ClindaMax Topical

Generic Name: clindamycin (Topical route)

klin-da-MYE-sin

Commonly used brand name(s)

In the U.S.

• Cleocin T


• Clinda-Derm


• Clindagel


• ClindaMax


• ClindaReach


• Clindets


• Evoclin


• Z-Clinz

Available Dosage Forms:

• Gel/Jelly


• Pad


• Solution


• Foam


• Lotion

Therapeutic Class: Antiacne

Chemical Class: Lincosamide

Uses For ClindaMax

Clindamycin belongs to the family of medicines called antibiotics. Topical clindamycin is used to help control acne. It may be used alone or with one or more other medicines that are used on the skin or taken by mouth for acne. Topical clindamycin may also be used for other problems as determined by your doctor.

Clindamycin is available only with your doctor's prescription.

Before Using ClindaMax

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 this medicine in children up to 12 years of age 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. Although there is no specific information comparing use of this medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

• Erythromycin

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.

• Atracurium


• Metocurine


• Tubocurarine

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:

• History of stomach or intestinal disease (especially colitis, including colitis caused by antibiotics, or enteritis)—These conditions may increase the chance of side effects that affect the stomach and intestines

Proper Use of clindamycin

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

Before applying this medicine, thoroughly wash the affected areas with warm water and soap, rinse well, and pat dry.

When applying the medicine, use enough to cover the affected area lightly. You should apply the medicine to the whole area usually affected by acne, not just to the pimples themselves. This will help keep new pimples from breaking out.

You should avoid washing the acne-affected areas too often. This may dry your skin and make your acne worse. Washing with a mild, bland soap 2 or 3 times a day should be enough, unless you have oily skin. If you have any questions about this, check with your doctor.

Topical clindamycin will not cure your acne. However, to help keep your acne under control, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. You may have to continue using this medicine every day for months or even longer in some cases. If you stop using this medicine too soon, your symptoms may return. It is important that you do not miss any doses.

For patients using the topical foam form of clindamycin:

• After washing or shaving, it is best to wait 30 minutes before applying this medicine. The alcohol in it may irritate freshly washed or shaved skin.


• This medicine contains alcohol and is flammable. Do not use near heat, near open flame, or while smoking.


• To apply this medicine:
  
  • Do not dispense clindamycin topical foam directly onto your hands because the foam will begin to melt on contact with warm skin.
  
  
  • Remove the clear cap. Align the black mark with the nozzle of the actuator.
  
  
  • Hold the can upright and press firmly to dispense. Dispense amount that will cover the affected area(s) directly into the cap or onto a cool surface.
  
  
  • The can may be placed under cold running water if the can seems warm or the foam seems runny.
  
  
  • A small amount of topical foam should be picked up with your fingertips and massaged gently into the affected areas until the foam disappears.
  
  
  • Unused medicine that was removed from the can should be throw away.
  
  
  • Since this medicine contains alcohol, it will sting or burn. In addition, it has an unpleasant taste if it gets on the mouth or lips. Therefore, do not get this medicine in the eyes, nose, or mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If this medicine does get in the eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.
  
  


• It is important that you do not use this medicine more often than your doctor ordered. It may cause your skin to become too dry or irritated.

For patients using the topical solution form of clindamycin:

• After washing or shaving, it is best to wait 30 minutes before applying this medicine. The alcohol in it may irritate freshly washed or shaved skin.


• This medicine contains alcohol and is flammable. Do not use near heat, near open flame, or while smoking.


• To apply this medicine:
  
  • This medicine comes in a bottle with an applicator tip, which may be used to apply the medicine directly to the skin. Use the applicator with a dabbing motion instead of a rolling motion (not like a roll-on deodorant, for example). Tilt the bottle and press the tip firmly against your skin. If needed, you can make the medicine flow faster from the applicator tip by slightly increasing the pressure against the skin. If the medicine flows too fast, use less pressure. If the applicator tip becomes dry, turn the bottle upside down and press the tip several times to moisten it.
  
  
  • Since this medicine contains alcohol, it will sting or burn. In addition, it has an unpleasant taste if it gets on the mouth or lips. Therefore, do not get this medicine in the eyes, nose, or mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If this medicine does get in the eyes, wash them out immediately, but carefully, with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.
  
  


• It is important that you do not use this medicine more often than your doctor ordered. It may cause your skin to become too dry or irritated.

For patients using the topical suspension form of clindamycin:

• Shake well before applying.

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 topical dosage form (foam):
  
  • For acne:
    
    • Adults and children 12 years of age and over—Apply once a day to areas affected by acne.
    
    
    • Infants and children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  


• For topical dosage forms (gel, solution, and suspension):
  
  • For acne:
    
    • Adults and children 12 years of age and over—Apply two times a day to areas affected by acne.
    
    
    • Infants and children up to 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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 ClindaMax

If your acne does not improve within about 6 weeks, or if it becomes worse, check with your health care professional. However, treatment of acne may take up to 8 to 12 weeks before full improvement is seen.

If your doctor has ordered another medicine to be applied to the skin along with this medicine, it is best to apply them at different times. This may help keep your skin from becoming too irritated. Also, if the medicines are used at or near the same time, they may not work properly.

For patients using the topical solution form of clindamycin:

• This medicine may cause the skin to become unusually dry, even with normal use. If this occurs, check with your doctor.

In some patients, clindamycin may cause diarrhea.

• Severe diarrhea may be a sign of a serious side effect. Do not take any diarrhea medicine without first checking with your doctor . Diarrhea medicines may make your diarrhea worse or make it last longer.


• For mild diarrhea, only diarrhea medicine containing attapulgite (e.g., Kaopectate, Diasorb) may be taken. Other kinds of diarrhea medicine (e.g., Imodium A.D. or Lomotil) should not be taken. They may make your condition worse or make it last longer.


