Cal-v-con

Cal-v-con Uses, Dosage, Side Effects, Food Interaction and all others data.

vitamin C, the water-soluble vitamin, is readily absorbed from the gastrointestinal tract and is widely distributed in the body tissues. It is believed to be involved in biological oxidations and reductions used in cellular respiration. It is essential for the synthesis of collagen and intracellular material. Vitamin C deficiency develops when the dietary intake is inadequate and when increased demand is not fulfilled. Deficiency leads to the development of well defined syndrome known as scurvy, which is characterized by capillary fragility, bleeding (especially from small blood vessels and the gums), anaemia, cartilage and bone lesions and slow healing of wounds.

Ascorbic Acid (vitamin C) is a water-soluble vitamin indicated for the prevention and treatment of scurvy, as ascorbic acid deficiency results in scurvy. Collagenous structures are primarily affected, and lesions develop in bones and blood vessels. Administration of ascorbic acid completely reverses the symptoms of ascorbic acid deficiency.

Calcium gluconate is used to prevent or treat negative calcium balance. It also helps facilitate nerve and muscle performance as well as normal cardiac function.

Calcium Gluconate is the gluconate salt of calcium. An element or mineral necessary for normal nerve, muscle, and cardiac function, calcium as the gluconate salt helps to maintain calcium balance and prevent bone loss when taken orally. This agent may also be chemopreventive for colon and other cancers.

Calcium glycerophosphate is a Calcium salt of glycerophosphoric acid that forms a white, fine, slightly hygroscopic powder. The commercial product is a mixture of calcium beta-, and D-, and L -alpha-glycerophosphate. By FDA, calcium glycerophosphate is considered a generally recognized as safe (GRAS) food ingredient as a nutrient supplement (source of calcium or phosphorus), or in food products such as gelatins, puddings, and fillings. It is also present in dental or oral hygiene products due to its cariostatic effects. It is suggested that calcium glycerophosphate promotes plaque-pH buffering, elevation of plaque Calcium and phosphate levels and direct interaction with dental mineral .

It is thought that calcium glycerophosphate may act through a variety of mechanisms to produce an anti-caries effect . These include increasing acid-resistance of the enamel, increasing enamel mineralization, modifying plaque, acting as a pH-buffer in plaque, and elevating Calcium and phosphate levels.

When used as an electrolyte replacement, calcium glycerophosphate donates Calcium and inorganic phosphate. Calcium glycerophosphate is preferable to calcium phosphate due to its increased solubility. Compared to combination calcium gluconate and potassium phosphate, calcium glycerophosphate produces greater phosphate retention which allows for increased Calcium retention and ultimately greater incorporation of the ions into bone structure .

Calcium is used to prevent or treat negative calcium balance. It also helps facilitate nerve and muscle performance as well as normal cardiac function. Bone mineral component; cofoactor in enzymatic reactions, essential for neurotransmission, muscle contraction, and many signal transduction pathways.

Both components of calcium lactate, calcium ion and lactic acid, play essential roles in the human body as a skeletal element an energy source, respectively .

An important compound functioning as a component of the coenzyme NAD. Its primary significance is in the prevention and/or cure of blacktongue and pellagra. Most animals cannot manufacture this compound in amounts sufficient to prevent nutritional deficiency and it therefore must be supplemented through dietary intake.

Pyridoxine is a water-soluble vitamin which functions in the metabolism of carbohydrates, proteins and fats. It is essential in Hb formation and GABA synthesis within the CNS. It also aids in the release of glycogen stored in the liver and muscles.

Vitamin B6 (pyridoxine) is a water-soluble vitamin used in the prophylaxis and treatment of vitamin B6 deficiency and peripheral neuropathy in those receiving isoniazid (isonicotinic acid hydrazide, INH). Vitamin B6 has been found to lower systolic and diastolic blood pressure in a small group of subjects with essential hypertension. Hypertension is another risk factor for atherosclerosis and coronary heart disease. Another study showed pyridoxine hydrochloride to inhibit ADP- or epinephrine-induced platelet aggregation and to lower total cholesterol levels and increase HDL-cholesterol levels, again in a small group of subjects. Vitamin B6, in the form of pyridoxal 5'-phosphate, was found to protect vascular endothelial cells in culture from injury by activated platelets. Endothelial injury and dysfunction are critical initiating events in the pathogenesis of atherosclerosis. Human studies have demonstrated that vitamin B6 deficiency affects cellular and humoral responses of the immune system. Vitamin B6 deficiency results in altered lymphocyte differentiation and maturation, reduced delayed-type hypersensitivity (DTH) responses, impaired antibody production, decreased lymphocyte proliferation and decreased interleukin (IL)-2 production, among other immunologic activities.

