Steadfast Medishield Pvt. Ltd

Description :
Renostead is a combination of N-Acetylcysteine and Taurine that acts synergistically to attenuate glomerular damage and microalbuminaria in diabetic kidney disease patients.
N- Acetylcysteine
N-Acetylcysteine (also known as N-acetyl-L-cysteine or NAC) is a derivative of cysteine with an acetyl group attached to the amino group of cysteine. NAC is essentially a prodrug that is converted to cysteine (in the intestine by the enzyme aminoacylase) and absorbed in the intestine into the blood stream. Cysteine is a key constituent to glutathione and hence administration of acetylcysteine replenishes glutathione stores.
Taurine
Taurine is a type of conditionally essential amino acid found throughout the body. It is particularly concentrated in the brain, eyes, heart and muscles. It comprises of over 50% of the total free amino acid pool of the heart. Taurine plays role in several biological processes in the kidney and helps in improving renal blood flow and endothelial cell function. Taurine has been shown to play a role in four different forms of kidney disease: glomerulonephritis, diabetic nephropathy, chronic renal failure, and acute kidney injury
Studies have shown that glomerular damage in diabetes can be prevented or at least attenuated by supplementation with Taurine and N-Acetylcysteine. Also Taurine in combination with
N-Acetylcysteine was useful in attenuating urinary albumin to creatinine ratio and sTGF-β1 levels in microalbuminuric type 2 diabetic patients. The benefits of taurine therapy on kidney function and blood pressure are noteworthy and may be useful in preventing the deterioration of microalbuminuria in diabetic kidney disease patients.
Composition
Each tablet of Renostead contains N-Acetylcysteine 150mg and Taurine 500mg.
Indications
Renostead should be used as an adjunct therapy in treating following conditions:
1. Diabetic Nephropathy
2. Tubulointerstitial damage
3. Mitochondrial dysfunction
4. Inflammatory Glomerular Injury
5. Chronic Renal Failure
Dosage & Administration
The optimal daily dose of Renostead is 1 tablet twice daily after meals.
Storage : Keep in dry place at a temperature not exceeding 30°C. Protect from light .
Presentation
Renostead is available as 10 tablets in a strip and 10 such strips in a box.

Description :
Tolvaptan is a small, synthetic molecule with an emperical formula and a molecular weight of 448.94.
Tolvaptan belongs to to a new class of medication called “Vaptan” drugs which blocks the action of Vasopressin receptors. Selective vasopressin V2-receptor antagonist.
Composition:
Vaptan is composed of Tolvaptan 15mg tablet. The tablet is a score tablet.
Introduction:
Tolvaptan is the first drug specifically for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). Tolvaptan is a new medication that affects how the kidneys control the concentration of urine.
Taking Tolvaptan will cause to produce a larger amount of more diluted urine.
Tolvaptan has been shown to slow down the growth of kidney cysts in some people with ADPKD.
Tolvaptan helps to protect the function of kidneys and delays the need for a kidney transplant or dialysis. Kidney function would continue to decline, but at a slower rate.
Indications & clinical use:
Tolvaptan is indicated to delay the progression of kidney enlargement in patients with ADPKD. In ADPKD, kidney enlargement reflects renal cyst burden.
Indicated for adults with clinically significant Euvolemic or Hypervolemic Hyponatremia (serum sodium <125 mEq/L or less marked Hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure, cirrhosis & SIADH.
Mechanism of Action:
Vaptan (Tolvaptan) is a selective vasopressin V2-receptor antagonist with an affinity for the V2-receptor that is 1.8 times that of native arginine vasopressin (AVP). When taken orally, Tolvaptan inhibits the binding of Vasopressin at the V2 receptor in the kidney. The decreased binding of Vasopressin to the V2 receptor lowers adenylate cyclase activity resulting in a decrease in intracellular adenosine 3’, 5’-cyclic monophosphate (cAMP) concentrations.
Dosage & Administration: ADPKD (As advised by Physician)
Vaptan treatment should be initiated and monitored by a physician experienced in the diagnosis and treatment of polycystic kidney disease.
Vaptan should be administered twice daily in split Tolvaptan dose regimens of:
45+15 mg 60+30 mg 90+30 mg
According to the split dose regimen, the total daily Tolvaptan doses are 60, 90 and 120mg respectively. Prior to initiating therapy, restrict overnight fluid intake for 10 to 14 hours to assess ability to concentrate urine using urine osmolality or specific gravity.
However, as per the international trials the recommended doses are between 60 – 120 mg but recent studies suggest to initiate at 15mg (morning) plus 15mg (evening) or
30 mg (morning) plus 15 mg (evening) to avoid discontinuation and tolerable titration.
Titrate every 1-4 weeks to 90mg (morning) plus 30mg (evening) daily or maximum tolerated dose.
Dosage & Administration: Hyponatremia (As advised by Physician) Initial:
15mg PO q Day
Maintenance: May increase to 30 mg qday after at least 24 hr to achieve the optimal serum sodium level, not to exceed 60mg/day
Not to exceed 30 days of treatment.
Pharmacodynamics/Kinetics:
Onset of Action- 2 to 4 hours
Peak effect- 4 to 8 hours
Duration- 60% peak serum sodium elevation is retained at 24 hours; urinary excretion of free water is no longer elevated.
Distribution- Vd: 3L/Kg
Protein Binding- 99%
Metabolism- Hepatic via CYP3A4
Bioavailability- ~40%
Half Life elimination- ~12 hours; dominant half life <12 hours
Time to peak, plasma- 2 to 4 hours
Excretion- Faeces (19% as unchanged drug)

