Aerius D-12
Aerius D-12 Uses, Dosage, Side Effects, Food Interaction and all others data.
Desloratadine is a long-acting, tricyclic, non-sedating, selective peripheral histamine H1-receptor antagonist which inhibits the release of pro-inflammatory mediators from human mast cells and basophils.
Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.
Trade Name | Aerius D-12 |
Generic | Desloratadine + Pseudoephedrine Sulphate |
Weight | 25mg, 120mg |
Type | Slow Release Tablet |
Therapeutic Class | Anti-histamine & decongestant |
Manufacturer | Schering Plough Labo, Merck Sharp Dohme Pharma |
Available Country | Indonesia |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
This is used for the relief of the nasal and non-nasal symptoms of allergic rhinitis including nasal congestion.
Aerius D-12 is also used to associated treatment for these conditions: Allergic Rhinitis (AR), Asthma, Chronic Idiopathic Urticaria, Common Cold, Nasal Congestion, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis, Nasal symptoms, Non-nasal symptoms, Antihistamine
How Aerius D-12 works
Like other H1-blockers, Desloratadine competes with free histamine for binding at H1-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms (eg. nasal congestion, watery eyes) brought on by histamine.
Dosage
Aerius D-12 dosage
Adults and children over 12 years of age: The recommended dose is Desloratadine 5 mg & Pseudoephedrine 240 mg tablet once daily or Desloratadine 2.5 mg & Pseudoephedrine 120 mg twice daily administered with or without a meal. In patients with renal impairment the dose may be given in every alternative day.
Side Effects
The common side effects are dry mouth, trouble sleeping, body aches or pain, hoarseness, weakness, restlessness, runny nose, sleepiness or unusual drowsiness, tender, swollen glands in neck, weight loss.
Toxicity
Information regarding desloratadine overdose is limited, although somnolence has been reported. In case of overdose, symptomatic and supportive treatment, including removing the unabsorbed drug, is recommended; note, however, that desloratadine and its active metabolite 3-hydroxydesloratadine cannot be eliminated by hemodialysis.
In animal studies, lethality was observed at or above doses of 250 mg/kg in rats and of 353 mg/kg in mice (oral LD50), doses that represent 120 and 290 times the human exposure based on the recommended daily oral dose. In monkey, no deaths occurred at doses up to 250 mg/kg, representing an exposure roughly 810 times that of the recommended dose in humans.
Precaution
This should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism or prostatic hypertrophy. Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may be produced by sympathomimetic amines.
Interaction
No specific interaction studies have been conducted with Desloratadine and Pseudoephedrine combination. However, Pseudoephedrine reduces the antihypertensive effects of beta-adrenergic blocking agents, methyldopa, mecamylamine, reserpine, and veratrum alkaloids. Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis.
Elimination Route
Desloratadine administered orally for ten days to healthy volunteers as a 5 mg tablet once daily resulted in a mean Tmax of approximately 3 hours, a mean steady-state Cmax of 4 ng/ml, and a mean steady-state AUC of 56.9 ng*hr/ml. A similar profile was observed using 10 ml of an oral solution containing 5 mg of desloratadine. Food was found not to affect desloratadine absorption.
Half Life
Desloratadine has a mean plasma elimination half-life of approximately 27 hours.
Elimination Route
Approximately 87% of a C-desloratadine dose was equally recovered in urine and feces as metabolic products.
Pregnancy & Breastfeeding use
Desloratadine and Pseudoephedrine combination may be used in pregnancy or during lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant.
Contraindication
Desloratadine and Pseudoephedrine combination is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients, or to Desloratadine. Due to its Pseudoephedrine component, it is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures.
Special Warning
It is not recommended for children under 12 years of age.
Acute Overdose
No clinically relevant adverse events have been reported in case of overdosage. However, in the event of overdosage, symptomatic and supportive treatment is recommended.
Storage Condition
Store in a cool and dry place. Protect from light.
Innovators Monograph
You find simplified version here Aerius D-12