Idroquark may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Idroquark in the following countries:
Ramipril is reported as an ingredient of Idroquark in the following countries:
International Drug Name Search
lin-a-GLIP-tin
In the U.S.
Available Dosage Forms:
Pharmacologic Class: Dipeptidyl Peptidase IV Inhibitor
Linagliptin is used together with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your blood. Chronic high blood sugar can lead to serious health problems in the future.
Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Linagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood.
Linagliptin does not help patients who have insulin-dependent or type 1 diabetes, because they do not produce insulin from the pancreas. The high blood sugar is best controlled with insulin injections in these patients.
linagliptin is available only with your doctor's prescription.
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 linagliptin, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to linagliptin 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 have not been performed on the relationship of age to the effects of linagliptin 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 linagliptin in the elderly.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | B | Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. |
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 linagliptin, 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 linagliptin 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.
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 linagliptin. Make sure you tell your doctor if you have any other medical problems, especially:
Take linagliptin exactly as directed by your doctor. 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. To do so may increase the chance of side effects.
Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Exercise regularly and test for sugar in your blood or urine as directed.
linagliptin comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Linagliptin may be taken with or without food.
The dose of linagliptin 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 linagliptin. 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 linagliptin, 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 very important that your doctor check your progress at regular visits to make sure that linagliptin is working properly. Blood and urine tests may be needed to check for unwanted effects.
linagliptin may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take linagliptin with other diabetes medicine (e.g., glimepiride, glipizide, or glyburide). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.
The symptoms of low blood sugar include anxiety; behavior changes similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty with thinking; drowsiness; excessive hunger; a fast heartbeat; headaches that continue; nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.
If symptoms of low blood sugar occur, check your blood sugar level. If you have low blood sugar, eat glucose tablets or gel, corn syrup, honey, or sugar cubes; or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Glucagon is a medicine that is used in emergency situations when severe symptoms, such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your family should also know how to use glucagon.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your diet plan, have a fever or infection, or do not exercise as much as usual.
The symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and amount); loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness (passed out); or unusual thirst.
If symptoms of high blood sugar occur, check your blood sugar level and call your doctor for instructions.
There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.
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:
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:
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: linagliptin 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.
Generic Name: tacrolimus (Intravenous route)
ta-KROE-li-mus
Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe, and they should have complete information requisite for the follow-up of the patient .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Immune Suppressant
Pharmacologic Class: Calcineurin Inhibitor
Tacrolimus injection is used together with other medicines to prevent the body from rejecting a transplanted organ (e.g., kidney, liver, or heart). This medicine may be used with steroids, azathioprine (Imuran®), or mycophenolate mofetil (Cellcept®). Tacrolimus belongs to a group of medicines known as immunosuppressive agents.
When a patient receives an organ transplant, the body's white blood cells will try to get rid of (reject) the transplanted organ. Tacrolimus works by suppressing the immune system to prevent the white blood cells from trying to get rid of the transplanted organ.
Tacrolimus is a very strong medicine. It can cause side effects that can be very serious, such as kidney problems. It may also decrease the body's ability to fight infections. You and your doctor should talk about the benefits of this medicine as well as the risks of using it.
This medicine is to be given only by or under the direct supervision of a doctor.
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 not specifically included in the product labeling, tacrolimus 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 tacrolimus injection in children with liver transplants.
Appropriate studies have not been performed on the relationship of age to the effects of tacrolimus injection in children with kidney and heart transplants. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tacrolimus injection in the elderly. However, elderly patients are more likely to have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving tacrolimus injection.
| 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 receiving 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:
A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins.
You will only receive this medicine for a few days. Then your doctor will switch you to the oral (by mouth) form of tacrolimus.
This medicine comes with a patient information insert. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
It is very important that your doctor check your progress while you are receiving this medicine to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Tacrolimus injection may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor or nurse right away if you have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.
This medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.
This medicine may increase your risk of developing infections. Avoid being near people who are sick while you are receiving this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.
