The following drugs and medications are in some way related to, or used in the treatment of Adjunct to Antibiotic Therapy. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
NATRILIX SR 1.5 mg Tablets
Indapamide …………………1.5 mg per prolonged-release film-coated tablet
Excipient : 124.5 mg lactose monohydrate
For a full list of excipients, see section 6.1.
Prolonged-release tablet.
White, round, film-coated tablet.
Essential hypertension.
Oral use.
One tablet per 24 hours, preferably in the morning, to be swallowed whole with water and not chewed.
At higher doses the antihypertensive action of indapamide is not enhanced but the saluretic effect is increased.
Renal failure (see sections 4.3 and 4.4):
In severe renal failure (creatinine clearance below 30 ml/min), treatment is contraindicated.
Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired.
Elderly (see section 4.4):
In the elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated with NATRILIX SR when renal function is normal or only minimally impaired.
Patients with hepatic impairment (see sections 4.3 and 4.4):
In severe hepatic impairment, treatment is contraindicated.
Children and adolescents:
NATRILIX SR is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
- Hypersensitivity to indapamide, to other sulfonamides or to any of the excipients.
- Severe renal failure.
- Hepatic encephalopathy or severe impairment of liver function.
- Hypokalaemia.
Special warnings
When liver function is impaired, thiazide-related diuretics may cause hepatic encephalopathy, particularly in case of electrolyte imbalance. Administration of the diuretic must be stopped immediately if this occurs.
Photosensitivity:
Cases of photosensitivity reactions have been reported with thiazides and thiazide-related diuretics (see section 4.8). If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment. If a re-administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Excipients:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Special precautions for use
- Water and electrolyte balance:
• Plasma sodium:
This must be measured before starting treatment, then at regular intervals subsequently. Any diuretic treatment may cause hyponatraemia, sometimes with very serious consequences. The fall in plasma sodium may be asymptomatic initially and regular monitoring is therefore essential, and should be even more frequent in the elderly and cirrhotic patients (see sections 4.8 and 4.9).
• Plasma potassium:
Potassium depletion with hypokalaemia is the major risk of thiazide and related diuretics. The risk of onset of hypokalaemia (< 3.4 mmol/l) must be prevented in certain high risk populations, i.e. the elderly, malnourished and/or polymedicated, cirrhotic patients with oedema and ascites, coronary artery disease and cardiac failure patients. In this situation, hypokalaemia increases the cardiac toxicity of digitalis preparations and the risks of arrhythmias.
Individuals with a long QT interval are also at risk, whether the origin is congenital or iatrogenic. Hypokalaemia, as well as bradycardia, is then a predisposing factor to the onset of severe arrhythmias, in particular, potentially fatal torsades de pointes.
More frequent monitoring of plasma potassium is required in all the situations indicated above. The first measurement of plasma potassium should be obtained during the first week following the start of treatment.
Detection of hypokalaemia requires its correction.
• Plasma calcium:
Thiazide and related diuretics may decrease urinary calcium excretion and cause a slight and transitory rise in plasma calcium. Frank hypercalcaemia may be due to previously unrecognised hyperparathyroidism.
Treatment should be withdrawn before the investigation of parathyroid function.
- Blood glucose:
Monitoring of blood glucose is important in diabetics, in particular in the presence of hypokalaemia.
- Uric acid:
Tendency to gout attacks may be increased in hyperuricaemic patients.
- Renal function and diuretics:
Thiazide and related diuretics are fully effective only when renal function is normal or only minimally impaired (plasma creatinine below levels of the order of 25 mg/l, i.e. 220 µmol/l in an adult). In the elderly, this plasma creatinine must be adjusted in relation to age, weight and gender.
Hypovolaemia, secondary to the loss of water and sodium induced by the diuretic at the start of treatment causes a reduction in glomerular filtration. This may lead to an increase in blood urea and plasma creatinine. This transitory functional renal insufficiency is of no consequence in individuals with normal renal function but may worsen preexisting renal insufficiency.
- Athletes:
The attention of athletes is drawn to the fact that this medicinal product contains a drug substance, which may give a positive reaction in doping tests.
Combinations that are not recommended:
Lithium:
Increased plasma lithium with signs of overdosage, as with a salt-free diet (decreased urinary lithium excretion). However, if the use of diuretics is necessary, careful monitoring of plasma lithium and dose adjustment are required.
