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DRUGS & SUPPLEMENTS
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How long you have been taking the medicine? |
Metronidazole:
Neo-Penotran Forte is an anti protozoal agent. It is believed that the mechanism of action is associated with DNA damage-sensitive microorganisms. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, and obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.).
Aerobic bacteria are resistant to Neo-Penotran Forte (Metronidazole).
In combination with amoxicillin Neo-Penotran Forte (Metronidazole) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Neo-Penotran Forte (Metronidazole).
Neo-Penotran Forte (Metronidazole) well absorbed after oral administration. The bioavailability is 80%. Neo-Penotran Forte (Metronidazole) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Neo-Penotran Forte (Metronidazole) is metabolized in the liver by oxidation and binding to glucuronic acid. T1/2 is 8 hours. This drug is excreted in the urine (60-80%) and feces (6-15%).
Trichomonazice vaginitis and urethritis in women, trichomonazice urethritis in men, giardiasis, amoebic dysentery, anaerobic infections caused by metronidazole-sensitive organisms, combination therapy of severe mixed aerobic-anaerobic infections. Preventing anaerobic infection in surgery (particularly abdominal, urinary tract). Chronic alcoholism.
Neo-Penotran Forte (Metronidazole) in combination with amoxicillin: chronic gastritis in acute phase, gastric ulcer and duodenal ulcer in acute phase, associated with Helicobacter pylori.
For external and topical use: treatment of acne vulgaris and pink, bacterial vaginosis, treatment of long-term healing of wounds and trophic ulcers.
Neo-Penotran Forte is administered for oral use for adults and children over 12 years in 7.5 mg / kg every 6 h or 250-750 mg 3-4 times / day. For children up to 12 years the dose is 5-16.7 mg / kg 3 times / day. For IV injections for adults and children over 12 years starting dose is 15 mg / kg, followed by 7.5 mg / kg every 6 hours or depending on the etiology of the disease - by 500-750 mg every 8 hours. The duration of treatment and frequency of tests is determined individually.
Intravaginally - 500 mg 1 time a night.
In combination with amoxicillin (2.25 g / day) daily dose of Neo-Penotran Forte (Metronidazole) is 1.5 g; multiplicity of admission - 3 times / day. For patients with severe renal impairment (creatinine clearance less than 30 ml / min) and / or liver daily dose of Neo-Penotran Forte (Metronidazole) is 1 g (amoxicillin - 1.5 g / day), the multiplicity of the reception is 2 times / day. This medication takes for external and local use 2 times / day, doses are determined individually.
The maximum daily dose for adults when taken orally and IV is 4 g.
Digestive system: nausea, vomiting, anorexia, metallic taste in the mouth.
CNS and peripheral nervous system: headache, nervousness, irritability, insomnia, dizziness, ataxia, weakness, confusion, depression, peripheral neuropathy, seizures, hallucinations.
Allergic reactions: skin rash, itching, hives.
Hemopoietic system: leucopenia.
Local reactions: irritation.
Other: arthralgia, burning sensation in the urethra.
Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Neo-Penotran Forte (Metronidazole).
Neo-Penotran Forte is rapidly crosses the placental barrier. In II and III trimester of pregnancy Neo-Penotran Forte (Metronidazole) is used only for health reasons.
Neo-Penotran Forte (Metronidazole) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.
Patients should with careful use of Neo-Penotran Forte (Metronidazole) in liver diseases.
In combination with amoxicillin this medication is not recommended for patients younger than 18 years. During the treatment period it is necessary the regular control of pattern of peripheral blood.
During the treatment of Trichomonas vaginitis in women and Trichomonas urethritis in men patients should refrain from sexual activity, simultaneous treatment of both partners is mandatory.
During the taking of Neo-Penotran Forte (Metronidazole) there is a more dark staining of urine.
During treatment with Neo-Penotran Forte (Metronidazole) should avoid alcohol because to violations of the oxidation of alcohol can accumulate acetaldehyde. As a result may develop reactions similar to those characteristic of disulfiram (abdominal cramps, nausea, vomiting, headache, a sudden rush of blood to the face).
Simultaneous administration of Neo-Penotran Forte (Metronidazole) with:
Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and seizures.
Treatment: symptomatic, there is no specific antidote.
