DRUGS & SUPPLEMENTS
What are the side effects you encounter while taking this medicine?
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.
Ginestatin (Benzalkonium Chloride) for external and local application is practically not absorbed.
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.
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.
Contact dermatitis, candidiasis, vulvovaginal and allergic reactions.
With prolonged use of Ginestatin (Benzalkonium Chloride) it is possible a local irritation.
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.
Ginestatin has no negative impact on pregnancy. This medicine is not excreted in breast milk and it can be used during lactation.
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.
Any substance introduced intravaginally can reduce local spermicidal action (including soaps and solutions containing it). Iodine solutions inactivate Ginestatin (Benzalkonium Chloride).
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).
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%).
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.
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.
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 Ginestatin (Metronidazole).
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.
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).
Simultaneous administration of Ginestatin (Metronidazole) with:
Symptoms: nausea, vomiting, ataxia, in severe cases - peripheral neuropathy and seizures.
Treatment: symptomatic, there is no specific antidote.
Ginestatin (Nystatin), USP is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:
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.
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.
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.
Ginestatin (Nystatin) tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.
Ginestatin (Nystatin) tablets are contraindicated in patients with a history of hypersensitivity to any of their components.
This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.
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.
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.
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.
Ginestatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (see PRECAUTIONS, General).
Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.
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).
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.
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.
TEVA CANADA LIMITED
Toronto, Canada M1B 2K9
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
Rev. N 2/2016
500,000 units (oral)
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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The information was verified by Dr. Rachana Salvi, MD Pharmacology