Betadine Cream/Ointment

Cream: Each gram contains povidone-iodine 50 mg equivalent to 5 mg available iodine.
Ointment: Each gram contains povidone-iodine 100 mg equivalent to 10 mg available iodine.

Pharmacology: Pharmacodynamics: POVIDONE-IODINE (BETADINE) is a topical agent active against organisms commonly encountered in skin and wound infections. It contains 10% povidone-iodine equivalent to 1% available iodine.
The active ingredient, povidone-iodine, substantially retains the broad spectrum germicidal activity of iodine against the commonly encountered organisms in skin and wound infections, without the undesirable features or disadvantages of iodine.
POVIDONE-IODINE (BETADINE) is decisively microbicidal against all 4 major classes of pathogens: bacteria (both Gram-positive and Gram-negative, as well as antibiotic-resistant strains) fungi, viruses and protozoa. The foremost documented broad spectrum topical microbicidal power of POVIDONE-IODINE (BETADINE) is active even in the presence of blood, pus and serum and the germicidal activity is more prolonged than that of iodine tincture.
POVIDONE-IODINE (BETADINE) is in a water-soluble base and is not greasy or sticky. It permits bandaging of treated area, is virtually non-irritating to skin and mucosa and does not block air from reaching site of application. It easily washes off from skin and natural fabrics.
Ointment: POVIDONE-IODINE (BETADINE) ointment does not interfere with granulation or skin grafting in burns.

Cream: POVIDONE-IODINE (BETADINE) cream is an ideal topical agent for prevention of infection in burns, lacerations, cuts and abrasions; treatment of common skin infections, and for infection control during circumcision, suture removal and dressing changes.
POVIDONE-IODINE (BETADINE) cream may be used for degerming care of stasis ulcers, decubitus ulcers and the umbilical area and in other procedures where degerming is needed.
Ointment: POVIDONE-IODINE (BETADINE) ointment is an ideal topical agent for the treatment of common skin infections; prevention of infection in minor burns, lacerations, cuts and abrasions; and for infection control during insertion and care of urinary catheters, circumcision, suture removal and dressing changes.
POVIDONE-IODINE (BETADINE) ointment may be used for degerming care of stasis ulcers, decubitus ulcers and the umbilical area. It can be used also for degerming during use of intravenous devices in blood transfusions, hyperalimentation, cutdowns, CVP catheterization and in other procedures where degerming is needed.

Cream: Clean and dry the affected skin. Apply POVIDONE-IODINE (BETADINE) cream liberally. May be covered with a dressing or bandage.
POVIDONE-IODINE (BETADINE) cream may be used as often as required. In the treatment of burns, every eight hours; in other treatments, apply once daily generally. Use POVIDONE-IODINE (BETADINE) cream as prescribed by the doctor.
Ointment: Use POVIDONE-IODINE (BETADINE) Ointment as prescribed by the doctor.
Clean and dry the affected skin. Apply POVIDONE-IODINE (BETADINE) ointment liberally and cover with a dressing or bandage.
POVIDONE-IODINE (BETADINE) ointment may be used as often as required.
Missed Dose: Follow the usage instructions mentioned in Dosage & Administration. If the patient misses a treatment use it as soon as remembered.

Signs & Symptoms: In the unlikely event that the patient experiences any of the following symptoms: stomach pain, unable to pass urine, loss of appetite, weakness, nausea and vomiting, coughing up blood, excessive sweating, difficulty in breathing, metabolic acidosis, anxiety and pale skin, immediately consult the doctor.
Treatment is symptomatic and supportive.

POVIDONE-IODINE (BETADINE) should not be used: If the patient is allergic to iodine or povidone; If the patient has an overactive thyroid gland (hyperthyroidism) or any thyroid diseases; If the patient is on lithium therapy; Before and after a specific medical treatment involving the use of radioactive iodine.
If the patient experienced an allergic reaction, stop using POVIDONE-IODINE (BETADINE) and inform the doctor or pharmacist immediately.

