Cenestin

Generic Name: conjugated estrogens (oral) (KON joo gay ted ES troe jenz)

Brand Names: Cenestin, Enjuvia, Premarin

What are conjugated estrogens?

Estrogen is a female sex hormone produced by the ovaries. Estrogen is necessary for many processes in the body.

Conjugated estrogens are a mixture of estrogen hormones used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. Other uses include prevention of osteoporosis in postmenopausal women, and replacement of estrogen in women with ovarian failure or other conditions that cause a lack of natural estrogen in the body. Conjugated estrogens are sometimes used as part of cancer treatment in women and men.

Conjugated estrogens should not be used to prevent heart disease or dementia, because this medicine may actually increase your risk of developing these conditions.

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

What is the most important information I should know about conjugated estrogens?

Do not use this medicine if you have any of the following conditions: a history of heart attack, stroke, or blood clot (especially in your lung or your lower body), liver disease, abnormal vaginal bleeding, or a hormone-related cancer such as breast or uterine cancer. Conjugated estrogens can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Long-term use of conjugated estrogens may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using conjugated estrogens.

Conjugated estrogens should not be used to prevent heart disease, strokes, or dementia, because this medicine may actually increase your risk of developing these conditions.

What should I discuss with my healthcare provider before taking conjugated estrogens?

Do not use conjugated estrogens if you have:

• 
  

  a history of heart attack, stroke, or blood clot (especially in your lung or your lower body);

  
  


• 
  

  abnormal vaginal bleeding that a doctor has not checked;

  
  


• 
  

  a bleeding or blood-clotting disorder;

  
  


• 
  

  liver disease; or

  
  


• 
  

  any type of breast, uterine, or hormone-dependent cancer.

  
  

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

• 
  

  high blood pressure, heart disease, or circulation problems;

  
  


• 
  

  a personal or family history of stroke;

  
  


• 
  

  endometriosis;

  
  


• 
  

  kidney disease;

  
  


• 
  

  asthma;

  
  


• 
  

  hereditary angioedema;

  
  


• 
  

  epilepsy or other seizure disorder;

  
  


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  migraines;

  
  


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  diabetes;

  
  


• 
  

  underactive thyroid;

  
  


• 
  

  high cholesterol or triglycerides;

  
  


• 
  

  high or low levels of calcium in your blood;

  
  


• 
  

  porphyria;

  
  


• 
  

  systemic lupus erythematosus (SLE);

  
  


• 
  

  gallbladder disease; or

  
  


• 
  

  if you have had your uterus removed (hysterectomy).

  
  

Conjugated estrogens increase your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using conjugated estrogens may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using conjugated estrogens. Long-term conjugated estrogens treatment may increase your risk of stroke or blood clots. Talk with your doctor about your individual risks before using conjugated estrogens long term, especially if you smoke or are overweight. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment. FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use conjugated estrogens if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication. Conjugated estrogens can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take conjugated estrogens?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Conjugated estrogens are sometimes taken on a daily basis. For certain conditions, the medication is given in a cycle, such as 3 weeks on followed by 1 week off. Follow your doctor's instructions.

If you see what looks like part of a conjugated estrogen tablet in your stool, talk with your doctor.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using conjugated estrogens.

Use conjugated estrogens regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Your thyroid function may also need to be tested. Visit your doctor regularly.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are taking conjugated estrogens. Store at room temperature away from moisture and heat. Keep the medicine container tightly closed.

See also: Cenestin dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, or vaginal bleeding.

What should I avoid while taking conjugated estrogens?

Do not smoke while using this medication. Smoking can increase your risk of blood clots, stroke, or heart attack caused by conjugated estrogens.

Conjugated estrogens side effects

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

• 
  

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

  
  


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

  
  


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

  
  


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  pain, swelling, warmth, or redness in one or both legs;

  
  


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  abnormal vaginal bleeding;

  
  


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  migraine headache;

  
  


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  pain, swelling, or tenderness in your stomach;

  
  


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  confusion, problems with memory or concentration;

  
  


• 
  

  jaundice (yellowing of the skin or eyes);

  
  


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  swelling in your hands, ankles, or feet; or

  
  


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  a breast lump.

  
  

Less serious side effects may include:

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  mild nausea, vomiting, bloating, stomach cramps;

  
  


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  breast pain, tenderness, or swelling;

  
  


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  freckles or darkening of facial skin;

  
  


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  increased hair growth, loss of scalp hair;

  
  


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  changes in weight or appetite;

  
  


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  problems with contact lenses;

  
  


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  vaginal itching or discharge;

  
  


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  changes in your menstrual periods, decreased sex drive; or

  
  


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  mild headache, nervousness, dizziness, tired feeling.

  
  

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 conjugated estrogens?

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

• 
  

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

  
  


• 
  

  a thyroid medication such as levothyroxine (Synthroid, Levoxyl, Levothroid and others);

  
  


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  insulin or diabetes medicine taken by mouth;

  
  


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  rifampin (Rifadin, Rifater, Rifamate, Rimactane);

  
  


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  ketoconazole (Nizoral) or itraconazole (Sporanox);

  
  


• 
  

  seizure medicines such as phenytoin (Dilantin), carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or primidone (Mysoline);

  
  


• 
  

  a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil).

