Bronchicum may be available in the countries listed below.
Codeine phosphate hemihydrate (a derivative of Codeine) is reported as an ingredient of Bronchicum in the following countries:
International Drug Name Search
Zazole® Vaginal Suppositories (terconazole vaginal suppositories, 80 mg) are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis - 1 - [p - [[2 - (2,4 - Dichlorophenyl) - 2 - (1H - 1,2,4 - triazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxy]phenyl] - 4 - Isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole. 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 oral (30 mg) administration of 14C-labeled 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 ultraviolet light.
Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with Zazole® Vaginal Suppositories.
Terconazole exhibits fungicidal activity in vitro against Candida albicans. Antifungal activity has also 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 were 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 Suppositories are indicated for the local treatment of vulvovaginal candidiasis (monilasis). As Zazole® Vaginal Suppositories are 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 suppositories.
None.
Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills, or flu-like symptoms are reported during use.
The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms, therefore concurrent use is not recommended.
If there is lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
The therapeutic effect of this product is not affected by oral contraceptive usage.
Studies to determine the carcinogenic potential of terconazole have not been performed.
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.
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 teratogencity when terconazole was administered orally up to 40 mg/kg/day (25× the recommended intravaginal human dose of the suppository 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 increased 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 17 times the mean peak plasma level (0.010 mcg/mL) seen in normal subjects after intravaginal administration of terconazole vaginal suppositories. 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.
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.
Safety and efficacy in children have not been established.
Clinical studies of terconazole 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, 284 patients with vulvovaginal candidiasis were treated with terconazole vaginal suppositories 80 mg.
Based on comparative analyses with placebo (295 patients), the adverse experiences considered adverse reactions most likely related to terconazole vaginal suppositories 80 mg were headache (30.3% vs. 20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo). Adverse reactions that were reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% v. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported. The therapy-related dropout rate was 3.5% and the placebo therapy-related dropout rate was 2.7%. The adverse drug experience on terconazole most frequently causing discontinuation was burning (2.5% vs. 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).
Overdose 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 Zazole® Vaginal Suppository (terconazole vaginal suppositories 80 mg) 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 terconazole vaginal suppositories is not affected by menstruation.
Zazole® Vaginal Suppositories (terconazole vaginal suppositories 80 mg are available in 2.5 g, elliptically shaped white to off-white suppositories in packages of three with a vaginal applicator.
NDC 0462-0348-03
Store at 20°-25° C (68°-77° F) [see USP Controlled Room Temperature].
PharmaDerm®
a division of ALTANA Inc
Duluth, GA 30096 USA
www.pharmaderm.com
IF8384A
R12/05
#34
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Zazole®Vaginal Suppositories (terconazole vaginal suppositories, 80 mg)
Three oval suppositories, for use inside the vagina only.
Designed to be inserted into the vagina.
HOW TO USE:
Place one suppository into the vagina each night at bedtime, for 3 nights, as directed by your doctor. The Zazole® Vaginal Suppository is self-lubricating and may be inserted with or without the applicator.
NOTE: Store the suppositories at 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 ALTANA Inc
Duluth, GA 30096 USA
www.pharmaderm.com
R12/05
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Generic Name: acetaminophen and hydrocodone (a SEET a MIN oh fen and hye droe KOE done)
Brand Names: Anexsia, Co-Gesic, Hycet, Liquicet, Lorcet 10/650, Lorcet Plus, Lortab 10/500, Lortab 2.5/500, Lortab 5/500, Lortab 7.5/500, Lortab Elixir, Maxidone, Norco, Polygesic, Stagesic, Vicodin, Vicodin ES, Vicodin HP, Xodol, Zamicet, Zolvit, Zydone
Hydrocodone is in a group of drugs called narcotic pain relievers.
Acetaminophen is a less potent pain reliever that increases the effects of hydrocodone.
The combination of acetaminophen and hydrocodone is used to relieve moderate to severe pain.
Acetaminophen and hydrocodone may also be used for purposes not listed in this medication guide.
To make sure you can safely take acetaminophen and hydrocodone, tell your doctor if you have any of these other conditions:
asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
low blood pressure;
a stomach or intestinal disorder;
underactive thyroid;
Addison's disease or other adrenal gland disorder;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.
One acetaminophen and hydrocodone tablet may contain up to 750 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.
Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
Acetaminophen can cause false results with certain lab tests for glucose (sugar) in the urine. Talk to your doctor if you are diabetic and you notice changes in your glucose levels during treatment.
If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and hydrocodone. You may need to stop using the medicine for a short time.
Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.
Since acetaminophen and hydrocodone is taken 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing
shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, fear, unusual thoughts or behavior;
seizure (convulsions);
problems with urination; or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
anxiety, dizziness, drowsiness;
mild nausea, vomiting, upset stomach, constipation;
headache, mood changes;
blurred vision;
ringing in your ears; or
dry mouth.
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 medicines you use, especially:
an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;
an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), glycopyrrolate (Robinul), mepenzolate (Cantil), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).
This list is not complete and other drugs may interact with acetaminophen and hydrocodone. 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: Maxidone side effects (in more detail)
Co-Quinapril EG may be available in the countries listed below.
Hydrochlorothiazide is reported as an ingredient of Co-Quinapril EG in the following countries:
Quinapril is reported as an ingredient of Co-Quinapril EG in the following countries:
Quinapril hydrochloride (a derivative of Quinapril) is reported as an ingredient of Co-Quinapril EG in the following countries:
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Dioxodin may be available in the countries listed below.
Povidone-Iodine is reported as an ingredient of Dioxodin in the following countries:
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Bucanest Sans Vasoconstricteur may be available in the countries listed below.
Articaine hydrochloride (a derivative of Articaine) is reported as an ingredient of Bucanest Sans Vasoconstricteur in the following countries:
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Zovirax Lip may be available in the countries listed below.
Aciclovir is reported as an ingredient of Zovirax Lip in the following countries:
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