Solpadol Capsules

1. Name Of The Medicinal Product

Solpadol Capsules

2. Qualitative And Quantitative Composition

Active Constituents
Paracetamol	500.0mg
Codeine Phosphate Hemihydrate	30.0mg

For excipients see 6.1.

3. Pharmaceutical Form

Capsules.

Solpadol Capsules are grey and purple with SOLPADOL printed on them in black ink.

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of severe pain.

4.2 Posology And Method Of Administration

Adults:	Two capsules not more frequently than every 4 hours, up to a maximum of 8 capsules in any 24 hour period.
Elderly:	As for adults, however a reduced dose may be required. See warnings.
Children:	Not recommended for children under 12 years of age.

Solpadol capsules are for oral administration.

4.3 Contraindications

Hypersensitivity to paracetamol or codeine which is rare.

Hypersensitivity to any of the other constituents.

Conditions where morphine and opioids are contraindicated e.g:

• Acute asthma

• Respiratory depression

• Acute alcoholism

• Head injuries

• Raised intra-cranial pressure

• Following biliary tract surgery

Monoamine oxidase inhibitor therapy, concurrent or within 14 days.

4.4 Special Warnings And Precautions For Use

Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression. Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.

The leaflet will state in the “pregnancy and breast-feeding” subsection of the section 2 “Before taking your medicine”:

Usually it is safe to take Solpadol while breast feeding as the levels of the active ingredients of this medicine in breast milk are too low to cause your baby any problems. However, some women who are at increased risk of developing side effects at any dose may have higher levels in their breast milk. If any of the following side effects develop in you or your baby, stop taking this medicine and seek immediate medical advice; feeling sick, vomiting, constipation, decreased or lack of appetite, feeling tired or sleeping for longer than normal, and shallow or slow breathing.

Care should be observed in administering the product to any patient whose condition may be exacerbated by opioids, particularly the elderly, who may be sensitive to their central and gastro-intestinal effects, those on concurrent CNS depressant drugs, those with prostatic hypertrophy and those with inflammatory or obstructive bowel disorders. Care should also be observed if prolonged therapy is contemplated.

Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease.

Patients should be advised not to exceed the recommended dose and not take other paracetamol containing products concurrently.

Patients should be advised to consult a doctor should symptoms persist and to keep the product out of the reach and sight of children.

The risk-benefit of continued use should be assessed regularly by the prescriber.

The leaflet will state in a prominent position in the 'before taking' section:

Do not take for longer than directed by your prescriber.

Taking codeine regularly for a long time can lead to addiction, which might cause you to feel restless and irritable when you stop the tablets.

Taking a pain killer for headaches too often or for too long can make them worse.

The label will state (To be displayed prominently on outer pack (not boxed) :

Do not take for longer than directed by your prescriber as taking codeine regularly for a long time can lead to addiction.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Paracetamol may increase the elimination half-life of chloramphenicol. Oral contraceptives may increase its rate of clearance. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

The effects of CNS depressants (including alcohol) may be potentiated by codeine.

4.6 Pregnancy And Lactation

There is inadequate evidence of the safety of codeine in human pregnancy. Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage. Both substances have been used for many years without apparent ill consequences and animal studies have not shown any hazard. Nonetheless careful consideration should be given before prescribing the products for pregnant patients. Opioid analgesics may depress neonatal respiration and cause withdrawal effects in neonates of dependent mothers.

Paracetamol is excreted in breast milk but not in a clinically significant amount.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.

However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolites may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant.

If symptoms of opioid toxicity develop in either the mother or the infant, then all codeine containing medicines should be stopped and alternative non-opioid analgesics prescribed. In severe cases consideration should be given to prescribing naloxone to reverse these effects.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.

4.8 Undesirable Effects

Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity. Tolerance and dependence can occur, especially with prolonged high dosage of codeine.

• Regular prolonged use of codeine/DHC is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped.

• Prolonged use of a painkiller for headaches can make them worse.

Adverse effects of paracetamol are rare:

Immune system disorders

- Hypersensitivity including skin rash may occur.

- Not known: Anaphylactic shock, angioedema.

There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol.

Very rare occurrence of pancreatitis.

4.9 Overdose

Codeine

The effects of Codeine overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs.

Symptoms

Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common. Hypotension and tachycardia are possible but unlikely.

Management

Management should include general symptomatic and supportive measures including a clear airway and monitoring of vital signs until stable. Consider activated charcoal if an adult presents within one hour of ingestion of more than 350 mg or a child more than 5 mg/kg.

Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life so large and repeated doses may be required in a seriously poisoned patient. Observe for at least 4 hours after ingestion, or 8 hours if a sustained release preparation has been taken.