Combinations requiring precautions for use:
Torsades de pointes-inducing drugs:
- class Ia antiarrhythmics (quinidine, hydroquinidine, disopyramide),
- class III antiarrhythmics (amiodarone, sotalol, dofetilide, ibutilide),
- some antipsychotics :
phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine),
benzamides (amisulpride, sulpiride, sultopride, tiapride)
butyrophenones (droperidol, haloperidol)
others: bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, vincamine IV.
Increased risk of ventricular arrhythmias, particularly torsades de pointes (hypokalaemia is a risk factor).
Monitor for hypokalaemia and correct, if required, before introducing this combination. Clinical, plasma electrolytes and ECG monitoring.
Use substances which do not have the disadvantage of causing torsades de pointes in the presence of hypokalaemia.
N.S.A.I.Ds. (systemic route) including COX-2 selective inhibitors, high dose salicylic acid (
Possible reduction in the antihypertensive effect of indapamide.
Risk of acute renal failure in dehydrated patients (decreased glomerular filtration). Hydrate the patient; monitor renal function at the start of treatment.
Angiotensin converting enzyme (A.C.E.) inhibitors:
Risk of sudden hypotension and/or acute renal failure when treatment with an A.C.E. is initiated in the presence of preexisting sodium depletion (particularly in patients with renal artery stenosis).
In hypertension, when prior diuretic treatment may have caused sodium depletion, it is necessary:
- either to stop the diuretic 3 days before starting treatment with the A.C.E. inhibitor, and restart a hypokalaemic diuretic if necessary;
- or give low initial doses of the A.C.E. inhibitor and increase the dose gradually.
In congestive heart failure, start with a very low dose of A.C.E. inhibitor, possibly after a reduction in the dose of the concomitant hypokalaemic diuretic.
In all cases, monitor renal function (plasma creatinine) during the first weeks of treatment with an A.C.E. inhibitor.
Other compounds causing hypokalaemia: amphotericin B (IV), gluco- and mineralo-corticoids (systemic route), tetracosactide, stimulant laxatives:
Increased risk of hypokalaemia (additive effect).
Monitoring of plasma potassium and correction if required. Must be particularly borne in mind in case of concomitant digitalis treatment. Use non-stimulant laxatives.
Baclofen:
Increased antihypertensive effect.
Hydrate the patient; monitor renal function at the start of treatment.
Digitalis preparations:
Hypokalaemia predisposing to the toxic effects of digitalis.
Monitoring of plasma potassium and ECG and, if necessary, adjust the treatment.
Combinations to be taken into consideration:
Potassium-sparing diuretics (amiloride, spironolactone, triamterene):
Whilst rational combinations are useful in some patients, hypokalaemia (particularly in patients with renal failure or diabetes) or hyperkalaemia may still occur. Plasma potassium and ECG should be monitored and, if necessary, treatment reviewed.
Metformin:
Increased risk of metformin induced lactic acidosis due to the possibility of functional renal failure associated with diuretics and more particularly with loop diuretics. Do not use metformin when plasma creatinine exceeds 15 mg/l (135 µmol/l) in men and 12 mg/l (110 µmol/l) in women.
Iodinated contrast media:
In the presence of dehydration caused by diuretics, increased risk of acute renal failure, in particular when large doses of iodinated contrast media are used.
Rehydration before administration of the iodinated compound.
Imipramine-like antidepressants, neuroleptics:
Antihypertensive effect and increased risk of orthostatic hypotension increased (additive effect).
Calcium (salts):
Risk of hypercalcaemia resulting from decreased urinary elimination of calcium.
Ciclosporin, tacrolimus:
Risk of increased plasma creatinine without any change in circulating cyclosporin levels, even in the absence of water/sodium depletion.
Corticosteroids, tetracosactide (systemic route):
Decreased antihypertensive effect (water/sodium retention due to corticosteroids).
Pregnancy:
As a general rule, the administration of diuretics should be avoided in pregnant women and should never be used to treat physiological oedema of pregnancy. Diuretics can cause foetoplacental ischaemia, with a risk of impaired foetal growth.
Lactation:
Breast-feeding is inadvisable (Indapamide is excreted in human milk).
Indapamide does not affect vigilance but different reactions in relation with the decrease in blood pressure may occur in individual cases, especially at the start of the treatment or when another antihypertensive agent is added.
As a result the ability to drive vehicles or to operate machinery may be impaired.
The majority of adverse reactions concerning clinical or laboratory parameters are dose-dependent.