  
  

This list is not complete and other drugs may interact with conjugated estrogens. 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 Cenestin resources

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

• Cenestin Advanced Consumer (Micromedex) - Includes Dosage Information


• Cenestin Prescribing Information (FDA)


• Cenestin MedFacts Consumer Leaflet (Wolters Kluwer)


• Conjugated Estrogens MedFacts Consumer Leaflet (Wolters Kluwer)


• conjugated estrogens Advanced Consumer (Micromedex) - Includes Dosage Information


• Enjuvia Prescribing Information (FDA)


• Enjuvia MedFacts Consumer Leaflet (Wolters Kluwer)


• Enjuvia Consumer Overview


• Premarin Prescribing Information (FDA)


• Premarin Consumer Overview

Compare Cenestin with other medications

• Abnormal Uterine Bleeding
• Atrophic Urethritis
• Atrophic Vaginitis
• Breast Cancer, Palliative
• Hypoestrogenism
• Oophorectomy
• Osteoporosis
• Postmenopausal Symptoms
• Primary Ovarian Failure
• Prostate Cancer

Where can I get more information?

• Your pharmacist can provide more information about conjugated estrogens.

See also: Cenestin side effects (in more detail)

Trospium

Pronunciation: TROSE-pee-um
Generic Name: Trospium
Brand Name: Sanctura

Trospium is used for:

Treating overactive bladder symptoms, such as incontinence, urgency, and frequency. It may also be used for other conditions as determined by your doctor.

Trospium is an antispasmodic and antimuscarinic agent. It works by reducing muscle tone of the bladder which decreases urinary spasm and frequency.

Do NOT use Trospium if:

• you are allergic to any ingredient in Trospium


• you have delayed or slow emptying of the stomach or uncontrolled narrow-angle glaucoma, you are unable to urinate, or you are at risk of developing these conditions


• you are taking a solid oral potassium product (eg, tablet)

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

Before using Trospium:

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

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


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


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


• if you have liver or kidney problems, or glaucoma or increased pressure in the eye


• if you have stomach or bowel problems (eg, inflammation, constipation, blockage, problems with the muscles in your intestines), myasthenia gravis, bladder blockage, or trouble urinating

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

• Solid oral potassium products (eg, tablets) because the risk of stomach or bowel irritation may be increased by Trospium


• Anticholinergic medicines (eg, scopolamine), metformin, morphine, procainamide, tenofovir, or vancomycin because they may increase the risk of Trospium's side effects


• Phenothiazines (eg, thioridazine) because their effectiveness may be decreased by Trospium

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

How to use Trospium:

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

• Take Trospium by mouth on an empty stomach at least 1 hour before or 2 hours after eating.


• If you miss a dose of Trospium, take it 1 hour before your next meal. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

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


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


• Trospium may cause dry mouth. To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Tell your doctor or dentist that you take Trospium before you receive any medical or dental care, emergency care, or surgery.


• A severe and sometimes life-threatening side effect called angioedema has been reported with Trospium. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.


• Use Trospium with caution in the ELDERLY; they may be more sensitive to its effects, including dry mouth, constipation, stomach upset, and trouble urinating.


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


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Trospium while you are pregnant. It is not known if Trospium is found in breast milk. If you are or will be breast-feeding while you take Trospium, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Trospium:

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

Blurred vision; constipation; dizziness; drowsiness; dry mouth or eyes; headache; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; dark urine; difficulty urinating; fainting; fast or irregular heartbeat; hallucinations; mental or mood changes; muscle pain or weakness; red, swollen, peeling, or blistered skin; vision changes.

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

See also: Trospium side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include dry eyes; fast heartbeat.

Proper storage of Trospium:

Store Trospium at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Trospium out of the reach of children and away from pets.

General information:

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


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


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


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

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

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Trospium resources

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

• trospium Advanced Consumer (Micromedex) - Includes Dosage Information


• Sanctura Prescribing Information (FDA)


• Sanctura Monograph (AHFS DI)


• Sanctura Consumer Overview


• Sanctura XR Prescribing Information (FDA)

Compare Trospium with other medications

• Interstitial Cystitis
• Overactive Bladder
• Urinary Incontinence

Boots 98.66% w / w Styptic Pencil

1. Name Of The Medicinal Product

Styptic Pencil

Nix 98.66% w/w Styptic pencil

Boots 98.66 % w/w Styptic Pencil

Murrays 98.66% w/w Styptic Pencil

2. Qualitative And Quantitative Composition

Aluminium sulphate. (Active) 98.66% w/w

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Compressed solid cylinder mounted in a plastic base

4. Clinical Particulars

4.1 Therapeutic Indications

Used as a haemostatic for superficial wounds and abrasions

Relief of discomfort of insect bites and stings

4.2 Posology And Method Of Administration

Administered topically by direct application to the wound or sting.

For topical application only.

