STROMECTOL Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Merck Sharp & Dohme Corp.

Λέξεις κλειδιά

0006-0032

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Description

STROMECTOL (Ivermectin) is a semisynthetic, anthelmintic agent for oral administration. Ivermectin is derived from the avermectins, a class of highly active broad-spectrum, anti-parasitic agents isolated ...

2. Clinical Pharmacology

Pharmacokinetics Following oral administration of ivermectin, plasma concentrations are approximately proportional to the dose. In two studies, after single 12-mg doses of STROMECTOL in fasting healthy ...

3. Indications and Usage

STROMECTOL is indicated for the treatment of the following infections: Strongyloidiasis of the intestinal tract: STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis ...

4. Contraindications

STROMECTOL is contraindicated in patients who are hypersensitive to any component of this product.

5. Warnings

Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological ...

6. Precautions

Strongyloidiasis in Immunocompromised Hosts In immunocompromised (including HIV-infected) patients being treated for intestinal strongyloidiasis, repeated courses of therapy may be required. Adequate and ...

6.1. General

After treatment with microfilaricidal drugs, patients with hyperreactive onchodermatitis (sowda) may be more likely than others to experience severe adverse reactions, especially edema and aggravation ...

6.2. Information for Patients

STROMECTOL should be taken on an empty stomach with water. (See CLINICAL PHARMACOLOGY, Pharmacokinetics.) Strongyloidiasis: The patient should be reminded of the need for repeated stool examinations ...

6.4. Drug Interactions

Post-marketing reports of increased INR (International Normalized Ratio) have been rarely reported when ivermectin was co-administered with warfarin.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of ivermectin. Ivermectin was not genotoxic in vitro in the Ames microbial mutagenicity assay of ...

6.7. Pregnancy

Teratogenic Effects Ivermectin has been shown to be teratogenic in mice, rats, and rabbits when given in repeated doses of 0.2, 8.1, and 4.5 times the maximum recommended human dose, respectively (on a ...

6.9. Nursing Mothers

STROMECTOL is excreted in human milk in low concentrations. Treatment of mothers who intend to breast-feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients weighing less than 15 kg have not been established.

6.11. Geriatric Use

Clinical studies of STROMECTOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...

7. Adverse Reactions

Strongyloidiasis In four clinical studies involving a total of 109 patients given either one or two doses of 170 to 200 mcg/kg of STROMECTOL, the following adverse reactions were reported as possibly, ...

9. Overdosage

Significant lethality was observed in mice and rats after single oral doses of 25 to 50 mg/kg and 40 to 50 mg/kg, respectively. No significant lethality was observed in dogs after single oral doses of ...

10. Dosage and Administration

Strongyloidiasis The recommended dosage of STROMECTOL for the treatment of strongyloidiasis is a single oral dose designed to provide approximately 200 mcg of ivermectin per kg of body weight. See Table ...

11. How Supplied

No. 8495 — Tablets STROMECTOL 3 mg are white, round, flat, bevel-edged tablets coded MSD on one side and 32 on the other side. They are supplied as follows: NDC 0006-0032-20 unit dose packages of 20. ...

12. Storage and Handling

Store at temperatures below 30°C (86°F).

13. Clinical Studies

Strongyloidiasis Two controlled clinical studies using albendazole as the comparative agent were carried out in international sites where albendazole is approved for the treatment of strongyloidiasis of ...