While you are being treated with tacrolimus, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Tacrolimus may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.
This medicine may increase your risk for developing a rare and serious virus infection with the BK polyoma virus. This virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.
This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you are having more than one of these symptoms: vision changes, loss of coordination, clumsiness, confusion, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.
This medicine may cause serious nervous system problems. Tell your doctor right away if you have the following symptoms while using this medicine: blurred vision, dizziness, headache, mental changes, seizures, high blood pressure, or a fast heartbeat.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeat; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.
Tacrolimus may cause a condition called pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat; pale skin; unusual bleeding or bruising; or unusual tiredness or weakness.
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 or nurse immediately if any of the following side effects 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
Zydol Soluble Tablets.
1 Zydol soluble tablet contains 50 mg tramadol hydrochloride.
For a full list of excipients, see section 6.1.
White to near white, round, flat tablets with bevelled edges, characteristic peppermint odour, engraved with 'T4' on one side, manufacturer's logo on the other.
For oral administration.
Treatment of moderate to severe pain.
The dose should be adjusted to the intensity of the pain and the sensitivity of the individual patient.
Unless otherwise prescribed, Zydol soluble tablets should be administered as follows:
Adults and Children aged 12 years and over:
Oral administration
Acute Pain: An initial dose of 100mg is usually necessary. This can be followed by doses of 50 or 100mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need.
Pain Associated with Chronic Conditions: Use an initial dose of 50mg and then titrate dose according to pain severity. The need for continued treatment should be assessed at regular intervals as withdrawal symptoms and dependence have been reported (See section 4.4).
The lowest analgesically effective dose should generally be selected. Daily doses of 400 mg active substance should not be exceeded, except in special clinical circumstances.
The tablets should be dissolved in at least 50 ml water before administration, independently of meals.
Zydol should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with Zydol is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary with breaks in treatment) to establish whether and to what extent further treatment is necessary.
Children
Zydol soluble tablets are not suitable for children below the age of 12 years.
Geriatric patients
The usual dosages may be used although it should be noted that in volunteers aged over 75 years the elimination half-life of tramadol was increased by 17% following oral administration.
Renal Insufficiency/Dialysis and Hepatic Insufficiency
The elimination of tramadol may be prolonged. The usual initial dosage should be used. For patients with creatinine clearance <30ml/min, the dosage interval should be increased to 12 hours. Tramadol is not recommended for patients with severe renal impairment (creatinine clearance <10ml/min). As tramadol is only removed very slowly by haemodialysis or haemofiltration, post-dialysis administration to maintain analgesia is not usually necessary.
Hepatic impairment
The elimination of tramadol may be prolonged. The usual initial dosage should be used but in severe hepatic impairment the dosage interval should be increased to 12 hours.
Zydol is contraindicated
- in hypersensitivity to tramadol or any of the excipients (see section 6.1),
- in acute intoxication with alcohol, hypnotics, analgesics, opioids, or psychotropic medicinal products,
- in patients who are receiving MAO inhibitors or who have taken them within the last 14 days (see section 4.5),
- in patients with epilepsy not adequately controlled by treatment,
- for use in narcotic withdrawal treatment.
Zydol may only be used with particular caution in opioid-dependent patients, patients with head injury, shock, a reduced level of consciousness of uncertain origin, disorders of the respiratory centre or function, increased intracranial pressure.
In patients sensitive to opiates the product should only be used with caution.
Care should be taken when treating patients with respiratory depression, or if concomitant CNS depressant drugs are being administered (see section 4.5), or if the recommended dosage is significantly exceeded (see section 4.9) as the possibility of respiratory depression cannot be excluded in these situations.
Convulsions have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses of tramadol exceed the recommended upper daily dose limit (400 mg). In addition, tramadol may increase the seizure risk in patients taking other medicinal products that lowers the seizure threshold (see section 4.5). Patients with epilepsy or those susceptible to seizures should be only treated with tramadol if there are compelling circumstances.