4.3 Contraindications

Hypersensitivity to aluminium sulphate or to any of the excipients

4.4 Special Warnings And Precautions For Use

For topical application to skin only. For use by one person only.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

None

4.7 Effects On Ability To Drive And Use Machines

Not relevant

4.8 Undesirable Effects

None known

4.9 Overdose

None known

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Aluminium agents ATC code: D08AB

Aluminium sulphate precipitates protein and is a powerful astringent

5.2 Pharmacokinetic Properties

None stated

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

Purified Talc 1.34% w/w

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Plastic holder and push-on cover.

Pack size 5g

6.6 Special Precautions For Disposal And Other Handling

Moisten end of the pencil with water. Apply topically by direct application to the wound or sting. Dry pencil after use.

7. Marketing Authorisation Holder

Bray Group Ltd, 1 Regal Way, Faringdon, Oxfordshire SN7 7BX.

8. Marketing Authorisation Number(S)

PL 04286/0002

9. Date Of First Authorisation/Renewal Of The Authorisation

29^th September 1982 / 3^rd February 1993

10. Date Of Revision Of The Text

March 2008

Voltarol Ophtha Multidose 0.1% Eye Drops

1. Name Of The Medicinal Product

Voltarol^® Ophtha Multidose 0.1% Eye Drops

2. Qualitative And Quantitative Composition

Contains diclofenac sodium 1mg/ml

3. Pharmaceutical Form

Eye drops solution

4. Clinical Particulars

4.1 Therapeutic Indications

i. Inhibition of peroperative miosis during cataract surgery (Voltarol Ophtha Multidose has no intrinsic mydriatic properties and does not replace standard mydriatic agents).

ii. Treatment of post-operative inflammation in cataract surgery.

iii. Control of ocular pain and discomfort associated with corneal epithelial defects after excimer PRK surgery or accidental non-penetrating trauma.

iv. Control of inflammation after Argon Laser Trabeculoplasty (ALT).

v. The relief of the ocular signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).

vi. Treatment of inflammation and discomfort after strabismus surgery

vii. Treatment of ocular pain and discomfort after radial keratotomy

4.2 Posology And Method Of Administration

Voltarol Ophtha eye drop solution is for instillation into the conjunctival sac only. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Adults:

Prophylaxis of preoperative miosis	Apply 1 drop four times during the 2 hours before surgery.
Control of post-operative inflammation	Apply 1 drop 4 times daily for up to 28 days.
Control of post-PRK pain and discomfort	Apply 1 drop 2 times in the hour prior to surgery, 1 drop 2 times five minutes apart immediately after PRK surgery and then post-operatively 1 drop every 2-5 hours while awake for up to 24 hours.
Control of ocular pain associated with corneal epithelial defects after accidental non-penetrating trauma.	Apply 1 drop 4 times daily for up to 2 days.
Control of post-ALT inflammation	Apply one drop 4 times during the 2 hours before ALT, and then one drop 4 times daily for up to 7 days.
The relief of the ocular signs and symptoms of Seasonal Allergic Conjunctivitis.	Apply one drop 4 times daily for as long as required.
Treatment of inflammation and discomfort after strabismus surgery	one drop 4 times daily in the 1st week, thrice daily in the 2nd week, twice daily in the 3rd week and as required in the 4th week.
Treatment of ocular pain and discomfort after radial keratotomy	pre-operatively one drop before surgery, post-operatively one drop immediately after surgery, and then one drop 4 times daily for up to 2 days.

Paediatric use: Voltarol Ophtha and Voltarol Ophtha Multidose are not indicated for use in children. Paediatric experience is limited to a few published clinical studies in strabismus surgery.

4.3 Contraindications

Patients with known hypersensitivity to any of the ingredients.

Like other non-steroidal anti-inflammatory agents, Voltarol is also contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibiting activity. Intraocular use during surgical procedure is also contraindicated. There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents.

4.4 Special Warnings And Precautions For Use

This product contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses. Therefore this product should not be used while wearing soft contact lenses. The lenses must be removed before application of the drops and not reinserted earlier than 15 minutes after use.

The anti-inflammatory activity of ophthalmic non-steroidal anti-inflammatory agents (NSAIDs) may mask the onset and/or progression of ocular infections. In the presence of infection, or if there is a risk of infection, appropriate therapy (e.g. antibiotics) should be given concurrently with Voltarol Ophtha Multidose.

Although there have been no reported adverse events, there is a theoretical possibility that patients receiving other medications which may prolong bleeding time, or with known haemostatic defects may experience exacerbation with Voltarol Ophtha Multidose.

Caution should be exercised when topical NSAIDs such as diclofenac are used concomitantly with topical steroids (see section 4.5 Interaction with other medicinal products and other forms of interaction).

Following instillation of the eye drops, nasolacrimal occlusion or closing the eyes for 3 minutes may reduce the systemic absorption. This may result in a decrease in systemic side effects and an increase in local activity.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Concomitant use of topical NSAIDs such as diclofenac and topical steroids in patients with significant pre-existing corneal inflammation may increase the risk of developing corneal complications, therefore caution should be used.

An interval of at least five minutes between the application of the different medicinal products must be allowed.

4.6 Pregnancy And Lactation

Pregnancy

There are no data on the use of Voltarol Ophtha or Voltarol Ophtha Multidose 0.1% in pregnancy. Studies in animals with diclofenac have shown reproductive toxicity (see Section 5.3).

