Mirapex

Pronunciation: PRAM-i-PEX-ole
Generic Name: Pramipexole
Brand Name: Mirapex

Mirapex is used for:

Treating the signs and symptoms of Parkinson disease. It is also used to treat restless legs syndrome (RLS). It may also be used for other conditions as determined by your doctor.

Mirapex is a dopamine agonist. Exactly how Mirapex works is not known. It may increase the action of certain chemical receptors in the brain.

Do NOT use Mirapex if:

• you are allergic to any ingredient in Mirapex

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

Before using Mirapex:

Some medical conditions may interact with Mirapex. 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 kidney problems, low blood pressure, lightheadedness when you sit or stand up, or daytime sleepiness


• if you drink alcohol or have a history of compulsive behavior (eg, eating, gambling, shopping)


• if you have trouble controlling your muscles

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

• Cimetidine because it may increase the risk of Mirapex's side effects


• Butyrophenones (eg, haloperidol), metoclopramide, phenothiazines (eg, chlorpromazine), or thioxanthenes (eg, thiothixene) because they may decrease Mirapex's effectiveness


• Levodopa because the risk of its side effects may be increased by Mirapex

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mirapex 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 Mirapex:

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

• An extra patient leaflet is available with Mirapex. Talk to your pharmacist if you have questions about this information.


• Take Mirapex by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Your dose will be started low and gradually increased to achieve the best results. Do not change your dose sooner than recommended.


• Do not suddenly stop taking Mirapex without checking with your doctor. Severe side effects, including fever, mental or mood changes, and stiff muscles, may occur.


• If you miss a dose of Mirapex, 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. If you miss several doses, contact your doctor before you start to take Mirapex again.

Ask your health care provider any questions you may have about how to use Mirapex.

Important safety information:

• Mirapex may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Mirapex with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol while you are using Mirapex.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Mirapex; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Mirapex may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Some patients who take Mirapex have reported suddenly falling asleep while performing daily activities (eg, driving, eating, conversing). Many patients reported drowsiness before falling asleep; however, some patients did not experience drowsiness and felt that they were alert immediately before suddenly falling asleep. Use caution when driving, operating machinery, or performing other activities that could be dangerous. Inform your doctor if you experience unusual drowsiness or sleepiness while using Mirapex.


• If you are taking Mirapex for RLS, contact your doctor if you experience new or worsening symptoms, especially in the early morning hours.


• Some people have experienced new, unusual, or increased urges (eg, gambling, sexual urges) while using Mirapex. Tell your doctor right away if you notice such effects.


• Patients with Parkinson disease may have an increased risk of developing a certain type of skin cancer (melanoma). It is not known if Mirapex also increases the risk of melanoma. You may need to have skin exams while you are using Mirapex. Discuss any questions or concerns with your doctor.


• Lab tests, including blood pressure or skin checks, may be performed while you use Mirapex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Mirapex with caution in the ELDERLY; they may be more sensitive to its effects, especially hallucinations.


• Mirapex should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mirapex while you are pregnant. It is not known if Mirapex is found in breast milk. Do not breast-feed while taking Mirapex.

Possible side effects of Mirapex:

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:

Abnormal dreams; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; stuffy nose; tiredness; trouble sleeping; upset stomach; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; balance problems; change in behavior, mood, or emotions; chest pain; confusion; decreased sexual ability; difficulty walking; fainting; hallucinations; increased urination; memory loss; muscle pain, tenderness, or weakness; new or unusual skin growths; severe or persistent drowsiness or sleepiness; shortness of breath; sudden irresistible urge to sleep or suddenly falling asleep at unusual times; swelling of the arms or legs; trouble swallowing; unusual or intense urges (eg, gambling, sexual urges); unusual twitching or muscle movements; vision changes; vivid dreams or daydreams.

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: Mirapex 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 agitation; chest pain; confusion; decrease in blood pressure; difficulty moving; drowsiness; nausea; sedation; vomiting.

Proper storage of Mirapex:

Store Mirapex at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mirapex out of the reach of children and away from pets.

General information:

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


• Mirapex 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 Mirapex. 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 Mirapex resources

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

• Mirapex Prescribing Information (FDA)


• Mirapex Consumer Overview


• Mirapex Monograph (AHFS DI)


• Mirapex Advanced Consumer (Micromedex) - Includes Dosage Information


• Pramipexole Prescribing Information (FDA)


• Mirapex ER Prescribing Information (FDA)

Compare Mirapex with other medications

• Parkinson's Disease
• Periodic Limb Movement Disorder
• Restless Legs Syndrome

Buspar Tablets

1. Name Of The Medicinal Product

BUSPAR TABLETS 5 MG.

BUSPAR TABLETS 10 MG.

2. Qualitative And Quantitative Composition

Each tablet contains buspirone hydrochloride 5 mg or 10 mg.

3. Pharmaceutical Form

Oral tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

Buspar is indicated for the short-term management of anxiety disorders and the relief of symptoms of anxiety with or without accompanying depression.

4.2 Posology And Method Of Administration

Adults:

Dosage should be adjusted according to response for maximum effect. The recommended initial dose is 5 mg two to three times daily and this may be increased every two to three days. The usual therapeutic dose is 15 to 30 mg daily in divided doses with a maximum recommended dose of 45 mg daily in divided doses.

Elderly:

Dosage should be adjusted according to response for maximum effect. The recommended initial dose is 5 mg two to three times daily and this may be increased as required. The usual therapeutic dose is 15 to 30 mg daily in divided doses with a maximum recommended dose of 45 mg daily in divided doses.

Renal and Hepatic Impairment:

Dosage should be reduced in renal or hepatic impairment.

Children:

Placebo-controlled trails, in which 334 patients were treated with buspirone for up to six weeks, have not shown buspirone at doses recommended for adult to be an effective treatment for generalised anxiety disorder in patients less than 18 years.

Plasma concentrations of buspirone and its active metabolite were higher in paediatric patients, compared to adults given equivalent doses. (See 5.2, Pharmacokinetic Properties.)