Miconazole Nitrate:
Neo-Penotran Forte (Miconazole Nitrate) Ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. A positive fungal culture for Candida albicansis not adequate evidence of candidal infection since colonization with C. albicans can result in a positive culture. The presence of candidal infection should be established by microscopic evaluation prior to initiating treatment.
Neo-Penotran Forte (Miconazole Nitrate) should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes.
Neo-Penotran Forte (Miconazole Nitrate) should not be used as a substitute for frequent diaper changes. Neo-Penotran Forte (Miconazole Nitrate) should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.
The safety and efficacy of Neo-Penotran Forte (Miconazole Nitrate) have not been demonstrated in immunocompromised patients, or in infants less than 4 weeks of age (premature or term).
The safety and efficacy of Neo-Penotran Forte (Miconazole Nitrate) have not been evaluated in incontinent adult patients. Neo-Penotran Forte (Miconazole Nitrate) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.
Neo-Penotran Forte (Miconazole Nitrate) is not for oral, ophthalmic, or intravaginal use.
Before applying Neo-Penotran Forte (Miconazole Nitrate), gently cleanse the skin with lukewarm water and pat dry with a soft towel. Avoid using any scented soaps, shampoos, or lotions on the diaper area.
Apply Neo-Penotran Forte (Miconazole Nitrate) to the affected area at each diaper change for 7 days. Continue treatment for the full 7 days, even if there is improvement. The safety of Neo-Penotran Forte (Miconazole Nitrate) when used for longer than 7 days is not known. Do not use Neo-Penotran Forte (Miconazole Nitrate) for longer than 7 days. If symptoms have not improved by day 7, see your health care provider.
Gently apply a thin layer of Neo-Penotran Forte (Miconazole Nitrate) to the diaper area with the fingertips. Do not rub Neo-Penotran Forte (Miconazole Nitrate) into the skin as this may cause additional irritation. Thoroughly wash hands after applying Neo-Penotran Forte (Miconazole Nitrate).
White ointment containing 0.25% Neo-Penotran Forte (Miconazole Nitrate) nitrate, 15% zinc oxide, and 81.35% white petrolatum.
None
If irritation occurs or if the disease worsens, discontinue use of the medication, and contact the health care provider.
The safety and efficacy of Neo-Penotran Forte (Miconazole Nitrate) have not been evaluated in incontinent adult patients. Neo-Penotran Forte (Miconazole Nitrate) should not be used to prevent the occurrence of diaper dermatitis, such as in an adult institutional setting, since preventative use may result in the development of drug resistance.
To report SUSPECTED ADVERSE REACTIONS, contact Prestium Pharma, Inc. at 1-866-897-5002 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical trials are conducted under widely varying conditions, adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 835 infants and young children were evaluated in the clinical development program. Of 418 subjects in the Neo-Penotran Forte group, 58 (14%) reported one or more adverse events. Of 417 subjects in the zinc oxide/white petrolatum control group, 85 (20%) reported one or more adverse events. Adverse events that occurred at a rate of ≥ 1% for subjects who were treated with Neo-Penotran Forte (Miconazole Nitrate) were approximately the same in type and frequency as for subjects who were treated with zinc oxide/white petrolatum ointment.
The following adverse reactions have been identified during post approval use of Neo-Penotran Forte (Miconazole Nitrate).
GASTROINTESTINAL DISORDERS: vomiting
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: burning sensation, condition aggravated, inflammation, pain
INJURY, POISONING AND PROCEDURAL COMPLICATIONS: accidental exposure
SKIN AND SUBCUTANEOUS TISSUE DISORDERS: blister, dermatitis contact, diaper dermatitis, dry skin, erythema, pruritus, rash, skin exfoliation
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug-drug interaction studies were not conducted. Women who take a warfarin anticoagulant and use a Neo-Penotran Forte (Miconazole Nitrate) intravaginal cream or suppository may be at risk for developing an increased prothrombin time, international normalized ratio (INR), and bleeding. The potential for this interaction between warfarin and Neo-Penotran Forte (Miconazole Nitrate) is unknown.
