RENOFAM TABLET

RENOFAM

RENOFAM TABLETS

Alpha Ketoanalogue Tablets

 

Composition:

Each film coated tablet contains:

Calcium-3-methyl-2-oxo-valerate (Alpha-ketoanalogue to isoleucine, calcium salt) ……….. 67 mg
Calcium-4-methyl-2-oxo-valerate (Alpha-ketoanalogue to leucine, calcium salt) ……………. 101 mg
Calcium-2-oxo-3-phenylpropionate (Alpha-ketoanalogue to phenylalanine, calcium salt)… 68 mg
Calcium-3-methyl-2-oxo-butyrate (Alpha-ketoanalogue to valine, calcium salt)………………. 86 mg
Calcium-DL-2-hydroxy-4-(methylthio)-butyrate (Alpha-hydroxyanalogue to methionine, calcium salt)….. 59 mg
L-Lysine acetate USP …………………………………………………………………………………………………. 105 mg
L-Threonine USP ………………………………………………………………………………………………………. 53 mg
L-Tryptophan USP …………………………………………………………………………………………………….. 23 mg
L-Histidine USP ………………………………………………………………………………………………………… 38 mg
L-Tyrosine USP …………………………………………………………………………………………………………. 30 mg
Excipients …………………………………………………………………………………………………………………. q.s.

Colour :- Approved Colour used in Tablets

 

Indication

Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40 g/day or less (adult).

 

Recommended Dosage

For Oral Use

Renofam Tablets

If not otherwise prescribed the dose for adults (70 kg body weight) is 4 to 8 tablets three times daily during meals. The tablets must not be chewed. Ingestion during meals facilitates proper absorption and the metabolism into the corresponding amino acids.

 

Pharmacodynamics
Pharmacotherapeutic group: Amino acids, including combinations with polypeptides.
ATC code: V06DD

RENOFAM are administered for nutrition therapy in chronic kidney disease.
RENOFAM allows the intake of essential amino acids while minimising the amino-nitrogen intake. Following absorption, the keto- and hydroxy-analogues are transaminated to the corresponding essential amino acids by taking nitrogen from non-essential amino acids, thereby decreasing the formation of urea by re-using the amino group. Hence, the accumulation of uraemic toxins is reduced. Keto and hydroxy acids do not induce hyperfiltration of the residual nephrons. Ketoacid containing supplements exert a positive effect on renal hyperphosphataemia and secondary hyperparathyroidism. Moreover, renal osteodystrophy may be improved. The use of RENOFAM TABLET in combination with a very low protein diet allows to reduce nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.

 

Pharmacokinetics

The plasma kinetics of amino acids and their integration in the metabolic pathways are well established. It should nevertheless be noted that in uraemic patients, the cause of the changed plasma levels, which occur frequently in these patients, does not seem to be the absorption of the supplied amino acids, i. e. the absorption itself is not disturbed. The changed plasma levels seem to be due to impaired post-absorptive kinetics, which can be detected in a very early stage of the disease. In healthy individuals, the plasma levels of ketoacids increase within 10 min after oral administration. Increases of up to the 5-fold the baseline levels are achieved. Peak levels occur within 20-60 min, and after 90 min levels stabilise in the range of the base levels. Gastrointestinal absorption is thus very rapid. The simultaneous increases in the levels of the ketoacids and the corresponding amino acids show that the ketoacids are transaminated very rapidly. Due to the physiological utilisation pathways of ketoacids in the body it is likely that exogenously supplied ketoacids are very rapidly integrated into the metabolic cycles. Ketoacids follow the same catabolic pathways as classical amino acids. No specific study on ketoacid excretion has been performed to date.

 

Mode of Administration

For Oral administration only.

 

Contraindications

The use of this medicine is contra-indicated in the following cases:
− Hypersensitivity to the active substances or to any of the excipients
− Hypercalcaemia
− Disturbed amino acid metabolism

 

Warnings and Precautions

The serum calcium level should be monitored regularly. Ensure sufficient calorie intake. No experience has been gained so far with the administration in paediatric patients. In the presence of hereditary phenylketonuria, attention should be given to the fact that RENOFAM contains phenylalanine. Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide.

 

Effects on ability to drive and use machines

RENOFAM has no influence on the ability to drive and use machines.

 

Interactions with Other Medicaments

Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels. Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolines such as ciprofloxacin and norfloxacin as well as drugs containing iron,
fluoride or estramustine) should not be taken at the same time with RENOFAM TABLET to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of RENOFAM TABLET and these drugs. The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase if RENOFAM TABLET produces elevated serum calcium levels. Uraemic symptoms improve under therapy with RENOFAM TABLET. Thus, in case of aluminium hydroxide administration, the dose of this drug has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease.

 

Statement on Usage during Pregnancy and Lactation

There are no adequate data from the use of RENOFAM TABLET in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution
should be exercised when prescribing to pregnant women. No experience has been made so far with the use during lactation.

 

Adverse Effects / Undesirable Effects

Adverse effect frequencies are ranked as follows:
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)
Not known (cannot be estimated from the available data)
Metabolism and nutrition disorders
Very rare: hypercalcaemia
If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting
hypercalcaemia, the dose of RENOFAM TABLET as well as the intake of any other calcium
sources has to be reduced

 

Overdose and Treatment

No case of overdose has been reported.

 

Packaging Information

Tablets:

10 x 10 Tablets in a Alu-Alu blister pack

 

Storage Condition

Store below 30°C. Protect from light & moisture.

Keep all the medicines out of reach of children.

 

Shelf Life

24 Months from the date of manufacturing.

 

Product of:
Zifam Pinnacle Pty Ltd.,
Sydney, Australia

 

Manufactured By:
RAVENBHEL HEALTHCARE PVT LTD,
16-17, EPIP, SIDCO, Kartholi, Bari Brahmana,
Jammu, J & K-181133, India.

 

Updated on February 21, 2024.