Len may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Mebendazole is reported as an ingredient of Len in the following countries:
International Drug Name Search
Cefamar may be available in the countries listed below.
Cefadroxil is reported as an ingredient of Cefamar in the following countries:
Cefuroxime sodium salt (a derivative of Cefuroxime) is reported as an ingredient of Cefamar in the following countries:
International Drug Name Search
See also: Generic Ritalin LA, Generic Ritalin-SR
Ritalin is a brand name of methylphenidate, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Ritalin:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ritalin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Ritalin.
Cloment may be available in the countries listed below.
Clozapine is reported as an ingredient of Cloment in the following countries:
International Drug Name Search
Adrenaline (Epinephrine) Injection BP 1 in 1000.
Each ml of solution for injection contains 1 mg of adrenaline (epinephrine) as the acid tartrate.
Sterile Injection.
Adrenaline Injection BP 1 in 1000 may be used in the treatment of acute allergy and anaphylactic shock.
The intramuscular route is the preferred choice for most individuals who have to be given adrenaline for the management of an anaphylactic reaction.
The following adrenaline doses are advised by the Working Group of the Resuscitation Council (UK).
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1. Use suitable syringe for measuring small volume
2. 300 micrograms (0.3ml) if child is small or prepubertal
There is lack of robust evidence for the doses recommended in children: the recommended doses are based on what is considered to be safe and practical.
Hypersensitivity to adrenaline, sodium metabisulphite or any of the other ingredients.
Adrenaline 1 in 1000 should not be used in fingers, toes, ears, nose or genitalia owing to the risk of ischaemic tissue necrosis.
Adrenaline should be used with caution in patients with hyperthyroidism, diabetes mellitus, phaeochromocytoma, narrow angle glaucoma, hypokalaemia, hypercalcaemia, severe renal impairment, prostatic adenoma leading to residual urine, cerebrovascular disease, organic brain damage or arteriosclerosis, in elderly patients, in patients with shock (other than anaphylactic shock) and in organic heart disease or cardiac dilatation (severe angina pectoris, obstructive cardiomyopathy, hypertension) as well as most patients with arrhythmias. Anginal pain may be induced when coronary insufficiency is present.
Adrenaline should be used cautiously, if at all, during general anaesthesia with halogenated hydrocarbon anaesthetics (See section 4.5).
Adrenaline should not be used during the second stage of labour (See Section 4.6).
Accidental intravascular injection may result in cerebral haemorrhage due to the sudden rise in blood pressure.
Adrenaline 1 in 1000 should not be diluted to 1 in 10,000 for use in cardiac resuscitation - when the 1 in 10,000 strength of adrenaline is required for this indication a “ready to use” preparation should be selected.
Monitor the patient as soon as possible (pulse, blood pressure, ECG, pulse oximetry) in order to assess the response to adrenaline.
The best site for IM injection is the anterolateral aspect of the middle third of the thigh. The needle used for injection needs to be sufficiently long to ensure that the adrenaline is injected into muscle. Intramuscular injections of Adrenaline into the buttocks should be avoided because of the risk of tissue necrosis.
Prolonged use of Adrenaline can result in severe metabolic acidosis because of elevated blood concentrations of lactic acid.
Adrenaline Injection contains sodium metabisulphite, which can cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals.
The presence of sodium metabisulphite in parenteral Adrenaline and the possibility of allergic-type reactions should not deter use of the drug when indicated for the treatment of serious allergic reactions or for other emergency situations.
Sympathomimetic agents:
Adrenaline should not be administered concomitantly with other sympathomimetic agents because of the possibility of additive effects and increased toxicity.
Alpha-adrenergic blocking agents:
Alpha-blockers such as phentolamine antagonise the vasoconstriction and hypertension effects of adrenaline. This effect may be beneficial in adrenaline overdose (See section 4.9).
Beta-adrenergic blocking agents:
Severe hypertension and reflex bradycardia may occur with non-cardioselective beta-blocking agents such as propranolol, due to alpha-mediated vasoconstriction.
