Iopamidol (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

V08AB04 (Iopamidol)

Active Substance

Iodine (Ph.Eur. European Pharmacopoeia)

Clinical-Pharmacological Group

Radiocontrast non-ionic diagnostic agent for intravascular administration

Pharmacotherapeutic Group

Contrast agents; X-ray contrast agents containing iodine; water-soluble nephrotropic low-osmolar X-ray contrast agents

Pharmacological Action

Elemental Iodine possesses pronounced antimicrobial properties.

Preparations of elemental iodine are characterized by a pronounced local irritant effect on tissues, and in high concentrations, by a cauterizing effect.

The local action is due to the ability of elemental iodine to precipitate tissue proteins.

Preparations that release elemental Iodine have a significantly less pronounced irritant effect, while iodides possess local irritant properties only in very high concentrations.

Pharmacokinetics

Upon contact with skin or mucous membranes, 30% is converted into iodides, and the remainder into active Iodine.

It is partially absorbed.

The absorbed part penetrates into tissues and organs and is selectively absorbed by the thyroid gland.

It is excreted mainly by the kidneys, intestines, sweat glands, and mammary glands.

Indications

For external use: infectious and inflammatory skin lesions, trauma, wounds, myalgia.

For topical use: chronic tonsillitis, atrophic rhinitis, purulent otitis, trophic and varicose ulcers, wounds, infected burns, fresh thermal and chemical burns of I-II degree.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
H66	Suppurative and unspecified otitis media
I83.2	Varicose veins of lower extremities with ulcer and inflammation
J31.0	Chronic rhinitis (including ozaena, atrophic and hypertrophic rhinitis)
J35.0	Chronic tonsillitis
L01	Impetigo
L08.0	Pyoderma
L08.8	Other specified local infections of skin and subcutaneous tissue
L98.4	Chronic skin ulcer, not elsewhere classified
M79.1	Myalgia
T14.0	Superficial injury of unspecified body region (including abrasion, bruise, contusion, hematoma, bite of nonvenomous insect)
T14.1	Open wound of unspecified body region
T30	Burns and corrosions of unspecified body region
T79.3	Posttraumatic wound infection, not elsewhere classified

ICD-11 code	Indication
1B72.0	Bullous impetigo
1B72.1	Nonbullous impetigo
1B72.Z	Impetigo, unspecified
1B7Y	Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44	Non-pyogenic bacterial infections of skin
AA9Z	Unspecified suppurative otitis media
BD74.Z	Chronic venous insufficiency of lower extremities, unspecified
CA09.0	Chronic rhinitis
CA0F.Y	Other specified chronic diseases of the palatine tonsils and adenoids
EA40	Tropical phagedenic ulcer
EA50.3	Staphylococcal scarlet fever
EB21	Pyoderma gangrenosum
EF60	Ischemic ulceration of the skin
EH92	Dermatoses provoked by friction or mechanical impact
EH92.1	Blister due to friction
EM0Z	Unspecified skin disorder
FB56.2	Myalgia
ME60.2	Ulcerative skin lesion of unspecified nature
ND56.0	Superficial injury of unspecified body region
ND56.1	Open wound of unspecified body region
NE11	Burn of unspecified body region
NF0A.3	Posttraumatic wound infection, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

It is used externally and topically.

For external use, the damaged areas of the skin are treated with iodine.

Topically, it is used for washing lacunae and supratonsillar spaces, for irrigating the nasopharynx, for instillation into the ear and washing; in surgical practice and for burns, gauze napkins applied to the affected surface are moistened as needed.

The doses, method of application, and duration of treatment are determined depending on the indications.

Adverse Reactions

Rarely skin irritation; with prolonged use on extensive surfaces – iodism (rhinitis, urticaria, angioedema, salivation, lacrimation, acne).

Contraindications

Hypersensitivity to iodine.

For external use: thyrotoxicosis, dermatitis herpetiformis.

