Keto Log 275v6f

Ketolog • • • • • • • • • • • • • • • • •

Manufacturer Distributor Contents Indications Dosage istration Contraindications Special Precautions Adverse Drug Reactions Drug Interactions Storage Description Mechanism of Action MIMS Class ATC Classification Poison Schedule Presentation/Packing

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Manufacturer

Claris Lifesciences

Distributor

Macropharma Corp

Contents

Ketoanalogues and essential amino acids.

Indications

Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein food of ≤40 g/day (for adults).

Dosage

Adults (70 kg/body weight): 4-8 tablets 3 times daily during meals. istration: For oral use. Tablets may be taken during meals; should be swallowed whole. Duration of Use: Ketolog tablets are given as long as the GFR is between 5 and about 15 mL/min. Simultaneously for adults, food should contain ≤40 g/day of protein ie, generally in patients with glomerular filtration rate (GFR) between 5 and about 15 mL/min.

istration

May be taken with or without food.

Contraindications

Hypercalcemia, disturbed amino acid metabolism. In case of hereditary phenylketonuria, it has to be taken into that Ketolog contains phenylalanine.

Special Precautions

Ketolog should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium levels should be monitored regularly. Ensure the sufficient supply with calories. Use in pregnancy: No experience has been made so far with the application in

pregnancy. Use in children: No experience has been made so far with the application in pediatry. Adverse Drug Reactions

Hypercalcemia may develop. Click to view ADR Monitoring Form

Drug Interactions

Simultaneous istration of medicaments containing calcium (eg, acetolyte) may lead to pathological increases of the serum calcium level or intensification. As the uremic symptoms improve under Ketolog, a possible istration of aluminum hydroxide should be reduced. Pay attention to a reduction of serum phosphate. Do not take drugs together with Ketolog that form sparingly soluble compounds with calcium (eg, tetracyclines) in order not to interfere with absorption.

Storage

Store at temperatures not exceeding 30°C. Keep in a cool and dry place. Shelf-Life: 24 months.

Description

Each tablet of Ketolog contains: Calcium-4-methyl-2-oxo-valerate (αketoanalogues to leucine, calcium salt) 101 mg, calcium-3-methyl-2-oxo-butyrate (α-ketoanalogues to valine, calcium salt) 86 mg, calcium-2-oxo-3phenylpropionate (α-ketoanalogues to phenylalanine, calcium salt) 68 mg, calcium-3-methyl-2-oxo-valerate (α-ketoanalogues to isoleucine, calcium salt) 67 mg, calcium-DL-2-hydroxy-4 (methylthio) butyrate (α-hydroxyanalogue to methionine, calcium salt) 59 mg, L-lysine-acetate USP 105 mg, L-threonine USP 53 mg, L-histidine USP 38 mg, L-tyrosine USP 30 mg, L-tryptophan USP 23 mg, total nitrogen content 36 mg, calcium 1.25 mmol equivalent to 0.05 g.

Mechanism of Action Pharmacokinetics: The plasma kinetics of amino acids and their integration in metabolic pathways are well established. It should nevertheless be noted that, in uremic patients, the plasma disturbances do not seem to depend on digested amino acid intake, and that the post-absorptive kinetics seems to be distributed very early in the development of the disease. In normal individuals, there is an increase in the plasma level of ketoanalogues, 10 min after oral ingestion. These levels reach values that are approximately 5 times higher than the initial level. Peak levels are reached within 20-60 min and normal levels are reached again after 90 min. Gastrointestinal absorption is thus very rapid. In the plasma a simultaneous increase in levels of the ketoanalogue and the corresponding amino acid show that transamination of the ketoanalogues are very rapid. Due to natural pathways of disposal of α-ketonic acids in the organism, it is probable that exogenous intakes are very rapidly integrated into metabolic cycles. Ketoacids follow the same catabolic pathways as the classical amino acids. No specific study on ketoacid excretion has been performed to date. MIMS Class

Other Drugs Acting on the Genito-Urinary System

ATC Classification

G04BX - Other urologicals ; Used in the treatment of urological problems.

