Ethidan may be available in the countries listed below.
Clindamycin hydrochloride (a derivative of Clindamycin) is reported as an ingredient of Ethidan in the following countries:
International Drug Name Search
Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, Ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.
Ketoconazole is cis - 1 - acetyl - 4 - [4 - [[2 - (2,4 - dichlorophenyl) - 2 - (1H - imidazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxy]phenyl] piperazine and has the following structural formula:
Molecular Formula: C26H28CI2N4O4
Molecular Weight: 531.43
When Ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/mL.
After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of Ketoconazole was not detected at the 5 ng/mL level in blood over a 72-hour period.
Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to Ketoconazole cream, 2%.
Microbiology: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare). Only those organisms listed in the INDICATIONS AND USAGE section have been proven to be clinically affected. Development of resistance to Ketoconazole has not been reported.
Mode of Action: In vitro studies suggest that Ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated that the therapeutic effect of Ketoconazole in seborrheic dermatitis is due to the reduction of M. ovale, but this has not been proven.
Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Ketoconazole cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Ketoconazole cream, 2% is not for ophthalmic use.
General: If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. Hepatitis (1:10,000 reported incidence) and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered Ketoconazole; these effects have not been seen with topical Ketoconazole.
Carcinogenesis, Mutagenesis, Impairment of Fertility: A long-term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity. The dominant lethal mutation test in male and female mice revealed that single oral doses of Ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames’ salmonella microsomal activator assay was also negative.
Pregnancy: Teratogenic effects: Pregnancy Category C: Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day, (10 times the maximum recommended human oral dose). However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Ketoconazole cream, 2% administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Pediatric Use: Safety and effectiveness in children have not been established.
During clinical trials 45 (5.0%) of 905 patients treated with Ketoconazole cream, 2% and 5 (2.4%) of 208 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with Ketoconazole cream developed a painful allergic reaction.
In worldwide postmarketing experience, rare reports of contact dermatitis have been associated with Ketoconazole cream or one of its excipients, namely propylene glycol.
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor: It is recommended that Ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.
Seborrheic dermatitis: Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing.
If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.
Ketoconazole cream, 2% is supplied in 60 g (NDC 23589-054-60) tubes.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
Manufactured by:
Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1
Manufactured for:
TIBER LABORATORIES, Suwanee, GA 30024
Issued: April, 2010
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA075638 | 04/06/2011 | 06/30/2012 |
| Labeler - Tiber Laboratories, LLC (008913939) |
Generic Name: chlorpheniramine, dextromethorphan, and pseudoephedrine (klor feh NEER a meen, dex tro meh THOR fan, and soo doe eh FEH drin)
Brand Names: AccuHist PDX Drops, Atuss DS, Children's NyQuil, Creomulsion Cough/Cold/Allergy, Creomulsion Pediatric, Dicel DM, Dicel DM Chewables, Entre-S, Esocor P, Kidcare Cough and Cold, M-End DM, Mesehist DM, Neutrahist PDX Drops, Nyquil Child Cough and Cold, Pediatric Cough & Cold Medicine, Rescon-DM, Robitussin Pediatric Night Relief, Robitussin PM Cough & Cold, Triaminic Cold and Cough, Triaminic Multi-Sympton, Triaminic Night Time, Triaminic Softchew Cold and Cough, Triaminic-D Multi-Symptom Cold, Vicks 44M Pediatric, Vicks Pediatric Formula 44M
Chlorpheniramine is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It affects the signals in the brain that trigger cough reflex.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of chlorpheniramine, dextromethorphan, and pseudoephedrine is used to treat runny or stuffy nose, sneezing, itching, watery eyes, cough, and sinus congestion caused by allergies, the common cold, or the flu.
Chlorpheniramine, dextromethorphan, and pseudoephedrine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist before taking this medicine if you have heart disease, high blood pressure, kidney disease, diabetes, glaucoma, a thyroid disorder, emphysema or bronchitis, an enlarged prostate, or urination problems.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
heart disease or high blood pressure;
kidney disease;
diabetes;
glaucoma;
a thyroid disorder;
emphysema or chronic bronchitis;
an enlarged prostate; or
problems with urination.
Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough or cold medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
The chewable tablet should be chewed before you swallow it.
This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include severe forms of some of the side effects listed in this medication guide.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Chlorpheniramine can decrease sweating and you may be more prone to heat stroke.
Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeats;
slow, shallow breathing;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
urinating less than usual or not at all;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
dry mouth, nose, or throat;
mild stomach pain, constipation;
blurred vision;
dizziness, drowsiness, mild headache;
sleep problems (insomnia);
feeling restless or excited (especially in children);
problems with memory or concentration; or
flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ask a doctor or pharmacist if it is safe for you to use chlorpheniramine, dextromethorphan, and pseudoephedrine if you are also using any of the following drugs:
glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);
a diuretic (water pill), or blood pressure medicine;
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or
salicylates such as aspirin, Backache Relief Extra Strength, Novasal, Nuprin Backache Caplet, Doan's Pills Extra Strength, Pepto-Bismol, Tricosal, and others.
This list is not complete and other drugs may interact with chlorpheniramine, dextromethorphan, and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Kidcare Cough and Cold side effects (in more detail)
Metenix 5mg Tablets
Metolazone 5 mg
Tablet
Metenix 5mg Tablets is a diuretic for use in the treatment of mild and moderate hypertension. Metenix 5mg Tablets may be used in conjunction with non-diuretic antihypertensive agents and, in these circumstances, it is usually possible to achieve satisfactory control of blood pressure with a reduced dose of the non-diuretic agent. Patients who have become resistant to therapy with these agents may respond to the addition of Metenix 5mg Tablets to their antihypertensive regimen.
Metenix 5mg Tablets may also be used for the treatment of cardiac, renal and hepatic oedema, ascites or toxaemia of pregnancy.
Route of administration: Oral
Hypertension: The recommended initial dose in mild and moderate hypertension is 5 mg daily. After three to four weeks, the dose may be reduced if necessary to 5 mg on alternate days as maintenance therapy.
Oedema: In oedematous conditions, the normal recommended dose is 5-10 mg daily, given as a single dose. In resistant conditions, this may be increased to 20 mg daily or above. However, no more than 80 mg should be given in any 24-hour period.
Children: There is insufficient knowledge of the effects of Metenix 5mg Tablets in children for any dosage recommendations to be made.
Elderly: Metolazone may be excreted more slowly in the elderly.
Metenix 5mg Tablets is contra-indicated in electrolyte deficiency states, anuria, coma or pre-comatose states associated with liver cirrhosis; also in patients with known allergy or hypersensitivity to metolazone.
Because of the antihypertensive effects of metolazone the dosage of concurrently administered non-diuretic antihypertensive agents may need to be reduced.
Caution should be exercised during Metenix 5mg Tablets therapy in patients liable to electrolyte deficiency.
Chloride deficit, hyponatraemia and a low salt syndrome may also occur, particularly when the patient is also on a diet with restricted salt intake. Hypomagnesaemia has been reported as a consequence of prolonged diuretic therapy.
Prolonged therapy with Metenix 5mg Tablets may result in hypokalaemia. Serum potassium levels should be determined at regular intervals and, if necessary, potassium supplementation should be instituted.
Fluid and electrolyte balance should be carefully monitored during therapy especially if Metenix 5mg Tablets is used concurrently with other diuretics. In particular, Metenix 5mg Tablets may potentiate the diuresis produced by furosemide and, if the two agents are used concurrently, patients should be carefully monitored.
The dosage of concurrently administered cardiac glycosides may require adjustment. Metenix 5mg Tablets may aggravate the increased potassium excretion associated with steroid therapy or diseases such as cirrhosis or severe ischaemic heart disease. Latent diabetes may become manifest or the insulin requirements of diabetic patients may increase.
Non steroidal anti-inflammatory drugs (e.g. Indometacin, Sulindac) may attenuate the action of Metolazone.
Prolongation of bleeding time has been reported during concomitant administration of Metenix and warfarin.
There is little evidence of safety of the drug in human pregnancy, but it has been in wide, general use for many years without apparent ill consequence, animal studies having shown no hazard.
If Metenix 5mg Tablets is given to nursing mothers, metolazone may be present in the breast milk.
None known.
Metenix 5mg Tablets is generally well tolerated. There have been occasional reports of headache, anorexia, vomiting, abdominal discomfort, muscle cramps and dizziness. There have been isolated reports of urticaria, leucopenia, tachycardia, chills and chest pain.
Hyperuricaemia or azotaemia may occur during treatment with Metenix 5mg Tablets, particularly in patients with impaired renal function. On rare occasions, clinical gout has been reported.
In cases of overdose there is a danger of dehydration and electrolyte depletion. Treatment should therefore be aimed at fluid replacement and correction of the electrolyte imbalance.
