Faculty of Pharmacy and Biotechnology
Pharmaceutical Technology Department
Pharmaceutics-I, PHTCt 312
Due date : 14.12.2021
Assignment
Name: Farah Alasmar
Group: T-8
ID: 49-14569
Grade:-----------/10
Answer the following questions:
Question
1. The name of the
product (0.5 mark)
2. The indication of this
product (0.5 mark)
Answer
Livlocaine
Active ingredient: Lidocaine hydrochloride
anhydrous
Uses :
1.is indicated to produce topical anesthesia of
irritated or inflamed mucous membranes of
the mouth and pharynx.
2. mucositis from cancer treatment
3.It is also useful for reducing gagging during
the taking of X-ray pictures and dental
impressions.
Viscous lidocaine works by blocking nerve
cells in the affected area
3. The type of dosage
form (0.5 mark)
4. The route of
administration (0.5
mark)
5. Directions for use (1
mark)
Solution (non-aqueous → jelly )
Oral topical
All patients should be aware that when topical
anesthetics are used in the mouth or throat,
the production of topical anesthesia may
impair swallowing and thus enhance the
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danger of aspiration. For this reason, food
should not be ingested for 60 minutes following
use of local anesthetic preparations in the
mouth or throat area. This is particularly
important in children because of their
frequency of eating.
For a sore or irritated mouth, the dose should
be placed in the mouth, swished around until
the pain goes away, and spit out.For a sore
throat, the dose should be gargled and then
may be swallowed. To avoid or decrease side
effects, use the minimum amount of drug
needed to relieve your pain.
Adults: The maximum recommended single
dose of Lidocaine Hydrochloride Oral Topical
Solution, USP (Viscous) 2% for healthy adults
should be such that the dose of lidocaine HCI
does not exceed 4.5 mg/kg or 2 mg/lb body
weight and does not in any case exceed a total
of 300 mg.
for symptomatic treatment of irritated or
inflamed mucous membranes of the mouth
and pharynx, the usual adult dose is 15 mL
undiluted.
For use in the mouth, the solution should be
swished around in the mouth and spit out.
For use in the pharynx, the undiluted solution
should be gargled and may be swallowed. This
dose should not be administered at intervals of
less than three hours, and not more than eight
doses should be given in a 24-hour period. The
dosage should be adjusted commensurate with
the patient's age, weight and physical
condition
Pediatric:
Care must be taken to ensure correct dosage in
all pediatric patients as there have been cases
of overdose due to inappropriate dosing. It is
difficult to recommend a maximum dose of
any drug for children since this varies as a
function of age and weight.
For children over 3 years of age who have a
normal lean body mass and normal body
development, the maximum dose is determined
by the child's weight or age. For example: in a
child of 5 years weighing 50 lbs., the dose of
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lidocaine hydrochloride should not exceed 75100 mg (3.7 to 5 mL of Lidocaine
Hydrochloride Oral Topical Solution, USP
(Viscous) 2%).
For infants and in children under 3 years of
age, the solution should be accurately
measured and no more than 1.2 mL be applied
to the immediate area with a cotton-tipped
applicator. Wait at least 3 hours before giving
the next dose; a maximum of four doses may
be given in a 12-hour period. Lidocaine
Hydrochloride Oral Topical Solution, USP
(Viscous) 2%) should only be used if the
underlying condition requires treatment with a
volume of product that is less than or equal to
1.2 mL
6. Suggest a formula for
the following dosage
form. Emphasis the
role of each
ingredient you have
chosen (not less than
six ingredients with
their use) (3 marks):
1.Active ingredient: lidocaine HCl anhydrous
2.Preservative: methylparaben
Propylparaben
3.Flavoring agent: Orange
4.Sweetening agent: saccharin sodium
5.Viscosity enhancer: carboxymethyl cellulose
sodium
6.coloring agent :FDA approved red colour
7.Buffer : sodium borate and boric acid
8.Vehicle: purified water
7. State all other dosage
forms for the same
active ingredient
available in the
market and their
route of
administration. What
are the precautions
or steps that you
should tell the patient
for each (4 marks)
1.Lidocaine Hydrochloride Injection BP 2%
w/v.
Route of administration: parenteral
Precautions:
Hypokalemia, hypoxia and disorders of acidbase balance should be corrected before
treatment with intravenous lidocaine begins.
2.Lidocaine HCl 4% w/w Cream
Route of administration: topically
Precautions:
For external use only. When using this product
- do not use in or near the eyes - do not use in
large quantities
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Adults and children 2 years and older: Apply
externally to the affected area up to 3-4 times
daily.
3.Lidocaine HCl 4 % Topical Patch
Route of administration: topically
Precautions:
This product should only be applied to normal
intact skin. Do not apply to skin that is broken
or irritated.
do not apply more than 3 patches once a day
or leave any patch on for longer than the
stated time period
avoid getting this medication in your eyes or
mucous membranes (e.g., nose, mouth)
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