Description:

APLAZAR contains all amino acids essential for uremic patients, five out of them are keto or hydroxyanalogue in the form of calcium salts. Therefore it allows reduction in the nitrogen supply and provides calcium. It is a medication for the treatment of chronic kidney disease patients on Conservative management therapy (CKD stage I, II, III). In combination with very low protein diet / low protein diet, it helps in delaying the progression of kidney disease in the Predialysis period.

Composition

One film-coated tablet contains:

        Calcium-3-methyl-2-oxovalerate (α-ketoanalogue of isoleucine,Calcium salt)67 mg

        Calcium-4-methyl-2-oxovalerate (α-ketoanalogue of leucine,Calcium-salt)101 mg

    101 mg Calcium-2-oxo-3-phenylpropionate (α-ketoanalogue of phenylalanine,Calcium-salt) 68 mg

    Calcium-3-methyl-2-oxobutyrate (α-ketoanalogue of valine,Calcium-salt) 86 mg

    Calcium-DL-2-hydroxy-4-(methylthio)-butyrate α-hydro xyanalogue of methionine,Calcium salt)59mg

    L-lysine 75 mg

    L-threonine 53 mg

    L-tryptophan 23 mg

    L-histidine 38 mg

    L-tyrosine 30 mg

Indications:

Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40 g per day (for adults) and less; i.e. generally in patients with a glomerular filtration rate (GFR) below 25 ml/min.

Contraindications:

Hypercalcemia, disturbed amino acid metabolism. In case of hereditary phenylketonurie it has to be taken into account that this product contains phenylalanine.

Precautions and Warnings:

No experience has been made so far with the application in pregnancy and pediatrics. APLAZAR should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly.

Undesirable effects:

Hypercalcemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcaemia persists, reduce the dosage of APLAZAR as well as any other source of calcium.

Drug Interactions:

Simultaneous administration of medicinal products that contain calcium (e.g. acetolyte) may trigger, or worsen, a pathological increase in the serum calcium level.

As the uremic symptoms improve under therapy with APLAZAR tablets, the dose of aluminum hydroxide administered should be reduced.

Dosage and Administration:

In general, unless prescribed otherwise, four to eight tablets are swallowed whole three times daily during meals. This dosage applies to adults (70 kg bodyweight) (1 tablet/5 kg body weight/day).