• If you have any questions about this or if mild diarrhea continues or gets worse, check with your health care professional.

You may continue to use cosmetics (make-up) while you are using this medicine for acne. However, it is best to use only “water-base” cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your acne worse. If you have any questions about this, check with your doctor.

ClindaMax 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:

Rare

• Abdominal or stomach cramps, pain, and bloating (severe)


• diarrhea (watery and severe), which may also be bloody


• fever


• increased thirst


• nausea or vomiting


• unusual tiredness or weakness


• weight loss (unusual)—these side effects may also occur up to several weeks after you stop using this medicine

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Skin rash, itching, redness, swelling, or other sign of irritation not present before use of this medicine

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

• Dryness, scaliness, or peeling of skin (for the topical solution)

Less common

• Abdominal pain


• diarrhea (mild)


• headache


• irritation or oiliness of skin


• stinging or burning feeling of skin

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: ClindaMax Topical side effects (in more detail)

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More ClindaMax Topical resources

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

Compare ClindaMax Topical with other medications

• Bacterial Vaginitis

Indocin Rectal

Generic Name: indomethacin (Rectal route)

in-doe-METH-a-sin

Rectal route(Suppository)

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s)

In the U.S.

• Indocin

In Canada

• Indocid


• Novo-Methacin Suppositories


• Ratio-Indomethacin


• Rhodacine

Available Dosage Forms:

• Suppository

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Uses For Indocin

Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain and help relieve symptoms of arthritis (e.g., osteoarthritis and rheumatoid arthritis) or gout, such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will help you only as long as you continue to take it.

Indomethacin is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine. This medicine may also be used to treat painful shoulder caused by bursitis or tendinitis.

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

Before Using Indocin

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 indomethacin in children below 14 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indomethacin in the elderly. However, elderly patients may be more sensitive to the effects of indomethacin than younger adults, and are more likely to have unwanted effects (e.g., stomach ulcers, confusion, psychosis) and age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving indomethacin.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

• Ketorolac


• Pentoxifylline

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.

• Abciximab


• Ardeparin


• Argatroban


• Beta Glucan


• Bivalirudin


• Certoparin


• Cilostazol


• Citalopram


• Clopidogrel


• Clovoxamine


• Dabigatran Etexilate


• Dalteparin


• Danaparoid


• Desirudin


• Digoxin


• Dipyridamole


• Enoxaparin


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Ginkgo


• Heparin


• Lepirudin


• Methotrexate


• Nadroparin


• Nefazodone


• Parnaparin


• Paroxetine


• Pemetrexed


• Potassium


• Protein C


• Reviparin


• Rivaroxaban


• Sertraline


• Sibutramine


• Tacrolimus


• Ticlopidine


• Tinzaparin


• Tirofiban


• Vilazodone


• Zimeldine

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


• Acetohexamide


• Alacepril


• Alprenolol


• Amiloride


• Arotinolol


• Atenolol


• Azilsartan Medoxomil


• Azosemide


• Befunolol


• Bemetizide


• Benazepril


• Bendroflumethiazide


• Benzthiazide


• Betaxolol


• Bevantolol


• Bisoprolol


• Bopindolol


• Bucindolol


• Bumetanide


• Bupranolol


• Buthiazide


• Candesartan Cilexetil


• Canrenoate


• Captopril


• Carteolol


• Carvedilol


• Celiprolol


• Chlorothiazide


• Chlorpropamide


• Chlorthalidone


• Cilazapril


• Clopamide


• Cyclopenthiazide


• Cyclosporine


• Delapril


• Desvenlafaxine


• Dilevalol


• Dipyridamole


• Duloxetine


• Enalaprilat


• Enalapril Maleate


• Eprosartan


• Esmolol


• Ethacrynic Acid


• Fosinopril


• Furosemide


• Gentamicin


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Hydrochlorothiazide


• Hydroflumethiazide


• Imidapril


• Indapamide


• Irbesartan


• Labetalol


• Landiolol


• Levobetaxolol


• Levobunolol


• Lisinopril


• Lithium


• Losartan


• Mepindolol


• Methyclothiazide


• Metipranolol


• Metolazone


• Metoprolol


• Milnacipran


• Moexipril


• Nadolol


• Nebivolol


• Nipradilol


• Olmesartan Medoxomil


• Oxprenolol


• Penbutolol


• Pentopril


• Perindopril


• Pindolol


• Piretanide


• Polythiazide


• Propranolol


• Quinapril


• Ramipril


• Sotalol


• Spirapril


• Spironolactone


• Talinolol


• Tasosartan


• Telmisartan


• Temocapril


• Tertatolol


• Timolol


• Tolazamide


• Tolbutamide


• Torsemide


• Trandolapril


• Triamterene


• Trichlormethiazide


• Valsartan


• Venlafaxine


• Warfarin


• Xipamide


• Zofenopril

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:

• Anemia or


• Bleeding problems or


• Blood clots or


• Depression or other mental changes or


• Edema (fluid retention or body swelling) or


• Heart attack, history of or


• Heart disease (e.g., congestive heart failure) or


• Hepatitis or jaundice, history of or


• Hypertension (high blood pressure) or


• Kidney disease or


• Parkinsonism or


• Seizures or epilepsy, history of or


• Stomach ulcers or bleeding, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma, history of or


• Aspirin sensitivity, history of or


• Proctitis (inflammation of the rectum), history of or


• Rectal bleeding, recent—Should not be used in patients with these conditions.

• Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.

• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of indomethacin

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

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken regularly as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of this medicine.

Do not take rectal suppositories by mouth.

To use the suppository:

• If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.


• Remove the foil wrapper and moisten the suppository with cold water.


• Lie down on your side and use your finger to push the suppository well up into the rectum


• Remain lying down for about 15 minutes to keep the suppository from coming out before it melts.


