You are on page 1of 20

DESCRIPTION:

Each gram of ointment contains 500 units of Bacitracin in a


low melting special base containing White Petrolatum and
Mineral Oil.
CLINICAL PHARMACOLOGY:
The antibiotic, Bacitracin, exerts a profound action against
many gram-positive pathogens, including the common
Streptococci and Staphlococci. It is also destructive for
certain gram-negative organisms. It is ineffective against
fungi.
INDICATIONS AND USAGE:
For the treatment of superficial ocular infections involving the
conjunctiva and/or cornea caused by Bacitracin susceptible
organisms.
CONTRAINDICATIONS:
This product should not be used in patients with a history of
hypersensitivity to Bacitracin.
PRECAUTIONS:
Bacitracin ophthalmic ointment should not be used in deep-
seated ocular infections or in those that are likely to become
systemic. The prolonged use of antibiotic containing
preparations may result in overgrowth of nonsusceptible
organisms particularly fungi. If new infections develop during
treatment appropriate antibiotic or chemotherapy should be
instituted.
ADVERSE REACTIONS:
Bacitracin has such a low incidence of allergenicity that for all
practical purposes side reactions are practically non-existent.
However, if such reaction should occur, therapy should be
discontinued.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo
at 1-866-634-9120 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION:
The ointment should be applied directly into the conjunctival
sac 1 to 3 times daily. In blepharitis all scales and crusts should
be carefully removed and the ointment then spread uniformly
over the lid margins. Patients should be instructed to take
appropriate measures to avoid gross contamination of the
ointment when applying the ointment directly to the infected
eye.
HOW SUPPLIED:
NDC 0574-4022-13 3 – 1 g sterile tamper evident tubes with
ophthalmic tip.
NDC 0574-4022-35 3.5 g (1/8 oz.) sterile tamper evident tubes
with ophthalmic tip.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room
Temperature].
Manufactured For
Perrigo®
Minneapolis, MN 55427
0S400 RC J1
Rev 08-13 A
R0813
Ini0813
PACKAGE/LABEL PRINCIPAL DISPLAY
PANEL – 1 g Carton (Sample Only)
Rx Only
NDC 0574-4022-01
Bacitracin Ophthalmic Ointment USP
FOR USE IN THE EYES ONLY
NET WT 1 g
STERILE
The following image is a placeholder representing the
product identifier that is either affixed or imprinted on the
drug package label during the packaging operation.
PACKAGE/LABEL PRINCIPAL DISPLAY
PANEL – 1 g Label
Rx Only
NDC 0574-4022-11
Bacitracin Ophthalmic Ointment, USP 500 units/g
FOR USE IN THE EYES ONLY
NET WT 1 g
STERILE

PACKAGE/LABEL PRINCIPAL DISPLAY


PANEL – 3 – 1 g Tube Carton
Rx Only
NDC 0574-4022-13
Bacitracin Ophthalmic Ointment USP, 500 units/g
3 – 1 g tubes
Sterile Ophthalmic Ointment
FOR USE IN THE EYES ONLY
Weighing 1 gram each
The following image is a placeholder representing the
product identifier that is either affixed or imprinted on the
drug package label during the packaging operation.
PACKAGE/LABEL PRINCIPAL DISPLAY
PANEL – 1 g Label
Rx Only
NDC 0574-4022-11
Bacitracin Ophthalmic Ointment, USP 500 units/g
FOR USE IN THE EYES ONLY
NET WT 1 g
STERILE

PACKAGE/LABEL PRINCIPAL DISPLAY


PANEL – 3.5 g Carton
Rx Only
NDC 0574-4022-35
Bacitracin Ophthalmic Ointment USP
NET WT 3.5 g (1/8 oz)
STERILE
The following image is a placeholder representing the
product identifier that is either affixed or imprinted on the
drug package label during the packaging operation.
PACKAGE/LABEL PRINCIPAL DISPLAY
PANEL – 3.5 g Label
Rx Only
NDC 0574-4022-35
Bacitracin Ophthalmic Ointment USP
NET WT 3.5 g (1/8 oz)
STERILE

What happens if I miss a dose?


Since Halcion is taken as needed, you are not likely to be on a
dosing schedule. Take Halcion only when you have time for
several hours of sleep.

What happens if I overdose?


Seek emergency medical attention or call the Poison Help
line at 1-800-222-1222. An overdose of triazolam can be
fatal, especially if taken with alcohol.
Overdose symptoms may include extreme drowsiness,
confusion, slurred speech, weak or shallow breathing,
fainting, or coma.

What should I avoid while taking


Halcion?
Avoid drinking alcohol. Dangerous side effects could occur.
Halcion may impair your thinking or reactions. You may still
feel sleepy the morning after taking Halcion. Wait until you
are fully awake before you drive, operate machinery, or do
anything that requires you to be awake and alert.
Grapefruit and grapefruit juice may interact with Halcion
and lead to unwanted side effects. Avoid the use of grapefruit
products while taking this medicine.

