Pharbaco Loratadine Tablets

LORATADINE 10 mg

 

Presentation

Box of 1 blister x 10 tablets.

 

Composition

Each tablet contains

Loratadine 10mg

Excipients: Tapioca starch, lactose, talc powder, stearate magnesium, povidone, enough for 1 tablet.

 

Action

Loratadine is a potent, long-acting nonsedating antihistamine with minimal anticholinergic effects. It is a selective histamine H-receptor antagonist which shows greater affinity for peripheral than central nervous system histamine receptors.

Loratadine has a rapid onset of action and exhibits an antihistaminic effect lasting in excess of 24 hours, thus promoting once-daily dosing.

 

Indication

Treatment:

Allergic rhinitis.

Allergic conjunctivitis.

Itch and hives due to Histamine.

 

Contraindication

Allergy to any component of drug.

 

Precaution

Safety and efficacy for use in children < 2 years and during pregnancy or lactation have not yet been established, and should be used only if clearly needed.

Antihistamines should be discontinued at least 72 hours prior to skin testing procedures since these drugs may produce false-negative result.

 

Side effects

Usually occur: ADR > 1/100.

Mental system: headache.

Digestion: dry mouth.

Seldom occur: 1/1000 < ADR < 1/100.

Mental system: headache.

Respiratory system: dry nose and sneeze.

Other effects: conjunctivitis.

Rarely occur ADR < 1/1000.

Mental system: depression.

Blood circulation: palpitation, arrhythmia, heard throbbing.

Digestion: vomiting.

Transformation: unusual liver function, irregular menses.

Other effects: exanthan, hives, anaphylaxis.

Inform to your doctor when side effect occurs.

 

Interactions

– Loratadine taken with cimetidine may increase concentration of Loratadine in serum up to 60%. Because Cimetidine inhibit transformation of Loratadine and have none symptom.

– Loratadine taken with Ketoconazole may increase concentration of Loratadine, in serum up to 3 times, because of inhibiting CYP3A4. There are none symptom because Loratadine has large coefficient of treatment.

– Loratadine taken with Erythromycin may increase concentration of Loratadine in serum. On clinical aspect, there are none symptom about change of security, and have none information about sedative effect or swooning when taking them simultaneously.

 

Dosage and Administration

Dosage

-Adults, old people and children over 12 years old: take 1 tablet/day.

– Children from 2 to 12 years old:

– Weight of body > 30 kg: take 1 tablet/day.

-Weight of body < 30 kg: ½ tablet/day.

– Patients having hepatitis or serious nephrosis (creatinine clearance < 30ml/minute), take initial dosage at 10mg for each 2 days.

Administration: oral route.

 

Overdose

Symptoms:

Adult: Sleepiness, palpitation, headache.

Children: heard throbbing, extra pyramidal syndrome.

 

Use in Pregnancy and Lactation

Safe use during pregnancy has not been established. Loratadine should be used only if clearly needed. Loratadine passes easily into breast milk. Because of the increased risk of antihistamines on infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 

Storage

Store in a dry, cool place, protect from light, temperature at 10 – 30°C.

 

Shelf life

36 months from manufacturing date.

 

Specification

Manufacture’s standard.

Read the leaflet carefully before using.

If you want more information, please ask your doctor.

Don‘t use the drug after the expiry date or when its color has changed.

 

Manufactured by

PHARBACO – CENTRAL PHARMACEUTICAL JOINT STOCK COMPANY NO. 1

160 Ton Duc Thang Dong Da – Hanoi – Vietnam

pkh@pharbaco.com.vn

www.pharbaco.com.vn

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