1.

Ferrous Sulfate
Generic Name
ferrous sulfate

Trade Name
Feosol(capsule,tablet )
Fero-Gradumet (525 mg.)
Mol-iron(195 mg)
Slow Fe(160 mg.)
This drug is available in a generic form.

What is ferrous sulfate?

This preparation contains the mineral, iron, which is necessary for the formation and function of red blood cells. It is
these cells that carry oxygen through the blood stream. In tiny amounts, the mineral is also necessary for the
chemical functioning of many of the bodies cells.

What is it used for?

Iron should only be taken for very specific reasons and only under a physicians direction. These reasons are as
follows:

Iron deficiency anemia. Anemia means a low red blood cell count. An anemia may be due to lack of iron in
the diet, blood loss in the intestinal tract or excessive menstrual flow
Pregnancy

Except for these two reasons, do not take iron, even the small amount in a daily vitamin-mineral pill, unless advised
by a physician.

How do I take it?

Follow your physicians instructions carefully. The best absorption occurs when taken on an empty stomach, but
these products may be taken with meals to avoid stomach upset. Keep in a tightly sealed container. Protect this
medication from excess moisture and heat. Do not freeze the elixir. Liquid forms should be diluted and sipped
through a straw into the back of the mouth to prevent tooth discoloration. Keep all medications away from children.
Never share your medications with anyone else.

What do I do for a missed dose?

If you miss a dose of this medicine, take it as soon as possible. If it is almost time for your next dose, skip the
missed dose and return to your regular schedule. Do not double up on this medication.

Are there interactions with food or beverages?

Coffee, tea, eggs and milk may prevent the full absorption of iron. However, absorption is enhanced by vitamin C.
Fiber or bran may also reduce absorption but may be helpful to correct the constipation or diarrhea that iron may
cause. Do not take this medication at the same time as oral calcium supplements.

Are there interactions with other drugs?

An interaction generally means that one drug may increase or decrease the effect of another drug. Also, the more
medications a person takes, the more likely there will be a drug interaction.
Interactions with this drug may occur with the following:

antacids
penicillamine (Cuprimine, Depen)
levodopa (Dopar, Larodopa)
methyldopa (Aldomet)
quinolone antibiotics (Cipro, Floxin)
cimetidine (Tagamet)
tetracycline antibiotic (Achromycin)

Sometimes a simple adjustment, like staggering doses by 2 hours, is sufficient to avoid problems, but always check
with your physician.

Is there a problem if I have another disorder or disease?

At times, a drug may have a different or enhanced effect when other diseases are present. At other times, the drug
may worsen or effect another disease.
With this drug, the following disorders may be a problem:

Hemochromatosis
Hemosiderosis
Hemolytic anemia

What about allergies?

People who have known allergies or asthma may be at an increased risk for a reaction from any new medication.
The physician should always know a patients allergy history. Signs of an allergic reaction are skin rash, hives and
itching. Of course, a person should not take ferrous sulfate if there has been a previous reaction to this or a similar
drug.

What if Im pregnant, considering pregnancy or breast-feeding?

Most females now know that, if possible, no drug, including alcohol, should be taken during pregnancy or lactation.
The potential danger, of course, is an injury to the baby. However, some drugs are much safer than others in this
regard. So, the FDA has a grading system for each drug which reflects what is known medically. It ranks drugs from
A, where medical studies show no evidence for danger to the fetus or mother, to B, C, D and X, where the medical
evidence indicates that the risk to the fetus outweighs any benefit to the mother. Ferrous sulfate is not ranked.
However, the pregnant female needs additional iron for her baby. The amount and frequency of iron
supplementation should be discussed with your physician. Always consult your physician before taking any drug
during or when planning pregnancy.

What are the effects on sexual function?

There are no known adverse effects of ferrous sulfate on sexual function.

Are there other precautions?

Iron supplements will cause black stool which is harmless. They also have a tendency to cause constipation,
diarrhea or abdominal discomfort. Some of the dosage forms are designed to release the ferrous sulfate in the
intestine rather than the stomach. This can significantly lower the incidence of GI side effects.

How long is it safe to take ferrous sulfate?

The length of oral iron therapy is usually determined by the success in discovering the underlying cause of the
anemia. Once the cause is determined and treated, it takes approximately 4 to 6 months for iron therapy to reverse
anemias. The iron supplement should then be discontinued to prevent iron build up in the body. Long-term use
should always be with physician supervision.

How about side effects?

