Permitil

Generic Name: fluphenazine (floo FEN a zeen)

Brand Names: Permitil

What is Permitil (fluphenazine)?

Fluphenazine is an anti-psychotic medication in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Fluphenazine is used to treat psychotic disorders such as schizophrenia.

Fluphenazine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Permitil (fluphenazine)?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. Fluphenazine is not for use in psychotic conditions related to dementia. Fluphenazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use fluphenazine if you have liver disease, brain damage, bone marrow depression, a blood cell disorder, or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to fluphenazine or other phenothiazines.

Before you take fluphenazine, tell your doctor if you have heart disease or high blood pressure, a history of seizures, Parkinson's disease, liver or kidney disease, severe asthma or breathing problem, past or present breast cancer, adrenal gland tumor, enlarged prostate, urination problems, glaucoma, low levels of calcium in your blood, or if you have ever had a serious side effect while using fluphenazine or similar medicines.

Before taking fluphenazine, tell your doctor about all other medications you use.

What should I discuss with my healthcare provider before taking Permitil (fluphenazine)?

Fluphenazine is not for use in psychotic conditions related to dementia. Fluphenazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use fluphenazine if you have liver disease, brain damage, bone marrow depression, or a blood cell disorder (such as low platelets or low red or white blood cell counts), or if you are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to fluphenazine or other phenothiazines such as chlorpromazine (Thorazine), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Adgan, Pentazine, Phenergan), thioridazine (Mellaril), or trifluoperazine (Stelazine).

To make sure you can safely take fluphenazine, tell your doctor if you have any of these other conditions:

• 
  

  heart disease or high blood pressure;

  
  


• 
  

  a history of seizures or brain injury;

  
  


• 
  

  Parkinson's disease;

  
  


• liver or kidney disease;


• 
  

  severe asthma, emphysema, or other breathing problem;

  
  


• 
  

  past or present breast cancer;

  
  


• 
  

  adrenal gland tumor (pheochromocytoma);

  
  


• 
  

  enlarged prostate or urination problems;

  
  


• 
  

  low levels of calcium in your blood (hypocalcemia);

  
  


• 
  

  glaucoma; or

  
  


• 
  

  if you have ever had a serious side effect while using fluphenazine or any other phenothiazine.

  
  

Tell your doctor if you will be exposed to extreme heat or cold, or to insecticide poisons while you are taking fluphenazine.

Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking fluphenazine, do not stop taking it without your doctor's advice. It is not known whether fluphenazine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

How should I take Permitil (fluphenazine)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

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

Fluphenazine oral solution concentrate solution must be mixed with at least 2 ounces (1/4 cup) of a liquid such as milk, tomato juice, fruit juice (but not apple juice), or a soft drink that does not contain caffeine.

To be sure this medication is not causing harmful effects, your liver and kidney function will need to be checked with frequent blood tests. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using fluphenazine. Do not stop using fluphenazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using fluphenazine. 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. Overdose symptoms may include extreme drowsiness, deep sleep, uncontrollable muscle movements, and weak or shallow breathing.

What should I avoid while taking Permitil (fluphenazine)?

Fluphenazine 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. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of fluphenazine. Avoid exposure to sunlight or tanning beds. Fluphenazine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Permitil (fluphenazine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using fluphenazine and call your doctor at once if you have a serious side effect such as:

• 
  

  twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  
  


• 
  

  tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  blurred vision, eye pain, seeing halos around lights;

  
  


• 
  

  pale skin, easy bruising or bleeding, mouth sores, severe tingling, numbness, pain, muscle weakness;

  
  


• 
  

  dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

  
  

Less serious side effects may include:

• 
  

  headache, dizziness, drowsiness;

  
  


• 
  

  feeling anxious or restless;

  
  


• 
  

  strange dreams;

  
  


• 
  

  nausea, constipation, loss of appetite;

  
  


• 
  

  mild skin rash;

  
  


• 
  

  dry mouth, stuffy nose;

  
  


• 
  

  increased sweating or urination;

  
  


• 
  

  breast swelling or discharge;

  
  


• 
  

  changes in your menstrual periods;

  
  


• 
  

  impotence, trouble having an orgasm; or

  
  


• 
  

  weight gain, swelling in your hands or feet.

  
  

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.

What other drugs will affect Permitil (fluphenazine)?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with fluphenazine and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines, or any other anti-psychotic medications.