1^st and 2^nd trimester: Animal studies to date have shown no risk to the foetus but no controlled studies in pregnant women are available.

3^rd trimester: Voltarol Ophtha Multidose Eye Drops should not be used due to a possible risk of premature closure of the ductus arteriosus and possible inhibitions of contractions.

Lactation

Diclofenac is excreted in breast milk. However, at therapeutic doses of Voltarol Ophtha no effects on the suckling child are anticipated. Use of ocular diclofenac is not recommended during breast feeding unless the expected benefits outweigh the possible risks.

4.7 Effects On Ability To Drive And Use Machines

Patients with blurred vision should refrain from driving a vehicle or operating machines.

4.8 Undesirable Effects

The most frequently observed adverse reaction is a transient, mild to moderate eye irritation.

Other less frequently observed reactions are eye pain, eye pruritus, ocular hyperaemia and blurred vision immediately after instillation of the eye drops.

Punctate keratitis or corneal disorders have been observed, usually after frequent application.

In patients with risk factors of corneal disorders such as during the use of corticosteroids or with concomitant diseases such as infections or rheumatoid arthritis, diclofenac has been associated, in rare cases, with ulcerative keratitis, corneal thinning, punctuate keratitis, corneal epithelium defect and corneal oedema, which might become sight-threatening. Most patients were treated for a prolonged period of time.

Allergic conditions have been reported for ocular reactions such as conjunctival hyperaemia, allergic conjunctivitis, eyelid erythema, oedema, and pruritus, and systemic hypersensitivity reactions such as urticaria, rash, eczema, erythema, pruritus, cough and rhinitis.

In rare cases dyspnoea and exacerbation of asthma have been reported.

4.9 Overdose

There is practically no risk of adverse effects due to accidental oral ingestion, since a 5ml bottle of the eye drops contains only 5mg of diclofenac sodium, corresponding to about 3% of the recommended maximum daily adult dose of Voltarol after oral administration. By way of comparison, the maximum oral daily dose for diclofenac sodium recommended in children is 2mg/kg body weight.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Voltarol Ophtha Multidose contains diclofenac sodium, a non-steroidal compound with pronounced anti-inflammatory and analgesic properties. Inhibition of prostaglandin biosynthesis, which has been demonstrated experimentally, is regarded as having an important bearing on its mechanism of action. Prostaglandins play a major role in the causation of inflammation and pain.

In clinical trials, Voltarol Ophtha has been found to:

i. inhibit miosis during cataract surgery

ii. reduce inflammation following surgical interventions

iii. reduce ocular pain and discomfort associated with corneal epithelial defects after excimer PRK surgery or accidental trauma.

iv. reduce the incidence of angiographic cystoid macular oedema after cataract surgery but clinical significance remains to be established.

v. reduce ocular inflammation and discomfort more effectively than topical steroids after strabismus surgery whilst avoiding steroidal adverse effects such as delayed conjunctival wound healing and raised intraocular pressure

vi. reduce ocular inflammation, pain and discomfort (photophobia, burning/stinging, foreign body sensation, deep headache-like ocular pain and itching) more effectively than placebo eye drops after corneal incisional surgery such as radial keratotomy.

The effective daily dose after ocular application of Voltarol Ophtha Multidose (approximately 0.25 - 0.5 mg diclofenac sodium) corresponds to less than 1% of the daily dose recommended for Voltarol in rheumatic indications.

Voltarol Ophtha Multidose Eye Drops contain a cyclodextrin, hydroxypropyl γ-cyclodextrin (HPγ-CD). Cyclodextrins (CDs) increase the aqueous solubility of some lipophilic water-insoluble drugs. It is believed that CDs act as true carriers by keeping hydrophobic drug molecules in solution and delivering them to the surface of biological membranes.

5.2 Pharmacokinetic Properties

In rabbits, peak concentrations of ¹⁴C-labelled diclofenac could be demonstrated in the cornea and conjunctiva 30 minutes after application. The highest amounts are found in these two tissues and in the choroid and retina. Elimination was fast and almost complete after 6 hours.

Penetration of diclofenac into the anterior chamber has been confirmed in humans. No measurable levels of diclofenac could be found in humans after ocular application of diclofenac sodium eye drops.

5.3 Preclinical Safety Data

Preclinical data of systemically applied diclofenac from acute and repeated dose toxicity studies, as well as from genotoxicity and carcinogenicity studies revealed no specific hazard for humans at the intended therapeutic doses.

In reproductive and developmental toxicity studies systemic diclofenac has been shown to cross the placental barrier in mice and rats. Whilst no teratogenic effects have been demonstrated, maternally toxic doses were associated with dystocia, prolonged gestation, decreased foetal survival, and intrauterine growth retardation. The effects of diclofenac on fertility and delivery as well as the constriction of the ductus arteriosus in utero are pharmacological consequences of this class of prostaglandin synthesis inhibitors

Local ocular tolerance and toxicity of Voltarol Ophtha and Voltarol Ophtha Multidose 0.1% eye drops (containing hydroxypropyl-gamma cyclodextrin) were investigated and no evidence of toxicity and local adverse effects was found.

