Lamotrigine Raitopharm may be available in the countries listed below.
Lamotrigine is reported as an ingredient of Lamotrigine Raitopharm in the following countries:
International Drug Name Search
Lilacillin may be available in the countries listed below.
Sulbenicillin sodium salt (a derivative of Sulbenicillin) is reported as an ingredient of Lilacillin in the following countries:
International Drug Name Search
0023167-96-6
C7-H13-K-O8
264
Pharmaceutic aid
Treatment of potassium deficiency
D-glycero-D-gulo-Heptonic acid, monopotassium salt
International Drug Name Search
Glossary
| IS | Inofficial Synonym |
Slice may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Emamectin benzoate (a derivative of Emamectin) is reported as an ingredient of Slice in the following countries:
International Drug Name Search
Nivemycin Tablets 500mg
Neomycin sulphate Ph Eur.
an amount equivalent to 550mg of material having a potency of 700 units per mg
Tablets
Nivemycin (Neomycin sulphate BP) is indicated for pre-operative sterilisation of the bowel and may be useful in the treatment of impending hepatic coma, including portal systemic encephalopathy.
For oral administration.
Pre-operative sterilisation of the bowel.
Adults: 2 tablets every hour for 4 hours; then 2 tablets every 4 hours for two or three days before the operation.
Children over 12 years: 2 tablets every 4 hours for 2 or 3 days before the operation.
Children from 6 to 12 years: ½ to 1 tablet every 4 hours for 2 or 3 days before the operation.
For practical reasons, use of the tablets in children under 6 years is not recommended.
In hepatic coma, the adult dose is 4-12 gm/day in divided doses for a period of 5-7 days, whilst for children, 50-100mg/kg/day in divided doses appears appropriate. Chronic hepatic insufficiency may require up to 4 gm/day over an indefinite period.
The elderly dose is the same as for adults.
Nivemycin should not be given when intestinal obstruction is present.
Hypersensitivity to aminoglycosides.
Infants under 1 year.
Myasthenia gravis
The absorption of neomycin is poor from the alimentary tract, with about 97% of an orally administered dose being excreted unchanged in the faeces. Impaired G.I. motility however may increase absorption of the drug and it is therefore possible, as with other broad spectrum antibiotics, that prolonged therapy could result in ototoxicity and nephrotoxicity, particularly in patients with a degree of renal failure. In such patients, and in infants and the elderly, it is generally desirable to determine dosage requirements of aminoglycosides by individual monitoring. Some authorities consider that monitoring is also important in obese patients and those with cystic fibrosis.
Impaired hepatic function or auditory function, bacteraemia, fever, and possibly exposure to loud noises have been reported to increase the risk of ototoxicity, while volume depletion or hypotension, liver disease, or female sex have been reported as additional risk factors for nephrotoxicity. Regular assessment of auditory, vestibular and renal function is particularly necessary in patients with additional risk factors.
When used as an adjunct in the management of hepatic coma, care should be taken that administration is of the minimal period necessary, since prolonged exposure to the drug may result in malabsorption.
Neomycin should be used with caution in patients with neuromuscular disorders and parkinsonism.
There is almost complete cross-resistance between neomycin, kanamycin, paromomycin and framycetin. Cross-resistance with gentamicin has also been reported.
Since prolonged therapy may result in the overgrowth of non-sensitive organisms, treatment should not be continued longer than necessary to prevent superinfection due to the overgrowth of non-sensitive organisms.
Neomycin may impair absorption of other drugs including phenoxymethylpenicillin,digoxin, methotrexate and some vitamins. Aminoglycosides exhibit synergistic activity with a number of beta lactams, but aminoglycoside activity was reported to be diminished in a few patients with severe renal impairment.
Care should be taken when considering the use of neomycin concurrently with drugs with a potential to cause nephrotoxicity (including other aminoglycosides, some of the cephalosporins, amphotericin, ciclosporin, capreomycin, polymyxins, platinum compounds, teicoplanin and vancomycin) or ototoxicity (including, loop diuretics, capreomycin, teicoplanin, vancomycin and possibly platinum coumpounds).
The effect of non-depolarising muscle relaxants may be enhanced by aminoglycosides.
