King Tonic

Uses

Ferrous Fumarate is used to prevent or treat iron deficiency anaemia. The prevention of iron deficiency during pregnancy usually requires a combination of iron and folic acid. Iron is usually found in foods and is necessary for the normal development of red blood cells. A lack of iron affects the development of the red blood cells and causes a reduction in the number of red blood cells found in the body (iron deficiency anaemia).

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).

Preventing and treating riboflavin deficiency and conditions related to riboflavin deficiency.

Cataracts, an eye disorder. People who eat more riboflavin as part of their diet seems to have a lower risk of developing cataracts. Also, taking supplements containing riboflavin plus niacin seems to help prevent cataracts.

High amounts of homocysteine in the blood (hyperhomocysteinemia). Some people are unable to convert the chemical homocysteine into the amino acid methionine. People with this condition, especially those with low riboflavin levels, have high amounts of homocysteine in the blood. Taking riboflavin for 12 weeks seems to reduce homocysteine levels by up to 40% in some people with this condition. Also, certain antiseizure drugs can increase homocysteine in the blood. Taking riboflavin along with folic acid and pyridoxine seems to lower homocysteine levels by 26% in people with high homocysteine levels due to antiseizure drugs.

Migraine headaches. Taking high-dose riboflavin (400 mg/day) seems to significantly reduce the number of migraine headache attacks. However, taking riboflavin does not appear to reduce the amount of pain or the amount of time a migraine headache lasts. Also, taking lower doses of riboflavin (200 mg/day) does not seem to reduce the number of migraine headache attacks.

King Tonic is also used to associated treatment for these conditions: Folic acid antagonist overdose, Iron Deficiency (ID), Iron Deficiency Anemia (IDA), Oral ContraceptivesGastrointestinal 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 LiverAriboflavinosis, Beriberi, Constipation, Functional Gastrointestinal Disorders, Joint Pain, Metabolic cardiomyopathy, Migraine, Neuralgia, Peripheral neuritis, Peripheral paralysis, Soreness, Muscle, Vitamin B complex deficiency, Vitamin B1 deficiency, Vitamin Deficiency, Wernicke's encephalopathy, Dietary and Nutritional Therapies, Nutritional supplementation, Vitamin supplementation, Dietary supplementation

How King Tonic works

Iron is necessary for the production of hemoglobin. Iron-deficiency can lead to decreased production of hemoglobin and a microcytic, hypochromic anemia.

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).

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

Dosage

King Tonic dosage

Iron-deficiency anemia:

• Adult: Usual dose range: Up to 600 mg daily. May increase up to 1.2 g daily if necessary.
• Child:Preterm neonate: 0.6-2.4 ml / kg daily; up to 6 yr: 2.5-5 ml bid.

Should be taken on an empty stomach. Best taken on an empty stomach. May be taken with meals to reduce GI discomfort.

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

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin (Vitamin B2) daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: a daily dietary intake of approximately 2.6 mg of riboflavin (Vitamin B2) has been used. A combination of 3 mg of riboflavin (Vitamin B2) plus 40 mg of niacin daily has also been used.

The daily recommended dietary allowances (RDAs) of riboflavin (Vitamin B2) are:

• Infants 0-6 months: 0.3 mg
• Infants 7-12 months: 0.4 mg
• Children 1-3 years: 0.5 mg
• Children 4-8 years: 0.6 mg
• Children 9-13 years: 0.9 mg
• Men 14 years or older: 1.3 mg
• Women 14-18 years: 1 mg
• Women over 18 years: 1.1 mg
• Pregnant women: 1.4 mg
• Breastfeeding women: 1.6 mg

Side Effects

Like all medicines, Ferrous Fumarate Tablets can sometimes cause side effects, although not everybody gets them. They might be:

• Heartburn
• Feeling sick or being sick
• Diarrhoea or constipation.

Also, you might find your stools are darker in color after you have taken this medicine. This is quite commonly seen with all iron preparations and is normal.

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Riboflavin may cause your urine to turn a yellow-orange color, but this is usually not a harmful side effect.

Toxicity

Acute iron overdosage can be divided into four stages. In the first stage, which occurs up to six hours after ingestion, the principal symptoms are vomiting and diarrhea. Other symptoms include hypotension, tachycardia and CNS depression ranging from lethargy to coma. The second phase may occur at 6-24 hours after ingestion and is characterized by a temporary remission. In the third phase, gastrointestinal symptoms recur accompanied by shock, metabolic acidosis, coma, hepatic necrosis and jaundice, hypoglycemia, renal failure and pulmonary edema. The fourth phase may occur several weeks after ingestion and is characterized by gastrointestinal obstruction and liver damage. In a young child, 75 milligrams per kilogram is considered extremely dangerous. A dose of 30 milligrams per kilogram can lead to symptoms of toxicity. Estimates of a lethal dosage range from 180 milligrams per kilogram and upwards. A peak serum iron concentration of five micrograms or more per ml is associated with moderate to severe poisoning in many.

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

Precaution

Patients with intestinal strictures and diverticular disease. May worsen diarrhoea in patients with inflammatory bowel disease. May cause constipation and faecal impaction in elderly. Avoid prolonged admin (>6 mth) except in patients with continued bleeding, menorrhagia or repeated pregnancies. Not for routine use in treatment of haemolytic anaemia unless an iron-deficient state exists. Parenteral iron should not be used concurrently with oral iron treatment. Avoid use in patients receiving repeated blood tranfusions. 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

Oral absorption of iron may be increased when taken with ascorbic acid. May reduce the absorption of quinolones and tetracyclines when taken concurrently via the oral route. Concurrent admin with antacids may reduce the absorption of ferrous fumarate from the GI tract. May reduce the absorption of penicillamine in the gut when taken concurrently.

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.

Rate and extent of absorption may be affected by propantheline bromide.

Volume of Distribution

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

The efficiency of absorption depends on the salt form, the amount administered, the dosing regimen and the size of iron stores. Subjects with normal iron stores absorb 10% to 35% of an iron dose. Those who are iron deficient may absorb up to 95% of an iron dose.

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.

Vitamin B2 is readily absorbed from the upper gastrointestinal tract.

Half Life

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

66-84 minutes

Elimination Route

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

Pregnancy & Breastfeeding use

Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category

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.

Riboflavin is LIKELY SAFE for pregnant or breast-feeding women when taken in the amounts recommended. The recommended amounts are 1.4 mg per day for pregnant women and 1.6 mg per day in breast-feeding women. Riboflavin is POSSIBLY SAFE when taken by mouth in larger doses, short-term. Some research shows that riboflavin is safe when taken at a dose of 15 mg once every 2 weeks for 10 weeks.

Contraindication

Patients with a known hypersensitivity to any of the ingredients. Hemochroma

Acute Overdose

Symptoms: Nausea, vomiting, abdominal pain, diarrhoea, haematemesis and rectal bleeding. Hypotension, coma and hepatocellular necrosis may occur later.

Treatment: Empty stomach contents by gastric lavage within 1 hr of ingestion. In severe toxicity, IV desferrioxamine may be given. Whole bowel irrigation may also be considered in severe poisoning.

Storage Condition

Store at 15-30° C.

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