Flora may be available in the countries listed below.
Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Flora in the following countries:
International Drug Name Search
Cefuroxim Astro may be available in the countries listed below.
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Cefuroxim Astro in the following countries:
International Drug Name Search
Fandhi may be available in the countries listed below.
Von Willebrand Factor, Human is reported as an ingredient of Fandhi in the following countries:
International Drug Name Search
The following drugs and medications are in some way related to, or used in the treatment of Seasonal Affective Disorder. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Medical Encyclopedia:
Metazol may be available in the countries listed below.
Metronidazole is reported as an ingredient of Metazol in the following countries:
International Drug Name Search
Drug Facts
| Active ingredients (in each packet) | Purpose |
| Dextromethorphan HBr 5 mg | Cough suppressant |
| Guaifenesin 100 mg | Expectorant |
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.
If pregnant or breast-feeding, ask a healthcare professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
| Age | Dose |
|---|---|
| adults and children 12 years and over | 2 to 4 packets every 4 hours |
| children 6 years to under 12 years | 1 to 2 packets every 4 hours |
| children 4 years to under 6 years | 1 packet every 4 hours |
| children under 4 years | do not use |
aspartame, butylated methacrylate copolymer, carbomer homopolymer, creme flavor, magnesium stearate, microcrystalline cellulose, orange flavor, povidone, sodium bicarbonate, sodium carboxymethylcellulose, sorbitol, stearic acid, talc, triethyl citrate
1-866-MUCINEX (1-866-682-4639) or www.mucinex.com
Made in Germany
Distributed by:
Reckitt Benckiser Inc.
Parsippany, NJ
07054-0224
© RBI 2009
NDC 63824-256-12
Mucinex®
Guaifenesin 100 mg
Dextromethorphan HBr 5 mg
COUGH
EXPECTORANT • COUGH SUPPRESSANT
mini-melts™
For Kids!
Orange Creme
Flavor
Controls Cough
Thins And Loosens Mucus
12 GRANULE PACKETS
| Mucinex for Kids guaifenesin and dextromethorphan hydrobromide granule | ||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| OTC monograph final | part341 | 03/24/2009 | |
| Labeler - Reckitt Benckiser, Inc. (094405024) |
One-Alpha
Injection
alfacalcidol
One-Alpha belongs to a group of medicines called vitamin D analogues. It is a type of vitamin D.
Vitamin D controls the levels of two substances in your body. These substances are called calcium and phosphate. Your body needs both of these substances for healthy bones and teeth.
One-Alpha works by increasing the amount of vitamin D in your body. This means the levels of calcium and phosphate in your body will increase too.
One-Alpha is used to treat diseases where the amount of calcium in your body needs changing. It is used to treat:
If you are unsure if any of the above apply to you, talk to your doctor before having One-Alpha.
Before you have One-Alpha tell your doctor:
You may get too much calcium or phosphate in your blood when you have this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor may need to change your dose.
While you are having One-Alpha your doctor will take regular blood tests. This is very important in children, patients with kidney problems, or patients on a high dose
of medicine. This is to check the level of calcium and phosphate in your blood while you have your medicine.
Your doctor may prescribe another medicine called a phosphate binding agent to take as well as One-Alpha. This will help to keep the right amount of phosphate in your blood.
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines. This includes any medicines which you have bought without a prescription. You must tell your doctor or pharmacist if you are taking any of the following medicines:
Please ask your doctor or pharmacist for advice before having One-Alpha:
Tell your doctor if you become pregnant while having this medicine.
Usually your medicine may have very little effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines.
One-Alpha contains:
Please ask your doctor if you are worried about any of the ingredients in this medicine.
One-Alpha will be given to you by a doctor or nurse.
Your doctor or nurse will give you One-Alpha because it is an injection.
This injection goes into your vein. This may be called IV (intravenous) by your doctor or nurse.
At first you will have weekly blood tests to check the levels of some substances in your blood. These tests are to check the levels of calcium, an enzyme called alkaline phosphatase or the parathyroid hormone. This is so your doctor knows that you are taking the dose that is right for you. When you are getting the correct dose you will not need blood tests so often.