4.3 Contraindications

Buspar should not be used in patients hypersensitive to any of the ingredients in the formulation. Buspar should not be used in patients with epilepsy. Buspar should not be used in patients with severe renal impairment, defined as creatinine clearance of 20 ml/minute or below, or a plasma creatinine above 200 micromoles/litre. Buspar should not be used in patients with severe hepatic disease.

4.4 Special Warnings And Precautions For Use

In controlled studies in healthy volunteers, Buspar in single doses up to 20 mg caused no significant impairment of cognitive or psychomotor functions, unlike the benzodiazepines, diazepam or lorazepam. In studies in healthy volunteers, Buspar did not potentiate the psychomotor impairment produced by alcohol, in contrast to a comparative benzodiazepine. However, no data are available on concomitant use of alcohol and Buspar at single doses greater than 20mg. It is prudent therefore to avoid alcohol while taking Buspar.

As Buspar does not exhibit cross-tolerance with benzodiazepines and other common sedative/hypnotic agents, it will not block the withdrawal syndrome often seen with cessation of therapy with these compounds. Before starting therapy with Buspar, it is advisable to withdraw patients gradually from prior chronic treatment with these agents.

In patients with a history of renal or hepatic impairment, Buspar should be used with caution.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The occurrence of elevated blood pressure in patients receiving both buspirone and monoamine oxidase inhibitors (phenelzine and tranylcypromine) has been reported. It is therefore recommended that Buspar should not be used concomitantly with a monoamine oxidase inhibitor (MAOI).

In vitro studies have shown that buspirone does not displace warfarin, digoxin, phenytoin or propranolol from plasma proteins.

In a study in normal volunteers, no interaction with amitriptyline was seen. A similar study with diazepam showed a slight increase in metabolite (nordiazepam) levels.

Buspirone has been shown “in vitro” to be metabolised by Cytochrome P450 3A4 (CYP3A4). This is consistent with the interaction observed between buspirone and substances that inhibit this isoenzyme, e.g. erythromycin, itraconazole, nefazodone, grapefruit juice, diltiazem and verapamil. In cases where Buspar is likely to be used with a potent inhibitor of CYP3A4 a lower dose of buspirone (e.g. 2.5mg b.i.d.) should be used.

Co-administration of rifampicin, a potent inducer of CYP3A4, with Buspar has been shown to considerably decrease the plasma concentration and pharmacodynamic effects of buspirone.

4.6 Pregnancy And Lactation

In some studies, administration of high doses of buspirone to pregnant animals produced effects on survival, birth and weaning weights, although there was no effect on foetal development. Since the relevance of this finding in humans has not been established, Buspar is contraindicated in pregnancy and in lactation.

4.7 Effects On Ability To Drive And Use Machines

Since early and transient adverse events may occur, patients should be cautioned not to drive or operate machines until they are certain that Buspar does not affect them adversely.

4.8 Undesirable Effects

Buspar is generally well tolerated. If side-effects occur they are normally observed at the beginning of treatment and usually subside with continued use and/or decreased dosage.

In controlled trials, the only side-effects that occurred with significantly greater frequency with buspirone treatment than with placebo were dizziness, headache, nervousness, light-headedness, excitement and nausea. Tachycardia, palpitations, chest pain, drowsiness, confusion, seizures, dry mouth, fatigue and sweating/clamminess have also been reported rarely.

4.9 Overdose

There is no specific antidote to Buspar. Buspar is not removed by haemodialysis. The stomach should be emptied as quickly as possible. Treatment should be symptomatic and supportive. The ingestion of multiple agents should be suspected.

Death by deliberate or accidental overdose has not been observed. A dose of 375 mg per day in healthy volunteers produced no significant adverse effects. As maximum dose levels are reached symptoms most commonly observed are: nausea, vomiting, dizziness, drowsiness and miosis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Buspar is an azaspirodecanedione. The exact mechanism of Buspar anxioselective action is not fully known. It does not act on benzodiazepine receptor sites and lacks sedative, anticonvulsant and muscle relaxant properties. From animal studies it is known to interact with serotonin, noradrenaline, acetylcholine and dopamine systems of the brain. Buspar enhances the activity of specific noradrenergic and dopaminergic pathways, whereas the activity of serotonin and acetylcholine are reduced.

5.2 Pharmacokinetic Properties

Buspar is rapidly absorbed when given orally. It is then subject to considerable first-pass metabolism. Peak plasma levels occur 60-90 minutes after dosing. Plasma concentration is linearly related to dose. Following multiple dosing steady state plasma concentrations are achieved within 2 days. Buspar is 95% protein bound. Buspar is eliminated primarily by liver metabolism. In pharmacokinetic studies mean plasma half-lives varied from 2 to 11 hours.

At steady state, the following doses of buspirone in children aged 6-12 years resulted in increases in Cmax (maximum concentration) and AUC (area under the curve), compared with adults, as shown in the table:

Dosage	Cmax	AUC
7.5 mg b.i.d	2.9 – fold	1.8 – fold
15 mg b.i.d	2.1 – fold	1.5 – fold

Across the dose range studied, the Cmax and AUC of 1-PP (the active metabolite of buspirone, 1-pyrimidinylpiperazine) in children were approximately double those of adults.

5.3 Preclinical Safety Data

No further relevant information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose anhydrous, sodium carboxymethyl starch, microcrystalline cellulose, silicon dioxide colloidal, magnesium stearate.

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 25°C

6.5 Nature And Contents Of Container

The tablets are packaged in blisters packs containing 90 tablets.

6.6 Special Precautions For Disposal And Other Handling

No specific instructions.

7. Marketing Authorisation Holder

Bristol-Myers Squibb Holdings Ltd

t/a Bristol-Myers Pharmaceuticals

Uxbridge Business Park

Sanderson Road

Uxbridge

Middlesex

UB8 1DH

8. Marketing Authorisation Number(S)

Buspar Tablets 5mg: PL 00125/0162

Buspar Tablets 10mg: PL 00125/0163

9. Date Of First Authorisation/Renewal Of The Authorisation

11.06.1987 / 16.05.2008

10. Date Of Revision Of The Text

16.05.2008

Endal HD

Generic Name: diphenhydramine, hydrocodone, and phenylephrine (dye fen HYE dra meen, hye droe KOE dohn, feh nill EH frin)

Brand Names: Endal HD, Tussinate

What is Endal HD (diphenhydramine, hydrocodone, and phenylephrine)?