Paracetamol

Patients in whom oxidative liver enzymes have been induced, including alcoholics and those receiving barbiturates and patients who are chronically malnourished, may be particularly sensitive to the toxic effects of paracetamol in overdose.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, coma and death. Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Liver damage is likely in adults who have taken 10g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.

Management

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any patient who has ingested around 7.5g or more of paracetamol in the preceding 4 hours should undergo gastric lavage. Administration of oral methionine or intravenous N-acetylcysteine which may have a beneficial effect up to at least 48 hours after the overdose, may be required. General supportive measures must be available.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Anilides, Paracetamol combinations

ATC Code: NO2B E51

Paracetamol is an analgesic which acts peripherally, probably by blocking impulse generation at the bradykinin sensitive chemo-receptors which evoke pain. Although it is a prostaglandin synthetase inhibitor, the synthetase system in the CNS rather than the periphery appears to be more sensitive to it. This may explain paracetamol's lack of appreciable anti-inflammatory activity. Paracetamol also exhibits antipyretic activity.

Codeine is a centrally acting analgesic which produces its effect by its action at opioid-binding sites (μ-receptors) within the CNS. It is a full agonist.

5.2 Pharmacokinetic Properties

Following oral administration of two capsules (ie, a dose of paracetamol 1000mg and codeine phosphate 60mg) the mean maximum plasma concentrations of paracetamol and codeine phosphate were 17.5 μg/ml and 327ng/ml respectively. The mean times to maximum plasma concentrations were 1.03 hours for paracetamol and 1.10 hours for codeine phosphate.

The mean AUC_(0-10) following administration was 48.0μg/ml per hour for paracetamol and 1301ng/ml per hour for codeine.

The bioavailabilities of paracetamol and codeine when given as the combination are similar to those when they are given separately.

5.3 Preclinical Safety Data

None stated

6. Pharmaceutical Particulars

6.1 List Of Excipients

Maize starch

Magnesium stearate

Talc

Indigotine E132

Azorubine E122

Titanium dioxide E171

Gelatin

Black iron oxide E172

Shellac

Propylene glycol

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Store in the original package. Do not store above 25°C.

6.5 Nature And Contents Of Container

White, opaque PVC (250μm)/aluminium foil (20μm)/ PVC (15μm) blister packs or White, opaque PVC (250μm)/ 35gsm Glassine (Pergamin) paper/9µm soft temper Aluminium foil contained in cardboard cartons.

Pack sizes of 100 capsules.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS, UK

8. Marketing Authorisation Number(S)

PL 04425/0635

9. Date Of First Authorisation/Renewal Of The Authorisation

4^th December 2008

10. Date Of Revision Of The Text

2 November 2011

LEGAL STATUS

POM

International Apex Bromhexine HCl

International Apex Bromhexine HCl may be available in the countries listed below.

Ingredient matches for International Apex Bromhexine HCl

Bromhexine

Bromhexine hydrochloride (a derivative of Bromhexine) is reported as an ingredient of International Apex Bromhexine HCl in the following countries:

• Philippines

International Drug Name Search

Canasa Rectal

Generic Name: mesalamine (Rectal route)

me-SAL-a-meen

Commonly used brand name(s)

In the U.S.

• Canasa


• Rowasa


• sfRowasa

In Canada

• Mesasal


• Pentasa


• Salofalk

Available Dosage Forms:

• Suppository


• Enema

Therapeutic Class: Gastrointestinal Agent

Chemical Class: Salicylate, Non-Aspirin

Uses For Canasa

Mesalamine is used to treat inflammatory bowel disease, such as ulcerative colitis. This medicine works inside the bowel by helping to reduce inflammation and other symptoms.

Mesalamine 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 this use is not included in product labeling, mesalamine is used in certain patients with the following medical condition:

• Ulcerative colitis, history of—prevent it from occurring again

Before Using Canasa

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of mesalamine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesalamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

• Varicella Virus Vaccine

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.

• Ardeparin


• Certoparin


• Dalteparin


• Danaparoid


• Enoxaparin


• Nadroparin


• Parnaparin


• Reviparin


• Tamarind


• Tinzaparin


• Warfarin

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:

• Kidney disease—The use of mesalamine may make this condition worse.

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Canasa. Please read with care.

For best results, empty your bowel just before using the rectal enema or suppository.

Keep using this medicine for the full time of treatment even if you begin to feel better after a few days. Do not miss any doses.

For patients using the enema form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Remove the bottles from the protective foil pouch, being careful not to squeeze or puncture them. The enema is an off-white to tan color. Contents of the enemas removed from the foil pouch may darken with time. Slight darkening will not affect the potency of the contents. However, enemas with dark brown contents should be discarded.


• Shake the bottle well to make sure that the medication is thoroughly mixed. Remove the protective cover from the applicator tip. Hold bottle at the neck so that no medicine spills out.