Halcion side effects


Get emergency medical help if you have signs of an allergic
reaction: hives; difficulty breathing; swelling of your face,
lips, tongue, or throat.
Call your doctor at once if you have:
• unusual changes in mood or behavior;
• confusion, memory loss (amnesia), hallucinations; or
• depression, suicidal thoughts.
Some people using Halcion have engaged in activity such
as driving, eating, making phone calls, or sleep-walking
and later having no memory of the activity. If this happens
to you, stop taking this medicine and talk with your doctor.
The sedative effects of triazolam may last longer in older
adults. Accidental falls are common in elderly patients who
take benzodiazepines. Use caution to avoid falling or
accidental injury while you are taking Halcion.
Common side effects may include:
• dizziness, daytime drowsiness (or during hours when you
are not normally sleeping);
• loss of coordination;
• headache; or
• tingling or prickly feeling on your skin.
This is not a complete list of side effects and others may
occur. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
See also:
Halcion side effects (in more detail)

What other drugs will affect Halcion?


Taking Halcion with other drugs that make you sleepy or
slow your breathing can cause dangerous side effects or
death. Ask your doctor before taking a sleeping pill, narcotic
pain medicine, prescription cough medicine, a muscle relaxer,
or medicine for anxiety, depression, or seizures.
Many drugs can interact with Halcion, and some drugs should
not be used together. This includes prescription and over-the-
counter medicines, vitamins, and herbal products. Not all
possible interactions are listed in this medication guide. Tell
your doctor about all medicines you use, and those you start
or stop using during your treatment with this medicine. Give a
list of all your medicines to any healthcare provider who
treats you.
See also:
Halcion drug interactions (in more detail)

Further information
Remember, keep this and all other medicines out of the reach
of children, never share your medicines with others, and use
this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the
information displayed on this page applies to your personal
circumstances.

Halcion is a benzodiazepine (ben-zoe-dye-AZE-eh-peen)


similar to Valium. This medicine affects chemicals in the
brain that may be unbalanced and cause sleep problems
(insomnia).
Halcion is used to treat insomnia (trouble falling or staying
asleep).
Halcion may also be used for purposes not listed in this
medication guide.

Important Information
Do not use if you are pregnant.
Serious drug interactions can occur when certain medicines
are used together with Halcion. Tell each of your healthcare
providers about all medicines you use now, and any medicine
you start or stop using.

Before taking this medicine


You should not use Halcion if you are allergic to Halcion or
similar medicines, such as alprazolam (Xanax), clonazepam
(Klonopin), clorazepate (Tranxene), diazepam (Valium),
lorazepam (Ativan), and others.
This medicine can harm an unborn baby or cause birth
defects. Do not use if you are pregnant. Use effective birth
control to prevent pregnancy while you are using this
medicine.
Some medicines can cause unwanted or dangerous effects
when used with Halcion. Your doctor may need to change
your treatment plan if you use certain medicines, including:
• imatinib;
• isoniazid;
• nefazodone;
• a narcotic (opioid) medication;
• an antibiotic--clarithromycin, erythromycin,
telithromycin;
• antifungal medicine--itraconazole, ketoconazole,
posaconazole, voriconazole;
• heart medication--nicardipine, quinidine; or
• antiviral medicine to treat hepatitis C or HIV/AIDS--
atazanavir, boceprevir, cobicistat (Evotaz, Prezcobix,
Stribild, Tybost), delavirdine, fosamprenavir, indinavir,
lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir.
To make sure Halcion is safe for you, tell your doctor if you
have:
• a history of depression, mental illness, or addiction;
• a history of suicidal thoughts or actions;
• liver or kidney disease; or
• lung disease or breathing problems.
It is not known whether triazolam passes into breast milk or if
it could harm a nursing baby. You should not breast-feed
while using this medicine.
Halcion is not approved for use by anyone younger than 18
years old.

How should I take Halcion?


Follow the directions on your prescription label. Do not take
this medicine in larger or smaller amounts or for longer than
recommended.
medicine with another person, especially someone with a
history of drug abuse or addiction. Keep the medication in a
place where others cannot get to it. Selling or giving away
this medicine is against the law.
Take Halcion on an empty stomach, at least 2 hours after
eating.
Take this medicine only when you are getting ready for
several hours of sleep. You may fall asleep very quickly after
taking the medicine.
Avoid using Halcion to prevent jet lag while traveling by
airplane.
Call your doctor if your insomnia does not improve after
taking Halcion for 7 to 10 nights, or if you have any mood or
behavior changes. Insomnia can be a symptom of depression,
mental illness, or certain medical conditions.
Do not take Halcion for longer than 10 nights in a row, unless
your doctor has told you to. Ask your doctor how to avoid
withdrawal symptoms when you stop using this medicine.
Store at room temperature away from moisture, heat, and
light. Keep track of the amount of medicine used from each
new bottle. Halcion is a drug of abuse and you should be
aware if anyone is using your medicine improperly or without
a prescription.

Haldol can be taken with or without food.