Diphenhydramine is an antihistamine. It blocks the effects of the naturally occurring chemical histamine in the body and reduces congestion.

Hydrocodone is a narcotic. It is a pain reliever and a cough suppressant.

Phenylephrine is a decongestant. It works by constricting (shrinking) blood vessels (veins and arteries) in the body. Constriction of blood vessels in the sinuses and nose decreases congestion.

Diphenhydramine, hydrocodone, and phenylephrine is used to treat cough and nasal congestion associated with upper respiratory tract infections and allergies.

Diphenhydramine, hydrocodone, and phenylephrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Endal HD (diphenhydramine, hydrocodone, and phenylephrine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine, hydrocodone, and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine, hydrocodone, and phenylephrine.

Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.

Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if diphenhydramine, hydrocodone, and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

What should I discuss with my healthcare provider before taking Endal HD (diphenhydramine, hydrocodone, and phenylephrine)?

Do not take diphenhydramine, hydrocodone, and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Before taking diphenhydramine, hydrocodone, and phenylephrine, tell your doctor if you have

• 
  

  epilepsy or another seizure disorder;

  
  


• 
  

  been diagnosed with sleep apnea (periods of not breathing during sleep);

  
  


• 
  

  thyroid problems;

  
  


• 
  

  asthma;

  
  


• 
  

  gallbladder disease;

  
  


• 
  

  a head injury;

  
  


• 
  

  Addison's disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  an ulcer or an obstruction in the stomach;

  
  


• 
  

  bladder problems or difficulty urinating;

  
  


• an enlarged prostate;


• 
  

  high blood pressure, irregular heartbeats, or any type of heart disease;

  
  


• kidney problems; or


• liver problems.

You may not be able to take diphenhydramine, hydrocodone, and phenylephrine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Diphenhydramine, hydrocodone, and phenylephrine is in the FDA pregnancy category C. This means that it is not known whether diphenhydramine, hydrocodone, and phenylephrine will be harmful to an unborn baby. Do not take diphenhydramine, hydrocodone, and phenylephrine without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether diphenhydramine, hydrocodone, and phenylephrine passes into breast milk. Do not take diphenhydramine, hydrocodone, and phenylephrine without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine, hydrocodone, and phenylephrine. Your doctor may prescribe a lower dose of this medication.

How should I take Endal HD (diphenhydramine, hydrocodone, and phenylephrine)?

Take diphenhydramine, hydrocodone, and phenylephrine exactly as directed by your doctor. If you do not understand the directions on your prescription bottle, ask your pharmacist, nurse, or doctor to explain the instructions to you.

Diphenhydramine, hydrocodone, and phenylephrine can be taken with or without food.

To ensure that you get a correct dose, measure the liquid form of diphenhydramine, hydrocodone, and phenylephrine with a special dose-measuring spoon or cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Store diphenhydramine, hydrocodone, and phenylephrine at room temperature away from moisture and heat.

What happens if I miss a dose?

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 of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine, hydrocodone, and phenylephrine overdose may include severe drowsiness, dizziness, headache, seizures, dry mouth, cold and clammy skin, flushing, nausea, vomiting, difficulty or decreased breathing, and unconsciousness.

What should I avoid while taking Endal HD (diphenhydramine, hydrocodone, and phenylephrine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine, hydrocodone, and phenylephrine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine, hydrocodone, and phenylephrine.

Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, antihistamines, sedatives (used to treat insomnia), pain relievers, anxiety medicines, seizure medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any other medicine without first talking to your doctor.

Endal HD (diphenhydramine, hydrocodone, and phenylephrine) side effects

If you experience any of the following serious side effects, stop taking diphenhydramine, hydrocodone, and phenylephrine and seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

  
  


• 
  

  confusion, hallucinations, or unusual behavior.

  
  

Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine, hydrocodone, and phenylephrine and talk to your doctor if you experience

• 
  

  dizziness, drowsiness, or sleepiness;

  
  


• 
  

  restlessness or irritability;

  
  


• 
  

  blurred vision;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth, nausea, vomiting, or decreased appetite;

  
  


• 
  

  muscle twitches;

  
  


• 
  

  sweating;

  
  


• 
  

  itching;

  
  


• 
  

  decreased urination;

  
  


• 
  

  increased sensitivity to sunlight.

  
  

Hydrocodone is habit forming. It is possible become physically and/or psychologically dependent on the medication. Do not take more than the prescribed amount of medication or take it for longer than is directed by your doctor. Withdrawal effects may occur if diphenhydramine, hydrocodone, and phenylephrine is stopped suddenly after several weeks of continuous use. Your doctor may recommend a gradual reduction in dose.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Endal HD (diphenhydramine, hydrocodone, and phenylephrine)?

Do not take diphenhydramine, hydrocodone, and phenylephrine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Diphenhydramine, hydrocodone, and phenylephrine may increase the effects of other drugs that cause drowsiness, including antidepressants, alcohol, sedatives (used to treat insomnia), pain relievers, anxiety medicines, and muscle relaxants. Tell your doctor about all medicines that you are taking, and do not take any medicine without first talking to your doctor.

Drugs other than those listed here may also interact with diphenhydramine, hydrocodone, and phenylephrine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Endal HD resources

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

• Diphenhydramine/Hydrocodone/Phenylephrine Syrup MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Endal HD with other medications

• Cough and Nasal Congestion

Where can I get more information?

• Your pharmacist has more information about diphenhydramine, hydrocodone, and phenylephrine written for health professionals that you may read.

See also: Endal HD side effects (in more detail)

Minipress

Generic Name: prazosin (Oral route)

PRAZ-oh-sin

Commonly used brand name(s)

In the U.S.

