LAURA 10 Tablets
(and dosage form):
LAURA 10 Tablets
Each tablet contains:
Loratadine (micronized) 10 mg.
A 5.7.1 Antihistaminics.
Mechanism of action
Loratadine is a long acting tricyclic antihistamine with selective peripheral H1-receptor antagonistic activity and no central sedative or anticholinergic effects. It acts by competing with histamine for H1-receptor sites on effector cells. Loratadine thereby prevents, but does not reverse responses mediated by histamine alone.
Loratadine is well absorbed from the gastro-intestinal tract after oral administration. Bioavailability is increased when administered with food. Loratadine undergoes extensive metabolism. The major metabolite, descarboethoxyloratadine, has potent histamine-H1 blocking activity. Reported half-lives for loratadine and descarboethoxyloratadine are 8 +6 hours and 18 +6 hours respectively. Loratadine is about 97% bound to plasma proteins; descarboethoxyloratadine is less extensively bound (73-77%). The volume of distribution is about 120 +80 L/kg. Loratadine and its metabolites have been detected in breast milk, but do not appear to cross blood-brain barrier to a significant extent. Loratadine and its metabolites are excreted in the urine and faeces.
Laura 10 Tablets are indicated in adults for the relief of symptoms associated with seasonal allergic rhinitis and chronic urticaria.
Laura 10 Tablets are contra-indicated in patients who have shown hypersensitivity or idiosyncrasy to any components of the product.
Safety of loratadine in the elderly has not been established.
Pregnancy and lactation as safety has not been established.
Antihistamines, including Laura 10 Tablets, should be discontinued about two days prior to skin testing procedures, since these medicines may prevent or diminish otherwise positive reactions to dermal reactivity indicators.
When administered concurrently with alcohol, Laura 10 Tablets have no potentiating effects. However, concomitant consumption of excessive amounts of alcohol should be avoided.
Potentially hazardous ventricular arrythmias have occurred when the non-sedating antihistamines have been given concomitantly with medicines liable to interfere with their hepatic metabolism, with other potentially arrythmogenic medicines and with those likely to cause electrolyte imbalance.
Laura 10 Tablets are metabolised by hepatic cytochromes P450 3A4 and 2D6. Concomitant therapy with medicines which inhibit or are metabolised by either system may therefore elevate plasma concentrations of either medicine and adverse reactions might result.
Studies have indicated that cimetidine, erythromycin and ketoconazole each may increase loratadine concentrations, although no adverse effects, clinical or electrocardiographic, have been observed. Caution should be exercised when other medicines known to inhibit hepatic microsomal enzymes are co-administered with Laura 10 Tablets. Other medicines known to inhibit either P450 3A4 or P450 2D6 are quinidine, fluconazole or fluoxetine.
PREGNANCY AND LACTATION
Contra-indicated in pregnancy and lactation.
DOSAGE AND DIRECTIONS FOR USE
One Laura 10 Tablet orally once daily.
In patients with hepatic failure or renal impairment, an initial dose of 5 mg once daily or 10 mg on alternate days is recommended.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
The incidence of side-effects associated with treatment with Laura 10 Tablets is generally comparable to that with placebo. Laura 10 Tablets have no clinically significant sedative or anti-cholinergic properties. Occasional gastro-intestinal side-effects of antihistamines include nausea, vomiting, diarrhoea, gastritis, or epigastric pain; anorexia has also been reported. Palpitations and arrythmias, including ventricular and supraventricular arrythmias have been reported with non-sedating antihistamines. Administration of antihistamines may sometimes cause hypersensitivity reactions (including skin rash, bronchospasm, angioedema and anaphylaxis) and cross-sensitivity to related medicines may occur.
Blood disorders such as thrombocytopaenia, and abnormal hepatic functions, including jaundice and hepatitis, may occur, but are reported less frequently.
Other adverse effects that have been reported with the antihistamines include convulsions, sweating, myalgia, paraesthesias, extrapyramidal effects, tremor, sleep disturbances, depression, tinnitus and hypotension. Fatigue, somnolence, dry mouth, alopecia and headache have been reported less frequently.
There are less frequent reports of sedation or antimuscarinic activity with Laura 10 Tablets. A few patients treated with non-sedating antihistamines have experienced drowsiness. Therefore, it is prudent that caution should be exercised before driving or operating machinery; the effect of Laura 10 Tablets on a particular patient can be ascertained after the first few doses.
Caution should be exercised when Laura 10 Tablets are administered to patients with severe hepatic function impairment. A lower initial dose of 5 mg once daily or 10 mg every other day is recommended in such patients.
Geriatrics: See CONTRA-INDICATIONS
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Overdosage with loratadine may manifest in any of the symptoms described under SIDE-EFFECTS AND SPECIAL PRECAUTIONS. There is no specific antidote for loratadine. In case of overdosage, treatment which should be started immediately is symptomatic and supportive. Loratadine is not dialyzable. After emergency treatment, the patient should continue to be under medical supervision.
White to off-white, uncoated, round, flat tablets with bevelled edges, debossed with 'R' on one side and '10' on the other.
Blister strips of clear, colourless PVC/PVDC film with aluminium foil backing containing 10 tablets. Cartons contain 10 and 30 tablets.
Store below 25°C, protected from moisture.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
RANBAXY (SA) (PTY) LTD
1006 Lenchen Avenue North
DATE OF PUBLICATION OF THE PACKAGE INSERT
New addition to this site: February 2004
Source: Pharmaceutical Industry
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