Care is required if other drugs with a neuromuscular blocking action, including botulinum toxin, are given concomitantly. Care is required when patients being treated with aminoglycosides are to receive a general anaesthetic or opioids in order to avoid the possible neuromuscular side-effects provoking severe respiratory depression.
The effect of the parasympathomimetic drugs neostigmine and pyridostigmine, may be antagonised by aminoglycosides.
The hypoglycaemic effect of acarbose may be enhanced by neomycin and the severity of gastrointestinal side effects increased.
Aminoglycosides may increase the risk of hypocalcaemia in patients receiving bisphosphonates.
Experience in anticoagulant clinics suggests that INR (International Normalised Ratio) may be altered by antibacterials such as neomycin given for local action on the gut, although studies have failed to demonstrate an interaction with phenindione.
The efficacy of oral contraceptives may be reduced with broad spectrum antibiotics.
Oral typhoid vaccine is inactivated by concomitant antibiotic administration.
The use of neomycin in pregnancy is not recommended unless the benefits outweigh the potential risks.
There are no reports linking the use of neomycin to congenital defects. However, small amounts of the drug are absorbed when given orally and neomycin and other aminoglycosides may have harmful effects on the foetus following oral absorption during pregnancy.
In some circumstances neomycin may enter the breast milk of lactating mothers. There is little risk of ototoxicity in the infant, but abnormal development of the gut flora may occur. The use of neomycin in lactating mothers is not recommended unless the benefits outweigh the potential risks.
Not applicable.
Nausea, vomiting, diarrhoea, increased salivation, stomatitis, nephrotoxicity, ototoxicity, rise in serum levels of hepatic enzymes and bilirubin, blood dyscrasias, haemolytic anaemia, confusion, paraesthesia, disorientation, nystagmus, hypersensitivity reactionsincluding dermatitis, pruritus, drug fever and anaphylaxis.
Cross-sensitivity with other aminoglycosides may occur.
Malabsorption syndrome with steatorrhoea and diarrhoea, which can be severe, may be caused by prolonged oral therapy.
Superinfection may occur, especially with prolonged oral treatment.
Electrolyte disturbances (notably hypomagnesaemia but also hypocalcaemia and hypokalaemia) have occurred with other aminoglycosides.
In overdose, exacerbation of the adverse events reported for neomycin (nausea, diarrhoea, nephrotoxicity, ototoxicity etc.) is expected.
Monitor renal and auditory function. If these are impaired, haemodialysis is indicated. Prolonged assisted ventilation may also be required.
Neomycin is an aminoglycoside antibiotic.
Neomycin acts by binding to polysomes, inhibiting protein synthesis and generating errors in the transcription of the genetic code.
The absorption of neomycin from the alimentary tract is poor: Only ~ 3% of an oral dose is absorbed, neomycin is rapidly excreted by the kidneys in the unchanged form. The plasma half-life in healthy adults is approximately 2-3 hours. Oral doses of 3 g produce peak plasma concentrations of up to 4 μg/ml.
Not applicable.
Plasdone K29-32
Isopropyl alcohol
Calcium stearate
Not applicable.
3 years.
Store below 30°C in a dry place – protect from light.
An amber glass bottle having a tin-plate screw cap with a waxed aluminium-faced pulpboard liner. The ullage is filled with cotton wool.
Pack size: 100 tablets.
Not applicable.
Waymade Plc.
Trading as Sovereign Medical
Sovereign House
Miles Gray Road
Basildon
Essex SS14 3FR
PL 06464/0710
11 January 1999
July 2003
Aprotex may be available in the countries listed below.
Aprotinin is reported as an ingredient of Aprotex in the following countries:
International Drug Name Search
Vancomax may be available in the countries listed below.
Vancomycin hydrochloride (a derivative of Vancomycin) is reported as an ingredient of Vancomax in the following countries:
International Drug Name Search
Landolaxin may be available in the countries listed below.
Lisinopril dihydrate (a derivative of Lisinopril) is reported as an ingredient of Landolaxin in the following countries:
International Drug Name Search
Lenident Zeta may be available in the countries listed below.
Procaine hydrochloride (a derivative of Procaine) is reported as an ingredient of Lenident Zeta in the following countries:
International Drug Name Search
Leucodinine may be available in the countries listed below.
Mequinol is reported as an ingredient of Leucodinine in the following countries:
International Drug Name Search
Lancid may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lancid in the following countries:
International Drug Name Search
Lattulosio Sandoz may be available in the countries listed below.