• Minipress

Available Dosage Forms:

• Tablet


• Capsule

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Alpha-1 Adrenergic Blocker

Uses For Minipress

Prazosin is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Prazosin belongs to the general class of medicines called antihypertensives. It works by relaxing the blood vessels so that blood passes through them more easily. This helps to lower blood pressure. Prazosin may also be used for other conditions as determined by your doctor.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, prazosin is used in certain patients with the following medical conditions:

• Benign enlargement of the prostate.


• Congestive heart failure.


• Ergot alkaloid poisoning.


• Pheochromocytoma.


• Raynaud's disease.

For patients taking this medicine for benign enlargement of the prostate:

• Prazosin will not shrink the size of your prostate, but it does help to relieve the symptoms.

Before Using Minipress

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 prazosin in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of prazosin in geriatric patients.

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.

• Tadalafil

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.

• Acebutolol


• Alprenolol


• Atenolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Bucindolol


• Carteolol


• Carvedilol


• Celiprolol


• Dilevalol


• Esmolol


• Labetalol


• Levobunolol


• Mepindolol


• Metipranolol


• Metoprolol


• Nadolol


• Nebivolol


• Oxprenolol


• Penbutolol


• Pindolol


• Propranolol


• Sildenafil


• Sotalol


• Talinolol


• Tertatolol


• Timolol


• Vardenafil

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:

• Angina (chest pain) or


• Heart disease, severe or


• Postural hypotension (low blood pressure)—Prazosin may make these conditions worse.

• Cataract surgery—An eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in patients who are taking or who have recently taken this medicine when they are having cataract surgery. You should tell your ophthalmologist (eye doctor) before your surgery if you are taking prazosin.

• Kidney disease—Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Minipress

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any symptoms of the condition. In fact, many patients may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life.

To help you remember to take your medicine, try to get into the habit of taking it at the same time each day.

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 (capsules or tablets):
  
  • For high blood pressure:
    
    • Adults—At first, 0.5 or 1 milligram (mg) two or three times a day. Then, your doctor will slowly increase your dose to 6 to 15 mg and divided into two or three doses per day. However, the dose is usually not more than 20 mg a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 50 to 400 micrograms (mcg) (0.05 to 0.4 mg) per kilogram of body weight (22.73 to 181.2 mcg per pound [0.023 to 0.18 mg per pound]) a day. This is divided into two or three doses.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 Minipress

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased.

You may also have dizziness, lightheadedness, or fainting if you drink alcohol, stand for a long time, exercise or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather.

Prazosin may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy, drowsy, or are not alert.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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.

Minipress 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:

More common

• Dizziness or lightheadedness, especially when getting up from a lying or sitting position


• fainting (sudden)

Less common

• Loss of bladder control


• pounding heartbeat


• swelling of the feet or lower legs

Rare

• Chest pain


• painful inappropriate erection of penis (continuing)


• shortness of breath

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

• Drowsiness


• headache


• lack of energy

Less common

• Dryness of the mouth


• nervousness


• unusual tiredness or weakness

Rare

• Frequent urge to urinate


• nausea

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: Minipress side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Minipress resources

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

• Minipress Prescribing Information (FDA)


• Minipress MedFacts Consumer Leaflet (Wolters Kluwer)


• Minipress Concise Consumer Information (Cerner Multum)


• Minipress Monograph (AHFS DI)


• Prazosin Prescribing Information (FDA)


• Prazosin Professional Patient Advice (Wolters Kluwer)

Compare Minipress with other medications

• Benign Prostatic Hyperplasia
• Heart Failure
• High Blood Pressure
• Raynaud's Syndrome

Boots Diarrhoea Loperamide Hydrochloride 2mg Capsules

1. Name Of The Medicinal Product

Diareze Diarrhoea Relief Loperamide Hydrochloride 2mg Capsules

2. Qualitative And Quantitative Composition

Active ingredients
Loperamide Hydrochloride	2 mg per capsule

3. Pharmaceutical Form

Capsules, hard

4. Clinical Particulars

4.1 Therapeutic Indications

For the symptomatic treatment of acute diarrhoea of any aetiology including acute exacerbations of chronic diarrhoea for up to 5 days in adults and children over 9 years. For the symptomatic treatment of chronic diarrhoea in adults. (POM)

For the symptomatic treatment of acute diarrhoea in adults and children over 12 years. (P and GSL)

For the symptomatic treatment of acute diarrhoea associated with irritable bowel syndrome in adults, previously medically diagnosed. (P only)

4.2 Posology And Method Of Administration

For oral administration.

a) Acute diarrhoea

i. P and POM

Adults, including the elderly and children over 12 years

Two capsules initially followed by 1 capsule after each loose motion, up to a maximum of eight capsules in 24 hours. The usual dose is 3 to 4 capsules daily.

ii. POM

1. Children 9-12 years

One capsule four times daily until diarrhoea is controlled (up to 5 days).

2. Children under 9 years

Not recommended.

iii. GSL

Adults, including the elderly and children over 12 years:

Two capsules initially followed by 1 capsule after every loose motion, up to a maximum of six capsules in 24 hours.

b) Chronic diarrhoea in adults and the elderly (POM)

Initially two to four capsules to be taken daily in divided doses depending on severity. The dose can subsequently be adjusted as necessary up to a maximum of 8 capsules daily.

c) Symptomatic treatment of diarrhoea associated with irritable bowel syndrome in adults and the elderly (P)

Two capsules to be taken initially. The usual dose is between two and four capsules daily in divided doses, depending on severity. If necessary, the dose may be increased up to a maximum daily dosage of 8 capsules.

4.3 Contraindications

This medicine should not be used in patients hypersensitive to any of the ingredients or in children under 9 years of age. Loperamide should not be used when inhibition of peristalsis is to be avoided, in particular where ileus or constipation occur and should be avoided in patients with abdominal distension. Toxic megacolon has occurred in patients with inflammatory bowel disease or pseudomembranous colitis given antidiarrhoeal therapy. Loperamide should not be used alone in patients with dysentery.

Loperamide should not be used when inflammatory bowel disease is present (GSL).