Metolazone is a substituted quinazolinone diuretic.
Diuresis and saluresis begin within one hour of administration of Metenix 5mg Tablets tablets, reaching a maximum in two hours and continuing for 12-24 hours according to dosage.
None applicable.
Microcrystalline cellulose, magnesium stearate, F D and C blue no 2 lake (E132)
None.
5 years.
Metenix 5mg Tablets tablets should be stored protected from light, in the original container or in containers similar to those of the manufacturer.
Blister pack of 100 tablets.
None.
Sanofi-aventis
One Onslow Street
Guildford
Surrey, GU1 4YS, UK
PL 04425/0212
5 November 2001
21 September 2010
POM
The K-Dur® 20 product is an immediately dispersing extended release oral dosage form of potassium chloride containing 1500 mg of microencapsulated potassium chloride, USP equivalent to 20 mEq of potassium in a tablet.
The K-Dur® 10 product is an immediately dispersing extended release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet.
These formulations are intended to slow the release of potassium so that the likelihood of a high localized concentration of potassium chloride within the gastrointestinal tract is reduced.
K-Dur is an electrolyte replenisher. The chemical name of the active ingredient is potassium chloride, and the structural formula is KCl. Potassium chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.
K-Dur is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated potassium chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, K-Dur begins disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of potassium chloride.
Inactive Ingredients: Crospovidone, Ethyl-cellulose, Hydroxypropyl Cellulose, Magnesium Stearate, and Microcrystalline Cellulose.
The potassium ion is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.
The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.
Potassium is a normal dietary constituent and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.
Potassium depletion will occur whenever the rate of potassium loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of potassium in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Potassium depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Potassium depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.
If potassium depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, eg, where the patient requires long-term diuretic therapy, supplemental potassium in the form of high-potassium food or potassium chloride may be able to restore normal potassium levels.
In rare circumstances (eg, patients with renal tubular acidosis) potassium depletion may be associated with metabolic acidosis and hyperchloremia. In such patients potassium replacement should be accomplished with potassium salts other than the chloride, such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED RELEASE POTASSIUM CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT POTASSIUM PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.
The use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. In more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated.
Potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE).
Controlled release formulations of potassium chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Potassium supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of K-Dur (see PRECAUTIONS: Information for Patients, and DOSAGE AND ADMINISTRATION sections).
All solid oral dosage forms of potassium chloride are contraindicated in any patient in whom there is structural, pathological (eg, diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.
(see OVERDOSAGE)
In patients with impaired mechanisms for excreting potassium, the administration of potassium salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment.
Hypokalemia should not be treated by the concomitant administration of potassium salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.
Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril, enalapril) will produce some potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.
Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of potassium chloride are associated with an increased frequency of small bowel lesions (40–50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. K-Dur is a tablet formulated to provide a controlled rate of release of microencapsulated potassium chloride and thus to minimize the possibility of a high local concentration of potassium near the gastrointestinal wall.
Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral potassium chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (ie, 96 mEq per day in divided doses of potassium chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing). The relevance of these findings to the usual conditions (ie, nonfasting, no anticholinergic agent, smaller doses) under which controlled release potassium chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. K-Dur should be discontinued immediately and the possibility of ulceration, obstruction, or perforation considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.
Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.
The diagnosis of potassium depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for potassium depletion. In interpreting the serum potassium level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body potassium while acute acidosis per se can increase the serum potassium concentration into the normal range even in the presence of a reduced total body potassium. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.
Physicians should consider reminding the patient of the following:
To take each dose with meals and with a full glass of water or other liquid.
To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration:
Aqueous suspension of K-Dur tablets that is not taken immediately should be discarded. The use of other liquids for suspending K-Dur tablets is not recommended.
To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.
To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.
When blood is drawn for analysis of plasma potassium it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.
Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS).
Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.
Animal reproduction studies have not been conducted with K-Dur. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.
The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk.
Safety and effectiveness in pediatric patients have not been established.
One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS, WARNINGS, and OVERDOSAGE). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS).
The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. These symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals or reducing the amount taken at one time.
The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly intravenously potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5–8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9–12 mEq/L).
Treatment measures for hyperkalemia include the following:
In treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.
The usual dietary intake of potassium by the average adult is 50 to 100 mEq per day. Potassium depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of potassium from the total body store.
Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40–100 mEq per day or more are used for the treatment of potassium depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.