Tell your doctor about all other medicines you use, especially:

• 
  

  atropine (Sal-Tropine, Atreza);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  birth control pills or hormone replacement estrogens;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  certain asthma medications or bronchodilators;

  
  


• 
  

  incontinence medications;

  
  


• 
  

  insulin or diabetes medications you take by mouth;

  
  


• 
  

  medication for nausea, vomiting, or motion sickness;

  
  


• 
  

  medications to treat or prevent malaria;

  
  


• 
  

  medicines used to prevent organ transplant rejection;

  
  


• 
  

  a stimulant or ADHD medication;

  
  


• 
  

  ulcer or irritable bowel medications; or

  
  


• 
  

  medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma).

  
  

This list is not complete and there are many other drugs that can interact with fluphenazine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

More Permitil resources

• Permitil Side Effects (in more detail)
• Permitil Use in Pregnancy & Breastfeeding
• Permitil Drug Interactions
• Permitil Support Group
• 0 Reviews for Permitil - Add your own review/rating

• Fluphenazine MedFacts Consumer Leaflet (Wolters Kluwer)


• Fluphenazine Professional Patient Advice (Wolters Kluwer)


• Prolixin Prescribing Information (FDA)


• Prolixin Decanoate Prescribing Information (FDA)


• fluphenazine decanoate Monograph (AHFS DI)

Compare Permitil with other medications

• Psychosis

Where can I get more information?

• Your pharmacist can provide more information about fluphenazine.

See also: Permitil side effects (in more detail)

Provigil

Generic Name: modafinil (Oral route)

moe-DAF-i-nil

Commonly used brand name(s)

In the U.S.

• Provigil

Available Dosage Forms:

• Tablet

Therapeutic Class: CNS Stimulant

Chemical Class: Amphetamine Related

Uses For Provigil

Modafinil is used to help people who have narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS), or shift work sleep disorder (SWSD) to stay awake during the day. Modafinil does not cure these conditions and will only work as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using Provigil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of modafinil in children younger than 17 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of modafinil have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of modafinil in the elderly. However, elderly patients may have a slower removal of this medicine from the body, which may require an adjustment in the dose for patients receiving modafinil.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Citalopram


• Tolvaptan

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clomipramine


• Cyclosporine


• Desogestrel


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Triazolam

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or


• Drug abuse or dependence, history of—Dependence may be more likely to develop.

• Angina (severe chest pain), unstable or


• Heart attack, recent or


• Heart disease—Use with caution. It is not known how modafinil will affect these conditions.

• Depression, history of or


• Hypertension (high blood pressure) or


• Mania, history of or


• Psychosis (mental illness), history of—Use with caution. May make these conditions worse.

• Left ventricular hypertrophy (heart disease), history of or


• Mitral valve prolapse (heart disease) after receiving CNS stimulants—Use is not recommended in patients with these conditions.

• Liver disease, severe—Use with caution. You may require a dose adjustment. Talk with your doctor if you have concerns about this.

Proper Use of Provigil

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

This medicine does not take the place of getting enough sleep. It should not be used for occasional sleepiness that has not been diagnosed as narcolepsy, sleep apnea, or shift work sleep problems. Ask your doctor for advice about good sleep habits.

If you have sleep apnea and use a continuous positive airway pressure (CPAP) machine at night, continue using this machine with modafinil.

Take this medicine at the same time each day. Do not change the time of day you take modafinil without talking first with your doctor.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  
  • For narcolepsy or obstructive sleep apnea/hypopnea syndrome:
    
    • Adults and teenagers 17 years of age and older—200 milligrams (mg) once a day, in the morning. Your doctor may increase your dose as needed.
    
    
    • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For shift work sleep disorder:
    
    • Adults and teenagers 17 years of age and older—200 milligrams (mg) one hour before you begin working.
    
    
    • Teenagers and children younger than 17 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of modafinil and you remember it before 12:00 noon the same day, take the missed dose as soon as possible.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Provigil

Your doctor should check your progress at regular visits to make sure that this medicine is working properly. Your blood pressure may need to be checked more often while taking this medicine.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

This medicine may cause you to have a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Stop taking this medicine and call your doctor right away if you have a skin rash; itching; hives; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause serious allergic reactions affecting multiple body organs (e.g., heart, liver, or blood cells). Stop using this medicine and check with your doctor right away if you have the following symptoms: chest pain or discomfort, fever and chills, dark urine, headache, rash, stomach pain, unusual tiredness, unusual bleeding or bruising, or yellow eyes or skin.

If you think modafinil is not working properly after you have taken it for a few weeks, do not increase the dose. Instead, check with your doctor.