4.4 Special Warnings And Precautions For Use

P and GSL

This medicine should be given with caution to patients with impaired liver function. Loperamide is for the symptomatic relief of acute diarrhoea and is not a suitable substitute for rehydration therapy. This product should not be used for prolonged periods.

Keep all medicines out of the reach of children.

If symptoms persist for more than 24 hours consult your doctor.

Ponceau 4R (E124) can cause allergic-type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.

Also for P use only

If you are an adult taking this medicine to control episodes of diarrhoea associated with irritable bowel syndrome, diagnosed by your doctor, you should seek medical advice if your symptoms continue for more than two weeks or if you need to take this product for more than two weeks.

Diarrhoea is a common presentation of a number of serious gastrointestinal conditions and this medicine should not be used for prolonged periods until the underlying cause for persistent diarrhoea has been investigated.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No clinically significant drug interactions known.

4.6 Pregnancy And Lactation

The safety of loperamide during pregnancy has not been established and therefore the product should be avoided during this period.

Whilst the fraction of loperamide secreted into breast milk is extremely low, caution is advised if the drug is to be given during lactation.

4.7 Effects On Ability To Drive And Use Machines

No adverse effects known.

4.8 Undesirable Effects

Abdominal pain, nausea, vomiting, constipation, dry mouth, dizziness, fatigue and hypersensitivity reactions, such as skin rashes including urticaria. Occasionally associated with the development of paralytic ileus and bloating.

4.9 Overdose

Symptoms of overdosage include constipation, paralytic ileus and CNS depression. Initial treatment consists of gastric lavage followed by the administration of activated charcoal and naloxone if necessary. Since the duration of action of loperamide is longer than that of naloxone the patient should be kept under constant observation for at least 48 hours in order to detect any possible CNS depression.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Loperamide hydrochloride is a synthetic opioid which inhibits gut motility by binding to opiate receptors in the gut wall and may also reduce gastrointestinal secretions, resulting in improvement in diarrhoea symptoms. Loperamide also increases the tone of the anal sphincter.

In a double blind randomised trial in 213 patients with acute diarrhoea, loperamide (56 patients) was compared with two other common antidiarrhoeal agents and placebo. Onset of antidiarrhoeal effect occurred as soon as one hour after intake of a 4mg dose of loperamide.

5.2 Pharmacokinetic Properties

More than 65% of a dose of loperamide is reported to be absorbed from the gastrointestinal tract. The drug undergoes considerable first pass metabolism in the liver and excretion via the bile in the faeces as the inactive conjugate. As a result of the drug's high affinity for the gut wall and its high first pass metabolism very little loperamide reaches the systemic circulation and therefore there is only a small amount of urinary excretion. The elimination half life is reported to be about 10 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose monohydrate

Magnesium stearate

Maize starch (pregelatinised)

Hard gelatin capsule (gelatin, Ponceau 4R-E124, Indigo Carmine-E132, Titanium dioxide-E171, Yellow and black iron oxides E172)

Ink (Black iron oxide E172, Shellac, Propylene glycol)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Do not store above 30°C. Store in the original package.

6.5 Nature And Contents Of Container

1. Blister of clear 250 micron PVC and 20 micron aluminium foil.

Pack size: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 48.

2. Blister of clear 250 micron PVC coated with 40 gsm PVdC and 20 micron aluminium foil.

Pack size: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36, 48.

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0611

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of First Authorisation:

14 August 2000

10. Date Of Revision Of The Text

April 2007

Recombinant human erythropoietins

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.

Recombinant human erythropoietins, act like endogenous erythropoietin to stimulate erythropoiesis, the process of red blood cell production. Endogenous erythropoietin is a hormone that is secreted by particular cells in the kidneys in response to reduced levels of oxygen reaching the tissues in the kidneys.

Recombinant human erythropoietins are given to patients with kidney failure to treat anemia.

See also

Medical conditions associated with recombinant human erythropoietins:

• Anemia
• Anemia Associated with Chronic Renal Failure
• Anemia Prior to Surgery
• Anemia, Chemotherapy Induced
• Anemia, Drug Induced

Drug List:

Aranesp

Epogen

Mircera

Procrit

Tositumomab

Pronunciation: tos-IT-too-moe-mab
Generic Name: Tositumomab
Brand Name: Bexxar

Tositumomab may cause serious allergic reactions, especially in patients who have received murine proteins previously. Seek immediate medical attention if you experience rash, itching, swelling, severe dizziness, or trouble breathing. Tositumomab may cause serious (possibly life-threatening) reductions in the number of white blood cells and platelets your body produces. This effect may last for an extended length of time. Additional treatment may be needed to manage this effect. Serious infections or bleeding could occur as a result of low blood cell levels. Contact your doctor immediately if you experience fever, persistent sore throat, any other sign of infection, or unusual bruising or bleeding. Tositumomab must not be used during pregnancy because fetal harm can result. Contact your doctor immediately if you suspect that you could be pregnant.

Tositumomab is used for:

Treating certain forms of non-Hodgkin lymphoma in patients who have not responded to other therapy.

Tositumomab is a monoclonal antibody protein. It works by recognizing and sticking to a protein receptor on cancer cells and then killing the cancer cell.

Do NOT use Tositumomab if:

• you are allergic to any ingredient in Tositumomab or to murine proteins


• you have bone marrow depression or a blood disorder such as anemia, neutropenia, or thrombocytopenia


• you are unable to take a thyroid blocker (eg, methimazole)

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

Before using Tositumomab:

Some medical conditions may interact with Tositumomab. 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 an infection or thyroid problems


• if you are scheduled to receive a vaccine

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

• Medicines that decrease blood clotting (eg, aspirin, clopidogrel, ibuprofen, warfarin) and medicines that affect the immune system (eg, azathioprine, corticosteroids, cyclosporine) because serious side effects, such as risk of bleeding or infections, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tositumomab 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 Tositumomab:

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

• Tositumomab is usually administered as an injection at your doctor's office, hospital, or clinic. Ask your doctor any question that you may have about Tositumomab.


• If you miss a dose of Tositumomab, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Tositumomab.