• Lie on your left side with your left leg straight and your right knee bent in front of you for balance. You can also lie in the knee-chest position, on your knees with your chest touching the bed.


• Gently insert the rectal tip of the enema applicator pointed slightly toward your naval to prevent damage to the rectal wall. Tilt the nozzle slightly toward the back and squeeze slowly to cause the enema to flow into your rectum. Steady pressure will discharge most of the medicine. After administering, withdraw and discard the bottle.


• Remain in position for at least 30 minutes to allow the medicine to distribute thoroughly. Retain the medicine all night if possible.

For patients using the suppository form of this medicine:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.


• Detach one suppository from strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.


• Avoid excessive handling of the suppository, which is designed to melt at body temperature.


• Insert suppository (pointed end first) completely into rectum with gentle pressure. Retain the suppository for 3 hours or longer, if possible, to achieve the best result.

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 inflammatory bowel disease:
  
  • For enema dosage form:
    
    • Adults and teenagers—4 grams (1 unit), used as directed, every night for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For suppository dosage form:
    
    • Adults and teenagers—500 milligrams (mg), inserted into your rectum, two or three times a day for three to six weeks or 1000 mg, inserted into your rectum, one time a day at bedtime for three to six weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

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.

Precautions While Using Canasa

It is important that your doctor check your progress at regular visits.

Contact your doctor if you develop cramping, acute abdominal pain, bloody diarrhea, fever, headache or rash. These may be symptoms of a serious condition.

Tell your doctor right away if you experience chest pain or shortness of breath.

Check with your doctor if you notice rectal bleeding, blistering, pain, burning, itching, or other sign of irritation not present before you started using this medicine.

Mesalamine rectal enema may stain clothing, fabrics, painted surfaces, marble, granite, vinyl, or other surfaces it touches.

Canasa 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 as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach cramps or pain (severe)


• anxiety


• back pain (severe)


• bloody, black, or tarry stools


• blue or pale skin


• bright red blood in the stool


• chest pain, possibly moving to the left arm, neck, or shoulder


• chills


• diarrhea (severe)


• fast heartbeat


• fever


• headache (severe)


• nausea or vomiting


• shortness of breath


• skin rash


• stomach cramps, tenderness, pain


• swelling of the stomach


• unusual tiredness or weakness


• watery or bloody diarrhea


• yellow eyes or skin

Incidence not known

• Blood in urine


• change in frequency of urination or amount of urine


• cough


• difficulty in breathing


• drowsiness


• high fever


• increased thirst


• loss of appetite


• lower back or side pain


• painful or difficult urination


• pale skin


• sore throat


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


• swelling of feet or lower legs


• swollen glands


• troubled breathing


• unexplained or unusual bleeding or bruising


• weakness

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

• Abdominal or stomach cramps or pain (mild)


• gas or flatulence


• headache (mild)


• nausea

Less common or rare

• Acne


• diarrhea


• dizziness


• leg or joint pain


• loss of hair


• rectal pain or irritation

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: Canasa Rectal 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.

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More Canasa Rectal resources

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

Compare Canasa Rectal with other medications

• Crohn's Disease
• Inflammatory Bowel Disease
• Ulcerative Colitis
• Ulcerative Colitis, Active
• Ulcerative Proctitis

AK-Spore HC Otic Suspension

Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)

Brand Names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic

What is AK-Spore HC Otic Suspension (hydrocortisone, neomycin, and polymyxin B otic)?

Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Neomycin and polymyxin B are antibiotics that fight bacteria.

The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.

This medication will not treat a viral infection such as herpes or shingles.

Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about AK-Spore HC Otic Suspension (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have a ruptured ear drum, or an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

Before using this medication, tell your doctor if you have herpes (simplex or zoster), chickenpox or small pox, any ear infection that causes blistering, asthma or sulfite allergy, or if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing. Stop using this medication and call your doctor at once if you have skin rash, redness, swelling, itching, dryness, scaling, severe burning or stinging, or other irritation in or around the ear. Other serious side effects include new signs of infection, hearing loss, or urinating less than usual or not at all.

What should I discuss with my health care provider before using AK-Spore HC Otic Suspension (hydrocortisone, neomycin, and polymyxin B otic)?

You should not use this medication if you are allergic to hydrocortisone, neomycin, or polymyxin B, or if you have:

• 
  

  a ruptured ear drum; or

  
  


• 
  

  an ear infection caused by chickenpox, or herpes infection (simplex or zoster).

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• 
  

  herpes (simplex or zoster);

  
  


• 
  

  chickenpox or small pox;

  
  


• 
  

  any ear infection that causes blistering;

  
  


• 
  

  asthma or sulfite allergy; or

  
  


• 
  

  if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).

