Imiquad 5% W/w Cream (3 Sachet)

IMIQUAD 5% W/W CREAM is a topical medication manufactured by Glenmark Pharmaceuticals Ltd. It is designed to stimulate the body's immune system to treat various skin conditions.

• Name:

  • Common Name: Imiquimod topical
  • Brand Name: IMIQUAD 5% W/W CREAM

• Composition:

  • Active Ingredient: Each 0.25 gm single-use sachet contains Imiquimod 12.5 mg (5% w/w). Imiquimod is an immune response modifier.
  • Excipients: Includes cream base, as well as preservatives such as methyl paraben and propyl paraben, and other components like cetyl alcohol, stearyl alcohol, and benzyl alcohol.

• Uses: IMIQUAD 5% W/W CREAM is an immune response modifier that works by stimulating the body's immune system to fight abnormal skin growths or infections. It is prescribed for the topical treatment of:

  • External Genital and Perianal Warts (Condyloma Acuminata): In adults and patients 12 years of age or older.
  • Actinic Keratosis: Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. These are precancerous skin growths caused by sun damage.
  • Superficial Basal Cell Carcinoma (sBCC): A type of skin cancer, when surgical methods are considered medically less appropriate.

• Dosage and Administration:

  • General Application: The cream should be applied as a thin layer to the affected area and rubbed in until it is no longer visible. It should be left on the skin for approximately 6 to 10 hours (typically overnight), after which the treated area should be washed with mild soap and water. Wash hands thoroughly before and after applying the cream. Do not use occlusive dressings.
  • External Genital Warts: Apply 3 times per week (e.g., Monday, Wednesday, Friday) until complete clearance of warts or for a maximum duration of 16 weeks.
  • Actinic Keratosis: Apply 2 times per week (e.g., Monday and Thursday, or Tuesday and Friday) for a full 16 weeks to a defined treatment area on the face or scalp. Some guidelines suggest 3 times per week for 4 weeks, followed by a 4-week treatment-free period, and repeating for another 4 weeks if lesions persist.
  • Superficial Basal Cell Carcinoma: Apply 5 times per week (e.g., Monday through Friday) for a full 6 weeks.
  • Each sachet is intended for single use, and any unused portion should be discarded.

• Side Effects:

  • Common Local Reactions: Treated areas may become inflamed, exhibiting itching, burning, redness (erythema), flaking, scaling, dryness, scabbing, crusting, pain, swelling, irritation, ulceration, excoriation, and tenderness. These reactions are often an indication that the treatment is working.
  • Systemic Reactions: Flu-like symptoms such as fever, fatigue, headache, nausea, diarrhea, muscle pain, and chills may occur.
  • Other: Changes in skin color (hypopigmentation) and swollen lymph nodes have also been reported.
  • Serious Side Effects: Discontinue use and contact a doctor immediately if severe vulvar swelling (potentially leading to urinary retention), severe skin irritation, skin breakdown or sores with drainage, or signs of an allergic reaction (skin rash, itching, hives, swelling of the face, lips, tongue, or throat) occur.

• Precautions:

  • Do not use IMIQUAD if there is a known hypersensitivity to imiquimod or any of its excipients.
  • Avoid application to broken, damaged, or sunburned skin; treatment should commence only after the skin has fully healed.
  • Minimize or avoid exposure to natural or artificial sunlight (including sunlamps and tanning beds) during treatment, and use protective clothing and sunscreen when outdoors.
  • IMIQUAD cream can weaken latex condoms and diaphragms, making them less effective in preventing pregnancy and the spread of sexually transmitted infections. For genital warts, avoid all sexual contact while the cream is on the skin.
  • This medication is not recommended for children under 12 years of age.
  • Exercise caution in patients with pre-existing autoimmune conditions.
  • Avoid contact with eyes, lips, nostrils, rectum, or vagina. If accidental contact occurs, rinse thoroughly with water.
  • The treatment period should not be extended beyond the recommended duration due to missed doses or rest periods.
  • IMIQUAD cream may be flammable; avoid smoking or open flames after application.
  • Pregnancy and Breastfeeding: Imiquimod should be used during pregnancy only if clearly needed after discussing risks and benefits with a doctor. It is unknown if imiquimod is excreted in human milk, so caution should be exercised if administered to nursing women.

• Storage: Store at room temperature, not exceeding 30°C. Keep in a dry and cool place, protected from direct sunlight. Keep out of the sight and reach of children.

IMIQUAD 5% W/W CREAM (3 SACHET) by GLENMARK PHARMACEUTICALS LTD.

What is IMIQUAD 5% W/W Cream used for?

