Stromectol is a medicine in tablet form (4) based on Ivermectin (3 mg).
Indications: why take Stromectol?
Indications for use
- Gastrointestinal anguillulosis
- Wuchereria bancrofti microfilaremia
- Human sarcoptic mange
- Treatment of strongyloidiasis (strongyloidiasis) gastrointestinal.
- Treatment of diagnosed or suspected microfilaria in affected patients of lymphatic filariasis caused by Wuchereria bancrofti .
- Treatment of human sarcoptic mange. Treatment is justified when the diagnosis of scabies is established clinically and / or by parasitological examination. The practice of so-called “trial” treatment in the face of pruritus is not justified.
Contraindications: why not take Stromectol?
Hypersensitivity to the active substance or to any of the excipients listed in the Composition section .
Posology and method of administration
Treatment of gastrointestinal anguillulosis :
The recommended dose is 200 µg of ivermectin per kilogram of body weight as a single oral dose.
As an indication, the dose according to weight is:
|BODY WEIGHT (kg)||DOSE (in number of 3 mg tablets)|
|15 to 24||a|
|25 to 35||of them|
|36 to 50||three|
|51 to 65||four|
|66 to 79||five|
Treatment of Wuchereria bancrofti microfilaremia :
The recommended dosage for mass treatment campaigns for Wuchereria bancrofti microfilaremia is approximately 150 to 200 m g of ivermectin per kilogram of body weight taken once orally every 6 months.
In endemic areas where treatment can only be given once every 12 months, the recommended dosage is 300 to 400 m g of ivermectin per kilogram of body weight to maintain sufficient suppression of microfilaraemia in patients. topics covered.
As an indication, the dose according to weight is:
|BODY WEIGHT(kg)||DOSE given every 6 months (number of 3 mg tablets)||DOSE given every 12 months (number of 3 mg tablets)|
|15 to 25||a||of them|
|26 to 44||of them||four|
|45 to 64||three||six|
|65 to 84||four||eight|
Alternatively and in the absence of a scale, the dosage, for administration in mass treatment campaigns, can be determined by the size of the patients, as follows:
|CUT(in cm)||DOSE administered every 6 months( number of 3 mg tablets)||DOSE administered every 12 months(number of 3 mg tablets)|
|90 to 119||a||of them|
|120 to 140||of them||four|
|141 to 158||three||six|
Treatment of human sarcoptic mange :
The recommended dose is 200 µg of ivermectin per kilogram of body weight as a single oral dose.
Healing will not be considered definitive until 4 weeks after treatment. The persistence of itching or scratching lesions does not justify a second treatment before this date.
Administration of a second dose 2 weeks after the initial dose should only be considered:
- If it appears new specific lesions,
- If parasitological examination is positive on that date.
Profuse scab and crusty scab:
In these forms with very many parasites, a second dose of ivermectin and / or the combination with a topical treatment may be necessary within 8 to 15 days to achieve healing.
Regardless of the indication, safety has not been established in children weighing less than 15 kg.
In children under 6 years old, the tablets will be crushed before being swallowed.
Treatment consists of a single oral dose administered on an empty stomach with water.
The dose can be taken at any time of the day, but care should be taken to ensure that it is not taken from food for 2 hours before or after its administration, the influence of food on the absorption not known.
The tablets are round, white, marked “MSD” on one side and “32” on the other side.
Warnings and precautions for use
The efficacy and modalities of use of ivermectin in the treatment of anguillulosis in immunocompromised subjects have not been established by suitable clinical studies. Cases reported suggest the persistence of a risk of massive infestation after a single dose of ivermectin, in particular in this type of patient.
Ivermectin is not a preventive chemoprophylaxis against infestation by filaria or eel; there are no data demonstrating the efficacy of ivermectin either in killing or in preventing the maturation of infesting larvae in humans.
There was no evidence of macrofilaricidal activity of ivermectin on the adult forms of any species of filaria.
No beneficial effect of ivermectin administration on tropical pulmonary eosinophilia syndrome, nor on lymphangitis or lymphadenitis observed during infestation by filaria has been demonstrated.
The intensity and severity of the adverse effects after administration of ivermectin seem to correlate with the importance of the blood load of microfilariae before treatment. In the event of co-infection with Loa loa , the level of microfilariae present in the blood is most often high, which predisposes the treated subjects to an increased risk of occurrence of serious side effects.