  
  

FDA pregnancy category C. It is not known whether hydrocortisone, neomycin, and polymyxin B otic ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Hydrocortisone and colistin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication in a child younger than 2 years old.

How should I use AK-Spore HC Otic Suspension (hydrocortisone, neomycin, and polymyxin B otic)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Before using this medication, clean and dry your ear canal with sterile cotton.

Shake the ear drops well just before you measure a dose.

This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor's instructions about how much medication you should use and how often.

Do not use this medication for longer than 10 days in a row unless your doctor tells you to. Long-term use of neomycin may cause damage to your hearing.

To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.

Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.

After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.

As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.

Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include hearing problems, or urinating less than usual.

What should I avoid while using AK-Spore HC Otic Suspension (hydrocortisone, neomycin, and polymyxin B otic)?

Avoid getting this medication in your eyes. If this does happen, rinse with water.

AK-Spore HC Otic Suspension (hydrocortisone, neomycin, and polymyxin B otic) 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:

• 
  

  skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;

  
  


• 
  

  severe burning, stinging, or other irritation when using the medication;

  
  


• 
  

  new signs of infection;

  
  


• 
  

  hearing loss; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

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 AK-Spore HC Otic Suspension (hydrocortisone, neomycin, and polymyxin B otic)?

It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. 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 AK-Spore HC Otic Suspension resources

• AK-Spore HC Otic Suspension Side Effects (in more detail)
• AK-Spore HC Otic Suspension Use in Pregnancy & Breastfeeding
• AK-Spore HC Otic Suspension Drug Interactions
• 0 Reviews for AK-Spore HC Otic - Add your own review/rating

• Cort-Biotic Advanced Consumer (Micromedex) - Includes Dosage Information


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Phosphasal

Generic Name: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate (Oral route)

hye-oh-SYE-a-meen SUL-fate, meth-EN-a-meen, METH-i-leen BLOO, FEN-il sal-I-si-late, SOE-dee-um FOS-fate, mono-BAY-sik

Commonly used brand name(s)

In the U.S.

• Phosphasal


• Urelle


• Uretron D/S


• Uribel


• Urimar-T


• UR N-C


• Ustell


• Uticap


• Utira-C


• Utrona-C

Available Dosage Forms:

• Tablet


• Capsule


• Tablet, Enteric Coated


• Tablet, Extended Release

Therapeutic Class: Urinary Antispasmodic

Pharmacologic Class: Hyoscyamine

Chemical Class: Salicylate, Non-Aspirin

Uses For Phosphasal

Urelle® is a combination of five medicines: hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It is used to relieve discomfort, swelling, pain, frequent urge to urinate, and cramps or spasms of the urinary tract caused by an infection or a diagnostic procedure.

Hyoscyamine is an antispasmodic drug, which relieves muscle cramps or spasms. Methenamine and methylene blue are antiseptic drugs, which help clear a urinary tract infection. Phenyl salicylate is a pain reliever. Sodium phosphate makes the urine more acidic, which helps methenamine work better.

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

Before Using Phosphasal

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Urelle® in children. However, use is not recommended in children 6 years of age and younger.

Geriatric

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

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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amitriptyline


• Amoxapine


• Bupropion


• Cisapride


• Citalopram


• Clomipramine


• Desipramine


• Desvenlafaxine


• Doxepin


• Duloxetine


• Escitalopram


• Fluoxetine


• Fluvoxamine


• Imipramine


• Isocarboxazid


• Linezolid


• Maprotiline


• Mesoridazine


• Mirtazapine


• Nortriptyline


• Paroxetine


• Phenelzine


• Pimozide


• Potassium


• Protriptyline


• Selegiline


• Sertraline


• Sparfloxacin


• Thioridazine


• Tranylcypromine


• Trimipramine


• Venlafaxine


• Vilazodone

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.

• Alfuzosin


• Amiodarone


• Amitriptyline


• Amoxapine


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Astemizole


• Azithromycin


• Buspirone


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Crizotinib


• Dasatinib


• Desipramine


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Erythromycin


• Flecainide


• Fluconazole


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Lapatinib


• Levofloxacin


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Nefazodone


• Nilotinib


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Paliperidone


• Pazopanib


• Perflutren Lipid Microsphere


• Posaconazole


• Procainamide


• Prochlorperazine


• Promethazine


• Propafenone


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Salmeterol


• Saquinavir


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Telavancin


• Telithromycin


• Terfenadine


• Tetrabenazine


• Trazodone


• Trimipramine


• Vandetanib


• Vardenafil


• Vemurafenib


• Voriconazole


• Ziprasidone

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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Calcium Acetate


• Calcium Carbonate


• Calcium Citrate


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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:

• Congestive heart failure or


• Coronary heart disease or


• Glaucoma or


• Heart disease (e.g., mitral stenosis) or


• Heart rhythm problems (e.g., arrhythmia) or


• Myasthenia gravis (severe muscle weakness) or


• Stomach or intestinal (bowel) blockage or


• Stomach ulcers or


• Urinary problems (e.g., bladder blockage due to an enlarged prostate)—Use with caution. May make these conditions worse.

