Ginestatin

What are the side effects you encounter while taking this medicine?
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Ginestatin uses

Ginestatin consists of Benzalkonium Chloride, Metronidazole, Nystatin.

Benzalkonium Chloride:


Pharmacological action

Ginestatin is an antiseptic. This medication is a quaternary ammonium compound, belongs to the cationic surfactant. Ginestatin (Benzalkonium Chloride) has antimicrobial and antiviral activity against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex Type 2, Staphylococcus aureus, little active against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

Ginestatin (Benzalkonium Chloride) is not active against Mycoplasma spp.

This medicine exerts spermicidal action which is due to the ability to damage the sperm membrane; inhibits sperm motility, disrupting electrolyte balance of the aqueous phase of cervical mucus.

Pharmacokinetics

Ginestatin (Benzalkonium Chloride) for external and local application is practically not absorbed.

Why is Ginestatin prescribed?

For external use only. Topical solution - a primary and delayed primary wound treatment, prevention of secondary infection of wounds hospital strains of microorganisms (injury of soft and bone tissue, burns), festering wounds, drainage of bone cavities following surgery for osteomyelitis.

Weight thick - superficial thermal burns, trophic ulcers, long-unhealed wounds of soft tissues (including infected), pyo-inflammatory skin diseases and diabetes mellitus; paraproctitis.

Tablets and capsules for intravaginal use, vaginal suppositories, creams, tampons - local contraception for women of reproductive age: for the presence of contraindications to the use of oral contraceptives or intrauterine devices, in the postpartum period, lactation, after the termination of pregnancy in premenopause period at irregular sexual life, omission or delay in receiving consistently used oral contraceptives.

Liquid concentrate - disinfection of facilities and medical products.

Dosage and administration

Topically. The solution was diluted with distilled water to make 1% aqueous solution, impregnated gauze dressings, napkins or tampons and put on the wound daily.

Mass is applied at the rate of 0.2-0.4 g/cm2 of wound surface, pre-clean the wound from the purulent discharge, necrotic tissue, or impose gauze or use turundas impregnated with drugs. The maximum daily dose is 50 g. Ligation is carried out daily, the course of treatment is 14 days.

Intravaginally. Ginestatin (Benzalkonium Chloride) entered deeply into the vagina before coition; in case of repeated sexual intercourse it should be re-imposition of tablets, capsules, suppositories, creams; tampon can be removed not earlier than 3 h after the last sexual intercourse but no later than 24 hours after its installation (with repeated sexual acts for 1 day shift tampon is not required).

Concentrate Liquid. Ginestatin (Benzalkonium Chloride) used for disinfection after prior dilution with water.

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Ginestatin (Benzalkonium Chloride) side effects, adverse reactions

Contact dermatitis, candidiasis, vulvovaginal and allergic reactions.

With prolonged use of Ginestatin (Benzalkonium Chloride) it is possible a local irritation.

Ginestatin contraindications

Hypersensitivity to Ginestatin (Benzalkonium Chloride), contact dermatitis, malignant neoplasm of the skin; for intravaginal use - coleitis, ulceration and irritation of the mucous membrane of the vagina and uterus.

Using during pregnancy and breastfeeding

Ginestatin has no negative impact on pregnancy. This medicine is not excreted in breast milk and it can be used during lactation.

Special instructions

To improve the efficiency it requires careful observance of the application method. Ginestatin (Benzalkonium Chloride) can be used in conjunction with a vaginal diaphragm or intrauterine device. You should avoid bathing or irrigation of the vagina with soapy water for 2 hours before and within 2 hours after sexual intercourse (this medication is destroyed by soap), outdoor toilet is only possible with clean water.

Ginestatin (Benzalkonium Chloride) is incompatible with soaps and other anionic surfactants as well as citrates, iodides, nitrates, permanganates, salicylates, silver salts and tartrates.

Ginestatin drug interactions

Any substance introduced intravaginally can reduce local spermicidal action (including soaps and solutions containing it). Iodine solutions inactivate Ginestatin (Benzalkonium Chloride).

Metronidazole:


Pharmacological action

Ginestatin 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 Ginestatin (Metronidazole).

In combination with amoxicillin Ginestatin (Metronidazole) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Ginestatin (Metronidazole).

Pharmacokinetics

Ginestatin (Metronidazole) well absorbed after oral administration. The bioavailability is 80%. Ginestatin (Metronidazole) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Ginestatin (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%).

Why is Ginestatin prescribed?

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.

Ginestatin (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.

Dosage and administration

Ginestatin 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 Ginestatin (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 Ginestatin (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.

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Ginestatin (Metronidazole) side effects, adverse reactions

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.

Ginestatin contraindications

Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Ginestatin (Metronidazole).

Using during pregnancy and breastfeeding

Ginestatin is rapidly crosses the placental barrier. In II and III trimester of pregnancy Ginestatin (Metronidazole) is used only for health reasons.

Ginestatin (Metronidazole) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.

Special instructions

Patients should with careful use of Ginestatin (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 Ginestatin (Metronidazole) there is a more dark staining of urine.

During treatment with Ginestatin (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).

