Naftidrofuryl Oxalate 100mg Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Naftidrofuryl Oxalate 100mg Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
100mg naftidrofuryl oxalate equivalent to 81.0 mg naftidrofuryl and 19.0 mg oxalate.
3. PHARMACEUTICAL FORM
Capsule
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Peripheral vascular disorders - intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud’s Syndrome, diabetic arteriopathy and acrocyanosis.
4.2 Posology and method of administration
Posology:
One or two capsules three times daily for a minimum of three months, or at the discretion of the physician.
Method of administration:
For oral administration. The capsules should be swallowed whole during meals with a sufficient amount of water (minimum) of one glass.
Paediatric _populationThe safety and efficacy of Naftidrofuryl oxalate in the paediatric population have not been established. This drug is not indicated for use in children.
4.3
Contra-Indications
Hypersensitivity to the drug. Patients with a history of hyperoxaluria or recurrent calcium-containing kidney stones.
4.4. Special Warnings and Special Precautions For Use
A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.
4.5. Interaction with other Medicinal Products and other Forms of Interaction
None known.
4.6. Pregnancy and Lactation
Pregnancy: There is no, or inadequate, evidence of the safety of naftidrofuryl oxalate in human pregnancy, but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard.
Lactation: No information is available. Naftidrofuryl should not be used by breastfeeding women.
4.7. Effects on Ability to Drive and Use Machines
None known.
4.8. Undesirable Effects
Naftidrofuryl oxalate is normally well tolerated in the dosage recommended. Occasionally nausea, epigastric pain, vomiting, diarrhoea and rashes have been noted.
Rarely, hepatitis has been reported. Very rarely, calcium oxalate kidney stones have been reported.
In a few patients, who took the medicine without liquid, difficulty in swallowing the medication resulted in local oesophagitis.
4.9 Overdose
Signs and symptoms: Depression of cardiac conduction and convulsions may occur.
Treatment: The stomach should be emptied by gastric lavage and emesis. Activated charcoal may be employed if necessary. Cardiovascular function and respiration should be monitored and, in severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed by diazepam.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Naftidrofuryl oxalate has been shown to exert a direct effect on intracellular metabolism. Thus it has been shown in man and animals that it produces an increase of ATP levels and a decrease of lactic acid levels in ischaemic conditions, evidence for in enhancement of cellular oxidative capacity. Furthermore, naftidrofuryl oxalate is a powerful spasmolytic agent.
5.2. Pharmacokinetic Properties
Naftidrofuryl oxalate is well absorbed when given orally. Peak plasma levels occur about 30 minutes after dosing and the half life is about an hour, although intersubject variation is relatively high. Cumulation does not occur at a dose level of 200mg three times daily.
The drug becomes extensively bound to plasma proteins and is excreted principally via the urine, all in the form of metabolites.
5.3. Pre-clinical Safety Data
No toxic effects were seen in animal studies which provide additional information to that obtained in man. In repeated dose studies the no effect level was 25mg/kg/day or greater. There was no evidence of effects on reproduction below doses which caused maternal toxicity.
6.
PHARMACEUTICAL PARTICULARS
6.1. List of Excipients
Talc
Magnesium Stearate Purified Water*
Denatured Ethanol*
Capsule Shells:
Erythrosine (E127)
Titanium Dioxide (E171)
Printing ink (containing iron oxide black E172)
Gelatine
*Not present in final product
6.2. Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4. Special Precautions for Storage
Store below 25°C in a dry place away from light.
6.5 Nature and contents of container
Pack size 10 (medical sample), 21 and 84 capsules:
Cardboard carton containing blister strips comprising heat-sealable PVC (250pm) and aluminium foil (30 pm).
Pack size 100 and 500:
Polypropylene securitainers with tamper evident closures.
6.6. Instructions for Use, Handling and Disposal
None.
7. MARKETING AUTHORISATION HOLDER
Merck Sante s.a.s.
37 Rue Saint Romain 69379 Lyon Cedex 08 FRANCE
8. MARKETING AUTHORISATION NUMBER(S)
PL 13466/0002
9. DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
13 May 1996
10 DATE OF REVISION OF THE TEXT
03/07/2014