• Allergy or intolerance to belladonna or salicylates—Use with caution. May be sensitive to this medicine also.

Proper Use of hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate

This section provides information on the proper use of a number of products that contain hyoscyamine, methenamine, methylene blue, phenyl salicylate, and sodium phosphate. It may not be specific to Phosphasal. Please read with care.

Take this medicine for the full time of treatment, even if you begin to feel better. Also, keep your appointments with your doctor for check-ups so that your doctor will be better able to tell you when to stop taking this medicine.

Drink extra fluids after you take this medicine so you will pass more urine.

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 treatment of symptoms of urinary tract infection or diagnostic procedure:
    
    • Adults—One tablet four times a day
    
    
    • Children 7 years of age and older—Use and dose must be determined by your doctor.
    
    
    • Children 6 years of age and younger—Use is not recommended.
    
    
  
  

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 Phosphasal

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

If your or your child's symptoms do not improve or if they get worse, call your doctor.

Stop using this medicine and check with your doctor right away if you or your child have blurred vision, dizziness, or rapid pulse.

This medicine will make your urine to be colored blue. This is normal and is nothing to worry about.

This medicine will not cure a serious urinary tract infection and will only work to relieve symptoms as long as you continue to take it.

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.

Phosphasal 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:

Incidence not known

• Blurred vision


• dizziness


• rapid pulse

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:

Incidence not known

• Blue-colored urine

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.

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.

Mavik

Generic Name: Trandolapril
Class: Angiotensin-Converting Enzyme Inhibitors
VA Class: CV800
Chemical Name: 1-Ethyl ester (2S,3aR,7aS)-1-[(S)-N-[(S)-1-carboxy-3-phenylpropyl] alanyl]hexahydro-2-indolinecarboxylic acid
Molecular Formula: C₂₄H₃₄N₂O₅
CAS Number: 87679-37-6

• 
  

  May cause fetal and neonatal morbidity and mortality if used during pregnancy.^{1 81 82} (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  If pregnancy is detected, discontinue trandolapril as soon as possible.^{1 82}

  
  

Introduction

Nonsulfhydryl ACE inhibitor.^{1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17}

Uses for Mavik

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).^{1 3 5 11 13 14 15 16 17 31}

One of several preferred initial therapies in hypertensive patients with heart failure, postmyocardial infarction, high coronary disease risk, diabetes mellitus, chronic renal failure, and/or cerebrovascular disease.⁵⁹

Can be used as monotherapy for initial management of uncomplicated hypertension; however, thiazide diuretics are preferred by JNC 7.⁵⁹

Heart Failure or Left Ventricular Dysfunction after AMI

Reduction of the risk of mortality (mainly cardiovascular mortality) and risk of heart failure-associated hospitalization following MI in hemodynamically stable patients who have evidence of left ventricular systolic dysfunction or who have demonstrated clinical signs of CHF within a few days following AMI.^{1 32}

CHF

Management of symptomatic CHF†, usually in conjunction with cardiac glycosides, diuretics, and β-adrenergic blocking agents.^{58 60 61 62 63 64}

Diabetic Nephropathy

A first-line agent in the treatment of diabetic nephropathy† in hypertensive patients with type 2 diabetes mellitus.^{31 72 73 74 75 76 77 78}

Mavik Dosage and Administration

General

Hypertension

• 
  

  Trandolapril/verapamil fixed combination should not be used for initial treatment of hypertension.³¹

  
  

Administration

Oral Administration

Administer orally once or twice daily.¹

Administer trandolapril/verapamil fixed combination with food;²⁹ manufacturer makes no specific recommendation regarding administration of trandolapril with meals.¹

Dosage

Adults

Hypertension

Oral

Initially, 2 mg once daily in black patients and 1 mg once daily in patients of other races as monotherapy.^{1 31 59} Adjust dosage at intervals of ≥1 week.¹

In patients currently receiving diuretic therapy, discontinue diuretic, if possible, 2–3 days before initiating trandolapril.¹ May cautiously resume diuretic therapy if BP not controlled adequately with trandolapril alone.¹ If diuretic cannot be discontinued, initiate therapy at 0.5 mg daily under close medical supervision for several hours until BP has stabilized.¹