Storage

    Do not use APLAZAR after expiry date

    Keep out of the reach of children

    Do not store above 25°C

    Protect from moisture

Presentation:

APLAZAR is available as tablets in a blister of 10 tablets and 10 such blisters in a box

Description :
Valganciclovir hydrochloride (C₁₄H₂₂N₆O₄.Hcl; MWt=390.83) is the Hcl salt of the L-valyl ester of Ganciclovir, which is a synthetic 2′-deoxy-guanosine analogue used for the prevention and treatment of cytomegalovirus (CMV) infections in immunocompromised or immunosuppressed patients. Valganciclovir is the pro-drug for Ganciclovir. After oral administration, it is rapidly converted to Ganciclovir by intestinal and hepatic esterases.
Pharmacology:
Following oral administration, Valganciclovir is rapidly hydrolysed to Ganciclovir by esterases in the intestinal and hepatic cells.
Absolute oral bioavailability is approximately 60%. When taken with food, a 900 mg dose of Valganciclovir is essentially equivalent to an IV Ganciclovir dose of 5 mg/kg. High fat food significantly increases the bioavailability and the peak serum level.
The time to maximum serum concentration (Cmax) is approximately 2 hours. The Cmax following the administration of 900 mg of Valganciclovir to adult patients with normal renal function is 5.6 and the serum level at 12 hours after the dose is about 1 µg/mL. In vitro, CMV resistance is defined as an IC50³1.5 µg/mL.
The plasma protein binding of Ganciclovir is 2% and its volume of distribution is approximately 0.7 L/kg. Liver transplant recipients attained similar exposures to Ganciclovir following the administration of 900 mg of Valganciclovir and 5 mg/kg IV Ganciclovir (42 vs 48 µg.hr/mL).
Valganciclovir is eliminated as Ganciclovir in the urine via glomerular filtration and active tubular secretion. The renal clearance of Ganciclovir is approximately 3 mL/min/kg.
The elimination half-life of Ganciclovir is about 4 hrs in patients with a creatinine clearance (ClCr) >75 mL/min and approximately 24 hrs in patients with CLcr between 10 and 20 mL/min.
Indications And Usage
Adult Patients:

For the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS).

For the prevention of CMV disease in kidney, heart and kidney-pancreas transplant patients at high risk.

Pediatric Patients:
For the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk.
Dosage And Administration:
VALSTEAD tablets should be taken with food.
Dosage Recommendations for Adult Patients with Impaired Renal Function
Contraindications
Hypersensitivity to Valganciclovir or Ganciclovir
Valganciclovir is contraindicated in patients with:
Absolute neutrophil count < 500 cells/µL.
Platelet count < 25,000 platelets/µL.
Hemoglobin concentration < 8 grams/dL.
Drug Interactions

Zidovudine: Potential to cause neutropenia and anaemia. Monitor with frequent tests of white blood cell counts with differential and haemoglobin levels.

Probenecid: May increase Ganciclovir levels. Monitor for evidence of Ganciclovir toxicity.

Mycophenolate Mofetil (MMF): May increase Ganciclovir concentrations and levels of MMF metabolites in patients with renal impairment. Monitor for Ganciclovir and MMF toxicity.

Didanosine: May increase didanosine concentrations. Monitor for didanosine toxicity.

Use In Specific Populations
Lactation: Breastfeeding is not recommended with use of VALSTEAD.
Presentation
Valstead is available in pink colored, oblong tablet of Vaganciclovir 450 mg.
2 such tablets are packed in a blister strip and 15 strips in a carton.

Description
APLAZAR contains all amino acids essential for uremic patients, five out of them are keto or hydroxyanalogue in the form of calcium salts. Therefore it allows reduction in the nitrogen supply and provides calcium. It is a medication for the treatment of chronic kidney disease patients on Conservative management therapy (CKD stage I, II, III). In combination with very low protein diet / low protein diet, it helps in delaying the progression of kidney disease in the Predialysis period.
Composition
One film-coated tablet contains:

Calcium-3-methyl-2-oxovalerate (α-ketoanalogue of isoleucine,Calcium salt)67 mg

Calcium-4-methyl-2-oxovalerate (α-ketoanalogue of leucine,Calcium-salt)101 mg

101 mg Calcium-2-oxo-3-phenylpropionate (α-ketoanalogue of phenylalanine,Calcium-salt) 68 mg