Thiazide-related diuretics, including indapamide, may cause the following undesirable effects ranked under the following frequency:
Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).
Blood and the lymphatic system disorders:
Very rare: thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia, haemolytic anaemia
Nervous system disorders:
Rare: vertigo, fatigue, headache, paresthesia
Not known: syncope
Cardiac disorders:
Very rare: arrhythmia, hypotension.
Not known: Torsade de pointes (potentially fatal) (see sections 4.4 and 4.5)
Gastrointestinal disorders:
Uncommon: vomiting
Rare: nausea, constipation, dry mouth
Very rare: pancreatitis
Renal and urinary disorders:
Very rare: renal failure
Hepato-biliary disorders:
Very rare: abnormal hepatic function
Not known:
- Possibility of onset of hepatic encephalopathy in case of hepatic insufficiency (see sections 4.3 and 4.4)
- Hepatitis
Skin and subcutaneous tissue disorders:
Hypersensitivity reactions, mainly dermatological, in subjects with a predisposition to allergic and asthmatic reactions:
- Common: maculopapular rashes
- Uncommon: purpura
- Very rare: angioneurotic oedema and/or urticaria, toxic epidermic necrolysis, Steven Johnson syndrome
Not known: possible worsening of pre-existing acute disseminated lupus erythematosus.
Cases of photosensitivity reactions have been reported (see section 4.4).
Investigations
Not known:
- Electrocardiogram QT prolonged (see sections 4.4 and 4.5)
- Blood glucose increased and blood uric acid increased during treatment: appropriateness of these diuretics must be very carefully weighed in patients with gout or diabetes
- Elevated liver enzyme levels.
Metabolism and nutrition disorder
During clinical trials, hypokalaemia (plasma potassium <3.4 mmol/l) was seen in 10 % of patients and < 3.2 mmol/l in 4 % of patients after 4 to 6 weeks treatment. After 12 weeks treatment, the mean fall in plasma potassium was 0.23 mmol/l.
Very rare : Hypercalcaemia
Not known:
- Potassium depletion with hypokalaemia, particularly serious in certain high risk populations (see section 4.4).
- Hyponatraemia with hypovolaemia responsible for dehydration and orthostatic hypotension.
Concomitant loss of chloride ions may lead to secondary compensatory metabolic alkalosis: the incidence and degree of this effect are slight
Indapamide has been found free of toxicity at up to 40 mg, i.e. 27 times the therapeutic dose.
Signs of acute poisoning take the form above all of water/electrolyte disturbances (hyponatraemia, hypokalaemia). Clinically, possibility of nausea, vomiting, hypotension, cramps, vertigo, drowsiness, confusion, polyuria or oliguria possibly to the point of anuria (by hypovolaemia).
Initial measures involve the rapid elimination of the ingested substance(s) by gastric wash-out and/or administration of activated charcoal, followed by restoration of water/electrolyte balance to normal in a specialised centre.
Pharmacotherapeutic group: Sulfonamides, plain
ATC code: C 03 BA 11
Indapamide is a sulphonamide derivative with an indole ring, pharmacologically related to thiazide diuretics, which acts by inhibiting the reabsorption of sodium in the cortical dilution segment. It increases the urinary excretion of sodium and chlorides and, to a lesser extent, the excretion of potassium and magnesium, thereby increasing urine output and having an antihypertensive action.
Phase II and III studies using monotherapy have demonstrated an antihypertensive effect lasting 24 hours. This was present at doses where the diuretic effect was of mild intensity.
The antihypertensive activity of indapamide is related to an improvement in arterial compliance and a reduction in arteriolar and total peripheral resistance.
Indapamide reduces left ventricular hypertrophy.
Thiazide and related diuretics have a plateau therapeutic effect beyond a certain dose, while adverse effects continue to increase. The dose should not be increased if treatment is ineffective.
It has also been shown, in the short-, mid- and long-term in hypertensive patients, that indapamide:
• does not interfere with lipid metabolism: triglycerides, LDL-cholesterol and HDL-cholesterol;
• does not interfere with carbohydrate metabolism, even in diabetic hypertensive patients.
Indapamide 1.5 mg is supplied in a prolonged release dosage based on a matrix system in which the drug substance is dispersed within a support which allows sustained release of indapamide.
Absorption:
The fraction of indapamide released is rapidly and totally absorbed via the gastrointestinal digestive tract.
Eating slightly increases the rapidity of absorption but has no influence on the amount of the drug absorbed.