Usual dosage: 2–4 mg once daily.^{1 31 59}

If 4 mg once daily does not adequately control BP, consider administering drug in 2 divided doses.¹ If trandolapril monotherapy does not adequately control BP, consider adding a diuretic.¹

Limited clinical experience with dosages >8 mg daily.^{1 28}

Trandolapril/Verapamil Combination Therapy

Oral

Adjust dosage by first administering each drug separately.^{18 31 55} For patients receiving verapamil (up to 240 mg) and trandolapril (up to 8 mg) in separate tablets once daily, replacement with the fixed combination can be attempted using tablets containing the same component doses.²⁹

Heart Failure or Left Ventricular Dysfunction after AMI

Oral

Initially, 1 mg once daily;^{1 32} therapy may be initiated about 3–5 days after AMI.^{1 32}

Titrate dosage as tolerated to a target dosage of 4 mg once daily; if 4 mg daily is not tolerated, may continue therapy at the highest tolerated dosage.¹

Prescribing Limits

Adults

Hypertension

Oral

Limited clinical experience with dosages >8 mg daily.^{1 28}

Special Populations

Hepatic Impairment

Hypertension

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with hepatic cirrhosis;^{1 16} titrate subsequent dosage according to BP response.¹

Heart Failure or Left Ventricular Dysfunction after AMI

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with hepatic cirrhosis;^{1 16} titrate subsequent dosage as tolerated according to response.¹

Renal Impairment

Hypertension

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with severe renal impairment (Cl_cr <30 mL/minute);^{1 3 4 16 17} titrate subsequent dosage according to BP response.¹

Heart Failure or Left Ventricular Dysfunction after AMI

Oral

Reduced initial dosage (0.5 mg once daily) recommended in patients with severe renal impairment (Cl_cr <30 mL/minute); titrate subsequent dosage as tolerated according to response.¹

Cautions for Mavik

Contraindications

• 
  

  Known hypersensitivity (e.g., history of angioedema) to trandolapril or another ACE inhibitor.¹

  
  

Warnings/Precautions

Warnings

Hypotension

Possible symptomatic hypotension, particularly in volume- and/or salt-depleted patients (e.g., those treated with diuretics or undergoing dialysis, patients with diarrhea or vomiting).¹ Risk of marked hypotension, sometimes associated with oliguria, azotemia, and rarely, death in patients with CHF with or without associated renal insufficiency.¹

Hypotension may occur in patients undergoing surgery or during anesthesia with agents that produce hypotension; recommended treatment is fluid volume expansion.¹

To minimize potential for hypotension, consider recent antihypertensive therapy, extent of BP elevation, sodium intake, fluid status, and other clinical conditions.¹ May minimize potential for hypotension by correcting volume and/or salt depletion prior to initiating trandolapril therapy.¹ (See Dosage under Dosage and Administration.)

Initiate therapy in patients with CHF (with or without associated renal insufficiency) under close medical supervision; monitor closely for first 2 weeks following initiation of trandolapril or any increase in trandolapril or diuretic dosage.¹

Take care to avoid hypotension in patients with ischemic heart disease, aortic stenosis, or cerebrovascular disease.¹

If symptomatic hypotension occurs, place patient in supine position and, if necessary, administer IV infusion of 0.9% sodium chloride injection.¹ Transient hypotension is not a contraindication to additional doses; however, consider reinitiating therapy at reduced doses of trandolapril and/or diuretic.¹

Fetal/Neonatal Morbidity and Mortality

Possible fetal and neonatal morbidity and mortality when used during pregnancy.^{1 21 22 23 24 30 31 81 82} (See Boxed Warning.) Such potential risks occur throughout pregnancy, especially during the second and third trimesters.⁸²

Also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy.^{81 82}

Discontinue as soon as possible when pregnancy is detected, unless continued use is considered lifesaving.⁸² Nearly all women can be transferred successfully to alternative therapy for the remainder of their pregnancy.^{1 21}

Hepatic Effects

Clinical syndrome that usually is manifested initially by cholestatic jaundice and may progress to fulminant hepatic necrosis (occasionally fatal) reported rarely with ACE inhibitors.^{1 29}

If jaundice or marked elevation of liver enzymes occurs, discontinue drug and monitor patient.^{1 29}

Hematologic Effects

Neutropenia and agranulocytosis reported with captopril; risk of neutropenia appears to depend principally on presence of renal impairment and presence of collagen vascular disease (e.g., systemic lupus erythematosus, scleroderma); risk with trandolapril is unknown.¹

Consider monitoring leukocytes in patients with collagen vascular disease, especially if renal impairment exists.^{1 29}

Sensitivity Reactions

Anaphylactoid reactions and/or head and neck angioedema possible; angioedema associated with laryngeal edema may be fatal.^{1 29} If angioedema occurs, promptly discontinue trandolapril and observe patient until swelling disappears.¹ Immediate medical intervention (e.g., epinephrine) for involvement of tongue, glottis, or larynx.^{1 29}