If you are using a medicine for birth control (such as birth control pills, implants, shots, patches, vaginal rings, or an IUD), it may not work properly while you are taking modafinil. To keep from getting pregnant, use another form of birth control while you are using this medicine and for one month after your last dose. Other forms of birth control include condoms, diaphragms, or contraceptive foams or jellies.

Modafinil may cause some people to feel dizzy, drowsy, have trouble thinking or controlling movements, or trouble seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Stop using this medicine and check with your doctor right away if you have the following symptoms while taking the medicine: aggressive behavior, anxiety, depression, hallucinations, mania, thoughts of suicide, or other mental problems.

If you have been taking this medicine for a long time or in large doses and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs of dependence on modafinil are:

• a strong desire or need to continue taking the medicine.


• a need to increase the dose to receive the effects of the medicine.


• withdrawal side effects when you stop taking the medicine.

While you are taking this medicine, be careful to limit the amount of alcohol that you drink.

If you have been taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Provigil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Black, tarry stools


• blurred vision or other vision changes


• chest pain


• chills or fever


• clumsiness or unsteadiness


• confusion


• dizziness or fainting


• increased thirst and urination


• mental depression


• problems with memory


• rapidly changing moods


• shortness of breath


• sore throat


• trembling or shaking


• trouble in urinating


• uncontrolled movements of the face, mouth, or tongue


• unusual bleeding or bruising


• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation or excitement


• fast or pounding heartbeat


• increased blood pressure


• trouble with sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Anxiety


• headache


• nausea


• nervousness

Less common

• Back pain


• belching


• decrease in appetite


• diarrhea


• difficulty having a bowel movement


• dryness of the mouth


• dryness of the skin


• feeling of constant movement of self or surroundings


• flushing or redness of the skin


• heartburn


• indigestion


• muscle stiffness


• sores, ulcers, or white spots on the lips or in the mouth


• sour stomach


• stomach discomfort upset or pain


• stuffy or runny nose


• swelling


• tingling, burning, or prickling sensations in the skin


• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Provigil side effects (in more detail)

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More Provigil resources

• Provigil Side Effects (in more detail)
• Provigil Dosage
• Provigil Use in Pregnancy & Breastfeeding
• Drug Images
• Provigil Drug Interactions
• Provigil Support Group
• 99 Reviews for Provigil - Add your own review/rating

• Provigil Prescribing Information (FDA)


• Provigil Consumer Overview


• Provigil Monograph (AHFS DI)


• Provigil MedFacts Consumer Leaflet (Wolters Kluwer)


• Modafinil Professional Patient Advice (Wolters Kluwer)

Compare Provigil with other medications

• Narcolepsy
• Obstructive Sleep Apnea/Hypopnea Syndrome
• Shift Work Sleep Disorder

Azyter

1. Name Of The Medicinal Product

Azyter

2. Qualitative And Quantitative Composition

Each gram of solution contains 15 mg of azithromycin dihydrate equivalent to 14.3 mg of azithromycin.

One single-dose container of 250 mg solution contains 3.75 milligrams of azithromycine dihydrate.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, solution in single-dose container.

Clear, colourless to slightly yellow, oily liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

Local antibacterial treatment of conjunctivitis caused by susceptible strains:

- Purulent bacterial conjunctivitis,

- Trachomatous conjunctivitis caused by Chlamydia trachomatis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology And Method Of Administration

Posology

Adults, Adolescents (12 to 17 years), children (2 to 11 years):

Instil one drop in the conjunctival fornix twice a day, morning and evening, during three days.

It is unnecessary to prolong treatment beyond three days.

Adherence to the dosing regimen is important for the success of treatment.

Children (1 to 2 years)

For trachomatous conjunctivitis, no dose adjustment is necessary.

For purulent bacterial conjunctivitis, there is no sufficient experience with Azyter in children younger than 2 years of age (see section 5.1).

Children (less than1 year)

There is no sufficient experience with Azyter in children younger than 1 year of age for trachomatous conjunctivitis as well as for purulent bacterial conjunctivitis (see section 5.1).

Elderly patients:

No dose adjustment is necessary.

Method of administration

Ocular use.

The patient should be advised to:

- thoroughly wash hands before and after the instillation,

- avoid touching the eye or eyelids with the dropper tip of the single-dose container,

- discard the single-dose container after use, and not keep it for subsequent use.

4.3 Contraindications

Hypersensitivity to azithromycin, to any other macrolide or to the excipient.

4.4 Special Warnings And Precautions For Use

The eye drops solution should not be injected nor be swallowed.

The eye drops solution should not be used for peri- or intra-ocular injection.

In the event of an allergic reaction, the treatment should be discontinued.

