Drug Interaction:
Not available
Indication:
LIST OF DRUGS DURING 2004
Sr.No- 264
Name of the Drug- Imiquinmol Cream 5% w/w Pharmacological Classification- For warts in adults
Date of Approval- 28-12-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
Imiquimod cream 5%w/w 28-12-2004
For warts in adults
Active Keratosis
Superficial basal cell carcinoma
Adverse Reaction:
Adverse Reactions-
Application site disorders 25%
Cardiovascular - Hypertension 2%
CNS- Anxiety 1% Dizziness 1% Headache 6%
Dermatologic - Hyperkeratonis 1% Rash 1% Skin disorder 1%
GI - Abdominal pain 0.5% Diarrhea 0.5% Dyspepsia 1% GI disorder 0.5%
Nausea 1%
Metabolic /nutritional - Gout 1%
Musculoskeletal - Skeletal pain 1%
Respiratory - Coughing 1% Pharyngitis 1% Rhinitis 2% Sinusitis 2%
Upper respiratory tract infection - 3%
Miscellaneous- Aggravated allergy - 1% Back pain 3% Chest pain 1% Fatigue 2%
Back pain 1% Chest pain 1% Fatigue 2% Fever 1%
Infection 1% Infection fungal 1% Infected injury 1%
Lymphadenopathy 2% Pain 1% Procedural site infection 1%
Contra-Indications:
Sensitivity reactions to any of the components
Special precaution-
Inflammatory conditions- imiquinol has the potential to excerabate inflammatory conditions of the skin
Genital and perianial warts- local skin reactions at the treatment site are common. A rest period of several days may be required by the patients discomfort or severity of the local skin reactions. Treatment may resume once the reaction subsides
Nonocclusive dressings- nonocclusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reaction.
Photosensitivity - Avoid exposure to sunlight or minimise it during use of imiquimod cream
because of concern for hightened sunburn susceptibility
Pregnancy - No adequate or well controlled studies in pregnant women. Use during pregnancy if potential benefits justifies the potential risk to fetus
Lactation- not known whether topically appied imiquinol is excreted in breast milk.
Children- Safety and efficacy in patients with external genital/ perianal warts younger than
12 years of age have not been established
Elderly- no overall differences in safety and efficacy were observed between these and
younger patients
Dosages/ Overdosage Etc:
Indication-
Active Keratosis
Superficial basal cell carcinoma
Dosage-
For external use only- - Imiquimod cream is not opthalmic use.
Apply 2 times per week for 16 weeks to a definite treatment area on the face or scalp ( but not both concurrently ). Treatment should be one contignous area of approx. 25cm2
Patient Information:
1. Follow the doctors instruction regarding the use of this medicine.
2. Do not bandage the treatment area or otherwise cover or wrap as to be occlusive
3. Actinic keratosis - it is recommended that the treatment area be washed with mild soap and water 8 hours following imiquimod cream
4. It is common for patients to experience local skin reactions ( mild to severe intensity ) during treatment, and may extend beyond the appilcation site onto the surrounding areas.
5. Skin reactions generally decrease in intensity or resolve after cessation of imiquimod
therapy.
6.Avoid contact with the eyes, lips or nostrils
7. Use of sunscreen is encooraged during tratment.
8. Discard partially used packets and do not reuse.
9. Dosing is twice weekly for the full 16 weeks , unless otherwise directed by the doctor. however, treatment period should not be extended beyond 16 weeks due to missed doses or rest period
Pregnancy and lactation:
Pregnancy -
No adequate or well controlled studies in pregnant women. Use during pregnancy if
potential benefits justifies the potential risk to fetus
Lactation-
Not known whether topically appied imiquinol is excreted in breast milk.
Children-
Safety and efficacy in patients with external genital/ perianal warts younger than
12 years of age have not been established
Elderly-
No overall differences in safety and efficacy were observed between these and
younger patients