Lactulose is reported as an ingredient of Lattulosio Sandoz in the following countries:
International Drug Name Search
Topocid may be available in the countries listed below.
Fusidic Acid is reported as an ingredient of Topocid in the following countries:
International Drug Name Search
Liquid Soap Pre-Op Wash may be available in the countries listed below.
Triclosan is reported as an ingredient of Liquid Soap Pre-Op Wash in the following countries:
International Drug Name Search
Losartan/Hydrochlorothiazide Arrow may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Losartan/Hydrochlorothiazide Arrow in the following countries:
Losartan potassium salt (a derivative of Losartan) is reported as an ingredient of Losartan/Hydrochlorothiazide Arrow in the following countries:
International Drug Name Search
Leukase may be available in the countries listed below.
Framycetin sulfate (a derivative of Framycetin) is reported as an ingredient of Leukase in the following countries:
International Drug Name Search
Vanarl may be available in the countries listed below.
Tocopherol, α- acetate (a derivative of Tocopherol, α-) is reported as an ingredient of Vanarl in the following countries:
International Drug Name Search
Treating certain types of seizures. It may also be used for other conditions as determined by your doctor.
Peganone is a hydantoin anticonvulsant. It works by reducing the spread of seizure activity in the brain.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Peganone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Peganone. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Peganone 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.
Use Peganone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Peganone.
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:
Diarrhea; dizziness; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; clumsiness or unsteadiness; dark urine; fever, chills, or sore throat; general body discomfort; headache; joint pain; loss of coordination; new or worsening mental or mood changes (eg, depression); nosebleed; numbness; reddened, swollen, blistered or peeling skin; slurred speech; small red spots under the skin; suicidal thoughts or attempts; swollen glands; trouble sleeping; unusual bruising or bleeding; unusual eye movements; unusual weakness or fatigue; yellowing of the skin or eyes.
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: Peganone side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include drowsiness; loss of consciousness; loss of coordination; severe or persistent nausea; vision changes.
Store Peganone below 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Peganone out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Peganone. 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.
ratio-Clonazepam may be available in the countries listed below.
Clonazepam is reported as an ingredient of ratio-Clonazepam in the following countries:
International Drug Name Search
Cystistat may be available in the countries listed below.
Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Cystistat in the following countries:
International Drug Name Search
Generic Name: fluoxetine (Oral route)
floo-OX-e-teen hye-droe-KLOR-ide
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. PROZAC(R) is approved for use in pediatric patients with MDD and obsessive compulsive disorder (OCD) .
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SARAFEM(R) is not approved for use in pediatric patients .
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antidepressant
Pharmacologic Class: Fluoxetine
Fluoxetine is used to treat mental depression, obsessive-compulsive disorder (OCD), bulimia nervosa, premenstrual dysphoric disorder (PMDD), and panic disorder.
Fluoxetine is used with olanzapine to treat depression that is a part of bipolar disorder. These medicines are also used together to treat treatment resistant depression in patients who have been treated with other antidepressants that did not work well. This medicine may also be used for other conditions as determined by your doctor.
Fluoxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain.
This medicine is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, fluoxetine is used in certain patients with the following medical conditions:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with depression. However, safety and efficacy have not been established in children younger than 8 years of age.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of fluoxetine in children with obsessive-compulsive disorder. However, safety and efficacy have not been established in children younger than 7 years of age.
Appropriate studies have not been performed on the relationship of age to the effects of fluoxetine in children with bulimia nervosa and panic disorder. Safety and efficacy have not been established.
Appropriate studies have not been performed on the relationship of age to the effects of olanzapine and fluoxetine combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluoxetine in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood), which may require caution and an adjustment in the dose for patients receiving fluoxetine.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
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.
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.
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.
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:
This section provides information on the proper use of a number of products that contain fluoxetine. It may not be specific to Prozac Weekly. Please read with care.
Take this medicine only as directed by your doctor, to benefit your condition as much as possible. 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.
This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
If this medicine upsets your stomach, it may be taken with food.
If you are taking fluoxetine for depression, it may take 4 weeks or longer before you begin to feel better. Also, you may need to keep taking this medicine for 6 months or longer to stop the depression from returning.