Intestinal angioedema possible; consider in differential diagnosis of patients who develop abdominal pain.¹

Anaphylactoid reactions reported in patients receiving ACE inhibitors while undergoing LDL apheresis with dextran sulfate absorption or following initiation of hemodialysis that utilized high-flux membrane.^{1 29}

Life-threatening anaphylactoid reactions reported in at least 2 patients receiving ACE inhibitors while undergoing desensitization treatment with hymenoptera venom.^{1 29}

Contraindicated in patients with a history of angioedema associated with ACE inhibitors.¹

General Precautions

Renal Effects

Transient increases in BUN and S_cr possible, especially in patients with preexisting renal impairment or those receiving concomitant diuretic therapy.¹ Possible increases in BUN and S_cr in patients with unilateral or bilateral renal artery stenosis; generally reversible following discontinuance of ACE inhibitor and/or diuretic.^{1 29}

Possible oliguria, progressive azotemia, and rarely, acute renal failure and/or death in patients with severe CHF.¹

Closely monitor renal function following initiation of therapy in hypertensive patients with unilateral or bilateral renal artery stenosis.^{1 29} Some patients may require dosage reduction or discontinuance of ACE inhibitor and/or diuretic.¹

Hyperkalemia

Possible hyperkalemia, especially in patients with renal impairment or diabetes mellitus and those receiving drugs that can increase serum potassium concentration (e.g., potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes).¹ (See Specific Drugs under Interactions.)

Monitor serum potassium concentration carefully in these patients.¹

Cough

Persistent and nonproductive cough; resolves after drug discontinuance.¹

Specific Populations

Pregnancy

Category C (1st trimester); Category D (2nd and 3rd trimesters).¹ (See Boxed Warning.)

Lactation

Distributed into milk in rats.¹ Use not recommended.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults; however, possibility exists of greater sensitivity to the drug in some geriatric individuals.¹

Hepatic Impairment

Consider dosage reduction.¹ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Deterioration of renal function may occur.¹ (See Renal Effects under Cautions.)

Initial dosage adjustment recommended in patients with Cl_cr <30 mL/minute.¹ (See Renal Impairment under Dosage and Administration.)

Blacks

BP reduction may be smaller in black patients compared with nonblack patients;^{24 25 56 57} however, no apparent population difference during combined therapy with ACE inhibitor and thiazide diuretic.^{24 26 27 31} Use in combination with a diuretic.^{24 26 27 31}

Higher incidence of angioedema reported with ACE inhibitors in blacks compared with other races.^{1 57 59}

Common Adverse Effects

Patients with hypertension: Cough, dizziness, diarrhea.¹

Patients with left ventricular dysfunction after AMI: Cough, dizziness, hypotension, elevated serum uric acid concentrations, elevated BUN, percutaneous transluminal coronary angioplasty (PTCA) or CABG, dyspepsia, syncope, hyperkalemia.¹

Interactions for Mavik

Specific Drugs

Drug	Interaction	Comments
Cimetidine	Possible increase in plasma trandolapril concentrations but no change in plasma trandolaprilat concentrations and no change in ACE inhibition1
Digoxin	Pharmacokinetic interaction unlikely1
Diuretics	Increased hypotensive effect1	If possible, discontinue diuretic before initiating trandolapril1 (See Dosage under Dosage and Administration)
Diuretics, potassium-sparing (amiloride, spironolactone, triamterene)	Enhanced hyperkalemic effect1	Use with caution; monitor serum potassium concentrations frequently1
Lithium	Increased serum lithium concentrations; possible toxicity1	Use with caution; monitor serum lithium concentrations frequently1
Nifedipine	Pharmacokinetic interaction unlikely29
Potassium supplements or potassium-containing salt substitutes	Enhanced hyperkalemic effect1	Use with caution; monitor serum potassium concentrations frequently1
Warfarin	Pharmacologic interaction unlikely1

Mavik Pharmacokinetics

Absorption

Bioavailability

Prodrug;^{2 9} has little pharmacologic activity until hydrolyzed to trandolaprilat.^{1 3 4 5 7 12 16 17} Absolute bioavailability following oral administration of trandolapril is about 10% as trandolapril and 70% as trandolaprilat.¹

Peak concentrations of trandolapril and trandolaprilat are achieved within 1 and 4–10 hours, respectively, following administration in fasted state.¹

Onset

A single 2-mg dose results in approximately 70–85% inhibition of plasma ACE activity at 4 hours after administration.¹

During chronic therapy, maximum antihypertensive effect with any dosage is achieved within 1 week.¹