Concentrations of HP-gamma-CD in plasma and aqueous humor were below detection limits (1 nMol/mL) in rabbits after single or four times daily (q.i.d.) ocular administration of Voltarol Ophtha Multidose 0.1% eye drops.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Disodium edetate

Hydroxypropyl γ-cyclodextrin

Hydrochloric acid

Propylene glycol

Trometamol

Tyloxapol

Water for injections

6.2 Incompatibilities

None known

6.3 Shelf Life

Unopened:	24 months
Opened:	4 weeks

6.4 Special Precautions For Storage

No special precautions for storage

6.5 Nature And Contents Of Container

5ml white LDPE bottle with LDPE dropper and HDPE closure.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Novartis Pharmaceuticals UK Limited

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

8. Marketing Authorisation Number(S)

PL 00101/0632

9. Date Of First Authorisation/Renewal Of The Authorisation

22 August 2002 / 26 February 2009

10. Date Of Revision Of The Text

30 November 2011

LEGAL CATEGORY

POM

Helixate NexGen 1000 IU

Helixate NexGen 1000 IU powder and solvent for solution for injection

Recombinant coagulation factor VIII (octocog alfa)

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or your pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Helixate NexGen 1000 IU is and what it is used for


• 2. Before you use Helixate NexGen 1000 IU


• 3. How to use Helixate NexGen 1000 IU


• 4. Possible side effects


• 5. How to store Helixate NexGen 1000 IU


• 6. Further information

WHAT Helixate NexGen 1000 IU IS AND WHAT IT IS USED FOR

Helixate NexGen 1000 IU belongs to a pharmacotherapeutic group called blood coagulation Factor VIII (ATC-Code B02B D02).

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

One vial with powder for solution for injection nominally contains 1000 IU octocog alfa (IU equals International Units). After reconstitution with the appropriate volume of solvent (water for injections), each vial contains octocog alfa 400 IU/ml.

BEFORE YOU USE Helixate NexGen 1000 IU

Do not use Helixate NexGen 1000 IU if you are allergic (hypersensitive) to octocog alfa, to mouse or hamster protein or to any of the other ingredients of Helixate NexGen 1000 IU.

If you are unsure about this, ask your doctor.

Take special care with Helixate NexGen 1000 IU as there is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction). If you experience tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing, you may be experiencing an allergic reaction to Helixate NexGen 1000 IU. If this occurs, stop administering the product immediately and seek medical advice.

Your doctor may wish to carry out tests to ensure that your current dose of Helixate NexGen 1000 IU is sufficient to reach and maintain adequate factor VIII levels.

If your bleeding is not being controlled with Helixate NexGen 1000 IU, consult your doctor immediately. You may have developed factor VIII inhibitors and your doctor may wish to carry out tests to confirm this. Factor VIII inhibitors are antibodies in the blood which block the factor VIII you are using. This makes factor VIII less effective in controlling bleeding.

If you have previously developed a factor VIII inhibitor and you switch factor VIII products, you may be at risk of your inhibitor coming back.

Using other medicines

Interactions with other medicines are not known. However, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Based on the rare occurrence of haemophilia A in women, experience regarding the use of Helixate NexGen 1000 IU during pregnancy and breast-feeding is not available. Therefore, if you are pregnant or breast-feeding consult your doctor before using this product.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Important information about some of the ingredients of Helixate NexGen 1000 IU

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium-free”.

HOW TO USE Helixate NexGen 1000 IU

Helixate NexGen 1000 IU is intended for intravenous administration only and must be administered immediately after reconstitution. Aseptic conditions (meaning clean and germ free) are required during reconstitution and administration. Use only the medical devices for reconstitution and administration provided with each package of Helixate NexGen 1000 IU. Helixate NexGen 1000 IU must not be mixed with other infusion solutions. Do not use solutions containing visible particles or that are cloudy. Follow the directions given by your doctor closely and use the instructions below as a guide:

• 1. Wash hands thoroughly using soap and warm water.


• 2. Warm both unopened vials in your hands to a comfortable temperature (do not exceed 37 °C).


• 3. Ensure product and solvent vial flip caps are removed and the stoppers are treated with an aseptic solution and allowed to dry prior to opening the Mix2Vial package.

• 4. Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!

• 5. Place the solvent vial on an even, clean surface and hold the vial tight. Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.

• 6. Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards. Make sure that you only pull away the blister package and not the Mix2Vial set.

• 7. Place the product vial on an even and firm surface. Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper. The solvent will automatically flow into the product vial.

• 8. With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully into two pieces. Discard the solvent vial with the blue Mix2Vial adapter attached.

• 9. Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved. Do not shake.

• 10. Draw air into an empty, sterile syringe. While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting. Inject air into the product vial.

• 11. While keeping the syringe plunger pressed, invert the system upside down and draw the solution into the syringe by pulling the plunger back slowly.

• 12. Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe. Hold the syringe upright and push the plunger until no air is left in the syringe.


• 13. Apply a tourniquet.


• 14. Determine the point of injection and prepare antiseptically.


• 15. Puncture the vein and secure the venipuncture set with a plaster.