Central neurological disorders (encephalopathies) have rarely been described in subjects treated with ivermectin and with high Loa loa microfilaraemia . Therefore, in areas endemic to Loa loa , special precautions should be taken before treatment with ivermectin (see section 4.8 ).
In the mass treatment campaigns for filariasis caused by Wuchereria bancrofti , carried out in Africa, it is recommended not to combine diethylcarbamazine citrate (DEC) with ivermectin. The frequent existence of co-endemia with other microfilariae such as Loa loa may be at the origin of the existence of strong microfilaraemias in infested subjects.
Systemic exposure to diethylcarbamazine (DEC) in such patients would result in the occurrence of serious adverse events related to the rapid and massive microfilaricidal effect of this drug.
It has been described following the administration of drugs with rapid microfilaricidal action, such as diethylcarbamazine citrate (DEC), in patients with onchocerciasis, the occurrence of cutaneous and / or systemic reactions of varying severity ( Mazzotti reactions) as well as eye reactions. It is likely that these manifestations are related to an inflammatory process triggered by the death of the microfilariae and the release of degradation products. These reactions may also be seen in patients treated for onchocerciasis during the first courses of ivermectin.
Patients with hyperreactive onchocercial dermatitis or “Sowda” (observed in particular in Yemen) seem to develop severe skin reactions more frequently (edema, worsening of dermatitis, etc.) after microfilaricidal treatment.
Precautions for use
Safety has not been established in children weighing less than 15 kg
Pregnancy and breast feeding
During mass treatment of onchocerciasis, data from a limited number of pregnant women (approximately 300) did not reveal harmful effects such as: congenital anomalies, spontaneous abortions, stillbirths and infant mortality which could be related to treatment with ivermectin during the first trimester of pregnancy. To date, there are no other epidemiological data available.
Studies in animals have shown reproductive toxicity (see section Preclinical safety data ); however, the predictive value for humans of these observations has not been established.
Ivermectin should only be used when needed.
Feeding with milk
Less than 2 percent of the administered dose of ivermectin appears in breast milk.
Safety has not been established in newborn children. Ivermectin will only be given to nursing mothers if the expected benefit outweighs the potential risk to the infant.
Treatment for mothers who intend to breastfeed their child will not be given until 1 week after the birth of the child.
Interactions with other drugs and other forms of interactions
No interaction studies have been performed.
Side effects of Stromectol
Transient hypereosinophilia, hepatic dysfunction including acute hepatitis, elevated liver enzymes, hyperbilirubinemia and hematuria have been reported.
Very rarely, toxic epidermal necrolysis and Stevens-Johnson syndrome have also been reported.
The side effects are related to the parasite density and are in most cases mild and transient, but their incidence and severity may be increased in people with multiple parasites, especially in case of Loa loa infestation .
Rarely, cases of severe encephalitis which may have resulted in death have been described after administration of ivermectin, particularly in subjects also heavily infested with Loa loa. In these patients, the following side effects have also been reported: back pain or neck pain, ocular hyperemia, subconjunctival hemorrhage, dyspnea, urinary and / or anal incontinence, difficulty in standing / walking, changes in mental status, confusion, lethargy, stupor or coma (see section 4.4 ).
In subjects receiving ivermectin for strongyloidiasis, the following side effects have been reported: asthenia, abdominal pain, anorexia, constipation, diarrhea, nausea, vomiting, dizziness, drowsiness, dizziness, tremors, transient eosinophilia, leukopenia / anemia and increased ALT / alkaline phosphatase.
In the treatment of Wuchereria bancrofti filariasis , the intensity of the side effects does not seem to depend on the dose of ivermectin administered but is correlated with the load of blood microfilariae. The following have been described: fever, headache, asthenia, feeling of weakness, myalgia, arthralgia, diffuse pain, digestive disorders such as anorexia, nausea, abdominal and epigastric pain, cough, feeling of respiratory discomfort, sore throat, postural hypotension, chills, dizziness, diffuse sweating, pain or discomfort in the testicles.
Following the administration of ivermectin in subjects infested with Onchocerca volvulus , the hypersensitivity reactions observed resulting from the death of the microfilariae are part of the Mazzotti-type reactions: pruritus, urticarial rash, conjunctivitis, arthralgia, myalgia (including including abdominal myalgia), fever, edema, lymphadenitis, lymphadenopathy, nausea, vomiting, diarrhea, orthostatic hypotension, dizziness, tachycardia, asthenia, headache. These symptoms have rarely been severe. A few cases of asthma exacerbation have been described.