Poison Schedule

Rx

Presentation/Packing FC tab x 100's.

human albumin > Indication & Dosage > Contraindicatio ns > Special Precautions

> Adverse Drug Reactions > Drug Interactions > Lab Interference > Pregnancy Category (US FDA)

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Storage Mechanism of Action MIMS Class ATC Classification

Related Information

See related human albumin informationAbbreviation Index

Indication & Dosage

Intravenous Acute hypovolaemic shock Adult: Initially, 25 g of albumin, adjusted according to patient's response. Usual rates of infusion: Up to 5 ml/minute (5% solution) or 1-2 ml/minute (20% solution). Child: Up to 1 g/kg, adjusted according to patient's response. Usual rates of infusion: Up to 5 ml/minute (5% solution) or 1-2 ml/minute (20% solution). Intravenous Hypoproteinaemia Adult: Up to 2 g/kg daily. Usual rates of infusion: Up to 5 ml/minute (5% solution) or 1-2 ml/minute (20% solution). Intravenous Neonatal hyperbilirubinaemia Child: 1 g/kg of albumin before exchange transfusion. Usual rates of infusion: Up to 5 ml/minute (5% solution) or 1-2 ml/minute (20% solution). Incompatibility: Dilution with water will produce a hypo-osmolar solution that may cause severe haemolysis and renal failure. Y-site : Midazolam, vancomycin, verapamil. ixture: Verapamil.

Contraindications

Cardiac failure, severe anaemia, history of hypersensitivity, parenteral nutrition.

Special Precautions

Hypertension or low cardiac reserve; additional fluids for dehydrated patients. Monitor for signs of cardiac overload in injured or postoperative patients. May carry risk of viral transmission. Volume and rate of infusion must always be individualised according to situation and response. Pregnancy, lactation.

Adverse Drug Reactions

Allergic reactions, nausea, vomiting, increased salivation, fever and chills; vascular overload, haemodilution and pulmonary oedema. Potentially Fatal: Anaphylactic shock.

Drug Interactions

Albumin solution should not be mixed by protein hydrolysates or alcoholic solutions. Risk of atypical reactions to ACE inhibitors in patients undergoing therapeutic plasma exchange with albumin human replacement. Potentially Fatal: Albumin solution should not be mixed by protein hydrolysates or alcoholic solutions. Risk of atypical reactions to ACE inhibitors in patients undergoing therapeutic plasma exchange with albumin human replacement. Click to view more human albumin Drug Interactions

Lab Interference

False elevations of serum alkaline phosphatase concentrations may occur.

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus. Storage

Intravenous: Store below 30°C. Do not freeze.

Mechanism of Action

Human albumin increases intravascular oncotic pressure and causes movement of fluids from interstitial into intravascular space. Human albumin solutions are available in various concentrations. Solutions containing 5% human albumin are usually used in hypovolemic patients, whereas more concentrated 25% solutions are recommended in patients in whom fluid and sodium intake must be minimised e.g. patients with hypoproteinaemia or cerebral oedema or in paediatric patients.

MIMS Class

Intravenous & Other Sterile Solutions

ATC Classification

B05AA01 - albumin ; Belongs to the class of blood substitutes and plasma protein fractions. Used as blood substitutes.

lamivudine > Indication & Dosage > istration > Contraindicatio ns > Special Precautions

> Adverse Drug Reactions > Drug Interactions > Pregnancy Category (US FDA)

Related Information

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Storage Mechanism of Action MIMS Class ATC Classification

See related lamivudine informationAbbreviation Index

Indication & Dosage

Oral HIV infection Adult: 150 mg bid or 300 mg once daily, in combination with other antiretrovirals. Child: 3 mth-12 yr: 4 mg/kg bid. Max: 300 mg/day. Renal impairment: Dialysis patients: Not recommended.