• 16 Let blood flow back to the open end of the venipuncture set and then attach the syringe with the solution. Make sure that no blood enters the syringe.


• 17. Remove tourniquet.


• 18. Inject the solution intravenously over several minutes, keeping an eye on the position of the needle. The rate of administration should be determined by the patient’s comfort (maximum rate of infusion: 2 ml/min).


• 19. If a further dose needs to be administered, use a new syringe with product reconstituted as described above.


• 20. If no further dose is required, remove the venipuncture set and syringe. Hold a swab firmly over the injection site on the outstretched arm for approx. 2 minutes. Finally, apply a small pressure dressing to the wound.

The amount of Helixate NexGen 1000 IU you should use and how often you use it depends on many factors such as your weight, the severity of your haemophilia, the site and extent of bleeding, the amount of factor VIII inhibitors that you may have and the factor VIII level required.

Your doctor will calculate the dose of Helixate NexGen 1000 IU and how frequently you should use it to get the necessary level of factor VIII activity in your blood. He will do this according to your particular needs using the formulae below.

I. Required IU = body weight (kg) × desired factor VIII rise as % of normal × 0.5

II. Expected factor VIII rise as % of normal = 2 × administered IU ÷ bodyweight in kg

The following information provides a guide for factor VIII minimum blood levels. In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period:

Degree of haemorrhage : Factor VIII level required (% or IU/dl) : Frequency of doses in hours; duration of therapy in days

Early haemathrosis, muscle bleed or oral bleed : 20 to 40 : Repeat every 12 to 24 hours. At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.

More extensive haemathrosis, muscle bleed or haematoma : 30 to 60 : Repeat infusion every 12 to 24 hours for 3 to 4 days or more until pain and disability are resolved.

Life-threatening bleeds such as intracranial bleed, throat bleed, severe abdominal bleed : 60 to 100 : Repeat infusion every 8 to 24 hours until threat is resolved.

Type of surgical procedure : Factor VIII level required (% or IU/dl) : Frequency of doses in hours; duration of therapy in days

Minor, including tooth extraction : 30 to 60 : Every 24 hours for at least 1 day until healing is achieved.

Major : 80 to 100 (pre-and post-operatively) : a) By bolus infusions. Repeat infusion every 8 to 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30 to 60 %. b) By continuous infusion. Raise factor VIII activity pre-surgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/kg/h) adjusting according to patient’s daily clearance and desired factor VIII levels for at least 7 days.

Your doctor should always adapt the amount of Helixate NexGen 1000 IU to be administered and the frequency of administration according to the clinical effectiveness in your individual case. Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.

If you are using Helixate NexGen 1000 IU to prevent bleeding (prophylaxis), your doctor will calculate the dose for you. This will usually be in the range of 20 to 60 IU of octocog alfa per kg of body weight, administered at intervals of 2 to 3 days. However, in some cases, especially younger patients, shorter dose intervals or higher doses may be necessary.

Although dosage can be estimated by the calculations presented above, it is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained. In the case of major surgical interventions in particular, a precise monitoring of the substitution therapy by means of coagulation analysis is indispensable.

If the factor VIII level of your plasma fails to reach expected levels, or if bleeding is not controlled after apparently adequate dosage, the presence of factor VIII inhibitors should be suspected. By appropriate laboratory procedures, the presence of factor VIII inhibitors must be checked and quantified by an experienced doctor.

If you have the impression that the effect of Helixate NexGen 1000 IU is too strong or too weak, talk to your doctor.

Patients with inhibitors

If you have been informed by your doctor that you have developed factor VIII inhibitors you will possibly be required to use a larger amount of Helixate NexGen than previously to control a bleeding. If this dose does not control your bleeding your doctor may consider the use of an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate. Do not increase the dose of Helixate NexGen you use to control your bleeding without consulting your doctor. Speak to your doctor if you would like further information on this.

These therapies should be directed by doctors with experience in the care of patients with haemophilia A.

Helixate NexGen 1000 IU should be injected intravenously over several minutes. The rate of administration should be determined by the patient’s comfort level (maximal rate of infusion: 2 ml/min).

Your doctor will tell you, how often and at what intervals Helixate NexGen 1000 IU is to be administered.

Usually, the substitution therapy with Helixate NexGen 1000 IU is a life-time treatment.

If you use more Helixate NexGen 1000 IU than you should

No symptoms of overdosage with recombinant coagulation factor VIII have been reported.

If you have used more Helixate NexGen 1000 IU than you should, please inform your doctor.

If you forget to use Helixate NexGen 1000 IU

• Proceed with the next administration immediately and continue at regular intervals as advised by your doctor.


• Do not take a double dose to make up for a forgotten dose.

If you stop using Helixate NexGen 1000 IU

Do not stop using Helixate NexGen 1000 IU without consulting your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible Side Effects

Like all medicines, Helixate NexGen 1000 IU can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

very common (affects more than 1 user in 10)

common (affects 1 to 10 users in 100)

uncommon (affects 1 to 10 users in 1,000)

rare (affects 1 to 10 users in 10,000)

very rare (affects less than 1 user in 10,000)

not known (frequency cannot be estimated from the available data).