In pre-operative preparation, avoid pooling beneath the patient. Prolonged exposure to wet solution may cause irritation or rarely, severe skin reactions. Chemical burns of skin due to pooling may occur. In instances of skin irritation, contact dermatitis or hypersensitivity, discontinue use.
Do not heat POVIDONE-IODINE (BETADINE) prior to use.
Avoid getting POVIDONE-IODINE (BETADINE) in the eyes. Avoid solutions containing a detergent if treating open wounds with povidone-iodine.
POVIDONE-IODINE (BETADINE) is intended FOR EXTERNAL USE ONLY. Not for use on extensive body areas and should not be used over a long period of time unless strictly indicated.
Patients with goiter, thyroid nodules or other non-acute thyroid diseases are at risk of developing thyroid hyperfunction (hyperthyroidism) from the administration of large amounts of iodine. In this patient population, povidone-iodine should not be applied for an extended period of time and to large areas of the skin unless strictly indicated. Even after the end of the treatment one should look for the early symptoms of possible hyperthyroidism and if necessary the thyroid function should be monitored.
It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma.
Newborns and small infants are at increased risk of developing hypothyroidism from the administration of large amounts of iodine. Because of the permeable nature of the skin and their increased sensitivity to iodine, the use of povidone-iodine should be kept to the absolute minimum in newborns and small infants. A check of their thyroid function (e.g. T4 levels and TSH levels) may be necessary.
Avoid use in patients with renal impairment.

During pregnancy and lactation, POVIDONE-IODINE (BETADINE) should only be used if strictly prescribed by the doctor and its use should be kept to the absolute minimum. Seek medical advice from the doctor or pharmacist.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. The patient may need medical attention if he/she gets some of the side effects.
The side effects listed as follows may not include all of the side effects reported. For more information about any other possible risks associated with POVIDONE-IODINE (BETADINE), please consult the doctor or pharmacist.
Please note that the side effects related to the use of POVIDONE-IODINE (BETADINE) ointment occur rarely.
Rarely, hypersensitive/allergic skin reaction may occur, which can appear in the form of: itchiness; redness; small blisters.
Very rarely, acute generalized allergic reactions have been reported with drop in blood pressure; difficulty in breathing; swelling of the skin and mucosa.
If the patient notices any side effects, please consult the doctor or pharmacist.
The long term use of the product, not in accordance with the usage instructions mentioned under Dosage & Administration, may lead to possible absorption of iodine into the body. This may lead to: overactive thyroid gland function if the patient has a history of thyroid problems, rapid heartbeat (tachycardia) and restlessness; imbalance of electrolytes; abnormal blood concentration (osmolarity); abnormal kidney function (renal impairment).

Do not apply other medications to the same affected areas treated with POVIDONE-IODINE (BETADINE), unless the doctor has told so.
It is not likely that other drugs the patient takes orally or inject will have an effect on externally applied POVIDONE-IODINE (BETADINE).
The concomitant use of other externally applied wound healing medicines/preparations may alter the effect of POVIDONE-IODINE (BETADINE) or both. Products containing enzymatic component, alkali, mercury, silver, hydrogen peroxide, tannic acid and taurolidine may interact with povidone-iodine and should not be used concomitantly.
Povidone-iodine products when used concomitantly or immediately after application of octenidine containing antiseptics in the same or adjacent sites may lead to transient dark discolorations in the areas involved.
Due to the oxidative effect of povidone-iodine preparations various diagnostic agents can show false-positive lab results (e.g., tests with toluidine or gum guaiac for the determination of hemoglobin or glucose in the stool or the urine).
Absorption of iodine from povidone-iodine may interfere with thyroid function tests.
Do not start a new treatment medication without telling the doctor.
For more information about any other possible risks associated with POVIDONE-IODINE (BETADINE), please consult the doctor or pharmacist.

Store at temperature not exceeding 30°C.

Skin Antiseptics & Disinfectants

D08AG02 - povidone-iodine ; Belongs to the class of iodine product antiseptics. Used in the treatment of dermatological diseases.

Non-Rx