Beta-blockers, especially non-cardioselective agents, also antagonise the cardiac and bronchodilator effects of adrenaline. Patients with severe anaphylaxis who are taking non-cardioselective beta-blockers may not respond to adrenaline treatment.
General Anaesthetics:
Administration of Adrenaline in patients receiving halogenated hydrocarbon general anaesthetics that increase cardiac irritability and seem to sensitise the myocardium to Adrenaline may result in arrhythmias including ventricular premature contractions, tachycardia or fibrillation (See section 4.4).
Antihypertensive agents:
Adrenaline specifically reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine, with the risk of severe hypertension. Adrenaline increases blood pressure and may antagonise the effects of antihypertensive drugs.
Antidepressant agents:
Tricyclic antidepressants such as imipramine inhibit reuptake of directly acting sympathomimetic agents, and may potentiate the effect of adrenaline, increasing the risk of development of hypertension and cardiac arrhythmias.
Although monoamine oxidase (MAO) is one of the enzymes responsible for Adrenaline metabolism, MAO inhibitors do not markedly potentiate the effects of Adrenaline.
Phenothiazines:
Phenothiazines block alpha-adrenergic receptors (see above).
Adrenaline should not be used to counteract circulatory collapse or hypotension caused by phenothiazines; a reversal of the pressor effects of Adrenaline may result in further lowering of blood pressure.
Other drugs:
Adrenaline should not be used in patients receiving high dosage of other drugs (e.g. cardiac glycosides) that can sensitise the heart to arrhythmias. Some antihistamines (e.g. diphenhydramine) and thyroid hormones may potentiate the effects of Adrenaline, especially on heart rhythm and rate.
Hypokalaemia:
The hypokalaemic effect of adrenaline may be potentiated by other drugs that cause potassium loss, including corticosteroids, potassium-depleting diuretics, aminophylline and theophylline.
Hyperglycaemia:
Adrenaline-induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with insulin or oral hypoglycaemic agents.
Adrenaline usually inhibits spontaneous or oxytocin induced contractions of the pregnant human uterus and may delay the second stage of labour. In dosage sufficient to reduce uterine contractions, the drug may cause a prolonged period of uterine atony with haemorrhage. If used during pregnancy, Adrenaline may cause anoxia to the foetus. For this reason parenteral Adrenaline should not be used during the second stage of labour. Adrenaline should only be used during pregnancy if the potential benefits justify the possible risks to the foetus.
Adrenaline is distributed into breast milk. Breast-feeding should be avoided in mothers receiving Adrenaline injection.
None noted.
The adverse events of adrenaline mainly relate to the stimulation of both alpha- and beta-adrenergic receptors. The occurrence of undesirable effects depends on the sensitivity of the individual patient and the dose involved.
Immune system disorders:
Anaphylaxis, possibly with severe bronchospasm (See section 4.4).
Metabolism and nutrition disorders:
Hyperglycaemia, hypokalaemia, metabolic acidosis (see section 4.4).
Psychiatric disorders:
Anxiety
Nervous system disorders
Headache, dizziness, tremors
In patients with Parkinsonian Syndrome, Adrenaline increases rigidity and tremor.
Subarachnoid haemorrhage and hemiplegia have resulted from hypertension, even following subcutaneous administration of usual doses of Adrenaline.
Cardiac disorders:
Disturbances of cardiac rhythm and rate may result in palpitation and tachycardia. Chest pain/angina may occur. Adrenaline can cause potentially fatal ventricular arrhythmias including fibrillation, especially in patients with organic heart disease or those receiving other drugs that sensitise the heart to arrhythmias.
Adrenaline causes E.C.G. changes including a decrease in T-Wave amplitude in all leads in normal subjects.
Vascular disorders:
Hypertension (with risk of cerebral haemorrhage).
Coldness of extremities may occur even with small doses of Adrenaline.