• Make sure to wash your hands with soap and water before and after inserting this medicine.

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 rectal dosage form (suppositories):
  
  • For ankylosing spondylitis, osteoarthritis, rheumatoid arthritis, bursitis, tendinitis, or gout:
    
    • Adults and teenagers older than 14 years of age—One 50-milligram (mg) suppository, inserted into the rectum up to four times a day.
    
    
    • Teenagers and children 14 years of age or younger—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.

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

Precautions While Using Indocin

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as a steroid medicine or a blood thinner).

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, loosening of the skin; chills; cough; diarrhea; fever; itching; joint or muscle pain; red skin lesions; sore throat; sores, ulcers, white spots in the mouth or on the lips; or unusual tiredness or weakness.

Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools; decreased urination; severe stomach pain; skin rash; swelling of the face, fingers, feet, or lower legs; unusual bleeding or bruising; unusual weight gain; vomiting of blood or material that looks like coffee grounds; or yellow skin or eyes. Also, signs of serious heart problems could occur, such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Stop using this medicine and check with your doctor right away if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in color of the skin of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine in the last few months of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if used at bedtime, it may cause some people to feel drowsy or less alert on arising. 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 not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

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. .

Indocin Side Effects

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

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

Less common

• Acid or sour stomach


• belching


• diarrhea


• heartburn


• indigestion


• nausea


• stomach discomfort, upset, or pain


• vomiting

Rare

• Abdominal or stomach cramping, burning, or tenderness


• back or leg pains


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloody or black, tarry stools


• blue lips and fingernails


• blurred vision


• breast enlargement and tenderness


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning upper abdominal pain


• canker sores


• change in consciousness


• change in hearing


• chest pain, discomfort, or burning


• clay colored stools


• cloudy or bloody urine


• confusion


• continuing diarrhea


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• cracks in the skin


• dark urine


• decreased appetite


• decreased vision or any change in vision


• depression


• difficult or labored breathing


• difficulty with swallowing


• dilated neck veins


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position


• double vision


• dry mouth


• extreme fatigue


• false sense of well-being


• feeling of unreality


• feeling of warmth


• fever with or without chills


• flushed, dry skin


• fruit-like breath odor


• general body swelling


• greatly decreased frequency of urination or amount of urine


• hair loss


• headache


• heavier menstrual periods


• hives or welts


• increased hunger


• increased sweating


• increased thirst


• increased urination


• irregular breathing


• irritation and swelling of the eye


• itching skin


• jerky movements of the head, face, mouth, and neck


• joint pain


• large, flat, blue or purplish patches in the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of balance control


• loss of bladder control


• loss of consciousness


• loss of hearing


• loss of heat from the body


• lower back or side pain


• mask-like face


• mental confusion


• mood swings


• muscle aches, pains, or weakness


• muscle spasm or jerking of all extremities


• nervousness


• noisy, rattling breathing


• nosebleeds


• numbness or tingling in the hands, feet, or lips


• pain in ankles or knees


• pain or discomfort in upper stomach or throat


• pain with swallowing


• painful or difficult urination


• painful, red lumps under the skin, mostly on the legs


• pale skin


• persistent bleeding or oozing from puncture sites, mouth, or nose


• personality changes


• pinpoint red or purple spots on the skin


• pounding in the ears


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• redness of the face, neck, arms and occasionally, upper chest


• scaly skin


• seeing double


• seeing, hearing, or feeling things that are not there


• seizures


• sense of detachment from self or body


• severe constipation


• severe mental changes


• severe or continuing stomach pain


• shortness of breath


• shuffling walk


• skin rash


• slow, fast, irregular, pounding, or racing heartbeat or pulse


• slowed movements


• slurred speech


• small red or purple spots on the skin


• sore throat


• sores, ulcers, or white spots on the lips or tongue or inside the mouth


• stiffness of the arms and legs


• sudden loss of consciousness


• sugar in the urine


• swelling in the legs and ankles


• swelling of the face, fingers, feet, or lower legs


• swelling of the breasts or breast soreness in both females and males


• swollen or painful glands


• tightness in the chest


• trembling and shaking of the fingers and hands


• troubled breathing at rest


• troubled breathing with exertion


• unexplained weight loss


• unpleasant breath odor


• unsteadiness or awkwardness


• unusual bleeding or bruising


• unusual tiredness or weakness


• vaginal bleeding


• vomiting of blood or material that looks like coffee grounds


• weakness in the arms, hands, legs, or feet


• weight gain


• wheezing


• yellow eyes or skin

Incidence not known

• Frequent urge to defecate


• rectal bleeding, burning, dryness, itching, or pain


• straining while passing stool

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

Symptoms of overdose

• Confusion about identity, place, and time


• severe headache


• unusual drowsiness, dullness, or feeling of sluggishness

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

• Mild headache

Less common

• Continuing ringing or buzzing or other unexplained noise in the ears


• difficulty having a bowel movement (stool)


• discouragement


• feeling sad or empty


• general feeling of discomfort or illness


• hearing loss


• irritability


• loss of interest or pleasure


• sleepiness


• trouble with concentrating

Rare

• Anxiety


• bloated full feeling


• changes in patterns and rhythms of speech


• excess air or gas in the stomach or intestines


• feeling of constant movement of self or surroundings


• involuntary muscle movements


• lightheadedness


• passing gas


• sensation of spinning


• sleeplessness


• tiredness


• trouble with speaking


• trouble sleeping


• unable to sleep

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: Indocin 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.

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 Indocin Rectal resources

• Indocin Rectal Side Effects (in more detail)
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• Drug Images
• Indocin Rectal Drug Interactions
• Indocin Rectal Support Group
• 14 Reviews for Indocin Rectal - Add your own review/rating

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• Bursitis
• Cluster Headaches
• Frozen Shoulder
• Gitelman Syndrome
• Gout, Acute
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laronidase

Generic Name: laronidase (lah RAH nih daze)

Brand Names: Aldurazyme

What is laronidase?