Trade Name Cal-v-con
Generic Ascorbic Acid + Calcium Gluconate + Calcium Glycerophosphate + Calcium Lactate + Nicotinamide + Pyridoxine + Riboflavin (Vitamin B2) + Thiamine HCl (Vitamin B1)
Weight 100mg, 250mg, 373.3mg, 50mg, 10mg, 15mg
Type Sachet
Therapeutic Class
Manufacturer Helicon Pharmaceutek Pakistan (pvt) Ltd,
Available Country Pakistan
Last Updated: September 19, 2023 at 7:00 am
Cal-v-con
Cal-v-con

Uses

Vitamin C is used for prevention and treatment of scurvy. It may be used for pregnancy, lactation, infection, trauma, burns, cold exposure, following surgery, fever, stress, peptic ulcer, cancer, methaemoglobinaemia and in infants receiving unfortified formulas. It is also prescribed for haematuria, dental caries, pyorrhea, acne, infertility, atherosclerosis, fractures, leg ulcers, hay fever, vascular thrombosis prevention, levodopa toxicity, succinyl-choline toxicity, arsenic toxicity etc. To reduce the risk of stroke in the elderly, long-term supplementation with Vitamin C is essential.

Calcium Gluconate is used for Antidote in severe hypermagnesaemia, Severe hyperkalaemia, Hypocalcaemic tetany, Severe acute hypocalcaemia, Hypocalcaemia and calcium deficiency states

Calcium glycerophosphate is an medication used to treat low levels of phosphate or calcium, as well as an ingredient in dental products to prevent dental caries.

Calcium glycerophosphate is found in OTC dental products such as toothpastes for the prevention of dental caries. As OTC products these do not have an official indication.

In prescription products it is indicated as a Calcium or phosphate donor for replacement or supplementation in patients with insufficient Calcium or phosphate.

Calcium Lactate is used for heartburn, calcium supplement, calcium deficiencies.

Nicotinamide is an ingredient found in a variety of cosmetic products.

Pyridoxine (vitamin B6) is used to prevent or treat low levels of vitamin B6 in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra vitamin B6. However, some conditions (such as alcoholism, liver disease, overactive thyroid, heart failure) or medications (such as isoniazid, cycloserine, hydralazine, penicillamine) can cause low levels of vitamin B6. Vitamin B6 plays an important role in the body. It is needed to maintain the health of nerves, skin, and red blood cells.

Pyridoxine has been used to prevent or treat a certain nerve disorder (peripheral neuropathy) caused by certain medications (such as isoniazid). It has also been used to treat certain hereditary disorders (such as xanthurenic aciduria, hyperoxaluria, homocystinuria).

Cal-v-con is also used to associated treatment for these conditions: Common Cold, Deficiency, Vitamin A, Deficiency, Vitamin D, Fever, Flu caused by Influenza, Folate deficiency, Iron Deficiency (ID), Iron Deficiency Anemia (IDA), Oral bacterial infection, Scurvy, Vitamin C Deficiency, Vitamin Deficiency, Nutritional supplementation, Vitamin supplementationBone and tooth decay, Bone and tooth growth, Calcium Deficiency, Hypocalcemia, Nutritional Rickets, Osteomalacia, Osteoporosis, Otospongiosis, Postmenopausal Osteoporosis, Vitamin D Insufficiency, Vitamin D Resistant RicketsCalcium DeficiencyGastrointestinal insufficiency, Hepatic Insufficiency, Macrocytic anemia, Secondary anemia, Vitamin Deficiency, Severe debilitation, Dietary and Nutritional Therapies, Nutritional supplementation, Dietary supplementationBackache, Dizziness, Fever, Headache, Hepatic; Functional Disturbance, Hepatitis, Iron Deficiency Anemia (IDA), Ketosis, Macrocytic anemia, Menière's Disease, Menstrual Distress (Dysmenorrhea), Metabolic Acidosis, Motion Sickness, Nausea and vomiting, Neuralgia, Sciatic, Neuritis, Neurological Conditions caused by B Vitamin Deficiency, Secondary anemia, Soreness, Muscle, Toothache, Toxinfectious state, Trigeminal Neuralgia (TN), Vitamin B1 deficiency, Vitamin B12 Deficiency, Vitamin B6 Deficiency, Vitamin Deficiency, Minor aches and pains, Minor pain, Nutritional supplementation, Supplementation, Vitamin supplementation, Wellness of the Liver

