Drugs and medications

DESCRIPTION
Pharmaniaga Loratadine tablet 10 mg.
White, oval shaped tablet, with characteristic markings.

A clear, colourless syrup.

COMPOSITION
Pharmaniaga Loratadine tablet 10 mg.

Each mL contains Loratadine 1 mg.

ACTIONS
Loratadine is a long-acting tricyclic antihistamine with selective peripheral histamine H₁-receptor antagonistic activity. It is a piperidine derivative related to azatadine and has little central sedative or antimuscarinic activity.

Loratadine is rapidly absorbed from the gastro-intestinal tract after oral administration, peak plasma concentrations being attained in about one hour. Bioavailability is increased and time to peak plasma concentrations is delayed when administered with food. Loratadine undergoes extensive metabolism. The major metabolite, descarbo-ethoxyloratadine has potent histamine-H₁ blocking activity. Reported half-lives for loratadine and descarbo-ethoxyloratadine are 12 and 18 hours respectively. Loratadine is about 98% bound to plasma proteins; descarbo-ethoxyloratadine is less extensively bound. Loratadine and its metabolites have been detected in breast milk, but do not appear to cross the blood brain barrier to a significant extent. Loratadine and its metabolites are excreted in the urine and faeces.

INDICATIONS
Loratadine is indicated for the relief of symptoms associated with allergic rhinitis e.g. sneezing, nasal discharge (rhinorrhea) and itching, as well as ocular itching and burning.

Also indicated for the relief of symptoms and signs of chronic urticaria and other allergic dermatological disorders.

CONTRAINDICATIONS
Loratadine is contraindicated in patients who are hypersensitive to loratadine.

ADVERSE REACTIONS
In worldwide controlled clinical studies, the following adverse events have been reported in adults and paediatric patients.

Autonomic Nervous System: Altered lacrimation, altered salivation, flushing, hypoesthesia, impotence, increased sweating, thirst.

Body as a Whole: Angioneurotic oedema, asthenia, back pain, blurred vision, chest pain, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, viral infection, weight gain.

Cardiovascular System: Hypertension, hypotension, palpitations, supraventricular tachyarrhythmias, syncope, tachycardia.

Central and Peripheral Nervous System: Blepharospasm, dizziness, dysphonia, hypertonia, migraine, paresthesia, tremor, vertigo.

Gastro-intestinal System: Altered taste, anorexia, constipation, diarrhoea, dyspepsia, flatulence, gastritis, hiccup, increased appetite, nausea, stomatitis, toothache, vomiting.

Musculoskeletal System: Arthralgia, myalgia.

Psychiatric: Agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, irritability, paroniria.

Reproductive System: Breast pain, dysmenorrhoea, menorhagia, vaginitis.

Respiratory System: Bronchitis, bronchospasm, coughing, dyspnea, epistaxis, haemoptysis, laryngitis, nasal dryness, pharyngitis, sinusitis, sneezing.

Skin and Appendages: Dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, rash, urticaria.

Urinary System: Altered micturition, urinary discolouration, urinary incontinence, urinary retention.

PRECAUTIONS
Patients with severe liver impairment should be administered a lower initial dose because they may have reduced clearance of loratadine, an initial dose of 5 mg once daily or 10 mg every other day is recommended.

Use in pregnancy and lactation:
Safe use of loratadine during pregnancy has not been established; therefore, use only if potential benefit justifies potential risk to the foetus.

Since loratadine is excreted in breast milk and because of the increased risk of antihistamines for infants, particularly newborns and premature infants, a decision should be made whether to discontinue nursing or discontinue the drug.

Paediatric use:
The safety and effectiveness of loratadine in paediatric patients under 6 years of age have not been established.

Warning
Drugs known to inhibit hepatic metabolism should be coadministered with caution until definitive interaction studies can be completed. The number of subjects who concomitantly received macrolide antibiotics, ketoconazole, cimetidine, ranitidine, or theophylline along with loratadine in controlled clinical trials is too small to rule out possible drug interactions.

Drug Interactions
When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies. Increase in plasma concentrations of loratadine has been reported with concomitant use of ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiographic). Other drugs known to inhibit hepatic metabolism should be co-administered with caution until definitive interaction studies can be completed.

DOSAGE AND ADMINISTRATION
Pharmaniaga Loratadine tablet 10 mg.
Adults and children 12 years of age and over, the recommended dose is 1 tablet (10 mg) once daily.

Pharmaniaga Loratadine syrup 1 mg.
Children 6 - 11 years of age: 2 tsp (10 mg) syrup once daily.

OVERDOSAGE
In adults, somnolence, tachycardia and headache have been reported with overdoses greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be initiated promptly and maintained for as long as necessary.

Treatment of overdosage would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful, or contraindicated, gastric lavage should be performed with normal saline. Saline cathartics may also be of value for rapid dilution of bowel contents. Loratadine is not eliminated by haemodialysis. It is not known if loratadine is eliminated by peritoneal dialysis.

STORAGE CONDITIONS
Pharmaniaga Loratadine tablet 10 mg.

Store below 25°C.
Keep container tightly closed.
Protect from light and excessive moisture.

Protect from light.

SHELF LIFE
Product should not be used beyond the expiry date imprinted on the product packaging.

In blisters of 10, 100 and 250 tablets.

Pharmaniaga Loratadine syrup 1 mg.
In bottles of 30 mL, 60 mL, 90 mL and 100 mL.