Ferrolab 12 Ferrous Fumarate Vitamin and Folic Acid Capsules

FERROLAB-12
Ferrous Fumarate, Vitamin B12 & Folic Acid Capsules

 

“For Medical/Pharmacy Professionals only”

 

DOSAGE FORMS STRENGTH

Oral Dosage Form: Capsules

Strength-

Ferrous Fumarate: 200mg

Vitamin B12: 100mcg

Folic Acid: 1000mcg

 

HISTORY OF ACTIVE INGREDIENTS

Iron (II) fumurate, also known as ferrous fumarate, is the iron (ll) of, occurring as a reddish-powder, used to iron intake.

Vitamin B12 also called cobalamin, is a water-soluble vitamin with a key role in the normal functioning of the brain and for the formation of blood. It is one of the eight. It is normally involved in the metabolism of every of the human body, especially affecting DNA synthesis and regulation, but also synthesis and energy production.

Folic acid is itself not biologically active, but its biological importance is due to tetrahydrofolate and other derivatives after its conversion in the liver.

 

NET CONTENT

Each hard gelatin capsule contains:

Ferrous Fumarate BP 200mg

Vitamin B12 BP 100mcg

Folic Acid BP 1000mcg

Excipients q.s.

Approved colours used in empty capsule shells

 

CLINIICAL PHARMACOLOGY

ATC CODE:

Ferrous Fumarate: BO3AA2

Vitamin B12: B03BA01

Folic Acid: B03BB01

 

PHARAMACODYNAMICS

Ferrous Fumarate supplies iron in ferric form to the body. Ferric is complexed with polymaltose with better absorption. It rapidly supplements iron so that iron deficiency is quietly controlled, thus leading to faster correction of anaemia and replenishment of tissue iron stores. CyanocobaIamin is used to ensure there are adequate levels of Vitamin B12 deficiency. Folic acid is important in aiding rapid cell division and growth.

 

PHARMACOKINETICS

Folic acid is rapidly absorbed, mainly from the proximal part of the small intestine. Iron is irregularly and incompletely absorbed from the gastro-intestinal tract, the main site of absorption being the duodenum and Jejunum. Absorption is aided by the acid secretion of the stomach or by dietary acids, and is more readily affected when the iron is in the ferrous state. Absorption is also increased in conditions of iron deficiency or in the fasting state but is decreased if body stores are overloaded.

 

INDICATION AND USAGE

As an adjuvant therapy in iron deficiency anaemia during pregnancy.

Iron deficiency related anaemia in children and adults.

General fatigue and weakness.

As dietary supplement

 

CONTRA-INDICATION

Contra-indicated in patients with a known hypersensitivity to the product or its ingredients.

 

INTERACTIONS

Antibiotics (e.g., Penicillamine, Chloramphenicol, Quinolones such as Ciprofloxacin/Norfloxacin), Bisphosphonates (e.g., Alendronate), Levodopa, Methyldopa and Levothyroxine.

 

WARNINGS

Iron overload disorder (e.g., hemochromatosis, hemosiderosis), medical history especially of liver problems, stomach/intestinal problems (e.g., ulcer, colitis).

 

PREGNANCY

Ferrolab 12 capsules is suitable for use during pregnancy.

 

LACTATION

Ferrolab 12 capsules is suitable for use during Lactation.

 

KEEP ALL MEDICINES OUT OF THE REACH OF CHILDREN

 

PRECAUTIONS

Iron preparations should be used with caution in patients with erythropoietic protoporphyria.

 

ADVERSE REACTIONS

Constipation, rash, itching, diarrhoea, nausea and vomiting other gastro-intestinal disturbances.

Rarely, folic acid may cause allergic reactions.

 

DRUG ABUSE AND DEPENDENCE

Not applicable.

 

SYMPTOMS OF OVERDOSE AND TREATMENT

Symptoms

Initial symptoms of iron overdosage include nausea, vomting, diarrhoea, abdominal pain, haematemesis, rectal bleeding, lethargy and circulatory collapse. Hyperglycemia and metabolic acidosis may occur. However, if overdosage is suspected, treatment should be implemented immediately. In severe cases, after a latent phase, relapse may occur after 24-48 hours manifested by hypotension, coma, hypothermia, hepatocellular necrosis, renal failure, pulmonary oedema, diffuse vascular congestion, coagulopathy and/or convulsions. In many cases, full recovery may be complicated by long-term effects such as hepatic necrosis, toxic encephalitis, CNS damage and pyloric stenosis.

Treatment

The following steps are recommended to minimise or prevent further absorption of the medication.

Children:
1. Administer an emetic such as syrup of ipecac.

2. Emesis should be followed by gastric lavage with desferrioxamine solution (2g/l). This should then be followed by the installation of desferrioxamine 5g in 50 – 100 ml water, to be retained in the stomach. Inducing diarrhoea in children may be dangerous and should not be undertaken in young children. Keep the patient under constant surveillance to detect possible aspiration of vomitus – maintain suction apparatus and standby emergency oxygen in case of need.

3.Severe poisoning: in the presence of shock and/or coma with high serum iron levels (serum iron > 90umol/l) immediate supportive measure plus IV infusion of desferrioxamine should be administered every hour by slow IV infusion to a maximum 80mg/kg/24 hours.

 

DOSAGE AND ADMINISTRATION

For oral administration

Adults: One capsule daily throughout pregnancy or as directed by a physician.

Children: Not applicable.

Elderly: Not applicable.

 

THE PREPARATION FOR USE

Not Applicable.

 

PRESENTATION

3 x 10 capsule packed in a unit carton along with patient information leaflet

 

STORAGE CONDITION

Store in a cool, dry & dark place.

 

NAFDAC Reg. No.: 04-5887

 

MANUFACTURED IN INDIA BY

LABORATE PHARMACEUTICAL (INDIA)

E-11, IND. AREA, PANIPAT-132103

 

Sole Agent

Embassy Pharmaceuticals and Chemicals Ltd.

Lagos, Nigeria.