Calcium-3-methyl-2-oxobutyrate (α-ketoanalogue of valine,Calcium-salt) 86 mg

Calcium-DL-2-hydroxy-4-(methylthio)-butyrate α-hydro xyanalogue of methionine,Calcium salt)59mg

L-lysine 75 mg

L-threonine 53 mg

L-tryptophan 23 mg

L-histidine 38 mg

L-tyrosine 30 mg

Indications
Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40 g per day (for adults) and less; i.e. generally in patients with a glomerular filtration rate (GFR) below 25 ml/min.
Contraindications
Hypercalcemia, disturbed amino acid metabolism. In case of hereditary phenylketonurie it has to be taken into account that this product contains phenylalanine.
Precautions and Warnings
No experience has been made so far with the application in pregnancy and pediatrics. APLAZAR should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly. An adequate supply of calories should be ensured.
Undesirable effects
Hypercalcemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcaemia persists, reduce the dosage of APLAZAR as well as any other source of calcium.
Drug Interactions
Simultaneous administration of medicinal products that contain calcium (e.g. acetolyte) may trigger, or worsen, a pathological increase in the serum calcium level.
As the uremic symptoms improve under therapy with APLAZAR tablets, the dose of aluminum hydroxide administered should be reduced, as appropriate. The patient should be monitored for reduced levels of serum phosphate.
In order not to interfere with absorption, an appropriate interval should be observed between administration of APLAZAR tablets and medicinal products which form poorly soluble compounds with calcium (e.g. tetracyclines, quinolones such as ciprofloxacin and norfloxacin, preparations that contain iron, fluoride and estramustin). An interval of at least 2 hours should be observed between the intake of APLAZAR tablets and such preparations.
If administration of APLAZAR tablets leads to increased blood levels of calcium, the sensitivity to medicinal products which increase heart action (cardiac glycosides) and thus also the risk of cardiac arrhythmia is increased

Description:
Mystead is mycophenolate mofetil, which is chemically the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Pharmacology:
Mechanism of action:
Mycophenolate Mofetil is a morpholinoethyl ester prodrug of the immunosuppressant mycophenolic acid (MPA), a fermentation product of several Penicillium species. The mechanism of action of MPA is based on interference with purine synthesis. It is a reversible, noncompetitive inhibitor of inosine monophosphate dehydrogenase (IMPDH) which is an enzyme that facilitates the conversion of inosine monophosphate (IMP) to xanthosine monophosphate, a precursor of guanine nucleotides.This blocks the de novo synthesis of guanosine nucleotides which are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathways, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine.
Pharmacokinetics
Mycophenolate Mofetil is rapidly absorbed after oral administration and converted to the active metabolite, MPA. MPA is then further metabolized to MPA glucuronide (MPAG), which is pharmacologically inactive.
Bioavailability:
The mean relative bioavailability of MPA is 94% for oral administration. The maximum plasma concentration (Cmax) occurs approximately 2 hours after oral administration. Observed secondary peaks in plasma levels are due to the enterohepatic circulation of the drug.
Absorption:
Food has no effect on the extent of absorption (MPA AUC) of Mycophenolate Mofetil when administered at doses of 1.5 g BID to renal transplant patients. However MPA Cmax was lowered by 40% in the presence of food. MPA binds to plasma albumin in a concentration dependent manner. MPA binding is not altered by the common immunosuppressive medications, including cyclosporine, prednisone, and tacrolimus, or other common medications, including warfarin, digoxin, and phenytoin. MPA is minimally bound to plasma lipoproteins in a concentration – independent manner.
Metabolism:
MPA is converted to MPAG and three additional inactive metabolites, N-(2-carboxymethyl)-morpholine, N-(2-hydroxyethyl)-morpholine, and the N-oxide of N-(2-hydroxyethyl)-morpholine. Alcoholic cirrhosis does not appear to appreciably alter the hepatic metabolism of MPA to MPAG.
Excretion:
MPA is eliminated primarily by the kidneys, with more than 90% of the dose excreted in the urine as MPAG.
Drug interactions
Drugs which are eliminated by renal tubular secretion (e.g. aciclovir, ganciclovir) have the potential to inhibit the elimination of MPAG through competition for renal tubular secretion.Agents that interfere with enterohepatic recycling (e.g. bile acid sequestrants, antibiotics) may reduce the amount of mycophenolic acid available for reabsorption. In healthy volunteers concomitant administration of single doses of Mycophenolate Mofetil and aciclovir resulted in a significantly higher AUC of MPAG than when Mycophenolate Mofetil was given alone.Co administration of Mycophenolate Mofetil and cholestyramine resulted in a 40% decrease in the AUC of mycophenolic acid. Administration of a single dose of Mycophenolate Mofetil 2 g to patients with rheumatoid arthritis who were receiving an aluminum hydroxide / magnesium hydroxide antacid resulted in reductions on the AUC24 (33%) and Cmax (17%) of mycophenolic acid compared with administration of Mycophenolate Mofetil alone.Single and/or multiple dose studies have reported no pharmacokinetic interaction between Mycophenolate Mofetil and ganciclovir, cotrimoxazole, oral contraceptives or cyclosporine.