Tramadol has a low dependence potential. On long-term use tolerance, psychic and physical dependence may develop. In patients with a tendency to drug abuse or dependence, treatment with Zydol should only be carried out for short periods under strict medical supervision.
Tramadol is not suitable as a substitute in opioid-dependent patients. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms.
Zydol should not be combined with MAO inhibitors (see section 4.3).
In patients treated with MAO inhibitors in the 14 days prior to the use of the opioid pethidine, life-threatening interactions on the central nervous system, respiratory and cardiovascular function have been observed. The same interactions with MAO inhibitors cannot be ruled out during treatment with Zydol.
Concomitant administration of Zydol with other centrally depressant medicinal products including alcohol may potentiate the CNS effects (see section 4.8).
The results of pharmacokinetic studies have so far shown that on the concomitant or previous administration of cimetidine (enzyme inhibitor) clinically relevant interactions are unlikely to occur. Simultaneous or previous administration of carbamazepine (enzyme inducer) may reduce the analgesic effect and shorten the duration of action.
The combination with mixed agonist/antagonists (e.g. buprenorphine, nalbuphine, pentazocine) and tramadol is not advisable, because the analgesic effect of a pure agonist may be theoretically reduced in such circumstances.
Tramadol can induce convulsions and increase the potential for selective serotonin re-uptake inhibitors, tricyclic anti-depressants, anti-psychotics and other seizure threshold lowering medicinal products to cause convulsions.
In isolated cases there have been reports of serotonin syndrome in a temporal connection with the therapeutic use of tramadol in combination with other serotoninergic medicinal products such as selective serotonin re-uptake inhibitors (SSRIs) or with MAO inhibitors. Signs of serotonin syndrome may be for example confusion, agitation, fever, sweating, ataxia, hyperreflexia, myoclonus and diarrhoea. Withdrawal of the serotoninergic medicinal products usually brings about a rapid improvement. Treatment depends on the nature and severity of the symptoms.
Caution should be exercised during concomitant treatment with tramadol and coumarin derivatives (e.g. warfarin) due to reports of increased INR with major bleeding and ecchymoses in some patients.
Other active substances known to inhibit CYP3A4, such as ketoconazole and erythromycin, might inhibit the metabolism of tramadol (N-demethylation) probably also the metabolism of the active O-demethylated metabolite. The clinical importance of such an interaction has not been studied (see section 4.8).
In a limited number of studies the pre- or postoperative application of the antiemetic 5-HT3 antagonist ondansetron increased the requirement of tramadol in patients with postoperative pain.
Animal studies with tramadol revealed at very high doses effects on organ development, ossification and neonatal mortality. Teratogenic effects were not observed. Tramadol crosses the placenta. There is inadequate evidence available on the safety of tramadol in human pregnancy. Therefore Zydol should not be used in pregnant women.
Tramadol - administered before or during birth - does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant. Chronic use during pregnancy may lead to neonatal withdrawal symptoms. During lactation about 0.1 % of the maternal dose is secreted into the milk. Zydol is not recommended during breast-feeding. After a single administration of tramadol it is not usually necessary to interrupt breast-feeding.
Even when taken according to instructions, Zydol may cause effects such as somnolence and dizziness and therefore may impair the reactions of drivers and machine operators. This applies particularly in conjunction with alcohol and other psychotropic substances.
The most commonly reported adverse reactions are nausea and dizziness, both occurring in more than 10 % of patients.
Cardiovascular disorders:
uncommon ( cardiovascular regulation (palpitation, tachycardia, postural hypotension or cardiovascular collapse). These adverse reactions may occur especially on intravenous administration and in patients who are physically stressed.
rare ( bradycardia, increase in blood pressure
Nervous system disorders:
very common ( dizziness
common ( headache, somnolence
rare ( changes in appetite, paraesthesia, tremor, respiratory depression, epileptiform convulsions, involuntary muscle contractions, abnormal coordination, syncope.