Important safety information:

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


• Tositumomab may reduce the number of certain blood cells, including red blood cells, white blood cells, and platelets. This may increase your risk of infection and bleeding. Prevent infection by avoiding contact with people with colds or other infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. Notify your doctor of any signs of infection, including fever, sore throat, rashes, or chills. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding or bruising; blood in stools; or black, tarry stools to your doctor.


• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Tositumomab.


• As with other cancer medicines, Tositumomab can cause a secondary cancer. Discuss the benefits and risks of using Tositumomab with your doctor.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Tositumomab.


• Tositumomab may reduce the levels of thyroid hormone your thyroid produces. Thyroid tests will be done before your doses and every year thereafter to monitor for any change in function of the thyroid gland.


• Some patients may develop an immune response called HAMA (human anti-murine antibody) after using Tositumomab. This antibody may interfere with certain lab test results. Be sure all of your doctors and laboratory personnel know that you are being treated, or have been treated, with Tositumomab.


• Both men and women capable of having children who receive Tositumomab should use reliable methods of birth control (eg, condoms) during and for at least 1 year after receiving Tositumomab.


• LAB TESTS, including complete blood cell counts, platelet counts, thyroid function tests, and kidney function tests, will be required to monitor your progress and check for side effects. Frequent monitoring will be done for up to 12 weeks after treatment. Be sure to keep all doctor and lab appointments.


• Caution is advised when using Tositumomab in the ELDERLY because they may be more sensitive to the effect Tositumomab has on blood cells.


• PREGNANCY and BREAST-FEEDING: It is unknown if Tositumomab can cause harm to the fetus. If you become pregnant while taking Tositumomab, discuss with your doctor the benefits and risks of using Tositumomab during pregnancy. Tositumomab is most likely excreted in breast milk. Do not breast-feed while receiving Tositumomab.

Possible side effects of Tositumomab:

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:

Constipation; diarrhea; dizziness; drowsiness; headache; muscle aches; nausea; pain, swelling, or redness at the injection site; stomach upset; vomiting.

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); black stools; easy bruising or bleeding; fast heartbeat; flu-like symptoms such as chills, cough, or sweating; infection; itching; lightheadedness; loss of appetite; lung infection; new growths or lumps; pain, including chest, stomach, muscle, neck, back, or joint pain; pale skin; persistent sore throat or fever; shortness of breath; sudden weight loss; swelling of the hands or feet; unusual tiredness or weakness; vomit that looks like coffee grounds.

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: Tositumomab 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.

Proper storage of Tositumomab:

Tositumomab is usually handled and stored by a health care professional. Keep Tositumomab out of reach of children and away from pets.

General information:

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


• Tositumomab 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 Tositumomab. 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 Tositumomab resources

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

• Tositumomab Monograph (AHFS DI)


• tositumomab Concise Consumer Information (Cerner Multum)


• tositumomab Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Tositumomab with other medications

• Diagnosis and Investigation

Autism Medications

Drugs associated with Autism

The following drugs and medications are in some way related to, or used in the treatment of Autism. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Topics under Autism

• Asperger Syndrome (4 drugs)

Learn more about Autism

Medical Encyclopedia:

• Autism

Harvard Health Guide:

• Symptoms and treatment for Autism (Autism Spectrum Disorder)

Drugs.com Health Center:

• Mental Health Disorders

Drug List:

Abilify

Abilify-Discmelt-Orally-Disintegrating-Tablets

Effexor

Effexor-Xr-Extended-Release-Capsules

Geodon

Risperdal

Risperdal-M-Tab-Orally-Disintegrating-Tablets

Triplex AD

Generic Name: chlorpheniramine, pyrilamine, and phenylephrine (KLOR fe NEER a meen, pir IL a meen, FEN il EFF rin)

Brand Names: AllerTan, Chlorex-A 12, Conal, MyHist-PD, Nalex A 12, Phena-Plus, Phena-S, Poly Hist PD, R-Tannate, Ru-Hist Forte, Tri-Hist Pediatric, Triotann-S Pediatric, Triple Tannate Pediatric, Triplex AD

What is chlorpheniramine, phenylephrine, and pyrilamine?

Chlorpheniramine and pyrilamine are antihistamines that reduce the effects of 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, phenylephrine, and pyrilamine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, and sinus congestion caused by allergies, the common cold, or the flu.

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

What is the most important information I should know about chlorpheniramine, phenylephrine, and pyrilamine?

Do not use this medicine 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. 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. Ask a doctor or pharmacist before using any other cold, cough, allergy, or pain medicine. Antihistamines and decongestants 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. This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase drowsiness caused by chlorpheniramine, phenylephrine, and pyrilamine. Before using chlorpheniramine, phenylephrine, and pyrilamine, tell your doctor if you regularly use other medicines that make you sleepy (such as sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine and pyrilamine.

What should I discuss with my healthcare provider before taking chlorpheniramine, phenylephrine, and pyrilamine?

Do not use this medicine 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, phenylephrine, pyrilamine, or to other decongestants, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  diabetes;

  
  


• 
  

  overactive thyroid; or

  
  


• 
  

  asthma, pneumonia, or other breathing problems.

  
  

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

• liver disease;


• kidney disease;


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  glaucoma;

  
  


• 
  

  enlarged prostate;

  
  


• 
  

  bladder obstruction or other urination problems; or

  
  


• 
  

  a blockage in your digestive tract (stomach or intestines).

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine, phenylephrine, and pyrilamine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Chlorpheniramine, phenylephrine, and pyrilamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using chlorpheniramine, phenylephrine, and pyrilamine.

How should I take chlorpheniramine, phenylephrine, and pyrilamine?

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. Cough or 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, or break an extended-release tablet. Swallow the pill whole. Breaking or crushing the pill may cause too much of the drug to be released at one time.

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.

Shake the oral suspension (liquid) well just before you measure a dose. Store at room temperature away from moisture, heat, and light.

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 dry mouth, dilated pupils, nausea, vomiting, and warmth, redness, or tingly feeling under your skin.

What should I avoid while taking chlorpheniramine, phenylephrine, and pyrilamine?

