Ferlin Syrup/Ferlin Drops

Ferlin Syrup/Ferlin Drops

Manufacturer:

Amherst Lab

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Iron, vitamin B-complex.
Description
Ferlin Drops Syrup (Oral drops): Each mL contains: Iron, elemental (as Ferrous Sulfate, 76.64 mg) 15 mg, Thiamine HCl (Vitamin B1) 10 mg, Pyridoxine HCl (Vitamin B6) 5 mg, Cyanocobalamin (Vitamin B12) 25 mcg, Folic Acid 10 mcg.
Ferlin Syrup: Each 5 mL (1 teaspoonful) contains: Iron, elemental (as Ferrous Sulfate, 149.34 mg) 30 mg, Thiamine HCl (Vitamin B1) 10 mg, Pyridoxine HCl (Vitamin B6) 10 mg, Cyanocobalamin (Vitamin B12) 50 mcg.
Action
Hematinic.
Pharmacology: Iron is an essential constituent of the body necessary for hemoglobin formation and for processes in living tissues involving oxygen. Administration of iron corrects erythropoietic abnormalities due to iron deficiency. Iron does not stimulate erythropoiesis in the absence of iron deficiency.
The vitamin B complex group functions as coenzymes for various metabolic and biochemical reactions. Thiamine is converted to thiamine pyrophosphate (TPP), a coenzyme needed for oxidation of carbohydrate. Pyridoxine hydrochloride is converted to pyridoxal phosphate, a coenzyme required in the metabolism of amino acids. Cyanocobalamin is converted to methylcobalamin and 5-deoxyadenosylcobalamin essential for carbohydrate and fat metabolism. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis.
Pharmacokinetics: Iron is irregularly and incompletely absorbed from the gastrointestinal tract, the main sites 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 effected 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 the body stores are overloaded.
Ferrous iron passes through the gastrointestinal mucosa directly into the blood and is immediately bound to transferrin. Transferrin transports iron to the bone marrow where it is incorporated into hemoglobin.
Most of the iron liberated by destruction of hemoglobin is conserved and reused by the body. Iron excretion occurs primarily as desquamation of cells such as skin, GI mucosa, nails and hair; only trace amounts of iron are excreted in the bile and sweat.
The B complex vitamins are generally readily absorbed from the gastrointestinal tract. They are also widely distributed in the body tissues. Excretion is through the urine as metabolites or in the original form.
Indications/Uses
For the prevention and treatment of iron deficiency anemia in infants and children.
Dosage/Direction for Use
(Note: Dose is based on elemental iron.)
Syrup (Oral Drops): Supplemental (Prophylactic) Dose: Term infants: 1 mg/kg body weight per day up to a maximum of 15 mg/day.
To start no later than 4 months of age and to continue at least through the remainder of the 1st year of life.
Preterm infants: 2 mg/kg body weight per day up to maximum of 15 mg/day.
To start no later than 2 months of age and to continue at least through the remainder of the first year of life.
Therapeutic Dose: 3 mg/kg body weight per day in 3 to 4 divided doses.
Duration of treatment depends on the cause and severity of iron deficiency but in general, approximately 4 to 6 months of oral iron therapy is required to reverse uncomplicated iron deficiency anemia.
Syrup: Supplemental Dose: Equivalent to RDA: 10 to 15 mg daily.
Therapeutic Dose: 3 mg/kg body weight per day in 3 to 4 divided doses.
Duration of treatment depends on the cause of the severity of iron deficiency but in general, approximately 4 to 6 months of oral iron therapy is required to reverse uncomplicated iron deficiency anemia. (See table.)

Click on icon to see table/diagram/image
Contraindications
Primary hemochromatosis, peptic ulcer, regional enteritis or ulcerative colitis.
Special Precautions
Do not use iron to treat hemolytic anemias unless an iron deficient state also exists. Do not administer therapeutic iron doses longer than six months except under the supervision of a physician. Do not administer parenteral iron together with oral iron to avoid iron overload. Do not administer iron to patients receiving repeated blood transfusions, since there is considerable amount of iron in the hemoglobin of transfused erythrocytes. Folic acid should be administered with caution to patients with undiagnosed anemia since it may obscure the diagnosis of pernicious anemia resulting to progression of neurologic complications.
Adverse Reactions
Orally administered iron, due to its astringent action, produces gastrointestinal irritation and abdominal pain with nausea and vomiting. These irritant side effects are usually related to the amount of elemental iron taken rather than the type of preparation. Other effects may include either diarrhea or constipation. Side effects may be reduced by administration with or after food or by starting therapy with a small dose and increasing gradually.
May cause temporary staining of teeth. Stools may appear darker in color.
Prolonged folic acid therapy may cause a decrease in vitamin B12 serum concentration.
Drug Interactions
Concurrent administration of antacids with oral iron may decrease iron absorption. When taken concomitantly, absorption of both iron salts and tetracyclines is diminished. Responses to iron may be delayed when receiving concomitant chloramphenicol therapy. Iron salts have also been reported to decrease absorption and thus reduce the bioavailability and clinical effect of levodopa with carbidopa, methyldopa, penicillamine, and some quinolones (ciprofloxacin, norfloxacin, ofloxacin). Oral iron preparations should not be ingested concomitantly with or within 2 hrs of a dose of these medications.
Concurrent administration of chloramphenicol and folic acid in folate-deficient patients may result in the antagonism of the hematopoietic response to folic acid.
Storage
Store at temperatures not exceeding 30°C.
ATC Classification
B03AE10 - various combinations ; Belongs to the class of iron in other combinations. Used in the treatment of anemia.
B03XA - Other antianemic preparations ; Used in the treatment of anemia.
Presentation/Packing
Ferlin Syrup: Syr (bottle) 120 mL.
Ferlin Drops: Oral drops (bottle) 15 mL.
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