Peak serum level following a single dose occurs about 12 hours after ingestion, repeated administration reduces the variation in serum levels between 2 doses. Intra-individual variability exists.
Distribution:
Binding of indapamide to plasma proteins is 79%.
The plasma elimination half-life is 14 to 24 hours (mean 18 hours).
Steady state is achieved after 7 days.
Repeated administration does not lead to accumulation.
Metabolism:
Elimination is essentially urinary (70% of the dose) and faecal (22%) in the form of inactive metabolites.
High risk individuals:
Pharmacokinetic parameters are unchanged in renal failure patients.
The highest doses administered orally to different animal species (40 to 8000 times the therapeutic dose) have shown an exacerbation of the diuretic properties of indapamide. The major symptoms of poisoning during acute toxicity studies with indapamide administered intravenously or intraperitoneally were related to the pharmacological action of indapamide, i.e. bradypnoea and peripheral vasodilation.
Indapamide has been tested negative concerning mutagenic and carcinogenic properties.
Tablet:
Silica, colloidal anhydrous
Hypromellose
Lactose monohydrate
Magnesium stearate
Povidone
Film-coating:
Glycerol
Hypromellose
Macrogol 6000
Magnesium stearate
Titanium dioxide
Not applicable
2 years.
Store below 30°C.
10, 14, 15, 20, 30, 50, 60, 90, 100 tablets in blisters (PVC/aluminium).
Not all pack sizes may be marketed.
No special requirements
Les Laboratoires Servier
22 rue Garnier
92200 Neuilly Sur Seine
France
PL 05815/0010
9th January 1996/25th February 2007 (MRP)
08/2011
Generic Name: alcaftadine ophthalmic (al KAF ta deen off THAL mik)
Brand Names: Lastacaft
Alcaftadine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms such as itchy or watery eyes.
Alcaftadine ophthalmic (for the eyes) is used to prevent itching in the eyes caused by allergies.
Alcaftadine ophthalmic may also be used for purposes not listed in this medication guide.
To make sure you can safely usar alcaftadine ophthalmic, tell your doctor about any medical conditions that affect your eyes.
Alcaftadine ophthalmic should not be used to treat eye irritation caused by contact lenses.
To make sure you can safely usar alcaftadine ophthalmic, tell your doctor about any medical conditions that affect your eyes.
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
To apply the eye drops:
Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
Use only the number of drops your doctor has prescribed.
Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
Wait at least 10 minutes before using any other eye drops that your doctor has prescribed.
Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.
Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Do not use other eye medications during treatment with alcaftadine ophthalmic unless your doctor tells you to.
Less serious side effects may include:
mild burnng, stinging, or irritation;
eye redness or itching;
runny or stuffy nose, sore throat, flu symptoms; or
headache.
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 alcaftadine ophthalmic used in the eyes. But many drugs can interact with each other. Tell your doctor about all medicines you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Lastacaft side effects (in more detail)
Generic Name: paclitaxel (Intravenous route)
pak-li-TAX-el
Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in clinical trials. Fatal reactions have occurred in patients despite premedication and all patients should be pretreated with corticosteroids, diphenhydramine, and H(2) antagonists. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm(3) and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 cells/mm(3). Monitor peripheral blood cell counts frequently .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Mitotic Inhibitor
Paclitaxel injection is used to treat advanced cancer of the ovaries, breast, non-small cell lung cancer, and Kaposi sarcoma. Kaposi sarcoma is a cancer of the skin and mucous membranes that is commonly found in patients with acquired immunodeficiency syndrome (AIDS).
Paclitaxel belongs to the group of medicines called antineoplastics. It interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected, other unwanted effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.
Before you begin treatment with paclitaxel, you and your doctor should talk about the good this medicine will do as well as the risks of using it.
This medicine is to be administered only by or under the immediate supervision of your 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 these uses are not included in product labeling, paclitaxel 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 have not been performed on the relationship of age to the effects of paclitaxel injection 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 paclitaxel injection in the elderly. However, elderly patients are more likely to have unwanted side effects (e.g., heart disease, bone marrow problems, and nerve problems), which may require caution in patients receiving paclitaxel injection.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
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:
This section provides information on the proper use of a number of products that contain paclitaxel. It may not be specific to Taxol. Please read with care.
Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, you and your doctor should talk about the good this medicine will do as well as the risks of using it. .
A doctor or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins.
This medicine is usually given every 3 weeks and is used together with other cancer medicines, such as cisplatin or doxorubicin.