Duration

Following a single 2-mg dose, inhibition of plasma ACE activity declines by about 10% at 24 hours and by about one-half after 8 days.¹

Food

Food decreases rate of absorption but does not affect extent of absorption or peak plasma concentration.¹

Special Populations

In patients with mild to moderate alcoholic cirrhosis, plasma trandolapril and trandolaprilat concentrations are increased approximately 9- and 2-fold, respectively.¹

In patients with Cl_cr <30 mL/minute, plasma trandolapril and trandolaprilat concentrations are increased approximately 2-fold.¹

Distribution

Extent

Distributed into milk in rats.¹

Plasma Protein Binding

Trandolapril: 80% (independent of concentration).¹

Trandolaprilat: Concentration-dependent binding (65% at 1000 ng/mL and 94% at 0.1 ng/mL).¹

Elimination

Metabolism

Metabolized in the liver^{3 4 8 17} to an active metabolite, trandolaprilat.^{1 3 4 5 6 12 16 17} At least 7 other metabolites, principally glucuronide conjugates or de-esterification products, have been identified.¹

Elimination Route

Eliminated in urine (33%), principally as trandolaprilat, and in feces (66%).¹

Half-life

Trandolapril: 6 hours.¹

Trandolaprilat: 10 hours.¹

Stability

Storage

Oral

Tablets

20–25°C.¹

ActionsActions

• 
  

  Prodrug;^{2 9} has little pharmacologic activity until hydrolyzed in the liver^{3 4 8 17} to trandolaprilat.^{1 3 4 5 6 12 16 17}

  
  


• 
  

  Suppresses the renin-angiotensin-aldosterone system.¹

  
  

Advice to Patients

• 
  

  Risk of angioedema, anaphylactoid reactions, or other sensitivity reactions.¹ Importance of reporting sensitivity reactions (e.g., edema of face, eyes, lips, tongue, or extremities; hoarseness; swallowing or breathing with difficulty) immediately to clinician and of discontinuing the drug.¹

  
  


• 
  

  Importance of reporting signs of infection (e.g., sore throat, fever).¹

  
  


• 
  

  Risk of hypotension.¹ Importance of informing clinicians promptly if lightheadedness or fainting occurs.¹

  
  


• 
  

  Importance of adequate fluid intake; risk of volume depletion with excessive perspiration, dehydration, vomiting, or diarrhea.¹

  
  


• 
  

  Risks of use during pregnancy.^{1 81 82} (See Boxed Warning.)

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (including salt substitutes containing potassium), as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of patients informing clinicians that they are receiving an ACE inhibitor with a long duration of action prior to undergoing surgery and/or anesthesia.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Trandolapril

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	1 mg	Mavik (with povidone; scored)	Abbott
		2 mg	Mavik (with povidone)	Abbott
		4 mg	Mavik (with povidone)	Abbott

Trandolapril Combinations

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, extended-release core (containing verapamil hydrochloride 240 mg), film-coated	1 mg with Verapamil Hydrochloride 240 mg	Tarka (with povidone)	Abbott
	Tablets, extended-release core (containing verapamil hydrochloride 180 mg), film-coated	2 mg with Verapamil Hydrochloride 180 mg	Tarka (with povidone)	Abbott
	Tablets, extended-release core (containing verapamil hydrochloride 240 mg), film-coated	2 mg with Verapamil Hydrochloride 240 mg	Tarka (with povidone)	Abbott
	Tablets, extended-release core (containing verapamil hydrochloride 240 mg), film-coated	4 mg with Verapamil Hydrochloride 240 mg	Tarka (with povidone)	Abbott

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Mavik 1MG Tablets (ABBOTT): 100/$139.99 or 300/$397.95

Mavik 2MG Tablets (ABBOTT): 30/$56.99 or 90/$137.97

Mavik 4MG Tablets (ABBOTT): 30/$56.99 or 90/$137.97

Tarka 1-240MG Controlled-release Tablets (ABBOTT): 30/$105.99 or 90/$285.96

Tarka 2-180MG Controlled-release Tablets (ABBOTT): 30/$113.99 or 90/$329.97

Tarka 2-240MG Controlled-release Tablets (ABBOTT): 30/$113.99 or 90/$314.97

Tarka 4-240MG Controlled-release Tablets (ABBOTT): 30/$115.99 or 90/$334.98

Trandolapril 2MG Tablets (TEVA PHARMACEUTICALS USA): 100/$110.98 or 300/$310.97

Trandolapril 4MG Tablets (TEVA PHARMACEUTICALS USA): 100/$111.99 or 300/$315.95

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References

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Biliary Obstruction Medications

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Definition of Biliary Obstruction: Biliary obstruction involves the blockage of any duct that carries bile from the liver to the gallbladder or from the gallbladder to the small intestine.

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