CrCl Dosage Recommendation (ml/min) 30-49

1st dose 150 mg, then 150 mg once daily.

15-29

1st dose 150 mg, then 100 mg once daily.

5-14

1st dose 150 mg, then 50 mg once daily.

<5

1st dose 50 mg, then 25 mg once daily.

Oral Chronic hepatitis B Adult: 100 mg once daily. For patients with concomitant HIV infection: 300 mg once daily or in 2 divide Child: >2 yr: 3 mg/kg once daily. Max: 100 mg/day. Renal impairment: Haemodialysis patients: Dose adjustment in accordance with CrCl. Peritoneal dialy

CrCl Dosage Recommendation (ml/min) 30-49

1st dose 100 mg, then 50 mg once daily.

15-29

1st dose 100 mg, then 25 mg once daily.

5-14

1st dose 35 mg, then 15 mg once daily.

<5

1st dose 35 mg, then 10 mg

once daily.

istration

May be taken with or without food.

Contraindications

Hypersensitivity. Lactation.

Special Precautions

Discontinue use if there is rapid increase in aminotransferase levels, progressive hepatomegaly, or me origin. Discontinue use if clinical signs, symptoms or lab abnormalities suggestive of pancreatitis develo factors for hepatic impairment. Monitor hepatic function in chronic hepatitis B patients. Exclude HIV infe Renal impairment. Pregnancy.

Adverse Drug Reactions

Abdominal pain, nausea, vomiting, diarrhoea, insomnia, cough, nasal symptoms, arthralgia, muscle pai malaise, increased creatinine phosphokinase and alanine aminotransferase, peripheral neuropathy. Ra hepatitis. Neutropenia and anaemia (in combination with zidovudine), thrombocytopenia, increases in L urticaria, and anaphylactoid reaction. Potentially Fatal: Lactic acidosis associated with severe hepatomegaly and hepatic steatosis.

Drug Interactions

Renal excretion may be inhibited by high doses of trimethoprim (co-trimoxazole). May antagonise the a Potentially Fatal: Renal excretion may be inhibited by high doses of trimethoprim (co-trimoxazole). Ma zalcitabine. Click to view more lamivudine Drug Interactions

Pregnancy Category (US FDA)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or emb controlled studies in women or studies in women and animals are not available. Drugs should be given the potential risk to the foetus. Storage

Oral: Store at 25°C (77°F).

Mechanism of Action

Lamivudine, a nucleoside analogue, is phosphorylated in the body to the active triphosphate form. In th virus polymerase and HIV reverse transcriptase enzymes. Absorption: Rapidly absorbed from the GI tract, delayed if taken with food (oral); peak plasma concen Distribution: Crosses the blood-brain barrier and placenta; enters breast milk. Protein-binding: Up to 3 Metabolism: Intracellular; low hepatic metabolism. Excretion: Via urine (as unchanged drug); 5-7 hr (elimination half-life).

MIMS Class

Antivirals

ATC Classification

J05AF05 - lamivudine ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibito viral infections.

Pharmacology Indication

For the treatment of HIV infection and chronic hepatitis B (HBV).

Pharmacodynamics

Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Hum Type 1 (HIV-1) and hepatitis B (HBV). Lamivudine is phosphorylated to active metabolites into viral DNA. They inhibit the HIV reverse transcriptase enzyme competitively and act a synthesis. The lack of a 3'-OH group in the incorporated nucleoside analogue prevents th phosphodiester linkage essential for DNA chain elongation, and therefore, the viral DNA g

Mechanism of action

Lamivudine is a synthetic nucleoside analogue and is phosphorylated intracellularly to its metabolite, lamivudine triphosphate (L-TP). This nucleoside analogue is incorporated into transcriptase and HBV polymerase, resulting in DNA chain termination.