Use in Pregnancy and Lactation

Used as indicated during pregnancy and breastfeeding.

Use in Hepatic Impairment

Used as indicated.

Use in Renal Impairment

Used as indicated.

Pediatric Use

Used as indicated.

Geriatric Use

Used as indicated.

Special Precautions

With prolonged use, manifestations of iodism are possible.

Drug Interactions

Pharmaceutically incompatible with essential oils, ammonia solutions, white precipitated mercury (forms an explosive mixture).

Alkaline or acidic environment, the presence of fat, pus, blood weaken the antiseptic activity.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Iopamidol [Jodas Expoim, LLC (Russia)]
Injection solution 200 mg iodine/1 ml: 30 ml, 50 ml, 100 ml, 200 ml, or 500 ml vials

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Dosage Form

Iopamidol

Injection solution 200 mg iodine/1 ml: 30 ml, 50 ml, 100 ml, 200 ml, or 500 ml vials

Dosage Form, Packaging, and Composition

Solution for injection light yellow in color, transparent, colorless.

	1 ml
Iopamidol	408 mg,
Equivalent to iodine content	200 mg

Excipients : trometamol – 1 mg, sodium calcium edetate – 0.26 mg, hydrochloric acid – to pH 6.5-7.5, water for injections – to 1 ml.

30 ml – vials of colorless glass (1) – cardboard packs.
50 ml – vials of colorless glass (1) – cardboard packs.
100 ml – vials of colorless glass (1) – cardboard packs.
200 ml – vials of colorless glass (1) – cardboard packs.
500 ml – vials of colorless glass (1) – cardboard packs.

Iopamidol [Jodas Expoim, LLC (Russia)]
Injection solution 300 mg iodine/1 ml: 30 ml, 50 ml, 100 ml, 200 ml, or 500 ml vials

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Dosage Form

Iopamidol

Injection solution 300 mg iodine/1 ml: 30 ml, 50 ml, 100 ml, 200 ml, or 500 ml vials

Dosage Form, Packaging, and Composition

Solution for injection light yellow in color, transparent, colorless.

	1 ml
Iopamidol	612 mg,
Equivalent to iodine content	300 mg

Excipients : trometamol – 1 mg, sodium calcium edetate – 0.39 mg, hydrochloric acid – to pH 6.5-7.5, water for injections – to 1 ml.

Iopamidol [Jodas Expoim, LLC (Russia)]
Injection solution 370 mg iodine/1 ml: 30 ml, 50 ml, 100 ml, 200 ml, or 500 ml vials

Marketing Authorization Holder

Jodas Expoim, LLC (Russia)

Manufactured By

Jodas Expoim, Pvt. Ltd. (India)

Dosage Form

Iopamidol

Injection solution 370 mg iodine/1 ml: 30 ml, 50 ml, 100 ml, 200 ml, or 500 ml vials

Dosage Form, Packaging, and Composition

Solution for injection light yellow in color, transparent, colorless.

	1 ml
Iopamidol	755 mg,
Equivalent to iodine content	370 mg

Excipients : trometamol – 1 mg, sodium calcium edetate – 0.48 mg, hydrochloric acid – to pH 6.5-7.5, water for injections – to 1 ml.

Iopamidol [Mosfarm LLC (Russia)]
Solution for injection 200 mg iodine/mL: bottles 20 mL, 50 mL, 100 mL, 200 mL, or 500 mL
Injection solution 300 mg iodine/ml: 20 ml, 50 ml, 100 ml, 200 ml, or 500 ml bottles
Injection solution 370 mg iodine/ml: 20 ml, 50 ml, 100 ml, 200 ml, or 500 ml bottles

Marketing Authorization Holder

Mosfarm LLC (Russia)

Dosage Forms

	Iopamidol	Solution for injection 200 mg iodine/mL: bottles 20 mL, 50 mL, 100 mL, 200 mL, or 500 mL
		Injection solution 300 mg iodine/ml: 20 ml, 50 ml, 100 ml, 200 ml, or 500 ml bottles
		Injection solution 370 mg iodine/ml: 20 ml, 50 ml, 100 ml, 200 ml, or 500 ml bottles

Dosage Form, Packaging, and Composition

Solution for injection light yellow in color, transparent, colorless.

