Fefol Vit Spansule Capsule is clear, colorless, opaque white-capped and filled with a mixture of the dark red, orange-yellow, pale yellow and white palette. It is the most valuable iron, vitamins and folic acid supplement by GlaxoSmithKline Private Limited.
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Fefol-Vit Capsule Composition:
Each spansule sustained release capsule contains the following ingredients;
Exsiccated Ferrous Sulphate B.P ...................... 150 mg
Folic Acid B.P .................... 0.5 mg
Aneurine Mononitrate B.P. ................. 2 mg
Riboflavin B.P ....................... 2 mg
Pyridoxine Hydrochloride B.P ....................1 mg
Nicotinamide B.P ........................ 10 mg
Ascorbic Acid B.P ........................ 50 mg
Indications
Prevention of iron deficiency anemia. Fefol Vit Capsules are indicated for iron supplementation, especially suitable during pregnancy and lactation.It is also suitable for use as prophylaxis against iron and folic acid deficiency against menstruating women of childbearing age.
Treatment of Iron Deficiency ANEMIA:
These Spansule Capsules are indicated for the treatment of adults with iron deficiency anemia in conditions such as,
- Nutritional deficiency resulting from qualitative and quantitative dietary inadequacy or dietary restrictions
- Age-related to iron deficiencies in the elderly
- Increased requirements as in pregnant and lactating women
- Following a period of chronic blood loss as in patients with chronic menorrhagia
- Prolonged or recurrent hookworm infestation
- Bleeding peptic ulcer
- Bleeding piles and other conditions characterized by intractable bleeding
Dosage & Administration
Fefol Vit capsules should be taken without chewing with a glass of water and should not be taken with hot liquids. The capsules are to be taken at sufficient intervals from meals because absorption can be reduced by ingredients of food.
Adults:
For Prophylaxis:
One spansule capsule daily.For Treatment:
Two capsules a day. In severe or moderately severe anemia, the dose may be increased by the recommendation of Doctor, Physician or Pharmacist.
Contra-Indications
These capsules are contraindicated in the following conditions;
Hypersensitivity:
If anyone has hypersensitivity to any of its ingredients i.e, ferrous sulfate, vitamin b6, folic, etc. Consult your doctor before using it.
Anemia other than Iron Deficiency
Fefol vit capsules are contraindicated in all forms of anemia which are not associated with;
- Iron deficiency (e.g, megaloblastic associated with vitamin b12 deficiency)
- Iron Overload (hemochromatosis, chronic hemolysis, frequent transfusion)
- Problems with the incorporation of iron (sickle cell anemia, anemia associated with lead poisoning, thalassemia, porphyria cutanea tarda)
- Confirmed iron intolerance (e.g, severe inflammatory changes of the gastrointestinal tract)
- Severe hepatic and renal dysfunction.
- Pediatric use
Warnings & Precautions
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- Care should be taken when administering oral iron products to patients with active gastrointestinal inflammation.
- Tooth discoloration may occur during therapy with ferrous-containing drugs
- Benzidine or similar tests for the detection of fecal occult blood may yield false positives.
- The product must be discontinued 3 days prior to the planned performance of this test.
- Oral and parenteral iron therapy should be used together.
In cases of delayed gastric emptying, pyloric stenosis and confirmed intestinal diverticulosis, liquids rather than the solid formation of iron should be administered.
Interactions
Intravenous administration of iron salts, Doxycycline, Tetracyclines, Cholestyramine, Penicillamine, gold compounds, and dietary phosphates, salicylates, phenylbutazone and oxyphenbutazone, chloramphenicol, calcium antacids, calcium compounds, iron complexing agents (such as oxalates, phytates, phosphates, and magnesium trisilicate, trientine and zinc salts), bisphosphonates, fluoroquinolones, levodopa, carbidopa and methyldopa, thyroid hormones, non-steroidal anti-inflammatory agents.
Administration of iron salts with food may impair the absorption of iron. The concurrent intake of products with a high content of vegetable constituents, phosphates, and tannins limits the absorption of iron, while fish and food with a high content of vitamin c (Ascorbic Acid) and fruit acids have the opposite effects.
Fefol Vit Capsules in Pregnancy & Lactation
These are indicated for the treatment of iron deficiency anemia of pregnancy. Fefol vit should be used during the first trimester of pregnancy. Prophylaxis of iron and folate deficiency where inadequate diet calls for supplementary vitamin B and C is justified during the remainder of the pregnancy.
Adverse Reactions
Common:
feces discolored.Uncommon:
abdominal bloating, abdominal pain, constipation, diarrhea and nausea,
Not Known:
Vomiting, tooth discoloration, heartburn, anorexia, hypersensitivity reactions of the skin, e.g; exanthema, rash, and urticaria.
Very Rare:
dermatitis allergic.
Overdosage:
Symptoms of intoxication may appear after dosages are small as 20mg of iron per kilogram body weight. The appearance of serious toxic effects must be anticipated for dosages from 60mg of iron per kilogram body weight or more.
Intoxication by dosages of 200mg to 400mg of iron per kilogram body weight results in death when left untreated.
A dose as small as 400mg of iron can lead to life-threatening states in infants.
Symptoms and Signs of Overdosage:
Iron poisoning can show several phases. During the first phase about 30 minutes to 5 hours following oral administration. symptoms such as restlessness, stomachache, nausea, vomiting, and diarrhea are observed.
The feces show a tarry coloration. The vomit can contain blood. Shock, convulsions, metabolic acidosis and coma can develop. This is often followed by a phase of apparent recovery that may last up to 24 hours.
Then diarrhea, shock, and acidosis reappear. Death can occur after convulsions, Cheynye-Stokes breathing, coma, and pulmonary edema.
Delayed effects of acute poisoning may appear from 2 to 6 weeks after overdosing with intestinal obstruction, pyloric stenosis and extensive scarring of the acid overdose.
Treatment:
The treatment of mild and moderate poisoning is based on the induction of emesis. It should be borne in mind that perforation may occur in patients in whom the gastric wall is already damaged.
Furthermore, the ingestion of raw eggs and milk results in the formation of compounds with ferrous ions and therefore, this decreases absorption.
In severe cases of poisoning, particularly if the serum iron concentration exceeds the total iron-binding capacity, desferrioxamine, an iron-chelating agent should be administered orally or parenterally as a specific antidote. Dimercaprol is contraindicated because of the formation of toxic compounds.