Ask a doctor or pharmacist before using any other cold, cough, allergy, or pain medicine. Antihistamines and decongestants 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. This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Drinking alcohol can increase certain side effects of this medication.

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.

Chlorpheniramine, phenylephrine, and pyrilamine 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:

• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  fast, pounding, or uneven heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure); or

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  upset stomach, constipation;

  
  


• 
  

  dry mouth;

  
  


• 
  

  blurred vision;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory;

  
  


• 
  

  sleep problems (insomnia); 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 chlorpheniramine, phenylephrine, and pyrilamine?

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by chlorpheniramine or pyrilamine. Tell your doctor if you regularly use any of these medicines, or any other cough and cold medications.

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

• 
  

  digoxin (Lanoxin);

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  an antidepressant;

  
  


• 
  

  a barbiturate such as phenobarbital (Solfoton) and others;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others); or

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others.

  
  

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

More Triplex AD resources

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

• Chlorpheniramine/Phenylephrine/Pyrilamine MedFacts Consumer Leaflet (Wolters Kluwer)


• AllerTan Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Phena-S Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Poly Hist PD Prescribing Information (FDA)


• Ru-Hist Forte Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Triplex AD with other medications

• Cold Symptoms
• Hay Fever

Where can I get more information?

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

See also: Triplex AD side effects (in more detail)

Nitroglycerin Injection USP 0.5% w / v, 10ml

1. Name Of The Medicinal Product

Nitroglycerin Injection U.S.P. 0.5% w/v, 10ml.

2. Qualitative And Quantitative Composition

Each 10ml contains 50mg of Nitroglycerin U.S.P.

3. Pharmaceutical Form

Clear, colourless or pale yellow sterile solution intended for parenteral administration to human beings after dilution in either Sodium Chloride Injection B.P. or Glucose Injection B.P.

4. Clinical Particulars

4.1 Therapeutic Indications

a) Control of blood pressure in perioperative hypertension, i.e. hypertension associated with surgical procedures, especially cardiovascular procedures and in the immediate post-surgical period.

b) Unresponsive congestive cardiac failure secondary to acute myocardial infarction.

c) Treatment of angina pectoris in patients who have not responded to recommended doses of organic nitrates and/or beta-adrenoceptor blocking agents.

d) Production of elective hypotension and maintenance of controlled hypotension during surgical procedures.

4.2 Posology And Method Of Administration

Route of administration: Intravenous infusion after dilution.

Nitroglycerin Injection is a concentrated potent drug which must be diluted in either Sodium Chloride Injection B.P. or Glucose Injection B.P. prior to its infusion.

Nitroglycerin Injection should not be mixed with other drugs. It is recommended that the drug is diluted to give a final concentration of 400 micrograms/ml or less, according to the dosage requirements of the patient. Most patients respond to doses between 10 – 200 micrograms/minute, although doses up to 400 micrograms/minute may be required during some surgical procedures.

Dosage: The usual recommended dose range is 10 - 200 micrograms/minute. Doses in excess of these have been used and up to 400 micrograms/minute may be required during some surgical procedures. Careful clinical assessment and frequent monitoring of blood pressure and heart rate are essential to maintain the appropriate rate of infusion. Where available, monitoring of pulmonary capillary wedge pressure and cardiac output can be used to titrate dosage to response.

Surgery: For the control of hypertensive episodes, the recommended starting dose is 25 micrograms/minute increasing in steps of 25 micrograms/minute at 5 minute intervals until the desired reduction in blood pressure is achieved. Although most patients respond to doses between 10 to 200 micrograms/minute, doses up to 400 micrograms/minute have been required during some surgical procedures. In the treatment of perioperative myocardial ischaemia, the recommended starting dose is 15 to 20 micrograms/minute increasing in steps of 10 to 15 micrograms/minute until the desired effect is achieved.

Unresponsive congestive cardiac failure secondary to acute myocardial infarction : The recommended starting dose is 20 to 25 micrograms/minute which can be decreased to 10 micrograms/minute or increased in steps of 20 to 25 micrograms/minute at 15 to 30 minute intervals until the desired effect is achieved.

Unstable angina: The recommended starting dose is 10 micrograms/minute increasing in steps of 5 to 10 micrograms/minute at approximately 30 minute intervals.

Children: The safety and effectiveness of nitroglycerin in children have not been established.

Use in the elderly : Special care in dose titration and monitoring is required in elderly patients, as there is an increased risk of a fall in perfusion pressure owing to a higher prevalence of coronary or cerebral artery disease in the elderly.

4.3 Contraindications

Known hypersensitivity to organic nitrates. Marked anaemia, raised intracranial pressure (e.g. due to head trauma or cerebral haemorrhage), uncorrected hypovolaemia or severe hypotension. Constrictive pericarditis and pericardiac tamponade.

The hypotensive effects of nitrates are potentiated by sildenafil, and their co-administration is contra-indicated.

4.4 Special Warnings And Precautions For Use

Nitroglycerin Injection should be used with caution in patients suffering from severe hepatic or renal disease, hypothyroidism, malnutrition, hypothermia and in those predisposed to closed angle glaucoma.

In order to achieve and maintain the correct dosage, continuous monitoring of physiological parameters must be performed, including blood pressure and heart rate in all patients and other measurements such as capillary wedge pressure as appropriate. The systemic blood pressure and coronary perfusion pressure must be maintained adequately at all times.

Nitroglycerin Injection should be administered by means of a micro-drip set infusion pump or similar device which permits maintenance of a constant infusion rate. The giving set should be composed of glass or rigid polyethylene. Infusion systems composed of PVC may absorb up to 50% of the nitroglycerin from solution, resulting in reduced potency of the infusion (see incompatibilities).

Excessive hypotension, especially for prolonged periods of time, must be avoided because of the possible deleterious effects of poor perfusion on body organs and the consequent risk of ischaemic damage.

Paradoxical bradycardia and increased angina pectoris may accompany nitroglycerin induced hypotension.