Side effects where frequency is common:

You may notice any of the following side effects after administration of Helixate NexGen 1000 IU:

• rash/itchy rash


• local reactions at the injection site (e.g. burning sensation, temporary redness)

Side effects where frequency is rare:

You may notice any of the following side effects after administration of Helixate NexGen 1000 IU:

• hypersensitivity reactions (e.g. tightness of the chest/general feeling of being unwell, dizziness and nausea and mildly reduced blood pressure, which may make you feel faint upon standing)


• fever.

Furthermore, the possibility of an anaphylactic shock cannot be completely excluded. If you notice any of the following symptoms during injection/infusion:

• chest tightness/general feeling of being unwell


• dizziness


• mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)


• nausea

this can constitute an early warning for hypersensitivity and anaphylactic reactions. If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately. Please consult your doctor immediately.

During studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation. However, the possibility of allergic reactions to constituents, e.g. trace amounts of mouse and hamster protein in the preparation exists in certain predisposed patients.

The formation of neutralising antibodies to factor VIII (inhibitors) is a known complication in the management of individuals with haemophilia A. In studies with recombinant factor VIII preparations, development of inhibitors is predominantly observed in previously untreated haemophiliacs.

You should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.

In clinical studies, Helixate NexGen has been used in the treatment of bleeding episodes in 37 previously untreated patients (PUPs) and 23 minimally treated pediatric patients (MTPs, defined as having equal to or less than 4 exposure days). Five out of 37 (14%) PUP and 4 out of 23 (17%) MTP patients treated with Helixate NexGen developed inhibitors: Overall 6 out of 60 (10%) with a titre above 10 BU and 3 out of 60 (5%) with a titre below 10 BU. The median number of exposure days at the time of inhibitor detection in these patients was 9 days (range 3 - 18 days).

The median number of exposure days in the clinical studies was 114 (range: 4-478). Four of the five patients, who had not achieved 20 exposure days at the end of the study, ultimately achieved more than 20 exposure days in post-study follow-up and one of them developed a low titre inhibitor. The fifth patient was lost to follow-up.

In clinical studies with 73 previously treated patients (PTP, defined as having more than 100 exposure days), followed over four years, no de-novo inhibitors were observed.

In extensive post-registration studies with Helixate NexGen, involving more than 1000 patients the following was observed: Less than 0.2% PTP developed de-novo inhibitors. In a subset defined as having less than 20 exposure days at study entry, less than 11% developed de-novo inhibitors.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

HOW TO STORE Helixate NexGen 1000 IU

Keep out of the reach and sight of children.

Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the vials in the outer carton in order to protect from light.

You may store the product when kept in its outer carton at ambient room temperature (up to 25°C) for a single period of up to 3 months. In this case, the product expires at the end of this 3-month period; you must note the new expiry date on the top of the outer carton.

Do not refrigerate the solution after reconstitution. The reconstituted solution should be used immediately. This product is for single use only. Any unused solution must be discarded.

Do not use Helixate NexGen 1000 IU after the expiry date which is stated on labels and cartons. The expiry date refers to the last day of that month.

Do not use Helixate NexGen 1000 IU if you notice any particles or the solution is cloudy.

Further Information

What Helixate NexGen 1000 IU contains

Powder:

The active substance is recombinant coagulation factor VIII (octocog alfa).

The other ingredients are glycine, sodium chloride, calcium chloride, histidine, polysorbate 80, and sucrose.

Solvent:

Water for injections.

What Helixate NexGen 1000 IU looks like and content of the pack

Helixate NexGen 1000 IU is provided as a powder and solvent for solution for injection and is a dry white to slightly yellow powder or cake. After reconstitution the solution is clear. Medical devices for reconstitution and administration are provided with each package of Helixate NexGen 1000 IU.

Marketing Authorisation Holder:

Bayer Schering Pharma AG

13342 Berlin

Germany

Manufacturer:

Bayer HealthCare Manufacturing S.r.l.

Via delle Groane 126

20024 Garbagnate Milanese (MI)

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom

CSL Behring UK Limited

Tel:+44-(0)1444 447400

This leaflet was last approved in 03/2010

Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu.

Savient Pharmaceuticals, Inc.

Address Savient Pharmaceuticals, Inc., One Tower Center 14th Floor East Brunswick, NJ 08816 Contact Details Phone: (732) 418-9300 Website: http://www.savientpharma.com Careers: http://www.savientpharma.com/careers...

Colestid Flavored

Generic Name: colestipol (koe LES ti pol)

Brand Names: Colestid, Colestid Flavored

What is Colestid Flavored (colestipol)?

Colestipol is a cholesterol-lowering drug.

Colestipol lowers "bad" cholesterol in the blood, which is also called LDL (low-density lipoprotein) cholesterol. Lowering your LDL cholesterol may reduce your risk of hardened arteries, which can lead to heart attacks, stroke, and circulation problems.

Lowering high cholesterol levels is an important part of preventing heart disease and arteriosclerosis (hardening of the arteries).

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

What is the most important information I should know about Colestid Flavored (colestipol)?

You should not take this medication if you are allergic to colestipol, or if you have a blockage in your intestines.