Based on the international consensus on diseases involving the eye and genital tractus and susceptible to be transmitted to new-borns, non-trachomatous conjunctivitis caused by Chlamydia trachomatis and conjunctivitis caused by Neisseria gonorrhoeae require a systemic treatment.

Except for the treatment of trachomatous conjunctivitis, Azyter is not recommended in infants under 2 years of age due to the lack of sufficient clinical data in this class of age.

This treatment is not intended to be used as prophylaxic treatment of bacterial conjunctivitis in newborn infants.

The patient should be informed that it is not necessary to continue to instil the eye drops solution after the end of treatment on the third day, even if residual signs of bacterial conjunctivitis remain.

Symptomatic relief occurs generally within 3 days. If there are no signs of improvement after 3 days, diagnosis should be reconsidered.

Contact lenses should not be worn by patients with bacterial conjunctivitis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interaction study has been performed with Azyter.

In view of the absence of detectable concentrations of azithromycin in the plasma during the administration of Azyter by ocular instillation (see section 5.2), none of the interactions with other medicinal products described for orally administered azithromycin is expected with use of the eye drops solution.

In the event of concomitant treatment with another eye drops solution, an interval of 15 minutes should be respected between instillation of the two solutions. Azyter should be instilled last.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate and well controlled studies in pregnant women. Animal reproduction studies show passage across the placenta. No teratogenic effects were observed in rat reproduction studies (see further section 5.3). Since animal studies are not always predictive of human response, Azyter should be used with caution during pregnancy.

Lactation

Limited data indicate that azithromycin is excreted in breast milk, but, considering the low dose and the low systemic availability, the doses taken by the new-born are negligible. Consequently, breast feeding is possible during the treatment.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effects on the ability to drive and use machines have been performed.

Vision may be transiently blurred after instillation. In this case, the patient should be advised to avoid driving or using machines until normal vision has been re-established.

4.8 Undesirable Effects

During clinical trials and according to post-marketing safety data on Azyter eye drops solution, the following treatment-related signs and symptoms were reported:

Eye disorders
	Very common (
	Ocular discomfort (pruritus, burning, stinging) upon instillation.
	Common (
	Blurred vision, sticky eye sensation, foreign body sensation upon instillation.
	Uncommon (
	Lachrymation increased upon instillation.
Immune system disorders
	Very rare (< 10,000)
	Hypersensitivity.

4.9 Overdose

The total amount of azithromycin in a single-dose container, containing a sufficient quantity for treating both eyes, is too small to induce adverse effects after inadvertent intravenous or oral administration.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: antibiotics, ATC code: S01AA26

Mode of action

Azithromycin is a second-generation macrolide antibiotic belonging to the azalide group.

It inhibits the synthesis of bacterial proteins by binding to the 50S ribosomal subunit and preventing peptide translocation.

Mechanism of resistance

Generally, the resistance of different bacterial species to macrolides has been reported to occur by three mechanisms associated with target site alteration, antibiotic modification, or altered antibiotic transport (efflux). Various efflux pump systems have been described in bacteria. An important efflux system in streptococci is conferred by the mef genes and results in a macrolide-restricted resistance (M phenotype). Target modification is controlled by erm encoded methylases (MLSB phenotype) and results in cross-resistance to several classes of antibiotics (see below).

A complete cross-resistance exists among erythromycin, azithromycin, other macrolides and lincosamides and streptogramin B for Streptococcus pneumoniae, beta-haemolytic streptococci of group A, Enterococcus spp. and Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA).

Constitutive mutants in inducibly resistant strains with erm(A) or erm(C) can be selected in vitro at low frequencies ~10^-7 cfu in the presence of azithromycin.

Breakpoints

The list of micro-organisms presented hereafter has been targeted to the indications (see section 4.1.).

Note that the breakpoints and in-vitro activity spectrum presented hereafter are those applicable to systemic use. These breakpoints may not be applicable to topical ocular application of the drug product due to the local concentrations that are reached and the local physicochemical conditions that may influence the overall activity of the agent at the site of application.

According to the EUCAST (European Committee on Antimicrobial Susceptibility Testing) the following breakpoints have been defined for azithromycin:

- Haemophilus influenzae : S

- Moraxella catarrhalis: S

- Neisseria gonorrhoeae: S

- Staphylococcus aureus: S

- Streptococcus pneumoniae: S

- Streptococcus A, B, C, G: S

For other species, EUCAST allows that erythromycin can be used to determine the susceptibility of the listed bacteria to azithromycin.

The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence is such that the utility of the agent in at least some types of infections is questionable.