Each K-Dur 20 tablet provides 20 mEq of potassium chloride.
Each K-Dur 10 tablet provides 10 mEq of potassium chloride.
K-Dur tablets should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS).
Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:
Aqueous suspension of K-Dur tablets that is not taken immediately should be discarded. The use of other liquids for suspending K-Dur tablets is not recommended.
K-Dur 20 mEq Extended Release Tablets are available in bottles of 100 (NDC 0085-0787-01); bottles of 500 (NDC 0085-0787-06); bottles of 1000 (NDC 0085-0787-10); and boxes of 100 for unit dose dispensing (NDC 0085-0787-81). K-Dur 20 mEq tablets are white to off-white mottled capsule-shaped tablets, imprinted "K-Dur 20" and scored on the other side for flexibility of dosing.
K-Dur 10 mEq Extended Release Tablets are available in bottles of 100 (NDC 0085-0263-01) and boxes of 100 for unit dose dispensing (NDC 0085-0263-81). K-Dur 10 mEq tablets are white to off-white mottled capsule-shaped tablets, imprinted "K-Dur 10" on one side and plain on the other.
Keep tightly closed.
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]
Rx only.
Copyright © 1986, 1989, 1990, Key Pharmaceuticals, Inc. All rights reserved.
Rev. 4/04
24206726T
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Treating certain fungal infections of the skin.
Ketoconazole Cream is an imidazole antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it. The weakened cell membrane allows the cell contents to leak out and results in the death of the fungus.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Ketoconazole Cream. 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 Ketoconazole Cream. Because little, if any, of Ketoconazole Cream is absorbed into the blood, the risk of it interacting with another medicine is low.
Ask your health care provider if Ketoconazole Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Ketoconazole Cream 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 Ketoconazole Cream.
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:
Itching; mild irritation or stinging.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); reddening, blistering, peeling, itching, or burning of your skin.
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.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Ketoconazole Cream between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketoconazole Cream out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Ketoconazole Cream. 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.
Anabolex may be available in the countries listed below.
Metandienone is reported as an ingredient of Anabolex in the following countries:
International Drug Name Search
Generic Name: procyclidine (proe SYE kli deen)
Brand Names: Kemadrin
Procyclidine reduces the effects of certain chemicals in your body that may become unbalanced as a result of disease (such as Parkinson's disease), drug therapy, or other causes.
Procyclidine is used to treat the stiffness, tremors, spasms, and poor muscle control of Parkinson's disease. It is also used to treat and prevent these same muscular conditions when they are caused by drugs such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), and others.
Procyclidine may also be used for purposes other than those listed in this medication guide.
Avoid becoming overheated. Procyclidine may cause decreased sweating. This could lead to heat stroke in hot weather or with vigorous exercise.
have ever had an allergic reaction to it
have narrow-angle glaucoma,
have an obstruction in your bowel or a complication of bowel disease known as megacolon; or
have myasthenia gravis.
Before taking this medication, tell your doctor if you have
an enlarged prostate or difficulty urinating,
epilepsy or another seizure disorder,
heart disease or an irregular heartbeat,
depression or any other psychiatric illness, or
kidney or liver disease.
You may need a lower dose or special monitoring during treatment if you have any of the conditions listed above.
Take procyclidine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Procyclidine is usually taken three to four times a day. Follow your doctor's instructions.
See also: Kemadrin dosage (in more detail)
Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and only take your next regularly scheduled dose. Do not take a double dose of this medication.
Symptoms of a procyclidine overdose include large pupils; warm, dry skin; flushed face; fever; dry mouth; fast or irregular heartbeat; anxiety; hallucinations; confusion; agitation; hyperactivity; loss of consciousness; and seizures.
Avoid becoming overheated. Procyclidine may cause decreased sweating. This could lead to heat stroke in hot weather or with vigorous exercise. Try to keep as cool as possible and watch for signs of heat stroke such as decreased sweating, nausea, and dizziness.
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
unusual fever;
fast or irregular heartbeat;
anxiety, hallucinations, confusion, hyperactivity, or loss of consciousness;
agitation, disorientation, or unusual behavior;
seizures;
eye pain; or
a rash.