If you are taking fluoxetine for obsessive-compulsive disorder, it may take 5 weeks or longer before you begin to get better. Your doctor should check your progress at regular visits during this time.
If you are taking fluoxetine for bulimia nervosa, you may begin to get better after 1 week. However, it may take 4 weeks or longer before you get better.
If you are using the oral liquid, shake the bottle well before measuring each dose. Use a small measuring cup or a measuring spoon to measure each dose. The teaspoons and tablespoons that are used for serving and eating food do not measure exact amounts.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
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.
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.
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.
It is important that your doctor check your progress at regular visits, to allow changes in your dose and help reduce any side effects. Blood tests may be needed to check for unwanted effects.
Do not take fluoxetine within 2 weeks of taking an monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor for at least 5 weeks after taking fluoxetine. If you do, you may develop extremely high blood pressure or seizures.
Do not take thioridazine (Mellaril®) while you are taking fluoxetine or less than 5 weeks after you have stopped taking fluoxetine. You should not use pimozide (Orap®) while you are taking this medicine. Using these medicines together can cause very serious heart problems.
You should not take other medicines that also contain fluoxetine. This includes Symbyax®, Sarafem®, or Prozac® Weekly. Using these medicines together may increase your chance for more serious side effects.
If you develop a skin rash or hives, stop taking fluoxetine and check with your doctor as soon as possible.
Fluoxetine may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
Do not stop suddenly taking this medicine without checking first with your doctor. If you have been instructed to stop taking fluoxetine, ask your doctor how to slowly decrease the dose. This is to decrease the chance of having symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, a fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble with sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.
Make sure your doctor knows about all the other medicines you are using. Fluoxetine may cause serious conditions such as serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as linezolid [Zyvox®], lithium, tryptophan, St. John's Wort, or some pain medicines (e.g., tramadol [Ultram®], rizatriptan [Maxalt®], sumatriptan [Imitrex®], or zolmitriptan [Zomig®]). Check with your doctor first before taking any other medicines.
Fluoxetine may increase your risk for bleeding problems. Make sure your doctor knows if you are also using other medicines that thin the blood, such as aspirin, pain or arthritis medicines, sometimes called “NSAIDs” (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or warfarin (Coumadin®).
Hyponatremia (low sodium in the blood) may occur with this medicine. Stop using the medicine and check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.
Avoid drinking alcohol while you are taking fluoxetine.
For diabetic patients:
This medicine may cause some people to become drowsy or less able to think clearly, or to have poor muscle control. Make sure you know how you react to fluoxetine before you drive, use machines, or do anything else that could be dangerous if you are not alert and well able to control your movements.
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.
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:
Get emergency help immediately if any of the following symptoms of overdose occur:
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:
After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:
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: Prozac Weekly 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.
Panadol Adultos may be available in the countries listed below.
Paracetamol is reported as an ingredient of Panadol Adultos in the following countries:
International Drug Name Search
Helping you to quit smoking.
Nicotrol Inhaler is a smoking deterrent. It works by providing low levels of nicotine, which may help you to quit smoking by lessening the physical signs of withdrawal symptoms.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Nicotrol Inhaler. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Nicotrol Inhaler. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nicotrol Inhaler 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.
Use Nicotrol Inhaler as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Nicotrol Inhaler.
When used for long periods of time or at high doses, some people develop a need to continue taking Nicotrol Inhaler. This is known as DEPENDENCE or addiction.
Do not suddenly stop taking Nicotrol Inhaler without your doctor's approval. Stopping Nicotrol Inhaler suddenly may cause serious WITHDRAWAL symptoms. These may include anxiety; depression; dizziness; fatigue; muscle aches; sleep problems.
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:
Anxiety; coughing; diarrhea; flu-like symptoms; headache; hiccups; indigestion; mouth or throat irritation; muscle aches; nausea; pain in the jaw and neck; runny nose; taste changes.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal skin sensations; chest pain; depression; fever; irregular or fast heartbeat; pounding in the chest; severe dizziness or headache; shortness of breath.
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: Nicotrol side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cold and clammy skin; confusion; diarrhea; difficulty breathing; dizziness; excessive drooling; fainting; headache; hearing and vision problems; nausea; rapid, weak, or irregular heartbeat; seizures; stomach pain; sweating; tremor; vomiting; weakness.