Adverse reactions can occur with any drug, even over-the-counter medications. Some of these are mild such as a
stomach upset, which may be avoided by taking the medication with food. Minor reactions may go away on their
own but if they persist, contact the physician. For major reactions, the patient should contact the physician
immediately.
For ferrous sulfate, the following are the observed side effects:
Minor:

heartburn

nausea

vomiting

constipation

diarrhea

black stools
Major:

stomach pain or cramping

bloody stools

A physicians comment
Oral iron therapy is usually effective in treating iron deficiency anemia. However, the cause of this type of anemia
should always be known. Bleeding peptic ulcers and colon cancer are two causes of this type of anemia. As noted
above, oral iron should not be taken when the anemia is corrected and generally is not used to prevent such
anemias. It is always critical to know and correct the underlying cause. Furthermore, since the body cannot rid itself
of iron and since excessive amounts of iron are damaging to the body, the drug should not be taken long-term
without approval from the physician. This means you should not even take iron as part of a vitamin-mineral formula
unless there is a specific reason to do so. Simply feeling tired or fatigued is not a good reason.
2. Folic Acid

INDICATIONS & USAGE

Folic Acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of Folic Acid (as may be seen in tropical or
nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.

Contraindications
Folic Acid, USP is contraindicated in patients who have shown previous intolerance to the drug.

Warnings
Administration of Folic Acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is
deficient.

Precautions
General

Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic
manifestations remain progressive.
There is a potential danger in administering Folic Acid to patients with undiagnosed anemia, since Folic Acid may obscure the diagnosis of
pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This

may result in severe nervous system dam age before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or
improve the neurologic changes caused by pernicious anemia.

Drug Interactions

There is evidence that the anti-convulsant action of phenytoin is antagonized by Folic Acid. A patient whose epilepsy is completely
controlled by phenytoin may require increased doses to prevent convulsions if Folic Acid is given.
Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., Folic Acid
antagonists such as methotrexate); the administration of anti-convulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol
consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.
False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the
growth of Lactobacillus casei.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential and studies to evaluate the mutagenic potential or effect on fertility have not
been con ducted.

Pregnancy

Teratogenic Effects
Pregnancy Category A
Folic Acid is usually indicated in the treatment of megaloblastic anemias of pregnancy. Folic Acid requirements are markedly increased
during pregnancy, and deficiency will result in fetal damage(see INDICATIONS AND USAGE).Studies in pregnant women have not shown

that Folic Acid increases the risk of fetal abnormalities if administered during pregnancy. If the drug is used during pregnancy, the possibility
of fetal harm appears remote. Because studies cannot rule out the possibility of harm, however, Folic Acid should be used during pregnancy
only if clearly needed.

Nursing Mothers

Folic Acid is excreted in the milk of lactating mothers. During lactation, Folic Acid requirements are markedly increased; however, amounts
present in human milk are adequate to fulfill infant requirements, although supplementation may be needed in low- birth-weight infants, in
those who are breast-fed by mothers with Folic Acid deficiency (50 mcg daily), or in those with infections or prolonged diarrhea.

Adverse Reactions
Allergic sensitization has been reported following both oral and parenteral administration of Folic Acid.
Folic Acid is relatively nontoxic in man. Rare instances of allergic responses to Folic Acid preparations have been report ed and have
included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms
suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention,
flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg Folic Acid daily for 1 month. Other side effects reported
in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental
depression, confusion, and impaired judgment. Decreased vitamin B12 serum levels may occur in patients receiving prolonged Folic Acid
therapy. In an uncontrolled study, orally administered Folic Acid was reported to increase the incidence of seizures in some epileptic
patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels
in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of Folic Acid daily.

verdosage

Except during pregnancy and lactation, Folic Acid should not be given in therapeutic doses greater than 0.4 mg daily until pernicious
anemia has been ruled out. Patients with pernicious anemia receiving more than 0.4 mg of Folic Acid daily who are inadequately treated
with vitamin B12 may show reversion of the hematologic parameters to normal, but neurologic manifestations due to vitamin B12 deficiency
will progress. Doses of Folic Acid exceeding the Recommended Dietary Allowance (RDA) should not be included in multivitamin
preparations; if therapeutic amounts are necessary, Folic Acid should be given separately.

