Bicaine 5% Cream

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

PRILOCAINE; LIGNOCAINE/LIDOCAINE

Available from:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (International Name):

PRILOCAINE; LIGNOCAINE/LIDOCAINE

Units in package:

30gm0 mcg/mL

Manufactured by:

L.B.S. LABS LTD PART

Summary of Product characteristics

WARNING AND PRECAUTIONS :
_GENERAL :_ Repeated doses of Bicaine may increase blood levels of
Lidocaine and Prilocaine. Bicaine should be used with caution in
patients
who may be more sensitive to the systemic effects of Lidocaine and
Prilocaine including acutely ill, debilitated, or elderly patients.
Bicaine coming in contact with the eye should be avoided because
animal studies have demonstrated severe eye irritation. Also the loss
of protective reflexes can permit corneal irritation and potential
abrasion. If eye contact occurs, immediately wash out the eye with
water or
saline and protect the eye until sensation returns.
Bicaine should be used with caution in patients with a history of drug
sensitivities, especially if the etiologic agent is uncertain.
Patients with severe hepatic disease, because of their inability to
metabolize local anaesthetics normally, are at greater risk of
developing
toxic plasma concentrations of Licocaine and Prilocaine.
_INFORMATION FOR PATIENTS :_
When Bicaine is used, the patient should be aware that the production
of dermal analgesia may be accompanied by the block of all
sensations in the treated skin. For this reason, the patients should
avoid inadvertent trauma to the treated area by scratching, rubbing or
exposure to extreme hot or cold temperatures until complete sensation
has returned.
WARNING :
Application of Bicaine to larger areas or for longer times than those
recommended could result in sufficient absorption of Lidocaine and
Prilocaine resulting in serious adverse effects. Bicaine should not be
used in any clinical situation in which its penetration or migration
beyond the tympanic membrane into the middle ear is possible. _ METHEMOGLOBINEMIA :_ Bicaine should not be used in those rare
patients with congenital or idiopathic methemoglobinemia and in
infants
under the age of 12 months who are receiving treatment with
methemoglobin inducing agents. Very young patients or patients with
glucose-6-phosphatatase dehydrogenase deficiency are more susceptible
to methemoglobin