You may also receive other medicines to help prevent allergic reactions and nausea or vomiting from paclitaxel.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have a cough; dizziness; wheezing; trouble with breathing; chest or throat tightness; swelling in your face or hands; fever; chills; rash; itching or hives; skin redness; or lightheadedness or faintness while you are receiving this medicine.
While you are being treated with paclitaxel, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Paclitaxel 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.
Paclitaxel can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:
This medicine may cause peripheral neuropathy. Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet while using this medicine.
Cancer medicines can cause diarrhea, nausea, or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects if you still have nausea or vomiting after receiving the 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 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: Taxol side effects (in more detail)
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Suspension 10% (100 mg/mL)
5 mg/kg (2.3 mg/lb) for the removal and control of:
Lungworm: (Dictyocaulus viviparus)
Stomach worm (adults): Ostertagia ostertagi (brown stomach worm).
Stomach worm (adults & 4th stage larvae): Haemonchus contortus/placei (barberpole worm), Trichostrongylus axei (small stomach worm).
Intestinal worm (adults & 4th stage larvae): Bunostomum phlebotomum (hookworm), Nematodirus helvetianus (threadnecked intestinal worm), Cooperia punctata and C. oncophora (small intestinal worm), Trichostrongylus colubriformis (bankrupt worm), Oesophagostomum radiatum (nodular worm).
10 mg/kg (4.6 mg/lb) for the removal and control of:
Stomach worm (4th stage inhibited larvae): Ostertagia ostertagi (Type II Ostertagiasis)
Tapeworm: Moniezia benedeni
Do not use in dairy cattle at 10 mg/kg.
Determine the proper dose according to estimated body weight. Administer orally. In beef and dairy cattle, the recommended dose of 5 mg/kg is achieved when 2.3 mL of the drug are given for each 100 lb of body weight. In beef cattle only, the recommended dosage of 10 mg/kg for treatment of Ostertagiasis Type II (inhibited 4th stage larvae) or tapeworm is achieved when 4.6 mL of the drug is given for each 100 lb of body weight.
| EXAMPLES: | Dose (5 mg/kg) | Dose (10 mg/kg) | Cattle Weight |
|---|---|---|---|
| 2.3 mL | 4.6 mL | 100 lb | |
| 4.6 mL | 9.2 mL | 200 lb | |
| 6.9 mL | 13.8 mL | 300 lb | |
| 9.2 mL | 18.4 mL | 400 lb | |
| 11.5 mL | 23.0 mL | 500 lb | |
| 23.0 mL | 46.0 mL | 1,000 lb | |
| 34.5 mL | 69.0 mL | 1,500 lb |
Under conditions of continued exposure to parasites, retreatment may be needed after 4-6 weeks. There are no known contraindications to the use of the drug in cattle. For dairy cattle, there is no milk withdrawal period at 5 mg/kg.
Store at or below 25°C (77°F).
Protect from freezing.
Shake well before use.
Cattle must not be slaughtered for human consumption within 8 days following treatment. For dairy cattle, there is no milk withdrawal period at the 5 mg/kg dose. Do not use at 10 mg/kg in dairy cattle. Dose rate of 10 mg/kg is for beef cattle only. Dose rate of 10 mg/kg in dairy cattle could result in violative residues in milk. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Keep this and all medication out of the reach of children.
Made in France
Distributed by: Intervet Inc., Millsboro, DE 19966
NADA # 128-620, Approved by FDA
intervet
Panacur®
(fenbendazole)
Dewormer for Beef & Dairy Cattle Suspension 10% (100 mg/mL)
RESIDUE WARNINGS: Cattle must not be slaughtered for human
consumption within 8 days following treatment. For dairy cattle,
there is no milk withdrawal period at the 5 mg/kg dose. Do not use
at 10 mg/kg in dairy cattle. Dose rate of 10 mg/kg is for beef cattle
only. Dose rate of 10 mg/kg in dairy cattle could result in violative
residues in milk. A withdrawal period has not been established for
this product in pre-ruminating calves. Do not use in calves to be
processed for veal.
CAUTION: Federal law restricts this drug to use
by or on the order of a licensed veterinarian.
Keep this and all medication out of the
reach of children.
1 Gallon (3,785 mL)
055602 LPFI240 01
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA128620 | 09/16/2009 | |
| Labeler - Schering Corporation (001317601) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Intervet Production S.A. | 771867553 | ANALYSIS, MANUFACTURE | |
IBUGEL FORTE
ibuprofen 10% w/w
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
This medicine has been prescribed for you.