In these subjects, abnormal eye sensation, eyelid edema, anterior uveitis, conjunctivitis, limbitis, keratitis, and chorioretinitis or choroiditis have also been described. These manifestations, which may be due to the condition itself, have also been described occasionally after treatment. They were rarely severe and usually went away without corticosteroid treatment.
Conjunctival hemorrhage has been reported in patients with onchocerciasis.
Observations of expulsion of adult roundworms have been described following the intake of ivermectin.
In subjects with scabies, a transient exacerbation of pruritus may be observed at the start of treatment.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals report any suspected adverse reactions via the national reporting system: National Agency for Medicines and Health Products Safety
Accidental ivermectin overdose has been reported, but none has resulted in death.
During accidental poisoning by unknown doses of products intended for veterinary use (oral, injectable, cutaneous application), the symptoms described were: rash, contact dermatitis, edema, headache, dizziness, asthenia, nausea, vomiting, diarrhea and abdominal pain. Other side effects have also been observed including convulsions, ataxia, dyspnea, paraesthesia and urticaria.
What to do in the event of accidental poisoning:
· Symptomatic treatment and hospital-based surveillance with fluid replacement and hypertensive treatment if necessary.
Although no specific study is available, it is recommended to avoid the combination of GABA agonist drugs in the treatment of accidental poisoning due to ivermectin.
Effect on ability to drive and use machines
The effect of Stromectol on the ability to drive and use machines has not been studied. The possibility in some patients of side effects such as dizziness, drowsiness, vertigo and tremors which may affect the ability to drive or use machines, is not excluded
Stromectol Pharmacological properties
Pharmacotherapeutic group: ANTIHELMINTIQUE, ATC code: P02CF01 .
Ivermectin is a derivative of avermectins isolated from the fermentation of Streptomyces avermitilis broths . It has a strong affinity for the glutamate-dependent chloride channels present in the nerve and muscle cells of invertebrates. Its attachment to these channels promotes an increase in membrane permeability to chloride ions leading to hyperpolarization of the nerve or muscle cell. This results in neuromuscular paralysis which can lead to the death of some parasites. Ivermectin also interacts with other ligand-dependent chloride channels than that involving the neuro-mediator GABA (gamma-amino-butyric acid).
Mammals do not have glutamate-dependent chloride channels. Avermectins have only a weak affinity for other ligand-dependent chloride channels. They do not easily pass the blood brain barrier.
Clinical studies carried out in Africa, Asia, South America, the Caribbean and Polynesia show a reduction (to less than 1%) in Wuchereria bancrofti microfilaremia within one week after administration of an oral dose. of ivermectin of at least 100 m g / kg. These studies have demonstrated a dose-dependent effect on the time during which the decrease in microfilaremia and the percentage of infestation in the treated populations is maintained.
Administration as a mass treatment appears useful for limiting the transmission of Wuchereria bancrofti by vector insects and interrupting the epidemiological chain by treating microfilaremic humans (the only reservoir of parasites for Wuchereria bancrofti).
Treatment with a single dose of ivermectin of 200 micrograms per kilogram of body weight has been shown to be effective and well tolerated in patients with normal immunity and in whom infection with Strongyloïdes stercoralis is limited to the digestive tract.
The mean peak plasma concentration of the main compound (H 2 B 1 a) observed approximately 4 hours after oral administration of a single dose of 12 mg ivermectin tablet is 46.6 ( ± 21.9) ng / ml.
The plasma concentration increases with increasing doses in an overall proportional manner. Ivermectin is absorbed and metabolized in the human body. Ivermectin and / or its metabolites are excreted almost exclusively in the faeces while less than 1% of the administered dose is excreted in the urine. An in vitro study carried out on human liver microsomes suggests that cytochrome P450 3A4 may be the main isoform involved in the hepatic metabolism of ivermectin. In humans, the plasma half-life of ivermectin is approximately 12 hours and that of the metabolites is approximately 3 days.
Preclinical studies suggest that ivermectin, used at therapeutic oral doses, does not significantly inhibit CYP3A4 (IC 50 = 50 µm), nor the other CYP enzymes: 2D6, 2C9, 1A2 and 2E1.
Duration and special precautions for storage
Retention period :
2 years.Special precautions for storage :
No special storage conditions.
No special requirements.
Any unused medication or waste must be disposed of in accordance with the regulations in force.
Tablets in cold-formed blister packs (Aluminum / Aluminum). Box of 4.