How Cal-v-con works

In humans, an exogenous source of ascorbic acid is required for collagen formation and tissue repair by acting as a cofactor in the posttranslational formation of 4-hydroxyproline in -Xaa-Pro-Gly- sequences in collagens and other proteins. Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body. These two forms of the vitamin are believed to be important in oxidation-reduction reactions. The vitamin is involved in tyrosine metabolism, conversion of folic acid to folinic acid, carbohydrate metabolism, synthesis of lipids and proteins, iron metabolism, resistance to infections, and cellular respiration.

Calcium is essential for the functional integrity of the nervous, muscular, and skeletal systems. It plays a role in normal cardiac function, renal function, respiration, blood coagulation, and cell membrane and capillary permeability. Also, calcium helps to regulate the release and storage of neurotransmitters and hormones, the uptake and binding of amino acids, absorption of vitamin B 12, and gastrin secretion. The major fraction (99%) of calcium is in the skeletal structure primarily as hydroxyapatite, Ca 10(PO 4) 6(OH) 2; small amounts of calcium carbonate and amorphous calcium phosphates are also present. The calcium of bone is in a constant exchange with the calcium of plasma. Since the metabolic functions of calcium are essential for life, when there is a disturbance in the calcium balance because of dietary deficiency or other causes, the stores of calcium in bone may be depleted to fill the body's more acute needs. Therefore, on a chronic basis, normal mineralization of bone depends on adequate amounts of total body calcium.

Calcium glycerophosphate in combination with sodium monofluorophosphate was found to reduce the acid solubility of enamel. This is thought to be due to increased uptake of fluoride in a non-alkali soluble form at the expense of a fraction remaining in the alkali-soluble form of calcium fluoride . It is also thought that calcium glycerophosphate enhances the remineralization effect of sodium monofluorophosphate leading to greater remineralization of enamel but the mechanism behind this is unknown.

Calcium glycerophosphate reduces the decrease in plaque pH produced by sucrose solutions . This may be due to the buffering action of donated phosphate which acts as an acceptor to three hydrogen ions to form biphosphate, dihydrogen phosphate, and finally phosphoric acid. As bisphosphate and dihydrogen phosphate are amphoteric, these molecules can act as buffers against both acids and bases.

Studies on plaque-modification by calcium glycerophosphate have been inconsistent . Redections in plaque weight and plaque area have been noted in separate studies but neither has been confirmed and no causative link has been established in regards to calcium glycerophosphate's anti-caries effect.

Calcium glycerophosphate donates Calcium and inorganic phosphate resulting in elevated levels of the ions in plaque . These ions are important components of the mineral structure of teeth. As such, their presence supports maintenance of healthy tooth structure and mineralization.

In electrolyte replacement calcium glycerophosphate again acts as a donor of Calcium and phosphate. See Calcium Phosphate for pharmacological descriptions of calcium and phosphate.

In aqueous environments such as the gastrointestinal (GI) tract, calcium lactate will dissociate into calcium cation and lactic acid anions, the conjugate base of lactic acid. Lactic acid is a naturally-occurring compound that serves as fuel or energy in mammals by acting as an ubiquitous intermediate in the metabolic pathways . Lactic acid diffuses through the muscles and is transported to the liver by the bloodstream to participate in gluconeogenesis .