Description:
My360 is an enteric formulation of Mycophenolate sodium that delivers the active moiety Mycophenolic acid (MPA). My360 is an immunosuppressant agent. MPA is chemically designated as(E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C17H19O6 Na and molecular weight is 342.32.

Composition:

Each film-coated tablet contains enteric coated Mycophenolate Sodium 360 mg.

Mode of Action
The mechanism of action of MPA is based on interference with purine synthesis. It is a reversible, noncompetitive inhibitor of inosine monophosphate dehydrogenase (IMPDH), which is an enzyme that facilitates the conversion of inosine monophosphate (IMP) to xanthosine monophosphate, a precursor of guanine nucleotides. This blocks the de novo synthesis of guanosine nucleotides that are necessary substrates for DNA and RNA synthesis. Unlike other cell types which can use the salvage pathways, B and T lymphocytes are dependent upon the de novo pathway for the generation of guanosine. My360 is designed to reduce the adverse GI events of MPA (in particular nausea, vomiting, dyspepsia and abdominal pain).

Pharmacokinetics:
Absorption

My360 is extensively absorbed from the GI tract. The protein binding of Mycophenolic acid glucuronide (MPAG) is 82%. The free MPA concentration may increase under conditions of decreased protein binding (uremia, hepatic failure and hypoalbuminemia). Vitro studies demonstrated that the enteric-coated My360 tablet does not release MPA under acidic conditions (pH <5) as in the stomach, but is highly soluble in neutral pH conditions as in the intestine.

Distribution

Mycophenolic acid is 97% bound to plasma proteins. The mean (± SD) volume of distribution at steady state and elimination phase for MPA is 54 (± 25) L and 112 (± 48) L respectively. MPA is highly protein bound to albumin >98%. The protein binding of Mycophenolic acid glucuronide (MPAG) is 82%. The free MPA concentration may increase under conditions of decreased protein binding (uremia, hepatic failure, and hypoalbuminemia).

Metabolism

Mycophenolate is converted to active MPA, which undergoes enterohepatic recirculation. MPA is metabolised by glucuronidation to the inactive glucuronide.

Excretion

Via urine (as the glucuronide and negligible amounts of MPA); via faeces (about 6% of a dose). Mean half-life of MPA: 17.9 hours (as oral Mycophenolate mofetil) and 16.6 hours (as IV Mycophenolate mofetil); 12 hours (as Mycophenolate sodium).

Indication

Mycophenolate Sodium is indicated for the prophylaxis of organ rejection in patients receiving allogenic renal transplants, administered in combination with Cyclosporine and corticosteroids.

Contraindication

My360 is contraindicated in patients with a hypersensitivity to Mycophenolic acid, Mycophenolate mofetil (MMF) or to any of its excipients.

Precautions

Monitoring: Perform complete blood counts weekly during first month of treatment, twice monthly for second and third months, then monthly throughout the first year.

GI hemorrhage: Since Mycophenolate has been associated with an increased incidence of GI adverse events, including infrequent cases of GI tract ulceration, hemorrhage and perforation.

Delayed renal graft function post transplant: No dose adjustment is recommended for these patients.