Store Nicotrol Inhaler at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Store the mouthpiece and cartridges in the plastic case provided. Do not store in the bathroom. Keep Nicotrol Inhaler out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Nicotrol Inhaler. 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.
Dilaclan may be available in the countries listed below.
Diltiazem hydrochloride (a derivative of Diltiazem) is reported as an ingredient of Dilaclan in the following countries:
International Drug Name Search
Loradon may be available in the countries listed below.
Loratadine is reported as an ingredient of Loradon in the following countries:
International Drug Name Search
Ranomin may be available in the countries listed below.
Cilostazol is reported as an ingredient of Ranomin in the following countries:
International Drug Name Search
Loracare may be available in the countries listed below.
Loratadine is reported as an ingredient of Loracare in the following countries:
International Drug Name Search
Synchron Sponge may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Medroxyprogesterone 17α-acetate (a derivative of Medroxyprogesterone) is reported as an ingredient of Synchron Sponge in the following countries:
International Drug Name Search
The active ingredient in Colestid Tablets is micronized colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and 1-chloro-2, 3-epoxypropane, with approximately 1 out of 5 amine nitrogens protonated (chloride form). It is a light yellow water-insoluble resin which is hygroscopic and swells when suspended in water or aqueous fluids.
Each Colestid Tablet contains one gram of micronized colestipol hydrochloride. Colestid Tablets are light yellow in color and are tasteless and odorless. Inactive ingredients: cellulose acetate phthalate, glyceryl triacetate, carnauba wax, hypromellose, magnesium stearate, povidone, silicon dioxide. Colestid Tablets contain no calories.
Cholesterol is the major, and probably the sole precursor of bile acids. During normal digestion, bile acids are secreted via the bile from the liver and gall bladder into the intestines. Bile acids emulsify the fat and lipid materials present in food, thus facilitating absorption. A major portion of the bile acids secreted is reabsorbed from the intestines and returned via the portal circulation to the liver, thus completing the enterohepatic cycle. Only very small amounts of bile acids are found in normal serum.
Colestipol hydrochloride binds bile acids in the intestine forming a complex that is excreted in the feces. This nonsystemic action results in a partial removal of the bile acids from the enterohepatic circulation, preventing their reabsorption. Since colestipol hydrochloride is an anion exchange resin, the chloride anions of the resin can be replaced by other anions, usually those with a greater affinity for the resin than the chloride ion.
Colestipol hydrochloride is hydrophilic, but it is virtually water insoluble (99.75%) and it is not hydrolyzed by digestive enzymes. The high molecular weight polymer in colestipol hydrochloride apparently is not absorbed. In humans, less than 0.17% of a single 14C-labeled colestipol hydrochloride dose is excreted in the urine when given following 60 days of dosing of 20 grams of colestipol hydrochloride per day.
The increased fecal loss of bile acids due to colestipol hydrochloride administration leads to an increased oxidation of cholesterol to bile acids. This results in an increase in the number of low-density lipoprotein (LDL) receptors, increased hepatic uptake of LDL and a decrease in beta lipoprotein or LDL serum levels, and a decrease in serum cholesterol levels. Although colestipol hydrochloride produces an increase in the hepatic synthesis of cholesterol in man, serum cholesterol levels fall.
There is evidence to show that this fall in cholesterol is secondary to an increased rate of clearance of cholesterol-rich lipoproteins (beta or low-density lipoproteins) from the plasma. Serum triglyceride levels may increase or remain unchanged in colestipol hydrochloride treated patients.
The decline in serum cholesterol levels with colestipol hydrochloride treatment is usually evident by one month. When colestipol hydrochloride is discontinued, serum cholesterol levels usually return to baseline levels within one month. Periodic determinations of serum cholesterol levels as outlined in the National Cholesterol Education Program (NCEP) guidelines, should be done to confirm a favorable initial and long-term response.1
In a large, placebo-controlled, multiclinic study, the LRC-CPPT2, hypercholesterolemic subjects treated with cholestyramine, a bile-acid sequestrant with a mechanism of action and an effect on serum cholesterol similar to that of colestipol hydrochloride, had reductions in total and LDL-C. Over the 7-year study period the cholestyramine group experienced a 19% reduction (relative to the incidence in the placebo group) in the combined rate of coronary heart disease (CHD) death plus nonfatal myocardial infarction (cumulative incidences of 7% cholestyramine and 8.6% placebo). The subjects included in the study were middle-aged men (aged 35–59) with serum cholesterol levels above 265 mg/dL, LDL-C above 175 mg/dL on a moderate cholesterol-lowering diet, and no history of heart disease. It is not clear to what extent these findings can be extrapolated to other segments of the hypercholesterolemic population not studied.