Laronidase is used to treat some of the symptoms of a genetic condition called Hurler syndrome. Hurler syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).

Hurler syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision or hearing loss, and changes in mental or physical abilities.

Laronidase may improve breathing and walking ability in people with this condition. However, this medication is not a cure for Hurler syndrome.

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

What is the most important information I should know about laronidase?

Laronidase may improve breathing and walking ability in people with Hurler syndrome. However, laronidase is not a cure for this condition. Some people receiving a laronidase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, or trouble breathing when laronidase is injected.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that laronidase has on long-term treatment of Hurler syndrome.

What should I discuss with my healthcare provider before receiving laronidase?

You should not use this medication if you are allergic to laronidase.

Before using laronidase, tell your doctor if you are allergic to any drugs.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that laronidase has on long-term treatment of Hurler syndrome.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether laronidase passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use laronidase?

Laronidase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting. Laronidase is usually given once per week.

The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.

Your doctor may also prescribe other medications to help prevent an allergic reaction to laronidase. Take all of your medications as directed.

To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your laronidase injection.

What happens if I overdose?

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

Symptoms of a laronidase overdose are not known.

What should I avoid while receiving laronidase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving laronidase.

Laronidase 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. Some people receiving a laronidase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, skin rash or itching, warmth or tingly feeling, or trouble breathing when laronidase is injected.

Less serious side effects may include:

• 
  

  runny or stuffy nose, sore throat, cough;

  
  


• 
  

  mild skin rash;

  
  


• 
  

  numbness or tingling; or

  
  


• 
  

  pain, redness, swelling, or other irritation where the medicine was injected.

  
  

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

Laronidase Dosing Information

Usual Adult Dose for Mucopolysaccharidosis Type I:

Recommended dose: 0.58 mg/kg of body weight administered once-weekly by intravenous infusion.

Pretreatment with antipyretics and/or antihistamines is recommended 60 minutes prior to the start of the infusion.

The total volume of the infusion is determined by the patient's body weight and should be delivered over approximately 3 to 4 hours. Patients with a body weight of 20 kg or less should receive a total volume of 100 mL. Patients with a body weight of greater than 20 kg should receive a total volume of 250 mL. The initial infusion rate of 10 mcg/kg/hr may be incrementally increased every 15 minutes during the first hour, as tolerated, until a maximum infusion rate of 200 mcg/kg/hr is reached. The maximum rate is then maintained for the remainder of the infusion (2 to 3 hours).

For Patients Weighing 20 kg or Less
Total Volume of laronidase Infusion = 100 mL
Start at 2 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 4 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 8 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 16 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 32 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

For Patients Weighing Greater than 20 kg
Total Volume of laronidase Infusion = 250 mL
Start with 5 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 10 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 20 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 40 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 80 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

Usual Pediatric Dose for Mucopolysaccharidosis Type I:

Greater then or equal to 5 years old:

Recommended dose: 0.58 mg/kg of body weight administered once-weekly by intravenous infusion.

Pretreatment with antipyretics and/or antihistamines is recommended 60 minutes prior to the start of the infusion.

The total volume of the infusion is determined by the patient's body weight and should be delivered over approximately 3 to 4 hours. Patients with a body weight of 20 kg or less should receive a total volume of 100 mL. Patients with a body weight of greater than 20 kg should receive a total volume of 250 mL. The initial infusion rate of 10 mcg/kg/hr may be incrementally increased every 15 minutes during the first hour, as tolerated, until a maximum infusion rate of 200 mcg/kg/hr is reached. The maximum rate is then maintained for the remainder of the infusion (2 to 3 hours).

For Patients Weighing 20 kg or Less
Total Volume of laronidase Infusion = 100 mL
Start at 2 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 4 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 8 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 16 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 32 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

For Patients Weighing Greater than 20 kg
Total Volume of laronidase Infusion = 250 mL
Start with 5 mL/hr x 15 minutes (10 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 10 mL/hr x 15 minutes (20 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 20 mL/hr x 15 minutes (50 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 40 mL/hr x 15 minutes (100 mcg/kg/hr). Obtain vital signs, if stable then increase the rate to 80 mL/hr x approximately 3 hours (200 mcg/kg/hr) for the remainder of the infusion.

What other drugs will affect laronidase?

There may be other drugs that can interact with laronidase. 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 laronidase resources

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

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


• Laronidase Professional Patient Advice (Wolters Kluwer)


• Laronidase MedFacts Consumer Leaflet (Wolters Kluwer)


• Laronidase Monograph (AHFS DI)


• Aldurazyme Prescribing Information (FDA)


• Aldurazyme Consumer Overview

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• Mucopolysaccharidosis Type I

Where can I get more information?

• Your doctor or pharmacist can provide more information about laronidase.

See also: laronidase side effects (in more detail)

Sotalol 160 mg Tablets

1. Name Of The Medicinal Product

Sotalol 160mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains 160mg Sotalol hydrochloride

For Excipients see 6.1.

3. Pharmaceutical Form

Tablet

Round, blue coloured, flat bevelled edged tablets with a break line on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Sotalol 160mg Tablets are indicated for:

1. Ventricular arrhythmias:

• Treatment of life-threatening ventricular tachyarrhythmias;

• Treatment of symptomatic non-sustained ventricular tachyarrhythmias

2. Supraventricular arrhythmias:

• Prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal A-V nodal re-entrant tachycardia, paroxysmal A-V re-entrant tachycardia using accessory pathways, and paroxysmal supraventricular tachycardia after cardiac surgery;

• Maintenance of normal sinus rhythm following conversion of atrial fibrillation or atrial flutter

4.2 Posology And Method Of Administration

As with other antiarrhythmic agents, it is recommended that Sotalol 160mg Tablets be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm. The dosage must be individualised and based on the patient's response. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.