DOSAGE & ADMINISTRATION

Oral administration is preferred. Although most patients with malabsorption cannot absorb food folates, they are able to absorb Folic Acid,
USP given orally. Parenteral administration is not advocated but may be necessary in some individuals (e.g., patients receiving parenteral
or enteral alimentation). Doses greater than 0.1 mg should not be used unless ane mia due to vitamin B12 deficiency has been ruled out or
is being adequately treated with a cobalamin. Daily doses greater than 1 mg do not enhance the hematologic effect, and most of the excess
is excreted unchanged in the urine.
The usual therapeutic dosage in adults and children (regard less of age) is up to 1 mg daily. Resistant cases may require larger doses.
When clinical symptoms have subsided and the blood picture has become normal, a daily maintenance level should be used, i.e., 0.1 mg
for infants and up to 0.3 mg for children under 4 years of age, 0.4 mg for adults and children 4 or more years of age, and 0.8 mg for
pregnant and lactating women, but never less than 0.1 mg/day. Patients should be kept under close supervision and adjustment of the
maintenance level made if relapse appears imminent.
In the presence of alcoholism, hemolytic anemia, anti-convulsant therapy, or chronic infection, the maintenance level may need to be
increased.

How is Folic Acid Supplied

Folic Acid Tablets, USP 1 mg are supplied as yellow, round, biconvex uncoated tablets, debossed with "C3" on one side and breakline on
other side and supplied in bottles of 100 and 1000.

Folic Acid Tablets, USP 1 mg is having functional scoring.

They are available as follows:
Bottles of 100s: NDC 65691-0088-1
Bottles of 1000s: NDC 65691-0088-2
Dispense in well-closed container with child-resistant closure.
Store at 20-25C (68-77F) [See USP Controlled Room Temperature].
Manufactured by:
Cadila Pharmaceuticals Limited,
1389 Trasad Road,
Dholka 387810,
District - Ahmedabad, Gujarat, INDIA
Rev. 01-2014
Check with your doctor as soon as possible if any of the following side effects occur while taking folic acid:
Rare

Fever

general weakness or discomfort

reddened skin

shortness of breath

skin rash or itching

tightness in chest

troubled breathing

wheezing

 For Healthcare Professionals

Applies to folic acid: compounding powder, injectable solution, oral tablet

Gastrointestinal

Gastrointestinal side effects have been reported rarely. They have included anorexia, nausea, abdominal distention, flatulence, and
bitter taste.
Gastrointestinal side effects have been reported among patients with doses of 15 mg/day.

Nervous system

Nervous system side effects have included sleep disturbances, concentration problems, irritability, anxiety, depression, confusion,
and impaired judgment.
Parenteral administration of high doses of folic acid have been associated with increased seizure activity in patients with epilepsy.
Nervous system side effects have been reported in some patients who were taking 15 mg/day.
Daily doses of folic acid > 100 mcg/day can obscure pernicious anemia in that hematologic remission can occur while neurologic
signs and symptoms progress.

Hypersensitivity

Hypersensitivity side effects have been reported rarely. They have included erythema, rash, pruritus, malaise, dyspnea with
bronchospasm, and a single case of apparent anaphylaxis.

Metabolic

Metabolic side effects have included impaired gastrointestinal absorption of zinc.

A measurable decline in plasma zinc has been associated with folic acid dosages as low as 400 mcg/day.
Zinc is an intrinsic part of at least 70 metalloenzymes and other cellular components, and is essential for the synthesis of protein,
DNA, and RNA. While zinc deficiency is rare, it may become a problem during pregnancy or with patients who have inflammatory
bowel disease, malabsorption, liver cirrhosis, and high alcohol intake. Zinc deficiency usually presents as diarrhea; mental irritability;
depression; skin lesions of the face, perineum, limbs, and skin folds; alopecia; loss of taste; and defects in the immunologic system.

3. Aluminum Hydroxide
Generic Name
aluminum hydroxide

Trade Name
Amphojel

What are antacids?

An antacid is a compound that absorbs and neutralizes stomach acid. The use of antacids has declined because of the
availability of many very potent drugs that are more effective and much less troublesome to take than antacids. Still, these
drugs can be helpful in relieving intermittent, infrequent heartburn and indigestion. If these symptoms occur frequently such as
multiple times a day or at night, then the cause should be sought, as a more serious disorder may be present.

Following are some facts about antacids:

Taken on an empty stomach, they only neutralize acid for 30 to 60 minutes because the antacid quickly leaves the
stomach.
If taken with food, the protective effect may be 2 or 3 hours.
To get as much acid reduction as prescription medicines produce is expensive as the antacid must be taken frequently
during the day and night. It is probably cheaper to take an acid-reducing pill once or twice a day.
All antacids, but especially calcium carbonate, can result in an acid rebound effect where the stomach acid surges back
after the antacid has left the stomach, another reason for long-acting medications.

Antacids interfere with many drugs. (See below.) Staggering the antacid away from medications is always preferable but again
is a nuisance and hard to comply with long-term.

What are antacids used for?