Treatment with colestipol results in a significant increase in lipoprotein LpAI. Lipoprotein LpAI is one of the two major lipoprotein particles within the high-density lipoprotein (HDL) density range3, and has been shown in cell culture to promote cholesterol efflux or removal from cells4. Although the significance of this finding has not been established in clinical studies, the elevation of the lipoprotein LpAI particle within the HDL fraction is consistent with an antiatherogenic effect of colestipol hydrochloride, even though little change is observed in HDL cholesterol (HDL-C).
In patients with heterozygous familial hypercholesterolemia who have not obtained an optimal response to colestipol hydrochloride alone in maximal doses, the combination of colestipol hydrochloride and nicotinic acid has been shown to further lower serum cholesterol, triglyceride, and LDL-cholesterol (LDL-C) values. Simultaneously, HDL-C values increased significantly. In many such patients it is possible to normalize serum lipid values.5–7
Preliminary evidence suggests that the cholesterol-lowering effects of lovastatin and the bile acid sequestrant, colestipol hydrochloride, are additive.
The effect of intensive lipid-lowering therapy on coronary atherosclerosis has been assessed by arteriography in hyperlipidemic patients. In these randomized, controlled clinical trials, patients were treated for two to four years by either conventional measures (diet, placebo, or in some cases low-dose resin), or with intensive combination therapy using diet and Colestid Granules plus either nicotinic acid or lovastatin. When compared to conventional measures, intensive lipid-lowering combination therapy significantly reduced the frequency of progression and increased the frequency of regression of coronary atherosclerotic lesions in patients with or at risk for coronary artery disease.8–11
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use.
Colestid Tablets are indicated as adjunctive therapy to diet for the reduction of elevated serum total and LDL-C in patients with primary hypercholesterolemia (elevated LDL-C) who do not respond adequately to diet. Generally, Colestid Tablets have no clinically significant effect on serum triglycerides, but with their use, triglyceride levels may be raised in some patients.
Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD.
According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below.
| LDL-Cholesterol mg/dL (mmol/L) | |||
|---|---|---|---|
| Definite Atherosclerotic Disease* | Two or More Other Risk Factors† | Initiation Level | Goal |
| |||
| No | No | ≥190 (≥4.9) | <160 (<4.1) |
| No | Yes | ≥160 (≥4.1) | <130 (<3.4) |
| Yes | Yes or No | ≥130 (≥3.4) | ≤100 (≤2.6) |
Colestid Tablets are contraindicated in those individuals who have shown hypersensitivity to any of their components.
Prior to initiating therapy with Colestid Tablets, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded, and a lipid profile performed to assess total cholesterol, HDL-C, and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation:
LDL-C = Total cholesterol − [(Triglycerides/5) + HDL-C]
For TG levels >400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases Colestid Tablets may not be indicated.
Because it sequesters bile acids, colestipol hydrochloride may interfere with normal fat absorption and, thus, may reduce absorption of folic acid and fat soluble vitamins such as A, D, and K.
Chronic use of colestipol hydrochloride may be associated with an increased bleeding tendency due to hypoprothrombinemia from vitamin K deficiency. This will usually respond promptly to parenteral vitamin K1 and recurrences can be prevented by oral administration of vitamin K1.
Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm a favorable initial and adequate long-term response.
Colestid Tablets may produce or severely worsen pre-existing constipation. The dosage should be increased gradually in patients to minimize the risk of developing fecal impaction. In patients with pre-existing constipation, the starting dose should be 2 grams once or twice a day. Increased fluid and fiber intake should be encouraged to alleviate constipation and a stool softener may occasionally be indicated. If the initial dose is well tolerated, the dose may be increased as needed by a further 2 to 4 grams/day (at monthly intervals) with periodic monitoring of serum lipoproteins. If constipation worsens or the desired therapeutic response is not achieved at 2 to 16 grams/day, combination therapy or alternate therapy should be considered. Particular effort should be made to avoid constipation in patients with symptomatic coronary artery disease. Constipation associated with Colestid Tablets may aggravate hemorrhoids.