Table: Antibacterial spectrum of azithromycin for bacterial species relevant to the indications

Commonly susceptible species

Aerobic Gram-negative

Moraxella (Branhamella) catarrhalis

Neisseria gonorrhoeae1

Haemophilus influenzae$

Haemophilus parainfluenzae$

Other micro-organisms

Chlamydia trachomatis*

Species for which acquired resistance may be a problem

Aerobic Gram-positive

Staphylococcus aureus Methi-S

Staphylococcus aureus Methi-R

Staphylococcus capitis

Staphylococcus coagulase negative Methi-S

Staphylococcus coagulase negative Methi-R

Staphylococcus epidermidis

Staphylococcus haemolyticus

Staphylococcus hominis

Staphylococcus hyicus

Staphylococcus intermedius

Staphylococcus warnerii

Streptococcus pneumoniae

Streptococcus pyogenes

Streptococci viridans

Streptococcus agalactiae

Streptococcus group G

Inherently resistant organisms

Aerobic Gram positive

Corynebacterium spp.

Enterococcus faecium

Aerobic Gram-negative

Pseudomonas aeruginosa

Acinetobacter

* Clinical effectiveness is demonstrated by sensitive isolated organisms for approved indications.

$ The correlation between H. influenzae macrolide MICs and clinical outcome is weak. Therefore, breakpoints for macrolides and related antibiotics were set to categorise wild type H. influenzae as intermediate.

Natural intermediate susceptibility

1 Conjunctivitis caused by Neisseria gonorrhoeae require a systemic treatment (see section 4.4).

Information from clinical trials

- Trachomatous conjunctivitis caused by Chlamydia trachomatis.

Azyter was evaluated in a two-month, randomised, double-masked study comparing Azyter with a single oral dose of azithromycin for the treatment of trachoma in 670 children (1-10 years). The primary efficacy variable was the clinical cure at Day 60, i.e. a grade TF0 (simplified WHO grading scale). At Day 60, clinical cure rate of Azyter instilled twice daily for 3 days (96.3%) was non-inferior to that of oral azithromycin (96.6%).

- Purulent bacterial conjunctivitis.

Azyter was evaluated in a randomised, investigator-masked study comparing Azyter, instilled twice daily for 3 days, with tobramycin 0.3% eye drops, instilled every two hours for 2 days then four times daily for 5 days, for the treatment of purulent bacterial conjunctivitis in 1043 patients (ITT set), including 109 children up to the age of 11 years from whom 5 were newborn infants (0 to 27 days) and 38 infants and toddlers (28 days to 23 months of age). In the Per Protocol set (n=471), there were no newborns and only 16 infants and toddlers. The clinical study was performed in different areas in Europe, North Africa, and India. The primary efficacy variable was the clinical cure at Day 9 in the PP set, defined as a score of 0 for both the bulbar conjunctival injection and the purulent discharge. At Day 9, clinical cure rate of Azyter (87.8%) was non-inferior to that of tobramycin (89.4%). Microbiological resolution rate of Azyter was comparable to that of tobramycin.

5.2 Pharmacokinetic Properties

Azithromycin was not detected in the blood of patients with bacterial conjunctivitis after instillation of Azyter at the recommended dose (detection limit: 0.0002 µg/mL of plasma).

5.3 Preclinical Safety Data

In animals, azithromycin caused reversible phospholipidosis. This effect was seen after oral exposures which were about 300 times in excess of the maximum human exposure after ocular administration indicating little relevance to clinical use.

Electrophysiological investigations have shown that azithromycin prolongs the QT interval.

Carcinogenic potential

Long-term studies in animals have not been performed to evaluate carcinogenic potential.

Mutagenic potential

There was no evidence of a potential for genetic and chromosome mutations in in vivo and in vitro test models.

Reproductive toxicity

No teratogenic effects were observed in embryotoxicity studies in rats after oral administration of azithromycin. In rats, azithromycin dosages of 100 and 200 mg/kg body weight/day led to mild retardations in fetal ossification and in maternal weight gain. In peri- and postnatal studies in rats, mild retardations following treatment with 50 mg/kg/day azithromycin and above were observed. These effects were seen after oral administration at exposures which were about 1000 times in excess of the maximum human exposures after ocular administration. Because of the high safety margin, these findings do not point to a relevant risk for human reproduction.

Ocular toxicity

Ocular administration of Azyter eye drops to animals twice or three times a day during 28 days did not demonstrate any local or systemic toxic effect.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Triglycerides, medium-chain.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Shelf-life of product in its commercial packaging: 18 months

After opening of the single-dose container, the eye drops, solution should be used immediately.