Respiratory disorders:
Pulmonary oedema may occur after excessive doses or in extreme sensitivity.
Gastrointestinal disorders:
Nausea, vomiting.
Renal and urinary disorders:
Difficulty in micturition, urinary retention.
General disorders and administrative site conditions:
Sweating, weakness.
Repeated injections of Adrenaline can cause necrosis as a result of vascular constriction at the injection site. Tissue necrosis may also occur in the extremities, kidneys and liver.
Symptoms
After overdosage or inadvertent intravenous administration of usual intramuscular subcutaneous doses of Adrenaline, systolic and diastolic blood pressure rise sharply; venous pressure also rises. Cerebrovascular or other haemorrhages and hemiplegia may result, especially in elderly patients. Pulmonary oedema may occur.
Adrenaline overdosage causes transient bradycardia followed by tachycardia and may cause other potentially fatal cardiac arrhythmias. Kidney failure, metabolic acidosis and cold white skin may also occur.
Treatment
Because Adrenaline is rapidly inactivated in the body, treatment of acute toxicity is mainly supportive.
The pressor effects of Adrenaline may be counteracted by an immediate intravenous injection of a quick-acting alpha-adrenoreceptor blocking agent, such as 5-10 mg of phentolamine mesylate, followed by a beta-adrenoreceptor blocking agent, such as 2.5 - 5 mg of propranolol. Arrhythmias, if they occur, may be counteracted by propranolol injection.
Pharmacotherapeutic group: adrenergic and dopaminergic agents, adrenaline.
ATC code: C01 CA 24
Adrenaline is a naturally occurring catecholamine secreted by the adrenal medulla in response to exertion or stress. It is a sympathomimetic amine which is a potent stimulant of both alpha- and beta-adrenergic receptors and its effects on target organs are therefore complex. It is used to provide rapid relief of hypersensitivity reactions to allergies or to idiopathic or exercise-induced anaphylaxis.
Adrenaline has a strong vasoconstrictor action through alpha- adrenergic stimulation. This activity counteracts the vasodilatation and increased vascular permeability leading to loss of intravascular fluid and subsequent hypotension, which are the major pharmacological features in anaphylactic shock.
Adrenaline stimulates bronchial beta-adrenergic receptors and has a powerful bronchodilator action. Adrenaline also alleviates pruritus, urticaria and angioedema associated with anaphylaxis.
Adrenaline has a rapid onset of action after intramuscular administration and in the shocked patient its absorption from the intramuscular site is faster and more reliable than from the subcutaneous site.
Adrenaline is rapidly inactivated in the body, mostly in the liver by the enzymes catechol-O-methyltransferase (COMT) and monoamine oxidase (MAO). Much of a dose of adrenaline is excreted as metabolites in urine. The plasma half-life is about 2-3 minutes. However, when given by subcutaneous or intramuscular injection, local vasoconstriction may delay absorption so that the effects may last longer than the half-life suggests.
No further information other than that which is included in the Summary of Product Characteristics.
Sodium Metabisulphite Ph. Eur.
Sodium Chloride Ph. Eur.
Sodium Hydroxide Ph. Eur.
Water for Injections Ph. Eur.
Hydrochloric Acid Ph. Eur.
Adrenaline is rapidly denatured by oxidising agents and alkalis including sodium bicarbonate, halogens, nitrates, nitrites and salts of iron, copper and zinc. Adrenaline may be mixed with 0.9% Sodium Chloride injection but is incompatible with 5% sodium chloride injection. The stability of Adrenaline in 5% dextrose injection decreases when the pH is greater than 5.5.
24 months.
Store at less than 25 C and protect from light.
Clear glass ampoules of 1 ml. Packed in cardboard cartons to contain 10 ampoules x 1 ml.
Use as directed by the Physician.
hameln pharmaceuticals ltd
Gloucester
UK
PL 01502/0024
14th December 1978 / 23rd August 2001
06/08/09
Symbicord Turbuhaler may be available in the countries listed below.
