HIPREX Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Hiprex 1 g Tablets.
Qualitative and quantitative composition
Each Hiprex tablet contains methenamine hippurate 1 g. For the full list of excipients, see 6.1.
Pharmaceutical form
A white to creamy-white oblong shaped tablet coded HX with break line on one face and break line on the other face with or without 3M.
Therapeutic indications
Hiprex is indicated in the prophylaxis and treatment of urinary tract infections: As maintenance therapy after successful initial treatment of acute infections with antibiotics. As long-term therapy in ...
Posology and method of administration
Posology Adults 1g twice daily. In patients with catheters the dosage may be increased to 1g three times daily. Paediatric population Children under 6 years: Not recommended. Children: 6-12 years: 500mg ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Hepatic dysfunction, renal parenchymal infection, severe dehydration, metabolic acidosis, severe renal failure ...
Special warnings and precautions for use
None.
Interaction with other medicinal products and other forms of interaction
Methenamine hippurate should not be given/administered concurrently with sulphonamides because of the possibility of crystalluria, or with alkalising agents such as potassium citrate. Concurrent use with ...
Fertility, pregnancy and lactation
Pregnancy There is inadequate evidence of safety of methenamine hippuratein human pregnancy, but it has been in wide use for many years without apparent ill consequence. Animal studies are insufficient ...
Effects on ability to drive and use machines
None.
Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as: Very common (≥1/l0) Common (≥1/100 and <1/10) Uncommon (≥1/1000 and <1/100) Rare (≥1/10,000 and <1/1000) ...
Overdose
Vomiting and haematuria may occur. These can be treated by the use of an anti-emetic and drinking copious quantities of water respectively. Bladder symptoms can be treated by the consumption of copious ...
Pharmacodynamic properties
Pharmacotherapeutic group: G04AA01 Hiprex is a urinary antibacterial agent with a wide antibacterial spectrum covering both gram-positive and gram-negative organisms. Urinary antibacterial activity can ...
Pharmacokinetic properties
Methenamine hippurate is readily absorbed from the gastro-intestinal tract and excreted via the kidney. Plasma concentrations of methenamine hippurate reach maximum 1-2 hours after a single dose and then ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on repeated dose toxicity studies. No carcinogenicity or genotoxicity data are available for methenamine hippurate. Methenamine did not demonstrate ...
List of excipients
Magnesium stearate Povidone Colloidal anhydrous silica
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C. Keep bottle tightly closed.
Nature and contents of container
Glass bottles of 60 tablets.
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.
Marketing authorization holder
Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK
Marketing authorization number(s)
PL 46302/0200
Date of first authorization / renewal of the authorization
12 October 1989/13 September 2005
Date of revision of the text
December 2019
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