Indications
Rosela is indicated for the symptomatic treatment of
Seasonal & Perennial Allergic Rhinitis and Urticaria.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Montica - MedEx campaign banner
Pharmacology
Rupatadine is a long-acting, non-sedative antagonist of
histamine H1-receptors. It also antagonizes the platelet activating factor
(PAF). Both histamine and PAF cause broncho constriction which leads to an
increase in the vascular permeability and act as a mediator in the inflammatory
process. With the dual mode of action, Rupatadine shows better therapeutic
effect than an isolated antihistamine. Rupatadine possesses other anti allergic
properties such as the inhibition of the degranulation of mast cells induced by
immunological and non immunological stimuli and inhibition of the release of
cytokines, particularly of the tumor necrosis factor alpha (TNF α) in human
mastocytes and monocytes.
Dosage & Administration
Adults and adolescents (over 12 years): The recommended dose
is 10 mg once a day. Rupatadine may be taken with or without food.
Children aged 2 to 11 years:
Children weighing 25 kg or more: 1 teaspoonful (5 ml) of the
oral solution once daily with or without food.
Children weighing equal or more than 10 kg to less than 25
kg: 1/2 teaspoonful (2.5 ml) oral solution once daily with or without food.
* রেজিস্টার্ড
চিকিৎসকের পরামর্শ মোতাবেক ঔষধ সেবন করুন'
Interaction
With medicine: The concomitant administration of Rosela 20
mg and ketoconazole or erythromycin increases the systemic exposure. Rosela
should be used with caution when it is administered concomitantly with these
drug substances and other inhibitors of the isozyme CYP3A4. Rosela should be
used with caution when it is co-administered with statins, CNS depressants or
alcohol.
With food: Grapefruit and Grapefruit juice should not be
taken simultaneously with Rupatadine
Contraindications
Hypersensitivity to Rupatadine or to any of the excipients.
Side Effects
Common: Asthenia, dizziness, drowsiness. Uncommon: Appetite
increased, arthralgia, back pain, concentration impaired, constipation, cough,
diarrhea, dry throat, epistaxis, fever, gastrointestinal discomfort, increased
risk of infection, irritability, malaise, myalgia, nasal dryness, nausea,
oropharyngeal pain, rash, thirst, vomiting, weight increased. Rare:
Palpitations, tachycardia.
Pregnancy & Lactation
There is no clinical data available on the exposure of
Rupatadine during pregnancy. Pregnant women should therefore not use Rupatadine
unless the potential benefit outweighs the potential risk for the infant. No
information is available, whether Rupatadine is excreted in the mother's milk.
Therefore, it should not be used during lactation, unless the potential
benefits for the mother justify the potential risk to the infant.
Precautions & Warnings
Rosela should be used with caution in patients with known
prolongation of the QT interval, patients with uncorrected hypokalemia, and
patients with ongoing proarrhythmic conditions, such as clinically significant
bradycardia or acute myocardial ischemia. Rosela should be used with caution in
elderly patients (65 years and older). As there is no clinical experience in
patients with impaired kidney or liver function, the use of Rosela 10 mg
tablets is at present not recommended in these patients.
Use in Special Populations
Elderly: Rosela should be used with caution in elderly. No
information is available that indicates the requirement of any dose adjustment
in this population.
Children: Neither the safety nor the efficacy of Rosela has
been established in patients less than 12 years of age.
Patients with renal or hepatic insufficiency: Use of Rosela
is not recommended in patients with renal or hepatic insufficiency. As no
relevant clinical data is available.
Overdose Effects
The most common adverse reaction was somnolence. If accidental
ingestion of very high doses occurs, symptomatic treatment together with the
required supportive measures should be given.
Therapeutic Class
Non-sedating antihistamines
Storage Conditions
Store in cool & dry place below 30°C, protect from light
& moisture. Keep out of reach of children.
No review given yet!
You need to Sign in to view this feature
This address will be removed from this list