Budesonide is reported as an ingredient of Symbicord Turbuhaler in the following countries:
Formoterol fumarate dihydrate (a derivative of Formoterol) is reported as an ingredient of Symbicord Turbuhaler in the following countries:
International Drug Name Search
Generic Name: pseudoephedrine and triprolidine (try PROE li deen and soo doe e FED rin)
Brand Names: A-Phedrin, Allerfrim, Allerphed, Altafed, Aphedrid, Aprodine, Biofed-PE, Genac, Histafed, Pediatex TD, Tripohist D, Vi-Sudo, Zymine-D
Triprolidine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of pseudoephedrine and triprolidine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.
Pseudoephedrine and triprolidine may also be used for other purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take pseudoephedrine and triprolidine if you have:
diabetes;
glaucoma;
heart disease or high blood pressure;
diabetes;
a thyroid disorder;
an enlarged prostate; or
problems with urination.
Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.
Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.
Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.
This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.
Since cold or allergy medicine is usually taken only as 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).
Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
confusion, hallucinations, unusual thoughts or behavior;
severe dizziness, anxiety, restless feeling, or nervousness;
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
confusion, hallucinations, unusual thoughts or behavior;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
urinating less than usual or not at all.
Less serious side effects may include:
blurred vision;
dry mouth;
nausea, stomach pain, constipation;
mild loss of appetite, stomach upset;
warmth, tingling, or redness under your skin;
sleep problems (insomnia);
restless or excitability (especially in children);
skin rash or itching;
dizziness, drowsiness;
problems with memory or concentration; or
ringing in your ears.
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.
Tell your doctor about all other medications you use, especially:
medicines to treat high blood pressure;
a diuretic (water pill);
medication to treat irritable bowel syndrome;
bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);
aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and there may be other drugs that can interact with pseudoephedrine and triprolidine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
See also: Genac side effects (in more detail)
Rx Only
Zazole® Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis - 1 - [p - [[2 - (2,4 - Dichlorophenyl) - 2 - (1 - H - 1,2,4 - triazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxy]phenyl] - 4 - isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water. The structural formula of terconazole is as follows:
Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.
Following intravaginal administration of terconazole in humans, absorption ranged from 5-8% in three hysterectomized subjects and 12-16% in two non-hysterectomized subjects with tubal ligations.
Following daily intravaginal administration of 0.8% terconazole 40 mg (0.8% cream x 5 g) for seven days to normal humans, plasma concentrations were low and gradually rose to a daily peak (mean of 5.9 ng/mL or 0.006 mcg/mL) at 6.6 hours. Results from similar studies in patients with vulvovaginal candidiasis indicate that the slow rate of absorption, the lack of accumulation, and the mean peak plasma concentration of terconazole was not different from that observed in healthy women. The absorption characteristics of terconazole 0.8% in pregnant or non-pregnant patients with vulvovaginal candidiasis were also similar to those found in normal volunteers.
Following oral (30 mg) administration of 14C-labelled terconazole, the harmonic half-life of elimination from the blood for the parent terconazole was 6.9 hours (range 4.0-11.3). Terconazole is extensively metabolized; the plasma AUC for terconazole compared to the AUC for total radioactivity was 0.6%. Total radioactivity was eliminated from the blood with a harmonic half-life of 52.2 hours (range 44-60). Excretion of radioactivity was both by renal (32-56%) and fecal (47-52%) routes.
In vitro, terconazole is highly protein bound (94.9%) and the degree of binding is independent of drug concentration.
Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultra-violet light.
Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream 0.8%.
Microbiology: Terconazole exhibits fungicidal activity in vitro against Candida albicans. Antifungal activity also has been demonstrated against other fungi. The MIC values of terconazole against most Lactobacillus spp. typically found in the human vagina were ≥ 128 mcg/mL; therefore these beneficial bacteria are not affected by drug treatment. The exact pharmacologic mode of action of terconazole is uncertain; however, it may exert its antifungal activity by the disruption of normal fungal cell membrane permeability. No resistance to terconazole has developed during successive passages of C. albicans.