If the recommended doses are considerably exceeded and other centrally depressant substances are administered concomitantly (see section 4.5), respiratory depression may occur.
Epileptiform convulsions occurred mainly after administration of high doses of tramadol or after concomitant treatment with medicinal products which can lower the seizure threshold (see sections 4.4 and 4.5).
Psychiatric disorders:
rare ( hallucinations, confusion, sleep disturbance, anxiety and nightmares. Psychic adverse reactions may occur following administration of Zydol SR which vary individually in intensity and nature (depending on personality and duration of treatment). These include changes in mood (usually elation, occasionally dysphoria), changes in activity (usually suppression, occasionally increase) and changes in cognitive and sensorial capacity (e.g. decision behaviour, perception disorders). Dependence may occur.
Eye disorders:
rare ( blurred vision
Respiratory disorders:
rare (dyspnoea
Worsening of asthma has been reported, though a causal relationship has not been established.
Gastrointestinal disorders:
very common ( nausea
common ( vomiting, constipation, dry mouth
uncommon ( retching; gastrointestinal irritation (a feeling of pressure in the stomach, bloating), diarrhoea
Skin and subcutaneous disorders:
common ( sweating
uncommon (dermal reactions (e.g. pruritus, rash, urticaria)
Musculoskeletal disorders:
rare ( motorial weakness
Hepatobiliary disorders:
In a few isolated cases an increase in liver enzyme values has been reported in a temporal connection with the therapeutic use of tramadol.
Renal and urinary disorders:
rare (: micturition disorders (difficulty in passing urine, dysuria and urinary retention)
General disorders:
common ( fatigue
rare ( allergic reactions (e.g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis; Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal, may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms. Other symptoms that have very rarely been seen with tramadol discontinuation include: panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms.
Symptoms
In principle, on intoxication with tramadol symptoms similar to those of other centrally acting analgesics (opioids) are to be expected. These include in particular miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest.
Treatment
The general emergency measures apply. Keep open the respiratory tract (aspiration!), maintain respiration and circulation depending on the symptoms. The stomach is to be emptied by vomiting (conscious patient) or gastric irrigation. The antidote for respiratory depression is naloxone. In animal experiments naloxone had no effect on convulsions. In such cases diazepam should be given intravenously.
Tramadol is minimally eliminated from the serum by haemodialysis or haemo-filtration. Therefore treatment of acute intoxication with Zydol with haemodialysis or haemofiltration alone is not suitable for detoxification.
Pharmacotherapeutic group: other opioids; ATC-code N 02 AX 02
Tramadol is a centrally acting opioid analgesic. It is a non-selective pure agonist at μ, δ and κ opioid receptors with a higher affinity for the μ receptor. Other mechanisms which contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.
Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect. Also gastrointestinal motility is less affected. Effects on the cardiovascular system tend to be slight. The potency of tramadol is reported to be 1/10 (one tenth) to 1/6 (one sixth) that of morphine.
More than 90% of Zydol is absorbed after oral administration. The mean absolute bioavailability is approximately 70 %, irrespective of the concomitant intake of food. The difference between absorbed and non-metabolised available tramadol is probably due to the low first-pass effect. The first-pass effect after oral administration is a maximum of 30 %.
Tramadol has a high tissue affinity (V d,ß= 203 + 40 l). It has a plasma protein binding of about 20 %.
Following a single oral dose administration of tramadol 100 mg as capsules or tablets to young healthy volunteers, plasma concentrations were detectable within approximately 15 to 45 minutes within a mean Cmax of 280 to 208 mcg/L and Tmax of 1.6 to 2h.
Tramadol passes the blood-brain and placental barriers. Very small amounts of the substance and its O-desmethyl derivative are found in the breast-milk (0.1 % and 0.02 % respectively of the applied dose).
Elimination half-life t1/2,ß is approximately 6 h, irrespective of the mode of administration. In patients above 75 years of age it may be prolonged by a factor of approximately 1.4.