Vitamin B6 is the collective term for a group of three related compounds, pyridoxine (PN), pyridoxal (PL) and pyridoxamine (PM), and their phosphorylated derivatives, pyridoxine 5'-phosphate (PNP), pyridoxal 5'-phosphate (PLP) and pyridoxamine 5'-phosphate (PMP). Although all six of these compounds should technically be referred to as vitamin B6, the term vitamin B6 is commonly used interchangeably with just one of them, pyridoxine. Vitamin B6, principally in its biologically active coenzyme form pyridoxal 5'-phosphate, is involved in a wide range of biochemical reactions, including the metabolism of amino acids and glycogen, the synthesis of nucleic acids, hemogloblin, sphingomyelin and other sphingolipids, and the synthesis of the neurotransmitters serotonin, dopamine, norepinephrine and gamma-aminobutyric acid (GABA).

Dosage

Cal-v-con dosage

vitamin C is usually administered orally. When oral administration is not feasible or when malabsorption is suspected, the drug may be administered IM, IV, or subcutaneously. When given parenterally, utilization of the vitamin reportedly is best after IM administration and that is the preferred parenteral route.

For intravenous injection, dilution into a large volume parenteral such as Normal Saline, Water for Injection, or Glucose is recommended to minimize the adverse reactions associated with intravenous injection.

The average protective dose of vitamin C for adults is 70 to 150 mg daily. In the presence of scurvy, doses of 300 mg to 1 g daily are recommended. However, as much as 6 g has been administered parenterally to normal adults without evidence of toxicity.

To enhance wound healing, doses of 300 to 500 mg daily for a week or ten days both preoperatively and postoperatively are generally considered adequate, although considerably larger amounts have been recommended. In the treatment of burns, doses are governed by the extent of tissue injury. For severe burns, daily doses of 1 to 2 g are recommended. In other conditions in which the need for vitamin C is increased, three to five times the daily optimum allowances appear to be adequate.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

Intravenous: Antidote in severe hypermagnesaemia, Severe hyperkalaemia:

  • Adult: 10 ml of 10% calcium gluconate solution over 2 minutes, repeated every 10 minutes if needed.
  • Child: Neonate and 1 mth-18 yr: 0.5 ml/kg of 10% calcium gluconate solution as a single dose. Max: 20 ml of 10% calcium gluconate solution.

Intravenous: Hypocalcaemic tetany, Severe acute hypocalcaemia:

  • Adult: 2.25 mmol by slow IV inj over 10 minutes, followed by 58-77 ml of 10% calcium gluconate solution in 0.5-1 L of 5% dextrose solution as continuous IV infusion.
  • Child: Neonate and 1 mth-18 yr: 0.5 ml/kg of 10% calcium gluconate solution as a single dose. Max: 20 ml of 10% calcium gluconate solution.

19-50 year: 1,000 mg elemental Calcium Lactate per day.

>50 year: 1,200 mg elemental Calcium Lactate per day.

ADULTS:

BY MOUTH:

  • For hereditary sideroblastic anemia: Initially, 200-600 mg of vitamin B6 is used. The dose is decreased to 30-50 mg per day after an adequate response.
  • For vitamin B6 deficiency: In most adults, the typical dose is 2.5-25 mg daily for three weeks then 1.5-2.5 mg per day thereafter. In women taking birth control pills, the dose is 25-30 mg per day.
  • For abnormally high levels of homocysteine in the blood: For reducing high levels of homocysteine in the blood after childbirth, 50-200 mg of vitamin B6 has been taken alone. Also, 100 mg of vitamin B6 has been taken in combination with 0.5 mg of folic acid.
  • For preventing macular degeneration: 50 mg of vitamin B6 in the form of pyridoxine has been used daily in combination with 1000 mcg of vitamin B12 (cyanocobalamin) 1000 mcg and 2500 mcg of folic acid for about 7 years.
  • For hardening of the arteries (atherosclerosis): A specific supplement (Kyolic, Total Heart Health, Formula 108, Wakunga) containing 250 mg of aged garlic extract, 100 mcg of vitamin B12, 300 mcg of folic acid, 12.5 mg of vitamin B6, and 100 mg of L-argininedaily for 12 months.
  • For kidney stones: 25-500 mg of vitamin B6 has been used daily.
  • For nausea during pregnancy: 10-25 mg of vitamin B6 taken three or four times per day has been used. In people who don't respond to vitamin B6 alone, a combination product containing vitamin B6 and the drug doxylamine (Diclectin, Duchesnay Inc.) is used three or four times per day. Also, another product containing 75 mg of vitamin B6, 12 mcg of vitamin B12, 1 mg of folic acid, and 200 mg of calcium (PremesisRx, KV Pharmaceuticals) is used daily.
  • For symptoms of premenstrual syndrome (PMS): 50-100 mg of vitamin B6 is used daily, alone or along with 200 mg of magnesium.
  • For treating tardive dyskinesia: 100 mg of vitamin B6 per day has been increased weekly up to 400 mg per day, given in two divided doses.

