Drug Description
Each ml contains 50 mg of d-alpha-tocopherol, in the form of tocofersolan, corresponding to 74.5 IU oftocopherol.Excipients:Each ml contains 3 mg sodium methyl parahydroxybenzoate (E219), 0.90 mg sodium propylparahydroxybenzoate (E217), 0.03 mmoles of potassium and 0.14 mmoles of sodium.
Presentation
Oral solution.Slightly viscous, pale yellow solution.
Indications
Vedrop is indicated in vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis, from birth (in term newborns) to 16 or 18 years of age, depending on the region.
Adult Dosage
The treatment with Vedrop should be initiated and supervised by a physician experienced in the management of patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis.Bioavailability of vitamin E from Vedrop differs from that of other medicinal products. The dose should be prescribed in mg of d-alpha-tocopherol in the form of tocofersolan. Plasma vitamin E level should be monitored monthly for at least the first few months of therapy, thereafter at regular intervals and the dose adjusted accordingly if necessary.PosologyThe recommended total daily dose in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis is 0.34 ml/kg/day (17 mg/kg of d-alpha-tocopherol in the form of tocofersolan).The dose should be adjusted according to plasma vitamin E level.To calculate the dose of Vedrop to be administered, divide the prescribed dose of d-alpha-tocopherol (in mg) by 50. The result is the volume of Vedrop in ml:Dose of Vedrop (in ml) = dose of d-alpha-tocopherol (in mg)50In congenital chronic or hereditary chronic cholestasis patients, the posology is 17 mg/kg/day of d-alpha-tocopherol in the form of tocofersolan; the following table gives the volume of Vedrop in function of patients’ weights.Weight (kg)Vedrop volume (ml)31.041.451.762.072.482.793.1103.4155.1Method of administrationVedrop is administered orally with or without water. The 1-ml or 2-ml oral syringes included in the container are designed to assist in measuring out the exact dose in accordance with the prescribed posology.
Contra Indications
Hypersensitivity to the active substance or to any of the excipients.Vedrop must not be used in prematures.
Special Precautions
As large doses of vitamin E have been reported to increase bleeding tendency in vitamin-K deficient patients or those taking oral anti-vitamins K treatment, it is therefore recommended to monitor the prothrombin time and international normalised ratio (INR). A possible adjustment of the dose of oral anticoagulant during and after treatment with Vedrop may be necessary.Due to the potential for renal toxicity of polyethylene glycols, Vedrop should be administered with caution and under close monitoring of the renal function in patient with renal impairment e.g. dehydrated patients.As data on patients with hepatic impairment are limited, Vedrop should be administered with caution and under close monitoring of the hepatic functions in such patients.Renal function and serum osmolarity should be eva luated and monitored under treatment with Vedrop.Vedrop contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.And it also contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium- free’.
Interactions
Due to inhibition of P-Glycoprotein transporter, tocofersolan may also enhance intestinal absorption of other concomitant fat-soluble vitamins (A, D, E, K) or that of highly lipophilic medicinal products (such as 3 steroids, antibiotics, antihistamines, cyclosporine, tacrolimus). Therefore, monitoring should be performed and, when necessary, doses should be adjusted.
Adverse Reactions
Reported adverse reactions are listed below, by system organ class and by frequency.Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.System organ classAdverse drug reactionsGastrointestinal disordersCommon: diarrhoeaSkin and subcutaneous tissue disordersUncommon: alopecia, pruritus, rashGeneral disorders and administration siteconditionsUncommon: asthenia, headacheInvestigationsUncommon: serum sodium abnormal, serum potassiumabnormal, transaminases increase
Updated
15 September 2009