Description:

NEFITA is a multi-vitamins formulation specifically designed to suit the nutritional needs of patients of kidney disease and/or on dialysis treatment, as regular multi-vitamins are not suitable for such patients.

Composition:

NEFITA combines various water soluble Vitamins in proportion recommended by NDT.

    Ascorbic Acid I.P. 60 mg

    Niacinamide I.P. 20 mg

    Pyridoxine HCl I.P. 20 mg

    Folic Acid I.P. 10 mg

    Pantothenic Acid 10 mg (As Calcium Pantothenate I.P.)

    Riboflavin I.P. 3 mg

    Thiamine Hydrochloride I.P. 2 mg

    Methylcobalamin 1500 mcg

    Biotin U.S.P. 300 mcg

    Excipients q.s.

Indications:
    In the wasting syndrome in chronic renal failure

    Uremia

    Impaired metabolic functions of the kidney

    To maintain levels when the dietary intake of vitamins is inadequate or excretion and loss are excessive

Side Effects:

When taken as directed, multivitamins are not expected to cause serious side effects. Less serious side effects may include:

    upset stomach

    headache; or

    unusual or unpleasant taste in your mouth

Precautions:

Folic acid may mask the symptoms of pernicious anemia in that hematological remission may occur while neurological manifestations remain progressive.

Dosage and Administration:

Dosage prescribed is one tablet daily or as directed by a physician. If on dialysis, take after treatment. Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Never take more than the recommended dose of a multivitamin. Avoid taking more than one multivitamin product at the same time unless your doctor tells you to. Taking similar vitamin products together can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin. It is important to take multivitamins regularly to get the most benefit.

Overdose:

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Storage:

Store NEFITA at room temperature away from moisture and heat.

Presentation:

NEFITA is available as tablets in a blister of 10 tablets and 10 such blisters in a box.

Description:

The active ingredient in Phoscut is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counter ion. While the counter ions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same.

Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3 diamino-2-

hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water.

Pharmacology:

Patients with CKD retain phosphorus and can develop Hyperphosphatemia. When the product of serum calcium and phosphorus concentrations (Ca*P) surpasses 55 mg/dL, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency.

Management of Hyperphosphatemia includes Diet, Dialysis and use of Phosphate Binders. Sevelamer carbonate taken with meals has been shown to control serum phosphorus concentrations in patients with CKD who are on dialysis.

Mechanism of Action:

Phoscut contains sevelamer carbonate, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the gastrointestinal tract and decreasing absorption, Sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

Drug Interactions:

It may develop drug interaction with the following drug

    Ciprofloxacin

    Digoxin

    Warfarin

    Enalapril

    Metoprolol

    Iron

Overdosage:

Sevelamer hydrochloride, which contains the same active moiety as sevelamer carbonate, has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. In CKD patients on dialysis, the maximum dose studied was 14 grams of sevelamer carbonate and 13 grams of sevelamer hydrochloride. There are no reports of overdosage with sevelamer carbonate or sevelamer hydrochloride in patients.

Contraindications:

Phoscut is contraindicated in patients with bowel obstructions.

Warnings & Precautions:

Serious cases of dysphagia, bowel instruction, and perforation have been associated with Sevelamer use some requiring hospitalization and surgery.

Adverse reactions:

Sevelamer carbonate may cause constipation ,if left untreated it may lead to severe complications. Patients should be cautioned to report new onset or worsening of existing constipation promptly to their physician.

Indication & usage:

Phoscut (Sevelamer Carbonate 400/800 mg) is a phosphate binder indicated in Hyperphosphatemia for the control of serum phosphorus in patients with Chronic Kidney Disease on dialysis.

Dosage & administration:

Patient must take Phoscut three times a day with meals.