You may also have other tests such as X-rays. This is also so your doctor knows that the dose is right for you.
Your doctor may adjust your dose. Your doctor may ask you to have more or less medicine depending on your test results.
You may get too much calcium or phosphate in your blood when you have this medicine. Please read section 4 of this leaflet so you can spot any signs this may be happening to you. Your doctor will tell you not to have any more medicine. You will need to have some blood tests. When the blood tests are normal you can start your medicine again. It is important that you only have half the dose you had before.
The usual starting dose is 1 microgram each day. People usually take between 1 and 3 micrograms each day.
Most people take between 0.25 and 1 microgram each day once the blood test results show the medicine is working.
If you have very low levels of calcium in your blood, the doctor may prescribe between 3 and 5 micrograms each day. Your doctor may prescribe another medicine called a calcium supplement to take as well as One-Alpha. This will help to keep the right amount of calcium in your blood.
The usual starting dose is 0.5 microgram each day.
The dose depends on the weight of the child (called bodyweight).
Your doctor or nurse will give you this medicine. If you think you may have been given too much, tell your doctor or nurse straight away. You may need to stop having this medicine.
You may get too much calcium or phosphate in your blood. Please read section 4 of this leaflet so you can spot any signs this may be happening to you.
Your doctor or nurse will give you this medicine. If you think that you have missed a dose then tell your doctor or nurse. If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
Like all medicines, One-Alpha can cause side effects, although not everybody gets them.
You should tell your doctor straight away if you spot any of the following signs which may be due to too much calcium or phosphate in your blood:
Skin problems:
Kidney problems:
These are signs that there may be problems developing with your kidneys. Kidney stones may be forming. Kidney stones may cause a sharp spasm in one side of your lower back.
The possible side effects described in this section of the leaflet probably affect about 1 in 10,000 people. Skin problems or too much calcium in your blood are the side effects most people get.
If any of the side effects become serious, or you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.
One-Alpha is a clear colourless solution.
One-Alpha comes in amber glass ampoules containing 0.5 or 1 ml.
There are 10 ampoules in a carton.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in May 2009.
Registered Trade Mark
LEO
024409-00
Cefmetazole Sodium may be available in the countries listed below.
Cefmetazole Sodium (JAN, USAN) is known as Cefmetazole in the US.
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| USAN | United States Adopted Name |
Generic Name: zinc oxide topical (ZINK OX ide)
Brand Names: ARC, Balmex, Boudreaux Butt Paste, Caldesene, Calmol-4 Suppository, Critic-Aid Skin Paste, Delazinc, Dermagran BC, Desitin, Desitin Maximum Strength Original, Desitin Rapid Relief Creamy, Diaper Rash Ointment, Diaper Relief, Dr. Smith's Diaper, Flanders Buttocks Ointment, Geri-Protect, Medi-Paste, PeriGuard, Pinxav, Rash Relief, RVPaque, Seniortopix Healix, Soothe & Cool Skin Paste, Sportz Block Dark, Sportz Block Light, Sportz Block Medium, Triple Paste, Tronolane Suppositories, Unna-Flex Elastic Unna Boot 3 inch, Unna-Flex Elastic Unna Boot 4 inch, Znlin
Zinc oxide is a mineral.
Zinc oxide topical (for the skin) is used to treat diaper rash, minor burns, severely chapped skin, or other minor skin irritations.
Zinc oxide rectal suppositories are used to treat itching, burning, irritation, and other rectal discomfort caused by hemorrhoids or painful bowel movements.
Zinc oxide topical may also be used for purposes not listed in this medication guide.
Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.
Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.
Avoid using other medications on the areas you treat with zinc oxide unless you doctor tells you to.
Zinc oxide topical will not treat a bacterial or fungal infection. Call your doctor if you have any signs of infection such as redness and warmth or oozing skin lesions.
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.
