Povisef Solution

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.