There are no adequate and well-controlled studies of Neo-Penotran Forte in pregnant women. Therefore, Neo-Penotran Forte (Miconazole Nitrate) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Neo-Penotran Forte (Miconazole Nitrate) nitrate administration has been shown to result in prolonged gestation and decreased numbers of live young in rats and in increased number of resorptions and decreased number of live young in rabbits at oral doses of 100 mg/kg/day and 80 mg/kg/day, which are 28 and 45 times the maximum possible topical exposure of caregivers, respectively, assuming 100% absorption.
Safety and efficacy of Neo-Penotran Forte (Miconazole Nitrate) have not been established in nursing mothers. It is not known if the active components of Neo-Penotran Forte (Miconazole Nitrate) may be present in milk.
Efficacy was not demonstrated in infants less than 4 weeks of age. Safety and efficacy have not been established in very-low-birth-weight infants.
Neo-Penotran Forte should not be used to prevent diaper dermatitis.
The safety of Neo-Penotran Forte (Miconazole Nitrate) when used for longer than 7 days is not known. Do not use more than 7 days.
Safety and efficacy in a geriatric population have not been evaluated.
Neo-Penotran Forte (Miconazole Nitrate) contains the synthetic antifungal agent, Neo-Penotran Forte (Miconazole Nitrate) nitrate (0.25%) USP, zinc oxide (15%) USP, and white petrolatum (81.35%) USP.
The chemical name of Neo-Penotran Forte (Miconazole Nitrate) nitrate is 1-[2, 4-dichloro-ß-{(2,4-dichlorobenzyl)oxy} phenethyl] imidazole mononitrate with empirical formula C18H14Cl4N2O-HNO3 and molecular weight of 479.15. The structural formula of Neo-Penotran Forte (Miconazole Nitrate) nitrate is as follows:
The zinc oxide has an empirical formula of ZnO and a molecular weight of 81.39.
The white petrolatum, which is obtained from petroleum and is wholly or nearly decolorized, is a purified mixture of semisolid saturated hydrocarbons having the general chemical formula CnH2n+2. The hydrocarbons consist mainly of branched and unbranched chains. White petrolatum contains butylated hydroxytoluene (BHT) as stabilizer.
Each gram of Neo-Penotran Forte (Miconazole Nitrate) contains 2.5 mg of Neo-Penotran Forte (Miconazole Nitrate) nitrate USP, 150 mg of zinc oxide USP, and 813.5 mg of white petrolatum USP containing butylated hydroxytoluene, trihydroxystearin, and Chemoderm® 1001/B fragrance.1
Neo-Penotran Forte (Miconazole Nitrate) is a smooth, uniform, white ointment.
Structural formula of Neo-Penotran Forte (Miconazole Nitrate) nitrate
The Neo-Penotran Forte component of Neo-Penotran Forte (Miconazole Nitrate) is an antifungal agent. The mechanism of action of white petrolatum and zinc oxide for the adjunctive treatment of diaper dermatitis is unknown.
The human pharmacodynamics of Neo-Penotran Forte (Miconazole Nitrate) is unknown.
The topical absorption of Neo-Penotran Forte from Neo-Penotran Forte (Miconazole Nitrate) was studied in immunocompetent male and female infants and children (n=17) with diaper dermatitis complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast) ranging in age from 1 month to 21 months. After multiple daily applications to the affected area at every diaper change (approximately 5-12 times per day) for 7 days, the plasma concentrations of Neo-Penotran Forte (Miconazole Nitrate) were below the lower limit of quantitation (LOQ) of 0.5 ng/mL in 15 out of 17 (88%) subjects. In the other 2 remaining subjects, the plasma concentrations of Neo-Penotran Forte (Miconazole Nitrate) were 0.57 and 0.58 ng/mL, respectively at a single timepoint (4 hours after the last application) on Day 7.
The Neo-Penotran Forte (Miconazole Nitrate) nitrate component in this product has been shown to have in vitro activity against Candida albicans, an organism that is associated with diaper dermatitis. The activity of Neo-Penotran Forte (Miconazole Nitrate) nitrate against C. albicans is based on the inhibition of the ergosterol biosynthesis in the cell membrane. The accumulation of ergosterol precursors and toxic peroxides results in cytolysis of the cell. In vitro minimal inhibitory concentration (MIC) test results for C. albicans isolates obtained from treatment failures in Clinical Study 1 (see Clinical Studies (14)) does not appear to indicate that resistance to Neo-Penotran Forte (Miconazole Nitrate) nitrate was the reason for treatment failure. The clinical significance of the in vitro activity of Neo-Penotran Forte (Miconazole Nitrate) nitrate against C. albicans in the setting of diaper dermatitis is unclear.