While there have been no reports of hypothyroidism induced in individuals with normal thyroid function, the theoretical possibility exists, particularly in patients with limited thyroid reserve.
Since colestipol hydrochloride is a chloride form of an anion exchange resin, there is a possibility that prolonged use may lead to the development of hyperchloremia acidosis.
In studies conducted in rats in which cholestyramine resin (a bile acid sequestering agent similar to colestipol hydrochloride) was used as a tool to investigate the role of various intestinal factors, such as fat, bile salts, and microbial flora, in the development of intestinal tumors induced by potent carcinogens, the incidence of such tumors was observed to be greater in cholestyramine resin treated rats than in control rats.
The relevance of this laboratory observation from studies in rats with cholestyramine resin to the clinical use of Colestid Tablets is not known. In the LRC-CPPT study referred to above, the total incidence of fatal and nonfatal neoplasms was similar in both treatment groups. When the many different categories of tumors are examined, various alimentary system cancers were somewhat more prevalent in the cholestyramine group. The small numbers and the multiple categories prevent conclusions from being drawn. Further follow-up of the LRC-CPPT participants by the sponsors of that study is planned for cause-specific mortality and cancer morbidity. When colestipol hydrochloride was administered in the diet to rats for 18 months, there was no evidence of any drug related intestinal tumor formation. In the Ames assay, colestipol hydrochloride was not mutagenic.
Since colestipol hydrochloride is essentially not absorbed systemically (less than 0.17% of the dose), it is not expected to cause fetal harm when administered during pregnancy in recommended dosages. There are no adequate and well-controlled studies in pregnant women, and the known interference with absorption of fat-soluble vitamins may be detrimental even in the presence of supplementation.
Caution should be exercised when Colestid Tablets are administered to a nursing mother. The possible lack of proper vitamin absorption described in the "Pregnancy" section may have an effect on nursing infants.
Safety and effectiveness in the pediatric population have not been established.
Colestid Tablets may be larger than pills you have taken before. If you have had swallowing problems or choking with food, liquids or other tablets or capsules in the past, you should discuss this with your doctor before taking Colestid Tablets.
It is important that you take Colestid Tablets correctly:
Difficulty swallowing and temporary obstruction of the esophagus (the tube between your mouth and stomach) have been rarely reported in patients taking Colestid Tablets. If a tablet does get stuck after you swallow it, you may notice pressure or discomfort. If this happens to you, you should contact your doctor. Do not take Colestid Tablets again without your doctor's advice.
If you are taking other medications, you should take them at least one hour before or four hours after taking Colestid Tablets.
Since colestipol hydrochloride is an anion exchange resin, it may have a strong affinity for anions other than the bile acids. In vitro studies have indicated that colestipol hydrochloride binds a number of drugs. Therefore, Colestid Tablets may delay or reduce the absorption of concomitant oral medication. The interval between the administration of Colestid Tablets and any other medication should be as long as possible. Patients should take other drugs at least one hour before or four hours after Colestid Tablets to avoid impeding their absorption.
Repeated doses of colestipol hydrochloride given prior to a single dose of propranolol in human trials have been reported to decrease propranolol absorption. However, in a follow-up study in normal subjects, single-dose administration of colestipol hydrochloride and propranolol and twice-a-day administration for 5 days of both agents did not affect the extent of propranolol absorption, but had a small yet statistically significant effect on its rate of absorption; the time to reach maximum concentration was delayed approximately 30 minutes. Effects on the absorption of other beta-blockers have not been determined. Therefore, patients on propranolol should be observed when Colestid Tablets are either added or deleted from a therapeutic regimen.
Studies in humans show that the absorption of chlorothiazide as reflected in urinary excretion is markedly decreased even when administered one hour before colestipol hydrochloride. The absorption of tetracycline, furosemide, penicillin G, hydrochlorothiazide, and gemfibrozil was significantly decreased when given simultaneously with colestipol hydrochloride; these drugs were not tested to determine the effect of administration one hour before colestipol hydrochloride.