Do not pass it on to others, even if their symptoms are the same as yours.
If any of the side effects get serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
Because Ibugel Forte is delivered through the skin, directly over the painful area, there is less risk of the complications that sometimes occur when ibuprofen (or a similar anti-inflammatory painkiller) is taken by mouth. However, in rare cases you may be at risk:
If any of the above apply to you, only use this product on advice from your doctor.
You should not use Ibugel Forte if you are pregnant or breast-feeding.
Using this product is not known to affect your ability to drive or use machinery.
To make Ibugel Forte easier and more economical to use, a red tube squeezer key has been provided. Once fitted to the tube, simply turning the key will dispense the gel more easily for patients who experience difficulties in squeezing tubes. For economy, the key will also help expel the last few grams of Ibugel Forte when the tube is nearly empty.
Do not worry if you occasionally forget to use this product, just carry on using it when you remember.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Ibugel Forte can cause side effects, although not everybody gets them.
Occasionally, mild skin rashes, itching or irritation can sometimes occur at the site of application.
If this is unacceptable, or persists, stop using the product and tell your doctor or pharmacist.
Very rarely, the following side effects can happen with ibuprofen, although these are extremely uncommon with products such as Ibugel Forte that are applied to the skin.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The active ingredient is ibuprofen (10% w/w).
The other ingredients are industrial methylated spirit, carbomers, diethylamine and purified water.
This leaflet was last approved in October 2007.
To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).
Please be ready to give the following information: Ibugel Forte, 00173/0175. This is a service provided by the Royal National Institute of Blind People (RNIB).
GP15/07/7
Generic Name: desmopressin (Nasal route, Oral route, Injection route)
des-moe-PRES-in
Desmopressin acetate is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies .
In the U.S.
Available Dosage Forms:
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Vasopressin (class)
Desmopressin is a hormone taken through the nose, by mouth, or given by injection to prevent or control the frequent urination, increased thirst, and loss of water associated with diabetes insipidus (water diabetes). It is used also to control bed-wetting and frequent urination and increased thirst associated with certain types of brain injuries or brain surgery. Desmopressin works by acting on the kidneys to reduce the flow of urine.
Desmopressin is also given by injection to treat some patients with certain bleeding problems such as hemophilia or von Willebrand's disease.
Desmopressin is available only with your doctor's prescription.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, desmopressin is used in certain patients to determine the cause of Cushing's syndrome.
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 pediatrics-specific problems that would limit the usefulness of nasal desmopressin in children and infants. However, infants may be more sensitive to the effects of nasal desmopressin, which may require caution in patients receiving this medicine .
Appropriate studies performed to date have not demonstrated pediatrics-specific problems that would limit the usefulness of oral desmopressin in infants and children with diabetes insipidus. However, safety and efficacy have not been established in children below 6 years of age with bed-wetting problems .
Appropriate studies have not been performed on the relationship of age to the effects of desmopressin injection in infants below 3 months of age for the treatment of hemophilia A or Von Willebrand's disease, and in children below 12 years of age with diabetes insipidus. Safety and efficacy have not been established in these age groups .
Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of desmopressin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving desmopressin .
| 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. |
Studies in women suggest that this medication poses minimal risk to the infant when used during 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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 desmopressin. It may not be specific to Stimate. Please read with care.
Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.
Your doctor may want you to decrease the amount of fluids that you drink while you are using this medicine .
For patients using the nasal solution form of this medicine:
For patients using the tablet form of this medicine:
For patients using the injection form of this medicine:
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.
Has a bulleted list describing how to handle missed doses for various possible dosing schedules.
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.
Store as directed on the label or by your health care professional.
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Urine tests may be needed to check for unwanted effects .
This medicine lowers the amount of sodium in your blood. Check with your doctor right away if you have confusion, nausea, vomiting, muscle cramps or spasms, or unusual tiredness or weakness .
Check with your doctor right away and stop using this medicine if you have fever, severe vomiting or diarrhea, or other conditions that may make you thirsty (such as during hot weather or having a strenuous exercise). This medicine may cause fluid or electrolyte imbalance which can lead to seizures and other serious conditions .
Do not take other medicines unless they have been discussed with your doctor, especially medicines that can make your mouth dry. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements .
Desmopressin may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after you use this medicine .
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: Stimate side effects (in more detail)
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