In view of its β-adrenergic blocking properties, treatment with Sotalol 160mg Tablets should not be discontinued suddenly, especially in patients with ischaemic heart disease (angina pectoris, prior acute myocardial infarction) or hypertension, to prevent exacerbation of the disease (see 4.4 Warnings).

The initiation of treatment or changes in dosage with sotalol should follow an appropriate medical evaluation including ECG control with measurement of the corrected QT interval, and assessment of renal function, electrolyte balance and concomitant medications (See 4.4 Warnings and precautions).

As with other antiarrhythmic agents, it is recommended that sotalol be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm. The dosage must be individualised and based on the patient's response. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment.

In view of its β-adrenergic blocking properties, treatment with sotalol should not be discontinued suddenly, especially in patients with ischaemic heart disease (angina pectoris, prior acute myocardial infarction) or hypertension, to prevent exacerbation of the disease (see 4.4 Warnings).

The following dosing schedule can be recommended:

The initial dose is 80 mg, administered either singly or as two divided doses.

Oral dosage of sotalol should be adjusted gradually allowing 2-3 days between dosing increments in order to attain steady-state, and to allow monitoring of QT intervals. Most patients respond to a daily dose of 160 to 320 mg administered in two divided doses at approximately 12 hour intervals. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 - 640 mg/day. These doses should be used under specialist supervision and should only be prescribed when the potential benefit outweighs the increased risk of adverse events, particularly proarrhythmias (see 4.4 Warnings).

Children

Sotalol is not intended for administration to children.

Dosage in renally impaired patients

Because sotalol is excreted mainly in urine, the dosage should be reduced when the creatinine clearance is less than 60 ml/min according to the following table:

Creatinine clearance (ml/min)	Adjusted doses
> 60	Recommended Dose
30-60	½ recommended Dose
10-30	¼ recommended Dose
< 10	Avoid Sotalol

Dosage in hepatically impaired patients

No dosage adjustment is required in hepatically impaired patients.

4.3 Contraindications

Sotalol should not be used where there is evidence of:

• sick sinus syndrome

• second and third degree AV heart block unless a functioning pacemaker is present

• congenital or acquired long QT syndromes

• torsades de pointes

• symptomatic sinus bradycardia

• uncontrolled congestive heart failure

• cardiogenic shock

• anaesthesia that produces myocardial depression

• untreated phaeochromocytoma

• hypotension (except due to arrhythmia)

• Raynaud's phenomenon and severe peripheral circulatory disturbances

• history of chronic obstructive airway disease or bronchial asthma

• hypersensitivity to any of the components of the formulation

• metabolic acidosis

• renal failure (creatinine clearance < 10 ml/min).

• Contraindicated Combination: Sotalol should not be administered in combination with drugs like class Ia antiarrhythmics, class II antiarrhythmics such as amiodarone, dofetilide, ibutilide etc; neuroleptics such as trimipramine, phenobarbitone, chlorpromazine etc; and antibiotics such as erythromycin IV and moxifloxacin

4.4 Special Warnings And Precautions For Use

Abrupt Withdrawal

Hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias, and in some cases, myocardial infarction have been reported after abrupt discontinuation of therapy. Patients should be carefully monitored when discontinuing chronically administered sotalol, particularly those with ischaemic heart disease. If possible the dosage should be gradually reduced over a period of one to two weeks, if necessary at the same time initiating replacement therapy. Abrupt discontinuation may unmask latent coronary insufficiency. In addition, hypertension may develop.

Proarrhythmias

The most dangerous adverse effect of Class III antiarrhythmic drugs (such as sotalol) is the aggravation of pre-existing arrhythmias or the provocation of new arrhythmias. Drugs that prolong the QT-interval may cause torsades de pointes, a polymorphic ventricular tachycardia associated with prolongation of the QT-interval. Experience to date indicates that the risk of torsades de pointes is associated with the prolongation of the QT-interval, slow heart rate, reduction in serum potassium and magnesium, high plasma sotalol concentrations and with the concomitant use of sotalol and other medications which have been associated with torsades de pointes (see 4.5: Interactions). Females may be at increased risk of developing torsades de pointes.

Other risk factors for torsades de pointes were excessive prolongation of the QTc and history of cardiomegaly or congestive heart failure.

The incidence of torsades de pointes is dose dependent. Torsades de pointes usually occurs early after initiating therapy or escalation of the dose and can progress to ventricular fibrillation.

In clinical trials of patients with sustained VT/VF the incidence of severe proarrhythmia (torsades de pointes or new sustained VT/VF) was <2% at doses up to 320 mg. The incidence more than doubled at higher doses.

Patients with sustained ventricular tachycardia and a history of congestive heart failure have the highest risk of serious proarrhythmia (7%).

Proarrhythmic events must be anticipated not only on initiating therapy but with every upward dose adjustment. Initiating therapy at 80 mg with gradual upward dose titration thereafter reduces the risk of proarrhythmia. In patients already receiving sotalol caution should be used if the QTc exceeds 500msec whilst on therapy, and serious consideration should be given to reducing the dose or discontinuing therapy when the QTc-interval exceeds 550 msec. Due to the multiple risk factors associated with torsades de pointes, however, caution should be exercised regardless of the QTc-interval.

Electrolyte Disturbances

Sotalol should not be used in patients with hypokalaemia or hypomagnesaemia prior to correction of imbalance; these conditions can exaggerate the degree of QT prolongation, and increase the potential for torsades de pointes. Special attention should be given to electrolyte and acid-base balance in patients experiencing severe or prolonged diarrhoea or patients receiving concomitant magnesium- and/or potassium-depleting drugs.

