing other possibly unsafe tasks until the patient knows how he reacts to the drug.
- Use with caution in the ELDERLY; they may be more sensitive to the drug effects and more likely to cause adverse reactions.
PREGNANCY and BREAST-FEEDING:
- Category B, Safe use this drug during pregnancy has not been established, therefore, it should be used only if the potential benefit justifies the potential risk to the fetus.
- Since Loratadine and pseudoephedrine sulfate are excreted in breast milk, a decision should be made whether to discontinue nursing or discontinue the use of the drug.
- Increase in plasma concentration of loratadine has been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes.
- Drugs known to inhibit hepatic metabolism should be used with caution.
- The antihypertensive effects of methyldopa, mecamylamine, reserpine and alkaloids may be reduced by sympathomimetics.
- Beta-adrenergic blocking agents may also interact with sympathomimetics.
- Increased ectopic pacemaker activity can occur when pseudoephedrine is used concomitantly with digitalis therefor it should be used with caution.
- Antacids increase the rate of pseudoephedrine absorption; Kaolin decreases it.
- Laboratory Test Interactions: Antihistamines should be discontinued approximately 48 hrs prior to skin testing procedures since antihistamines may prevent or diminish positive reactions to dermal reactivity indicators.
- With Guanadrel and guanethidine their effectiveness may be decreased by the concomitant use.
- With Bromocriptine the risk of its side effects or toxic effects may be increased by the concomitant use.
- Urinary alkalinizers (eg, sodium bicarbonate) may increase the risk of this drug side effects
COMMON side effects:
Coughing; dizziness; drowsiness; dry mouth; excitability; fatigue; headache; loss of appetite; mild stomach upset; nausea; nervousness; sore throat; thirst, insomnia and somnolence.
Dosage and administration:
Duration of therapy should not exceed 5 days
Adults and children 12 years and over: 5 mL (one 5mL teaspoonful) twice daily
Children 6-12 years of age: according to doctor prescription
For SR CAPSULES 120/5:
Adults and children 12 years and over: 1 capsules twice daily
Children 12-6 years of age: according to doctor prescription
Patients with reduced renal function (Ccr less than 30 mL/min): should be started on 1 capsules every day
Patients with liver or other kidney disease: according to the doctor prescription
If the Patient misses a dose it should be taking as soon as possible. If it is almost time for the next dose, the missed dose should be skipped, 2 doses should not be taking at once.
Symptoms may vary from central nervous system depression (sedation, apnea, diminished mental alertness, cyanosis, coma, cardiovascular collapse) to stimulation (insomnia, hallucination, tremors or convulsions) to death.
Treatment: In the event of overdosage, general symptomatic and supportive treatment should be started immediately and maintained for as long as necessary.
Store in a dry place below 25°c protect from light.
Box of 10 capsules.
Box of 20 capsules.
Bottle of 100 mL