Aldisa SR
Aldisa SR Uses, Dosage, Side Effects, Food Interaction and all others data.
Loratadine is a non-sedating antihistamine. It works by selectively binding to peripheral histamine H1-receptors on effector cells.
Like other 2nd generation antihistamines, loratadine is selective for peripheral H1 receptors. Loratadine does not penetrate effectively into the central nervous system and has poor affinity for CNS H1-receptors. These qualities result in a lack of CNS depressant effects such as drowsiness, sedation, and impaired psychomotor function.
Trade Name | Aldisa SR |
Generic | Loratadine + pseudoephedrine sulfate |
Weight | 5mg, 120mg |
Type | Capsule Lepas Lambat |
Therapeutic Class | |
Manufacturer | Sanbe Farma |
Available Country | Indonesia |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Loratadine provides faster relief from the symptoms of hay fever, allergic rhinitis such as sneezing, nasal discharge, itching, ocular itching and burning, nasal and ocular sign and symptoms are relieved rapidly after oral administration.
Loratadine is also effective in idiopathic chronic urticaria. In children over 2 years, Loratadine is used for the symptomatic relief of seasonal allergic rhinitis and allergic skin conditions such as urticaria nettle rash.
Aldisa SR is also used to associated treatment for these conditions: Allergic Dermatologic Disorders, Allergic Rhinitis (AR), Allergies, Chronic Urticaria, Common Cold, Eye pruritus, Fever, Nasal Congestion, Nasal Itching, Pain, Perennial Allergic Rhinitis (PAR), Perennial Rhinitis, Pollen Allergy, Pruritus, Rhinorrhoea, Seasonal Allergic Rhinitis, Sneezing, Sensation of burning in the eyes, Watery eyes, Watery itchy eyes
How Aldisa SR works
Histamine release is a key mediator in allergic rhinitis and urticaria. As a result, loratadine exerts it's effect by targeting H1 histamine receptors.
Loratadine binds to H1 histamine receptors found on the surface of epithelial cells, endothelial cells, eosinophils, neutrophils, airway cells, and vascular smooth muscle cells among others. H1 histamine receptors fall under the wider umbrella of G-protein coupled receptors, and exist in a state of equilibrium between the active and inactive forms. Histamine binding to the H1-receptor facilitates cross linking between transmembrane domains III and V, stabilizing the active form of the receptor. On the other hand, antihistamines bind to a different site on the H1 receptor favouring the inactive form.
Hence, loratadine can more accurately be classified as an "inverse agonist" as opposed to a "histamine antagonist", and can prevent or reduce the severity of histamine mediated symptoms.
Dosage
Aldisa SR dosage
Adult & children over 12 years of age: One Loratadine 10 mg tablet once daily (usually in the morning).
Children:
- 2-12 years (body weight more than 30 Kg): 10 mg Loratadine once daily.
- 2-12 years (body weight less than 30 Kg): 5 mg Loratadine once daily.
- Below 2 years of age: Safety and efficacy of Loratadine have not been established.
Liver & renal impairment: Patients with liver impairment and renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (10 mg every other day).
Side Effects
Fatigue, nausea and headache were reported rarely. Scientific studies showed that Loratadine does not cause drowsiness. It does not affect performance and ability to drive or tasks requiring concentration.
Toxicity
Second generation antihistamines such as loratadine have very few adverse effects; however, insomnia, headache, fatigue, drowsiness and rash have been reported. Symptoms of loratadine overdose include gastrointestinal side effects, agitation, drowsiness, tachycardia, and headache. It is advised to obtain an ECG in the event of loratadine overdose.
Precaution
Patients with liver impairment and renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (10 mg every other day).
Interaction
When administered concurrently with alcohol, Loratadine has no potentiating effect as measured by psychomotor performance studies. Interactions with other drugs have not been reported.
Volume of Distribution
The volume of distribution of loratadine is 120 L/Kg.
Elimination Route
Loratadine is rapidly absorbed and achieves peak plasma concentration in 1-2 hours, while it's main metabolite achieves peak plasma concentration in 3-4 hours.
In the rapid dissolve formulation, the pharmacokinetic parameters of loratadine are as follows: Cmax = 2.56 ng/ml, Tmax = 1.14 hrs, AUC = 6.14 ng x hr/ml.
In the rapid dissolve formulation, the pharmacokinetic parameters of descarboethoxyloratadine are as follows: Cmax = 3.72 ng/ml, Tmax = 1.97 hr, AUC = 49.1 ng x hr/ml.
In the conventional formulation, the pharmacokinetic parameters of loratadine are as follows: Cmax = 2.11 ng/ml, Tmax = 1.00 hr, AUC = 4.64 ng x hr/ml
In the conventional formulation, the pharmacokinetic parameters of descarboethoxyloratadine are as follows: Cmax = 3.66 ng/ml, Tmax = 1.97 hr, AUC = 48.4 ng x hr/ml
Half Life
The elimination half life is approximately 10 hours for loratadine and 20 hours for descarboethoxyloratadine.
Clearance
The clearance of loratadine after single oral doses of 20 mg and 40 mg are 12 L/h/kg and 9 L/h/kg respectively. P-glycoprotein is involved in the clearance of many 2nd generation antihistamines, including loratadine, from the central nervous system. 1st generation antihistamines are not cleared by P-glycoprotein, which may help explain why they have a different central nervous system adverse effect profile compared to their 2nd generation counterparts. It appears that an antihistamine with higher affinity for p-glycoprotein will have a lower incidence of CNS adverse effects.
Elimination Route
Over a 10 day period, 40% of loratadine is excreted in the urine, and 42% is eliminated in the faeces.
Pregnancy & Breastfeeding use
Use in pregnancy: There is no experience of the use of Loratadine in human pregnancy, hence it should not be used during pregnancy.
Use in lactation: Loratadine is excreted in breast milk, so it should not be administered to lactating mother.
Contraindication
Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncracy to their components.
Acute Overdose
Symptoms: Somnolence, tachycardia headache, drowsiness, extrapyramidal manifestations and palpitations.
Management: Symptomatic and supportive treatment. Immediately empty stomach by inducing emesis with ipecac syrup. Admin of activated charcoal after emesis may be useful. If induction of vomiting is unsuccessful or contraindicated (e.g. patient is comatose, having seizures or lacks gag reflex), gastric lavage with NaCl 0.9% soln may be performed to prevent aspiration of gastric contents. Saline cathartics may be useful to rapidly dilute bowel contents.
Storage Condition
Store between 20-25° C.
Innovators Monograph
You find simplified version here Aldisa SR