Ginestatin drug interactions

Simultaneous administration of Ginestatin (Metronidazole) with:

  • antacids that contain aluminum hydroxide, with kolestiraminom slightly decreases absorption of Ginestatin (Metronidazole) from the gastrointestinal tract;
  • Ginestatin (Metronidazole) potentiates the effect of indirect anticoagulants;
  • disulfiram may develop acute psychosis and impaired consciousness;
  • lansoprazole possible glossitis, stomatitis and / or the appearance of dark color language; with lithium carbonate - may increase the concentration of lithium in blood plasma and the development of symptoms of intoxication with prednisone - increased excretion of Ginestatin (Metronidazole) from the body by accelerating its metabolism in the liver under the influence of prednisone. It is possible a decrease the effectiveness of Ginestatin (Metronidazole) AA Pharma.
  • rifampicin increased the clearance of Ginestatin (Metronidazole) from the body, with phenytoin - it is perhaps a slight increase in the concentration of phenytoin in blood plasma, described the case of toxic action;
  • phenobarbital significantly increased excretion of Ginestatin (Metronidazole) from the body, apparently due to acceleration of its metabolism in the liver under the influence of phenobarbital. It is possible a decrease the effectiveness of Ginestatin (Metronidazole) AA Pharma;
  • fluorouracil enhanced the toxic effect but not the effectiveness of fluorouracil;
  • cimetidine may inhibit the metabolism of Ginestatin (Metronidazole) in the liver that can lead to slow its elimination and increase the concentration in blood plasma. It can not be excluded the increase in the concentration of carbamazepine in plasma and increased risk of toxicity with concomitant use of Ginestatin (Metronidazole) AA Pharma. There was described a case of acute dystonia after a single dose of chloroquine in patients treated with Ginestatin (Metronidazole).

    Ginestatin in case of emergency / overdose

    Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and seizures.

    Treatment: symptomatic, there is no specific antidote.

  • Nystatin:


    DESCRIPTION

    Ginestatin (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

    • C47H75NO17 M.W. 926.13

    Ginestatin (Nystatin) Tablets USP contain the inactive ingredients: Corn Starch, Povidone, Compressible Sugar, Microcrystalline Cellulose, Sodium Starch Glycolate, Talc, Magnesium Stearate, Purified Water, and Coloring.

    Structural formula for Ginestatin (Nystatin)

    CLINICAL PHARMACOLOGY

    Pharmacokinetics

    Gastrointestinal absorption of Ginestatin is insignificant. Most orally administered Ginestatin (Nystatin) is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of Ginestatin (Nystatin) may occasionally occur.

    Microbiology

    Ginestatin (Nystatin) is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast like fungi. Candida albicans demonstrates no significant resistance to Ginestatin (Nystatin) in vitro on repeated subculture in increasing levels of Ginestatin (Nystatin); other Candida species become quite resistant. Generally, resistance does not develop in vivo. Ginestatin (Nystatin) acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Ginestatin (Nystatin) exhibits no appreciable activity against bacteria, protozoa, or viruses.

    INDICATIONS AND USAGE

    Ginestatin (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

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    CONTRAINDICATIONS

    Ginestatin (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

    PRECAUTIONS

    General

    This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C

    Animal reproduction studies have not been conducted with Ginestatin. It is also not known whether Ginestatin (Nystatin) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ginestatin (Nystatin) should be given to a pregnant woman only if clearly needed.

    Nursing Mothers

    It is not known whether Ginestatin (Nystatin) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ginestatin (Nystatin) is administered to a nursing woman.

    ADVERSE REACTIONS

    Ginestatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).

    Gastrointestinal

    Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

    Dermatologic

    Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

    Other

    Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

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    OVERDOSAGE

    Oral doses of Ginestatin (Nystatin) in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

    DOSAGE AND ADMINISTRATION

    The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units Ginestatin (Nystatin)) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

    HOW SUPPLIED

    Ginestatin (Nystatin) Tablets USP, 500,000 Units are round, convex, brown, film-coated tablet debossed with 93 on one side and 983 on the reverse and are packaged in bottles of 100 tablets (NDC 0093-0983-01).

    Store at 20° to 25°C (68° to 77°F).

    Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

    Keep tightly closed.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

    Manufactured By:

    TEVA CANADA LIMITED

    Toronto, Canada M1B 2K9

    Manufactured For:

    TEVA PHARMACEUTICALS USA, INC.

    North Wales, PA 19454

    Rev. N 2/2016

    NDC 0093-0983-01

    Ginestatin (Nystatin)

    Tablets USP

    500,000 units (oral)

    Rx only

    100 TABLETS

    TEVA

    Ginestatin pharmaceutical active ingredients containing related brand and generic drugs:

    Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


    Ginestatin available forms, composition, doses:

    Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
    Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
    Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


    Ginestatin destination | category:

    Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
    Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


    Ginestatin Anatomical Therapeutic Chemical codes:

    A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


    Ginestatin pharmaceutical companies:

    Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
    Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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    References

    1. Dailymed."NYSTATIN TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    2. Dailymed."ECOLAB INC. (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
    3. Dailymed."METRONIDAZOLE LOTION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

    Frequently asked Questions

    Can i drive or operate heavy machine after consuming Ginestatin?

    Depending on the reaction of the Ginestatin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Ginestatin 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 Ginestatin 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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    Review

    sdrugs.com conducted a study on Ginestatin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Ginestatin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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    The information was verified by Dr. Rachana Salvi, MD Pharmacology

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