Discard the opened single-dose container immediately after first use.

6.4 Special Precautions For Storage

Do not store above 25°C.

Keep the single-dose containers in the sachet in order to protect them from light.

6.5 Nature And Contents Of Container

Single-dose low-density polyethylene container, each containing 0.25 g, enclosed in a sachet.

Pack-size: box of six single-dose containers.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

LABORATOIRES THEA

12, rue Louis Blériot

63017 CLERMONT-FERRAND CEDEX 2

FRANCE

8. Marketing Authorisation Number(S)

PL 20162/0012

9. Date Of First Authorisation/Renewal Of The Authorisation

25/03/2011

10. Date Of Revision Of The Text

25/03/2011

Sinus & Allergy PE

Generic Name: chlorpheniramine and phenylephrine (KLOR fen IR a meen and FEN il EFF rin)

Brand Names: Actifed Cold & Allergy, Allan Tannate Pediatric, Allerest PE, AlleRx, BP Allergy JR, C Phen, Cardec, Ceron, Chlor-Mes Jr, ChlorTan D, Cold & Allergy Relief, CP Dec, Dallergy Drops, Dallergy-JR, Dec-Chlorphen, Ed A-Hist, Ed ChlorPed D, Histadec, Nasohist Pediatric, NoHist, Ny-Tannic, PD-Hist D, PD-Hist D Drops, PediaTan D, Phenchlor Tannate Pediatric, R-Tanna, Relera, Rinate Pediatric, Rondec, Rondex, Rynatan, Rynatan Pediatric, Sildec-PE, Sinus & Allergy Maximum Strength, Sinus & Allergy PE, Sonahist, Sudafed PE Sinus & Allergy, Tanahist-D, Triaminic Cold & Allergy

What is Sinus & Allergy PE (chlorpheniramine and phenylephrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Phenylephrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and phenylephrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and phenylephrine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Sinus & Allergy PE (chlorpheniramine and phenylephrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and phenylephrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking Sinus & Allergy PE (chlorpheniramine and phenylephrine)?

Do not use chlorpheniramine and phenylephrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or phenylephrine, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  narrow angle glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are having an asthma attack.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  circulation problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma, emphysema or chronic bronchitis; or

  
  


• 
  

  urination problems or an enlarged prostate.

  
  

It is not known whether chlorpheniramine and phenylephrine is harmful to an unborn baby. Do not take this medication with a doctor's advice if you are pregnant. It is not known whether chlorpheniramine and phenylephrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take Sinus & Allergy PE (chlorpheniramine and phenylephrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

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

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking Sinus & Allergy PE (chlorpheniramine and phenylephrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and phenylephrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and phenylephrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Sinus & Allergy PE (chlorpheniramine and phenylephrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry nose or mouth;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

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.

What other drugs will affect Sinus & Allergy PE (chlorpheniramine and phenylephrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medications you use, especially:

• 
  

  mecamylamine (Inversine);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with chlorpheniramine and phenylephrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Sinus & Allergy PE resources

• Sinus & Allergy PE Side Effects (in more detail)
• Sinus & Allergy PE Use in Pregnancy & Breastfeeding
• Sinus & Allergy PE Drug Interactions
• Sinus & Allergy PE Support Group
• 0 Reviews for Sinus & Allergy PE - Add your own review/rating

• AlleRx Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardec Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Dallergy-JR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Ny-Tannic MedFacts Consumer Leaflet (Wolters Kluwer)


• Relera Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Rondec MedFacts Consumer Leaflet (Wolters Kluwer)


• Rynatan Prescribing Information (FDA)


• Sonahist Prescribing Information (FDA)

Compare Sinus & Allergy PE with other medications

• Cold Symptoms
• Hay Fever

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and phenylephrine.

See also: Sinus & Allergy PE side effects (in more detail)

Meglitinides

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Meglinitides work by stimulating the pancreas to release insulin in response to a meal. It closes ATP-dependent potassium channels in functioning pancreatic beta cells. This blockade of potassium channels depolarizes the beta cells, which leads to opening of calcium channels resulting in influx of calcium. Increased intracellular calcium induces insulin secretion.

Meglitinides are used in the treatment of Type 2 diabetes.

See also

Medical conditions associated with meglitinides:

• Diabetes, Type 2

Drug List:

Prandin

Starlix

Allerhist-1

Pronunciation: KLEM-ass-teen
Generic Name: Clemastine
Brand Name: Examples include Allerhist-1 and Tavist-1

Allerhist-1 is used for:

Preventing or treating symptoms of hay fever and other upper respiratory allergies or the common cold, such as runny nose, sneezing, itching of the nose and throat, and itchy, watery eyes, and relieving cough. It may also be used for other conditions as determined by your doctor.