In humans tramadol is mainly metabolised by means of N- and O-demethylation and conjugation of the O-demethylation products with glucuronic acid. Only O-desmethyltramadol is pharmacologically active. There are considerable interindividual quantitative differences between the other metabolites. So far, eleven metabolites have been found in the urine. Animal experiments have shown that O-desmethyltramadol is more potent than the parent substance by the factor 2 - 4. Its half-life t1/2,ß (6 healthy volunteers) is 7.9 h (range 5.4 - 9.6 h) and is approximately that of tramadol.
The inhibition of one or both types of the isoenzymes CYP3A4 and CYP2D6 involved in the biotransformation of tramadol may affect the plasma concentration of tramadol or its active metabolite. Up to now, clinically relevant interactions have not been reported.
Tramadol and its metabolites are almost completely excreted via the kidneys. Cumulative urinary excretion is 90 % of the total radioactivity of the administered dose. In cases of impaired hepatic and renal function the half-life may be slightly prolonged. In patients with cirrhosis of the liver, elimination half-lives of 13.3 + 4.9 h (tramadol) and 18.5 + 9.4 h (O-desmethyltramadol), in an extreme case 22.3 h and 36 h respectively, have been determined. In patients with renal insufficiency (creatinine clearance < 5 ml/min) the values were 11 + 3.2 h and 16.9 + 3 h, in an extreme case 19.5 h and 43.2 h respectively.
Tramadol has a linear pharmacokinetic profile within the therapeutic dosage range.
The relationship between serum concentrations and the analgesic effect is dose-dependent, but varies considerably in isolated cases. A serum concentration of 100 - 300 ng/ml is usually effective.
On repeated oral and parenteral administration of tramadol for 6 - 26 weeks in rats and dogs and oral administration for 12 months in dogs haematological, clinico-chemical and histological investigations showed no evidence of any substance-related changes. Central nervous manifestations only occurred after high doses considerably above the therapeutic range: restlessness, salivation, convulsions, and reduced weight gain. Rats and dogs tolerated oral doses of 20 mg/kg and 10 mg/kg body weight respectively, and dogs rectal doses of 20 mg/kg body weight without any reactions.
In rats tramadol dosages from 50 mg/kg/day upwards caused toxic effects in dams and raised neonate mortality. In the offspring retardation occurred in the form of ossification disorders and delayed vaginal and eye opening. Male fertility was not affected. After higher doses (from 50 mg/kg/day upwards) females exhibited a reduced pregnancy rate. In rabbits there were toxic effects in dams from 125 mg/kg upwards and skeletal anomalies in the offspring.
In some in-vitro test systems there was evidence of mutagenic effects. In-vivo studies showed no such effects. According to knowledge gained so far, tramadol can be classified as non-mutagenic.
Studies on the tumorigenic potential of tramadol hydrochloride have been carried out in rats and mice. The study in rats showed no evidence of any substance-related increase in the incidence of tumours. In the study in mice there was an increased incidence of liver cell adenomas in male animals (a dose-dependent, non-significant increase from 15 mg/kg upwards) and an increase in pulmonary tumours in females of all dosage groups (significant, but not dose-dependent.
Zydol soluble tablets contain:
microcrystalline cellulose
maize starch
saccharin sodium
aniseed flavour
peppermint flavour
colloidal anhydrous silica
magnesium stearate
Not applicable.
3 years.
Do not store above 30°C.
Aluminium/Polypropylene foil blisters.
Pack sizes of 10, 20 or 100 tablets.
Not all pack sizes may be marketed.
The tablets are formulated to be dissolved in water prior to administration, producing a slightly peppermint/aniseed flavoured oral solution.
Any unused product or waste material should be disposed of in accordance with local requirements.
Grünenthal Ltd.