Zazole® Vaginal Cream 0.8% is indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As Zazole® Vaginal Cream 0.8% is effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Patients known to be hypersensitive to terconazole or to any of the components of the cream.
None.
General: Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.
Laboratory Tests: If there is a lack of response to terconazole, appropriate microbiological studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
Drug Interactions: The therapeutic effect of this product is not affected by oral contraceptive usage.
Carcinogenesis: Studies to determine the carcinogenic potential of terconazole have not been performed.
Mutagenicity: Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.
Impairment of Fertility: No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.
There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (50x the recommended intravaginal human dose of the 0.8% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats. Dosages at or below 10 mg/kg/day produced no embryotoxicity; however there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20-40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increase incidence of skeletal variants.
The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal cream 0.8%. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes. Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, 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.
Pediatric Use: Safety and efficacy in children have not been established.
Geriatric Use: Clinical studies of terconazole vaginal cream 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.
During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.8% for 3 days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole vaginal cream 0.8% were headache (21% vs 16% with placebo) and dysmenorrhea (6% vs 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole vaginal cream 0.8% 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole vaginal cream 0.8% were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole vaginal cream 0.8%. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole vaginal cream 0.8% group and 0.3% with the placebo group.
Overdosage of terconazole in humans has not been reported to date. In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≃ 1280 and ≥ 640 mg/kg, respectively.
One full applicator (5 g) of Zazole® Vaginal Cream 0.8% (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days. Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of Zazole® Vaginal Cream 0.8% is not affected by menstruation.
Zazole® Vaginal Cream 0.8% (terconazole vaginal cream 0.8%) (NDC 0462-0347-20) is available in 20 gram tubes with a measured dose applicator.
Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature].
March 2008
PharmaDerm®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com
I8347C
R3/08
#300
Filling the applicator:
Using the applicator:
Cleaning the applicator:
After each use, you should thoroughly clean the applicator by following the procedure below:
NOTE: Store at 20°-25°C (68°-77°F)[see USP Controlled Room Temperature].
See end flap for lot number and expiration date.
A WORD ABOUT YEAST INFECTIONS
Why do yeast infections occur?
Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge. Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.
How can I prevent yeast infections?
Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.
Controlling these factors can help eliminate yeast infections and may prevent them from coming back.
Some other helpful tips:
PharmaDerm®
A division of Nycomed US Inc.
Melville, NY 11747 USA
www.pharmaderm.com
I8347C
R3/08
#300
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 20 G LABEL
NDC 0462-0347-20 Rx only
ZAZOLE ®
VAGINAL CREAM 0.8%
(terconazole vaginal cream 0.8%)
Tube and Applicator
NET WT 20 grams Quantity by weight not by volume PHARMADERM ®
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 20 G CARTON
NDC 0462-0347-20 Rx only
ZAZOLE ®
VAGINAL CREAM 0.8%
(terconazole vaginal cream 0.8%)
Tube and Applicator
NET WT 20 grams
Quantity by weight not by volume PHARMADERM ®
| ZAZOLE terconazole cream | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA021735 | 10/02/2009 | |
| Labeler - Pharmaderm, A division of Nycomed US Inc. (043838424) |
| Registrant - Nycomed US Inc. (043838424) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nycomed US Inc. | 043838424 | ANALYSIS | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Nycomed US Inc. | 174491316 | MANUFACTURE | |
Pyridoxine Hydrochloride (BANM, JAN) is known as Pyridoxine in the US.
International Drug Name Search
Glossary
| BANM | British Approved Name (Modified) |
| JAN | Japanese Accepted Name |
Generic Name: carmustine (Implantation route)
kar-MUS-teen
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antineoplastic Agent
Pharmacologic Class: Alkylating Agent
Chemical Class: Nitrosourea
Carmustine belongs to the group of medicines known as alkylating agents. It is used to treat certain types of brain cancer.
Carmustine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by carmustine, other effects may also occur.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of carmustine in children with use in other age groups.
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of carmustine in the elderly with its use in younger adults.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | D | Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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 carmustine. Make sure you tell your doctor if you have any other medical problems.
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.
It is important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
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:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Gliadel side effects (in more detail)
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Generic Name: fluoride topical (FLOR ide TOP i kal)
Brand Names: ACT Fluoride Rinse, ACT Kids Fluoride Rinse, ACT Restoring Mouthwash Cinnamon, ACT Restoring Mouthwash Mint, ACT Restoring Mouthwash Spearmint, ACT Restoring Mouthwash Vanilla Mint, Control Rx, Denta 5000 Plus, Dentagel, Ethedent, Fluoridex, Fluoridex Daily Defense, Fluoridex Daily Defense Enhanced Whitening, Fluorigard, Fluorinse, Gel-Kam, Gel-Kam Dental Therapy Pak, Gel-Kam Dentinbloc, Gel-Kam Sensitivity Therapy, NaFrinse Daily/Acidulated, NaFrinse Daily/Neutral, Nafrinse Solution, NaFrinse Weekly, Neutracare Gel, Neutragard, Neutragard Advanced, Neutral Sodium Fluoride Rinse, Omnii Gel, Omnii Gel Just For Kids, Oral B Anti-Cavity, Perfect Choice, Perio Med, Phos-Flur, Prevident, Prevident 500 Plus Boost, PreviDent 5000 Booster, Prevident 5000 Dry Mouth, Prevident 5000 Plus, Prevident 5000 Sensitive, Prevident Dental Rinse, SF, SF 5000 Plus, Stop, Thera-Flur-N
Fluoride is a substance that strengthens tooth enamel. This helps to prevent dental cavities.
Fluoride topical is used as a medication to prevent tooth decay in patients that have a low level of fluoride topical in their drinking water. Fluoride topical is also used to prevent tooth decay in patients who undergo radiation of the head and/or neck, which may cause dryness of the mouth and an increased incidence of tooth decay.
Fluoride may also be used for other purposes not listed in this medication guide.
Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.
Overdose symptoms may result if you swallow large amounts of fluoride while using it.
Before using fluoride topical, tell your dentist and doctor if you are on a low salt or a salt free diet. You may not be able to use fluoride topical, or you may need special tests while you are using it.
If you have gum disease, some forms of fluoride topical may be irritating to your gums. Talk to your dentist or doctor if you have bothersome mouth irritation while using fluoride topical.
Use this medication exactly as directed on the label, or as it was prescribed by your dentist or doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
Fluoride topical should be used immediately after brushing or flossing your teeth. For best results, use the medication just before bedtime, unless your doctor tells you otherwise.
Swish this medication in your mouth without swallowing. Then spit it out.
Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, loss of feeling anywhere in your body, muscle stiffness, or seizure (convulsions).
Overdose symptoms may result if you swallow large amounts of fluoride while using it.
discolored teeth;
weakened tooth enamel; or
any changes in the appearance of your teeth.
Less serious side effects may include:
stomach upset;
headache; or
weakness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
It is not likely that other drugs you take orally or inject will have an effect on topically applied fluoride. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.
See also: Gel-Kam side effects (in more detail)
Treating overactive bladder with symptoms of urgency, frequency, or leakage. It may also be used for other conditions as determined by your doctor.
Gelnique Gel is an anticholinergic. It works by relaxing muscles in the bladder.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Gelnique Gel. 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 Gelnique Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Gelnique Gel 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 Gelnique Gel 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 Gelnique Gel.
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:
Blurred vision; constipation; dizziness; drowsiness; dry mouth; headache; mild redness, irritation, or itching at the application site.
