| Composition |
Each tablet contains:
– Triprolidine Hydrochloride 2.5 mg.
– Pseudoephedrine Hydrochloride 60 mg. |
| Pharmacodynamics properties |
Triprolidine provides symptomatic relief in condition believed to depend wholly or partly upon the triggered release of histamine.
It is a potent competitive histamine H1 receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness.Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective upper respiratory tract decongestant. |
| Therapeutic indications |
| Lidofrin is indicated for the symptomatic relief of upper respiratory tract disorders which are benefited by a combination of histamine H1 receptor antagonist and a nasal decongestant. These include allergic rhinitis, vasomotor rhinitis, the common cold, influenza and otitis. It may be useful in the treatment of otitis media accompanied by secretions. |
| Side effect |
Central nervous system depression or excitation may occur, drowsiness being reported most frequently. Sleep disturbances and rarely hallucinations have been reported.
Skin rashes, with or without irritation, tachycardia and dryness of the mouth, nose, and throat, have occasionally been reported.
Urinary retention has been reported occasionally in men receiving pseudoephedrine; prostatic enlargement could have been an important predisposing factor. |
| Contraindication |
Lidofrin is contraindicated in individuals who have previously exhibited intolerance to it or to any of its constituents.
Lidofrin is contraindicated in patients with severe hypertension or severe coronary artery disease. Lidofrin iscontraindication in patients who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks.
The concomitant use of pseudoephedrine and this type of product may occasionally cause a rise in blood pressure. |
| Warnings and precautions |
PRECAUTIONS:
Lidofrin may cause drowsiness and impair performance in tests of auditory vigilance.
Patients should not drive or operate machinery until they have determined their own response.
They should also avoid alcohol and other centrally acting sedatives during the treatment.
Lidofrin should be used with caution in patients taking antihypertensive agents, tricyclic antidepressant or other sympathomimetic agents such as decongestants, appetite suppressants
and amphetamine (like psychostimulants).
The effects of a single dose on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment as with other sympathomimetic agents.
Lidofrin should be used with caution in patients with prostatic enlargement or problems in the function of urinary bladder.
There have been no specific studies of Lidofrin in patients with hepatic and/or renal dysfunction. Caution should be exercised in the presence of severe renal or hepatic impairment and the dose
should be reduced. |
| Pregnancy and lactation |
PREGNANCY:
Although pseudoephedrine and triprolidine have been in widespread use for many years without apparent ill-consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefit of treatment to the mother against any possible hazards to the developing fetus.
NURSING MOTHERS:
Pseudoephedrine and triprolidine are excreted in breast milk amount but the effect of this on breast-fed infants is not known. It has been estimated that approximately 0.5–0.7% of a single dose of pseudoephedrine ingested by a mother will be excreted in the breast milk over 24 hours. |
| Drug interactions |
Concomitant use of Lidofrin with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine (like psychostimulants), or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure.
Because of its pseudoephedrine contents, Lidofrin may partially reverse the hypotensive action of drugs which interfere with sympathetic activity including bretylium, bethanidine, guanethidine, debrisoquine, methyldopa and alpha- and beta-adrenergic blocking agents.Although there are no objective data,users of Lidofrin should avoid the concomitant use of alcohol or other centrally acting sedatives due to the presence of Triprolidine. |
| DOSAGE & ADMINISTRATION |
| Adults and children over 12 years: One tablet three times daily. |
| Package |
| Carton box of 20 Tablets, blister packed. |
| Storage |
Store below 25°C in a dry place, protect from light.
Keep away from reach of children. |