Apply enough of this medication to cover the entire area to be treated. Zinc oxide often leaves a thin white residue that may not be entirely rubbed in.
To treat chapped skin, minor burn wounds, or other skin irritations, use the medication as often as needed. Apply a thin layer to the affected area and rub in gently.
To treat diaper rash, use this medication each time the diaper is changed. It is especially important to apply the medication at bedtime or whenever there will be a long period of time between diaper changes.
Keep the diaper area clean and dry to prevent worsening of skin rash. Change wet diapers as soon as possible. Allow the skin to dry thoroughly before putting on a fresh diaper.
Zinc oxide rectal suppositories come with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Try to empty your bowel and bladder just before using the suppository. Cleanse and dry your rectal area thoroughly.
Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands.
For best results, stay lying down after inserting the suppository and hold it in your rectum for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.
Since zinc oxide is used on an as needed basis, you are not likely to miss a dose. Using extra zinc oxide to make up a missed dose will not make the medication more effective.
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.
Avoid applying other skin medications on the same treatment area with zinc oxide, unless your doctor has told you to.
There may be other drugs that can interact with zinc oxide topical or rectal suppositories. 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: Desitiny Diaper Rash side effects (in more detail)
Intravenous Sodium DIURIL (chlorothiazide sodium) is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its empirical formula is C7H5ClN3NaO4S2 and its structural formula is:
Intravenous Sodium DIURIL is a sterile lyophilized white powder and is supplied in a vial containing:
Chlorothiazide sodium equivalent to chlorothiazide - 0.5 g
Inactive ingredients:
Mannitol - 0.25 g
Sodium hydroxide to adjust pH.
DIURIL (chlorothiazide) is a diuretic and antihypertensive. It is 6-chloro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H6ClN3O4S2 and its structural formula is:
It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7.
The mechanism of the antihypertensive effect of thiazides is unknown. DIURIL (chlorothiazide) does not usually affect normal blood pressure.
DIURIL (chlorothiazide) affects the distal renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy.
DIURIL (chlorothiazide) increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate.
After oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours. Following intravenous use of Sodium DIURIL, onset of the diuretic action occurs in 15 minutes and the maximal action in 30 minutes.
DIURIL is not metabolized but is eliminated rapidly by the kidney; 96 percent of an intravenous dose is excreted unchanged in the urine within 23 hours. The plasma half-life of chlorothiazide is 45-120 minutes. Chlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.
Intravenous Sodium DIURIL is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Intravenous Sodium DIURIL has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure.
Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia.
Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus, is properly treated through elevation of the lower extremities and use of support stockings. Use of diuretics to lower intravascular volume in this instance is illogical and unnecessary. During normal pregnancy there is hypervolemia which is not harmful to the fetus or the mother in the absence of cardiovascular disease. However, it may be associated with edema, rarely generalized edema. If such edema causes discomfort, increased recumbency will often provide relief. Rarely this edema may cause extreme discomfort which is not relieved by rest. In these instances, a short course of diuretic therapy may provide relief and be appropriate.
Anuria.
Hypersensitivity to any component of this product or to other sulfonamide-derived drugs.
Intravenous use in infants and children has been limited and is not generally recommended.
Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Thiazides may add to or potentiate the action of other antihypertensive drugs.
Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Lithium generally should not be given with diuretics (see PRECAUTIONS, Drug Interactions).
All patients receiving diuretic therapy should be observed for evidence of fluid or electrolyte imbalance: namely, hyponatremia, hypochloremic alkalosis, and hypokalemia. Serum and urine electrolyte determinations are particularly important when the patient is vomiting excessively or receiving parenteral fluids. Warning signs or symptoms of fluid and electrolyte imbalance, irrespective of cause, include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop especially with brisk diuresis, when severe cirrhosis is present or after prolonged therapy.
Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia may cause cardiac arrhythmias and may also sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Hypokalemia may be avoided or treated by use of potassium-sparing diuretics or potassium supplements such as foods with a high potassium content.
Although any chloride deficit is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease), chloride replacement may be required in the treatment of metabolic alkalosis.
Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction, rather than administration of salt, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.
Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazides.
In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required. Hyperglycemia may occur with thiazide diuretics. Thus latent diabetes mellitus may become manifest during thiazide therapy.
The antihypertensive effects of the drug may be enhanced in the postsympathectomy patient.
If progressive renal impairment becomes evident, consider withholding or discontinuing diuretic therapy.
Thiazides have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
Thiazides may decrease urinary calcium excretion. Thiazides may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism. Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function.
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Periodic determination of serum electrolytes to detect possible electrolyte imbalance should be done at appropriate intervals.
When given concurrently the following drugs may interact with thiazide diuretics.
Alcohol, barbiturates, or narcotics - potentiation of orthostatic hypotension may occur.
Antidiabetic drugs - (oral agents and insulin) - dosage adjustment of the antidiabetic drug may be required.
Other antihypertensive drugs - additive effect or potentiation.
Corticosteroids, ACTH - intensified electrolyte depletion, particularly hypokalemia.
Pressor amines (e.g., norepinephrine) - possible decreased response to pressor amines but not sufficient to preclude their use.
Skeletal muscle relaxants, nondepolarizing (e.g., tubocurarine) - possible increased responsiveness to the muscle relaxant.
Lithium - generally should not be given with diuretics. Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. Refer to the package insert for lithium preparations before use of such preparations with Sodium DIURIL.
Non-steroidal Anti-inflammatory Drugs - In some patients, the administration of a non-steroidal anti-inflammatory agent can reduce the diuretic, natriuretic, and antihypertensive effects of loop, potassium-sparing and thiazide diuretics. Therefore, when Sodium DIURIL and non-steroidal anti-inflammatory agents are used concomitantly, the patient should be observed closely to determine if the desired effect of the diuretic is obtained.
Thiazides should be discontinued before carrying out tests for parathyroid function (see PRECAUTIONS, General).
Carcinogenicity studies have not been conducted with chlorothiazide.
Chlorothiazide was not mutagenic in vitro in the Ames microbial mutagen test (using a maximum concentration of 5 mg/plate and Salmonella typhimurium strains TA98 and TA100) and was not mutagenic and did not induce mitotic nondisjunction in diploid-strains of Aspergillus nidulans.
Chlorothiazide had no adverse effects on fertility in female rats at doses up to 60 mg/kg/day and no adverse effects on fertility in male rats at doses up to 40 mg/kg/day. These doses are 1.5 and 1.0 times** the recommended maximum human dose, respectively, when compared on a body weight basis.
Teratogenic Effects - Pregnancy Category C: Although reproduction studies performed with chlorothiazide doses of 50 mg/kg/day in rabbits, 60 mg/kg/day in rats and 500 mg/kg/day in mice revealed no external abnormalities of the fetus or impairment of growth and survival of the fetus due to chlorothiazide, such studies did not include complete examinations for visceral and skeletal abnormalities. It is not known whether chlorothiazide can cause fetal harm when administered to a pregnant woman; however, thiazides cross the placental barrier and appear in cord blood. DIURIL should be used during pregnancy only if clearly needed (see INDICATIONS AND USAGE).
Nonteratogenic Effects: Chlorothiazide may cause fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions which have occurred in the adult.
Because of the potential for serious adverse reactions in nursing infants from Intravenous Sodium DIURIL, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness of Intravenous Sodium DIURIL in pediatric patients have not been established.
Clinical studies of Intravenous Sodium DIURIL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see WARNINGS).
The following adverse reactions have been reported and, within each category, are listed in order of decreasing severity.
Body as a Whole: Weakness.
Cardiovascular: Hypotension including orthostatic hypotension (may be aggravated by alcohol, barbiturates, narcotics or antihypertensive drugs).
Digestive: Pancreatitis, jaundice (intrahepatic cholestatic jaundice), diarrhea, vomiting, sialadenitis, cramping, constipation, gastric irritation, nausea, anorexia.
Hematologic: Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.