Regus Lakeside House
1 Furzeground Way
Stockley Park East
Uxbridge, Middlesex
UB 11, 1BD
United Kingdom
PL 21727/0006
14 February 2002
27 February 2009
Generic Name: hydrocortisone, neomycin, and polymyxin B otic (HYE droe KOR ti sone, NEE oh MYE sin, POL ee MIX in B)
Brand Names: Cort-Biotic, Cortatrigen, Cortatrigen Modified, Cortisporin Otic, Cortomycin, Oti-Sone, Pediotic
Hydrocortisone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.
Neomycin and polymyxin B are antibiotics that fight bacteria.
The combination of hydrocortisone, neomycin, and polymyxin B otic (for the ears) is used to treat ear infections caused by bacteria.
This medication will not treat a viral infection such as herpes or shingles.
Hydrocortisone, neomycin, and polymyxin B otic may also be used for other purposes not listed in this medication guide.
Before using this medication, tell your doctor if you have herpes (simplex or zoster), chickenpox or small pox, any ear infection that causes blistering, asthma or sulfite allergy, or if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.
a ruptured ear drum; or
an ear infection caused by chickenpox, or herpes infection (simplex or zoster).
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
herpes (simplex or zoster);
chickenpox or small pox;
any ear infection that causes blistering;
asthma or sulfite allergy; or
if you are allergic to an antibiotic similar to neomycin, such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), netilmicin (Netromycin), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi).
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Before using this medication, clean and dry your ear canal with sterile cotton.
This medication is usually given as 4 to 5 drops into the affected ear every 6 to 8 hours. Children may need to use fewer drops. Follow your doctor's instructions about how much medication you should use and how often.
To use the ear drops, first remove the cap from the dropper bottle. Lie down or tilt your head with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Hold the dropper upside down over the ear canal and drop the correct number of drops into the ear.
Do not place the dropper tip into your ear or allow the tip to touch any surface. It may become contaminated.
After using the ear drops, stay lying down or with your head tilted for at least 5 minutes.
As an alternative to dropping the medicine into your ear, you may insert a small piece of cotton into the ear canal and then drop the medicine directly onto the cotton to soak it. Leave the cotton in the ear and keep it moist by adding more of the medication every 4 to 8 hours. Replace the cotton at least every 24 hours. Follow your doctor's instructions about the use of cotton with this medication.
Wipe the ear dropper tip with a clean tissue. Do not wash the tip with water or soap.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Talk with your doctor if your symptoms do not improve after 1 week of using this medication.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include hearing problems, or urinating less than usual.
skin rash, redness, swelling, itching, dryness, scaling, or other irritation in or around the ear;
severe burning, stinging, or other irritation when using the medication;
new signs of infection;
hearing loss; or
urinating less than usual or not at all.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
It is not likely that other drugs you take orally or inject will have an effect on hydrocortisone, neomycin, and polymyxin B used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: Cort-Biotic side effects (in more detail)
Generic Name: etonogestrel (Intradermal route)
e-toe-noe-JES-trel
In the U.S.
Available Dosage Forms:
Therapeutic Class: Contraceptive, Progestin
Pharmacologic Class: Progestin
Etonogestrel implant is a medicine that is used in women to prevent pregnancy. It is a form of birth control. This medicine contains a hormone in a flexible plastic rod about the size of a matchstick. It is effective for three years when inserted just beneath the skin of your upper arm.
Etonogestrel implant will not protect a woman from sexually transmitted diseases (STDs), including human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). The use of latex (rubber) condoms or abstinence (not having sex) is recommended for protection from these diseases.
This medicine is available only with your doctor's prescription.
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 on the relationship of age to the effects of etonogestrel implant have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medication in teenagers are not expected. This medicine may be used for birth control in teenage females but should not be used before the start of menstruation.
Appropriate studies on the relationship of age to the effects of etonogestrel implant have not been performed in the geriatric population. This medicine should not be used in elderly 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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of 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 etonogestrel. It may not be specific to Implanon. Please read with care.