Severe allergic reactions (rash; hives; itching; difficulty swallowing or breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blisters, rash, pain, or loss of feeling at the application site; confusion; difficult or painful urination; fast or irregular heartbeat; fever; hallucinations; mental or mood changes (eg, agitation); seizures; severe or persistent redness, irritation, or itching at the application site; swelling of the hands, ankles, or feet; vision problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Gelnique side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; delirium; fever; flushing; hallucinations; inability to urinate; irregular heartbeat; paralysis; seizures; severe or persistent dizziness or headache; tremor; trouble breathing; vomiting.
Store Gelnique Gel at room temperature, 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Gelnique Gel out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Gelnique Gel. 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.
Generic Name: guaifenesin and phenylpropanolamine (gwye FEN e sin/fen ill proe pa NOLE a meen)
Brand Names: Ami-Tex LA, Banex-LA, Coldloc-LA, Dayquil Sinus Pressure and Congestion, Despec, Entex LA, Exgest LA, G-Vent, Guaifenex PPA 75, Guaivent, Guiatex LA, Naldecon-EX Pediatric, Nasahist LA, Phentex-LA, Phenylfenesin LA, Poly-Vent, Profen LA, Stamoist LA, Triaminic Expectorant, Vanex-LA
Guaifenesin is an expectorant. It is used to break up congestion and mucous to make breathing easier. Guaifenesin thins mucous, increases lubrication of the respiratory tract (lungs, nose and throat), and increases the removal of mucous.
Phenylpropanolamine is a decongestant. It constricts (shrinks) blood vessels (veins and arteries), which reduces swelling of mucous membranes in areas such as the nose and sinuses.
Guaifenesin and phenylpropanolamine is used to treat the symptoms of the common cold and of infections of the sinuses, lungs, and throat.
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Guaifenesin and phenylpropanolamine may also be used for purposes other than those listed in this medication guide.
Phenylpropanolamine, an ingredient in this product, has been associated with an increased risk of hemorrhagic stroke (bleeding into the brain or into tissue surrounding the brain) in women. Men may also be at risk. Although the risk of hemorrhagic stroke is low, the U.S. Food and Drug Administration (FDA) recommends that consumers not use any products that contain phenylpropanolamine.
Before taking this medication, tell your doctor if you have
high blood pressure or any other type of heart disease,
diabetes,
a peripheral vascular disorder (poor circulation),
glaucoma or increased pressure in the eyes,
an overactive thyroid, or
difficulty urinating or an enlarged prostate.
You may not be able to take guaifenesin and phenylpropanolamine, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Take guaifenesin and phenylpropanolamine exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.
Symptoms of a guaifenesin and phenylpropanolamine overdose include vomiting, high blood pressure (headache, redness of face, blurred vision), an irregular heartbeat, and numbness of the fingers or toes.
Other, less serious side effects may be more likely to occur. Continue to take guaifenesin and phenylpropanolamine and talk to your doctor if you experience
dizziness or headache;
nervousness, restlessness, or insomnia;
nausea or stomach upset; or
difficulty urinating.
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.
Heart medications such as methyldopa (Aldomet), reserpine (Serpalan, Serpasil), and guanethidine (Ismelin) may have decreased effects. Talk to your doctor before taking guaifenesin and phenylpropanolamine if you are taking any of these medications.
Do not take other over-the-counter cough, cold, allergy, diet, or sleep aids while taking guaifenesin and phenylpropanolamine without first talking to your doctor or pharmacist. Other medications may also contain guaifenesin, phenylpropanolamine, or other similar drugs. You may accidentally take too much of these medicines.
Drugs other than those listed here may also interact with guaifenesin and phenylpropanolamine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
Guaifenesin and phenylpropanolamine is available with a prescription under several brand names. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Entex LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--orange, scored tablets
Exgest LA, 400 mg of guaifenesin and 75 mg of phenylpropanolamine--white, oval-shaped, scored, long-acting tablets with blue speckles
Dura-Vent, 600 mg of guaifenesin and 75 mg of phenylpropanolamine--white, scored tablets
See also: G-Vent side effects (in more detail)