Hypersensitivity: Anaphylactic reactions, necrotizing angiitis (vasculitis and cutaneous vasculitis), respiratory distress including pneumonitis and pulmonary edema, photosensitivity, fever, urticaria, rash, purpura.
Metabolic: Electrolyte imbalance (see PRECAUTIONS), hyperglycemia, glycosuria, hyperuricemia.
Musculoskeletal: Muscle spasm.
Nervous System/Psychiatric: Vertigo, paresthesias, dizziness, headache, restlessness.
Skin: Erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis, alopecia.
Special Senses: Transient blurred vision, xanthopsia.
Renal: Renal failure, renal dysfunction, interstitial nephritis, (see WARNINGS); hematuria (following intravenous use).
Urogenital: Impotence.
Whenever adverse reactions are moderate or severe, thiazide dosage should be reduced or therapy withdrawn.
To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck Inc. at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias.
In the event of overdosage, symptomatic and supportive measures should be employed. Correct dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment.
The degree to which chlorothiazide sodium is removed by hemodialysis has not been established.
The intravenous LD50 of chlorothiazide in the mouse is 1.1 g/kg.
Intravenous Sodium DIURIL should be reserved for patients unable to take oral medication or for emergency situations.
Therapy should be individualized according to patient response. Use the smallest dosage necessary to achieve the required response.
Intravenous use in infants and children has been limited and is not generally recommended.
When medication can be taken orally, therapy with DIURIL tablets or oral suspension may be substituted for intravenous therapy, using the same dosage schedule as for the parenteral route.
Intravenous Sodium DIURIL may be given slowly by direct intravenous injection or by intravenous infusion.
Extravasation must be rigidly avoided. Do not give subcutaneously or intramuscularly.
The usual adult dosage is 0.5 to 1 g once or twice a day. Many patients with edema respond to intermittent therapy, i.e., administration on alternate days or on three to five days each week. With an intermittent schedule, excessive response and the resulting undesirable electrolyte imbalance are less likely to occur.
Directions for Reconstitution
Use aseptic technique. Because Intravenous Sodium DIURIL contains no preservative, a fresh solution should be prepared immediately prior to each administration, and the unused portion should be discarded.
Add 18 mL of Sterile Water for Injection to the vial to form an isotonic solution for intravenous injection. Never add less than 18 mL. When reconstituted with 18 mL of Sterile Water, the final concentration of Intravenous Sodium DIURIL is 28 mg/mL. The reconstituted solution is clear and essentially free from visible particles. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to use whenever solution and container permit. The solution is compatible with dextrose or sodium chloride solutions for intravenous infusion. Avoid simultaneous administration of solutions of chlorothiazide with whole blood or its derivatives.
Intravenous Sodium DIURIL is a dry, sterile lyophilized white powder usually in plug form, supplied in vials containing chlorothiazide sodium equivalent to 0.5 g of chlorothiazide.
NDC 67386-711-55.
Storage
Store at 20-25°C (68-77°F). See USP controlled room temperature.
For single dose only. Use solution immediately after reconstitution (see DOSAGE AND ADMINISTRATION, Directions for Reconstitution). Discard unused portion of the reconstituted solution.
Manufactured by: Catalent Pharma Solutions, Inc., Raleigh, NC 27616, U.S.A.
For: Lundbeck Inc., Deerfield, IL 60015, U.S.A.
® Registered trademark of Merck & Co., Inc., Whitehouse Station, NJ 08889, U.S.A.
** Calculations based on a human body weight of 50 kg.
Revised July 2009
NDC 67386-711-55
Vial:
Carton:
Package:
| SODIUM DIURIL chlorothiazide sodium injection, powder, lyophilized, for solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA011145 | 10/03/1958 | |
| Labeler - Lundbeck Inc. (018343595) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| APP Pharmaceuticals, Inc. | 803593743 | MANUFACTURE | |
Generic Name: sodium fluoride (Oral route, Dental route, Oromucosal route)
SOE-dee-um FLOOR-ide
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Cariostatic
Fluoride has been found to be helpful in reducing the number of cavities in the teeth. It is usually present naturally in drinking water. However, some areas of the country do not have a high enough level in the water to prevent cavities. To make up for this, extra fluoride may be added to the diet. Some children may require both dietary fluoride and topical fluoride treatments by the dentist. Use of a fluoride toothpaste or rinse may be helpful as well.