Measure liquid medicine with the dosing syringe provided, or with a special
dose-measuring spoon or medicine cup. If you do not have a dose-measuring
device, ask your pharmacist for one.

Taking too much Haldol can cause a serious heart rhythm disorder or sudden
death. Never take more than your prescribed dose.

It may take several weeks before your symptoms improve. Keep using the
medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using Haldol suddenly, or you could have unpleasant withdrawal
symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Do not allow
liquid medicine to freeze.

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is
almost time for your next scheduled dose. Do not take extra medicine to make
up the missed dose.

What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-
1222. An overdose of Haldol can be fatal.

What should I avoid while taking haloperidol?


Haldol may impair your thinking or reactions. Be careful if you drive or do
anything that requires you to be alert.
Avoid getting up too fast from a sitting or lying position, or you may feel
dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise and in hot weather.


You may be more prone to heat stroke while you are taking Haldol.

Haldol side effects


Get emergency medical help if you have signs of an allergic reaction: hives;
difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of haloperidol can cause a serious movement


disorder that may not be reversible. Symptoms of this disorder include
uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs.
The longer you take Haldol, the more likely you are to develop a serious
movement disorder. The risk of this side effect is higher in women and older
adults.

Call your doctor at once if you have:

 sudden mood changes, agitation, hallucinations, unusual thoughts or


behavior;
 twitching or uncontrollable movements of your eyes, lips, tongue, face,
arms, or legs;
 stiffness in your neck, tightness in your throat, trouble breathing or
swallowing;
 sudden weakness or ill feeling, fever, chills, sore throat, swollen gums,
painful mouth sores, pain when swallowing, skin sores, cold or flu
symptoms, cough, easy bruising or bleeding;
 stabbing chest pain, feeling short of breath, cough with yellow or green
mucus;
 headache with chest pain and severe dizziness, fainting, fast or pounding
heartbeats;
 seizure (convulsions); or
 severe nervous system reaction--very stiff (rigid) muscles, high fever,
sweating, confusion, fast or uneven heartbeats, tremors, feeling like you
might pass out.

Common side effects may include:


 headache, dizziness, spinning sensation, drowsiness;
 tremors, restless feeling, uncontrolled muscle movements;
 stiffness in the muscles of your neck or back, speech problems;
 sleep problems (insomnia);
 feeling restless or anxious;
 breast enlargement, irregular menstrual periods, loss of interest in sex; or
 overactive reflexes.

This is not a complete list of side effects and others may occur. Call your doctor
for medical advice about side effects. You may report side effects to FDA at 1-
800-FDA-1088.

See also:

Haldol side effects (in more detail)

What other drugs will affect Haldol?


Taking Haldol with other drugs that make you sleepy or slow your breathing
can cause dangerous or life-threatening side effects. Ask your doctor before
taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a
muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using,
especially:

 cancer medicine--arsenic trioxide, nilotinib, toremifene, vandetanib,


vemurafenib;
 an antidepressant--citalopram;
 anti-malaria medication--lumefantrine;
 heart rhythm medicine--
amiodarone, disopyramide, dofetilide, procainamide, quinidine, sotalol
; or
 medicine to treat a psychiatric disorder--
iloperidone, pimozide, thioridazine, ziprasidone, others.

This list is not complete. Other drugs may interact with haloperidol, including
prescription and over-the-counter medicines, vitamins, and herbal products.
Not all possible interactions are listed in this medication guide.
See also:

Haldol drug interactions (in more detail)

Further information
Remember, keep this and all other medicines out of the reach of children, never
share your medicines with others, and use this medication only for the indication
prescribed.

Always consult your healthcare provider to ensure the information displayed on


this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 13.05.

What is Haldol?

Haldol is an antipsychotic medicine. It works by changing the


actions of chemicals in your brain.
Haldol is used to treat schizophrenia. It is also used to control
motor and speech tics in people with Tourette's syndrome.
Haldol may also be used for purposes not listed in this
medication guide.

Important Information
Haldol is not approved for use in psychotic conditions related
to dementia. This medicine may increase the risk of death in
older adults with dementia-related conditions.
You should not use Haldol if you have Parkinson's disease or
certain conditions that affect your central nervous system.
Before taking this medicine
You should not use Haldol if you are allergic to it, or if you
have:
• Parkinson's disease; or
• certain conditions that affect your central nervous system
(such as severe drowsiness, or slowed thinking caused
by taking other medicines or drinking alcohol).
Haldol is not approved for use in psychotic conditions related
to dementia. This medicine may increase the risk of death in
older adults with dementia-related conditions.
To make sure Haldol is safe for you, tell your doctor if you
have:
• liver disease;
• kidney disease;
• heart disease, angina (chest pain);
• a thyroid disorder;
• epilepsy or other seizure disorder;
• personal or family history of long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or
magnesium in your blood); or
• if you take a blood thinner (warfarin, Coumadin, Jantoven).
It is not known whether this medicine will harm an unborn
baby. Tell your doctor if you are pregnant or plan

You might also like