Congestive Heart Failure

Beta-blockade may further depress myocardial contractility and precipitate more severe heart failure. Caution is advised when initiating therapy in patients with left ventricular dysfunction controlled by therapy (i.e. ACE Inhibitors, diuretics, digitalis, etc); a low initial dose and careful dose titration is appropriate.

Recent MI

In post-infarction patients with impaired left ventricular function, the risk versus benefit of sotalol administration must be considered. Careful monitoring and dose titration are critical during initiation and follow-up of therapy. Sotalol should be avoided in patients with left ventricular ejection fractions <40% without serious ventricular arrhythmias.

Electrocardiographic Changes

Excessive prolongation of the QT-interval,>500 msec, can be a sign of toxicity and should be avoided (see Proarrhythmias above). Sinus bradycardia has been observed very commonly in arrhythmia patients receiving sotalol in clinical trials. Bradycardia increases the risk of torsades de pointes. Sinus pause, sinus arrest and sinus node dysfunction occur in less than 1% of patients. The incidence of 2nd- or 3rd-degree AV block is approximately 1%.

Anaphylaxis

Patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge while taking beta-blockers. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reaction.

Anaesthesia

As with other beta-blocking agents, Sotalol 160mg Tablets should be used with caution in patients undergoing surgery and in association with anaesthetics that cause myocardial depression, such as cyclopropane or trichloroethylene.

Diabetes Mellitus

Sotalol should be used with caution in patients with diabetes (especially labile diabetes) or with a history of episodes of spontaneous hypoglycaemia, since beta-blockade may mask some important signs of the onset of acute hypoglycaemia, e.g. tachycardia.

Thyrotoxicosis

Beta-blockade may mask certain clinical signs of hyperthyroidism (e.g., tachycardia). Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might be followed by an exacerbation of symptoms of hyperthyroidism, including thyroid storm.

Renal Impairment

As sotalol is mainly eliminated via the kidneys the dose should be adjusted in patients with renal impairment (see dosage section 4.2).

Psoriasis

Beta-blocking drugs have been reported rarely to exacerbate the symptoms of psoriasis vulgaris.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Contraindicated Combinations

Class 1a antiarrhythmic drugs, such as disopyramide, quinidine and procainamide and other antiarrhythmic drugs such as amiodarone and bepridil are not recommended as concomitant therapy with sotalol, because of their potential to prolong refractoriness (see 4.4 Special Warnings and Precautions). The concomitant use of other beta-blocking agents with sotalol may result in additive Class II effects.

Not recommended combinations

Other drugs prolonging the QT-interval

Sotalol 160mg Tablets should be given with extreme caution in conjunction with other drugs known to prolong the QT-interval such as phenothiazines, tricyclic antidepressants, terfenadine and astemizole. Other drugs that have been associated with an increased risk for torsades de pointes include erythromycin IV, halofantrine, pentamidine, and quinolone antibiotics.

Floctafenine

beta-adrenergic blocking agents may impede the compensatory cardiovascular reactions associated with hypotension or shock that may be induced by Floctafenine.

Calcium channel blocking drugs

Concurrent administration of beta-blocking agents and calcium channel blockers has resulted in hypotension, bradycardia, conduction defects, and cardiac failure. Beta-blockers should be avoided in combination with cardiodepressant calcium-channel blockers such as verapamil and diltiazem because of the additive effects on atrioventricular conduction, and ventricular function.

Associations requiring precautions for use

Potassium-Depleting Diuretics

Hypokalaemia or hypomagnesaemia may occur, increasing the potential for torsade de pointes (see Special Warnings and Precautions for Use).

Other potassium-depleting drugs

Amphotericin B (IV route), corticosteroids (systemic administration), and some laxatives may also be associated with hypokalaemia; potassium levels should be monitored and corrected appropriately during concomitant administration with sotalol.

Clonidine

Beta-blocking drugs may potentiate the rebound hypertension sometimes observed after discontinuation of clonidine; therefore, the beta-blocker should be discontinued slowly several days before the gradual withdrawal of clonidine.

Digitalis glycosides

Single and multiple doses of sotalol do not significantly affect serum digoxin levels. Proarrhythmic events were more common in sotalol treated patients also receiving digitalis glycosides; however, this may be related to the presence of CHF, a known risk factor for proarrhythmia, in patients receiving digitalis glycosides. Association of digitalis glycosides with beta-blockers may increase auriculo-ventricular conduction time.

Catecholamine-depleting agents

Concomitant use of catecholamine-depleting drugs, such as reserpine, guanethidine, or alpha methyldopa, with a beta-blocker may produce an excessive reduction of resting sympathetic nervous tone. Patients should be closely monitored for evidence of hypotension and/or marked bradycardia which may produce syncope.

Insulin and oral hypoglycaemics

Hyperglycaemia may occur, and the dosage of antidiabetic drugs may require adjustment. Symptoms of hypoglycaemia (tachycardia) may be masked by beta-blocking agents

Neuromuscular blocking agents like Tubocurarin

The neuromuscular blockade is prolonged by beta-blocking agents

Beta-2-receptor stimulants

Patients in need of beta-agonists should not normally receive sotalol. However, if concomitant therapy is necessary beta-agonists may have to be administered in increased dosages.

Drug/Laboratory interaction

The presence of sotalol in the urine may result in falsely elevated levels of urinary metanephrine when measured by photometric methods. Patients suspected of having phaeochromocytoma and who are treated with sotalol should have their urine screened utilising the HPLC assay with solid phase extraction.

4.6 Pregnancy And Lactation

Pregnancy

Animal studies with sotalol hydrochloride have shown no evidence of teratogenicity or other harmful effects on the foetus. Although there are no adequate and well-controlled studies in pregnant women, sotalol hydrochloride has been shown to cross the placenta and is found in amniotic fluid. Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. In addition, adverse effects (especially hypoglycaemia and bradycardia) may occur in foetus and neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period. Therefore, sotalol should be used in pregnancy only if the potential benefits outweigh the possible risk to the foetus. The neonate should be monitored very carefully for 48 - 72 hours after delivery if it was not possible to interrupt maternal therapy with sotalol 2-3 days before the birthdate.

