ALAMAST Ophthalmic solution (1999)
Βιβλιογραφική αναφορά
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
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Name of the medicinal product
ALAMAST (pemiralast potassium ophthalmic solution) is a sterile, aqueous ophthalmic solution with a pH of approximately 8.0 containing 0.1% of the mast cell stabilizer, pemirolast potassium, for topical ...
2. Clinical Pharmacology
Mechanism of action Pemiralast potassium is a mast cell stabilizer that inhibits the in vivo Type I immediate hypersensitivity reaction. In vitro and in vivo studies have demonstrated that pernirolast ...
3. Indications and Usage
ALAMAST ophthalmic solution is indicated for the prevention of itching of the eye due to allergic conjunctivitis. Symptomatic response to therapy (decreased itching) may be evident within a few days, but ...
4. Contraindications
ALAMAST ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients of this product.
5. Warnings
For topical ophthalmic use only. Not for injection or oral use.
6.2. Information for Patients
To prevent contaminating the dropper tip and solution, do not touch the eyelids or surrounding areas with the dropper tip. Keep the bottle tightly closed when not in use. Patients should be advised not ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
Pemirolast potassium was not mutagenic or clastogenic when tested in a series of bacterial and mammalian tests for gene mutation and chromosomal injury in vitro nor was it clastogenic when tested in vivo ...
6.7. Pregnancy
Pregnancy Category C. Pemirolast potassium caused an increased incidence of thymic remnant in the neck, interventricular septal defect, fetuses with wavy rib, splitting of thoracic vertebral body, and ...
6.9. Nursing Mothers
Pemirolast potassium is excreted in the milk of lactating rats at concentrations higher than those in plasma. It is not known whether pemirolast potassium is excreted in human milk. Because many drugs ...
6.10. Pediatric Use
Safety and effectiveness in pediatric patients below the age of 3 years have not been established.
7. Adverse Reactions
In clinical studies lasting up to 17 weeks with ALAMAST ophthalmic solution, headache, thinitis, and cold/flu symptoms were reported at an incidence of 10-25%. The occurrence of these side effects was ...
9. Overdosage
No accounts of ALAMAST ophthalmic solution overdose were reported following topical ocular application. Oral ingestion of the contents of a 10 mL, bottle would be equivalent to 10 mg of pemirolast potassium. ...
10. Dosage and Administration
The recommended dose is one to two drops in each affected eye four times daily. Symptomatic response to therapy (decreased itching) may bo evident within a few days, but frequently requires longer treatment ...
11. How Supplied
ALAMAST (pemirolast potassium ophthalmic solution), 0.1% is supplied as follows: 10 mL in a white, low density polyethylene bottle with a controlled dropper tip and a white polypropylene screw cap. <u> ...