Other, less serious side effects may be more likely to occur. Continue to take procyclidine and talk to your doctor if you experience
a dry mouth,
large pupils or blurred vision,
drowsiness,
difficulty urinating or constipation,
upset stomach, or
decreased sweating.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Tell your doctor and pharmacist about all medicines you are taking especially any of the following:
a phenothiazine (used to treat mania, schizophrenia, other psychiatric conditions, and nausea and vomiting) chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), thioridazine (Mellaril), promazine (Sparine), trifluoperazine (Stelazine), and others;
an antihistamine such as diphenhydramine (Benadryl, others), chlorpheniramine (Chlor-Trimeton, others), triprolidine (Actifed, others), brompheniramine (Dimetapp, others), clemastine (Tavist), and others, (antihistamines are often found in prescription and over-the-counter cold, allergy, and sleep medicines);
quinidine (Quinora, Quinaglute, Quinidex, Cardioquin);
amantadine (Symmetrel)
digoxin (Lanoxin, Lanoxicaps); or
haloperidol (Haldol).
Drugs other than those listed here may also interact with procyclidine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Procyclidine is available with a prescription under the brand name Kemadrin. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Kemadrin 5 mg--white, round, scored tablets
See also: Kemadrin side effects (in more detail)
Penicillin is an antibiotic that disturbs the cell wall synthesis in bacteria. It was initially derived from the mold Penicillium rubrum. Since then, a number of naturally occurring penicillins have been derived e.g. penicillin G (benzylpenicillin) and penicillin V (phenoxymethylpenicillin).
Other antibiotics obtained from penicillins include amoxicillin, ampicillin, flucloxacillin. These are classed as semisynthetic penicillins.
Penicillins are bactericidal and mainly active against gram-positive bacteria.
The most important side effect of penicillins is hypersensitivity, such as rashes or anaphylaxis. Patients who are allergic to one penicillin will be allergic to all.
Renodiol may be available in the countries listed below.
Estradiol is reported as an ingredient of Renodiol in the following countries:
Normethandrone is reported as an ingredient of Renodiol in the following countries:
International Drug Name Search
Generic Name: factor ix complex (Intravenous route, Injection route)
FAK-tor NINE
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antihemophilic Agent
Factor IX is a protein produced naturally in the body. It helps the blood form clots to stop bleeding. Injections of factor IX are used to treat hemophilia B, which is sometimes called Christmas disease. This is a condition in which the body does not make enough factor IX. If you do not have enough factor IX and you become injured, your blood will not form clots as it should, and you may bleed into and damage your muscles and joints.
Injections of one form of factor IX, called factor IX complex, also are used to treat certain people with hemophilia A. In hemophilia A, sometimes called classical hemophilia, the body does not make enough factor VIII, and, just as in hemophilia B, the blood cannot form clots as it should. Injections of factor IX complex may be used in patients in whom the medicine used to treat hemophilia A is no longer effective. Injections of factor IX complex also may be used for other conditions as determined by your doctor.
The factor IX product that your doctor will give you is obtained naturally from human blood or artificially by a man-made process. Factor IX obtained from human blood has been treated and is not likely to contain harmful viruses such as hepatitis B virus, hepatitis C (non-A, non-B) virus, or human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS). The man-made factor IX product does not contain these viruses.
Factor IX 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.
Blood clots may be especially likely to occur in premature and newborn babies, who are usually more sensitive than adults to the effects of injections of factor IX.
This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.
| 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. |
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 factor ix complex. It may not be specific to Benefix. Please read with care.
Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.
To prepare this medicine:
Use this medicine right away. It should not be kept longer than 3 hours after it has been prepared.
A plastic disposable syringe and filter needle must be used with this medicine. The medicine may stick to the inside of a glass syringe, and you may not receive a full dose.
Do not reuse syringes and needles. Put used syringes and needles in a puncture-resistant disposable container, or dispose of them as directed by your health care professional.
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.
Call your doctor or pharmacist for instructions.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Some factor IX products must be stored in the refrigerator, and some may be kept at room temperature for short periods of time. Store this medicine as directed by your doctor or the manufacturer.
If you were recently diagnosed with hemophilia B, you should receive hepatitis A and hepatitis B vaccines to reduce even further your risk of getting hepatitis A or hepatitis B from factor IX products.
After a while, your body may build up a defense (antibody) against this medicine. Tell your doctor if this medicine seems to be less effective than usual.
It is recommended that you carry identification stating that you have hemophilia A or hemophilia B. If you have any questions about what kind of identification to carry, check with your health care professional.
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:
Check with your doctor immediately if any of the following side effects occur:
Check with your doctor immediately if any of the following side effects occur:
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: Benefix side effects (in more detail)
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