Antacids are useful for the temporary relief of occasional indigestion and heartburn. Frequent, daily or nightly symptoms usually
mean a more serious problem. Antacids by themselves do not correct these problems. The medications that are now available
to treat acid problems are generally superior to antacids.

How do I take antacids?

It is best to take them with food as the buffering effect in the stomach lasts for 2 to 3 hours. If you have symptoms at night,
take the antacids before retiring. However, it is more important not to eat within 2 hours of sleep as eating often promotes
reflux of acid into the esophagus. Keep all medications away from children.

What do I do for a missed dose?

This is usually not a problem since most people only use the antacid when they have symptoms. If you miss a physician
recommended dose, take it as soon as you remember. However, it is not necessary to double up on the next dose.

Are there interactions with food or beverages?

There are no known interactions between food or alcohol and any of the antacids. However, caffeine and alcohol do stimulate
the production of stomach acid and nicotine delays the healing of ulcers.

Are there interactions with other drugs?

An interaction generally means that one drug may increase or decrease the effect of another drug. Also, the more medications
a person takes, the more likely there will be a drug interaction. Antacids do interact with or prevent the absorption of many
medications. As a general rule it is best to separate antacid use and any other medications by at least 1 hour. When antacids
are only taken occasionally, this seldom presents a serious problem. Since there are so many good medications to reduce
stomach acid, some of them over-the-counter, it is unusual to require frequent antacid use during the day and night.
Interactions with this antacid may occur with the following:

allopurinol (Zyloprim)

benzodiazepine (Valium, Xanax)

chloroquine (Aralen)

steroids (prednisone, Deltasone, Medrol)

digoxin (Lanoxin)

ethambutol (Myambutol)

ulcer medications (Tagamet, Zantac, Pepcid, Axid)

iron (Feosol, ferrous sulfate, Nu-Iron)

isoniazid (INH)

penicillamine (Depen, Cuprimine)

phenothiazines (Thorazine, Stelazine, Compazine)

tetracycline (Sumycin, Tetracyn)

thyroid (Synthroid, levothyroxine)

ticlopidine (Ticlid)

Is there a problem if I have another disorder or disease?

At times, a drug may have a different or enhanced effect when other diseases are present. At other times, the drug may
worsen or effect another disease. Most antacids do not interfere with any underlying disease or disorder. An exception is the use
of sodium bicarbonate when high blood pressure or heart disease is present.

What if Im pregnant, considering pregnancy or breast-feeding?

Most females now know that, if possible, no drug, including alcohol, should be taken during pregnancy or lactation. The
potential danger, of course, is an injury to the baby. Antacids are generally thought to be safe during pregnancy although there
are no medical studies that prove it. Calcium carbonate (Tums and others) is probably the safest antacid, since the baby and
mother both need calcium to develop properly and maintain health. Heartburn is very common during pregnancy so the woman
and her physician should discuss this problem and the best method and antacid that would be helpful.

How long is it safe to take aluminum hydroxide?

Antacids can be used indefinitely if they are only taken occasionally. However, when they are necessary several times a day,
medical attention is required. Excessive antacid use in the short-term may indicate an underlying disorder that needs different
care. The long-term, heavy use of any antacid can produce medical problems and should not be done without a physicians
input.

How about side effects?

Adverse reactions can occur with any drug, even over-the-counter medications. Most antacids produce only minor side effects,
especially if they are used infrequently. Minor side effects are usually relieved by reducing the dose or frequency. For major
reactions, the patient should contact the physician immediately.

Aluminum hydroxide may lead to constipation and, uncommonly, blockage of the bowel. A high fiber diet is often helpful (links
below). Excessive or long-term use of aluminum containing antacids can lead to subtle poisoning, mental changes and weak
bones. They should not be used long-term or by patients with chronic kidney failure or who are on dialysis without discussion
with the physician.
For this antacid, the following are the observed side effects:

Minor:

constipation

abdominal discomfort

Major:

severe abdominal pain

mood or mental changes

severe weakness

physicians comment
Antacids are one of mankinds oldest friends. If you develop occasional heartburn or indigestion, you take an antacid and get
instant relief. No house should be without an antacid. Yet, if these symptoms occur daily or several times a day and especially
at night, then there could be a more serious problem. There may be an ulcer or serious acid injury to the esophagus (food
pipe). These conditions are rarely healed by antacids alone. A specific diagnosis must be made by the physician. If an ulcer is
being caused by the stomach bacteria, Helicobacter pylori, or if gastroesophageal injury is occurring, specific potent
medications are available to heal or control these conditions. Antacids, at best, just temporarily cover up the symptoms. They
do not solve the problem.