Lactation

Most beta-blockers, particularly lipophilic compounds, will pass into breast milk although to a variable extent. Breast feeding is therefore not recommended during administration of these compounds.

4.7 Effects On Ability To Drive And Use Machines

There are no data available, but the occasional occurrence of side-effects such as dizziness and fatigue should be taken into account (see 4.8 Undesirable effects).

4.8 Undesirable Effects

The most frequent adverse effects of sotalol arise from its beta-blockade properties. Adverse effects are usually transient in nature and rarely necessitate interruption of, or withdrawal from treatment. If they do occur, they usually disappear when the dosage is reduced. The most significant adverse effects, however, are those due to proarrhythmia, including torsades de pointes (see Warnings).

The following are adverse events considered related to therapy, occurring in 1% or more of patients treated with sotalol.

Cardiovascular

Bradycardia, dyspnoea, chest pain, palpitations, oedema, ECG abnormalities, hypotension, proarrhythmia, syncope, heart failure, presyncope.

Dermatologic

Rash

Gastro-intestinal

Nausea/vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence

Musculoskeletal

Cramps

Nervous/psychiatric

Fatigue, dizziness, asthenia, lightheadedness, headache, sleep disturbances, depression, paraesthesia, mood changes, anxiety

Urogenital

Sexual dysfunction

Special Senses

Visual disturbances, taste abnormalities, hearing disturbances

Body as a whole

Fever

In trials of patients with cardiac arrhythmia, the most common adverse events leading to discontinuation of sotalol were fatigue 4%, bradycardia ( <50 bpm) 3%, dyspnoea 3%, proarrhythmia 2%, asthenia 2%, and dizziness 2%.

Cold and cyanotic extremities, Raynaud's phenomenon, increase in existing intermittent claudication and dry eyes have been seen in association with other beta-blockers.

4.9 Overdose

Intentional or accidental overdosage with sotalol has rarely resulted in death. Haemodialysis results in a large reduction of plasma levels of sotalol.

Symptoms and treatment of overdosage: The most common signs to be expected are bradycardia, congestive heart failure, hypotension, bronchospasm and hypoglycaemia. In cases of massive intentional overdosage (2-16 g) of sotalol the following clinical findings were seen: hypotension, bradycardia, prolongation of QT-interval, premature ventricular complexes, ventricular tachycardia, torsades de pointes.

If overdosage occurs, therapy with SOTALOL should be discontinued and the patient observed closely. In addition, if required, the following therapeutic measures are suggested:

Bradycardia

Atropine (0.5 to 2 mg IV), another anticholinergic drug, a beta-adrenergic agonist (isoprenaline, 5 microgram per minute, up to 25 microgram, by slow IV injection) or transvenous cardiac pacing

Heart Block (second and third degree)

Transvenous cardiac pacing

Hypotension

Adrenaline rather than isoprenaline or noradrenaline may be useful, depending on associated factors

Bronchospasm

Aminophylline or aerosol beta-2-receptor stimulant

Torsades de pointes

DC cardioversion, transvenous cardiac pacing, adrenaline, and/or magnesium sulphate.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code - C70A A07

D,l-sotalol is a non-selective hydrophilic β-adrenergic receptor blocking agent, devoid of intrinsic sympathomimetic activity or membrane stabilising activity.

sotalol has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. Sotalol has no known effect on the upstroke velocity and therefore no effect on the depolarisation phase.

Sotalol uniformly prolongs the action potential duration in cardiac tissues by delaying the repolarisation phase. Its major effects are prolongation of the atrial, ventricular and accessory pathway effective refractory periods.

The Class II and III properties may be reflected on the surface electrocardiogram by a lengthening of the PR, QT and QTc (QT corrected for heart rate) intervals with no significant alteration in the QRS duration.

The d- and l-isomers of sotalol have similar Class III antiarrhythmic effects while the l-isomer is responsible for virtually all of the beta-blocking activity. Although significant beta-blockade may occur at oral doses as low as 25 mg, Class III effects are usually seen at daily doses of greater than 160 mg.

Its β-adrenergic blocking activity causes a reduction in heart rate (negative chronotropic effect) and a limited reduction in the force of contraction (negative inotropic effect). These cardiac changes reduce myocardial oxygen consumption and cardiac work. Like other β-blockers, sotalol inhibits renin release. The renin-suppressive effect of sotalol is significant both at rest and during exercise. Like other beta adrenergic blocking agents, sotalol produces a gradual but significant reduction in both systolic and diastolic blood pressures in hypertensive patients. Twenty-four-hour control of blood pressure is maintained both in the supine and upright positions with a single daily dose.

5.2 Pharmacokinetic Properties

The bioavailability of oral sotalol is essentially complete (greater than 90%). After oral administration, peak levels are reached in 2.5 to 4 hours, and steady-state plasma levels are attained within 2-3 days. The absorption is reduced by approximately 20% when administered with a standard meal, in comparison to fasting conditions. Over the dosage range 40-640 mg/day sotalol displays dose proportionality with respect to plasma levels. Distribution occurs to a central (plasma) and a peripheral compartment, with an elimination half-life of 10-20 hours. Sotalol does not bind to plasma proteins and is not metabolised. There is very little inter-subject variability in plasma levels. Sotalol crosses the blood brain barrier poorly, with cerebrospinal fluid concentrations only 10% of those in plasma. The primary route of elimination is renal excretion. Approximately 80 to 90% of a dose is excreted unchanged in the urine, while the remainder is excreted in the faeces. Lower doses are necessary in conditions of renal impairment (see Dosage and Administration in patients with renal dysfunction). Age does not significantly alter the pharmacokinetics, although impaired renal function in geriatric patients can decrease the excretion rate, resulting in increased drug accumulation.