The carcinogenic potential of Neo-Penotran Forte (Miconazole Nitrate) in animals has not been evaluated.
Neo-Penotran Forte (Miconazole Nitrate) nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.
Neo-Penotran Forte (Miconazole Nitrate) nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.
Study 1 was a double-blind, multicenter study in which Neo-Penotran Forte (Miconazole Nitrate) was compared to the zinc oxide and white petrolatum combination treatment and included 236 infants and toddlers with diaper dermatitis, complicated by candidiasis as documented by KOH tests that demonstrated psuedohyphae and/or budding yeasts. Study medication was applied at every diaper change for 7 days.
The primary endpoint was “Overall Cure” and required that subjects be both clinically cured (total resolution of all signs and symptoms of infection) and microbiologically cured (eradication of candidiasis). Primary efficacy was assessed 1 week following the end of treatment, at Day 14.
Study results are shown in the following table.
Overall Cure at Day 14 | ||
Neo-Penotran Forte (Miconazole Nitrate) n=112 | Zinc Oxide/White Petrolatum n=124 | |
26 (23%) | 12 (10%) |
Two additional studies provided supportive evidence of the clinical efficacy of Neo-Penotran Forte (Miconazole Nitrate) in infants and toddlers with diaper dermatitis, some of whom cultured positive for C. albicans. However, candidal infection was not documented in the culture-positive subjects, as microscopic testing (e.g. KOH) was not done. Therefore, the positive culture results may have reflected colonization rather than infection.
Neo-Penotran Forte is a smooth, uniform, white ointment supplied in an aluminum tube, as follows:
50g (NDC 40076-002-50)
Store at controlled room temperature between 20°C and 25°C (68°F and 77°F); with excursions permitted between 15°C and 30°C (59°F and 86°F).
Keep out of reach of children.
See FDA-Approved Patient Labeling
Patients using Neo-Penotran Forte (Miconazole Nitrate) should be informed about the following information:
Manufactured for:
Prestium Pharma, Inc.
Newtown, PA 18940
Manufactured by:
GlaxoSmithKline
Mississauga, ON, Canada
Made in Canada
© 2013 Delcor Asset Corporation, an affiliate of Prestium Pharma, Inc.
Revised Oct 2013 VSN:3PI
FDA-Approved Patient Labeling
Neo-Penotran Forte (Miconazole Nitrate)® (Vu-sion) Ointment
(0.25% Neo-Penotran Forte (Miconazole Nitrate) nitrate, 15% zinc oxide and 81.35% white petrolatum)
IMPORTANT: For Skin Use Only. Do not use in the mouth, eyes, or vagina.
Read the Patient Information that comes with Neo-Penotran Forte (Miconazole Nitrate) before you use it on your child. This leaflet does not take the place of talking to your health care provider about your child’s medical condition or treatment. If you have any questions or if you are not sure about any of the information on Neo-Penotran Forte (Miconazole Nitrate), ask your health care provider, or pharmacist.
What is Neo-Penotran Forte (Miconazole Nitrate)?
Neo-Penotran Forte (Miconazole Nitrate) is a prescription skin medicine used to treat diaper rash that also has a yeast infection in children who are at least 4 weeks old and who have a normal immune system. Neo-Penotran Forte (Miconazole Nitrate) contains medicines that will help treat the yeast infection and the diaper rash, but you must also change your child’s diapers very often so that your child is not wearing a wet or soiled diaper. Even if you use Neo-Penotran Forte (Miconazole Nitrate), diaper rash will not go away if you do not keep your child’s diaper area clean and dry. You should use water or a very mild cleanser to clean your child’s diaper area. Neo-Penotran Forte (Miconazole Nitrate) is not to be used to prevent diaper rash or to be used for more than 7 days.
Your health care provider will need to do a special test to tell if your child’s diaper rash also has a yeast infection. Do not use Neo-Penotran Forte (Miconazole Nitrate) on your child’s diaper rash unless your health care provider tells you that there is also a yeast infection.