INJECTED INTO THE MUSCLE:

  • Hereditary sideroblastic anemia: 250 mg of vitamin B6 daily, reduced to 250 mg of vitamin B6 weekly once adequate response is achieved.

CHILDREN:

BY MOUTH:

  • For kidney stones: Up to 20 mg/kg daily in children aged 5 years and up.

INJECTED INTO THE VEIN OR MUSCLE:

  • For seizures that respond to vitamin B6 (pyridoxine-dependent seizures): 10-100 mg is recommended.

The daily recommended dietary allowances (RDAs) of vitamin B6 are:

  • Infants 0-6 months, 0.1 mg
  • Infants 7-12 months, 0.3 mg
  • Children 1-3 years, 0.5 mg
  • Children 4-8 years, 0.6 mg
  • Children 9-13 years, 1 mg
  • Males 14-50 years, 1.3 mg
  • Males over 50 years, 1.7 mg
  • Females 14-18 years, 1.2 mg
  • Females 19-50 years, 1.3 mg
  • Females over 50 years, 1.5 mg
  • Pregnant women, 1.9 mg
  • Breast-feeding women, 2 mg
  • Some researchers think the RDA for women 19-50 years should be increased to 1.5-1.7 mg per day.

The recommended maximum daily intake is:

  • Children 1-3 years, 30 mg
  • Children 4-8 years, 40 mg
  • Children 9-13 years, 60 mg

Adults, pregnant and breast-feeding women:

  • 14-18 years, 80 mg
  • over 18 years, 100 mg

Side Effects

Ascorbic acid does not seem to have any important adverse effects at dosages less than 4 mg/day. Larger dose may cause diarrhoea or formation of renal calculi of calcium oxalate in patients with renal impairment. Ingestion of more than 600 mg daily have a diuretic action.

GI irritation; soft-tissue calcification, skin sloughing or necrosis after IM/SC inj. Hypercalcaemia characterised by anorexia, nausea, vomiting, constipation, abdominal pain, muscle weakness, mental disturbances, polydipsia, polyuria, nephrocalcinosis, renal calculi; chalky taste, hot flushes and peripheral vasodilation.

Gl discomfort e.g. nausea, vomiting, constipation; bradycardia, arrhythmias. Dry mouth, increased thirst or increased urination. Mental confusion, milk-alkali syndrome.

Pyridoxine usually has no side effects when used in recommended doses.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Pyridoxine can cause side effects when taken in large doses for a long time. Tell your doctor right away if any of these unlikely but serious side effects occur: headache, nausea, drowsiness, numbness/tingling of arms/legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Toxicity

Infants : LDLo (Intramuscular ) : 10gm/kg ; Effects - Brain and coverings : meningeal changes Infants : TDLo ( Intramuscular ) : 143 mg/kg ; Effects - Dermatits Mouse: LD50 ( intravenous ) : 950mg/kg Mouse : LDLo (Oral ) : 10gm/kg

The LDLo of calcium lactate pentahydrate following intravenous administration in mouse is 140 mg/kg .

Oral Rat LD50 = 4 gm/kg. Toxic effects include convulsions, dyspnea, hypermotility, diarrhea, ataxia and muscle weakness.

Precaution

Ingestion of megadose (more than 1000 mg daily) of vitamin C during pregnancy has resulted in scurvy in neonates. Vitamin C in mega-doses has been contraindicated for patients with hyperoxaluria. Vitamin C itself is a reactive substance in the redox system and can give rise to false positive reactions in certain analytical tests for glucose, uric acid, creatine and occult blood.

Impaired renal function; cardiac disease; hypercalcaemia-associated diseases, e.g. sarcoidosis; other malignancies. Pregnancy.

Sarcoidosis; history of nephrolithiasis. Avoid IV admin of calcium in patients on cardiac glycosides. Increased risk of hypercalcaemia and hypercalciuria in hypoparathyroid patients receiving high doses of vitamin D. Caution when used in patients with history of kidney stones. Patients should be advised to administer vitamin D concurrently to optimise calcium absorption. Pregnancy.