Allerhist-1 is an antihistamine. It works by blocking the action of histamine, reducing the symptoms of an allergic reaction.

Do NOT use Allerhist-1 if:

• you are allergic to any ingredient in Allerhist-1 or other similar medicines


• you are taking sodium oxybate (GHB)


• you are currently taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) in the past 14 days


• you are breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Allerhist-1:

Some medical conditions may interact with Allerhist-1. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung disease, shortness of breath, or sleep apnea


• if you have blockage of the stomach, intestine, or urinary tract; difficulty urinating; diabetes; ulcers; enlargement of the prostate; glaucoma; heart disease; high blood pressure; porphyria; or thyroid disease

Some MEDICINES MAY INTERACT with Allerhist-1. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Sodium oxybate (GHB) because an increase in sleep duration and a decrease in the ability to breathe are likely to occur


• MAO inhibitors (eg, phenelzine) because they can cause serious, sometimes fatal, reactions

This may not be a complete list of all interactions that may occur. Ask your health care provider if Allerhist-1 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Allerhist-1:

Use Allerhist-1 as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Allerhist-1 may be taken with or without food.


• Use Allerhist-1 exactly as directed on the package, unless instructed differently by your doctor. If you are taking Allerhist-1 without a prescription, follow any warnings and precautions on the label.


• If you miss a dose of Allerhist-1 and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Allerhist-1.

Important safety information:

• Allerhist-1 may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Allerhist-1. Using Allerhist-1 alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.


• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Allerhist-1. Allerhist-1 will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.


• Allerhist-1 may cause dizziness. Alcohol, hot weather, exercise, and fever can increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness.


• Do not become overheated in hot weather or during exercise or other activities since heatstroke may occur.


• Do not use Allerhist-1 with any other medicine that contains clemastine. Before you begin taking any new prescription or over-the-counter medicine, including one used on the skin, read the ingredients to see if it also contains clemastine. If it does, or if you are uncertain if it does, contact your doctor or pharmacist.


• Do not use Allerhist-1 for persistent or chronic cough, such as that occurs with smoking, asthma, or emphysema, or if the cough is accompanied by excessive mucus, unless directed by a health care provider.


• If you are using Allerhist-1 for cough, cold, or allergy symptoms, stop use and contact your doctor if your symptoms do not improve within 7 days or are accompanied by fever.


• Use Allerhist-1 with caution in the ELDERLY because they may be more sensitive to its effects, especially dizziness, sedation, and lightheadedness upon standing.


• Use Allerhist-1 with extreme caution in CHILDREN. Talk to your doctor or pharmacist if you have any questions about the brand you are using.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Allerhist-1 during pregnancy. Allerhist-1 is excreted in breast milk. Do not breast-feed while taking Allerhist-1.

Possible side effects of Allerhist-1:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; dry mouth, throat, and nose; excitability; thickening of mucus in nose or throat.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions; fast heartbeat or pounding in the chest; decreased alertness; hallucinations; tremor; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Allerhist-1 side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; excitement; hallucinations; loss of consciousness; muscle twitching; seizures; tremor; weakness.

Proper storage of Allerhist-1:

Store Allerhist-1 at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), or according to directions on the package label. Store in the original package or container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Allerhist-1 out of the reach of children and away from pets.

General information:

• If you have any questions about Allerhist-1, please talk with your doctor, pharmacist, or other health care provider.


• Allerhist-1 is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Allerhist-1. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Allerhist-1 resources

• Allerhist-1 Side Effects (in more detail)
• Allerhist-1 Use in Pregnancy & Breastfeeding
• Allerhist-1 Drug Interactions
• Allerhist-1 Support Group
• 0 Reviews for Allerhist-1 - Add your own review/rating

• Clemastine Prescribing Information (FDA)


• Clemastine Fumarate Monograph (AHFS DI)


• Tavist Consumer Overview

Compare Allerhist-1 with other medications

• Allergic Reactions
• Hay Fever
• Urticaria

Indocin SR

Generic Name: indomethacin (in doe METH a sin)

Brand Names: Indocin, Indocin SR

What is Indocin SR (indomethacin)?

Indomethacin is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Indomethacin works by reducing hormones that cause inflammation and pain in the body.

