Description
Povidone-lodine USP
Cream, Solution, Gargle & Mouthwash,
Surgical Scrub and Powder
POVISEP
DESCRIPTION
Povisep® contains Povidone-Iodine which is a
complex of iodine and an organic polymer,
povidone. This polymerization makes Povisep
superior to ordinary elemental iodine. It prolongs the
germicidal activity of iodine by liberating elemental
iodine slowly. Consequently it has a lower toxicity
than elemental iodine.
It gives rapid microbicidal activity against both
Gram-positive and Gram-negative bacteria, protozoa,
viruses and fungi/yeasts. It is also sporicidal. It is the
only microbicide with this broad spectrum of activity.
It is non-staining, exerts prolong germicidal action
and is also active in the presence of soap, blood,
serum, pus, mucosal secretions and water.
COMPOSITION
Povisep® Cream:
Each gram contains Povidone-Iodine USP 60 mg
(6 mg available Iodine)
Povisep® Solution:
Each mL contains Povidone-Iodine USP 100 mg
(10 mg available Iodine)
Povisep® Solution :
Each mL contains Povidone-Iodine USP 50 mg
(5 mg available Iodine)
Povisep® Gargle & Mouthwash:
Each mL contains Povidone-Iodine USP 10 mg
(1 mg available Iodine)
Povisep® Surgical Scrub :
Each mL contains Povidone-Iodine USP 75 mg
(7.5 mg available Iodine)
Povisep® Powder:
Each gram contains Povidone-Iodine USP 50 mg
(5 mg available Iodine)
INDICATIONS
Povisep® Cream
Therapeutically:As an adjunct to systemic therapy
in the following indications-
Primary or secondary topical infections
Infected surgical incisions
Infected decubitus or stasis ulcers
Pyodermas
Secondarily infected dermatoses
Infected traumatic lesions
Prophylactically :
To prevent microbial contaminations in burns,
incisions and other topical lesions
For degerming skin in hyperalimentation, the
umbilical area or circumcision
Its use for abrasions, minor cuts, and wounds
prevents the development of infections and
permits wound healing
Povisep® Solution
For the prevention and treatment of surface
infections as well as to degerm the skin, mucous
membrane and hyperalimentation procedures
For seborrhea
For preoperative and postoperative scrubbing
and washing of hospital operating room and
equipments
For preoperative prepping of operative site,
including the vagina
For disinfection of wounds, burns, lacerations
and abrasions
As a prophylactic anti-infective agent in house,
hospital & office procedures
Postoperative application to incisions to help
prevent infection
In oral moniliasis (thrush); bacterial and mycotic
skin infections, decubitus & stasis ulcers
As a preoperative swab in the mouth & throat
Povisep® Gargle & Mouthwash
It is a pleasantly flavoured solution which is used:
For the treatment of acute mucosal infections of
the mouth and pharynx.
For oral hygiene prior to, during and after
dental and oral surgery.
Povisep® Surgical Scrub
It is a golden surfactant solution, forms rich,
golden lather which is used :
As an antiseptic skin cleanser for preoperative
and postoperative scrubbing and washing by
surgeons and operation theatre staff and
preoperative preparation of patients’ skin
Povisep® Powder
It is used for topical application in the following indications-
Superficial wounds
Minor cuts
Burns
Abrasions
Lacerations
In the treatment and prevention of infections.
DIRECTION FOR USE
Povisep® Cream
Apply directly to the affected area as needed; may be
bandaged.
Povisep® Solution
Apply full strength as often as needed as a paint, spray, or
wet soak. May be bandaged (where necessary).
Povisep® Gargle & Mouthwash
Adults and children over 6 years of age: Use undiluted or
diluted with an equal volume of warm water. Gargle or
rinse with up to 10 mL for up to 30 seconds without
swallowing. Repeat up to four times daily, for up to 14
consecutive days, or as advised by the Registered Dental
Surgeon/Physician.
Povisep® Surgical Scrub
A) For Preoperative and Postoperative washing by
Operating Personnel
1. Wet hands and forearms with water. Pour about 5 mL of
Povisep Surgical Scrub on the palm of the hand and
spread over both hands and forearms. Without adding
more water, rub the Scrub thoroughly over all areas for
about five minutes. Use a brush if desired. Clean
thoroughly under fingernails. Add a little water and develop
copious suds. Rinse thoroughly under running water.
2. Complete the wash by scrubbing with another 5 mL of
Povisep Surgical Scrub in the same way.
