MOXISTAL 400 Tablet 5's

Introduction About MOXISTAL 400 TABLET

MOXISTAL 400 TABLET contains Moxifloxacin which belongs to the group of
medicines called Antibiotics. It is used to manage acute bacterial sinusitis,
acute bacterial exacerbation of chronic bronchitis, community acquired
pneumonia, skin and soft tissue infections, uncomplicated urinary tract
infection and pelvic inflammatory disease.

MOXISTAL 400 TABLET is not recommended for use in patients having liver and
heart problems. MOXISTAL 400 TABLET is not recommended for use in pregnant or
breastfeeding mothers. Consult your doctor before taking.

Before taking MOXISTAL 400 TABLET inform your doctor if you have or had
myasthenia gravis, diabetes, epilepsy or any mental disorders.

MOXISTAL 400 TABLET is not recommended for use in children and adolescents below
18 years of age. MOXISTAL 400 TABLET should be used with caution in elderly
patients with renal impairment. Consult your doctor before taking the medicine.

The common side effects of MOXISTAL 400 TABLET are headache, dizziness, nausea,
vomiting and stomach pain. Consult your doctor if the above symptoms does not
improve.

Uses Of MOXISTAL 400 TABLET

It is used to manage:

• acute bacterial sinusitis
• acute bacterial exacerbation of chronic bronchitis
• community acquired pneumonia
• skin and soft tissue infections
• uncomplicated urinary tract infection
• pelvic inflammatory disease

How MOXISTAL 400 TABLET Works

MOXISTAL 400 TABLET works by inhibiting the bacterial enzymes DNA gyrase and
topoisomerase IV which are required for DNA replication and transcri
resulting in cell death. This manages the bacterial cells from dividing and
repairing and destroys them.

How to use MOXISTAL 400 TABLET

Always take this medicine as directed by your physician. Swallow the medicine as
whole with a glass of water. Do not crush or chew the medicine. Your doctor will
give the correct dose depends on your age, body weight and severity of the
infection.

Side Effects Of MOXISTAL 400 TABLET

Common

• headache
• dizziness
• nausea
• vomiting
• stomach pain
• diarrhea
• increase in liver enzyme like yellowing of skin and eyes
• low blood potassium level such as irregular heartbeat

Uncommon

• sleep problems
• signs of low number of white blood cells like fever, infections, mouths sores
• constipation
• decreased appetite and food intake
• aches and pains such as back, chest, pelvic and extremities pains, joint pain
• signs of increase or decrease in blood cells necessary for blood clotting (Ex. weakness, bleeding, tingling in the hands and feet)
• sweating, anxiety, restlessness, agitation, confusion, disorientation, shaking
• palpitations, signs of angina pectoris like pressing, squeezing, or crushing pain
• difficulty in breathing (asthma)
• increase of a special digestive enzyme in the blood (amylase)
• visual disturbances like double and blurred vision
• weight gain
• muscle pain
• signs of increase of bilirubin abdominal pain or swelling, chills, fever
• dehydration or dry skin

Rare

• hallucination, abnormal dreams, disturbed concentration, balance disorder and poor co-ordination
• high or low blood pressure
• in­flammation of the mouth
• ringing/noise in the ears
• impairment of skin sensation
• changes in smell
• serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis characterized by reddish target-like macules or circular patch, skin peeling, ulcers of mouth, throat, nose, genitals, and eyes and can be preceded by fever and flu-like symptoms
• red, scaly widespread rash with bumps under the skin and blisters accomp
• syndrome associated with impaired water excretion and low levels of sodium (SIADH)

Stop taking MOXISTAL 400 TABLET and contact your doctor immediately if you
experience any of the following side effects:

• signs of inflammation of blood vessels such as red spots on your skin, usually on your lower legs or effects like joint pain
• pain and swelling of the tendons (tendonitis), rupture of tendons
• muscle weakness, tenderness, or pain
• severe diarrhea containing blood and/or mucus
• signs of inflammation of liver like feeling of unwell or yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought
• severe, sudden allergic reaction
• convulsions (fits)
• pain, burning, tingling, numbness and/or weakness in extremities
• depression
• abnormal heart rhythms, life-threatening irregular heartbeat
• worsening of the symptoms of myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis)
• signs of kidney problems such as decrease in urine output, swelling in legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion
• feeling mentally unwell (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts)

How To Manage Side Effects

Nausea or Vomiting:

Take this medicine with, or just after meals. Stick to simple meals. Try to
avoid oil rich or spicy foods, sugary snacks, and drinks. Try to drink liquid
slowly along with your meals, or in between meals. Consult your doctor if your
symptom is not improving.

Constipation:

Eat fibre rich foods like fresh fruit, vegetables, and cereals. Drink plenty of
water. Exercise more regularly.

Dizziness:

Lie, or sit down immediately when you feel dizzy. Try to avoid vehicle driving.
Discuss with your doctor if the symptom worsens.

Headache:

Apply hot or cold-water bag on your head. Try to take rest in a quiet and dark
room. Drink tea or coffee. Massage on scalp or head with mild pressure. Consult
your doctor for advice.

Stomach pain:

Try to rest and relax. Have smaller and frequent meals. Keep a heat pad on your
stomach. Consult your doctor for advice.