IMIQUAD 5% W/W Cream is primarily used to treat external genital and perianal warts (condylomata acuminata), superficial basal cell carcinoma (a type of skin cancer), and actinic keratoses (precancerous sun-damaged spots) on the face or scalp in immunocompetent adults.

How does IMIQUAD 5% W/W Cream work?

IMIQUAD 5% W/W Cream contains Imiquimod, an immune response modifier. It works by stimulating the body's immune system to produce certain chemicals called cytokines, such as interferon-alpha. These cytokines help activate the immune system to fight viruses and destroy abnormal or cancerous cells in the treated area.

What is the usual dosage for IMIQUAD 5% W/W Cream?

The dosage varies depending on the condition being treated:

• External Genital Warts: Typically applied 3 times per week (e.g., Monday, Wednesday, Friday) before normal sleeping hours. It should be left on the skin for 6 to 10 hours, then washed off with mild soap and water. Treatment continues until warts clear or for a maximum of 16 weeks.
• Actinic Keratoses: Usually applied 2 times per week for a full 16 weeks to the affected area on the face or scalp. It should be left on the skin for approximately 8 hours, then washed off. Some regimens may involve 3 times a week for 4 weeks, followed by a treatment-free period.
• Superficial Basal Cell Carcinoma: Applied 5 times per week (e.g., Monday through Friday) for a full 6 weeks. It should be applied before normal sleeping hours, left on for approximately 8 hours, and then washed off. Always apply a thin layer and rub it in until the cream is no longer visible. Wash your hands thoroughly before and after each application.

What are the possible side effects of IMIQUAD 5% W/W Cream?

Common side effects include local skin reactions at the application site, such as redness, itching, burning, pain, swelling, dryness, flaking, scabbing, crusting, and erosion or ulceration. These reactions indicate that the cream is working. Some individuals may also experience flu-like symptoms, including fever, fatigue, headache, nausea, diarrhea, and muscle pain. Rarely, changes in skin color (lighter) may occur and might not be reversible. Severe vulvar swelling can occur when treating genital warts.

Is IMIQUAD 5% W/W Cream safe during pregnancy or breastfeeding?

• Pregnancy: IMIQUAD Cream is generally classified as Pregnancy Category C. It should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus, and this should be discussed with your doctor. Limited human studies are available, while animal studies have shown harmful effects on the developing baby.
• Breastfeeding: It is not known if Imiquimod passes into breast milk. However, due to its topical application on a limited surface area and poor systemic absorption, effects on a breastfed infant are considered unlikely. As a precaution, avoid applying the cream to the breast or nipple area, and ensure the infant's skin does not come into direct contact with treated areas.

Can IMIQUAD 5% W/W Cream be taken with other medications?

No severe, serious, moderate, or minor drug-drug interactions have been explicitly established for imiquimod. As a topical medication, it is unlikely to have significant interactions with orally administered medications or affect liver or kidney health. However, it is always important to inform your doctor about all prescription and non-prescription medications, herbs, and supplements you are using.

What precautions should be taken while using IMIQUAD 5% W/W Cream?

• Avoid applying the cream in or near the eyes, lips, nostrils, vagina, or anus. If accidental contact occurs, rinse thoroughly with water.
• Do not apply the cream to broken, irritated, or inflamed skin.
• IMIQUAD Cream can increase your skin's sensitivity to the sun. Limit sun exposure, avoid tanning beds and sunlamps, and use sunscreen with protective clothing when outdoors.
• If treating genital or anal warts, avoid sexual contact while the cream is on your skin, as it can irritate your partner and may weaken latex condoms and diaphragms, reducing their effectiveness.
• Uncircumcised men treating warts under the foreskin should retract the foreskin and clean the area daily before and after each treatment.
• Do not cover the treated area with bandages or waterproof dressings unless specifically instructed by your doctor. Cotton gauze or cotton underwear may be used for genital areas.
• Regular follow-up with your doctor is important to monitor treatment progress and manage any side effects.

What happens if a dose of IMIQUAD 5% W/W Cream is missed?

If you miss a dose, apply it as soon as you remember that night. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular application schedule. Do not double the dose to catch up.

How should IMIQUAD 5% W/W Cream be stored?

Store IMIQUAD 5% W/W Cream at room temperature, typically around 25°C (77°F). Protect it from light and moisture. Keep the cream out of reach of children and pets. Do not use the medicine after its expiry date. Although sachets are intended for single use, some people may seal and store them if not all cream is used, but it's generally recommended to discard any unused portion from an opened sachet to ensure efficacy and sterility.