It is very important that you tell your doctor if you think you might be pregnant or if you missed a period before you receive this medicine. Tests will be done to make sure you are not pregnant before this medicine is inserted.
This medicine comes with patient instructions. After reading the instructions, you will be asked to sign a USER CARD and a Patient Consent Form before you receive this medicine. The Consent Form tells you about some possible risks when using this medicine, and when it must be removed. Make sure you understand what is in the patient instructions and the Consent Form before you sign it. Keep the USER CARD in a safe place at home with your health records. If you have any questions, ask your doctor to answer them.
After this medicine is inserted, you should check that it is in place. Gently press your fingertips over the skin in your arm where this medicine was inserted. You should be able to feel the small rod.
You may have to use another form of birth control (e.g., condoms, diaphragms, or spermicides) until the implant has been in place for 7 days. Talk with your doctor about this.
Your doctor must remove this medicine after 3 years. If you would like to stop using this medicine, your doctor can remove it at any time.
If you still want to prevent pregnancy after this medicine is removed, you should start using another form of birth control (e.g., condoms, diaphragms, or spermicides) right away. If you still want to continue using this medicine, your doctor can insert a new implant under your skin after taking the old one out.
If you will be using the etonogestrel implant for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.
If you become pregnant while using this medicine, you have a slightly higher chance of having an ectopic pregnancy (occurs outside the womb). Ectopic pregnancies can cause serious internal bleeding. Contact your doctor immediately to have the implant removed.
Tell your doctor if you are breastfeeding or planning to breastfeed. You may start using this medicine if you had a baby more than 4 weeks ago.
Etonogestrel implant will not protect you against HIV/AIDS or other sexually transmitted diseases. The use of latex (rubber) condoms or abstinence (not having sex) is recommended for protection from these diseases.
Tell your doctor if you have had an allergic reaction to numbing medicines (anesthetics) or skin cleansers (antiseptics). These medicines will be used when etonogestrel implant is inserted into your arm.
This medicine may cause several problems related to insertion and removal, such as pain, irritation, swelling, bruising, scarring, or other complications. Talk to your doctor about these possible risks.
Using this medicine may increase your risk of blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), brain (stroke), heart (heart attack), or eyes (blindness). Make sure your doctor knows at least 4 weeks before if you are going to have a surgery or will need to be on bed rest. Your risk of these serious medical problems is greater during surgery or bed rest, or if you smoke cigarettes.
This medicine may also increase your risk of having irregular monthly periods, ovarian cysts, high blood pressure, gallbladder problems, or liver tumors.
Call your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
If you wear contact lenses and you have blurred vision, difficulty in reading, or any other change in vision while using this medicine, check with your doctor right away. Your doctor may want you to get your eyes checked by an eye doctor (ophthalmologist).
This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.
Before you have any medical tests, tell the medical doctor in charge that you are using etonogestrel implant. The results of some tests may be affected by this medicine.
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 (St. John's wort) 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 or nurse immediately if any of the following side effects 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:
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: Implanon side effects (in more detail)
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Treating high potassium levels in the blood.
Kayexalate Powder is a potassium-removing resin. It works by drawing potassium into the large intestine and then removing it from the body.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Kayexalate Powder. 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 Kayexalate Powder. Tell your health care provider if you are taking any other medicines, especially any of the following:
Use Kayexalate Powder 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 Kayexalate Powder.
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:
Appetite loss; nausea; upset stomach; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; changes in emotions, mood, or behavior; confusion; constipation; dizziness; fast, slow, or irregular heartbeat; muscle cramps, pain, spasms, or weakness; seizures; severe or watery diarrhea; stomach pain; swelling of the feet or hands; swelling of the stomach; trouble breathing; trouble thinking or concentrating; vomit that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Kayexalate 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 confusion; dizziness; irregular heartbeat; irritability; muscle cramps, pain, weakness, or paralysis; trouble breathing; trouble thinking or concentrating.
Store Kayexalate Powder at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Kayexalate Powder out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Kayexalate Powder. 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.
