IVERGALEN Tablet Ref.[27783] Active ingredients: Ivermectin

Revision Year: 2020  Publisher: Galenicum Derma, S.L., Ctra. N-1, Km 36, 28750 San Agustin de Guadalix (Madrid), Spain

4.1. Therapeutic indications

  • Treatment of gastrointestinal strongyloidiasis (anguillulosis).
  • Treatment of suspected or diagnosed microfilaraemia in patients with lymphatic filariasis due to Wuchereria bancrofti.
  • Treatment of human sarcoptic scabies. Treatment is justified when the diagnosis of scabies has been established clinically and/or by parasitological examination. Without formal diagnosis treatment is not justified in case of pruritus.

Official guidelines should be taken into consideration. Official guidelines will normally include WHO and public health authorities' guidelines.

4.2. Posology and method of administration

Posology

Treatment of gastrointestinal strongyloidiasis

The recommended dosage is one single oral dose of 200 micrograms of ivermectin per kg body weight.

For guidance, the dose, as determined by the patient’s weight, is as follows:

BODY WEIGHT (kg) DOSE (number of 3 mg tablets)
15 to 24one
25 to 35two
36 to 50three
51 to 65four
66 to 79five
≥ 80six

Treatment of microfilaraemia caused by Wuchereria bancrofti

The recommended dosage for mass distribution for the treatment of microfilaraemia caused by Wuchereria bancrofti is a single oral dose once every 6 months designed to provide approximately 150 to 200 μg/kg of body weight.

In endemic areas where treatment can only be administered once every 12 months, the recommended dosage is 300 to 400 μg/kg of body weight to maintain adequate suppression of microfilaraemia in treated patients.

For guidance, the dose, as determined by the patient’s weight, is as follows:

BODY WEIGHT (kg) DOSE when given once every 6 months (number of 3 mg tablets)DOSE when given once every 12 months (number of 3 mg tablets)
15 to 25onetwo
26 to 44twofour
45 to 64threesix
65 to 84foureight

Alternatively and if no scales are available, the dose of ivermectin for use in mass chemotherapy campaigns may be determined by the patient’s height as follows:

HEIGHT (cm) DOSE when given once every 6 months (number of 3 mg tablets) DOSE when given once every 12 months (number of 3 mg tablets)
90 to 119onetwo
120 to 140twofour
141 to 158threesix
>158foureight

Treatment of human sarcoptic scabies

The recommended dosage is a single oral dose to provide ivermectin 200 μg/kg body weight.

Common scabies

Recovery will be considered as definite only after 4 weeks of the treatment. Persistence of pruritus or scraping lesions does not justify a second treatment before this date.

Administration of a second dose within 2 weeks after the initial dose should only be considered:

a) when new specific lesions occur,
b) when the parasitologic examination is positive at this date.

Profuse and crusting scabies

In these heavily infected forms, a second dose within 8 to 15 days of ivermectin and/or concomitant topical therapy may be necessary to obtain recovery.

Note for patients treated for scabies

Contact persons, especially family members and partners, should undergo a medical examination as soon as possible, and if necessary should be given prompt antiscabies treatment.

Hygienic measures to prevent reinfection should be taken into account (i. e. keeping fingernails short and clean) and official recommendations regarding the cleaning of clothing and bedding should be closely followed.

Paediatric population

For all indications, safety in paediatric patients weighing less than 15 kg of body weight has not been established.

Elderly patients

Clinical studies with ivermectin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, treatment of an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Method of administration

Oral route.

In children less than 6 years of age, tablets should be crushed before swallowing.

Treatment is one single oral dose taken with water on an empty stomach.

The dose may be taken at any time of the day, but no food should be taken within two hours before or after administration, as the influence of food on absorption is unknown.

4.9. Overdose

Cases of accidental overdose with ivermectin have been reported, but none have resulted in fatalities. In cases of accidental intoxication with unknown doses of products destined for veterinary use (oral use, as an injection, cutaneous use), the symptoms described were: rash, contact dermatitis, oedema, headache, vertigo, asthenia, nausea, vomiting, diarrhoea and abdominal pain. Other effects have also been observed, including: seizures, ataxia, dyspnoea, paraesthesia and urticaria.

Management in case of accidental intoxication:

  • symptomatic treatment and surveillance in a medical care setting with fluid replacement and hypertensive treatment, if necessary. Although there are no specific studies available, it is advisable to avoid combination of GABA agonists in the treatment of accidental intoxication due to ivermectin.

6.3. Shelf life

18 months.

6.4. Special precautions for storage

Do not store above 25°C.

Store in the original packaging in order to protect from light.

6.5. Nature and contents of container

Do not store above 25°C.

Store in the original packaging in order to protect from light.

6.6. Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.