Before taking colestipol, tell your doctor if have trouble swallowing, constipation or hemorrhoids, a stomach or intestinal disorder, liver disease, a thyroid disorder, a bleeding disorder, a history of major stomach or bowel surgery, or if you have a vitamin A, D, E, or K deficiency.

Before taking colestipol, tell your doctor if you are pregnant or breast-feeding a baby.

Colestipol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Do not take other medications at the same time you take colestipol. Taking colestipol can make it harder for your body to absorb certain drugs, making them less effective. Take your other medications at least 1 hour before or 4 hours after you take colestipol. Avoid constipation by drinking 8 to 12 full glasses (8 ounces each) every day while taking this medication. Ask your doctor before using a laxative or stool softener. Call your doctor at once if you have severe constipation or stomach pain.

To be sure colestipol is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with colestipol. Do not miss any scheduled appointments.

What should I discuss with my healthcare provider before taking Colestid Flavored (colestipol)?

You should not take this medication if you are allergic to colestipol, or if you have a blockage in your intestines.

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

• 
  

  trouble swallowing;

  
  


• 
  

  constipation or hemorrhoids;

  
  


• 
  

  a stomach, intestinal, or digestive disorder;

  
  


• 
  

  liver disease;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  a bleeding disorder;

  
  


• 
  

  a history of major stomach or bowel surgery; or

  
  


• 
  

  if you have a vitamin A, D, E, or K deficiency.

  
  

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

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking colestipol can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not take colestipol without telling your doctor if you are breast-feeding a baby.

Some forms of this medication may contain phenylalanine. Talk to your doctor before using colestipol if you have phenylketonuria (PKU).

How should I take Colestid Flavored (colestipol)?

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

Colestipol is usually taken 1 or 2 times per day with meals. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Dissolve the colestipol granules in a small amount of water, broth soup, applesauce, crushed pineapple, or hot or cold cereal. Stir this mixture and drink or eat all of it right away. Swallow the mixture without chewing or holding it in your mouth. Colestipol can damage your teeth if left in contact with them for too long.

If you mix colestipol granules with a liquid, after drinking the mixture add a little more water to the same glass, swirl gently and drink right away. This will assure that you get the entire dose.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with colestipol. Do not miss any scheduled appointments.

It may take 2 weeks to several months of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed.

Colestipol is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store colestipol at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take 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 severe stomach pain or constipation.

What should I avoid while taking Colestid Flavored (colestipol)?

Avoid taking other medications at the same time you take colestipol. Taking colestipol can make it harder for your body to absorb certain drugs, making them less effective. Take your other medications at least 1 hour before or 4 hours after you take colestipol. Avoid constipation by drinking 8 to 12 full glasses (8 ounces each) every day while taking this medication. Ask your doctor before using a laxative or stool softener.

Colestid Flavored (colestipol) 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:

• 
  

  trouble swallowing;

  
  


• 
  

  severe constipation or stomach pain;

  
  


• 
  

  black, bloody, or tarry stools; or

  
  


• 
  

  easy bruising or bleeding, muscle or joint pain, loss of appetite.

  
  

Less serious side effects may include:

• 
  

  mild or occasional constipation;

  
  


• 
  

  gas, indigestion, heartburn;

  
  


• 
  

  diarrhea; or

  
  


• 
  

  hemorrhoids or rectal irritation.

  
  

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

What other drugs will affect Colestid Flavored (colestipol)?

Taking colestipol can make it harder for your body to absorb many other medications. Below is just a partial list of these medications. Tell your doctor if you are using:

• 
  

  steroid drugs such as hydrocortisone (Cortef, Hydrocortone);

  
  


• 
  

  heart medication such as digoxin (Lanoxin, Lanoxicaps), propranolol (Inderal), furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), chlorothiazide (Diuril);

  
  


• 
  

  a diuretic (water pill) such as furosemide (Lasix), hydrochlorothiazide (HCTZ, HydroDiuril), or chlorothiazide (Diuril);

  
  


• 
  

  an antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

  
  


• 
  

  other cholesterol-lowering medications such as atorvastatin (Caduet, Lipitor), lovastatin (Altocor, Mevacor, Advicor), ezetimibe (Zetia, Vytorin), fenofibrate (Antara, Lipofen, Lofibra, TriCor, Triglide), gemfibrozil (Lopid), clofibrate (Atromid-S), nicotinic acid (niacin), or ursodiol (Actigall, Urso, Urso Forte).

  
  

This list is not complete and there may be other drugs that can interact with colestipol. 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 Colestid Flavored resources

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

• Colestipol Prescribing Information (FDA)


• Colestid Prescribing Information (FDA)


• Colestid Monograph (AHFS DI)


• Colestid Advanced Consumer (Micromedex) - Includes Dosage Information


• Colestid MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Colestid Flavored with other medications

• Hyperlipoproteinemia
• Hyperlipoproteinemia Type IIa, Elevated LDL
• Hyperlipoproteinemia Type IIb, Elevated LDL VLDL

Where can I get more information?

• Your pharmacist can provide more information about colestipol.

See also: Colestid Flavored side effects (in more detail)