5.3 Preclinical Safety Data

No further particulars.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Each tablet contains the following excipients:

Calcium hydrogen phosphate dihydrate

Maize Starch

Povidone K30

Sodium starch glycollate (Type A)

Talc

Magnesium stearate

Indigocarmine Aluminium Salt E132

6.2 Incompatibilities

None

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

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

6.5 Nature And Contents Of Container

The tablets are packed in 14's blisters constituted from a PVC/ PVdC and aluminium foil. Two such blisters are packed in a carton for a pack of 28 tablets.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Milpharm Limited,

Ares,

Odyssey Business Park,

West End Road,

South Ruislip HA4 6QD,

United Kingdom

8. Marketing Authorisation Number(S)

PL 16363/0129

9. Date Of First Authorisation/Renewal Of The Authorisation

21 July 2003

10. Date Of Revision Of The Text

17/06/2008

Platinol (Restricted Access)

Generic Name: cisplatin (sis PLA tin)

Brand Names: Platinol (Restricted Access)

What is Platinol (Restricted Access) (cisplatin)?

Cisplatin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Cisplatin is used together with other medications to treat bladder cancer, testicular cancer, or ovarian cancer.

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

What is the most important information I should know about Platinol (Restricted Access) (cisplatin)?

You should not receive cisplatin if you are pregnant. It could harm the unborn baby. You should not receive this medication if you are allergic to cisplatin or similar medications such as carboplatin (Paraplatin) or oxaliplatin (Eloxatin). You should not receive cisplatin if you have severe bleeding or bone marrow suppression.

Before receiving cisplatin, tell your doctor if you have liver or kidney disease, or if you have received cisplatin in the past.

Cisplatin can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before you receive cisplatin, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Cisplatin can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood may need to be tested often. Visit your doctor regularly.

Call your doctor if you have a serious side effect such as pale skin, easy bruising or bleeding, fever, chills, body aches, flu symptoms, mouth sores, hearing or vision problems, numbness or tingling, feeling short of breath, or muscle weakness.

Using cisplatin may increase your risk of developing leukemia. Ask your doctor about your individual risk.

What should I discuss with my healthcare provider before receiving Platinol (Restricted Access) (cisplatin)?

You should not receive this medication if you are allergic to cisplatin or similar medications such as carboplatin (Paraplatin) or oxaliplatin (Eloxatin). You should not receive cisplatin if you have kidney disease or hearing loss.

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

• 
  

  liver disease;

  
  


• 
  

  kidney disease; or

  
  


• 
  

  if you have ever received cisplatin in the past.

  
  

FDA pregnancy category D. Do not use cisplatin if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Cisplatin can pass into breast milk and may harm a nursing baby. Do not breast feed a baby while receiving this medication. Serious side effects may be more likely in older adults using cisplatin.

How is cisplatin given?

Cisplatin is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

You may be given IV fluids for 8 to 12 hours before you receive cisplatin.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when cisplatin is injected.

Cisplatin can be harmful if it gets on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water.

Cisplatin can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

What happens if I miss a dose?

Contact your doctor if you miss an appointment for your cisplatin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

What should I avoid while taking Platinol (Restricted Access) (cisplatin)?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Cisplatin can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Platinol (Restricted Access) (cisplatin) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  hearing problems;

  
  


• 
  

  trouble with walking or daily activities;

  
  


• 
  

  numbness, tingling, or cold feeling in your hands or feet;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath;

  
  


• 
  

  easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

  
  


• 
  

  fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  
  


• 
  

  severe or ongoing vomiting;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


• 
  

  low magnesium (confusion, uneven heart rate, jerking muscle movements, muscle weakness or limp feeling);

  
  


• 
  

  low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

  
  


• 
  

  low sodium (headache, trouble concentrating, memory problems, feeling unsteady, hallucinations, fainting, shallow breathing or breathing that stops).

  
  

Less serious side effects may include:

• 
  

  decreased sense of taste;

  
  


• 
  

  mild nausea or vomiting;

  
  


• 
  

  tired feeling;

  
  


• 
  

  temporary hair loss; or

  
  


• 
  

  pain, swelling, burning, or irritation around the IV needle.

  
  

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 Platinol (Restricted Access) (cisplatin)?

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

• 
  

  altretamine (Hexalen);

  
  


• 
  

  vitamin B6 (pyridoxine); or

  
  


• 
  

  seizure medication.

  
  

Cisplatin can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• 
  

  medicines to treat a bowel disorder;

  
  


• 
  

  medication to prevent organ transplant rejection;

  
  


• 
  

  antiviral medications;

  
  


• 
  

  pain or arthritis medicines; or

  
  


• 
  

  any injected antibiotics.

  
  

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

More Platinol (Restricted Access) resources

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

• Cisplatin Prescribing Information (FDA)


• Cisplatin MedFacts Consumer Leaflet (Wolters Kluwer)


• Cisplatin Professional Patient Advice (Wolters Kluwer)


• Cisplatin Monograph (AHFS DI)


• Platinol Prescribing Information (FDA)


• Platinol-AQ Prescribing Information (FDA)


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

Compare Platinol (Restricted Access) with other medications

• Bladder Cancer
• Blood Cell Transplantation
• Bone Marrow Transplantation
• Brain Tumor
• Cervical Cancer
• Neuroblastoma
• Non-Small Cell Lung Cancer
• Osteogenic Sarcoma
• Ovarian Cancer
• Testicular Cancer

Where can I get more information?

• Your doctor or pharmacist can provide more information about cisplatin.

See also: Platinol (Restricted Access) side effects (in more detail)