Taking extra oral fluoride does not replace good dental habits. These include eating a good diet, brushing and flossing the teeth often, and having regular dental checkups.
Fluoride may also be used for other conditions as determined by your doctor.
This medicine is available only with a prescription.
For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.
People get needed fluoride from fish, including the bones, tea, and drinking water that has fluoride added to it. Food that is cooked in water containing fluoride or in Teflon-coated pans also provides fluoride. However, foods cooked in aluminum pans provide less fluoride.
The daily amount of fluoride needed is defined in several different ways.
There is no RDA or RNI for fluoride. Daily recommended intakes for fluoride are generally defined as follows:
Remember:
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.
Problems in children have not been reported with intake of normal daily recommended amounts. Doses of sodium fluoride that are too large or are taken for a long time may cause bone problems and teeth discoloration in children.
Problems in older adults have not been reported with intake of normal daily recommended amounts. Older people are more likely to have joint pain, kidney problems, or stomach ulcers which may be made worse by taking large doses of sodium fluoride. You should check with your health care professional.
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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain sodium fluoride. It may not be specific to Denta 5000 Plus. Please read with care.
Take this medicine only as directed by your health care professional. Do not take more of it and do not take it more often than ordered. Taking too much fluoride over a period of time may cause unwanted effects.
For individuals taking the chewable tablet form of this medicine:
For individuals taking the oral liquid 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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
The level of fluoride present in the water is different in different parts of the U.S. If you move to another area, check with a health care professional in the new area as soon as possible to see if this medicine is still needed or if the dose needs to be changed. Also, check with your health care professional if you change infant feeding habits (e.g., breast-feeding to infant formula), drinking water (e.g., city water to nonfluoridated bottled water), or filtration (e.g., tap water to filtered tap water).
Do not take calcium supplements or aluminum hydroxide–containing products and sodium fluoride at the same time. It is best to space doses of these two products 2 hours apart, to get the full benefit from each medicine.
Inform your health care professional as soon as possible if you notice white, brown, or black spots on the teeth. These are signs of too much fluoride in children when it is given during periods of tooth development.
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 as soon as possible if any of the following side effects occur:
Sodium fluoride in drinking water or taken as a supplement does not usually cause any side effects. However, taking an overdose of fluoride may cause serious problems.
Stop taking this medicine and get emergency help immediately if any of the following effects occur:
Check with your doctor as soon as possible 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.
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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INDICATIONS: Dexamethsone is indicated for use as an anti-inflammatory agent.
DOSAGE AND ADMINISTRATION: Dosage and administration for Dexium Tablets are as follows:
Dogs: Administer orally at 0.25 to 1.25 mg. per day up to 7 days
Cats: Administer orally at 0.125 to 0.5 mg. per day up to 7 days
CONTRAINDICATIONS: Do not use in viral infections. Except for emergency therapy, do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome and peptic ulcers. Exsitence of congestive heart failure, diabetes and osteoporosis are relative contraindications.
PRECAUTIONS: Because of the anti-inflammatory action of corticosteroids, signs of infection may be hidden and it may be necessary to stop treatment until diagnosis is made. Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss and weight gain. When therapy with Dexamethasone is to be discontinued after long use, the dosage should be reduced gradually. The administration of ACTH during the period gradual dosage reduction may help to accelerate the normal adrenocortical function. Use of corticosteroids, depending on the dose, duration, and specific steroid, may result in inhibition of endogenous steriod production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapid acting corticosteroid should be considered in unusually stressful situations.
SIDE EFFECTS: Side reactions such as weight loss, anorexia, diarrhea, polydypsia, and polyuria have been frequently observed during corticosteroid therapy.