No depressant effect on blood levels in humans was noted when colestipol hydrochloride was administered with any of the following drugs: aspirin, clindamycin, clofibrate, methyldopa, nicotinic acid (niacin), tolbutamide, phenytoin or warfarin. Particular caution should be observed with digitalis preparations since there are conflicting results for the effect of colestipol hydrochloride on the availability of digoxin and digitoxin. The potential for binding of these drugs if given concomitantly is present. Discontinuing colestipol hydrochloride could pose a hazard to health if a potentially toxic drug that is significantly bound to the resin has been titrated to a maintenance level while the patient was taking colestipol hydrochloride.
Bile acid binding resins may also interfere with the absorption of oral phosphate supplements and hydrocortisone.
The most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal GI disturbance with an optimal LDL-C lowering effect, a gradual increase of dosage starting with 2 grams, once or twice daily is recommended. Constipation is the major single complaint and at times is severe. Most instances of constipation are mild, transient, and controlled with standard treatment. Increased fluid intake and inclusion of additional dietary fiber should be the first step; a stool softener may be added if needed. Some patients require decreased dosage or discontinuation of therapy. Hemorrhoids may be aggravated.
Other, less frequent gastrointestinal complaints consist of abdominal discomfort (abdominal pain and cramping), intestinal gas (bloating and flatulence), indigestion and heartburn, diarrhea and loose stools, and nausea and vomiting. Bleeding hemorrhoids and blood in the stool have been infrequently reported. Peptic ulceration, cholecystitis, and cholelithiasis have been rarely reported in patients receiving colestipol hydrochloride granules, and are not necessarily drug related.
Difficulty swallowing and transient esophageal obstruction have been rarely reported in patients taking Colestid Tablets.
Transient and modest elevations of aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT) and alkaline phosphatase were observed on one or more occasions in various patients treated with colestipol hydrochloride.
The following nongastrointestinal adverse reactions have been reported with generally equal frequency in patients receiving Colestid Tablets, colestipol granules, or placebo in clinical studies:
Chest pain, angina, and tachycardia have been infrequently reported.
Rash has been infrequently reported. Urticaria and dermatitis have been rarely noted in patients receiving colestipol hydrochloride granules.
Musculoskeletal pain, aches and pains in the extremities, joint pain and arthritis, and backache have been reported.
Headache, migraine headache, and sinus headache have been reported. Other infrequently reported complaints include dizziness, light-headedness, and insomnia.
Anorexia, fatigue, weakness, shortness of breath, and swelling of the hands or feet, have been infrequently reported.
Overdosage of Colestid Tablets has not been reported. Should overdosage occur, however, the chief potential harm would be obstruction of the gastrointestinal tract. The location of such potential obstruction, the degree of obstruction and the presence or absence of normal gut motility would determine treatment.
For adults, Colestid Tablets are recommended in doses of 2 to 16 grams/day given once or in divided doses. The starting dose should be 2 grams once or twice daily. Dosage increases of 2 grams, once or twice daily should occur at 1- or 2-month intervals. Appropriate use of lipid profiles as per NCEP guidelines including LDL-C and triglycerides, is advised so that optimal but not excessive doses are used to obtain the desired therapeutic effect on LDL-C level. If the desired therapeutic effect is not obtained at a dose of 2 to 16 grams/day with good compliance and acceptable side effects, combined therapy or alternate treatment should be considered.
Colestid Tablets must be taken one at a time and be promptly swallowed whole, using plenty of water or other appropriate liquid. Do not cut, crush, or chew the tablets. Patients should take other drugs at least one hour before or four hours after Colestid Tablets to minimize possible interference with their absorption. (See DRUG INTERACTIONS.)
Colestid Tablets are yellow, elliptical, imprinted U, and are supplied as follows:
Bottles of 120 NDC 0009-0450-03
Bottles of 500 NDC 0009-0450-04
Each tablet contains 1 gram of colestipol hydrochloride.
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Rx only
LAB-0053-3.0
NDC 0009-0450-03
120 Tablets
Rx only
Colestid®
micronized colestipol
hydrochloride tablets
1 g
Distributed by
Pharmacia & Upjohn Co
Division of Pfizer Inc, NY, NY 10017
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020222 | 07/19/1994 | |
| Labeler - Pharmacia and Upjohn Company (829076566) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pharmacia and Upjohn Company | 829076566 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Catalent Pharma Solutions, LLC | 829672745 | MANUFACTURE | |