Indomethacin is used to treat pain or inflammation caused by many conditions such as arthritis, gout, ankylosing spondylitis, bursitis, or tendinitis.

Indomethacin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Indocin SR (indomethacin)?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use indomethacin. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking indomethacin. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking indomethacin. Alcohol can increase the risk of stomach bleeding caused by indomethacin. Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to indomethacin (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

What should I discuss with my healthcare provider before taking Indocin SR (indomethacin)?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to indomethacin, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking indomethacin tell your doctor if you are allergic to any drugs, or if you have:

• 
  

  a history of heart attack, stroke, or blood clot;

  
  


• 
  

  heart disease, congestive heart failure, high blood pressure;

  
  


• 
  

  a history of stomach ulcers or bleeding;

  
  


• liver or kidney disease,


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma;

  
  


• 
  

  polyps in your nose;

  
  


• 
  

  a bleeding or blood clotting disorder; or

  
  


• 
  

  if you smoke.

  
  

If you have any of these conditions, you may need a dose adjustment or special tests to safely take indomethacin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking indomethacin during the last 3 months of pregnancy may harm the unborn baby. Do not take indomethacin during pregnancy unless your doctor has told you to. Indomethacin passes into breast milk and may affect a nursing baby. Do not take indomethacin without first talking to your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 14 years old without the advice of a doctor.

How should I take Indocin SR (indomethacin)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take indomethacin with food or milk to lessen stomach upset. Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you take indomethacin for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using indomethacin.

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

What happens if I miss a dose?

If you are taking indomethacin on a regular schedule, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose.

If you are taking indomethacin as needed, take the missed dose if it is needed, then wait the recommended or prescribed amount of time before taking another dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an indomethacin overdose may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

What should I avoid while taking Indocin SR (indomethacin)?

Do not drink alcohol while taking indomethacin. Alcohol can increase the risk of stomach bleeding caused by indomethacin. Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to indomethacin (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Indomethacin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Indocin SR (indomethacin) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking indomethacin and seek medical attention or call your doctor at once if you have any of these serious side effects:

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  chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  
  


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  black, bloody, or tarry stools;

  
  


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  coughing up blood or vomit that looks like coffee grounds;

  
  


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  swelling or rapid weight gain;

  
  


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  urinating less than usual or not at all;

  
  


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  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


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  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

  
  


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  bruising, severe tingling, numbness, pain, muscle weakness.

  
  

Less serious side effects may include:

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  upset stomach, mild heartburn, diarrhea, constipation;

  
  


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  bloating, gas;

  
  


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  dizziness, nervousness, headache;

  
  


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  skin rash, itching;

  
  


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  blurred vision; or

  
  


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  ringing in your ears.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Indocin SR (indomethacin)?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with indomethacin may cause you to bruise or bleed easily.

Before taking indomethacin, tell your doctor if you are taking any of the following drugs:

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  a blood thinner such as warfarin (Coumadin);

  
  


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  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


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  digoxin (digitalis, Lanoxin);

  
  


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  diuretics (water pills) such as furosemide (Lasix);

  
  


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  lithium (Eskalith, Lithobid);

  
  


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  methotrexate (Rheumatrex, Trexall);

  
  


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  probenecid (Benemid);

  
  


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  steroids (prednisone and others);

  
  


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  aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or

  
  


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  a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others.

  
  

This list is not complete and there may be other drugs that can interact with indomethacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Indocin SR resources

• Indocin SR Side Effects (in more detail)
• Indocin SR Use in Pregnancy & Breastfeeding
• Drug Images
• Indocin SR Drug Interactions
• Indocin SR Support Group
• 4 Reviews for Indocin SR - Add your own review/rating

• Indocin SR Prescribing Information (FDA)


• Indocin SR Advanced Consumer (Micromedex) - Includes Dosage Information


• Indocin SR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Indomethacin Professional Patient Advice (Wolters Kluwer)


• Indomethacin Prescribing Information (FDA)


• Indomethacin MedFacts Consumer Leaflet (Wolters Kluwer)


• Indocin Monograph (AHFS DI)


• Indocin MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Indocin SR with other medications

• Ankylosing Spondylitis
• Back Pain
• Bartter Syndrome
• Bursitis
• Cluster Headaches
• Frozen Shoulder
• Gitelman Syndrome
• Gout, Acute
• Langerhans' Cell Histiocytosis
• Osteoarthritis
• Pain
• Patent Ductus Arteriosus
• Rheumatoid Arthritis
• Sciatica
• Tendonitis

Where can I get more information?

• Your pharmacist can provide more information about indomethacin.

See also: Indocin SR side effects (in more detail)