Before taking pyridoxine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

During pregnancy, this vitamin has been found to be safe when used in recommended doses.

This vitamin passes into breast milk and is considered to be safe during breast-feeding when used in recommended doses. Consult your doctor for more information.

Interaction

Potentially hazardous interactions: Ascorbic acid is incompatible in solution with aminophylline, bleomycin, erythromycin, lactobionate, nafcillin, nitrofurantoin sodium, conjugated oestrogen, sodium bicarbonate, sulphafurazole diethanolamine, chloramphenicol sodium succinate, chlorthiazide sodium and hydrocortisone sodium succinate.

Useful interactions: Ascorbic acid increases the apparent half-life of paracetamol and enhances iron absorption from the gastrointestinal tract.

Co-administration of high calcium doses with thiazide diuretics may result in milk-alkali syndrome and hypercalcaemia. May potentiate digoxin toxicity. Decreases effects of calcium-channel blockers. Enhanced absorption with calcitriol (a vitamin D metabolite).

May reduce the efficacy of calcium-channel blockers. Concurrent admin of IV calcium salt with cardiac glycosides may lead to serious adverse events. Increased risk of hypercalcaemia when used with thiazide diuretics. May reduce absorption of tetracycline, alendronate, atenolol, iron, quinolone antibiotics, sodium fluoride and zinc.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this vitamin include: altretamine, cisplatin, phenytoin.

This vitamin may interfere with certain laboratory tests (including urine test for urobilinogen), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this vitamin.

Volume of Distribution

Not available

The majority of calcium absorbed (99%) is stored in the skeleton and teeth for structural integrity .

Pyridoxine main active metabolite, pyridoxal 5’-phosphate, is released into the circulation (accounting for at least 60% of circulating vitamin B6) and is highly protein bound, primarily to albumin.

Elimination Route

70% to 90%

Approximately one-fifth to one-third of orally administered calcium is absorbed in the small intestine, depending on presence of vitamin D metabolites, pH in lumen, and on dietary factors, such as calcium binding to fiber or phytates. Calcium absorption is increased when a calcium deficiency is present or when a patient is on a low-calcium diet. In patients with achlorhydria or hypochlorhydria, calcium absorption, especially with the carbonate salt, may be reduced.

In order to be absorbed, calcium must be in its freely soluble form (Ca2+) or bound to a soluble organic molecule. Calcium absorption mainly occurs at the duodenum and proximal jejunum due to more acidic pH and the abundance of the calcium binding proteins . The mean calcium absorption is about 25% of calcium intake (range is 10 – 40%) in the small intestine, and is mediated by both passive diffusion and active transport .

The B vitamins are readily absorbed from the gastrointestinal tract, except in malabsorption syndromes. Pyridoxine is absorbed mainly in the jejunum. The Cmax of pyridoxine is achieved within 5.5 hours.

Half Life

16 days (3.4 hours in people who have excess levels of vitamin C)

No pharmacokinetic data available.

The total adult body pool consists of 16 to 25 mg of pyridoxine. Its half-life appears to be 15 to 20 days.

Clearance

No pharmacokinetic data available.

Elimination Route

Renal (20%) - The amount excreted in the urine varies with degree of calcium absorption and whether there is excessive bone loss or failure of renal conservation. Fecal (80%) - Consists mainly of nonabsorbed calcium, with only a small amount of endogenous fecal calcium excreted.

Following oral administration to a human volunteer, 20 to 30% of a dose of lactic acid of up to 3000 mg was excreted via the urine during a period of 14 hours .

The major metabolite of pyridoxine, 4-pyridoxic acid, is inactive and is excreted in urine

Pregnancy & Breastfeeding use

The drug is safe in normal doses in pregnant women, but a daily intake of 5 gm or more is reported to have caused abortion. The drug may be taken safely during lactation.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (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 fetus.

Pregnancy Category-C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Category A: Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of foetal harm remains remote.

Contraindication

Patients with calcium renal calculi or history of renal calculi. Conditions associated with hypercalcaemia and hypercalciuria.

Conditions associated with hypercalcaemia and hypercalciuria.

Storage Condition

Should be stored in a dry place below 30˚C.

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