B) For Preoperative use on Patients
After the skin area is shaved, wet it with water. Apply
Povisep Surgical Scrub (1 mL is sufficient to cover an area
of 20-30 square inches), develop lather and scrub
thoroughly for about five minutes. Rinse off by aid of
sterile gauze saturated with water.
C) For use in the Physician’s Office
Use for washing whenever a germicidal soap is required.
For maximum degerming of the hands proceed as under
(A). To prepare the patient’s skin proceed as under (B).
Povisep® Powder
Apply a light dusting of powder to the affected area. When
dry, this forms a protective antiseptic layer over the area
treated. Or use as advised by the Registered
Physician.There are no special dosage recommendations
for children or elderly patients.
CONTRAINDICATIONS
It can cause hypersensitivity reactions. Regular use in
patients with thyroid disorders (in particular nodular colloid
goitre, endemic goitre and Hashimoto’s thyroiditis) or
those receiving lithium therapy is to be avoided. In severely
burnt patients serum iodide levels should be assessed due
to possible hepatic and renal impairment. Povisep Powder
should not be used in serious cavities and in Children
under the age of 2 years.
DRUG INTERACTIONS
It exhibits interaction with strong alkali, sodium
thiosulphate, sodium metabisulphite and thiomersal. Use
with concurrent lithium therapy has been shown to
exhibithypothyroidic effect.
SIDE EFFECTS/ADVERSE REACTIONS
Povidone-Iodine may cause hypersensitivity reactions and
irritation of the skin and mucous membranes.
The application of povidone-Iodine to severe burns or to
large areas otherwise denuded of skin may produce the
systemic adverse effects such as metabolic acidosis,
hypernatraemia, and impairment of renal function. It may
interfere with thyroid function tests.
PRECAUTIONS
Povisep® Cream
In case of deep or puncture wounds or serious burns,
consult Registered Physician. If redness, irritation, swelling
or pain persists or increases or if infection occurs,
discontinue use and consult Registered Physician.
Povisep® Solution
In preoperative prepping, avoid ‘pooling’ beneath the
patient. Prolonged exposure to wet solution may cause
irritation or rarely, severe skin reactions.
In case of deep or puncture wounds or serious burns,
consult Registered Physician. If redness, irritation, swelling
or pain persists or increases or if infection occurs,
discontinue use and consult Registered Physician.
Povisep® Gargle & Mouthwash
Regular use should be avoided as prolonged use may lead
to the absorption of a significant amount of iodine. Do not
use for more than 14 days. If sores or ulcers in the mouth
do not heal within 14 days seek dental or medical advice.
It is also not for use in children under 6 years of age.
Regular use should be avoided in patients on concurrent
lithium therapy.
Povisep® Surgical Scrub
Special caution is needed when regular applications to
broken skin are made to patients with pre-existing renal
insufficiency. Regular use should be avoided in patients on
concurrent lithium therapy. It can permanently discolor
white gold jewellery and it is recommended that this type of
jewellery should be removed before using this product.
Povisep® Powder
Care must be taken when used on known iodine sensitivity,
although do not normally react to Povidone-Iodine. Excess
powder can be washed off readily with warm water. It
should be used directly from the container. Not to be
administered internally.
USE IN PREGNANCY AND LACTATION
Povisep Cream, Solution & Powder are not recommended
for use during pregnancy because of the possibility of
absorption of sufficient iodine to affect the fetal thyroid.
American Academy of Pediatrics considers that the use of
Povidone-Iodine is usually compatible with breast feeding.
Consult Registered Physician. Regular use of Gargle &
Mouthwash and Surgical Scrub should also be avoided in
pregnant and lactating women.
PACKAGING
Povisep® Cream 6% : 5 g & 25 g in tube pack.
Povisep® Solution 10% : 30 mL, 100 mL, 500 mL, 1 Litre
& Hospital pack
Povisep® Solution 5% : 20 mL, 30 mL, 100 mL,500mL,
1 Litre & Hospital pack
Povisep® Gargle & Mouthwash 1% : 50 mL, 100 mL
& 125 mL in bottle.
Povisep® Surgical Scrub 7.5% : 250 mL, 500 mL &
1 Litre in container.
Povisep® Powder 5% : 10 g in plastic container
PHARMACEUTICAL PRECAUTIONS
Store below 25o
C in a dry place, away from light.
WARNING
Keep out of the reach of children.
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