Patients with normal or low left ventricular filling pressure or pulmonary capillary wedge pressure are especially sensitive to the hypotensive effects of intravenous nitroglycerin and may respond fully to doses as small as 5 micrograms/minute. Where pulmonary capillary wedge pressure is being monitored, it will be noted that a fall in wedge pressure precedes the onset of arterial hypotension. Therefore, pulmonary capillary wedge pressure is a useful guide to titration of the drug in these circumstances.

Nitroglycerin Injection contains both alcohol and propylene glycol. Safety for intracoronary injection has not been shown.

Propylene glycol can lead to lacticacidosis and it is recommended that the duration of therapy with this product be restricted to no more than three successive days.

There are no long-term studies to evaluate the carcinogenic potential of nitroglycerin

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Nitroglycerin may potentiate the hypotensive effect of other anti-hypertensive agents. The hypotensive effects of nitrates are potentiated by sildenafil (see Contra-indications).

4.6 Pregnancy And Lactation

There is inadequate evidence of the safety of nitroglycerin in pregnancy and lactation.

Nitroglycerin Injection should not be used during pregnancy or lactation unless considered essential by the physician.

4.7 Effects On Ability To Drive And Use Machines

The indications for Nitroglycerin Injection limit its use to situations in which there would not be an opportunity to drive or to operate machinery.

4.8 Undesirable Effects

Adverse reactions to nitroglycerin may include hypotension, tachycardia, headache, nausea, vomiting, restlessness, dizziness, muscle twitching, palpitation, paradoxical bradycardia, retrosternal discomfort and abdominal pain.

4.9 Overdose

Accidental overdosage may result in severe hypotension and reflex tachycardia which can be managed by elevating the lower limbs and decreasing or temporarily withdrawing the infusion until the condition is stabilised. In extreme states of hypotension, intravenous administration of an alpha adrenergic agonist such as methoxamine hydrochloride or phenylephrine hydrochloride should be considered.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Nitroglycerin is an organic nitrate. Relaxation of vascular smooth muscle is the principal pharmacological action of nitroglycerin. Nitroglycerin causes dilatation of both venous and arterial smooth muscle in a dose-related manner. Venodilatation predominates at lower infusion rates and, as the infusion rate increases, nitroglycerin dilates both arterial and venous systems. Pulmonary vascular resistance, systemic vascular resistance and arterial pressure are all reduced by administration of intravenous nitroglycerin.

Dilatation of the post-capillary vessels promotes peripheral pooling of blood and decreases venous return, reducing left ventricular end-diastolic pressure (pre-load). Relaxation of arterioles reduces systemic vascular resistance and arterial pressure (after-load).

Myocardial oxygen consumption (as measured by the rate-pressure product and tension-time index) is decreased by both the venous and arterial effects of nitroglycerin, and a more favourable supply-demand ratio can be achieved. Although the predominant clinical benefits result from the peripheral vasodilating effects and the resultant decrease in myocardial oxygen demand, some effect on oxygen supply may occur by direct coronary vasodilatation. Redistribution of blood from normal to ischaemic areas of the myocardium has been demonstrated.

5.2 Pharmacokinetic Properties

Pharmacokinetic data for intravenous nitroglycerin are difficult to interpret due to factors such as the variation in sensitivity of assay procedures for calculating plasma concentrations of the drug, intersubject variation in plasma concentrations and adsorption of nitroglycerin by some types of giving sets. There appears to be no close correlation between the infusion rates of intravenous nitroglycerin and the blood concentrations achieved.

Nitroglycerin is extensively distributed and is rapidly metabolised in the liver and erythrocytes by the enzyme glutathione - organic nitrate reductase. The enzyme converts nitroglycerin to dinitrates, mononitrates and inorganic nitrites, which have about one tenth of the vasodilating activity of nitroglycerin and which are excreted in the urine within 24 hours after a single dose. The elimination half-life of nitroglycerin ranges from less than one minute to three minutes. Impaired hepatic function may impair the clearance of the drug.

5.3 Preclinical Safety Data

No further relevant information other than that which is contained in the other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Propylene Glycol B.P.

Ethanol B.P.

Water for Injections B.P.

6.2 Incompatibilities

Nitroglycerin Injection is compatible with glass infusion bottles. It has been shown to be compatible with certain rigid infusion packs made of polyethylene, such as the polyfusor from Kendall or bottlepak and flatpak from Braun, Dublin. The injection can be administered as an infusion using one of these recommended infusion bottles/packs.

Nitroglycerin Injection is not compatible with infusion bags made from polyvinyl chloride (PVC) and over 40% of the nitroglycerin activity can be lost if contact with PVC is prolonged. Therefore, it is recommended that contact with PVC bags is avoided. Some loss of activity can also occur through the infusion sets but the clinical response should be used to determine the rate of infusion and thus the dosage of the drug required by the patient.

Alternatively, nitroglycerin injection may be infused slowly via a syringe pump using a glass syringe or rigid plastic syringe (Gillette Sabre syringe, Brunswick Disposable, B.D. Plastipak syringes). A high pressure polyethylene tubing known to be compatible with nitroglycerin is the Lectrocath tubing, Vygon, Gloucester.

6.3 Shelf Life

3 years (36 months).

If only part of an ampoule is used, discard the remaining solution.

6.4 Special Precautions For Storage

Protect from light.

Store in a cool dry place.

6.5 Nature And Contents Of Container

10ml, clear glass ampoules, glass type 1 Ph. Eur., packed in cardboard cartons to contain 5 x 10ml or 10 x 10ml ampoules.

6.6 Special Precautions For Disposal And Other Handling

For administration by i.v. infusion only after dilution with a suitable vehicle such as 5% dextrose in water or 0.9% w/v sodium chloride.

Use as directed by the physician.

Keep out of reach of children.

If only part used, discard the remaining solution.

7. Marketing Authorisation Holder

Antigen International Ltd.,

Roscrea,

Co. Tipperary,

Ireland.

8. Marketing Authorisation Number(S)

PL 2848/0169.

9. Date Of First Authorisation/Renewal Of The Authorisation

29 November 1991.

10. Date Of Revision Of The Text

April 1999.