Warning & Precautions

!### Pregnancy

MOXISTAL 400 TABLET is not recommended for use in pregnant women or if you think
you might become pregnant. Discuss the risks and benefits with your doctor.

!### Breastfeeding

MOXISTAL 400 TABLET is not recommended for use in breastfeeding women. Discuss
the risks and benefits with your doctor.

!### Driving and Using Machines

Do not drive or handle any machines while taking MOXISTAL 400 TABLET, since it
may cause dizziness, light-headedness, or transient loss of vision.

!### Kidney

Dosage adjustment is not required in patients with mild to severely impaired
renal function or in patients on chronic dialysis. Consult your doctor before
taking MOXISTAL 400 TABLET.

!### Liver

MOXISTAL 400 TABLET is not recommended in patients with severe liver disease or
increased liver enzymes or any active liver diseases. Consult your doctor for
advice.

!### Allergy

Do not take if you are allergic (hypersensitive) to Moxifloxacin or any other
ingredients of this medicine.

!### Heart Disease

MOXISTAL 400 TABLET is not recommended in patients with abnormal or slow heart
rhythm or abnormal heart rhythms. MOXISTAL 400 TABLET should be used with
caution in patients having heart valve heart disease, aortic aneurysm or aortic
dissection or congenital heart valve disease, enlargement, or bulge of a large
blood vessel or any other active heart disease. Consult your doctor before
taking this medicine.

Others

MOXISTAL 400 TABLET is not recommended for use if you:

• have a history of tendon disease/disorder
• have electrolyte disturbances (uncorrected hypokalaemia)
• have diabetes (elderly)

Before taking MOXISTAL 400 TABLET, inform your doctor if you:

• have epilepsy
• have mental health problems
• have glucose- 6-phosphate dehydrogenase deficiency
• have myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis)
• have a complicated infection of the female upper genital tract (associated with an abscess of the fallopian tubes and ovaries or of the pelvis)

Use in pediatrics:

MOXISTAL 400 TABLET is not recommended for use in children and adolescents below
18 years of age, since efficacy and safety have not been established. Consult
your doctor for taking.

Use in geriatrics:

Elderly patients with renal disorders should use MOXISTAL 400 TABLET with
caution if they are unable to maintain adequate fluid intake, because
dehydration may increase the risk of renal failure. Consult your doctor before
taking the medicine.

Interactions

A. Drug-Drug interactions:

Before taking MOXISTAL 400 TABLET, inform your doctor if you are taking the
following medicine:

• quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide (medicines used to manage heart problems)
• phenothiazines, pimozide, sertindole, haloperidol, sultopride and tricyclic antidepressant (medicines used to manage psychotic problems)
• saquinavir, sparfloxacin, intravenous erythromycin, pentamidine (medicine used to manage infection)
• halofantrine (medicine used to manage malaria)
• terfenadine, astemizole, mizolastine (medicine used to manage allergies)
• intravenous vincamine, bepridil (medicines used to lower blood pressure)
• diphem
• medicines that lower the blood potassium levels (Ex. spironolactone)
• laxatives like methylcellulose, wheat bran (medicines used to manage constipation)
• prednisolone, betamethasone, dexamethasone, hydrocortisone
• amphotericin B (medicine used to manage fungal infections)
• antacids magnesium or aluminium hydroxide (used to manage heart burn and indigestion)
• warfarin (medicine used as blood thinner)
• charcoal containing medicines (used to manage certain types of poisoning)

Overdosage:

If you or anyone else accidentally takes too much of MOXISTAL 400 TABLET,
consult your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Moxifloxacin
Pharmacological Category	:	Fluoroquinolones
Therapeutic Indication	:	Bacterial infections
Dosage Forms	:	Tablet, Injection, Infusion, Eye Drops, Ophthalmic solution, Eye Gel, Gel, Eye Ointment, Ointment

More Information

• Keep out of reach of children
• Store at room temperature

FAQs About MOXISTAL 400 TABLET

What are the uses of MOXISTAL 400 TABLET?

MOXISTAL 400 TABLET is used to manage acute bacterial sinusitis, acute bacterial
exacerbation of chronic bronchitis, community acquired pneumonia, skin and soft
tissue infections, uncomplicated urinary tract infection and pelvic inflammatory
disease.

How does MOXISTAL 400 TABLET works?

MOXISTAL 400 TABLET works by inhibiting the bacterial enzymes DNA gyrase and
topoisomerase IV which are required for DNA replication and transcri
resulting in cell death. This manages the bacterial cells from dividing and
repairing and destroys them.

Can MOXISTAL 400 TABLET be used in pregnant and breast-feeding woman?

MOXISTAL 400 TABLET is not recommended for use in pregnant women or if you think
you might become pregnant and in breast feeding woman. Discuss the risks and
benefits with your doctor.

Can MOXISTAL 400 TABLET be given to children?

MOXISTAL 400 TABLET is not recommended for use in children and adolescents aged
below 18 years as the efficacy and safety have not been established for this age
group. Consult your doctor for advice.

Does MOXISTAL 400 TABLET cause headache?

Yes, it may cause headache in some patients. Apply hot or cold-water bag on your
head. Try to take rest in a quiet and dark room. Drink tea or coffee. Massage on
scalp or head with mild pressure. Consult your doctor for advice.

Useful Diagnostic Tests

• Complete blood count