Description
Minoxidil (Dilminox) is an orally active peripheral vasodilator. The pure compound is soluble in water to the extent of approximately 2 mg/ml and is readily soluble in propylene glycol or ethanol. Chemically, Minoxidil (Dilminox) is 2.4-diamino-6-piperidino-pyrimidine-3-oxide. The Molecular Weight is 209.25.
Composition
Each uncoated tablet of Dilminox contains Minoxidil I.P. 5 mg
Pharmacology
Minoxidil (Dilminox) selectively relaxes the arteriolar smooth muscle, which reduces peripheral vascular resistance and lowers systemic blood pressure. This is accomplished without a diminution of nutritional flow to body tissues or interference with normal vasomotor reflexes.
Minoxidil (Dilminox) does not directly stimulate the heart or electrolyte reabsorption of the kidney. However, Minoxidil’s (Dilminox) administration elicits a reflex mediated increase in cardiac output, salt and water retention, and a rise in plasma renin activity. These effects are diminished by the simultaneous administration of diuretics and beta-adrenergic blocking agents.
Gastrointestinal absorption is rapid and amounts to at least 95% of the administered dose. Serum levels of the parent drug peak within the first hour. The plasma elimination half-life of Minoxidil (Dilminox) is approximately 4-4.5 hours, but the duration of its hypotensive action may exceed 24 hours. This disparity between blood level and pharmacological effect and the large volume of distribution indicated extensive tissue localization of the drug. However, on chronic treatment, accumulation does not occur and the pharmacological effect is slowly reversible.
With an effective oral dose, blood pressure usually starts to decline within one — half hour, reaches a minimum between 2 and 3 hours and recovers at a rate of approximately 30%/day.
During daily administration, there is a cumulative effect which reaches a steady state after 3 to 7 days. The magnitude of the blood pressure response is related to the extent of the original diastolic elevation above 85 mm Hg and is proportional to the logarithmic function of the dose administered. When the desired diastolic reduction is greater than 30 mm Hg, twice a day dosing is advised to keep the diurnal variation within 10 mm Hg.
Minoxidil does not bind to plasma proteins, enter the central nervous system or accumulate in body tissues. Metabolism is predominantly by glucuronic acid conjugation. Metabolites are excreted principally in the urine and can be removed by hemodialysis in anephric patients. Hemodialysis does not, however, rapidly reverse the pharmacological effect of Minoxidil.
Indications
It is indicated as adjunctive therapy in adults with severe refractory hypertension, which has failed to respond to extensive multiple therapies. When used in combination with an accompanying diuretic and beta-blocker, Minoxidil (Dilminox) has been shown to reverse encephalopathy and retinopathy in severe hypertensives.
Contraindications
Minoxidil (Dilminox) is contraindicated in phaeochromocytoma and pulmonary hypertension secondary to mitral stenosis.
Warnings
If used alone, Minoxidil (Dilminox) can cause a significant retention of salt and water, producing dependent oedema, puffiness of face, eyes or hands, neck vein distention and hepatojugular reflux. Chest X-rays may show evidence of pulmonary vascular engagement.
 

Description :
Calcium is the fifth most abundant element in the body. Calcium is an important structural component of bone and teeth and is also necessary for the normal functioning of all muscles (skeletal, heart and smooth muscles) and nerves as well as the normal clotting of blood. Prolonged, inadequate intake of Calcium causes weak bones. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.
Vapnik contains oyster shell calcium carbonate from organic sources. Calcium carbonate products contain 40% calcium (absorbable calcium). Therefore, a 1250 mg tablet of calcium carbonate provides 500 mg of calcium.
Composition
One film-coated tablet of Vapnik contains 500 mg calcium.
Indications
Vapnik is recommended to bind and remove excessive phosphate and to increase the intake of calcium in individuals whose diets are low in calcium for preventing and treating osteoporosis.
Precautions and Warnings
Avoid taking more doses than recommended.
Missed dose: If you miss a dose, take it as soon as you remember. Do not take it if it is near the time for the next dose. Instead, skip the missed dose and resume your usual dosing schedule. Do not ‘double-up’ the dose to catch up.
Pregnancy: Use of calcium supplements during pregnancy appears to be safe.
Nursing Mothers: Calcium supplements are safe when used by nursing mothers. Do not eat large amounts of bran or wholegrain cereals and breads. They may reduce absorption of calcium. Also, consuming alcohol, large amounts of caffeine and tobacco smoking may affect the absorption of calcium. Do not start or stop any medicine without your doctor’s approval.
Adverse Reactions
Calcium is generally well tolerated. High levels of calcium can cause nausea, vomiting, loss of appetite, constipation, stomach pain, thirst, dry mouth and increased urination. Severe hypercalcemia may cause confusion, delirium, stupor and coma.
Drug Interactions
Calcium may interact with or make it harder for your body to absorb certain drugs especially:

Digoxin

Antacids or other calcium supplement

Calcitriol or vitamin D supplement

 Tetracycline, Demeclocycline, Doxycycline, Minocycline or Oxytetracyclin

To prevent this interaction, doses of quinolone and tetracycline antibiotics should be separated by three or more hours from doses of calcium.
Calcium reduces acidity in the stomach, though there may be a rebound phenomenon which causes a greater than normal amount of acid to be produced after the initial acid-reducing effects of the calcium wears off. The reduction of acid decreases the absorption of iron from the intestine. Therefore, doses of calcium and iron should be separated by several hours.
Dosage and Administration
The usual recommended dose of Vapnik for adults is one tablet thrice a day with meals.
Storage
Store at room temperature, away from light and moisture.
Presentation
Vapnik is available as tablets in a blister of 15 tablets and 10 such blisters are made available in a box.

Description:

Ferric Citrate is known chemically as iron (+3),x(1,2,3-propanetricarboxylic acid,2-hydroxy-),y(H2O). It is used to treat hyperphosphatemia and iron deficiency in CKD patients on haemodialysis or peritoneal dialysis.

Mechanism of Action:

Ferric iron binds dietary phosphate in the GI tract and precipitates as ferric phosphate. This compound is insoluble and is excreted in the stool. By binding phosphate in the GI tract and decreasing absorption, ferric citrate lowers the phosphate concentration in the serum.

Pharmacodynamics:

In addition to the effects on serum phosphorus levels, Ferric Citrate has been shown to increase serum iron parameters, including ferritin, iron and TSAT. In dialysis patients treated with Ferric Citrate in a 52-week study in which IV iron could also be administered, mean (SD) ferritin levels rose from 593 (293) ng/mL to 895 (482) ng/mL, mean (SD) TSAT levels rose from 31% (11) to 39% (17) and mean (SD) iron levels rose from 73 (29) mcg/dL to 88 (42) mcg/dL. In contrast, in patients treated with active control, these parameters remained relatively constant.

Drug Interaction Studies:

Of the drugs screened for an interaction with ferric citrate in vitro, only doxycycline showed the potential for interaction with at least 70% decrease in its concentration. This interaction can be avoided by spacing the administration of doxycycline and ferric citrate.

Indications and Usage:

Ferric Citrate is a phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.

Dosage and Administration:

The recommended starting dose is 2 tablets orally 3 times per day with meals. Serum phosphorus levels should be monitored and the dose of Ferric Citrate titrated in decrements or increments of 1 to 2 tablets per day as needed to maintain serum phosphorus at target levels, up to a maximum dose of 12 tablets daily. Dose can be titrated at 1 week or longer intervals.

Contraindications:

Ferric Citrate is contraindicated in patients with iron overload syndromes.

Warnings and Precautions:
Iron Overload

Iron absorption from Ferric Citrate may lead to excessive elevations in iron stores. Increases in serum ferritin and transferrin saturation (TSAT) levels were observed in clinical trials. In a 56-week safety and efficacy trial in which concomitant use of Ferric Citrate and IV iron was permitted, 55 (19%) of patients treated with Ferric Citrate had a ferritin level >1500 ng/mL as compared with 13 (9%) of patients treated with active control.

Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating Ferric Citrate and

monitor iron parameters while on therapy.Patients receiving IV iron may require a reduction in

dose or discontinuation of IV iron therapy.

Assess iron parameters (e.g., serum ferritin and TSAT) prior to initiating Ferric Citrate and monitor iron parameters while on therapy Patients receiving IV iron may require a reduction in dose or discontinuation of IV iron therapy.

Patients with Gastrointestinal Bleeding or Inflammation:

Safety in patients with inflammatory bowel disease or active symptomatic gastrointestinal bleeding has not been established.