SAP AND SGPT (ALT) enzyme elevations, polydypsia and polyuria have occurred following parental or systemic use ofsynthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs.
Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.
WARNING: Clinical and experimental data have demonstration that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.
Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia and anasarca.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
HOW SUPPLIED: Available in bottles of 100 and 1000 tablets, each tablet containing 0.25 mg. Dexamethasone.
STORAGE: Store at controlled room temperature 20 degrees - 25 degrees C (68 degrees - 77 degrees F), with excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F).
| DEXIUM dexamethasone tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA095218 | 12/17/1976 | |
| Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
| Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (043653216) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Bimeda, Inc. Division of Cross Vetpharm Group | 043653216 | manufacture | |
Phentermine hydrochloride USP has the chemical name of α,α,-Dimethylphenethylamine hydrochloride. The structural formula is as follows:
C10H15N • HCl M.W. 185.7
Phentermine hydrochloride is a white, odorless, hygroscopic, crystalline powder which is soluble in water and lower alcohols, slightly soluble in chloroform and insoluble in ether.
Adipex-P®, an anorectic agent for oral administration, is available as a capsule or tablet containing 37.5 mg of phentermine hydrochloride (equivalent to 30 mg of phentermine base).
Adipex-P® Capsules contain the inactive ingredients Corn Starch, Gelatin, Lactose Monohydrate, Magnesium Stearate, Titanium Dioxide, Black Iron Oxide, FD&C Blue #1, FD&C Red #40 and D&C Red #33.
Adipex-P® Tablets contain the inactive ingredients Corn Starch, Lactose (Anhydrous), Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Starch, Sucrose, and FD&C Blue #1.
Adipex-P® is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, the amphetamines. Actions include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for.
Drugs of this class used in obesity are commonly known as “anorectics” or “anorexigenics.” It has not been established that the action of such drugs in treating obesity is primarily one of appetite suppression. Other central nervous system actions, or metabolic effects, may be involved, for example.
Adult obese subjects instructed in dietary management and treated with “anorectic” drugs lose more weight on the average than those treated with placebo and diet, as determined in relatively short-term clinical trials.
The magnitude of increased weight loss of drug-treated patients over placebo-treated patients is only a fraction of a pound a week. The rate of weight loss is greatest in the first weeks of therapy for both drug and placebo subjects and tends to decrease in succeeding weeks. The possible origins of the increased weight loss due to the various drug effects are not established. The amount of weight loss associated with the use of an “anorectic” drug varies from trial to trial, and the increased weight loss appears to be related in part to variables other than the drugs prescribed, such as the physician-investigator, the population treated and the diet prescribed. Studies do not permit conclusions as to the relative importance of the drug and non-drug factors on weight loss.
The natural history of obesity is measured in years, whereas the studies cited are restricted to a few weeks’ duration; thus, the total impact of drug-induced weight loss over that of diet alone must be considered clinically limited.
Adipex-P® (phentermine hydrochloride) is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes, hyperlipidemia).
Below is a chart of Body Mass Index (BMI) based on various heights and weights.
BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.
The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.
Advanced arteriosclerosis, cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
Agitated states.
Patients with a history of drug abuse.
During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
Adipex-P® is indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss, including selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of these drug products for weight loss is not recommended.
Primary Pulmonary Hypertension (PPH) – a rare, frequently fatal disease of the lungs – has been reported to occur in patients receiving a combination of phentermine with fenfluramine or dexfenfluramine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnea. Other initial symptoms include: angina pectoris, syncope or lower extremity edema. Patients should be advised to report immediately any deterioration in exercise tolerance. Treatment should be discontinued in patients who develop new, unexplained symptoms of dyspnea, angina pectoris, syncope or lower extremity edema.
Valvular Heart Disease: Serious regurgitant cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of phentermine with fenfluramine or dexfenfluramine for weight loss. The etiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. The possibility of an association between valvular heart disease and the use of phentermine alone cannot be ruled out; there have been rare cases of valvular heart disease in patients who reportedly have taken phentermine alone.
Tolerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather, the drug should be discontinued.
Adipex-P® may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or driving a motor vehicle; the patient should therefore be cautioned accordingly.
DRUG ABUSE AND DEPENDENCE: Adipex-P® is related chemically and pharmacologically to the amphetamines. Amphetamines and related stimulant drugs have been extensively abused, and the possibility of abuse of Adipex-P® should be kept in mind when evaluating the desirability of including a drug as part of a weight reduction program. Abuse of amphetamines and related drugs may be associated with intense psychological dependence and severe social dysfunction. There are reports of patients who have increased the dosage to many times that recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxications is psychosis, often clinically indistinguishable from schizophrenia.
Usage with Alcohol: Concomitant use of alcohol with Adipex-P® may result in an adverse drug interaction.
Caution is to be exercised in prescribing Adipex-P® (phentermine hydrochloride) for patients with even mild hypertension.
Insulin requirements in diabetes mellitus may be altered in association with the use of Adipex-P® and the concomitant dietary regimen.
Adipex-P® may decrease the hypotensive effect of guanethidine.
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed with Adipex-P® (phentermine hydrochloride) to determine the potential for carcinogenesis, mutagenesis or impairment of fertility.
Pregnancy—Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Adipex-P®. It is also not known whether Adipex-P® can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Adipex-P® should be given to a pregnant woman only if clearly needed.
Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Cardiovascular: Primary pulmonary hypertension and/or regurgitant cardiac valvular disease (see WARNINGS), palpitation, tachycardia, elevation of blood pressure.
Central Nervous System: Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache; rarely psychotic episodes at recommended doses.
Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.
Allergic: Urticaria.
Endocrine: Impotence, changes in libido.
Manifestations of acute overdosage with phentermine include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states. Fatigue and depression usually follow the central stimulation. Cardiovascular effects include arrhythmia, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma.
Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendations in this regard. Acidification of the urine increases phentermine excretion. Intravenous phentolamine (Regitine®, CIBA) has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage.
Exogenous Obesity: Dosage should be individualized to obtain an adequate response with the lowest effective dose.
The usual adult dose is one capsule or tablet (37.5 mg) daily, administered before breakfast or 1-2 hours after breakfast. For tablets, the dosage may be adjusted to the patient’s need. For some patients ½ tablet (18.75 mg) daily may be adequate, while in some cases it may be desirable to give ½ tablet (18.75 mg) two times a day.
Late evening medication should be avoided because of the possibility of resulting insomnia.
Phentermine is not recommended for use in patients sixteen (16) years of age and under.
Available in tablets and capsules containing 37.5 mg phentermine hydrochloride (equivalent to 30 mg phentermine base). Each blue and white, oblong, scored tablet is debossed with “Adipex-P” and “9”-“9”. The #3 capsule has an opaque white body and an opaque bright blue cap. Each capsule is imprinted with “Adipex-P” - “37.5” on the cap and two stripes on the body using dark blue ink.
Tablets are packaged in bottles of 30 (NDC 57844-009-56); 100 (NDC 57844-009-01); and 1000 (NDC 57844-009-10).
Capsules are packaged in bottles of 100 (NDC 57844-019-01).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).
Manufactured for:
GATE PHARMACEUTICALS
Div. of Teva Pharmaceuticals USA
Sellersville, PA 18960
Manufactured by:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. S 7/2005
NDC 57844-009-01
Adipex-P® 37.5 mg CIV
(phentermine hydrochloride tablets USP)
Rx only
USUAL ADULT DOSAGE:
See package insert for full
prescribing information.
100 TABLETS
GATE
NDC 57844-019-01
Adipex-P® 37.5 mg CIV
(phentermine hydrochloride capsules USP)
Rx only
USUAL ADULT DOSAGE:
See package insert for full
prescribing information.
100 CAPSULES
GATE
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| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA085128 | 02/14/2011 | |
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| ANDA | ANDA088023 | 02/14/2011 | |
| Labeler - Gate Pharmaceuticals (001627975) |