	1 ml
Iopamidol	408 mg,
Equivalent to iodine content	200 mg

Excipients : trometamol – 1 mg, sodium calcium edetate – 0.26 mg, hydrochloric acid – to pH 6.5-7.5, water for injections – to 1 ml.

20 ml – bottles – cardboard packs.
20 ml – bottles 1-28 pcs. – cardboard boxes (for hospitals).
50 ml – bottles – cardboard packs.
50 ml – bottles 1-28 pcs. – cardboard boxes (for hospitals).
100 ml – bottles – cardboard packs.
100 ml – bottles 1-28 pcs. – cardboard boxes (for hospitals).
200 ml – bottles – cardboard packs.
200 ml – bottles 1-28 pcs. – cardboard boxes (for hospitals).
500 ml – bottles – cardboard packs.
500 ml – bottles 1-28 pcs. – cardboard boxes (for hospitals).

Solution for injection light yellow in color, transparent, colorless.

	1 ml
Iopamidol	612 mg,
Equivalent to iodine content	300 mg

Excipients : trometamol – 1 mg, sodium calcium edetate – 0.39 mg, hydrochloric acid – to pH 6.5-7.5, water for injections – to 1 ml.

Solution for injection light yellow in color, transparent, colorless.

	1 ml
Iopamidol	755 mg,
Equivalent to iodine content	370 mg

Excipients : trometamol – 1 mg, sodium calcium edetate – 0.48 mg, hydrochloric acid – to pH 6.5-7.5, water for injections – to 1 ml.

Iopamidol [Promomed Rus LLC (Russia)]
Injection solution 300 mg iodine/1 ml: 20 ml, 30 ml, 50 ml, 100 ml, or 200 ml vials 1 or 10 pcs., 500 ml vials 1 or 8 pcs.
Injection solution 370 mg iodine/1 ml: 20 ml, 30 ml, 50 ml, 100 ml, or 200 ml vials 1 or 10 pcs., 500 ml vials 1 or 8 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

	Iopamidol	Injection solution 300 mg iodine/1 ml: 20 ml, 30 ml, 50 ml, 100 ml, or 200 ml vials 1 or 10 pcs., 500 ml vials 1 or 8 pcs.
		Injection solution 370 mg iodine/1 ml: 20 ml, 30 ml, 50 ml, 100 ml, or 200 ml vials 1 or 10 pcs., 500 ml vials 1 or 8 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a transparent, colorless or slightly yellowish liquid.

	1 ml
Iopamidol	612.4 mg,
Equivalent to iodine content	300 mg

Excipients : trometamol, sodium calcium edetate, hydrochloric acid (for pH adjustment), water for injections.

20 ml – vials of colorless glass (1) – cardboard packs (for hospitals).
20 ml – vials of colorless glass (10) – cardboard packs (for hospitals).
30 ml – vials of colorless glass (1) – cardboard packs (for hospitals).
30 ml – vials of colorless glass (10) – cardboard packs (for hospitals).
50 ml – vials of colorless glass (1) – cardboard packs (for hospitals).
50 ml – vials of colorless glass (10) – cardboard packs (for hospitals).
100 ml – vials of colorless glass (1) – cardboard packs (for hospitals).
100 ml – vials of colorless glass (10) – cardboard boxes (for hospitals).
200 ml – vials of colorless glass (1) – cardboard packs (for hospitals).
200 ml – vials of colorless glass (10) – cardboard boxes (for hospitals).
500 ml – vials of colorless glass (1) – cardboard packs (for hospitals).
500 ml – vials of colorless glass (8) – cardboard boxes (for hospitals).

Solution for injection in the form of a transparent, colorless or slightly yellowish liquid.