Who should not use Neo-Penotran Forte (Miconazole Nitrate)?
Neo-Penotran Forte (Miconazole Nitrate) is not for treatment of all cases of diaper rash. Neo-Penotran Forte (Miconazole Nitrate) is only for diaper rash that also has a yeast infection. Most cases of diaper rash do not need the yeast medicine that is in Neo-Penotran Forte (Miconazole Nitrate) because most cases of diaper rash do not also have a yeast infection.
Do not use Neo-Penotran Forte (Miconazole Nitrate) on any other children or other family member.
Do not use Neo-Penotran Forte (Miconazole Nitrate) on your child’s diaper rash if they are allergic to anything in it. See the end of this leaflet for a list of ingredients in Neo-Penotran Forte (Miconazole Nitrate).
Do not use on infants less than 4 weeks of age.
Do not use in infants or children who do not have a normal immune system.
How should I use Neo-Penotran Forte (Miconazole Nitrate) on my child?
Neo-Penotran Forte (Miconazole Nitrate) is applied to the skin on your child’s diaper area at each diaper change for 7 days.
Apply Neo-Penotran Forte (Miconazole Nitrate) for the full 7 days even if the diaper rash starts to go away. Call your child’s health care provider if the diaper rash gets worse or does not go away with 7 days of treatment with Neo-Penotran Forte (Miconazole Nitrate). Neo-Penotran Forte (Miconazole Nitrate) should not be used for more than 7 days.
To apply Neo-Penotran Forte (Miconazole Nitrate):
Neo-Penotran Forte (Miconazole Nitrate) is for skin use only.
Call your child’s health care provider or poison control center right away if any Neo-Penotran Forte (Miconazole Nitrate) is swallowed. Call your child’s health care provider if Neo-Penotran Forte (Miconazole Nitrate) gets in the eye.
Keep out of reach of children.
What other steps will help diaper rash go away?
What are the possible side effects of Neo-Penotran Forte (Miconazole Nitrate)?
Neo-Penotran Forte (Miconazole Nitrate) may cause irritation. You should call your child’s health care provider if irritation appears or if the diaper rash gets worse.
How should I store Neo-Penotran Forte (Miconazole Nitrate)?
General information about Neo-Penotran Forte (Miconazole Nitrate)
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets.
Do not use Neo-Penotran Forte (Miconazole Nitrate) for a condition for which it was not prescribed. Do not give Neo-Penotran Forte (Miconazole Nitrate) to other children or family members, even if they have the same symptoms your child has. It may harm them.
This leaflet summarizes the most important information about Neo-Penotran Forte (Miconazole Nitrate). If you would like more information, talk to your child’s health care provider. You can ask your child’s health care provider or pharmacist for information about Neo-Penotran Forte (Miconazole Nitrate) that is written for healthcare professionals.
Side effects may be reported to Prestium Pharma, Inc. at 1-866-897-5002 or the FDA at 1-800-FDA-1088.
What are the ingredients in Neo-Penotran Forte (Miconazole Nitrate)?
Active Ingredients: Neo-Penotran Forte (Miconazole Nitrate) nitrate, zinc oxide, and white petrolatum
Inactive Ingredients: trihydroxystearin, butylated hydroxyltoluene (BHT), and Chemoderm® 1001/B fragrance
This Patient Information leaflet has been approved by the U.S. Food and Drug Administration.
The Patient Information leaflet was last revised: October 2013
Manufactured for:
Prestium Pharma, Inc.
Newtown, PA 18940
Manufactured by:
GlaxoSmithKline
Mississauga, ON, Canada
Made in Canada
© 2013 Delcor Asset Corporation, an affiliate of
Prestium Pharma, Inc.
Revised Oct 2013
VSN:3PIL
Principal Display Panel
NDC 40076-002-50
Neo-Penotran Forte (Miconazole Nitrate)®
(miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP)
Ointment
50 grams
Rx only
Principal Display Panel NDC 40076-002-50 Vusion® (miconazole nitrate 0.25% USP, zinc oxide 15% USP, white petrolatum 81.35% USP) Ointment 50 grams Rx only
Depending on the reaction of the Neo-Penotran Forte after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Neo-Penotran Forte not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.
Is Neo-Penotran Forte addictive or habit forming?Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology